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Humogen is a human growth hormone produced by recombinant DNA
technology. Humogen has 191 amino acid residues and a molecular
weight of 22,125 daltons. Its amino acid sequence and structure
are identical to the dominant form of human pituitary growth
hormone. Humogen is produced by a mammalian cell line (mouse C127)
that has been modified by the addition of the human growth hormone
gene. Humogen, with the correct three-dimensional configuration,
is secreted directly through the cell membrane into the
cell-culture medium for collection and purification.
Humogen is a highly purified preparation. Biological potency is
determined by measuring the increase in body weight induced in
hypophysectomized rats.
Humogen is a sterile, non-pyrogenic, white, lyophilized powder
intended for subcutaneous or intramuscular injection after
reconstitution with Bacteriostatic Water for Injection, USP (0.9%
Benzyl Alcohol).
The quantitative composition per vial is:
5 mg vial:
Each vial contains 5 mg somatropin, 34.2 mg sucrose and 1.16 mg
O-phosphoric acid. The pH is adjusted with sodium hydroxide or
O-phosphoric acid.
8.8 mg vial:
Each vial contains 8.8 mg somatropin, 60.2 mg sucrose and 2.05 mg
O-phosphoric acid. The pH is adjusted with sodium hydroxide or
O-phosphoric acid.
The diluent is Bacteriostatic Water for Injection, USP containing
0.9% Benzyl Alcohol added as an antimicrobial preservative.
INDICATIONS
Pediatric Patients
Humogen [somatropin (rDNA origin) for injection] is indicated for
the long-term treatment of children with growth failure due to
inadequate secretion of endogenous growth hormone.
Adult Patients
Humogen [somatropin (rDNA origin) for injection] 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.
In general, confirmation of the diagnosis of adult growth hormone
deficiency in both groups usually requires an appropriate growth
hormone stimulation test. However, confirmatory growth hormone
stimulation testing may not be required in patients with
congenital/genetic growth hormone deficiency or multiple pituitary
hormone deficiencies due to organic disease.
DOSAGE AND ADMINISTRATION
Pediatric Growth Hormone Deficiency (GHD)
Humogen [somatropin (rDNA origin) for injection] dosage and
schedule of administration should be individualized for each
patient. The recommended weekly dosage is 0.18 mg/kg of body
weight. It should be divided into equal doses given either on 3
alternate days, 6 times per week or daily. The subcutaneous route
of administration is preferable; intramuscular injection is also
acceptable.
Treatment with Humogen of growth failure due to growth hormone
deficiency should be discontinued when the epiphyses are fused.
Patients who fail to respond adequately while on Humogen therapy
should be evaluated to determine the cause of unresponsiveness.
Adult Growth Hormone Deficiency (GHD)
Based on the weight-based dosing utilized in the original pivotal
study described herein, the recommended dosage at the start of
therapy is not more than 0.005 mg/kg given as a daily subcutaneous
injection. The dosage may be increased to not more than 0.01
mg/kg/day after 4 weeks according to individual patient
requirements. Clinical response, side effects, and determination
of age-and gender-adjusted serum IGF-I levels may be used as
guidance in dose titration.
Stability And Storage
Before Reconstitution - Humogen [somatropin (rDNA origin) for
injection] should be stored at room temperature
(15o-30oC/59o-86oF). Expiration dates are stated on the labels.
After Reconstitution - Humogen 5 mg and 8.8 mg vials reconstituted
with 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.
Humogen click.easy® cartridges reconstituted with the diluent
containing 0.3% (w/v) metacresol in Sterile Water for Injection
should be stored under refrigeration (2°-8°C/36°-46°F) for up to
21 days.
Avoid freezing reconstituted vials or cartridges of Humogen.
WARNINGS
There have been reports of fatalities after initiating therapy
with somatropin in pediatric patients with Prader-Willi syndrome
who had one or more of the following risk factors: severe obesity,
history of upper airway obstruction or sleep apnea, or
unidentified respiratory infection. Male patients with one or more
of these factors may be at greater risk than females. Patients
with Prader-Willi syndrome should be evaluated for signs of upper
airway obstruction and sleep apnea before initiation of treatment
with somatropin. If, during treatment with somatropin, patients
show signs of upper airway obstruction (including onset of or
increased snoring) and/or new onset sleep apnea, treatment should
be interrupted. All patients with Prader-Willi syndrome treated
with somatropin should also have effective weight control and be
monitored for signs of respiratory infection, which should be
diagnosed as early as possible and treated aggressively (see
CONTRAINDICATIONS). Unless patients with Prader-Willi syndrome
also have a diagnosis of growth hormone deficiency, Humogen is not
indicated for the long term treatment of pediatric patients who
have growth failure due to genetically confirmed Prader-Willi
syndrome.
CONTRAINDICATIONS
Humogen is contraindicated in patients with a known
hypersensitivity to somatropin or any of its excipients.
Humogen reconstituted with Bacteriostatic Water for Injection, USP
(0.9% Benzyl Alcohol) should not be administered to patients with
a known sensitivity to Benzyl Alcohol (see WARNINGS).
Somatropin should not be used for growth promotion in pediatric
patients with closed epiphyses.
Somatropin is contraindicated in patients with active
proliferative or severe non-proliferative diabetic retinopathy.
Presentation
Somatropin Injection
Each 1 ml Injection
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Quality
