Omnitrope (somatropin)

Omnitrope generic or biosimilar

Omnitrope is available only as a brand-name biologic drug. It isn’t available in a generic or biosimilar form.

Biologics are made using parts of living cells, while traditional drugs are made using chemicals. This allows traditional drugs to have generics that are exact copies of the active ingredient in a brand-name drug.

Instead of generics, biologics have biosimilars because they cannot be copied exactly. Like generics, biosimilars are considered to be as safe and effective as the original brand-name drug.

Note that several other brand-name biologic drugs are available that are similar to Omnitrope. For a list, see the “Similar drugs” section.

Omnitrope side effects

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

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

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 Omnitrope, you can do so through MedWatch.

Mild side effects

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

Mild side effects of Omnitrope can include:

• injection site reactions, such as a rash or lipoatrophy (dents or scars due to changes in your skin tissue)
• headache
• pain in your arms, legs, joints, or back
• arm or leg stiffness
• fluid retention, which may cause swelling in your arms, legs, and feet
• upper respiratory infection, such as colds

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 were rare during clinical trials of Omnitrope. However, the serious side effects listed below have been reported with similar medications. 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:

• changes in how your body regulates glucose (sugar), which can lead to diabetes (or make existing diabetes more challenging to manage)
• intracranial hypertension (increased pressure in the brain), which may cause papilledema (optic nerve swelling) and symptoms such as:
  • vision changes
• pancreatitis, which may cause symptoms such as:
  • pain in the upper abdomen
  • nausea, vomiting, or diarrhea
  • fever

Side effects in children

Many side effects of Omnitrope are similar in children and adults. But some side effects were reported in children that weren’t reported in adults. Also, the specific side effects may vary depending on the specific growth problem your child is receiving Omnitrope to treat.

Examples of side effects reported in children include:

• hematoma (a large, tender bruise)
• underactive thyroid
• aggressiveness or mood changes
• increased appetite
• hair loss
• a hip disorder called slipped capital femoral epiphysis, which may include symptoms such as:
  • pain, stiffness, or weakness in the affected leg
  • limping
  • difficulty walking

If you’d like more information about side effects of Omnitrope in children, talk with your doctor.

ALLERGIC REACTION

For some people, Omnitrope can cause an allergic reaction. Allergic reactions have been reported in people using Omnitrope, but this side effect did not occur during the drug’s clinical trials.

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 Omnitrope, your doctor may recommend taking a different medication instead.

Omnitrope price

As with all medications, the cost of Omnitrope 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 Omnitrope, or if you need help understanding your insurance coverage, help is available.

A program called OmniSource is available for Omnitrope. For more information and to find out if you’re eligible for support, call 877-456-6794 or visit the program website.

Generic or biosimilar version: Omnitrope is not available in a generic form or biosimilar form. It’s a biologic drug made from parts of living cells. Traditional drugs are made using chemicals, which allows generic drugs to have exact copies of the same active ingredient in the brand. But biologic drugs cannot be copied exactly.

As with generics, biosimilars are considered to be as safe and effective as the original brand-name drug. And they may cost less than brand-name drugs.

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

Common questions about Omnitrope

Here are answers to some frequently asked questions about Omnitrope.

Is Omnitrope used for IVF?

Possibly. In vitro fertilization (IVF) can be an off-label use of growth hormone. However, Omnitrope has not been approved by the Food and Drug Administration (FDA) for this purpose. (Off-label drug use is when an FDA-approved drug is prescribed for a purpose other than what it’s approved for.)

IVF is a treatment for infertility that helps people become pregnant when other methods haven’t worked. The process involves several steps to combine an egg and sperm outside the body. A doctor implants the fertilized egg in a person’s uterus (womb).

Doctors prescribe different medications during IVF. Some depend on the underlying cause of infertility. For instance, growth hormone is sometimes prescribed to help promote ovulation (the release of an egg) in people with low levels of a hormone called insulin-like growth factor (IGF-1). However, the evidence for the use of growth hormone in IVF has been mixed.

If you have questions about using growth hormone medication, such as Omnitrope for IVF, talk with your doctor.

Is Omnitrope used for bodybuilding?

Bodybuilders may turn to growth hormone injections, such as Omnitrope, to increase muscle mass. But studies show that these medications may not improve strength or physical performance.

Growth hormone injections may also cause side effects that negatively affect athletic performance. (Keep in mind that using growth hormone for athletic enhancement is illegal in the United States.)

Talk with your doctor about healthy ways to increase muscle mass.

Is Omnitrope similar to Genotropin, Norditropin, and Zomacton?

Yes, all four of these brand-name medications contain the same active ingredient: somatropin. They’re prescribed for growth hormone deficiency (GHD) and other growth problems in adults and children. They’re all given as subcutaneous injections.

If you have questions about how Omnitrope compares with other growth hormone injections, talk with your doctor or pharmacist. For details about the conditions Omnitrope is approved to treat, see the “Omnitrope uses” section.

How does Omnitrope work?

Omnitrope is a synthetic (lab-created) version of human growth hormone (HGH). It’s also known as recombinant HGH. It works by replacing the growth hormone that’s usually released by the pituitary gland in your brain.

In children, growth hormone is important for natural growth and development. Children whose bodies do not produce enough of this hormone typically have slowed growth and shorter stature.

Even after your body is done growing and developing, growth hormone is still important for many functions in adults. It helps regulate the metabolism of fats, protein, carbohydrates, and minerals. It also plays a role in the healthy functioning of bones, muscles, and other tissues. Adults whose bodies do not make enough growth hormones typically have low energy and other problems with their metabolism.

Talk with your doctor or pharmacist if you have questions about how Omnitrope works to treat your condition.

Omnitrope dosage

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

• the type and severity of the condition you’re using Omnitrope to treat
• your age and body weight
• the form of Omnitrope you use
• other medical conditions you may have

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

Drug forms and strengths

Omnitrope is available in two forms that come in different strengths. These forms and strengths are:

• cartridge prefilled with solution, for use in a reusable injection pen:
  • 5 milligrams (mg) in 1.5 milliliters (mL)
  • 12 mg in 1.5 mL
• vial of powder:
  • 5.8 mg

Omnitrope vials come with a vial of sterile water. If you use the vials, your doctor or another healthcare professional will teach you how to prepare the injection. It involves using a syringe to mix the powder and sterile water together to form a solution. (To learn more about this, see the “How to inject Omnitrope” section.)

Dosage for growth hormone deficiency (GHD) in adults

Omnitrope may be prescribed to treat growth hormone deficiency (GHD) in adults. (For details, see the “Omnitrope uses” section.)

The dosage of Omnitrope for GHD in adults may be based on body weight in kilograms (kg). In this case, the recommended starting dosage is 0.04 mg per kg (0.04 mg/kg) per week. This is divided into daily injections (6 to 7 days per week). For reference, 1 kg equals about 2.2 pounds (lb).

For example, an adult who weighs 60 kg (about 132 lb) may be prescribed an Omnitrope dosage of 2.4 mg per week. Your doctor will tell you how much to inject each day.

Your doctor may increase your dose every 4 to 8 weeks, depending on how your body responds to the medication. The typical maximum dosage is 0.08 mg/kg per week.

Alternatively, the Omnitrope dosage for adults does not have to be based on body weight. Using this approach, the recommended starting dose is approximately 0.2 mg per day. Your doctor may increase your dose every 1 to 2 months, depending on your body’s response.

Your doctor may adjust your dosage if you have side effects from Omnitrope.

Children’s dosage

Omnitrope is also approved for use in children of any age who have growth failure due to GHD or certain other conditions. (For details, see the “Omnitrope uses” section.)

The dosage of Omnitrope for children is based on their body weight and specific condition, as follows:

• GHD: 0.16 to 0.24 mg/kg per week
• Prader-Willi syndrome: 0.24 mg/kg per week
• Turner syndrome: 0.33 mg/kg per week
• Idiopathic short stature: up to 0.47 mg/kg per week
• Small for gestational age (SGA): up to 0.48 mg/kg per week

For example, a child with GHD who weighs 25 kg (about 55 lb) may be prescribed an Omnitrope dosage of 4 to 6 mg per week.

The dose is divided into daily injections (7 days per week) or may be divided over 6 days per week (with 1 day off). Your child’s doctor will tell you how much to inject and when.

How to inject Omnitrope

Your doctor or another healthcare professional will show you or a caregiver how to inject Omnitrope at home. Omnitrope is given as a subcutaneous injection.

Omnitrope can be injected under the skin of your abdomen, buttocks, or thigh. Be sure to use a different injection site for each dose. Reusing the same spot can damage the skin tissue and cause dents or scars.

For detailed instructions on how to use Omnitrope pen or Omnitrope vial and syringe, see the drug’s prescribing information. You can also visit the manufacturer’s website for instructional guides and videos.

About Omnitrope injections

Below you’ll find information about key dosage issues.

• When to inject: You’ll likely inject Omnitrope either once daily or once a day for 6 days per week. Always follow the dosage schedule your doctor prescribes.
• If you miss a dose: If you miss a dose of Omnitrope, inject it as soon as you remember. Then continue injecting your regular dose at the next typical time. If you have questions about what to do after missing doses of Omnitrope, talk with your doctor.
• Omnitrope and food: Omnitrope injections can be given at any time of day, with or without food.
• Length of treatment: Omnitrope is meant to be a long-term treatment. If you and your doctor determine that Omnitrope is safe and effective for you, you’ll likely receive the drug long term.
• Length of time to work: Omnitrope starts working from the first dose. But it may take several months to see a change in growth. Your doctor will check your height regularly to monitor how well the medication is working.

Overdose

Injecting more than the recommended dosage of Omnitrope can lead to serious side effects. Do not inject more Omnitrope than your doctor recommends.

Overdose symptoms

A short-term overdose of Omnitrope may cause symptoms such as high or low blood sugar and fluid retention in the body.

Injecting an overdose of growth hormone long term may lead to gigantism. Symptoms of this condition may include:

• changes in your facial features, such as a protruding jaw and a forehead that’s more prominent than usual
• enlarged hands and feet
• increased body hair

What to do in case of overdose

If you think you’ve injected 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.

Omnitrope uses

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

Omnitrope for growth hormone deficiency in adults

The FDA has approved Omnitrope to replace growth hormone in adults with growth hormone deficiency (GHD). This includes adults with either adult onset or childhood onset GHD.

With adult onset GHD, the condition starts after the age of 18 years. It may occur by itself or along with other hormone disorders. GHD can start in adulthood for different reasons. It may be the result of surgery, radiation treatments, traumatic injury, or disease affecting certain areas of the brain.

People with childhood onset GHD are usually born with this condition. Or it may have started for another reason, which may be known or unknown, during childhood.

Omnitrope for growth problems in children

The FDA has also approved Omnitrope to treat growth failure in children whose bodies don’t make enough growth hormone. Growth failure means the child grows slower than what is expected. It’s also known as failure to thrive.

More specifically, Omnitrope is approved to treat growth failure in children of any age who have growth failure due to one of the following conditions:

• GHD
• Prader-Willi syndrome
• Turner syndrome
• idiopathic short stature (idiopathic means without a known cause)

Omnitrope is also approved to treat growth failure in children who were born small for gestational age (SGA) and their growth hasn’t caught up by age 2 years.

SGA means their birth weight was lower than expected based on the length of the pregnancy. For instance, a low birth weight is expected for babies born prematurely but not for babies born on or after their due date (full term).

To learn more about GHD in children, view this list of articles.

Omnitrope interactions

Omnitrope can interact with several other medications.

Before using Omnitrope, 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 Omnitrope. This list does not contain all drugs that may interact with Omnitrope. If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.

Medications that can interact with Omnitrope include:

• other medications that contain benzyl alcohol
• corticosteroids, such as prednisone (Rayos) and cortisone
• oral estrogens, such as ethinyl estradiol (an ingredient in numerous birth control pills, such as Yaz) or estradiol (Estrace)
• insulin, such as insulin lispro (Humalog) or insulin glargine (Lantus, Toujeo, others)
• oral diabetes medications, such as metformin (Glumetza, Riomet, others) or glimepiride (Amaryl)
• medications, such as simvastatin (Zocor) and many others, that are broken down in the body by specific liver enzymes

Alcohol interaction

Alcohol is not known to interact with Omnitrope. If you drink alcohol, talk with your doctor or pharmacist if you have questions about how much is safe to drink while receiving Omnitrope.

Similar drugs

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

The following medications are similar to Omnitrope:

• somatrogon-ghla (Ngenla)
• lonapegsomatropin-tcgd (Skytrofa)
• somapacitan-beco (Sogroya)
• somatropin (Omnitrope’s active ingredient), available as several brand-name medications, including:
  • Accretropin
  • Genotropin
  • Humatrope
  • Norditropin
  • Nutropin
  • Nutropin AQ
  • Saizen
  • Serostim
  • Zomacton

Things to consider when using Omnitrope

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

Omnitrope and pregnancy

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

Omnitrope and breastfeeding

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