Tasigna is a brand-name prescription drug. It’s approved for use in adults and children ages 1 year and older with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML).

Ph+ CML is a form of cancer that develops in your bone marrow cells. It’s caused by a mutation (abnormal change) that forms a gene called BCR-ABL. This mutation forms the Philadelphia chromosome.

Tasigna is used in adults with either of the following:

  • newly diagnosed Ph+ CML in the chronic phase (typically considered the first stage of CML), or
  • Ph+ CML in either the chronic phase or the accelerated phase (a stage of CML where you have more symptoms of leukemia). For this use, Tasigna is prescribed for people who’ve used past treatment that included another cancer drug called imatinib (Gleevec). But this past treatment either didn’t work or caused side effects that they couldn’t tolerate.

Tasigna is used in children ages 1 year and older with either of the following:

  • newly diagnosed Ph+ CML in the chronic phase (typically considered the first stage of CML), or
  • Ph+ CML in the chronic phase that’s been treated in the past with a tyrosine kinase inhibitor (TKI). (TKIs are drugs that belong to a certain class of medications.) But this past treatment either didn’t work or caused side effects that the children couldn’t tolerate.

Drug details

Tasigna contains the active drug nilotinib, which is a TKI.

Tasigna comes as capsules that are taken by mouth. It’s available in three strengths: 50 mg, 150 mg, and 200 mg. It should be taken twice each day on an empty stomach.

Effectiveness

For details about Tasigna’s effectiveness at treating Ph+ CML, see the section “Tasigna for chronic myeloid leukemia (CML)” below.

Tasigna is available only as a brand-name medication. It’s not currently available in generic form. A generic drug is an exact copy of the active drug in a brand-name medication.

Tasigna contains the active drug ingredient nilotinib.

Tasigna can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while taking Tasigna. These lists do not include all possible side effects.

For more information on the possible side effects of Tasigna, talk with your doctor or pharmacist. They can give you tips on how to deal with any side effects that may be bothersome.

Note: The Food and Drug Administration (FDA) tracks side effects of drugs they have approved. If you would like to report to the FDA a side effect you’ve had with Tasigna, you can do so through MedWatch.

Mild side effects

The mild side effects of Tasigna that are more common* can include:

  • headache
  • fatigue (lack of energy)
  • fever
  • nausea
  • vomiting
  • constipation
  • diarrhea
  • itchy skin
  • rash
  • joint pain
  • cough
  • common cold
  • night sweats

The mild side effects of Tasigna that are less common** can include:

  • hair loss
  • dry skin
  • belly pain, indigestion, or gastroenteritis (an infection in your digestive tract)
  • weakness
  • muscle pain or spasms
  • pain in your bones, arms, or legs
  • shortness of breath
  • lack of appetite
  • insomnia (trouble sleeping)
  • high blood pressure
  • dizziness
  • peripheral edema (swelling in your hands, feet, and ankles)
  • influenza
  • mouth and throat pain

* occurred in about 20% or more of people in clinical studies
** occurred in about 20% or less of people in clinical studies

Most of these side effects may go away within a few days or a couple of weeks. But if they become more severe or don’t go away, talk with your doctor or pharmacist.

Serious side effects

Serious side effects from Tasigna aren’t common, but they can occur. Call your doctor right away if you have serious side effects. Call 911 if your symptoms feel life threatening or if you think you’re having a medical emergency.

Serious side effects and their symptoms can include:

  • Blood disorders, such as anemia (low red blood cell level) and neutropenia (low level of certain white blood cells). Symptoms can include:
    • weakness
    • fever
    • fatigue (lack of energy)
    • shortness of breath
    • frequent bruising
  • Blockages in your heart or blood vessels. Symptoms can include:
    • pain in your leg
    • feeling numb or weak
    • a cold feeling in your leg
    • change in the color of the skin on your leg
    • trouble walking
    • chest pain
    • shortness of breath
  • Pancreatitis (inflammation in your pancreas). Symptoms can include:
    • nausea
    • vomiting
    • lack of appetite
    • belly pain
    • fever
  • Electrolyte imbalances, which can lead to heart and muscle problems. Symptoms can include:
    • general weakness
    • abnormal heart rate or rhythm
    • muscle cramps
    • confusion
  • Tumor lysis syndrome (a condition that’s caused by harmful chemicals being released into your blood by dying cancer cells). Symptoms can include:
    • abnormal heart rate or rhythm
    • nausea
    • vomiting
    • diarrhea
    • muscle cramps
    • fatigue (lack of energy)
    • seizures
  • Severe bleeding. Symptoms can include:
    • bleeding that’s difficult to control or that doesn’t stop
    • severe headache
    • changes in vision
    • confusion
    • fatigue (lack of energy)
  • Severe edema (fluid retention), including in your lungs or around your heart. Symptoms can include:
    • rapid, unexplained weight gain
    • swelling in your belly, legs, or arms
    • shortness of breath
  • Slowed growth in children. See the “Side effects in children” section below for more details.

Other serious side effects, which are explained in more detail below in “Side effect details,” include:

* Tasigna has a boxed warning from the FDA regarding the risk of these side effects. A boxed warning is the strongest warning the FDA requires. It alerts doctors and patients about drug effects that may be dangerous.

Side effects in children

During clinical studies, the side effects of Tasigna in children were generally similar to those seen in adults. However, children taking Tasigna had the following side effects more often than adults did:

Some children who took Tasigna also had delayed (slowed) growth. This means that they didn’t reach the average height of other children in their same age group who weren’t using Tasigna. In fact, in one clinical study, 12% of children who took Tasigna had a significant delay in their growth. But the long-term effects of this delayed growth aren’t known at this time.

If you’re concerned about delayed growth or other side effects your child may have with Tasigna, talk with their doctor. They can recommend ways to help manage your child’s side effects.

Side effect details

You may wonder how often certain side effects occur with this drug. Here’s some detail on several of the side effects this drug may cause.

Allergic reaction

As with most drugs, some people can have an allergic reaction after taking Tasigna.

Symptoms of a mild allergic reaction can include:

  • skin rash
  • itchiness
  • flushing (warmth and redness in your skin)

A more severe allergic reaction is rare but possible. Symptoms of a severe allergic reaction can include:

  • swelling under your skin, typically in your eyelids, lips, hands, or feet
  • swelling of your tongue, mouth, or throat
  • trouble breathing or speaking

It’s not known how many people had an allergic reaction to Tasigna during clinical studies. However, about 30% to 40% of people using the drug in the studies had a rash, which may have been caused by an allergic reaction.

Call your doctor right away if you have a severe allergic reaction to Tasigna. Call 911 if your symptoms feel life threatening or if you think you’re having a medical emergency.

QT prolongation and sudden death

Tasigna has a boxed warning for QT prolongation (a type of abnormal heart rhythm) and sudden death.

A boxed warning is the strongest warning that the Food and Drug Administration (FDA) requires on a drug’s labeling. It’s used to warn healthcare providers and patients about serious risks or side effects of a drug.

QT prolongation happens when there are changes in the electrical rhythm of your heart.

Your doctor will check your heart rhythm on an electrocardiogram (EKG) before you start treatment with Tasigna. Then they’ll administer another EKG after 1 week of treatment to see if Tasigna has affected your heart rhythm. If you don’t have QT prolongation at that time, your doctor will recommend follow-up EKGs at certain times during your treatment.

QT prolongation can lead to serious heart problems and even death. Symptoms of QT prolongation include:

  • feeling like your heart is skipping a beat or having extra beats
  • dizziness
  • fainting

If you have any of these symptoms, call your doctor right away. But call 911 if your symptoms feel life threatening.

Sudden death has also happened in people taking Tasigna. It’s thought that cases of sudden death seen in clinical studies of the drug were due to QT prolongation.

How common is QT prolongation and sudden death with Tasigna?

In clinical studies of adults taking Tasigna, between 1% and 10% had QT prolongation. In clinical studies of children taking the drug, 25% had QT prolongation.

Also, during clinical studies, sudden death occurred in 0.3% of people taking this drug.

What increases the risk of QT prolongation and sudden death during Tasigna treatment?

Certain things can increase your risk of having QT prolongation, which may lead to sudden death, during Tasigna treatment. These risk factors are described below.

  • Certain heart conditions. Tasigna shouldn’t be taken by people who have a heart condition that causes QT prolongation. Talk with your doctor about any heart problems you have before starting Tasigna.
  • Electrolyte imbalances. QT prolongation is more likely to happen if you have electrolyte imbalances, such as a low level of either potassium or magnesium. Before you start treatment with Tasigna, your doctor will order blood tests to make sure that your potassium and magnesium levels are within a normal range. If the levels are low, your doctor will recommend treatment to increase the levels before you start Tasigna.
  • Taking Tasigna with food. If you take Tasigna with food, you have a higher risk of QT prolongation. This is because food increases the amount of drug that’s absorbed into your body. Because of this risk, you should avoid consuming food for 2 hours before your Tasigna dose and for 1 hour after taking your dose.
  • Using certain other medications with Tasigna. You also have a greater risk of QT prolongation if you take Tasigna with certain other medications. For more information about this, see the “Tasigna interactions” section below.

Weight loss or weight gain

You may have weight loss or weight gain during Tasigna treatment. In clinical studies, between 1% and 10% of people who took Tasigna had changes in their weight.

Rapid and unexplained weight gain may be a symptom of edema (fluid retention) in your body. Other symptoms of edema include shortness of breath and swelling.

If you have rapid, unexplained weight gain, call your doctor right away. But if you feel like you’re having a medical emergency, call 911.

Rash

Some people taking Tasigna may develop a skin rash. This is one of the most common side effects of the drug.

In one clinical study of adults with newly diagnosed Ph+ CML,* 38% of adults taking Tasigna had a rash. In comparison, skin rash occurred in 19% of people taking the cancer drug imatinib (Gleevec). In clinical studies of children taking Tasigna, more than 20% had a rash.

If you have a rash during Tasigna treatment, talk with your doctor. They can recommend ways to help manage this side effect.

In some cases, skin rash may be a symptom of allergic reaction. (See the section “Allergic reaction” above for information about other possible symptoms.) If you think you’re having an allergic reaction to Tasigna, call your doctor right away. But if you feel that your symptoms are life threatening, call 911.

* Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) is a condition Tasigna is used to treat. To learn more about this condition, see the “Tasigna for chronic myeloid leukemia (CML)” section below.

Liver effects

Tasigna can cause serious liver effects, including liver damage. If you already have liver damage or you’re affected by liver damage while taking Tasigna, you have an increased risk of serious side effects from the drug.

Before you start taking Tasigna, your doctor will check your liver function by ordering certain blood tests. These tests will check the levels of certain proteins in your body that are made by your liver. If the levels are high, your doctor may prescribe a lower dosage of Tasigna for you.

After checking your liver function initially, your doctor will likely continue to monitor your liver function at least monthly during treatment.

Symptoms of liver damage can include:

  • belly pain
  • dark-colored urine
  • jaundice (yellowing of your skin or the whites of your eyes)
  • nausea and vomiting

If you have any of these symptoms while using Tasigna, tell your doctor right away. They may recommend that you stop taking the drug for a while. If they recommend that you restart Tasigna treatment, they’ll likely recommend that you take a lower dosage of Tasigna than you were initially taking.

Hair loss

You may have hair loss during Tasigna treatment. In one clinical study, 13% of adults who took Tasigna had hair loss. This is compared to 7% of people who took the cancer drug imatinib (Gleevec).

If you’re concerned about hair loss during Tasigna treatment, talk with your doctor. They can recommend ways to help you manage this side effect.

The Tasigna dosage your doctor prescribes will depend on several factors. These include:

  • the type and severity of the condition you’re using Tasigna to treat
  • your age, height, and weight (for children taking the drug)
  • other medical conditions you may have
  • other medications you’re taking
  • how your body reacts to Tasigna

Typically, your doctor will start you on the usual dosage of Tasigna. Then they’ll adjust your dosage over time to reach the amount that’s right for you. Your doctor will ultimately prescribe the smallest dosage that provides the desired effect.

The following information describes dosages that are commonly used or recommended. However, be sure to take the dosage your doctor prescribes for you. Your doctor will determine the best dosage to fit your needs.

Drug forms and strengths

Tasigna comes as capsules that are taken by mouth. It’s available in three strengths:

  • 50 milligrams (mg)
  • 150 mg
  • 200 mg

Dosage for Ph+ CML in adults

The usual dosage of Tasigna for adults with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) is based on whether or not they’ve had treatment in the past.

Dosage in adults who are newly diagnosed

The usual dosage of Tasigna for adults with newly diagnosed Ph+ CML that hasn’t been treated in the past is 300 mg twice daily.

Dosage in adults who didn’t improve with or couldn’t tolerate certain past treatments

The usual dosage for adults with Ph+ CML who didn’t improve with or couldn’t tolerate certain past treatments is 400 mg twice daily.

Dosage for Ph+ CML in children

The usual dose of Tasigna for children with Ph+ CML is 230 mg of drug per square meter of their body surface area (mg/m2). This dose should be taken twice daily.

Body surface area can be calculated by completing the following steps:

  1. First, multiply the child’s height in centimeters (cm) by their weight in kilograms (kg). To do this, you can use the following conversions: 1 inch = 2.54 cm and 1 pound (lb) = 0.45 kg.
  2. Next, divide the answer you get in step 1 by 3,600.
  3. Lastly, find the square root of the answer you get in step 2.

To calculate the dose of Tasigna needed, start by multiplying the child’s body surface area by 230. Then round that number to the nearest 50. (This is done because Tasigna capsules come in 50-mg strengths.)

For example, a child who is 36 inches tall and weighs 50 lb would take a dose of 150 mg of Tasigna twice daily.

The information given above for calculating Tasigna dosages for children just provides a general idea of how a child’s dosage of Tasigna will be determined. But ultimately, your doctor will recommend the appropriate dosage of Tasigna for a child using the drug.

What if I miss a dose?

If you miss a dose of Tasigna, just skip the missed dose. Then take your next scheduled dose at the usual time. Don’t take more than one dose to make up for the missed dose. Taking more than one dose at a time will increase your risk of serious side effects.

To help make sure that you don’t miss a dose, try setting a reminder on your phone. A medication timer may be useful, too.

Will I need to use this drug long term?

Tasigna is meant to be used as a long-term treatment. If you and your doctor determine that Tasigna is safe and effective for you, you’ll likely take it long term.

The Food and Drug Administration (FDA) approves prescription drugs such as Tasigna to treat certain conditions.

Tasigna is FDA-approved to treat Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML). It’s approved for this use in adults and children ages 1 year and older.

Tasigna is used in adults with either of the following situations:

  • newly diagnosed Ph+ CML in the chronic phase (typically considered the first stage of CML), or
  • Ph+ CML in either the chronic phase or the accelerated phase (a stage of CML where you have more symptoms of leukemia). For this use, Tasigna is prescribed for people who’ve used past treatment that included another cancer drug called imatinib (Gleevec). But this past treatment either didn’t work or caused side effects that they couldn’t tolerate.

Tasigna is also approved for use in children. For information about using Tasigna in children, see the “Tasigna and children” section below.

What is Ph+ CML?

Ph+ CML is a form of cancer that develops in bone marrow cells. It’s caused by a mutation (abnormal change) that forms a gene called BCR-ABL. This mutation forms the Philadelphia chromosome.

As cancer cells grow in your bone marrow, they crowd out the healthy cells in your bone marrow. The cancer cells also spread into your bloodstream, where they can travel to and affect your organs.

The more cancer cells you have, the worse your CML symptoms will be. The number of cancer cells that are found in your bone marrow and blood stream determine the phase of CML that you have. The phases of CML are described as follows.

  • Chronic phase. This phase of CML is the first phase of the disease. In this phase, people typically have fewer cancerous cells than they do in other phases. People also generally have very few symptoms, which are mild. Symptoms can include fatigue (lack of energy) and a feeling of fullness below your ribs on the left side of your torso. Some people don’t have any symptoms during the chronic phase.
  • Accelerated phase. This phase of CML is the second phase of the disease. In this phase, people have an increased number of cancer cells in their blood. People generally have more symptoms in this phase than they do in the chronic phase. Symptoms can include fever, weight loss, and bone pain.

Effectiveness for CML

Tasigna has been found effective in treating Ph+ CML in adults.

Effectiveness in adults who are newly diagnosed

In one clinical study, adults with newly diagnosed Ph+ CML in the chronic phase took either Tasigna or another cancer drug called imatinib (Gleevec). The researchers tested people’s blood to measure levels of the cancer-causing gene, BCR-ABL.

In this study, people had a successful response to treatment when their BCR-ABL level was 0.1% or less than the level of a reference test. After 12 months of treatment, 44% of people who took Tasigna had a successful response.

In comparison, 22% of people who took imatinib had a successful response. And after 24 months of treatment, 62% of patients who took Tasigna had a successful response, compared to 38% who took imatinib.

Effectiveness in adults who didn’t improve with or couldn’t tolerate certain past treatments

Another clinical study looked at adults with Ph+ CML who’d used another cancer drug called imatinib (Gleevec) in the past. These people either didn’t improve with imatinib or couldn’t tolerate side effects of imatinib.

The people included had either chronic phase CML or accelerated phase CML. All the people took Tasigna for treatment. There weren’t any people in the study who took a placebo (no active drug) or alternative treatment.

In this study, people with chronic phase CML had a successful response to treatment when less than 35% of their bone marrow cells contained the Ph+ chromosome. With treatment, 51% of people had a successful response to Tasigna. And at least half of the people who had a successful response did so after about 3 months of treatment.

In this same study, people with accelerated phase CML had a successful response to treatment when all of their blood cells had returned to a normal state, or if there were no findings of leukemia in their blood tests. With treatment, 39% of people had a successful response to Tasigna. And at least half of the people who had a successful response did so after about 1 month of treatment.

Tasigna and children

Tasigna is used in children ages 1 year and older with either of the following situations:

  • newly diagnosed Ph+ CML in the chronic phase (typically considered the first stage of CML), or
  • Ph+ CML in the chronic phase that’s been treated in the past with a tyrosine kinase inhibitor (TKI). (TKIs are drugs that belong to a certain class of medications.) But this past treatment either didn’t work or caused side effects that the children couldn’t tolerate.

Effectiveness in children who are newly diagnosed

In a clinical study, children with newly diagnosed Ph+ CML were given Tasigna. There weren’t any children in the study who took a placebo (no active drug) or alternative treatment. The researchers measured levels of the cancer-causing gene, BCR-ABL, in the children’s blood.

The children’s response to Tasigna treatment was considered successful when their BCR-ABL level was 0.1% or less than the level of a reference test. In this study, 60% of the children had a successful response to Tasigna after 12 months.

Effectiveness in children who didn’t improve with or could not tolerate certain past treatments

Clinical studies also looked at children with Ph+ CML who’d been treated in the past with either imatinib (Gleevec) or dasatinib (Sprycel). The children either didn’t improve with or couldn’t tolerate the side effects of either of these cancer drugs.

All of the children in this study took Tasigna. There weren’t any children in the study who took a placebo (no active drug) or alternative treatment.

The children’s response to Tasigna treatment was considered successful when their BCR-ABL level was 0.1% or less than the level of a reference test. In these studies, 47.7% of the children had a successful response to treatment after 12 months.

In addition to the uses listed above, Tasigna may also be used off-label for other conditions. Off-label use is when a drug that’s approved to treat one condition is used to treat a different condition.

Tasigna for Parkinson’s disease

Tasigna isn’t FDA-approved to treat Parkinson’s disease, but it has been tested for this purpose. Parkinson’s disease is a condition that affects your nervous system. It can cause tremor, stiffness, and problems with body movements.

In one clinical study, researchers looked at using either Tasigna or a placebo (no active drug) in people with Parkinson’s disease. The study showed that Tasigna was safe for use in people with this condition, but that it didn’t help improve their symptoms. At this time, it’s not known if there will be continued testing of Tasigna for Parkinson’s disease treatment.

If you’d like to know more about options for treating Parkinson’s disease, talk with your doctor.

Some people may need to take other medications along with Tasigna to help manage their side effects during treatment.

For example, blood disorders are a common side effect of Tasigna that are often treated with other therapies. Blood disorders can include anemia (low level of red blood cells), neutropenia (low level of certain white blood cells), and thrombocytopenia (low level of platelets).

Therapies that may be used with Tasigna to treat blood disorders include the following:

  • Growth factors. In some cases, blood disorders caused by Tasigna can become very serious. If that happens, your doctor may prescribe medications called growth factors to increase your white blood cell and platelet levels. Growth factors work by telling your bone marrow to make more of these blood cells.
  • Transfusion. If your red blood cell level becomes severely low during Tasigna treatment, your doctor may prescribe a blood transfusion for you. With a transfusion, you’ll receive blood from a donor or blood that was previously collected from your body.

During treatment with Tasigna, your doctor will recommend whether you’ll need to use other therapies, such as those mentioned above.

There’s no known interaction between Tasigna and alcohol. However, Tasigna and alcohol can each cause liver problems when used alone. Drinking alcohol while you’re taking Tasigna could further increase your risk of liver damage.

Talk with your doctor about whether it’s safe for you to drink alcohol during Tasigna treatment.

Tasigna can interact with several other medications. It can also interact with certain supplements as well as certain foods.

Different interactions can cause different effects. For instance, some interactions can interfere with how well a drug works. Other interactions can increase side effects or make them more severe.

Tasigna and other medications

Below are lists of medications that can interact with Tasigna. These lists do not contain all the drugs that may interact with Tasigna.

Before taking Tasigna, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter (OTC), and other drugs you take. Also tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.

If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.

Tasigna and medications used to treat heartburn or GERD

Taking Tasigna with certain medications used to treat heartburn or gastroesophageal reflux disease (GERD) can reduce the level of Tasigna in your body. This can lower the effectiveness of Tasigna in treating your condition.

Below we describe certain classes of heartburn or GERD medications that may or may not be taken with Tasigna.

Tasigna and proton pump inhibitors

Taking Tasigna with proton pump inhibitors (PPIs) is not recommended. PPIs are used to treat conditions such as GERD and peptic ulcer disease (PUD).

Examples of PPIs include:

If you’re taking Tasigna, ask your doctor about options other than the PPIs listed above to treat your GERD or PUD. Some safer alternative medications for these conditions are described below.

Tasigna and H2 blockers

Taking Tasigna with a histamine (H2)blocker may be a safe alternative to using a PPI. However, H2 blockers can also reduce the level of Tasigna in your body, which may reduce Tasigna’s effectiveness.

Examples of H2 blockers include:

  • ranitidine (Zantac)
  • cimetidine (Tagamet HB)
  • famotidine (Pepcid)
  • nizatidine (Axid AR)

Because H2 blockers may interact with Tasigna, you should only take an H2 blocker with Tasigna if your doctor tells you to do so. If they recommend that you take an H2 blocker, you can help avoid this drug interaction by taking the H2 blocker either 10 hours before your Tasigna dose or 2 hours after your Tasigna dose.

Tasigna and antacids

Taking Tasigna with an antacidmay also be a safe alternative to using a PPI. Antacids are over-the-counter (OTC) products that are commonly used to treat heartburn or indigestion. However, antacids can also reduce the level of Tasigna in your body, which may reduce Tasigna’s effectiveness.

Examples of commonly used OTC antacids include:

  • calcium carbonate (some forms of Tums, Alka-Seltzer, and Rolaids)
  • bismuth salicylate (some forms of Pepto-Bismol)
  • aluminum hydroxide/magnesium hydroxide/simethicone (some forms of Mylanta)

Because antacids may interact with Tasigna, you should only take an antacid with Tasigna if your doctor tells you to do so. If they recommend that you take an antacid, you should take the antacid at least 2 hours before your Tasigna dose or 2 hours after your Tasigna dose. Doing this will help you to avoid this drug interaction.

Tasigna and certain antidepressants

Taking Tasigna with certain antidepressants can increase your risk of QT prolongation (a type of abnormal heart rhythm). QT prolongation can lead to serious, and possibly fatal, heart problems.

Examples of antidepressants that can increase your risk of heart problems if taken with Tasigna include:

Taking these medications with Tasigna isn’t recommended. If you have depression, talk with your doctor about safe ways to treat this condition while you’re taking Tasigna.

Note: There are many drugs other than those listed here that can increase your risk of QT prolongation if they’re taken with Tasigna. Talk with your doctor about all prescription and OTC drugs you take before starting Tasigna.

Tasigna and certain heart medications

Taking Tasigna with certain heart medications can increase your risk of QT prolongation. This condition is a type of abnormal heart rhythm that can lead to dangerous problems with your heart.

Examples of heart medications that can increase your risk of serious heart problems if taken with Tasigna include:

  • amiodarone (Pacerone, Nexterone)
  • diltiazem (Cardizem, Cartia XT)
  • verapamil (Calan, Verelan)
  • sotalol (Betapace, Sorine)

Taking these medications with Tasigna isn’t recommended. If you need to take a heart medication while you’re taking Tasigna, talk with your doctor about safe treatment options.

Note: There are many drugs other than those listed here that can increase your risk of QT prolongation if they’re taken with Tasigna. Talk with your doctor about all prescription and OTC drugs you take before starting Tasigna.

Tasigna and certain anti-infectives

Taking Tasigna with certain anti-infectives (medications used to treat infections) can increase the level of Tasigna in your body. This can increase your risk of serious side effects from Tasigna, including QT prolongation (a type of abnormal heart rhythm). QT prolongation can lead to serious, and possibly fatal, heart problems.

Examples of antibiotics that can increase your risk of serious side effects, including QT prolongation, if taken with Tasigna include:

  • clarithromycin (Biaxin XL)
  • ciprofloxacin (Cipro)
  • levofloxacin
  • moxifloxacin (Avelox)

Examples of antifungals that can increase your risk of serious side effects, including QT prolongation, if taken with Tasigna include:

  • ketoconazole (Extina, Xolegel)
  • itraconazole (Onmel, Sporanox)
  • posaconazole (Noxafil)
  • voriconazole (Vfend)

Taking Tasigna with the medications listed above is not recommended.

If you don’t have any other options for treating your infection, and you need to take one of these drugs, your doctor will likely reduce your Tasigna dosage until you’ve finished treatment for your infection. Your doctor will also monitor your heart more closely while you’re taking the drugs together.

Note: There are many drugs other than those listed here that can increase your risk of QT prolongation if they’re taken with Tasigna. Talk with your doctor about all prescription and OTC drugs you take before starting Tasigna.

Tasigna and herbs and supplements

Taking Tasigna with certain supplements can affect the level of Tasigna in your body.

For example, taking Tasigna with the herb St. John’s wort can reduce your Tasigna levels. This could decrease how effective Tasigna is in treating your condition. Because of this, it’s recommended that you don’t take St. John’s wort during Tasigna treatment.

On the other hand, certain other supplements can increase Tasigna levels in your body. This increases your risk of serious side effects from the drug. Examples of these supplements include curcumin (turmeric) and ginkgo biloba.

Because of this interaction, it’s recommended that you avoid using curcumin and ginkgo biloba during Tasigna treatment.

Before starting Tasigna treatment, talk with your doctor or pharmacist about all the herbs and supplements you’re taking or planning to take. Doing so can help you avoid interactions, such as those described above.

Tasigna and foods

Eating grapefruit or drinking grapefruit juice can affect the level of Tasigna in your body. Because of this, you shouldn’t consume grapefruit while you’re taking Tasigna.

If you have questions about foods to avoid while taking Tasigna, talk with your doctor or pharmacist.

Other drugs are available that can treat chronic myeloid leukemia (CML). Some may be a better fit for you than others. If you’re interested in finding an alternative to Tasigna, talk with your doctor. They can tell you about other medications that may work well for you.

Examples of other drugs that may be used to treat CML include:

  • imatinib (Gleevec)
  • bosutinib (Bosulif)
  • dasatinib (Sprycel)
  • ponatinib (Iclusig)
  • omacetaxine (Synribo)

You may wonder how Tasigna compares with other medications that are prescribed for similar uses. Here we look at how Tasigna and Sprycel are alike and different.

Ingredients

Tasigna contains the drug nilotinib, while Sprycel contains the drug dasatinib. Both drugs belong to a class of medications called tyrosine kinase inhibitors (TKIs).

Uses

Tasigna and Sprycel are each approved for use in people with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML).

Each of these medications can be prescribed for adults with either of the following:

  • newly diagnosed Ph+ CML in the chronic phase (typically considered the first stage of CML), or
  • Ph+ CML in the chronic phase or the accelerated phase (a stage of CML where you have more symptoms of leukemia). For this use, the drugs are prescribed for people who’ve used past treatment that included another cancer drug called imatinib (Gleevec). But this past treatment either didn’t work or caused side effects that they couldn’t tolerate.

Sprycel is also used in adults with Ph+ CML in the blast phase. (The blast phase is the most advanced phase of CML, and it causes severe symptoms.) For this use, Sprycel is given to people who’ve used treatment in the past that included another cancer drug called imatinib (Gleevec). But the past treatment either didn’t work or caused side effects that they couldn’t tolerate.

Tasigna and Sprycel are also each approved for use in children ages 1 year and older with newly diagnosed Ph+ CML in the chronic phase.

Tasigna can also be used in children ages 1 year and older with Ph+ CML in the chronic phase after they’ve tried treatment in the past. But this treatment must have included a certain type of cancer medication that belongs to the TKI class of drugs. For these children, this past treatment either didn’t work or caused side effects that they couldn’t tolerate.

In addition, Sprycel is used in adults with Ph+ acute lymphocytic leukemia (ALL) who’ve tried other treatments that either didn’t work or caused side effects that they couldn’t tolerate.

Sprycel is also used in children ages 1 and older with newly diagnosed Ph+ ALL. For this use, Sprycel is given in combination with other cancer treatments.

Drug forms and administration

Tasigna comes as capsules that are taken by mouth twice daily. It should be taken on an empty stomach.

Sprycel comes as tablets that are taken by mouth once each day. It can be taken with or without food.

Side effects and risks

Tasigna and Sprycel both belong to the same class of drugs. Therefore, these medications can cause very similar side effects. Below are examples of these side effects.

Mild side effects

These lists contain examples of the mild side effects that are more common with Tasigna, with Sprycel, or with both drugs (when taken individually).

  • Can occur with Tasigna:
    • night sweats
  • Can occur with Sprycel:
    • no unique mild side effects
  • Can occur with both Tasigna and Sprycel:
    • fever
    • cough
    • common cold
    • headache
    • rash
    • fatigue (lack of energy)
    • nausea, vomiting, and diarrhea
    • muscle, bone, or joint pain
    • shortness of breath

Serious side effects

These lists contain examples of serious side effects that can occur with Tasigna, with Sprycel, or with both drugs (when taken individually).

  • Can occur with Tasigna:
    • electrolyte imbalances, which can lead to heart and muscle problems
    • liver damage
  • Can occur with Sprycel:
  • Can occur with both Tasigna and Sprycel:
    • blood disorders, such as anemia (low red blood cell level) and neutropenia (low level of certain white blood cells)
    • severe edema (fluid retention), which may occur in your lungs or around your heart
    • severe bleeding that’s difficult to control
    • tumor lysis syndrome (a condition that’s caused by harmful chemicals being released into your blood by dying cancer cells)
    • blockages in your heart or blood vessels
    • slowed growth in children
    • severe allergic reaction

* Tasigna has a boxed warning from the FDA regarding these risks. A boxed warning is the strongest warning the FDA requires. It alerts doctors and patients about drug effects that may be dangerous.

Effectiveness

Tasigna and Sprycel have different approved uses, but they’re both used in:

  • adults and children ages 1 year and older with newly diagnosed Ph+ CML in the chronic phase.
  • adults with Ph+ CML in either the chronic phase or accelerated phase after they’ve tried past treatment that included the cancer drug imatinib (Gleevec). For these people, imatinib either didn’t work or caused side effects that they couldn’t tolerate.

The effectiveness of these drugs hasn’t been directly compared in clinical studies. But separate studies have found both Tasigna and Sprycel to be effective for treating certain people with Ph+ CML.

Costs

Tasigna and Sprycel are both brand-name drugs. There are currently no generic forms of either drug. Brand-name medications usually cost more than generics.

Tasigna and Sprycel generally cost about the same. The actual price you’ll pay for either drug depends on your insurance plan, your location, and the pharmacy you use.

You may wonder how Tasigna compares with other medications that are prescribed for similar uses. Here we look at how Tasigna and Gleevec are alike and different.

Ingredients

Tasigna contains the drug nilotinib, while Gleevec contains the drug imatinib. Both medications belong to a class of drugs called tyrosine kinase inhibitors (TKIs).

Uses

Tasigna and Gleevec are each approved for use in adults with newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in the chronic phase. (The chronic phase is typically considered the first stage of CML.)

Tasigna is also used in adults with Ph+ CML in the chronic phase or the accelerated phase (a stage of CML where you have more symptoms of leukemia) who’ve used past treatment that included Gleevec. For these people, this past treatment either didn’t work or caused side effects that they couldn’t tolerate.

Gleevec is also used in adults and children ages 1 year and older with Ph+ CML that’s in the chronic phase, accelerated phase, or blast phase. (The blast phase is the most advanced phase of CML, and it causes severe symptoms.) For this use, Gleevec is given to people who’ve used treatment in the past with a cancer drug called an interferon alpha, and it didn’t work for them.

As well, Tasigna and Gleevec are each approved for use in children ages 1 year and older with newly diagnosed Ph+ CML in the chronic phase.

Tasigna can also be used in children ages 1 year and older with Ph+ CML in the chronic phase after they’ve tried treatment in the past. But their past treatment must have included a certain type of cancer drug that belongs to the TKI class of drugs. For these children, the past treatment either didn’t work or caused side effects that they couldn’t tolerate.

In addition, Gleevec is used to treat the following types of blood cancer:

  • Ph+ acute lymphoblastic leukemia (ALL)
  • myelodysplastic/myeloproliferative diseases
  • hypereosinophilic syndrome or chronic eosinophilic leukemia
  • aggressive systemic mastocytosis
  • dermatofibrosarcoma protuberans
  • gastrointestinal stromal tumors

Drug forms and administration

Tasigna comes as capsules that are taken by mouth twice daily. It should be taken on an empty stomach.

Gleevec comes as tablets that are taken by mouth. Depending on the dosage your doctor prescribes, you’ll take Gleevec either once or twice each day. In either case, it should be taken with a meal.

Side effects and risks

Tasigna and Gleevec both belong to the same class of drugs. Therefore, these medications can cause very similar side effects. Below are examples of these side effects.

Mild side effects

This list contains examples of mild side effects that are more common with both Tasigna and Gleevec:

  • fever
  • constipation
  • cough
  • common cold
  • night sweats
  • nausea, vomiting, and diarrhea
  • headache
  • fatigue (lack of energy)
  • rash
  • muscle cramps or muscle pain
  • bone pain
  • belly pain

Serious side effects

These lists contain examples of serious side effects that can occur with Tasigna, with Gleevec, or with both drugs (when taken individually).

  • Can occur with Tasigna:
    • blockages in your heart or blood vessels
    • electrolyte imbalances, which can lead to heart and muscle problems
  • Can occur with Gleevec:
    • heart problems, such as congestive heart failure
    • gastrointestinal problems, including perforations (holes) in your stomach or intestines
    • severe skin reactions, such as Stevens-Johnson syndrome
    • hypothyroidism (low level of thyroid hormone)
    • kidney damage
    • certain side effects, such as blurry vision and dizziness, that can lead to motor vehicle accidents
  • Can occur with both Tasigna and Gleevec:
    • severe edema (fluid retention), which may occur in your lungs or around your heart
    • blood disorders, such as anemia (low red blood cell level) and neutropenia (low level of certain white blood cells)
    • liver damage
    • severe bleeding that’s difficult to control
    • slowed growth in children
    • tumor lysis syndrome (a condition that’s caused by harmful chemicals being released into your blood by dying cancer cells)
    • severe allergic reaction

* Tasigna has a boxed warning from the FDA regarding these risks. A boxed warning is the strongest warning the FDA requires. It alerts doctors and patients about drug effects that may be dangerous.

Effectiveness

Tasigna and Gleevec have different approved uses, but they’re both used to treat adults and children ages 1 year and older with newly diagnosed Ph+ CML in the chronic phase.

The use of Tasigna and Gleevec in treating adults with newly diagnosed Ph+ CML has been directly compared in a clinical study. In this study, the researchers tested people’s blood to measure levels of the cancer-causing gene, BCR-ABL.

In this study, people had a successful response to the treatment when their BCR-ABL level was 0.1% or less than the level of a reference test. After 12 months of treatment, 44% of people who took Tasigna had a successful response. In comparison, 22% of people who took imatinib had a successful response.

The use of Tasigna and Gleevec in treating newly diagnosed Ph+ CML in children hasn’t been directly compared. But separate studies have found Tasigna and Gleevec to each be effective for this use.

Costs

Tasigna and Gleevec are both brand-name drugs. There are currently no generic forms of Tasigna. There is a generic form of Gleevec called imatinib, however. Brand-name medications usually cost more than generics.

Tasigna may cost more than the brand-name and generic forms of Gleevec. The actual price you’ll pay for either drug depends on your insurance plan, your location, and the pharmacy you use.

You should take Tasigna according to your doctor’s or healthcare provider’s instructions.

When to take

Tasigna should be taken twice each day. You should try to take your doses about 12 hours apart. This will help keep the level of Tasigna steady in your body.

To help make sure that you don’t miss a dose, try setting a reminder on your phone. A medication timer may be useful, too.

Taking Tasigna with food

Tasigna must be taken on an empty stomach. Taking Tasigna with food will increase Tasigna levels in your body. This increases your risk of serious side effects, including QT prolongation (a type of abnormal heart rhythm) and sudden death.* See the “Tasigna side effects” section above for more details about these conditions.

To lower your risk of serious side effects, avoid eating food for at least 2 hours before taking Tasigna and for at least 1 hour after taking the drug.

* Tasigna has a boxed warning from the FDA regarding these risks. A boxed warning is the strongest warning the FDA requires. It alerts doctors and patients about drug effects that may be dangerous.

Can Tasigna be crushed, split, or chewed?

No, Tasigna capsules shouldn’t be crushed or chewed. But if you have trouble swallowing the capsules, you can open them and sprinkle their contents into 1 teaspoon of applesauce. Be sure to eat the applesauce within 15 minutes of sprinkling the drug onto it.

Here are answers to some frequently asked questions about Tasigna.

Will I have withdrawal symptoms after I stop taking Tasigna?

There aren’t any reports of withdrawal symptoms in people who’ve stopped taking Tasigna. However, stopping Tasigna treatment may lead to your cancer returning or getting worse.

In fact, one clinical study found that in people whose cancer went away during treatment and who then stopped Tasigna:

  • about 36% had their cancer return within 24 weeks
  • about 46% had their cancer return within 48 weeks
  • about 48% had their cancer return within 96 weeks

If you’re interested in stopping Tasigna treatment, talk with your doctor. They can discuss with you the risks and benefits of stopping treatment.

Is Tasigna a chemotherapy drug?

No, Tasigna isn’t considered a chemotherapy drug. The term “chemotherapy” is often used to describe traditional drugs that treat cancer.

In general, chemotherapy works by killing all the rapidly multiplying cells in your body. (Cells that multiply are making more cells.) Because cancer cells multiply rapidly, chemotherapy attacks them. But some of your body’s healthy cells also multiply rapidly. And these healthy cells can also be affected by chemotherapy.

Unlike chemotherapy, Tasigna is a targeted therapy for cancer. This means that it was designed to target (work on) specific cancer cells or parts of cancer cells.

Because targeted drugs like Tasigna affect fewer cells in your body than chemotherapy does, they typically have different, and sometimes fewer, side effects than chemotherapy drugs do.

Will Tasigna affect my child’s growth?

It might. In a clinical study, up to 12% of children who took Tasigna had slower growth than other children their age who weren’t taking the drug. But it’s not known how this delayed growth might affect the children on a long-term basis.

If you’re concerned about how Tasigna may affect your child’s growth, talk with their doctor. They can discuss with you what to expect when using Tasigna treatment for a child.

Can I take Tasigna if I have heart problems?

If you have heart problems, you might be able to take Tasigna. But some people with certain heart problems shouldn’t take this drug.

For example, if you have a heart condition called QT prolongation (also called long QT syndrome), Tasigna may not be safe for you. (QT prolongation is a type of abnormal heart rhythm.) This is because Tasigna can worsen QT prolongation and increase your risk of serious heart events and sudden death.*

If you have other heart conditions, including blocked arteries in your heart, Tasigna may not be safe for you, either.

If you any problems with your heart, talk with your doctor to find out if it’s safe for you to take Tasigna.

* Tasigna has a boxed warning from the FDA regarding these risks. A boxed warning is the strongest warning the FDA requires. It alerts doctors and patients about drug effects that may be dangerous.

As with all medications, the cost of Tasigna can vary. The actual price you’ll pay depends on your insurance plan, your location, and the pharmacy you use.

It’s important to note that you’ll have to get Tasigna at a specialty pharmacy. This type of pharmacy is authorized to carry specialty medications. These are drugs that may be expensive or may require help from healthcare professionals to be used safely and effectively.

Your insurance plan may require you to get prior authorization before approving coverage for Tasigna. This means that your doctor and insurance company will need to communicate about your prescription before the insurance company will cover the drug. The insurance company will review the request and let you and your doctor know if your plan will cover Tasigna.

If you’re not sure if you’ll need to get prior authorization for Tasigna, contact your insurance plan.

Financial and insurance assistance

If you need financial support to pay for Tasigna, or if you need help understanding your insurance coverage, help is available.

Novartis Pharmaceuticals Corporation, the manufacturer of Tasigna, offers a few different ways to help lower the cost of Tasigna. For more information about these programs and to find out if you’re eligible for support, visit the manufacturer’s website.

Tasigna is approved to treat Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML).

What is Ph+ CML?

Ph+ CML is a type of cancer that develops in certain cells inside your bone marrow. The cells that are affected by this form of cancer normally develop into white blood cells.

But with Ph+ CML, there’s a mutation (abnormal change) in a portion of your DNA (genetic material). This mutation creates the BCR-ABL gene, which leads to the Philadelphia chromosome being formed. Cancer that has the Philadelphia chromosome is called Philadelphia chromosome-positive (Ph+).

The BCR-ABL gene causes too many white blood cells to form in your bone marrow. Unfortunately, these white blood cells don’t mature and die on the usual schedule. Because of this, they crowd out some of the healthy cells that your body needs in order to work properly.

What does Tasigna do?

Tasigna contains the drug nilotinib. It belongs to a class of drugs called tyrosine kinase inhibitors (TKIs).

Tasigna works by binding (attaching) to proteins on the tyrosine kinase protein. It does this in cells that are made by the BCR-ABL gene. By binding to this protein, Tasigna prevents those cells from sending signals that encourage other cancer cells to grow and spread.

By stopping the cancer cells from growing and spreading, Tasigna ultimately causes them to die. This helps to restore your normal blood cells to a healthier level.

How long does it take to work?

Tasigna begins working shortly after you take your first dose. However, you may not notice that Tasigna is working to make you feel better until you’ve had treatment for several months.

Each person’s response to Tasigna will be unique. Your doctor will monitor your blood cell levels to see how well Tasigna is working for you.

It’s not known if Tasigna is safe to use during pregnancy because there aren’t any studies of pregnant people using the drug. However, animal studies found that Tasigna caused serious harm to a growing fetus when a pregnant female was given the drug.

Keep in mind that animal studies don’t always predict what will happen in people. But because of this possible risk, it’s recommended that you don’t take Tasigna during pregnancy.

If you’re pregnant or may become pregnant, talk with your doctor about the safety of using Tasigna.

Tasigna may cause serious harm to a growing fetus. Because of this, pregnancy should be avoided while you’re taking Tasigna. If you’re sexually active and you or your partner can become pregnant, talk with your doctor about your birth control needs while you’re using Tasigna.

Note: The terms “female” and “male” are used below. Sex and gender exist on spectrums. Use of these terms in this article refers to sex assigned at birth.

For females using Tasigna

If you’re a female who’s able to become pregnant, you should use effective birth control during Tasigna treatment. You should continue to use birth control for at least 14 days after your last dose of the drug.

For males using Tasigna

The manufacturer of Tasigna hasn’t stated whether males taking this drug need to use birth control during treatment. If you’re a male with a female sexual partner who’s able to become pregnant, talk with your doctor about whether you’ll need to use birth control during Tasigna treatment.

It’s not known if Tasigna passes into human breast milk or what effect it might have on a child who’s breastfed. But animal studies did show that Tasigna passed into animal breast milk.

Even though animal studies don’t always predict what will happen in humans, it’s recommended that breastfeeding be avoided while you’re taking Tasigna. This is because the drug may possibly cause serious side effects in a child who’s breastfed.

You shouldn’t breastfeed a child while you’re taking Tasigna. And you should continue to avoid breastfeeding for at least 14 days after your last dose of the drug.

Talk with your doctor about safe and healthy ways to feed your child during Tasigna treatment.

This drug comes with several precautions.

FDA warnings

This drug has a boxed warning. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). It alerts doctors and patients about drug effects that may be dangerous.

Tasigna has boxed warnings for an abnormal heart rhythm called QT prolongation and sudden death.

Tasigna causes QT prolongation, and this can lead to serious side effects, including fainting, seizures, and even death.

Because of this side effect, Tasigna shouldn’t be taken by people with existing QT prolongation or low levels of either potassium or magnesium.

Before and during Tasigna treatment, your doctor will order tests to check your heart rhythm and your potassium and magnesium levels. This helps your doctor to be sure that Tasigna is safe for you.

Also, Tasigna shouldn’t be taken with other drugs that can cause QT prolongation. It should also not be taken with other drugs that increase Tasigna levels in your body. (These other drugs are called strong CYP3A4 inhibitors.)

In addition, Tasigna should be taken on an empty stomach. You should avoid eating food for 2 hours before and 1 hour after taking your Tasigna dose. This is because taking Tasigna with food increases the amount of drug that’s absorbed into your body, which raises your risk for QT prolongation.

Other precautions

Before taking Tasigna, talk with your doctor about your health history. Tasigna may not be right for you if you have certain medical conditions or other factors affecting your health. These include:

  • Low levels of potassium or magnesium. If you have low levels of either potassium or magnesium, you have an increased risk of serious heart problems when you’re taking Tasigna. Your doctor will order blood tests to check your potassium and magnesium levels before and during treatment. This allows your doctor to make sure that Tasigna is safe for you.
  • Liver problems. If you have liver problems, you may have a greater risk of serious side effects from Tasigna. Talk with your doctor about your liver health before starting this drug.
  • Cardiovascular disease. If you have cardiovascular risk factors, such as atherosclerosis (plaque buildup in your arteries), you may have an increased risk of serious blockages in your heart or arteries during Tasigna treatment. Talk with your doctor about your cardiovascular health before starting this drug.
  • History of pancreatitis. If you’ve had pancreatitis (inflammation in your pancreas) in the past, you may have an increased risk of pancreatitis during Tasigna treatment. Talk with your doctor about any history of pancreas problems before you start taking this drug.
  • Surgical removal of your stomach. If you’ve had surgical removal of parts or all of your stomach or intestines, you may have a greater risk of serious side effects from Tasigna. Tell your doctor about all past surgeries before starting Tasigna.
  • Certain sugar intolerances. If you have severe problems digesting or metabolizing certain forms of milk sugars, Tasigna may not be safe for you. If you’re unsure whether you have these problems with milk sugars, talk with your doctor.
  • Pregnancy. Tasigna may cause serious harm to a developing fetus if it’s used during pregnancy. For more information, please see the “Tasigna and pregnancy” section above.
  • Breastfeeding. Tasigna could cause serious side effects in a child who consumes it in breastmilk. For more information, please see the “Tasigna and breastfeeding” section above.

Note: For more information about the potential negative effects of Tasigna, see the “Tasigna side effects” section above.

Using more than the recommended dosage of Tasigna can lead to serious side effects. Do not use more Tasigna than your doctor recommends.

Overdose symptoms

Symptoms of an overdose can include:

  • neutropenia (low level of certain white blood cells)
  • vomiting
  • drowsiness

What to do in case of overdose

If you think you’ve taken too much of this drug, call your doctor. You can also call the American Association of Poison Control Centers at 800-222-1222 or use their online tool. But if your symptoms are severe, call 911 or go to the nearest emergency room right away.

When you get Tasigna from the pharmacy, the pharmacist will add an expiration date to the label on the bottle. This date is typically 1 year from the date they dispensed the medication.

The expiration date helps guarantee that the medication is effective during this time. The current stance of the Food and Drug Administration (FDA) is to avoid using expired medications. If you have unused medication that has gone past the expiration date, talk to your pharmacist about whether you might still be able to use it.

Storage

How long a medication remains good can depend on many factors, including how and where you store the medication.

Tasigna tablets should be stored at room temperature (about 77°F/25°C) in a tightly sealed container away from light. Avoid storing this medication in areas where it could get damp or wet, such as in bathrooms.

Disposal

If you no longer need to take Tasigna and have leftover medication, it’s important to dispose of it safely. This helps prevent others, including children and pets, from taking the drug by accident. It also helps keep the drug from harming the environment.

The FDA website provides several useful tips on medication disposal. You can also ask your pharmacist for information on how to dispose of your medication.

The following information is provided for clinicians and other healthcare professionals.

Indications

Tasigna is approved to treat newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in the chronic phase in adults and children ages 1 year and older.

Tasigna is also approved to treat Ph+ CML in adults who are either resistant or intolerant to previous therapy that included imatinib. It is approved for this purpose in adults with Ph+ CML in either the chronic or accelerated phase.

In addition, Tasigna is approved to treat chronic phase Ph+ CML in children ages 1 year and older who are either resistant or intolerant to previous therapy that included a tyrosine kinase inhibitor (TKI).

Mechanism of action

Tasigna (nilotinib) is a TKI. It binds to and stabilizes the inactive form of the ABL protein, which prevents cancer cells from sending signals prompting cellular reproduction.

Pharmacokinetics and metabolism

Following twice-daily oral administration, steady state concentrations are reached by day 8 of treatment. Maximum concentrations are reached approximately 3 hours after administration.

Administration with a high fat meal increases absorption by 82% compared with administration in the fasted state.

Metabolism occurs primarily via CYP3A4 and to a lesser degree by CYPC8. Mean elimination half-life is approximately 17 hours, with 93% excreted in feces.

Contraindications

Tasigna is contraindicated in patients with long QT syndrome, hypomagnesemia, or hypokalemia.

Storage

Tasigna capsules should be stored at room temperature (77°F/25°C).

Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or other healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.

Tasigna Images