HUMATROPE- somatropin kit

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Somatropin (UNII: NQX9KB6PCL) (Somatropin - UNII:NQX9KB6PCL)

Available from:

Eli Lilly and Company

INN (International Name):

Somatropin

Composition:

Somatropin 5 mg in 5 mL

Administration route:

SUBCUTANEOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

HUMATROPE is indicated for the treatment of pediatric patients with: - growth failure due to inadequate secretion of endogenous growth hormone (GH), - short stature associated with Turner syndrome, - Idiopathic Short Stature (ISS), height standard deviation score (SDS) <-2.25, and associated with growth rates unlikely to permit attainment of adult height in the normal range, - short stature or growth failure in short stature homeobox-containing gene (SHOX) deficiency, - short stature born small for gestational age (SGA) with no catch-up growth by 2 years to 4 years of age. HUMATROPE is indicated for the replacement of endogenous GH in adults with GH deficiency. HUMATROPE is contraindicated in patients with: - Acute critical illness after open heart surgery, abdominal surgery or multiple accidental trauma, or those with acute respiratory failure due to the risk of increased mortality with use of pharmacologic doses of somatropin [see Warnings and Precautions (5.1)] . - Pediatri

Product summary:

HUMATROPE (somatropin) for injection is a white lyophilized powder available in the following cartridge sizes in Table 15: Cartridges Refrigerate cartridges of HUMATROPE and Diluent for HUMATROPE at 36° to 46°F (2° to 8°C). Avoid freezing Diluent for HUMATROPE. Store in the original carton to protect HUMATROPE from light.

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

HUMATROPE- SOMATROPIN
ELI LILLY AND COMPANY
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
HUMATROPE SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR HUMATROPE.
HUMATROPE (SOMATROPIN) FOR INJECTION, FOR SUBCUTANEOUS USE
INITIAL U.S. APPROVAL: 1987
INDICATIONS AND USAGE
HUMATROPE is a recombinant human growth hormone indicated for:
_Pediatric Patients:_ growth failure due to inadequate secretion of
endogenous growth hormone (GH);
short stature associated with Turner syndrome; Idiopathic Short
Stature (ISS), height standard
deviation score (SDS) <-2.25, and associated with growth rates
unlikely to permit attainment of adult
height in the normal range; short stature or growth failure in short
stature homeobox-containing gene
(SHOX) deficiency; short stature born small for gestational age (SGA)
with no catch-up growth by 2
years to 4 years of age. (1.1)
_Adult Patients:_ replacement of endogenous GH in adults with GH
deficiency. (1.2)
DOSAGE AND ADMINISTRATION
Administer by subcutaneous injection to the back of upper arm,
abdomen, buttock, or thigh with regular
rotation of injection sites. (2.1)
_Pediatric Dosage_ - divide the calculated weekly dosage into equal
doses given either 6, or 7 days per
week.
_GHD:_ 0.18 mg/kg/week to 0.3 mg/kg/week. (2.2)
_Turner Syndrome:_ Up to 0.375 mg/kg/week. (2.2)
_ISS:_ Up to 0.37 mg/kg/week. (2.2)
_SHOX Deficiency:_ 0.35 mg/kg/week. (2.2)
_SGA:_ Up to 0.47 mg/kg/week. (2.2)
_Adult Dosage_ - Either of the following two dosing regimens may be
used:
Non-weight based dosing: Initiate with a dose of approximately 0.2
mg/day (range: 0.15 mg/day-0.3
mg/day) and increase the dose every 1-2 months by increments of
approximately 0.1 mg/day-0.2
mg/day, according to individual patient requirements (2.3)
Weight-based dosing (Not recommended for obese patients): Initiate at
0.006 mg/kg daily and
increase the dose according to individual patient requirements to a
maximum of 0.0125 mg/kg daily
(2.3)
See Full Prescribi