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Information For Patients: Patients being treated with Serostim should be informed of the potential benefits and risks associated with treatment. Patients should be instructed to contact their physician should they experience any side effects or discomfort during treatment with Serostim.

It is recommended that Serostim be administered using sterile, disposable syringes and needles. Patients should be thoroughly instructed in the importance of proper disposal and cautioned against any reuse of needles and syringes. An appropriate container for the disposal of used syringes and needles should be employed.

Patients should be instructed to rotate injection sites to avoid lipodystrophy.

Drug Interactions: Formal in vitro drug interaction studies have not been conducted No data are available on drug interactions between Serostim and HIV protease inhibitors or the non-nucleoside reverse transcriptase inhibitors.

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.

Pregnancy: Pregnancy Category B. Reproduction studies have been performed in rats and rabbits. Doses up to 5 to 10 times the human dose, based on body surface area, have revealed no evidence of impaired fertility or harm to the fetus due to Serostim. There are, however, no adequate and well controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Nursing Women: It is not known whether Serostim is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Serostim is administered to a nursing woman.

Pediatric Use: Safety and effectiveness in pediatric patients with AIDS have not been established.

ADVERSE REACTIONS

In two placebo-controlled clinical trials in which 205 patients were treated with Serostim [somatropin (rDNA origin) for injection] the most common adverse reactions judged to be associated with Serostim were musculoskeletal discomfort and increased tissue turgor (swelling, particularly of the hands or feet) (see PRECAUTIONS: General). These symptoms were generally rated by investigators as mild to moderate in severity and usually subsided with continued treatment. Discontinuations as a result of these events were rare.

Because of the diverse clinical manifestations of AIDS, and the frequent occurrence of adverse events associated with underlying disease process, it was often difficult to distinguish adverse events possibly associated with the administration of Serostim from underlying signs or symptoms of AIDS or associated intercurrent illnesses.

Clinical adverse events which occurred during the first 12 weeks of study in at least 10% of those who received Serostim during the two placebo- controlled trials are listed below by treatment group, without regard to causality assessment.

Table 2: Controlled Trials Adverse Events

Adverse Event Serostim Placebo (n=205) (n=150) % %

Musculoskeletal discomfort 53.7 33.3 Fever 31.2 29.3 Increased tissue turgor 27.3 2.7 Diarrhea 25.9 20.0 Neuropathy 25.9 17.3 Nausea 25.9 16.0 Headache 19.0 20.7 Abdominal pain 17.1 18.7 Fatigue 17.1 16.0 Leukopenia 15.1 24.7 Albuminuria 15.1 9.3 Granulocytopenia 14.1 21.3 Lymphadenopathy 14.1 16.0 Increased sweating 14.1 8.7 Anorexia 12.2 9.3 Anemia 12.2 8.7 Vomiting 11.7 12.0 SGOT increased 11.7 6.0 Insomnia 11.2 9.3 Tachycardia 11.2 6.0 Hyperglycemia 10.2 6.0 SGPT increased 10.2 5.3

Adverse events that occurred in 1% to less than 10% of study participants receiving Serostim in the two placebo-controlled clinical efficacy studies are listed below by body system. The list of adverse events has been compiled regardless of causal relationship to Serostim.

Body as a Whole: rigors, flu-like symptoms, back pain, malaise, asthenia, carpal tunnel syndrome (see PRECAUTIONS: General), chest pain, hot flashes, allergic reaction.

Gastrointestinal System: oral leukoplakia, flatulence, dyspepsia, dry mouth, constipation, ulcerative stomatitis, increased amylase, dysphagia, esophagitis, colitis, pancreatitis, rectal disorder, gastritis, tongue ulceration, gingivitis

Musculoskeletal System: muscle weakness

Central and Peripheral Nervous System: dizziness, convulsions, hypertonia, neuralgia, tremor, encephalopathy, nystagmus, meningism

Respiratory System: dyspnea, coughing, sinusitis, upper respiratory tract infection, pharyngitis, rhinitis, pneumonia, bronchitis, increased sputum, respiratory disorder, bronchospasm, pneumonitis, pleurisy

White Blood Cell and Reticuloendothelial System Disorders: cervical lymphadenopathy, eosinophilia

Skin and appendages: skin disorder, folliculitis, rash, alopecia, photosensitivity reaction, erythematous rash, pruritus, abnormal pigmentation, seborrhea, dermatitis, skin ulceration, acne, skin discoloration, verruca Psychiatric: depression, anxiety, somnolence, nervousness, appetite increased, amnesia, abnormal thinking

Metabolic and Nutritional: hypertriglyceridemia, increased alkaline phosphatase, dehydration, increased creatinine phosphokinase, increased LDH, glycosuria, hypokalemia, cachexia, thirst, acidosis

Immune System Dysfunction: moniliasis, bacterial infection, Pneumocystis carinii infection, viral infection, infection, Herpes simplex, sepsis, abscess, fungal infection, Herpes zoster

Urinary System: hematuria, urinary tract infection, nocturia

Liver and Biliary System: abnormal hepatic function, hepatomegaly, hepatitis

Vision: retinitis, abnormal vision, photophobia

Platelet, Bleeding and Clotting: thrombocytopenia, purpura

Cardiovascular, General: abnormal ECG, heart murmur, hypertension, hypotension

Application Site: injection site pain, injection site reaction

Neoplasms: Kaposi's sarcoma

Male Reproductive: Epididymitis, penis disorder, inguinal hernia

Hearing and Vestibular: earache, ear disorder, decreasing hearing

Endocrine: gynecomastia, male breast pain

The types and incidences of adverse events reported in an open-label, extension trial and in a single, foreign trial, for up to one year, were not different from, or greater in frequency, than those observed in the primary, placebo-controlled, clinical trials.

OVERDOSAGE

Glucose intolerance can occur with overdosage. Long-term overdosage with growth hormone could result in signs and symptoms of acromegaly.

DOSAGE AND ADMINISTRATION

Serostim [somatropin (rDNA origin) for injection] should be administered subcutaneously daily at bedtime according to the following dosage recommendations:

Weight Range Dose*

>55 kg 6 mg SC daily 45-55 kg 5 mg SC daily 35-45 kg 4 mg SC daily

*Based on an approximate daily dosage of 0.1 mg/kg.

In patients who weigh less than 35 kg, Serostim_ should be administered at a dose of 0.1 mg/kg subcutaneously daily at bedtime.

Dose reductions for side effects felt to be related to treatment with Serostim, which are unresponsive to symptomatic treatment, may be effected by reducing the total daily dose or the number of doses given per week.

In patients who continue to lose weight at week 2, reevaluate for concurrent opportunistic infections or other clinical events.

Injection sites should be rotated.

Safety and effectiveness in pediatric patients with AIDS have not been established.

Each vial of Serostim 5 mg or 6 mg is reconstituted with 1 mL sterile water for injection.

To reconstitute Serostim, inject the diluent into the vial of Serostim aiming the liquid against the glass vial wall. Swirl the vial with a gentle rotary motion until contents are dissolved completely. The Serostim solution should be clear immediately after reconstitution. Do not inject Serostim if the reconstituted product is cloudy immediately after reconstitution or refrigeration. Occasionally, after refrigeration, small colorless particles may be present in the Serostim solution. This is not unusual for proteins like Serostim.

STABILITY AND STORAGE

Before reconstitution: Serostim [somatropin (rDNA origin) for injection] should be stored at room temperature, 59 deg. to 86 deg. F (15 deg. to 30 deg. C). Expiration dates are stated on product labels.

Copyright (c) 1996/PR NewsWire. Reproduced with permission. Reproduction of this article (other than one copy for personal reference) must be cleared through the Permissions Desk, PR Newswire, 810 Seventh Avenue, New York, NY 10019.
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