somapacitan (Rx)

Brand and Other Names:Sogroya, somapacitan-beco

Dosing & Uses

AdultPediatricGeriatric

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

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Interactions

Interaction Checker

and somapacitan

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      Serious - Use Alternative

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              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)

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                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%)
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                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
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                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.

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                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%

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                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
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                Images

                No images available for this drug.
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                Patient Handout

                A Patient Handout is not currently available for this monograph.
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                Formulary

                FormularyPatient Discounts

                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.

                The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

                Tier Description
                1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
                2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
                3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
                4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                NC NOT COVERED – Drugs that are not covered by the plan.
                Code Definition
                PA Prior Authorization
                Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
                QL Quantity Limits
                Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
                ST Step Therapy
                Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
                OR Other Restrictions
                Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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                Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.