HUMATROPE is indicated for the treatment of pediatric patients with:
\n\u2022 growth failure due to inadequate secretion of endogenous growth hormone (GH),
\n\u2022 short stature associated with Turner syndrome,
\n\u2022 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,
\n\u2022 short stature or growth failure in short stature homeobox-containing gene (SHOX) deficiency,
\n\u2022 short stature born small for gestational age (SGA) with no catch-up growth by 2 years to 4 years of age.
\n1.2 Adult Patients
\nHUMATROPE is indicated for the replacement of endogenous GH in adults with GH deficiency.
\n2 DOSAGE AND ADMINISTRATION
\n2.1 Administration and Use Instructions
\n\u2022 Therapy with HUMATROPE should be supervised by a physician who is experienced in the diagnosis and management of patients with the conditions for which HUMATROPE is indicated [see Indications and Usage
\n(1)].
\n\u2022 Fundoscopic examination should be performed routinely before initiating treatment with HUMATROPE to exclude preexisting papilledema, and periodically thereafter [see Warnings and Precautions (5.5)].
\n\u2022 Leave HUMATROPE at room temperature for 10 minutes prior to administration.
\n\u2022 Administer HUMATROPE by subcutaneous injection to the back of the upper arm, abdomen, buttock, or thigh with regular rotation of injection sites to avoid lipoatrophy.
\n2.2 Pediatric Dosage
\n\u2022 Individualize dosage for each patient based on the growth response.
\n\u2022 Divide the calculated weekly HUMATROPE dosage into equal doses given either 6 or 7 days per week.
\n\u2022 The recommended weekly dose in milligrams (mg) per kilogram (kg) of body weight for pediatric patients is:
\no Pediatric GH Deficiency: 0.18 mg\/kg\/week to 0.3 mg\/kg\/week (0.026 to 0.043 mg\/kg\/day)
\no Turner Syndrome: Up to 0.375 mg\/kg\/week (up to.054 mg\/kg\/day)
\no Idiopathic Short Stature: Up to 0.37 mg\/kg\/week (up to 0.053 mg\/kg\/day)
\no SHOX Deficiency: 0.35 mg\/kg\/week (0.05 mg\/kg\/day)
\no Small for Gestational Age (SGA): Up to 0.47 mg\/kg\/week (up to 0.067 mg\/kg\/day)
\n\uf0a7 In very short pediatric patients, height SDS less than -3, and older pubertal pediatric patients consider initiating treatment with a larger dose of HUMATROPE (up to 0.067 mg\/kg\/day). Consider a gradual reduction in dosage if substantial catch-up growth is observed during the first few years of therapy. In pediatric patients less than 4 years of age with less severe short stature, baseline height SDS values between -2 and -3, consider initiating treatment at 0.033 mg\/kg\/day and titrate the dose as needed.
\n\u2022 Assess compliance and evaluate other causes of poor growth such as hypothyroidism, under-nutrition, advanced bone age and antibodies to recombinant human GH if patients experience failure to increase height velocity, particularly during the first year of treatment.
\n\u2022 Discontinue HUMATROPE for stimulation of linear growth once epiphyseal fusion has occurred
\n2.3 Adult Dosage
\n\u2022 Patients who were treated with somatropin for GH deficiency in childhood and whose epiphyses are closed
\nshould be reevaluated before continuation of somatropin for GH deficient adults.
\n\u2022 Consider using a lower starting dose and smaller dose increment increases for geriatric patients as they may be at increased risk for adverse reactions with HUMATROPE than younger individuals
\n\u2022 Women may require higher doses and patients receiving oral estrogen may require higher doses
\n\u2022 Administer the prescribed dose daily.
\n\u2022 Either of two HUMATROPE dosing regimens may be used:
\no Non-weight based:
\n\uf0a7 Initiate HUMATROPE with a dose of approximately 0.2 mg\/day (range, 0.15 mg\/day to 0.3 mg\/day) and increase the dose every 1-2 months by increments of approximately 0.1 mg\/day to 0.2 mg\/day, according to individual patient requirements based on the clinical response and serum insulin-like growth factor 1 (IGF-1) concentrations.
\n\uf0a7 Use the patient\u2019s clinical response, adverse reactions, and determination of age- and gender-adjusted serum IGF-1 concentrations as guidance in dose titration.
\n4
\n\uf0a7 Maintenance dosages will vary considerably from person to person, and between male and female patients.
\no Weight-based:
\n\uf0a7 Initiate HUMATROPE at 0.006 mg\/kg daily and increase the dose according to individual patient requirements to a maximum of 0.0125 mg\/kg daily.
\n\uf0a7 Use the patient\u2019s clinical response, adverse reactions, and determination of age- and gender-adjusted serum IGF-1 concentrations as guidance in dose titration.
\n\uf0a7 Maintenance dosages will vary considerably from person to person, and between male and female patients
\n\uf0a7 Not recommended for obese patients as they are more likely to experience adverse reactions with this regimen.<\/p>","protected":false},"excerpt":{"rendered":"
HUMATROPE is indicated for the treatment of pediatric patients with: \u2022 growth failure due to inadequate secretion of endogenous growth<\/p>\n","protected":false},"featured_media":5411,"comment_status":"open","ping_status":"closed","template":"","meta":[],"product_brand":[],"product_cat":[76,3474],"product_tag":[],"class_list":{"0":"post-6756","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-hgh_peptido","7":"product_cat-packs","9":"first","10":"outofstock","11":"sale","12":"shipping-taxable","13":"purchasable","14":"product-type-simple"},"yoast_head":"\n