Serostim

Name: Serostim

Indications

SEROSTIM (somatropin) is indicated for the treatment of HIV patients with wasting or cachexia to increase lean body mass and body weight, and improve physical endurance. Concomitant antiretroviral therapy is necessary.

What should i discuss with my healthcare provider before using somatropin?

Before you receive somatropin, tell your doctor if you have ever had an allergic reaction to a growth hormone medicine, or to drug preservatives such as benzyl alcohol, metacresol or glycerin.

You should not use this medication if you are allergic to somatropin, or if you have:

  • diabetic retinopathy (a serious eye condition caused by diabetes);
  • cancer; or
  • Prader-Willi syndrome and are also overweight or have sleep apnea or severe respiratory (lung) problems.

You should also not use somatropin if you have a serious medical condition after having:

  • open heart surgery or stomach surgery;
  • trauma or other medical emergency; or
  • breathing problems (such as lung failure).

To make sure you can safely take somatropin, tell your doctor if you have any of these other conditions:

  • liver disease;
  • kidney disease (or if you are on dialysis);
  • diabetes;
  • a pituitary gland disorder;
  • scoliosis;
  • high blood pressure (hypertension);
  • a pancreas disorder (especially in children);
  • a history of cancer;
  • carpal tunnel syndrome;
  • underactive thyroid; or
  • a brain tumor or lesion.

FDA pregnancy category B. Some brands of somatropin are not expected to harm an unborn baby, including Genotropin, Omnitrope, Saizen, Serostim, and Zorbtive.

FDA pregnancy category C. It is not known whether certain other brands of somatropin will harm an unborn baby, including Humatrope, Norditropin, Nutropin, and Tev-tropin.

Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether somatropin passes into breast milk or if it could harm a nursing baby. Do not use somatropin without telling your doctor if you are breast-feeding a baby.

Serostim (somatropin) side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Serious breathing problems may occur in patients with Prader-Willi syndrome who use somatropin. If you have Prader-Willi syndrome, call your doctor promptly if you develop signs of lung or breathing problems such as shortness of breath, coughing, or new or increased snoring.

Also call your doctor at once if you have:

  • vision changes with sudden and severe pain behind your eyes and nausea or vomiting;

  • pain in your knees or hips, or walking with a limp;

  • ear pain, swelling, warmth, or drainage;

  • numbness or tingling in your wrist, hand, or fingers;

  • severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate; or

  • high blood sugar--increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss.

Common side effects may include:

  • swelling, rapid weight gain;

  • muscle or joint pain;

  • headache; or

  • pain, itching, or skin changes where the medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Serostim (somatropin)?

Tell your doctor about all your current medicines and any you start or stop using, especially:

  • birth control pills or hormone replacement therapy

  • insulin or oral diabetes medicine; or

  • steroid medicine (prednisone, dexamethasone, methylprednisolone, and others).

This list is not complete. Other drugs may interact with somatropin, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

What do I need to tell my doctor BEFORE I take Serostim?

  • If you have an allergy to human growth hormone or any other part of Serostim (somatropin for weight gain).
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you have any of these health problems: Brain tumor, cancer, diabetic eye disease, illness shortly after open heart or belly surgery, many injuries from a crash, lung disease, or sleep apnea.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Serostim with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some other side effects of Serostim?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Headache.
  • Feeling tired or weak.
  • Muscle or joint pain.
  • Muscle stiffness.
  • Not able to sleep.
  • Upset stomach or throwing up.
  • Gas.
  • Belly pain.
  • Irritation where the shot is given.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Indications and Usage for Serostim

Serostim (somatropin) is indicated for the treatment of HIV patients with wasting or cachexia to increase lean body mass and body weight, and improve physical endurance. Concomitant antiretroviral therapy is necessary.

Dosage Forms and Strengths

Single-use administration (to be reconstituted with Sterile Water for Injection):

  • Serostim 5 mg per vial
  • Serostim 6 mg per vial

Multi-use administration (to be reconstituted with Bacteriostatic Water for Injection):

  • Serostim 4 mg per vial

Contraindications

  • Acute Critical Illness
    Growth hormone therapy should not be initiated in patients with acute critical illness due to complications following open heart or abdominal surgery, multiple accidental trauma or acute respiratory failure [see Warnings and Precautions (5.1)].
  • Active Malignancy
    In general, somatropin is contraindicated in the presence of active malignancy. Any preexisting malignancy should be inactive and its treatment complete prior to instituting therapy with somatropin. Somatropin should be discontinued if there is evidence of recurrent activity [see Warnings and Precautions (5.3)].
  • Hypersensitivity
    Serostim is contraindicated in patients with a known hypersensitivity to somatropin or any of its excipients. Systemic hypersensitivity reactions have been reported with postmarketing use of somatropin products [see Warnings and Precautions (5.6)].
  • Diabetic Retinopathy
    Somatropin is contraindicated in patients with active proliferative or severe non-proliferative diabetic retinopathy.

Overdosage

Short-Term

Acute overdosage could lead initially to hypoglycemia and subsequently to hyperglycemia.

Long-Term

Long-term overdosage could result in signs and symptoms of acromegaly consistent with the known effects of excess growth hormone.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term animal studies for carcinogenicity have not been performed with Serostim. There is no evidence from animal studies to date of Serostim-induced mutagenicity or impairment of fertility.

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