About Treatment with Serostim^® (somatropin) for injection

You should not take Serostim^® (somatropin) if you have:

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

What is the most important information I need to know about Serostim^®?

• For patients with critical illness caused by certain types of heart or stomach surgery, serious injury or a sudden and severe breathing problem, there was an increase in death in those treated with Serostim^® compared to those patients not treated with Serostim^® (42% vs 19%).
• You must be on antiretroviral therapy.
• Cancer: Certain types are more common in people living with HIV.
• If you have, or are at high risk for, type 2 diabetes or have higher than normal blood sugar, talk to your doctor.
• Tell your doctor if you have changes in vision, headache, nausea, and/or vomiting which may be signs of increased brain pressure.
• Seek prompt medical attention if you have an allergic reaction while taking Serostim^®.
• You may have swelling, especially in the hands and feet, as well as discomfort in bones, joints, and muscles. This may lessen with analgesics or talk to your doctor about reducing Serostim^® dosing frequency.
• Carpal Tunnel Syndrome may occur, talk to your doctor about reducing the number of Serostim^® doses in a week. If not resolved, treatment should be stopped.
• If you have severe abdominal pain (possibly pancreatitis), call your doctor.

What are the most common side effects of Serostim^® reported in clinical trials in patients treated for HIV‑associated wasting or cachexia?

• Swelling, especially in the hands or feet or around the eyes
• Bone, muscle, and joint pain or stiffness
• Tingling, numbness and pain in the fingers, thumb or wrist
• Unusual skin sensations
• 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.
• Headaches, changes in vision, nausea or vomiting, which require immediate medical attention.
• Serious allergic reactions that require immediate medical attention.
• Pain and tenderness in the abdomen.

These are not all the possible side effects. Let your doctor know about any side effects you experience. Talk to your doctor or pharmacist about the following before taking Serostim^®

• If you are taking any other medicines (prescription or over the counter), vitamins, or supplements as these may affect each other. Your doctor may need to adjust the dose of Serostim^® or other medicines you are taking.
• Serostim^® should be used during pregnancy only if clearly needed.
• Caution should be used in nursing mothers as it is unknown if Serostim^® is passed in human milk.
• Safety and effectiveness in pediatric HIV patients have not been established.
• Unknown if HIV patients ≥ 65 years of age have a different response to Serostim^® than those <65 years of age.

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 to avoid injecting Serostim^® in areas that are sore or bruised.

What is Serostim^® (somatropin) for injection?

Serostim^® is an injectable prescription medicine used for the treatment of HIV‑positive patients with 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 are encouraged to report possible side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You can also contact EMD Serono at 1-800-283-8088 ext. 5563

Please see the full Prescribing Information for complete information on Serostim^® risks.