
Omnitrope
Omnitrope (somatropin) is a growth hormone therapy used to treat adults and children with low growth hormone. It's also used in children with certain conditions that affect growth, like Prader-Willi syndrome and Turner syndrome. The medication is given as an injection under the skin, usually once a day. Some side effects include headache, swelling, and joint pain.
What is Omnitrope (somatropin)?
What is Omnitrope (somatropin) used for?
- Growth problems caused by certain conditions in children (e.g., low growth hormone, Prader-Willi syndrome, small for gestational age, Turner syndrome, idiopathic short stature)
- Low growth hormone in adults
How Omnitrope (somatropin) works
Omnitrope (somatropin) is a recombinant human growth hormone medication. It works like the natural growth hormone your body makes.
In children, it helps bones and tissues grow. In both adults and children, it helps control important body functions to support overall metabolism.
Drug facts
| Common Brands | Omnitrope |
|---|---|
| Drug Class | Recombinant human growth hormone |
| Controlled Substance Classification | Not a controlled medication |
| Generic Status | No lower-cost generic available |
| Availability | Prescription only |
Side effects of Omnitrope (somatropin)
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Common Side Effects
Children
- Bruising (9%)
- Headache (7%)
- Leg pain (5%)
Adults*
- Swelling in the arms and legs (2-18%)
- Joint pain (3-17%)
- Upper respiratory infections (13-16%)
- Pain in the arms and legs (2-15%)
*Adult data comes from a study where a similar growth hormone medication was used.
Less Common Side Effects
- Injection site reaction
- Muscle pain
- Back pain
- Larger appetite
- Fever
- Hair loss
- Numbness or tingling
- Stiffness of the arms and legs
- Ear infections
Omnitrope (somatropin) serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Severe allergic reactions: skin rash, hives, itching, swelling of face or tongue, trouble breathing, chest tightness
- High pressure in the brain: changes in vision, headache, nausea, vomiting
- Swelling of the pancreas (pancreatitis): nausea, vomiting, severe stomach pain that spreads to your back
The following Omnitrope (somatropin) side effects have also been reported
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
More common
Bleeding gums
bloating or swelling of the face, arms, hands, ankles, lower legs, or feet
burning, numbness, pain, or tingling in all fingers except the smallest finger
coughing up blood
difficulty with breathing or swallowing
difficulty with moving
dizziness
increased menstrual flow or vaginal bleeding
muscle pain or stiffness
nosebleeds
not able to move
pain, swelling, or redness in the joints
prolonged bleeding from cuts
rapid weight gain
red or black, tarry stools
red or dark brown urine
tingling of the hands or feet
unusual weight gain or loss
Rare
Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
blurred vision
bone pain
change in personality
change in the ability to see colors, especially blue or yellow
changes in vision
chills
confusion
curved spine
darkened urine
fast heartbeat
flushed, dry skin
fracture
fruit-like breath odor
headache
increased hunger
increased thirst
increased urination
indigestion
limp pain in the hip or knee
loss of appetite
loss of consciousness
pains in the stomach, side, or abdomen, possibly radiating to the back
problems with walking or talking
seizures
stomachache
sweating
tumor
unusual tiredness or weakness
vomiting
yellow eyes or skin
Incidence not known
large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
skin lesions
tightness in the chest
unexplained weight loss
Get emergency help immediately if any of the following symptoms of overdose occur:
Symptoms of overdose
Backache
extreme weakness
increase in hand and foot size
increased volume of pale, diluted urine
pain in the arms or legs
stop in menstruation
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
Large, flat, blue, or purplish patches in the skin
unusually warm skin
Rare
Swelling of the breasts or breast soreness in both females and males
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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Pros and cons of Omnitrope (somatropin)
Pros
- Approved for many growth-related conditions in children
- Safe for children and adults
- Comes in a vial or pre-mixed pen
Cons
- Typically injected every day
- Requires regular monitoring
- Can cause injection site reactions and joint pain
Pharmacist tips for Omnitrope (somatropin)
- You'll typically inject Omnitrope (somatropin) almost every day, about 6 to 7 days each week. Check with your prescriber to confirm which days you should inject.
- Rotate where you inject Omnitrope (somatropin) each day, at least ½ inch from the site you used before. Using the same spot too often can damage fat tissue.
- You might have mild injection site reactions with Omnitrope (somatropin), like redness, swelling, or pain. These usually go away, but tell your care team if they don’t.
- Omnitrope (somatropin) can cause swelling in your body, such as in your hands, feet, or ankles. Let your care team know if this becomes uncomfortable or doesn’t go away.
- Omnitrope (somatropin) can raise your blood sugar. Tell your care team if you notice symptoms of high blood sugar like feeling more thirsty, urinating more often, or feeling tired.
- Tell your pharmacist and care team about all medications you take before starting Omnitrope (somatropin). It can interact with medications like steroids (e.g., prednisone), insulin, and thyroid medications, which might need dose adjustments.
- If your child is using Omnitrope (somatropin), their growth should be checked regularly. Tell their prescriber if they are limping or have hip or knee pain since it could mean they are growing too fast.
- Storage: Keep unused Omnitrope (somatropin) in the refrigerator. The pen/cartridge lasts 28 days after first use, and the vial lasts up to 21 weeks after mixing.
How to inject Omnitrope (somatropin):
- Before injecting Omnitrope (somatropin), review the instructions for use and ask your care team or pharmacist if you have questions.
- Wash your hands well with soap and water before injecting. Clean the injection site with an alcohol swab before giving your dose.
- If using the pen: Take a cartridge out of the refrigerator and let it sit at room temperature for about 30 minutes. Place the cartridge into the pen then attach the needle. Then follow instructions to prime the cartridge to remove any trapped air before your first dose.
- If using the vial: Mix the vial with the provided diluting liquid that comes in the kit.
- Inject Omnitrope (somatropin) under the skin of your thigh, buttock, or stomach. Avoid areas near your belly button or waistline.
- Pinch your skin and inject at a 45° to 90° angle straight into the skin. Press the plunger or button to inject the full dose.
- After injection, throw away needles and syringes in a sharps container to avoid injury. Check with your local waste removal company or health department to find out where to throw away the sharps container safely.
Risks and warnings for Omnitrope (somatropin)
Omnitrope (somatropin) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Higher risk of death during serious illness
- Risk factors: Open heart or stomach surgery | Serious injuries | Severe breathing problems
Using Omnitrope (somatropin) during a serious illness might raise the risk of death. This includes conditions like recovery after open heart or stomach surgery, serious injuries, or severe breathing problems.
Because of this risk, your care team will decide if it’s safe to continue Omnitrope (somatropin) if you become very sick. They'll weigh the benefits and risks before continuing treatment.
Higher risk of death in children with Prader-Willi syndrome
- Risk factors: Boys | Obesity | Blocked airways | Sleep apnea | Respiratory infection
Omnitrope (somatropin) is FDA approved to treat children with Prader-Willi syndrome, but extra care is needed. Some deaths have been reported, especially in boys with risk factors like severe obesity, breathing problems, or respiratory infections.
Before starting Omnitrope (somatropin), your child should be checked for breathing problems like sleep apnea. During treatment, tell your care team right away if your child snores more, has trouble breathing, or shows signs of infection, since they might have to stop the medication.
New or returning tumors
- Risk factors: History of cancer | Genetic causes of short stature
If you or your child had cancer in the past, there could be a higher risk of developing a new tumor while using Omnitrope (somatropin). Some tumors can also come back.
Your care team will monitor you closely during treatment. Tell them right away if you notice any symptoms of cancer, like headaches, vision problems, or changes in moles or skin growths.
High blood sugar
- Risk factors: Obesity | Turner syndrome | Family history of diabetes
Omnitrope (somatropin) can raise your blood sugar and make your body less sensitive to insulin. This might lead to new or worsening diabetes, especially if you have risk factors like obesity or a family history of diabetes.
If you have diabetes and take blood sugar-lowering medications, your dose might need to be adjusted. Your care team might also ask you to check your blood sugar regularly during treatment.
High pressure in the brain
- Risk factors: Turner syndrome | Prader-Willi syndrome
Omnitrope (somatropin) can rarely cause high pressure in the brain, also called intracranial hypertension. Symptoms include headache, vision changes, nausea, or vomiting, and they usually happen within the first 2 months of treatment. Your prescriber will probably perform routine exams to watch for this problem before you start the medication and throughout your treatment.
Severe allergic reactions
Severe allergic reactions can happen with Omnitrope (somatropin), including life-threatening reactions like anaphylaxis. Get medical help right away if you have symptoms like dizziness, a choking feeling, trouble breathing, nausea, or swelling of your eyes, lips, or tongue at any point during treatment.
Swelling in the body
- Risk factors: Adults
Omnitrope (somatropin) can cause your body to hold onto fluid, especially in adults. This might lead to swelling, joint or muscle pain, or tingling in your hands (like carpal tunnel symptoms). These side effects usually go away on their own or improve if your dose is lowered. Tell your care team if they bother you or don’t go away.
Low hormone levels
- Risk factors: Taking steroid medications | Turner syndrome | Children
Omnitrope (somatropin) can lower your cortisol levels, which is a hormone your body uses to handle stress and inflammation. The risk is higher if you're also taking steroid medications, like prednisone or methylprednisolone.
Omnitrope (somatropin) can also lower your thyroid hormone levels. This could make the medication work less well, especially for growth in children. Your care team will check your thyroid levels before and during treatment and adjust medications if needed.
Bone and growth changes in children
- Risk factors: Growing too fast
Omnitrope (somatropin) can sometimes cause a hip problem in children, especially when they're growing too fast. This can lead to serious bone damage if not treated. Tell your care team right away if your child starts limping or has hip or knee pain so they can be checked quickly.
Omnitrope (somatropin) can also worsen scoliosis in children who already have it and are growing quickly. Although the medication itself doesn't cause scoliosis. Tell your care team if you notice changes in your child's posture or back shape.
Ear infections and heart problems for people with Turner Syndrome
People with Turner syndrome have a higher risk of ear infections and hearing problems during treatment with Omnitrope (somatropin). They also have a higher risk for heart problems like high blood pressure or stroke. Your care team will check you closely during treatment to help catch and manage these problems early.
Fat tissue damage
Make sure you rotate where you inject Omnitrope (somatropin) each time. If you inject it in the same spot for a long time, it can damage the fat under your skin. This can cause dents or thinning in that area.
Swelling of the pancreas
- Risk factors: Children | Girls with Turner syndrome
It's rare, but Omnitrope (somatropin) can cause a serious problem called pancreatitis (swelling of the pancreas). Symptoms include nausea, vomiting, and severe stomach pain that may spread to your back. Stop using the medication and get help right away if you have these symptoms.
Benzyl alcohol warning for infants
- Risk factors: Infants
Some forms of Omnitrope (somatropin) contain benzyl alcohol, which can be dangerous for newborns and small babies. This can cause a condition called “gasping syndrome,” with symptoms like trouble breathing, low energy, and serious organ problems. Your care team will consider all sources of benzyl alcohol to keep your child safe.
Omnitrope (somatropin) dosage
Interactions between Omnitrope (somatropin) and other drugs
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
How much does Omnitrope (somatropin) cost?
$1,227.03
Omnitrope (somatropin) contraindications
Contraindications are specific health conditions or situations in which a person should not take a medication due to safety concerns. If you have any of the following conditions or if any of the following apply to you, let your healthcare provider know because Omnitrope (somatropin) will not be safe for you to take.
- Serious illness due to open heart surgery, stomach surgery, injury, or severe breathing problems
- Children with Prader-Willi syndrome with severe obesity, serious breathing problems, or sleep apnea
- Active cancer
- Allergy to somatropin
- Serious diabetic eye problem (diabetic retinopathy)
- Children whose bones have finished growing
What are alternatives to Omnitrope (somatropin)?
News about Omnitrope (somatropin)
