INDICATION AND IMPORTANT RISK INFORMATION
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 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
Eye problems caused by diabetes
Allergies to growth hormone or other ingredients in Serostim vials
What should I tell my doctor before using SEROSTIM?
If you have cancer or had cancer in the past.
If you have diabetes, are at risk for 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 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 adjust the dose of Serostim or other medicines you are taking.
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 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
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 requires immediate medical attention
Serious allergic reactions that require immediate medical attention
Pain and tenderness in the abdomen
These are not all of the possible side effects. Let your doctor know about any side effects you experience. Your doctor may prescribe a pain reliever or may decrease your dose of Serostim to help manage some side effects.
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. Avoid injecting Serostim in areas that are sore or bruised.
References: 1. Serostim PI. 2. Moyle GJ, et al. J Acquir Immune Defic Syndr. 2004.
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