SAIZEN- somatropin kit SAIZENPREP- 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 5 mg in 3 mL

Administration route:

SUBCUTANEOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

SAIZEN (somatropin) is indicated for the treatment of pediatric patients with growth failure due to inadequate secretion of endogenous growth hormone. SAIZEN is indicated for replacement of endogenous growth hormone in adults with growth hormone deficiency who meet either of the following two criteria: Adult Onset Patients who have growth hormone deficiency, either alone or associated with multiple hormone deficiencies (hypopituitarism), as a result of pituitary disease, hypothalamic disease, surgery, radiation therapy, or trauma; or Childhood Onset Patients who were growth hormone deficient during childhood as a result of congenital, genetic, acquired, or idiopathic causes. Patients who were treated with somatropin for growth hormone deficiency in childhood and whose epiphyses are closed should be reevaluated before continuation of somatropin therapy at the reduced dose level recommended for growth hormone deficient adults. Confirmation of the diagnosis of adult growth hormone deficiency in both groups invol

Product summary:

SAIZEN can be administered using (1) a standard sterile disposable syringe and needle, (2) a compatible SAIZEN needle-free injection device or (3) a compatible SAIZEN needle injection device. For proper use, refer to the Instructions for Use provided with the administration device. SAIZEN is a sterile, non pyrogenic, white, lyophilized powder supplied in packages containing: 1 vial of 5 mg SAIZEN and 1 vial of Bacteriostatic Water for Injection, USP (0.9% Benzyl Alcohol) NDC 44087-1005-2 1 vial of 8.8 mg SAIZEN and 1 vial of Bacteriostatic Water for Injection, USP (0.9% Benzyl Alcohol) NDC 44087-1088-1 1 saizenprep® cartridge of 8.8 mg SAIZEN and 1.51 mL Sterile Water for Injection 0.3% (w/v) metacresol as antimicrobial preservative NDC 44087-0016-1 Before Reconstitution - SAIZEN should be stored at room temperature (15°-30°C/59°-86°F). Expiration dates are stated on the labels. After Reconstitution - SAIZEN 5 mg and 8.8 mg vials reconstituted with the Bacteriostatic Water for Injection, USP (0.9% Benzyl Alcohol) provided should be stored under refrigeration (2°–8°C/36°–46°F) for up to 14 days. SAIZEN 8.8 mg saizenprep® cartridge reconstituted with the Sterile Water for Injection, 0.3% (w/v) metacresol provided should be stored under refrigeration (2°-8°C/36°-46°F) for up to 21 days. Avoid freezing reconstituted vials or cartridges of SAIZEN.

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

SAIZEN - SOMATROPIN
SAIZENPREP- SOMATROPIN
EMD SERONO, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SAIZEN SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR SAIZEN.
SAIZEN (SOMATROPIN) FOR INJECTION, FOR SUBCUTANEOUS USE
INITIAL U.S. APPROVAL: 1987
INDICATIONS AND USAGE
SAIZEN is a recombinant human growth hormone indicated for:
_PEDIATRIC:_ Treatment of children with growth failure due to growth
hormone deficiency (GHD) (1.1)
_ADULT:_ Treatment of adults with either adult onset or childhood
onset GHD. (1.2)
DOSAGE AND ADMINISTRATION
PEDIATRIC GHD: 0.18 mg/kg/week, divided into equal doses given either
on 3 alternate days, 6 times
per week or daily (2.1)
ADULT GHD: Either a non-weight based or a weight based dosing regimen
may be followed, with doses
adjusted based on treatment response and IGF-1 concentrations (2.2)
Non-weight-based dosing: A starting dose of approximately 0.2 mg/day
(range, 0.15-0.30 mg/day) may
be used without consideration of body weight, and increased gradually
every 1 to 2 months by
increments of approximately 0.1 to 0.2 mg/day (2.2)
Weight-based dosing: The recommended initial dose is not more than
0.005 mg/kg/day; the dose may
be increased as tolerated to not more than 0.01 mg/kg/day after 4
weeks (2.2)
Injection sites should always be rotated to avoid lipoatrophy (2.3)
DOSAGE FORMS AND STRENGTHS
SAIZEN lyophilized powder in vial (3): 5 mg and 8.8 mg
saizenprep reconstitution device: One vial SAIZEN containing 8.8 mg
somatropin and one cartridge
diluent containing 1.51 mL 0.3% (w/v) metacresol in Sterile Water for
Injection
CONTRAINDICATIONS
Acute Critical Illness (4)
Children with Prader-Willi syndrome who are severely obese or have
severe respiratory impairment –
reports of sudden death (4)
Active Malignancy (4)
Hypersensitivity to somatropin or excipients (4)
Active Proliferative or Severe Non-Proliferative Diabetic Retinopathy
(4)
Children with closed epiphyses (4)
WARNINGS AND PRECAUTIONS
Acute Cr