Dosing & Uses
Dosage Forms & Strengths
injection, solution
- 5mg/1.5mL (3.3mg/mL) prefilled pen
- 10mg/1.5mL (6.7mg/mL) prefilled pen
- 15mg/1.5mL (10mg/mL) prefilled pen
Growth Hormone Deficiency
Indicated for replacement of endogenous growth hormone in adults with growth hormone deficiency
Initial dose: 1.5 mg SC qWeek for either patients who are treatment naïve or those switching from daily growth hormone (somatropin)
Increase weekly dose q2-4weeks by ~0.5-1.5 mg until desired response achieved (based on clinical response and serum [insulinlike growth factor 1] IGF-1 concentrations)
Not to exceed 8 mg qWeek
Dosage Modifications
Decrease dose as necessary on the basis of adverse reactions and/or serum IGF-1 concentrations above the age- and sex-specific normal range
Hepatic impairment
- Mild (Child-Pugh A): No dose adjustment required
- Moderate (Child-Pugh B): Initiate with 1 mg SC qWeek and use smaller dose increment increases when titrating; not to exceed 4 mg qWeek
- Severe (Child-Pugh C): Not recommended
Renal impairment
- In general, systemic exposure tends to increase with decreasing eGFR
- 0.08 mg/kg dose at steady-state resulted in higher exposures in patients with renal impairment, which was most pronounced for patients with severe renal impairment and those requiring hemodialysis
- Higher IGF-1 levels were also observed with moderate and severe renal impairment and in patients requiring hemodialysis
Women receiving oral estrogen
- Initiate with 2 mg SC qWeek; titrate based on clinical response and serum IGF-1 concentrations
Dosing Considerations
Draw IGF-1 samples 3-4 days after the prior dose
Perform fundoscopic examination before initiating treatment to exclude preexisting papilledema; if papilledema identified, evaluate etiology and treat underlying cause before initiating treatment
Dosage Forms & Strengths
injection, solution
- 5mg/1.5mL (3.3mg/mL) prefilled pen
- 10mg/1.5mL (6.7mg/mL) prefilled pen
- 15mg/1.5mL (10mg/mL) prefilled pen
Growth Failure
Indicated for treatment of pediatric patients who have growth failure due to inadequate secretion of endogenous growth hormone (GH)
<2.5 years
- Safety and efficacy not established
≥2.5 years
- Initial: 0.16 mg/kg SC actual body weight once weekly for treatment-naïve patients and patients switching from daily growth hormone (HGH) (somatropin)
- Individualize dosage for each patient based on growth response
Switching from other HGH
- Choose preferred day of week for weekly dose
- Switching from daily HGH: Stop final dose of daily treatment the day before (or at least 8 hr before) taking first dose of once-weekly somapacitan
- Switching from other weekly HGH: Continue once-weekly dosing schedule
Dosage Modifications
Hepatic impairment
- Mild (Child-Pugh A): No dose adjustment required
- Moderate-to-severe (Child-Pugh B or C): Not recommended
Renal impairment
- In general, systemic exposure tends to increase with decreasing eGFR 0.08 mg/kg dose at steady-state resulted in higher exposures in patients with renal impairment, which was most pronounced for patients with severe renal impairment and those requiring hemodialysis
- Higher IGF-1 levels were also observed with moderate and severe renal impairment and in patients requiring hemodialysis
Dosing Considerations
Perform fundoscopic examination before initiating treatment to exclude preexisting papilledema; if papilledema identified, evaluate etiology and treat underlying cause before initiating treatment
Assess compliance and evaluate other causes of poor growth (eg, hypothyroidism, undernutrition, advanced bone age, antibodies to recombinant HGH) if patients experience failure to increase height velocity, particularly during first year of treatment
Patients who were treated with somapacitan for GH deficiency in childhood and whose epiphyses are closed should be reevaluated before continuing
Dosage Forms & Strengths
injection, solution
10mg/1.5mL (6.7mg/mL) prefilled pen
Growth Hormone Deficiency
Indicated for replacement of endogenous growth hormone in adults with growth hormone deficiency
Initial dose, age ≥65 years: 1 mg SC qWeek for either patients who are treatment naïve or those switching from daily growth hormone (somatropin)
Increase weekly dose q2-4weeks by small increments that are recommended for younger adults until desired response achieved (based on clinical response and serum IGF-1 concentrations)
Not to exceed 8 mg qWeek
Dosage Modifications
Decrease dose as necessary on the basis of adverse reactions and/or serum IGF-1 concentrations above the age- and sex-specific normal range
Hepatic impairment
- Mild: No dose adjustment required
- Moderate: Initiate with 1 mg SC qWeek and use smaller dose increment increases when titrating; not to exceed 4 mg qWeek
- Severe: Not recommended
Renal impairment
- In general, systemic exposure tends to increase with decreasing eGFR
- 0.08 mg/kg dose at steady-state resulted in higher exposures in patients with renal impairment, which was most pronounced for patients with severe renal impairment and those requiring hemodialysis
- Higher IGF-1 levels were also observed with moderate and severe renal impairment and in patients requiring hemodialysis
Women receiving oral estrogen
- Initiate with 2 mg SC qWeek; titrate based on clinical response and serum IGF-1 concentrations
Dosing Considerations
Draw IGF-1 samples 3-4 days after the prior dose
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (0)
Serious - Use Alternative (1)
- macimorelin
somapacitan decreases effects of macimorelin by Other (see comment). Avoid or Use Alternate Drug. Comment: Drugs affecting growth hormone (GH) release may impact accuracy of macrimorelin diagnostic testing for growth hormone deficiency. Discontinue GH products at least 1 week before administering macimorelin.
Monitor Closely (61)
- acarbose
somapacitan decreases effects of acarbose by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Growth hormone products may decrease insulin sensitivity, particularly at higher doses. Antidiabetic agents may require dose adjustment after initiating somapacitan. .
- albiglutide
somapacitan decreases effects of albiglutide by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Growth hormone products may decrease insulin sensitivity, particularly at higher doses. Antidiabetic agents may require dose adjustment after initiating somapacitan. .
- alogliptin
somapacitan decreases effects of alogliptin by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Growth hormone products may decrease insulin sensitivity, particularly at higher doses. Antidiabetic agents may require dose adjustment after initiating somapacitan. .
- bazedoxifene/conjugated estrogens
bazedoxifene/conjugated estrogens decreases effects of somapacitan by Other (see comment). Modify Therapy/Monitor Closely. Comment: Oral estrogens may reduce the serum IGF-1 response to somapacitan. Patients may require higher somapacitan dosages. See drug monograph for starting dose recommendations.
- betamethasone
somapacitan decreases effects of betamethasone by Other (see comment). Modify Therapy/Monitor Closely. Comment: Microsomal enzyme 11-beta-hydroxysteroid dehydrogenase type 1 (11-beta-HSD-1) required for cortisone conversion to its active metabolite, cortisol, in hepatic and adipose tissue. GH inhibits 11-beta-HSD-1. Patients treated with glucocorticoid for hypoadrenalism may require increased maintenance or stress doses after initiating somapacitan.
- bexagliflozin
somapacitan decreases effects of bexagliflozin by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Growth hormone products may decrease insulin sensitivity, particularly at higher doses. Antidiabetic agents may require dose adjustment after initiating growth hormone.
- canagliflozin
somapacitan decreases effects of canagliflozin by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Growth hormone products may decrease insulin sensitivity, particularly at higher doses. Antidiabetic agents may require dose adjustment after initiating somapacitan. .
- chlorpropamide
somapacitan decreases effects of chlorpropamide by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Growth hormone products may decrease insulin sensitivity, particularly at higher doses. Antidiabetic agents may require dose adjustment after initiating somapacitan. .
- conjugated estrogens
conjugated estrogens decreases effects of somapacitan by Other (see comment). Modify Therapy/Monitor Closely. Comment: Oral estrogens may reduce the serum IGF-1 response to somapacitan. Patients may require higher somapacitan dosages. See drug monograph for starting dose recommendations.
- conjugated estrogens, vaginal
conjugated estrogens, vaginal decreases effects of somapacitan by Other (see comment). Modify Therapy/Monitor Closely. Comment: Oral estrogens may reduce the serum IGF-1 response to somapacitan. Patients may require higher somapacitan dosages. See drug monograph for starting dose recommendations.
- cortisone
somapacitan decreases effects of cortisone by Other (see comment). Modify Therapy/Monitor Closely. Comment: Microsomal enzyme 11-beta-hydroxysteroid dehydrogenase type 1 (11-beta-HSD-1) required for cortisone conversion to its active metabolite, cortisol, in hepatic and adipose tissue. GH inhibits 11-beta-HSD-1. Patients treated with glucocorticoid for hypoadrenalism may require increased maintenance or stress doses after initiating somapacitan.
- dapagliflozin
somapacitan decreases effects of dapagliflozin by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Growth hormone products may decrease insulin sensitivity, particularly at higher doses. Antidiabetic agents may require dose adjustment after initiating somapacitan. .
- deflazacort
somapacitan decreases effects of deflazacort by Other (see comment). Modify Therapy/Monitor Closely. Comment: Microsomal enzyme 11-beta-hydroxysteroid dehydrogenase type 1 (11-beta-HSD-1) required for cortisone conversion to its active metabolite, cortisol, in hepatic and adipose tissue. GH inhibits 11-beta-HSD-1. Patients treated with glucocorticoid for hypoadrenalism may require increased maintenance or stress doses after initiating somapacitan.
- dexamethasone
somapacitan decreases effects of dexamethasone by Other (see comment). Modify Therapy/Monitor Closely. Comment: Microsomal enzyme 11-beta-hydroxysteroid dehydrogenase type 1 (11-beta-HSD-1) required for cortisone conversion to its active metabolite, cortisol, in hepatic and adipose tissue. GH inhibits 11-beta-HSD-1. Patients treated with glucocorticoid for hypoadrenalism may require increased maintenance or stress doses after initiating somapacitan.
- dulaglutide
somapacitan decreases effects of dulaglutide by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Growth hormone products may decrease insulin sensitivity, particularly at higher doses. Antidiabetic agents may require dose adjustment after initiating somapacitan. .
- empagliflozin
somapacitan decreases effects of empagliflozin by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Growth hormone products may decrease insulin sensitivity, particularly at higher doses. Antidiabetic agents may require dose adjustment after initiating somapacitan. .
- ertugliflozin
somapacitan decreases effects of ertugliflozin by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Growth hormone products may decrease insulin sensitivity, particularly at higher doses. Antidiabetic agents may require dose adjustment after initiating somapacitan. .
- estradiol
estradiol decreases effects of somapacitan by Other (see comment). Modify Therapy/Monitor Closely. Comment: Oral estrogens may reduce the serum IGF-1 response to somapacitan. Patients may require higher somapacitan dosages. See drug monograph for starting dose recommendations.
- estradiol vaginal
estradiol vaginal decreases effects of somapacitan by Other (see comment). Modify Therapy/Monitor Closely. Comment: Oral estrogens may reduce the serum IGF-1 response to somapacitan. Patients may require higher somapacitan dosages. See drug monograph for starting dose recommendations.
- estrogens conjugated synthetic
estrogens conjugated synthetic decreases effects of somapacitan by Other (see comment). Modify Therapy/Monitor Closely. Comment: Oral estrogens may reduce the serum IGF-1 response to somapacitan. Patients may require higher somapacitan dosages. See drug monograph for starting dose recommendations.
- estrogens esterified
estrogens esterified decreases effects of somapacitan by Other (see comment). Modify Therapy/Monitor Closely. Comment: Oral estrogens may reduce the serum IGF-1 response to somapacitan. Patients may require higher somapacitan dosages. See drug monograph for starting dose recommendations.
- estropipate
estropipate decreases effects of somapacitan by Other (see comment). Modify Therapy/Monitor Closely. Comment: Oral estrogens may reduce the serum IGF-1 response to somapacitan. Patients may require higher somapacitan dosages. See drug monograph for starting dose recommendations.
- exenatide injectable solution
somapacitan decreases effects of exenatide injectable solution by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Growth hormone products may decrease insulin sensitivity, particularly at higher doses. Antidiabetic agents may require dose adjustment after initiating somapacitan. .
- exenatide injectable suspension
somapacitan decreases effects of exenatide injectable suspension by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Growth hormone products may decrease insulin sensitivity, particularly at higher doses. Antidiabetic agents may require dose adjustment after initiating somapacitan. .
- exenatide subdermal implant
somapacitan decreases effects of exenatide subdermal implant by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Growth hormone products may decrease insulin sensitivity, particularly at higher doses. Antidiabetic agents may require dose adjustment after initiating somapacitan. .
- fludrocortisone
somapacitan decreases effects of fludrocortisone by Other (see comment). Modify Therapy/Monitor Closely. Comment: Microsomal enzyme 11-beta-hydroxysteroid dehydrogenase type 1 (11-beta-HSD-1) required for cortisone conversion to its active metabolite, cortisol, in hepatic and adipose tissue. GH inhibits 11-beta-HSD-1. Patients treated with glucocorticoid for hypoadrenalism may require increased maintenance or stress doses after initiating somapacitan.
- glimepiride
somapacitan decreases effects of glimepiride by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Growth hormone products may decrease insulin sensitivity, particularly at higher doses. Antidiabetic agents may require dose adjustment after initiating somapacitan. .
- glipizide
somapacitan decreases effects of glipizide by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Growth hormone products may decrease insulin sensitivity, particularly at higher doses. Antidiabetic agents may require dose adjustment after initiating somapacitan. .
- glyburide
somapacitan decreases effects of glyburide by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Growth hormone products may decrease insulin sensitivity, particularly at higher doses. Antidiabetic agents may require dose adjustment after initiating somapacitan. .
- hydrocortisone
somapacitan decreases effects of hydrocortisone by Other (see comment). Modify Therapy/Monitor Closely. Comment: Microsomal enzyme 11-beta-hydroxysteroid dehydrogenase type 1 (11-beta-HSD-1) required for cortisone conversion to its active metabolite, cortisol, in hepatic and adipose tissue. GH inhibits 11-beta-HSD-1. Patients treated with glucocorticoid for hypoadrenalism may require increased maintenance or stress doses after initiating somapacitan.
- insulin aspart
somapacitan decreases effects of insulin aspart by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Growth hormone products may decrease insulin sensitivity, particularly at higher doses. Antidiabetic agents may require dose adjustment after initiating somapacitan. .
- insulin aspart protamine/insulin aspart
somapacitan decreases effects of insulin aspart protamine/insulin aspart by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Growth hormone products may decrease insulin sensitivity, particularly at higher doses. Antidiabetic agents may require dose adjustment after initiating somapacitan. .
- insulin degludec
somapacitan decreases effects of insulin degludec by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Growth hormone products may decrease insulin sensitivity, particularly at higher doses. Antidiabetic agents may require dose adjustment after initiating somapacitan. .
- insulin detemir
somapacitan decreases effects of insulin detemir by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Growth hormone products may decrease insulin sensitivity, particularly at higher doses. Antidiabetic agents may require dose adjustment after initiating somapacitan. .
- insulin glargine
somapacitan decreases effects of insulin glargine by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Growth hormone products may decrease insulin sensitivity, particularly at higher doses. Antidiabetic agents may require dose adjustment after initiating somapacitan. .
- insulin glulisine
somapacitan decreases effects of insulin glulisine by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Growth hormone products may decrease insulin sensitivity, particularly at higher doses. Antidiabetic agents may require dose adjustment after initiating somapacitan. .
- insulin inhaled
somapacitan decreases effects of insulin inhaled by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Growth hormone products may decrease insulin sensitivity, particularly at higher doses. Antidiabetic agents may require dose adjustment after initiating somapacitan. .
- insulin isophane human/insulin regular human
somapacitan decreases effects of insulin isophane human/insulin regular human by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Growth hormone products may decrease insulin sensitivity, particularly at higher doses. Antidiabetic agents may require dose adjustment after initiating somapacitan. .
- insulin lispro
somapacitan decreases effects of insulin lispro by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Growth hormone products may decrease insulin sensitivity, particularly at higher doses. Antidiabetic agents may require dose adjustment after initiating somapacitan. .
- insulin lispro protamine/insulin lispro
somapacitan decreases effects of insulin lispro protamine/insulin lispro by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Growth hormone products may decrease insulin sensitivity, particularly at higher doses. Antidiabetic agents may require dose adjustment after initiating somapacitan. .
- insulin NPH
somapacitan decreases effects of insulin NPH by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Growth hormone products may decrease insulin sensitivity, particularly at higher doses. Antidiabetic agents may require dose adjustment after initiating somapacitan. .
- insulin regular human
somapacitan decreases effects of insulin regular human by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Growth hormone products may decrease insulin sensitivity, particularly at higher doses. Antidiabetic agents may require dose adjustment after initiating somapacitan. .
- linagliptin
somapacitan decreases effects of linagliptin by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Growth hormone products may decrease insulin sensitivity, particularly at higher doses. Antidiabetic agents may require dose adjustment after initiating somapacitan. .
- liraglutide
somapacitan decreases effects of liraglutide by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Growth hormone products may decrease insulin sensitivity, particularly at higher doses. Antidiabetic agents may require dose adjustment after initiating somapacitan. .
- lixisenatide (DSC)
somapacitan decreases effects of lixisenatide (DSC) by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Growth hormone products may decrease insulin sensitivity, particularly at higher doses. Antidiabetic agents may require dose adjustment after initiating somapacitan. .
- metformin
somapacitan decreases effects of metformin by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Growth hormone products may decrease insulin sensitivity, particularly at higher doses. Antidiabetic agents may require dose adjustment after initiating somapacitan. .
- methylprednisolone
somapacitan decreases effects of methylprednisolone by Other (see comment). Modify Therapy/Monitor Closely. Comment: Microsomal enzyme 11-beta-hydroxysteroid dehydrogenase type 1 (11-beta-HSD-1) required for cortisone conversion to its active metabolite, cortisol, in hepatic and adipose tissue. GH inhibits 11-beta-HSD-1. Patients treated with glucocorticoid for hypoadrenalism may require increased maintenance or stress doses after initiating somapacitan.
- miglitol
somapacitan decreases effects of miglitol by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Growth hormone products may decrease insulin sensitivity, particularly at higher doses. Antidiabetic agents may require dose adjustment after initiating somapacitan. .
- mometasone sinus implant
somapacitan decreases effects of mometasone sinus implant by Other (see comment). Modify Therapy/Monitor Closely. Comment: Microsomal enzyme 11-beta-hydroxysteroid dehydrogenase type 1 (11-beta-HSD-1) required for cortisone conversion to its active metabolite, cortisol, in hepatic and adipose tissue. GH inhibits 11-beta-HSD-1. Patients treated with glucocorticoid for hypoadrenalism may require increased maintenance or stress doses after initiating somapacitan.
- pioglitazone
somapacitan decreases effects of pioglitazone by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Growth hormone products may decrease insulin sensitivity, particularly at higher doses. Antidiabetic agents may require dose adjustment after initiating somapacitan. .
- pramlintide
somapacitan decreases effects of pramlintide by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Growth hormone products may decrease insulin sensitivity, particularly at higher doses. Antidiabetic agents may require dose adjustment after initiating somapacitan. .
- prednisolone
somapacitan decreases effects of prednisolone by Other (see comment). Modify Therapy/Monitor Closely. Comment: Microsomal enzyme 11-beta-hydroxysteroid dehydrogenase type 1 (11-beta-HSD-1) required for cortisone conversion to its active metabolite, cortisol, in hepatic and adipose tissue. GH inhibits 11-beta-HSD-1. Patients treated with glucocorticoid for hypoadrenalism may require increased maintenance or stress doses after initiating somapacitan.
- prednisone
somapacitan decreases effects of prednisone by Other (see comment). Modify Therapy/Monitor Closely. Comment: Microsomal enzyme 11-beta-hydroxysteroid dehydrogenase type 1 (11-beta-HSD-1) required for cortisone conversion to its active metabolite, cortisol, in hepatic and adipose tissue. GH inhibits 11-beta-HSD-1. Patients treated with glucocorticoid for hypoadrenalism may require increased maintenance or stress doses after initiating somapacitan.
- rosiglitazone
somapacitan decreases effects of rosiglitazone by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Growth hormone products may decrease insulin sensitivity, particularly at higher doses. Antidiabetic agents may require dose adjustment after initiating somapacitan. .
- saxagliptin
somapacitan decreases effects of saxagliptin by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Growth hormone products may decrease insulin sensitivity, particularly at higher doses. Antidiabetic agents may require dose adjustment after initiating somapacitan. .
- semaglutide
somapacitan decreases effects of semaglutide by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Growth hormone products may decrease insulin sensitivity, particularly at higher doses. Antidiabetic agents may require dose adjustment after initiating somapacitan. .
- sitagliptin
somapacitan decreases effects of sitagliptin by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Growth hormone products may decrease insulin sensitivity, particularly at higher doses. Antidiabetic agents may require dose adjustment after initiating somapacitan. .
- tolazamide
somapacitan decreases effects of tolazamide by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Growth hormone products may decrease insulin sensitivity, particularly at higher doses. Antidiabetic agents may require dose adjustment after initiating somapacitan. .
- tolbutamide
somapacitan decreases effects of tolbutamide by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Growth hormone products may decrease insulin sensitivity, particularly at higher doses. Antidiabetic agents may require dose adjustment after initiating somapacitan. .
- triamcinolone acetonide extended-release injectable suspension
somapacitan decreases effects of triamcinolone acetonide extended-release injectable suspension by Other (see comment). Modify Therapy/Monitor Closely. Comment: Microsomal enzyme 11-beta-hydroxysteroid dehydrogenase type 1 (11-beta-HSD-1) required for cortisone conversion to its active metabolite, cortisol, in hepatic and adipose tissue. GH inhibits 11-beta-HSD-1. Patients treated with glucocorticoid for hypoadrenalism may require increased maintenance or stress doses after initiating somapacitan.
- triamcinolone acetonide injectable suspension
somapacitan decreases effects of triamcinolone acetonide injectable suspension by Other (see comment). Modify Therapy/Monitor Closely. Comment: Microsomal enzyme 11-beta-hydroxysteroid dehydrogenase type 1 (11-beta-HSD-1) required for cortisone conversion to its active metabolite, cortisol, in hepatic and adipose tissue. GH inhibits 11-beta-HSD-1. Patients treated with glucocorticoid for hypoadrenalism may require increased maintenance or stress doses after initiating somapacitan.
Minor (0)
Adverse Effects
>10%
Pediatrics
- Nasopharyngitis (16.7%)
- Headache (12.1%)
1-10%
Pediatrics
- Pain in extremity (9.8%)
- Pyrexia (9.1%)
- Injection site reactions (6.1%)
- Diarrhea (4.5%)
- Nausea/Vomiting (4.5%)
- Bronchitis (3%)
Adults
- Back pain (10%)
- Arthralgia (6.7%)
- Dyspepsia (5%)
- Sleep disorder (4.2%)
- Dizziness (4.2%)
- Tonsillitis (3.3%)
- Peripheral edema (3.3%)
- Vomiting (3.3%)
- Adrenal insufficiency (3.3%)
- Hypertension (3.3%)
- Increased CPK (3.3%)
- Weight increased (3.3%)
- Anemia (2.5%)
Warnings
Contraindications
Acute critical illness after open heart surgery, abdominal surgery, multiple accidental trauma, or those with acute respiratory failure; risk of increased mortality with pharmacologic doses of somapacitan
Active malignancy
Hypersensitivity to drug or any of its excipients; systemic hypersensitivity reactions reported with other growth hormone products
Active proliferative or severe nonproliferative diabetic retinopathy
Pediatric patients with closed epiphyses
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 risk of sudden death
Cautions
Increased mortality reported after treatment with pharmacologic amounts of growth hormone products in patients with acute critical illness owing to complications following open heart surgery, abdominal surgery, and multiple accidental trauma, as well as those with acute respiratory failure
Serious systemic hypersensitivity reactions including anaphylactic reactions and angioedema reported
May decrease insulin sensitivity, particularly at higher doses; new-onset type 2 diabetes mellitus reported in patients taking growth hormone products; patients with undiagnosed prediabetes and diabetes mellitus may experience worsened glycemic control and become symptomatic; monitor glucose levels periodically in all patients receiving therapy, especially with prediabetes/diabetes or risk factors for diabetes mellitus (eg, obesity, family history)
Intracranial hypertension with papilledema, visual changes, headache, nausea, and/or vomiting reported with growth hormone products; symptoms usually occur within first 8 weeks of initiating; perform funduscopic examination before initiating and periodically thereafter; if papilledema observed by funduscopy during treatment, stop therapy; if intracranial hypertension diagnosed, may restart treatment at a lower dose after intracranial hypertension-associated signs and symptoms have resolved
Fluid retention may occur, manifested by edema and nerve compression syndromes, including carpal tunnel syndrome/paresthesia; these symptoms are usually transient and dose dependent
Patients receiving growth hormone therapy who have or are at risk for corticotropin deficiency may be at risk for reduced serum cortisol levels and/or unmasking of central (secondary) hypoadrenalism; additionally, those treated with glucocorticoid replacement for previously diagnosed hypoadrenalism may require increased maintenance or stress doses after initiating somapacitan
Undiagnosed/untreated hypothyroidism may prevent an optimal response; in patients with growth hormone deficiency, central (secondary) hypothyroidism may first become evident or worsen during treatment with growth hormone therapy; periodically monitor thyroid function
Slipped capital femoral epiphysis may occur more frequently in patients undergoing rapid growth; evaluate children with the onset of a limp or complaints of persistent hip or knee pain
Somatropin increases growth rate, and progression of preexisting scoliosis can occur in patients who experience rapid growth; has not been shown to increase scoliosis occurrence; monitor patients with history of scoliosis for disease progression
Pancreatitis reported; consider this in patients who develop persistent severe abdominal pain
SC administration at the same site over a long time may cause tissue lipohypertrophy or lipoatrophy; rotate injection sites
Increased serum levels of inorganic phosphorous, alkaline phosphatase, and parathyroid hormone may occur
Prader-Willi syndrome
- Fatalities reported after initiating therapy with somatropin in pediatric patients with Prader-Willi syndrome who had at least 1 of the following risk factors: severe obesity, history of upper airway obstruction or sleep apnea, or unidentified respiratory infection
- Males with these factors may be at greater risk than females
- Not indicated for treatment of pediatric patients who have growth failure due to genetically confirmed Prader-Willi syndrome
Malignancies
-
Active malignancy
- Increased risk of malignancy progression with growth hormone treatment in patients with active malignancy
- Any preexisting malignancy should be inactive, and its treatment complete before initiating somapacitan
- Discontinue drug if there is evidence of recurrent activity
-
Second neoplasm is pediatric patients
- In childhood cancer survivors who were treated with radiation to the brain/head for their first neoplasm and who developed subsequent GHD and were treated with somatropin, an increased risk of second neoplasm was reported
- Intracranial tumors, in particular meningiomas, were the most common of these second neoplasms
- Monitor all patients with a history of GHD secondary to an intracranial neoplasm while on somatropin therapy for progression or recurrence of the tumor
-
New malignancy during treatment
- Potential risk of malignant changes of preexisting nevi
- Monitor carefully for increased growth, or potential malignant changes, of preexisting nevi
- Advise patients to report changes in skin pigmentation or changes in nevi appearance
- Because children with certain rare genetic causes of short stature have an increased risk of developing malignancies, thoroughly consider the risks and benefits of starting somapacitan; if treatment is initiated, carefully monitor these patients for development of neoplasms
Drug interaction overview
-
Glucocorticoids
- Dosage modification of somapacitan
- Patients treated with glucocorticoid replacement for hypoadrenalism may require increased maintenance or stress doses after initiating somapacitan
- Microsomal enzyme 11 beta-hydroxysteroid dehydrogenase type 1 (11βHSD-1) required for conversion of cortisone to its active metabolite, cortisol, in hepatic and adipose tissue
- Growth hormone inhibits 11βHSD-1; consequently, individuals with untreated growth hormone deficiency have relative increases in 11βHSD-1 and serum cortisol
- Initiating somapacitan may inhibit 11βHSD-1 and reduce serum cortisol concentrations
-
CYP450 substrates
- Dosage modification of CYP450 substrates may be needed
- Limited data suggest growth hormone increases CYP450-mediated clearance
- Monitor CYP450 substrates
-
Oral estrogen
- Dosage modification of somapacitan
- Oral estrogens may reduce serum IGF-1 response to somapacitan
- Higher estrogen dosage may be required
-
Insulin and/or other hypoglycemic agents
- Dosage adjustment of insulin/hypoglycemic agents may be needed
- Somapacitan may decrease insulin sensitivity, particularly at higher doses
- Insulin or other hypoglycemia agents may require dose adjustment
Pregnancy & Lactation
Pregnancy
Data are not available regarding use in pregnant women
Published studies with short-acting recombinant growth hormone (rhGH) use in pregnant women over several decades have not identified any drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes
Animal data
- SC administration was not teratogenic in rats or rabbits during organogenesis at doses ~12 times the clinical exposure at the maximum recommended human dose (MRHD) of 8 mg/week
- No adverse developmental outcomes were observed in a prenatal and postnatal development study with administration to pregnant rats from organogenesis through lactation at ~275 times the clinical exposure at the MRHD
Lactation
Data are not available regarding presence in human milk, effects on breastfed infant, or effects on milk production
Somapacitan-related material was secreted into milk of lactating rats; when a substance is present in animal milk, it is likely to be present in human milk.
Available published data describing administration of short-acting rhGH to lactating women for 7 days reported that short-acting rhGH did not increase the normal breastmilk concentration of growth hormone and no adverse effects were reported in breastfed infants
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Long-acting human growth hormone derivative designed to bind to circulating albumin; it is based on a protein technology commonly used to formulate long-acting insulins and glucagonlike peptide-1
Binds to a dimeric growth hormone receptor in the cell membrane of target cells, resulting in intracellular signal transduction and a host of pharmacodynamic effects
Some of these pharmacodynamic effects are primarily mediated by insulin-like growth factor 1 (IGF-1) produced in the liver, while others are primarily a consequence of the direct effects of somapacitan
Absorption
Peak plasma concentration: 4-24 hr
Steady-state achieved following 1-2 weeks of once weekly dosing
Distribution
Protein bound: >99%
Vd: ~14.6 L
Metabolism
Metabolized via proteolytic cleavage of the linker sequence between the peptide backbone and albumin binder sidechain
Elimination
Half-life: ~2-3 days
Excretion: Urine ~81%; feces ~13%
Administration
SC Preparation
Write date of first use in space provided on carton
Always remove and safely discard needle after each injection and store prefilled pen without an injection needle attached
Always use a new needle for each injection to prevent contamination
Visually inspect for particulate matter and discoloration; solution should appear clear to slightly opalescent and colorless to slightly yellow
Do not use if solution is cloudy or contains particulate matter
SC Administration
Administer by SC injection once weekly, any time of the day, in upper arms, thigh, abdomen, or buttocks; rotate injection sites each week to avoid lipohypertrophy
Prefilled pens
- 5 mg/1.5 mL: Dials in 0.025-mg increments and delivers doses from 0.025-2 mg
- 10 mg/1.5 mL: Dials in 0.05-mg increments and delivers doses from 0.05-4 mg
- 15 mg/1.5 mL: Dials in 0.1-mg increments and delivers doses from 0.1-8 mg
Missed dose
- Administer missed dose as soon as possible, but not >3 days after the missed dose (72 hr)
- If >3 days have passed since missed dose, skip the dose and administer the next dose on the regular dosing day
Storage
Unused pen
- Refrigerate at 36-46ºF (2-8ºC) with cap on and in original carton to protect from light
- Do not freeze; do not use if it has been frozen
- May store at room temperature (up to 77°F [25°C]) for up to 72 hr; discard prefilled pen if kept above 86ºF (30ºC)
- Avoid direct or excessive heat
- Avoid sunlight
After first use
- Refrigerate at 36-46ºF (2-8ºC) with cap on for up to 6 weeks and in original carton to protect from light
- Do not freeze; do not use if it has been frozen
- May store at room temperature (up to 77°F [25°C]) for up to 72 hr; discard prefilled pen if kept above 86ºF (30ºC)
- Avoid direct or excessive heat
- Avoid sunlight
Images
Formulary
Adding plans allows you to compare formulary status to other drugs in the same class.
To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.
Adding plans allows you to:
- View the formulary and any restrictions for each plan.
- Manage and view all your plans together – even plans in different states.
- Compare formulary status to other drugs in the same class.
- Access your plan list on any device – mobile or desktop.
