Omnitrope 5 mg/1.5 mL (3.3 mg/mL) subcutaneous cartridge

Generic name:
Somatropin - injection

Pronunciation
(so-mah-TROW-pin)

Brand name(s)
Genotropin , Humatrope , Norditropin , Nutropin , Saizen , Serostim , Zorbtive

Various brands of this medication are used for the treatment of one of the following medical conditions: growth failure, growth hormone deficiency, intestinal disorder (short bowel syndrome) or HIV-related weight loss or wasting.

Somatropin is also used to increase height in children with certain disorders (such as Noonan syndrome, Turner syndrome, idiopathic short stature).

Read the Patient Information Leaflet and Instructions for Use if available from your pharmacist before you start using this medication and each time you get a refill. Ask your health care professional how to prepare and use this medication. If you have any questions, ask your doctor or pharmacist.

Inject this medication under the skin as directed by your doctor. Some brands may also be injected into the muscle. Follow your doctor's instructions carefully. The dosage is based on your age, weight, medical condition and response to treatment.

Do not shake the medication. Before using, check this product for particles or discoloration. If either is present, do not use the liquid. Before injecting each dose, clean the skin you are going to inject into (the injection site) with rubbing alcohol. Change the injection site each time to lessen injury under the skin. To lessen bruising, do not rub the injection site after a shot. Learn how to store and discard medical supplies safely.

If you are using a pen device, do not share your pen device with another person, even if the needle is changed. You may give other people a serious infection, or get a serious infection from them.

If this medicine is used for short bowel syndrome, consult your doctor if a special diet (high carbohydrate/low-fat) or the use of nutritional supplements may be helpful.

If this medicine is used for weight loss/muscle wasting, it may take up to 2 weeks to notice the effects of the drug. Do not use more of this medication than prescribed or use it more often since the risk of side effects will be increased.

Headache, nausea, vomiting, tiredness, muscle pain, or weakness may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

• nausea/vomiting that doesn't stop
• development of a limp
• unusual tiredness
• unusual/unexplained weight gain
• cold intolerance
• fast/slow heartbeat
• ear pain/itching
• hearing problems
• joint/hip/knee pain
• numbness/tingling
• unusual increase in thirst or urination
• swelling hands/ankles/feet
• change in the appearance or size of any mole
• severe stomach/abdominal pain

Get medical help right away if you have any very serious side effects, including:

• vision problems/changes
• seizure
• severe headache

Rare (possibly fatal) lung/breathing problems may be caused by this medication in children with Prader-Willi syndrome. Those at higher risk include males, severely overweight children, or those with serious lung/breathing problems ( such as sleep apnea, lung infections, lung disease). Children should be checked for certain breathing problems (upper airway obstruction) before and during treatment. Heavy snoring or irregular breathing during sleep (sleep apnea) are signs of airway obstruction. Tell the doctor right away if these signs occur. Also report any signs of lung infection, such as fever, cough, or trouble breathing.

Somatropin may increase your risk of getting a tumor or cancer. Discuss the details and the risks and benefits of this medication with your doctor.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/severe swelling (especially of the face/tongue/throat)
• dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

See also Side Effects section.

Before using somatropin, tell your doctor or pharmacist if you are allergic to it; or to lonapegsomatropin; or if you have any other allergies. This product may contain inactive ingredients (such as benzyl alcohol or metacresol found in some brands), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• adrenal gland problems
• eye problems (such as diabetic retinopathy)
• recent major surgery/injury
• breathing problems
• diabetes or family history of diabetes
• obesity
• kidney disease
• cancer/tumor (especially of the head/neck)
• thyroid problems
• back problems (scoliosis)

If you have diabetes, this drug may increase your blood sugar. Check your blood sugar regularly as directed and share the results with your doctor. Tell your doctor right away if you have symptoms of high blood sugar such as increased thirst/urination. Your doctor may need to adjust your diabetes medication, exercise program, or diet.

When this medication is given to newborns, mix with sterile water for injection that does not contain a preservative. A preservative (benzyl alcohol) which may be found in the liquid used to mix this product can rarely cause serious problems (sometimes death), if given by injection to an infant during the first months of life. The risk is greater with lower birth weight infants and is greater with increased amounts of benzyl alcohol. Symptoms include sudden gasping, low blood pressure, or a very slow heartbeat. Report these symptoms to the doctor right away should they occur.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the side effects of this drug, especially effects on blood sugar, or swelling ankles/feet.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Somatropin is very similar to lonapegsomatropin. Do not use medications containing lonapegsomatropin while using somatropin.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669. Symptoms of overdose may include: severe headache, severe nausea/vomiting, signs of low blood sugar (such as sudden sweating, shaking, confusion), ongoing swelling of the hands and feet.

Do not share this medication with others.

Lab and/or medical tests (such as eye exams, thyroid function, glucose levels, growth hormone antibody levels) will be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.

It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule. Do not double the dose to catch up.

Consult the product instructions and your pharmacist for storage details. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.