The dose of this medicine will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For injection dosage form:

For treatment of growth hormone deficiency:

Adults—

Non-weight based: At first, the usual dose is 0.15 to 0.3 milligrams (mg) injected under the skin once a day. Your doctor may adjust your dose if needed.

Weight-based: Dose is based on body weight and must be determined by your doctor. At first, the usual dose is not more than 0.006 milligram (mg) per kilogram (kg) of body weight injected under the skin once a day. Your doctor may adjust your dose if needed. However, the dose is usually not more than 0.025 to 0.0125 mg per kg of body weight per day.

: Dose is based on body weight and must be determined by your doctor. At first, the usual dose is not more than 0.005 mg per kg of body weight injected under the skin once a day. Your doctor may adjust your dose if needed.

: Dose is based on body weight and must be determined by your doctor. The weekly dose is up to 0.3 to 0.7 mg per kg of body weight injected under the skin and divided into daily doses. Your doctor may adjust your dose if needed.

: Dose is based on body weight and must be determined by your doctor. The usual dose is 0.06 mg per kg of body weight, given 3 times per week and injected under the skin or into a muscle. Your doctor may adjust your dose if needed.Children—

For treatment of growth failure due to chronic kidney disease:

Children—Dose is based on body weight and must be determined by your doctor. The weekly dose is up to 0.35 milligram (mg) per kilogram (kg) of body weight injected under the skin and divided into daily doses. Your doctor may adjust your dose if needed.

For treatment of idiopathic short stature:

Children—Dose is based on body weight and must be determined by your doctor. The weekly dose is up to 0.3 milligram (mg) per kilogram (kg) of body weight injected under the skin and divided into daily doses. Your doctor may adjust your dose if needed.

For treatment of short bowel syndrome:

Adults—Dose is based on body weight and must be determined by your doctor. At first, the usual dose is 0.1 milligram (mg) per kilogram (kg) of body weight injected under the skin once a day for 4 weeks. Your doctor may adjust your dose if needed.

Children—Use and dose must be determined by your doctor.

For treatment of short stature with Turner syndrome;

Children—Dose is based on body weight and must be determined by your doctor. The weekly dose is up to 0.375 milligram (mg) per kilogram (kg) of body weight injected under the skin and divided into equal doses 3 to 7 times per week. Your doctor may adjust your dose if needed.

What is Serostim (somatropin) for injection?

Serostim is an injectable prescription medicine used for the treatment of adults with HIV and wasting or cachexia to increase lean body mass and body weight and improve physical endurance. Treatment with antiretroviral therapy at the same time is necessary.

You should not take Serostim if you have:

• A critical illness from surgery, serious injuries, or a severe breathing problem
• Cancer or undergoing treatment for cancer
• Allergies to growth hormone or other ingredients in Serostim
• Eye problems caused by diabetes

What should I tell my doctor before using Serostim?

• If you have a critical illness from surgery, serious injury, or a severe breathing problem.
• If you are on antiretroviral therapy for HIV.
• If you have cancer or had cancer in the past.
• If you have diabetes, are at risk of getting diabetes, or have blood sugar levels that are higher than normal. New cases of type 2 diabetes have been reported in patients taking Serostim.
• If you are allergic to growth hormone, benzyl alcohol, sucrose, phosphoric acid or sodium hydroxide.
• If you have or had fluid retention/Carpal Tunnel Syndrome (swelling, particularly of hands and feet) and musculoskeletal discomfort (pain, swelling and/or stiffness of your bones, joints and muscles).
• If you have or had pancreatis (painful swelling and inflammation or the pancreas)
• If you are taking any other medicines (both prescription or over the counter), vitamins, or supplements because these medicines may affect each other. Your doctor may need to monitor for drug-drug interactions.
• If you are nursing, pregnant, or plan to become pregnant. It is not known if Serostim passes into your breast milk or could harm your unborn baby.

What are the most common side effects of Serostim?

• Bone, muscle, and joint pain or stiffness
• Swelling, especially in the hands or feet or around the eyes
• Tingling, numbness and pain in the fingers, thumb or wrist
• Breast enlargement in men
• Nausea
• Extreme tiredness

Other less common but serious side effects of Serostim are:

• High blood sugar (hyperglycemia/diabetes) which can include symptoms of increased thirst and urination, tiredness, or trouble concentrating
• Serious allergic reactions that require immediate medical attention
• Pain and tenderness in the abdomen
• Headaches, changes in vision, nausea or vomiting, which require immediate medical attention

These are not all of the possible side effects. Let your healthcare provider know about any side effects you experience.

You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

How should you administer Serostim®?

Patients and caregivers should be trained by a healthcare professional on how to mix and inject Serostim prior to use. Never share Serostim with another person, even if the needle is changed. Injection sites can include arms, legs, abdomen and should be changed daily.

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