Somatropin, mammalian derived (Injection)

Possible Side Effects While Using This Medicine

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Chest pain or uneven heartbeat.
• Fever, chills, cough, sore throat, and body aches.
• Increased thirst, hunger, or weakness, increase in how much or how often you urinate.
• Numbness, tingling or burning pain in your hands, arms, legs, or feet.
• Sudden and severe stomach pain, nausea, vomiting, fever, and lightheadedness.
• Vision changes, or severe headache.

If you notice these less serious side effects, talk with your doctor:

• Breast enlargement in men.
• Depression, or trouble sleeping.
• In a child: Hip or knee pain, or trouble walking.
• Joint or muscle pain.
• Pain or aching in your hands.
• Pain, redness, or swelling where the shot is given.
• Rapid weight gain.
• Rash.
• Swelling in your hands, ankles, or feet.

Introduction

Somatropin, Mammalian Derived (soe-ma-TROE-pin, mam-MAY-lee-un dee-RIVED)

Serostim® and Serostim® LQ promote weight gain and increase physical endurance in people with HIV or AIDS. Saizen® is used in children and adults when their bodies do not make enough growth hormone. Zorbtive? treats short bowel syndrome (SBS). This medicine is a human growth hormone.

Brand Name(s)

Serostim, Zorbtive, Saizen, Saizen Click Easy Cartridge

There may be other brand names for this medicine.

When This Medicine Should Not Be Used

You should not use this medicine if you have had an allergic reaction to somatropin or a similar growth hormone. You should not receive this medicine if you have a growing tumor (cancer), certain breathing problems, or if you are allergic to benzyl alcohol. You should not use this medicine if you have a severe illness after having surgery or a major medical emergency. Your child might not be able to use Saizen® if they have Prader-Willi syndrome, a brain tumor, or bones that are already grown. You should not use Zorbtive? if you are receiving chemotherapy treatments. You should not use this medicine unless you have a growth hormone deficiency.

How to Use This Medicine

Injectable

• Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given as a shot under your skin.Saizen® can also be given as a shot into one of your muscles.
• A nurse or other trained health professional will give you this medicine.
• You may be taught how to give your medicine at home. Make sure you understand all instructions before giving yourself an injection. Do not use more medicine or use it more often than your doctor tells you to.
• Allow Serostim® LQ to reach room temperature before giving yourself a shot.
• You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas.
• Use a new needle and syringe each time you inject your medicine.

If a dose is missed:

• Call your doctor or pharmacist for instructions.

How to Store and Dispose of This Medicine

• Saizen®, Serostim®, and Zorbtive? should be stored at room temperature, away from heat and direct light. Serostim® LQ must be stored in the refrigerator away from direct light. Keep from freezing.
• Once the powder medicine has been mixed with the liquid, this mixture must be stored in the refrigerator. Saizen® and Zorbtive? that has been mixed should be used within 14 days. Serostim® that has been mixed should be used within 24 hours. Make sure you understand how long you can store the medicine after it has been mixed. Throw away any mixed medicine that has not been used within this time.
• Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any leftover medicine, containers, and other supplies. You will also need to throw away old medicine after the expiration date has passed.
• Keep all medicine away from children and never share your medicine with anyone.

Drugs and Foods to Avoid

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you are using a steroid such as dexamethasone, prednisolone, prednisone, or Medrol®.

Warnings While Using This Medicine

• Make sure your doctor knows if you are pregnant or breast feeding.
• You should not breast feed if you have HIV or AIDS, because you may give the infection to your baby through your breast milk.
• Make sure your doctor knows if you have diabetes, psoriasis, or thyroid problems, or if you have had recent heart surgery or stomach surgery. Tell your doctor if you have a family history of diabetes.
• Serostim® is used with other medicines to treat HIV infection. Take all other medicines your doctor has prescribed as part of your combination treatment.
• Saizen® and Zorbtive? are usually mixed with Bacteriostatic Water for Injection. You should not use Bacteriostatic Water for Injection if you have had an allergic reaction to benzyl alcohol. Ask your pharmacist about other ways you can mix this medicine.
• Zorbtive? is one part of a therapy used to treat Short Bowel Syndrome. Carefully follow your doctor's instructions about any special diet. Take all other medicines or supplements your doctor has prescribed as part of your combination treatment.
• This medicine may raise or lower your blood sugar, or it may cover up symptoms of very low blood sugar (hypoglycemia).
• Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests.
• Your doctor will need to check your progress at regular visits while you are using this medicine. Be sure to keep all appointments.

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088