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. Nutropin®, Nutropin AQ®, and Saizen® are used in children and adults who do not make enough growth hormone. Nutropin® and Nutropin AQ® are used in children with growth failure caused by chronic kidney disease, idiopathic short stature, or Turner syndrome. Zorbtive® treats short bowel syndrome (SBS). Treats conditions in which a person's body does not grow properly or does not produce enough natural growth hormone. This medicine is a human growth hormone.

Brand Name(s):

Saizen, Saizen Saizenprep Cartridge, Serostim

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• This medicine is given as a shot under your skin in the stomach, buttock, upper arm, or thigh area or into your muscle.
• A nurse or other health provider 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.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• There are many different types of injection devices available for this medicine. Check if you have received the proper device each time you get your medicine. Talk to your pharmacist if you have questions about the device that you were given.
• Allow Serostim® LQ to reach room temperature before you give 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.
• You might not use all of the medicine in each vial (glass container). Use each vial only 1 time. Do not save an open vial. Do not use this medicine if it has changed color or you see particles in it.
• Missed dose: Call your doctor or pharmacist for instructions.
• The storage instructions differ from brand to brand. Ask your pharmacist how to store your brand of medicine. Make sure you know how long you can store this medicine after mixing.
  • • Saizen®, Serostim®, and Zorbtive®: Should be stored at room temperature, away from heat and direct light.
    • Nutropin®, Nutropin AQ®, and Serostim® LQ: Should be stored in the refrigerator away from direct light. Do not freeze.
  • Once the powder medicine has been mixed with the liquid, the mixture must be stored in the refrigerator.
    • Nutropin®, Saizen®, and Zorbtive®: Mixed medicine should be used within 14 days.
    • Nutropin AQ® vial, cartridge, and injection device should be used within 28 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.
  • You may store mixed Zomacton® in the refrigerator for up to 28 days. Do not freeze
• Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

Drugs and Foods to Avoid:

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

• Some medicines can affect how somatropin works. Tell your doctor if you are using any of the following:
  • Cyclosporine
  • Birth control pills or hormone replacement treatment (including estrogen)
  • Insulin or diabetes medicine
  • Medicine for seizures
  • Steroid medicine (including dexamethasone, hydrocortisone, methylprednisolone, prednisolone, prednisone)

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, diabetes, fluid retention (body swelling), pancreas problems, pituitary problems, psoriasis, thyroid problems, or you have had recent heart or stomach surgery. Tell your doctor if you have a history of cancer or scoliosis. Tell your child's doctor if your child has a history of ear infection.
• Serostim® is used with other medicines to treat HIV infection. Take all other medicine your doctor has prescribed as part of your combination treatment.Do not breastfeed. You can spread HIV or AIDS to your baby through your breast milk.
• This medicine may cause the following problems:
  • Hip bone dislocation
  • Increased risk for cancer
  • Changes in blood sugar levels
  • Increased pressure in the head
  • Fluid retention (extra water in the body)
  • Pancreatitis (swelling of the pancreas)
  • Changes in vision
• Nutropin®, Nutropin AQ®, 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 part of the treatment used to treat short bowel syndrome. Carefully follow your doctor's instructions about any special diet. Take all other medicine or supplements your doctor has prescribed as part of your combination treatment.
• Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

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
• Changes in skin color, dark freckles, weakness, tiredness, weight loss
• Chest pain, fast, pounding, or uneven heartbeat
• Decrease or loss of body fat, especially in the face, arms, legs, or buttocks
• Fever, chills, cough, sore throat, body aches
• Headache, pain behind your eyes, vision problems
• Hip or knee pain, limping
• Increased thirst, hunger, or tiredness, or increase in how much or how often you urinate
• Numbness, tingling or burning pain in your hands, arms, legs, or feet
• Rapid weight gain, swelling in your hands, ankles, or feet
• Sudden and severe stomach pain, loss of appetite, nausea, or vomiting
• Changes in skin color, dark freckles, weakness, tiredness, weight loss

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

• Pain or aching in your hands
• Pain, redness, or swelling where the shot was given
• Trouble sleeping

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