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Serostim

Generic Name: somatropin (rdna origin - nonrefrigerated) (SOE-ma-TROE-pin)
Brand Name: Serostim

Serostim is used for:

Treating wasting or cachexia (weight loss, loss of appetite) in certain patients with HIV infection. It is usually used along with other medicines that treat HIV infection. It may also be used for other conditions as determined by your doctor.

Serostim is a growth hormone. It works by increasing lean body weight, body mass, and physical endurance.

Do NOT use Serostim if:

  • you are allergic to any ingredient in Serostim or in the diluent
  • you have active or recurring cancer or brain tumor, or you currently receive treatment for cancer
  • you have severe breathing problems (eg, respiratory failure) or a serious illness caused by complications from a surgery or injury
  • you have a certain type of eye problem caused by diabetes (diabetic retinopathy)

Contact your doctor or health care provider right away if any of these apply to you.

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Before using Serostim:

Some medical conditions may interact with Serostim. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances (including benzyl alcohol)
  • if you have a history of lung or breathing problems (eg, airway blockage, respiratory infection, sleep apnea), an underactive thyroid, heart problems, high blood pressure, pancreas problems, liver or kidney problems, or endocrine problems (eg, pituitary or adrenal gland problems)
  • if you have a history of diabetes, high blood sugar levels, or if a member of your family has had diabetes
  • if you have a history of leukemia, other types of cancer (eg, skin cancer), or any unusual growths or tumors (especially in the brain)
  • if you have curvature of the spine (scoliosis), carpal tunnel syndrome, Prader-Willi syndrome, or a certain eye problem called papilledema (swelling of the area around your optic nerve)
  • if you are very overweight or have had a recent major surgery or injury

Some MEDICINES MAY INTERACT with Serostim. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Estrogens because they may decrease Serostim's effectiveness
  • Anticonvulsants (eg, carbamazepine) or cyclosporine because the risk of their side effects may be increased by Serostim
  • Corticosteroids (eg, cortisone, prednisone) or insulin or other medicines for diabetes because their effectiveness may be decreased by Serostim

This may not be a complete list of all interactions that may occur. Ask your health care provider if Serostim may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Serostim:

Use Serostim as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Serostim is given as an injection under the skin. A health care provider will teach you how to use it. Be sure you understand how to use Serostim. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
  • Serostim should be clear and colorless. Do not use Serostim if it contains particles, is cloudy or discolored, or if the container is cracked or damaged.
  • Do not shake Serostim. Swirl the vial gently to mix it.
  • Be sure to rotate your injection site as directed to help avoid thickening or hardening of the skin.
  • Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
  • If you miss a dose of Serostim, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Serostim.

Important safety information:

  • Do NOT use more than the recommended dose or change your dose without checking with your doctor.
  • Severe and sometimes fatal lung and breathing problems have occurred with the use of somatropin in certain children with Prader-Willi syndrome. These children were usually either very overweight or had severe breathing problems (eg, airway blockage, sleep apnea, lung or airway infection). The risk may be greater in boys. Children with Prader-Willi syndrome should have certain breathing tests before they start Serostim. They should be monitored for signs of lung or airway infection. They should also have effective weight control. Contact the doctor at once if the patient develops irregular breathing during sleep, new or increased snoring, or symptoms of lung or airway infection (eg, fever, coughing, sore throat, shortness of breath, chest pain or discomfort).
  • An increased risk of a second cancer has been seen in patients that had certain types of cancer as a child and received Serostim to treat the lack of growth hormone. Discuss any questions or concerns with your doctor.
  • Rarely, increased pressure in the head has been reported in patients using somatropin. The risk may be greater in patients with chronic kidney problems, Turner syndrome, or Prader-Willi syndrome. Symptoms usually occurred within the first 8 weeks after the start of treatment. The symptoms have gone away after the dose was lowered or treatment was stopped. Discuss any questions or concerns with your doctor. Contact your doctor right away if you develop symptoms such as vision changes or severe headache, nausea, or vomiting.
  • Pancreas inflammation (pancreatitis) has been reported rarely in patients who use Serostim. The risk may be greater in children, especially in girls who have Turner syndrome. Contact your doctor right away if you develop severe stomach or back pain.
  • Serostim may cause mild swelling (particularly in the hands or feet), or muscle or joint pain, swelling, or stiffness. These effects may go away on their own. If they persist or become bothersome, check with your doctor for ways to lessen these effects. Do not take any pain medicine unless your doctor tells you to.
  • Serostim may raise your blood sugar. High blood sugar may make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, urinate more often, or have a fruit-like breath odor. If these symptoms occur, tell your doctor right away.
  • Diabetes patients - Serostim may affect your blood sugar levels. Check your blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
  • Lab tests, including blood sugar levels, blood electrolytes, thyroid function, and eye exams, may be performed while you use Serostim. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Use Serostim with caution in the ELDERLY; they may be more sensitive to its effects.
  • Serostim may have benzyl alcohol in it. Do not use it in NEWBORNS or INFANTS. It may cause serious and sometimes fatal nervous system problems and other side effects.
  • Serostim should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Serostim while you are pregnant. It is not known if Serostim is found in breast milk. If you are or will be breast-feeding while you use Serostim, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Serostim:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Mild swelling (eg, of the hands or feet); muscle or joint pain; nausea.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); body pain or stiffness; breast enlargement; burning, numbness, or tingling; change in appearance or size of a mole; chest pain; depression; fast heartbeat; fever, chills, or persistent cough or sore throat; new growth on the skin; severe or persistent headache or dizziness; severe or persistent stomach or back pain, nausea, or vomiting; severe or persistent swelling of the ankles, legs, hands, or feet; shortness of breath; snoring or irregular breathing during sleep; symptoms of high blood sugar (eg, increased thirst, hunger, or urination; confusion; unusual drowsiness); thickened or hardened skin at the injection site; trouble breathing; unusual bruising; vision changes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include swelling of the ankles, feet, or hands; symptoms of high or low blood sugar (eg, dizziness; fainting; fast breathing; fast heartbeat; flushing; increased sweating; increased thirst, hunger, or urination; vision changes; unusual weakness).

Proper storage of Serostim:

Store new (unopened) vials at room temperature between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Do not use Serostim past the expiration date on the product label.

If you mix Serostim with bacteriostatic water for injection, the mixed medicine may be stored in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. Throw away mixed vials after 14 days, even if they still contain medicine.

If you mix Serostim with sterile water for injection, use it right away. Throw away any medicine left in the vial. Do not save medicine mixed with sterile water for injection for use at a later time.

Contact your pharmacist if you have questions about the proper storage of Serostim. Keep Serostim out of the reach of children and away from pets.

General information:

  • If you have any questions about Serostim, please talk with your doctor, pharmacist, or other health care provider.
  • Serostim is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take Serostim or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Serostim. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Serostim. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Serostim.

Issue Date: September 3, 2014
Database Edition 14.3.1.003
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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