SEROSTIM- somatropin kit

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

SOMATROPIN (UNII: NQX9KB6PCL) (SOMATROPIN - UNII:NQX9KB6PCL)

Available from:

EMD Serono, Inc.

INN (International Name):

SOMATROPIN

Composition:

SOMATROPIN 4 mg in 1 mL

Administration route:

SUBCUTANEOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic 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. - 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

Product summary:

SEROSTIM is available in the following forms: Before reconstitution: Vials of SEROSTIM and diluent should be stored at room temperature, (15°-30°C/59°-86°F). Expiration dates are stated on product labels. Single-use vials: After reconstitution with Sterile Water for Injection, USP, the reconstituted solution should be used immediately and any unused portion should be discarded. Multi-use vials: After reconstitution with Bacteriostatic Water for Injection, USP (0.9% Benzyl Alcohol), the reconstituted solution should be stored under refrigeration (2-8°C/36-46° F) for up to 14 days. Avoid freezing reconstituted vials of SEROSTIM.

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

SEROSTIM - SOMATROPIN
EMD SERONO, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SEROSTIM SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR SEROSTIM.
SEROSTIM (SOMATROPIN) FOR INJECTION, FOR SUBCUTANEOUS USE
INITIAL U.S. APPROVAL: 1987
INDICATIONS AND USAGE
SEROSTIM is indicated for the treatment of HIV patients with wasting
or cachexia to increase lean body
mass and body weight, and improve physical endurance (1)
DOSAGE AND ADMINISTRATION
The recommended dose of SEROSTIM is 0.1 mg/kg subcutaneously (SC)
daily (up to 6 mg) at bedtime
for HIV patients with wasting or cachexia (2.1)
Injection sites, which may be located on thigh, upper arm, abdomen or
buttock, should be rotated to
avoid local irritation (2.2)
DOSAGE FORMS AND STRENGTHS
Single-dose administration (to be administered with Sterile Water for
Injection) (3):
Multi-dose administration (to be administered with Bacteriostatic
Water for Injection):
CONTRAINDICATIONS
Acute Critical Illness (4)
Active Malignancy (4)
Diabetic Retinopathy (4)
Hypersensitivity to somatropin or excipients (4)
WARNINGS AND PRECAUTIONS
Acute Critical Illness: Increased mortality in patients with acute
critical illness following open heart
surgery, abdominal surgery or multiple accidental trauma, or those
with acute respiratory failure has
been reported after treatment with pharmacologic amounts of somatropin
(5.1)
Concomitant Antiretroviral Therapy: In vitro experimental systems have
demonstrated the potential to
potentiate HIV replication. No significant somatropin-associated
increase in viral load was observed in
clinical trials. HIV patients should be maintained on antiretroviral
therapy for the duration of SEROSTIM
treatment (5.2)
Neoplasms: Monitor all patients with a history of any neoplasm
routinely while on somatropin therapy
for progression, recurrences, or development of a tumor (5.3)
Impaired Glucose Tolerance/Diabetes: May be unmasked. Periodically
monitor glucose levels. Dose
adjustment