NUTROPIN AQ NUSPIN 5- somatropin injection, solution NUTROPIN AQ NUSPIN 10- somatropin injection, solution NUTROPIN AQ NUSPIN

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Genentech, Inc.

INN (International Name):

SOMATROPIN

Composition:

SOMATROPIN 10 mg in 2 mL

Administration route:

SUBCUTANEOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Growth Hormone Deficiency (GHD) - Nutropin AQ® is indicated for the treatment of pediatric patients who have growth failure due to inadequate secretion of endogenous growth hormone (GH). Growth Failure Secondary to Chronic Kidney Disease (CKD) - Nutropin AQ is indicated for the treatment of growth failure associated with CKD up to the time of renal transplantation. Nutropin AQ therapy should be used in conjunction with optimal management of CKD. Idiopathic Short Stature (ISS) - Nutropin AQ is indicated for the treatment of ISS, also called non-GHD short stature, defined by height SDS ≤ –2.25, and associated with growth rates unlikely to permit attainment of adult height in the normal range, in pediatric patients whose epiphyses are not closed and for whom diagnostic evaluation excludes other causes associated with short stature that should be observed or treated by other means. Short Stature Associated with Turner Syndrome (TS) - Nutropin AQ is indicated for the treatment of short stature associated wit

Product summary:

Storage and Handling Nutropin AQ cartridge and NuSpin injection device contents are stable for 28 days after initial use when stored at 2–8°C/36–46°F (under refrigeration). Avoid freezing Nutropin AQ in the cartridge or NuSpin injection device. Nutropin AQ is light sensitive and the cartridges and Nutropin AQ NuSpin should be protected from light. Store the cartridge and Nutropin AQ NuSpin injection device refrigerated in a dark place when they are not in use.

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

NUTROPIN AQ NUSPIN 5- SOMATROPIN INJECTION, SOLUTION
NUTROPIN AQ NUSPIN 10- SOMATROPIN INJECTION, SOLUTION
NUTROPIN AQ NUSPIN 20- SOMATROPIN INJECTION, SOLUTION
GENENTECH, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
NUTROPIN AQ SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR NUTROPIN AQ.
NUTROPIN AQ (SOMATROPIN) INJECTION, FOR SUBCUTANEOUS USE
INITIAL U.S. APPROVAL: 1987
RECENT MAJOR CHANGES
CONTRAINDICATIONS (4)
12/2016
WARNINGS AND PRECAUTIONS, (5)
12/2016
INDICATIONS AND USAGE
Nutropin AQ is a recombinant human growth hormone indicated for:
PEDIATRIC PATIENTS: Treatment of children with growth failure due to
growth hormone deficiency
(GHD), idiopathic short stature (ISS), Turner syndrome (TS), and
chronic kidney disease (CKD) up to the
time of renal transplantation (1.1).
ADULT PATIENTS: Treatment of adults with either childhood-onset or
adult-onset GHD (1.2).
DOSAGE AND ADMINISTRATION
Nutropin AQ should be administered subcutaneously (2).
Injection sites should always be rotated to avoid lipoatrophy (2.3).
_PEDIATRIC GHD:_
_PUBERTAL PATIENTS:_
_IDIOPATHIC SHORT STATURE:_
_CHRONIC KIDNEY DISEASE:_
_TURNER SYNDROME:_
_ADULT GHD:_ Either a non-weight based or weight-based dosing regimen
may be followed, with doses
adjusted based on treatment response and IGF-I concentrations (2.2).
Non-weight-based: A starting dose of approximately 0.2 mg/day (range
0.15–0.3 mg/day) increased
gradually every 1–2 months by increments of approximately 0.1–0.2
mg/day.
Weight-based: Initiate from not more than 0.006 mg/kg/day; the dose
may be increased up to a
maximum of 0.025 mg/kg/day in patients ≤ 35 years old or 0.0125
mg/kg/day in patients > 35 years
old.
DOSAGE FORMS AND STRENGTHS
Nutropin AQ is a sterile liquid available in the following pen
cartridge and NuSpin forms (3):
Pen Cartridge: 10 mg/2 mL (yellow color band), and 20 mg/2 mL (purple
color band).
NuSpin: 5 mg/2 mL (clear device), 10 mg/2 mL (green device), and 20
mg/2 mL (