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#Post#: 7210--------------------------------------------------
Genryzon HGH is Produce by Pfizer 72 iu & 180 Pens
Information (Coming Soon)
DIR By: Road2HardCoreIron
Date: July 3, 2026, 9:04 pm
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IU Content in a 24 mg Genryzon Pen
A Genryzon 24 mg pen contains 72 International Units
(IU) of somatrogon IndiaMART.
This is because the active ingredient, somatrogon, is
standardized so that 1 mg equals 3 IU medxdrg.com.
Therefore:
24 mg × 3 IU/mg = 72 IU.
Key points:
Product: Genryzon (Somatrogon) 24 mg/1.2 mL
pre-filled pen Pfizer Labeling
Total IU per pen: 72 IU
Conversion factor: 1 mg hGH = 3 IU (applies to all
brands) medxdrg.com
Dose range: Each pen can deliver doses from 0.2 mg to
12 mg in 0.2 mg increments Pfizer Labeling.
Note: The total IU is the pen’s capacity, not the daily dose.
Your prescribed weekly dose will be a fraction of the total,
depending on your body weight and treatment plan. Always follow
your endocrinologist’s instructions for dosing.
GENRYZON® Summary of Product Information
GENERIC NAME: Somatrogon injection PRESENTATION: Somatrogon 24
mg/1.2 ml solution for injection in pre-filled pen and
Somatrogon 60
mg/1.2 ml solution for injection in pre-filled pen.
INDICATION(s): Somatrogon is indicated for the treatment of
children and adolescents from 3
years of age with growth disturbance due to insufficient
secretion of growth hormone DOSAGE AND ADMINISTRATION: The
recommended dose
is 0.66 mg/kg body weight administered once weekly by
subcutaneous injection. Each pre-filled pen is capable of
setting and delivering the dose
prescribed by the physician. When doses higher than 30 mg are
needed (i.e., bodyweight > 45 kg), two injections have to be
administered. For
patients switching from daily growth hormone medicinal products,
the weekly therapy with somatrogon may be initiated at a dose of
0.66
mg/kg/week on the day following their last daily injection.
Somatrogon dose may be adjusted as necessary, based on growth
velocity, adverse
reactions, body weight and serum insulin-like growth factor 1
(IGF-1) concentrations. Somatrogon is administered by
subcutaneous injection.
Somatrogon is to be injected in the abdomen, thighs, buttocks,
or upper arms. The site of injection should be rotated at each
administration.
Treatment should be discontinued when there is evidence of
closure of the epiphyseal growth plates. Treatment should also
be discontinued in
patients having achieved final height or near final height. The
safety and efficacy of somatrogon in patients over the age of 65
years have not
been established. Somatrogon has not been studied in patients
with renal impairment and hepatic impairment. The safety and
efficacy of
somatrogon in neonates, infants and children less than 3 years
of age have not yet been established. CONTRAINDICATIONS:
Hypersensitivity to
somatrogon or to any of the excipients. Somatrogon must not be
used when there is any evidence of activity of a tumour based on
experience
with daily growth hormone medicinal products. Intracranial
tumours must be inactive and antitumour therapy must be
completed prior to starting
growth hormone (GH) therapy. Treatment should be discontinued if
there is evidence of tumour growth. Somatrogon must not be used
for
growth promotion in children with closed epiphyses. Patients
with acute critical illness suffering complications following
open heart surgery,
abdominal surgery, multiple accidental trauma, acute respiratory
failure or similar conditions must not be treated with
somatrogon. WARNING
AND PRECAUTIONS: Hypersensitivity-Serious systemic
hypersensitivity reactions (e.g. anaphylaxis, angioedema) have
been reported with daily
growth hormone medicinal products. Hypoadrenalism- Based on
published data patients receiving daily growth hormone therapy
who have or
are at risk for pituitary hormone deficiency(s) may be at risk
for reduced serum cortisol levels and/or unmasking of central
(secondary)
hypoadrenalism. Thyroid function- Growth hormone increases the
extrathyroidal conversion of T4 to T3 and may unmask incipient
hypothyroidism. Prader-Willi syndrome- Somatrogon has not been
studied in patients with Prader-Willi syndrome. Glucose
metabolism-
Treatment with growth hormone medicinal products may reduce
insulin sensitivity and induce hyperglycaemia. Neoplasm- In
patients with
previous malignant disease, special attention should be given to
signs and symptoms of relapse. Benign intracranial hypertension-
Intracranial
hypertension (IH) with papilledema, ataxia, visual changes,
headache, nausea and/or vomiting has been reported in a small
number of patients
treated with growth hormone medicinal products. Acute critical
illness- The benefits of continued somatrogon treatment in this
situation should
be weighed against the potential risks involved Pancreatitis
-Although rare in patients treated with growth hormone medicinal
products,
pancreatitis should be considered in somatrogon-treated patients
Scoliosis- Because somatrogon increases growth rate, signs of
development or
progression of scoliosis should be monitored during treatment.
Epiphyseal disorders- Any paediatric patient with the onset of a
limp or complaints
of hip or knee pain during treatment should be carefully
evaluated. Oral oestrogen therapy- If a female patient taking
somatrogon begins or
discontinues oral oestrogen containing therapy, IGF-1 value
should be monitored to determine if the dose of growth hormone
should be adjusted
to maintain the serum IGF-1 levels within the normal range.
DRUG INTERACTIONS: No interactions studies in paediatrics have
been performed.
Glucocorticoids- Concomitant treatment with glucocorticoids may
inhibit the growth-promoting effects of somatrogon. Insulin and
hypoglycaemic medicinal products- In patients with diabetes
mellitus requiring medicinal product therapy, the dose of
insulin and/or
oral/injectable hypoglycaemic medicinal products may require
adjustment when somatrogon therapy is initiated. Thyroid
medicinal products
Treatment with daily growth hormone may unmask previously
undiagnosed or subclinical central hypothyroidism. Oral
oestrogen therapy- In
female patients on oral oestrogen-containing therapy, a higher
dose of somatrogon may be required. Drug-drug interaction
studies have not
been performed with somatrogon. Somatrogon has been shown to
induce CYP3A4 mRNA expression in vitro. The clinical
significance of this is
unknown. OVERDOSE: Single doses of somatrogon higher than 0.66
mg/kg/week have not been studied. Based on experience with daily
growth
hormone medicinal products, short-term overdose could lead
initially to hypoglycaemia and subsequently to hyperglycaemia.
Long-term
overdose could result in signs and symptoms of gigantism and/or
acromegaly consistent with the effects of growth hormone excess.
Treatment
of overdose with somatrogon should consist of general supportive
measures. ADVERSE REACTION: Very common (≥ 1/10)-
Injection site reactions
(injection site pain, erythema, pruritus, swelling, induration,
bruising, haemorrhage, warmth, hypertrophy, inflammation,
deformation, urticaria),
Pyrexia Common (≥ 1/100 to < 1/10)- Anaemia, Eosinophilia,
Hypothyroidism, Conjunctivitis Allergic, Arthralgia, Pain in
extremity.
PHARMACEUTICAL PRECAUTIONS: Store in a refrigerator (2 °C to 8
°C). Do not freeze. Keep somatrogon in the outer carton to
protect from light.
PHARMACOKINETICS / PHARMACODYNAMICS: Following subcutaneous
injection, serum concentrations increased slowly, peaking 6 to
18 hours
after dosing. There is no accumulation of somatrogon after once
weekly administration. In paediatric patients with GHD, the
population PK
estimated steady-state peak concentration following 0.66
mg/kg/week was 636 ng/mL. In paediatric patients with GHD, the
population PK
estimated apparent central volume of distribution was 0.728 L/kg
and apparent peripheral volume of distribution was 0.165 L/kg.
The metabolic
fate of somatrogon is believed to be classical protein
catabolism, with subsequent reclamation of the amino acids and
return to the systemic
circulation. In paediatric patients with GHD, the population PK
estimated apparent clearance was 0.0317 L/h/kg. With a
population PK estimated
effective half-life of 28.2 hours, somatrogon will be present in
the circulation for about 6 days after the last dose.
REFERENCE: Adapted from Local Product document GENRYZON
LPDGEN092022
Full prescription information available on request. For the use
only of registered medical practitioner, or a hospital or a
laboratory
HTML https://labeling.pfizer.com/ShowLabeling.aspx?id=17609
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