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Somatropin, Mammalian Derived (Injection) (Injectable)

(SAIZEN CLICK EASY CARTRIDGE)
Somatropin, Mammalian Derived (By injection)
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). This medicine is a human growth hormone.
Saizen , Saizen Click Easy Cartridge , Serostim , Zorbtive

When This Medicine Should Not Be Used:
Do 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 diabetes with eye problems, active cancer, or certain breathing problems or if you have a severe illness after surgery or a major medical emergency. Children might not be able to use Nutropin®, Nutropin AQ®, and Saizen® if they have Prader-Willi syndrome and are severely overweight or have severe breathing problems, a brain tumor, or bones that are already mature. Do not use Zorbtive® if you are receiving cancer treatments.

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 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. Read all instructions carefully to be sure you know how to use your device.
  • Each time you get your medicine, check to be sure you have received the proper device. 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.

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 use cyclosporine (Gengraf®, Neoral®, Sandimmune®), an oral estrogen hormone replacement, a steroid medicine (such as dexamethasone, prednisolone, prednisone, or Medrol®), or medicine for seizures (such as Depakote®, Dilantin®, Keppra™, Luminal®, or Tegretol®). Tell your doctor if you also use insulin or diabetes medicine that you take by mouth such as glyburide, metformin, Actos®, Amaryl®, Avandia®, or Glucotrol®.

Warnings While Using This Medicine:

  • Make sure your doctor knows if you are pregnant or breastfeeding. Tell your doctor if you have kidney disease, fluid retention (body swelling), pancreas problems, pituitary problems, psoriasis, or thyroid problems or if you have had recent heart or stomach surgery. Tell your doctor if you have a history of cancer or scoliosis.
  • Make sure your child's doctor knows 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 changes in your blood sugar. Make sure your doctor knows if you have diabetes or a family history of diabetes.
  • Check with your doctor immediately if headache, nausea, vomiting, or any other change in vision occurs during treatment. Your doctor may want an eye doctor to check your eyes.
  • This medicine may cause problems in the hip bone, especially in patients with growth hormone deficiency or Turner syndrome. Check with your doctor right away if you have a limp or pain in the hip or knee.
  • Pancreatitis has occurred rarely in some patients who receive this medicine. Tell your doctor right away if you have sudden and severe stomach pain, loss of appetite, nausea, vomiting, or fever.
  • 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.
  • Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments.

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 fast, pounding, or uneven heartbeat
  • Fever, chills, cough, sore throat, and body aches
  • Headache or vision problems
  • 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
  • Sudden and severe stomach pain, loss of appetite, nausea, or vomiting
  • Swelling in your hands, ankles, or feet
  • Hip or knee pain, or trouble walking (in children)

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