Somatropin
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Dosing in kidney impairment
Perform fundoscopic examinations prior to initiation and periodically thereafter. If papilledema occurs, stop treatment. Hypersensitivity: Serious hypersensitivity reactions may occur. In the event of an allergic reaction, seek prompt medical attention. Fluid Retention: May occur in adults and may be dose dependent. Hypoadrenalism: Monitor patients for reduced serum cortisol levels and/or need for glucocorticoid dose increases in those with known hypoadrenalism.
Clinical manifestations of fluid retention (e.g. edema, arthralgia, myalgia, nerve compression syndromes including carpal tunnel syndrome/paresthesia) are usually transient and dose dependent. 5.8 Hypoadrenalism Patients receiving somatropin 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.
In addition, patients treated with glucocorticoid replacement for previously diagnosed hypoadrenalism may require an increase in their maintenance or stress doses following initiation of HUMATROPE treatment. Monitor patients for reduced serum cortisol levels and/or need for glucocorticoid dose increases in those with known hypoadrenalism [see Drug Interactions]. 5.9 Hypothyroidism Undiagnosed/untreated hypothyroidism may prevent an optimal response to HUMATROPE, in particular, the growth response in pediatric patients.
Preparation and administration
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Administration and Use Instructions 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] . Fundoscopic examination should be performed routinely before initiating treatment with HUMATROPE to exclude preexisting papilledema, and periodically thereafter [see Warnings and Precautions] .
Leave HUMATROPE at room temperature for 10 minutes prior to administration. 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.
Reconstitution of Cartridges Each single-patient-use HUMATROPE cartridge is designed for use only with the appropriate corresponding HumatroPen ® supplied separately. Reconstitute each cartridge of HUMATROPE using only the diluent syringe that accompanies the cartridge. Do not shake. The reconstituted solution should be clear.
Inspect visually for particulate matter and discoloration. If the resulting solution is cloudy or contains particulate matter do not use. The somatropin concentrations for the reconstituted HUMATROPE cartridges are as follows in Table 1 : [See table below.] Reconstituted cartridges of HUMATROPE are stable for up to 28 days when refrigerated at 36° to 46°F (2° to 8°C).
Do not leave at room temperature more than 30 minutes per day. Avoid freezing the reconstituted cartridge. Protect HUMATROPE from light during storage. For patients with known hypersensitivity to the diluent supplied with the HUMATROPE cartridge [see Warnings and Precautions] , do not use HUMATROPE cartridge.
| Cartridge | Somatropin Concentration | |
| 6 mg | 2.08 mg/mL | |
| 12 mg | 4.17 mg/mL | |
| 24 mg | 8.33 mg/mL | |
Drug interactions
Check somatropin against a medication listLabel text (6 paragraphs)
Table 8 includes a list of drugs with clinically important drug interactions when administered concomitantly with HUMATROPE and instructions for preventing or managing them. Table 8: Clinically Important Drug Interactions with HUMATROPE Replacement Glucocorticoid Treatment Clinical Impact: Microsomal enzyme 11β-hydroxysteroid dehydrogenase type 1 (11βHSD-1) is required for conversion of cortisone to its active metabolite, cortisol, in hepatic and adipose tissue. HUMATROPE inhibits 11βHSD-1. Consequently, individuals with untreated GH deficiency have relative increases in 11βHSD-1 and serum cortisol.
Initiation of HUMATROPE may result in inhibition of 11βHSD-1 and reduced serum cortisol concentrations. Intervention: Patients treated with glucocorticoid replacement for hypoadrenalism may require an increase in their maintenance or stress doses following initiation of HUMATROPE [see Warnings and Precautions ( 5.8 )]. Examples: Cortisone acetate and prednisone may be effected more than others since conversion of these drugs to their biologically active metabolites is dependent on the activity of 11βHSD-1.
Non-Replacement Glucocorticoid Treatment in Pediatric Patients Clinical Impact: Non-replacement glucocorticoid treatment, including supraphysiologic glucocorticoid treatment, may attenuate the growth promoting effects of HUMATROPE in pediatric patients. Intervention: Carefully adjust glucocorticoid dosing in pediatric patients receiving glucocorticoid treatments to avoid both hypoadrenalism and an inhibitory effect on growth. Cytochrome P450-Metabolized Drugs Clinical Impact: Limited published data indicate that somatropin treatment increases cytochrome P450 (CP450)-mediated antipyrine clearance. HUMATROPE may alter the clearance of compounds known to be metabolized by CP450 liver enzymes.
Intervention: Careful monitoring is advisable when HUMATROPE is administered in combination with drugs metabolized by CP450 liver enzymes. Oral Estrogen Clinical Impact: Oral estrogens may reduce the serum IGF-1 response to HUMATROPE. Intervention: Patients receiving oral estrogen may require greater HUMATROPE dosages [see Dosage and Administration ( 2.3 )] . Insulin and/or Other Hypoglycemic Agents Clinical Impact: Treatment with HUMATROPE may decrease insulin sensitivity, particularly at higher doses. Intervention: Patients with diabetes mellitus may require adjustment of their doses of insulin and/or other hypoglycemic agents [see Warnings and Precautions ( 5.4 )].
Replacement Glucocorticoid Treatment: Patients treated with glucocorticoids for hypoadrenalism may require an increase in their maintenance or stress doses following initiation of HUMATROPE. ( 7 ) Non-Replacement Glucocorticoid Treatment in Pediatric Patients: Adjust glucocorticoid dosing in pediatric patients receiving glucocorticoid treatment to avoid both hypoadrenalism and an inhibitory effect on growth. ( 7 ) Cytochrome P450-Metabolized Drugs: HUMATROPE may alter the clearance. Monitor carefully if used with HUMATROPE. ( 7 ) Oral Estrogen: Patients may require larger doses of HUMATROPE.
( 7 ) Insulin and/or Other Hypoglycemic Agents: Dose adjustment of insulin or hypoglycemic agent may be required. ( 5.4 , 7 )
Contraindications
4 CONTRAINDICATIONS 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 )] . Pediatric patients with Prader-Willi syndrome who are severely obese, have a history of upper airway obstruction or sleep apnea, or have severe respiratory impairment due to the risk of sudden death [see Warnings and Precautions ( 5.2 )] . Active malignancy [see Warnings and Precautions ( 5.3 )] .
Known hypersensitivity to somatropin or any of the excipients in HUMATROPE. Systemic hypersensitivity reactions have been reported with postmarketing use of somatropins [see Warnings and Precautions ( 5.6 )] . Active proliferative or severe non-proliferative diabetic retinopathy. Pediatric patients with closed epiphyses. Acute critical illness. ( 4 ) Pediatric patients with Prader-Willi syndrome who are severely obese, have history of upper airway obstruction or sleep apnea, or have severe respiratory impairment due to risk of sudden death. ( 4 ) Active malignancy. ( 4 ) Hypersensitivity to somatropin or excipients.
( 4 ) Active proliferative or severe non-proliferative diabetic retinopathy. ( 4 ) Pediatric patients with closed epiphyses. ( 4 )
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary Limited available data with somatropin use in pregnant women are insufficient to determine a drug-associated risk of adverse developmental outcomes. Animal reproduction studies have not been conducted with HUMATROPE. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.
Supply and cost
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