NovoSeven RT (coagulation factor VIIa, recombinant)

NovoSeven RT generic or biosimilar

NovoSeven RT is a biologic drug that’s available only as a brand-name medication. It’s not currently available in generic or biosimilar form.

Biologic drugs are made using living cells. Traditional drugs are made using chemicals. A generic drug is an exact copy of the active ingredient in a brand-name chemical drug.

It’s not possible to make an exact copy of the active ingredient in a brand-name biologic drug. Instead, biosimilars can sometimes be made. These are considered to be as safe and effective as the original brand-name biologic drug.

NovoSeven RT cost

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

Financial and insurance assistance: If you need financial support to pay for NovoSeven RT, or if you need help understanding your insurance coverage, help is available.

A program called NovoCare is available for NovoSeven RT. For more information and to find out if you’re eligible for support, call 844-668-6732 or visit the program website.

Generic or biosimilar version: NovoSeven RT is a brand-name biologic drug. It’s not available in a generic or biosimilar form. A generic drug is an exact copy of the active ingredient in a brand-name medication. A biosimilar drug is like a generic for a biologic brand-name medication. Like generics, biosimilars tend to cost less than brand-name drugs. To learn more, see the “NovoSeven RT generic or biosimilar” section.

To learn more about saving money on prescriptions, check out this article.

NovoSeven RT uses

The Food and Drug Administration (FDA) approves prescription drugs such as NovoSeven RT to treat certain conditions. These are the drug’s licensed indications. NovoSeven RT’s indications are described below.

NovoSeven RT may also be used off-label for other conditions. Off-label drug use is when an FDA-approved drug is prescribed for a purpose other than what it’s approved for.

NovoSeven RT for hemophilia

NovoSeven RT is FDA approved to treat bleeding episodes and help prevent bleeding related to surgery in certain people with hemophilia.

With hemophilia, you have lower than normal amounts of certain clotting factors or clotting factors that don’t work correctly. Clotting factors are proteins that help your blood clot. Blood clotting is necessary to help heal wounds and prevent unwanted or excessive bleeding. Having faulty, missing, or low levels of clotting factors makes your blood take longer to form clots. It raises your risk of serious bleeding.

Symptoms of hemophilia can include:

• nosebleeds
• bleeding from your mouth or gums
• bruising easily
• bleeding heavily or for a long time after an injury
• bleeding excessively with dental procedures or surgeries
• internal bleeding, such as bleeding in your joints, muscles, or digestive system

NovoSeven RT is FDA approved to treat bleeding episodes and help prevent bleeding related to surgery in the following groups:

• Adults and children with hemophilia A or B with inhibitors: With hemophilia A, you have a faulty, missing, or low level of clotting factor VIII (eight). With hemophilia B, you have a faulty, missing, or low level of clotting factor IX (nine). These conditions are usually treated with factor replacement therapy, which are injections of clotting factor VIII or IX. Inhibitors are antibodies that your body can sometimes make against the replacement clotting factors. The inhibitors stop the factors from working. As such, factor replacement therapy doesn’t work in people who have inhibitors.
• Adults with acquired hemophilia: With acquired hemophilia, your immune system mistakenly makes antibodies that attack factor VIII or IX in your blood. This causes low levels of these clotting factors.

NovoSeven RT contains clotting factor VIIa (seven a). It’s a type of hemophilia treatment called a bypassing agent. It helps your blood to clot without needing factor VIII or IX. For more information, see the “How NovoSeven RT works” section.

For this purpose, NovoSeven RT may be prescribed by itself or with other drugs for hemophilia.

Examples of other hemophilia drugs that may be used with NovoSeven RT include desmopressin (DDAVP). NovoSeven RT may also be used with emicizumab-kxwh (Hemlibra). This is a drug that’s taken on a regular basis for bleeding prophylaxis (prevention of bleeding).

NovoSeven RT for other bleeding disorders

NovoSeven RT is also FDA approved to treat bleeding episodes and help prevent bleeding related to surgery in:

• Adults and children with congenital (present from birth) factor VII deficiency: With this inherited condition, your body makes lower than normal amounts of clotting factor VII.
• Adults and children with Glanzmann thrombasthenia, when platelet transfusions don’t work: With this inherited condition, your body makes faulty platelets (blood cells that help with clotting). This condition is usually treated with platelet transfusions, but for some people these don’t work.

With these bleeding disorders, your blood takes a long time to form clots. This raises your risk of serious bleeding. Symptoms of these bleeding disorders are the same as those listed above for hemophilia.

If you have factor VII deficiency, NovoSeven RT helps your blood to clot by increasing your low factor VII levels. If you have Glanzmann thrombasthenia, NovoSeven RT helps your blood to clot without functioning platelets. See “How NovoSeven RT works” for details.

For this purpose, NovoSeven RT may be prescribed by itself or with other drugs for bleeding disorders. Examples of other drugs that may be used with NovoSeven RT include aminocaproic acid (Amicar).

NovoSeven RT and children

NovoSeven RT is FDA approved to treat bleeding episodes and help prevent bleeding related to surgery in children of all ages with:

• hemophilia A or B with inhibitors
• congenital factor VII deficiency
• Glanzmann thrombasthenia, when platelet transfusions don’t work

For more information about these bleeding disorders, see the previous sections.

NovoSeven RT dosage

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

• the type of bleeding disorder you have
• your body weight in kilograms (kg)
• whether NovoSeven RT is being used to treat a bleeding episode or help prevent bleeding related to surgery

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 NovoSeven RT dosing schedule to fit your needs.

Drug forms and strengths

NovoSeven RT comes as a powder in a single-dose vial. It’s available in the following strengths:

• 1 milligram (mg), which is 1,000 micrograms (mcg)
• 2 mg (2,000 mcg)
• 5 mg (5,000 mcg)
• 8 mg (8,000 mcg)

The vial of powder comes with a prefilled syringe or a vial containing a solution of histidine. This is called a diluent. It’s mixed with the powder to make a solution that’s given by intravenous (IV) infusion. For more information about infusions, see “How NovoSeven RT is administered.”

Dosage for treating bleeding episodes

NovoSeven RT is prescribed to treat bleeding episodes in certain situations. For information about the following conditions, see the “NovoSeven RT uses” section.

For adults with hemophilia A or B with inhibitors: The recommended dosage is 90 mcg per kg (mcg/kg) of body weight every 2 hours until the bleeding stops.

If the bleed was severe, your doctor may recommend further doses of 90 mcg/kg every 3 to 6 hours for a period of time.

For adults with acquired hemophilia: The recommended dosage is 70 to 90 mcg/kg every 2 to 3 hours until the bleeding stops.

For adults with congenital (present from birth) factor VII deficiency: The recommended dosage is 15 to 30 mcg/kg every 4 to 6 hours until the bleeding stops.

For adults with Glanzmann thrombasthenia: The recommended dosage is 90 mcg/kg every 2 to 6 hours until the bleeding stops.

If you have questions about your specific dosage for treating bleeding episodes, talk with your doctor.

Dosage for preventing bleeding related to surgery

NovoSeven RT is also prescribed to help prevent bleeding related to surgery in certain situations. To learn more, see the “NovoSeven RT uses” section.

Dosing recommendations are typically based on whether you’re having a minor or a major surgery. In some situations, common minor surgeries include procedures such as cataract surgery or tooth extractions. Examples of major surgeries typically include joint replacement surgery or gastric bypass surgery.

There are many factors to consider when your doctor is deciding your bleeding risk during surgery. Your doctor will determine if the type of surgery you’re having is minor or major and calculate your dose. If you have questions about this, you can follow up with your doctor.

For adults with hemophilia A or B with inhibitors: The recommended dosage is 90 mcg/kg of body weight given right before surgery, then 90 mcg/kg every 2 hours during surgery.

After surgery, the recommended dosage varies depending on the type of surgery:

• After minor surgery: 90 mcg/kg every 2 hours for 48 hours, then 90 mcg/kg every 2 to 6 hours until healing occurs.
• After major surgery: 90 mcg/kg every 2 hours for 5 days, then 90 mcg/kg every 4 hours until healing occurs.

For adults with acquired hemophilia: The recommended dosage is 70 to 90 mcg/kg given right before surgery, then 70 to 90 mcg/kg every 2 to 3 hours during surgery and until any bleeding stops.

For adults with congenital factor VII deficiency: The recommended dosage is 15 to 30 mcg/kg given right before surgery, then 15 to 30 mcg/kg every 4 to 6 hours during surgery and until any bleeding stops.

For adults with Glanzmann thrombasthenia: The recommended dosage is 90 mcg/kg given right before surgery, then 90 mcg/kg every 2 hours during the surgery.

After the surgery, the recommended dosage is 90 mcg/kg every 2 to 6 hours for a period of time to prevent bleeding.

Talk with your doctor for more information about your specific dosage for this NovoSeven RT use.

Children’s dosage

NovoSeven RT is FDA approved to treat bleeding episodes and help prevent bleeding related to surgery in children with:

• hemophilia A or B with inhibitors
• congenital (present from birth) factor VII deficiency
• Glanzmann thrombasthenia, when platelet transfusions don’t work

The recommended dosages depend on the child’s body weight and are the same as for adults. The previous section describes the recommended dosages. If you have questions about your child’s dosage, talk with their doctor.

For details about NovoSeven RT’s approved uses in children, see the “NovoSeven RT uses” section.

How NovoSeven RT is administered

NovoSeven RT is given by IV infusion, which is an injection into a vein that’s given over a period of time.

If you’re receiving NovoSeven RT to help prevent bleeding related to surgery, a doctor or another healthcare professional will administer the medication. A doctor may also administer NovoSeven RT to treat episodes of bleeding.

NovoSeven RT infusions are typically given over 2 to 5 minutes. However, when used to help prevent bleeding with major surgeries, doctors may sometimes administer the drug as a continuous infusion. A continuous infusion is an injection into a vein continuously over a longer period of time.

In some cases, you or your caregiver may be able to prepare and administer NovoSeven RT infusions for yourself or your child to treat bleeding episodes at home. A healthcare professional will teach you how to do this.

The manufacturer supplies detailed instructions for preparing and administering NovoSeven RT. You can also find instructions and videos on the manufacturer’s website.

About NovoSeven RT treatment

Below you’ll find information about key dosage issues:

• Length of treatment: NovoSeven RT is meant to be a short-term treatment to control bleeding. If you and your doctor determine that the medication is safe and effective for you, you’ll likely receive it to treat future bleeding episodes and to help prevent bleeding with any future surgeries.
• Length of time to work: NovoSeven RT starts working as soon as you start treatment. You may need to receive a dose every few hours until your bleeding is controlled.

Your doctor can provide more information about your dosing schedule and how long you’ll likely receive infusions.

Overdose

If you administer NovoSeven RT at home, do not administer more than your doctor recommends. For some drugs, doing so may lead to unwanted side effects or overdose.

What to do in case you administer too much NovoSeven RT

If you think you’ve administered or received too much of this drug, call your doctor. You can also call America’s Poison Centers at 800-222-1222 or use its online tool. However, if your symptoms are severe, call 911 or your local emergency number, or go to the nearest emergency room right away.

NovoSeven RT side effects

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

For more information about the possible side effects of NovoSeven RT, talk with your doctor or pharmacist. They can give you tips on how to manage any side effects that may concern or bother you.

Note: The Food and Drug Administration (FDA) tracks side effects of drugs it has approved. If you would like to notify the FDA about a side effect you’ve had with NovoSeven RT, you can do so through MedWatch.

Mild side effects

Below is a partial list of mild side effects of NovoSeven RT. To learn about other mild side effects, talk with your doctor or pharmacist, or view the drug’s prescribing information.

Mild side effects of NovoSeven RT can include:

• headache
• fever
• nausea

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

Serious side effects

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

Serious side effects and their symptoms can include:

• high blood pressure
• blood clots

Note: NovoSeven RT has a boxed warning for the risk of blood clots. A boxed warning is the most serious warning from the FDA. To learn more, see the “NovoSeven RT precautions” section.

ALLERGIC REACTION

For some people, NovoSeven RT injection can cause an allergic reaction.

In general, symptoms of allergic reaction can be mild or serious.

Ways to manage

For mild allergic reaction symptoms, such as a mild rash, call your doctor right away. They may recommend treatments to help manage your symptoms. They’ll also let you know whether you should keep taking the medication.

For severe allergic reaction symptoms, such as swelling or trouble breathing, call 911 or your local emergency number right away. These symptoms require immediate medical care because they can become life threatening. If you’ve had a serious allergic reaction to NovoSeven RT injection at home or in a healthcare setting, your doctor may recommend a different medication instead.

NovoSeven RT interactions

NovoSeven RT can interact with some other medications.

Before taking NovoSeven RT, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, 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.

Interactions with medications

Below is a list of medications that can interact with NovoSeven RT. This list does not contain all drugs that may interact with NovoSeven RT. If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.

The following medications can interact with NovoSeven RT:

• activated prothrombin complex concentrate (aPPC), such as:
  • anti-inhibitor coagulant complex (Feiba)
• clotting factor XIII (Corifact, Tretten)

Alcohol interaction

Alcohol is not known to interact with NovoSeven RT.

However, drinking alcohol can make it harder for your blood to form clots. If you have hemophilia or another bleeding disorder, consuming alcohol can raise your risk of bleeding. For this reason, your doctor may recommend avoiding alcohol or limiting your intake.

If you have questions about how much alcohol is safe to drink with your bleeding disorder, talk with your doctor or pharmacist.

NovoSeven RT alternatives

Other drugs are available that may be able to treat your condition. Some may be a better fit for you than others. If you’re interested in finding an alternative to NovoSeven RT, talk with your doctor. They can tell you about other medications that may work well for you.

The following drugs are alternatives to NovoSeven RT:

• aminocaproic acid (Amicar)
• antihemophilic factor (recombinant), porcine sequence (Obizur)
• anti-inhibitor coagulant complex (Feiba)
• coagulation factor VIIa (recombinant)-jncw (Sevenfact)
• desmopressin (DDAVP)
• emicizumab-kxwh (Hemlibra)

Things to consider when taking NovoSeven RT

If you can become pregnant, consider the following information about pregnancy, fertility, birth control, and breastfeeding.

NovoSeven RT and pregnancy

It’s not known whether NovoSeven RT should be used during pregnancy. If you’re planning a pregnancy or can become pregnant, talk with your doctor before starting this medication.

NovoSeven RT and birth control

It’s not known whether NovoSeven RT is safe to use during pregnancy. If you’re sexually active and you or your partner can become pregnant, talk with your doctor about your birth control needs during NovoSeven RT treatment.

NovoSeven RT and breastfeeding

It’s not known whether NovoSeven RT should be used while breastfeeding. If you’re currently breastfeeding or planning to do so, talk with your doctor before using or receiving this medication.

How NovoSeven RT works

NovoSeven RT is used to treat bleeding episodes and help prevent bleeding related to surgery in people with the following bleeding disorders (see “NovoSeven RT uses” for additional details):

• hemophilia A or B with inhibitors
• acquired hemophilia
• congenital (present at birth) factor VII deficiency
• Glanzmann thrombasthenia

With these disorders, you have faulty, missing, or low levels of certain clotting factors (proteins that help blood clot) or platelets (blood cells that help blood clot). These problems make your blood take longer to form clots, which raises your risk of serious bleeding.

The process of blood clotting involves several different proteins and a sequence of chemical reactions. It’s often called the blood clotting cascade.

NovoSeven RT contains clotting factor VIIa (seven a). It works by allowing the clotting cascade to bypass the faulty or missing clotting factor or platelets. This helps your blood to form clots that stop bleeding.