Dosing & Uses
See pediatric dosing
Dosage Forms & Strengths
injection, lyophilized powder for reconstitution
- 3mg
- 3.6mg
- 4.3mg
- 5.2mg
- 6.3mg
- 7.6mg
- 9.1mg
- 11mg
- 13.3mg
- Available in a single-dose, dual-chamber, prefilled cartridge containing lonapegsomatropin in one chamber and water for injection (diluent) in the second chamber
Growth Hormone Deficiency
Indicated for treatment of pediatric patients aged ≥1 year who weigh ≥11.5 kg and have growth failure due to inadequate secretion of endogenous growth hormone (GH)
<1 year: Safety and efficacy not established
≥1 year and weighs ≥11.5 kg
- Naïve patients and patients switching from daily somatropin therapy: 0.24 mg/kg IV qWeek
- Individualize and titrate dosage based on response
- Discontinue once epiphyseal fusion has occurred
Dosage Modifications
Renal or hepatic impairment: No specific studies have been performed
Dosing Considerations
Assess compliance; evaluate other causes of poor growth such as hypothyroidism, undernutrition, advanced bone age, and antibodies to recombinant human GH if patients experience failure to increase height velocity, particularly during the first year of treatment
Switching from somatropin therapy to lonapegsomatropin
- Separate first dose of lonapegsomatropin and final dose of somatropin by at least 8 hr
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (0)
Serious - Use Alternative (0)
Monitor Closely (67)
- acarbose
lonapegsomatropin decreases effects of acarbose by Other (see comment). Modify Therapy/Monitor Closely. Comment: Closely monitor blood glucose when treated with antidiabetic agents. Lonapegsomatropin may decrease insulin sensitivity, particularly at higher doses. Patients with diabetes mellitus may require adjustment of their doses of insulin and/or other antihyperglycemic agents.
- albiglutide
lonapegsomatropin decreases effects of albiglutide by Other (see comment). Use Caution/Monitor. Comment: Closely monitor blood glucose when treated with antidiabetic agents. Lonapegsomatropin may decrease insulin sensitivity, particularly at higher doses. Patients with diabetes mellitus may require adjustment of their doses of insulin and/or other antihyperglycemic agents.
- alogliptin
lonapegsomatropin decreases effects of alogliptin by Other (see comment). Use Caution/Monitor. Comment: Closely monitor blood glucose when treated with antidiabetic agents. Lonapegsomatropin may decrease insulin sensitivity, particularly at higher doses. Patients with diabetes mellitus may require adjustment of their doses of insulin and/or other antihyperglycemic agents.
- bazedoxifene/conjugated estrogens
bazedoxifene/conjugated estrogens will decrease the level or effect of lonapegsomatropin by Other (see comment). Use Caution/Monitor. Oral estrogens may reduce serum insulin-like growth factor-1 response to lonapegsomatropin. Patients receiving oral estrogen replacement may require higher lonapegsomatropin dosages.
- betamethasone
lonapegsomatropin decreases effects of betamethasone by Other (see comment). Use Caution/Monitor. Comment: Growth hormone (GH) inhibits microsomal enzyme 11 beta-hydroxysteroid dehydrogenase type 1, which converts cortisone to its active metabolite, cortisol. Patients with untreated GH deficiency may have increases in serum cortisol, and initiation of lonapegsomatropin may result decreased serum cortisol. Patients with hypoadrenalism treated with glucocorticoids may require an increase glucocorticoid stress or maintenance doses following lonapegsomatropin initiation.
betamethasone decreases effects of lonapegsomatropin by Other (see comment). Use Caution/Monitor. Comment: Glucocorticoid therapy and supraphysiologic glucocorticoid treatment may attenuate the growth promoting effects of lonapegsomatropin in children. Carefully adjust glucocorticoid replacement dosing in children receiving glucocorticoid treatments to avoid both hypoadrenalism and an inhibitory effect on growth. - bexagliflozin
lonapegsomatropin 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
lonapegsomatropin decreases effects of canagliflozin by Other (see comment). Use Caution/Monitor. Comment: Closely monitor blood glucose when treated with antidiabetic agents. Lonapegsomatropin may decrease insulin sensitivity, particularly at higher doses. Patients with diabetes mellitus may require adjustment of their doses of insulin and/or other antihyperglycemic agents.
- chlorpropamide
lonapegsomatropin decreases effects of chlorpropamide by Other (see comment). Use Caution/Monitor. Comment: Closely monitor blood glucose when treated with antidiabetic agents. Lonapegsomatropin may decrease insulin sensitivity, particularly at higher doses. Patients with diabetes mellitus may require adjustment of their doses of insulin and/or other antihyperglycemic agents.
- conjugated estrogens
conjugated estrogens will decrease the level or effect of lonapegsomatropin by Other (see comment). Use Caution/Monitor. Oral estrogens may reduce serum insulin-like growth factor-1 response to lonapegsomatropin. Patients receiving oral estrogen replacement may require higher lonapegsomatropin dosages.
- corticotropin
lonapegsomatropin decreases effects of corticotropin by Other (see comment). Use Caution/Monitor. Comment: Growth hormone (GH) inhibits microsomal enzyme 11 beta-hydroxysteroid dehydrogenase type 1, which converts cortisone to its active metabolite, cortisol. Patients with untreated GH deficiency may have increases in serum cortisol, and initiation of lonapegsomatropin may result decreased serum cortisol. Patients with hypoadrenalism treated with glucocorticoids may require an increase glucocorticoid stress or maintenance doses following lonapegsomatropin initiation.
corticotropin decreases effects of lonapegsomatropin by Other (see comment). Use Caution/Monitor. Comment: Glucocorticoid therapy and supraphysiologic glucocorticoid treatment may attenuate the growth promoting effects of lonapegsomatropin in children. Carefully adjust glucocorticoid replacement dosing in children receiving glucocorticoid treatments to avoid both hypoadrenalism and an inhibitory effect on growth. - cortisone
lonapegsomatropin decreases effects of cortisone by Other (see comment). Use Caution/Monitor. Comment: Growth hormone (GH) inhibits microsomal enzyme 11 beta-hydroxysteroid dehydrogenase type 1, which converts cortisone to its active metabolite, cortisol. Patients with untreated GH deficiency may have increases in serum cortisol, and initiation of lonapegsomatropin may result decreased serum cortisol. Patients with hypoadrenalism treated with glucocorticoids may require an increase glucocorticoid stress or maintenance doses following lonapegsomatropin initiation.
cortisone decreases effects of lonapegsomatropin by Other (see comment). Use Caution/Monitor. Comment: Glucocorticoid therapy and supraphysiologic glucocorticoid treatment may attenuate the growth promoting effects of lonapegsomatropin in children. Carefully adjust glucocorticoid replacement dosing in children receiving glucocorticoid treatments to avoid both hypoadrenalism and an inhibitory effect on growth. - dapagliflozin
lonapegsomatropin decreases effects of dapagliflozin by Other (see comment). Use Caution/Monitor. Comment: Closely monitor blood glucose when treated with antidiabetic agents. Lonapegsomatropin may decrease insulin sensitivity, particularly at higher doses. Patients with diabetes mellitus may require adjustment of their doses of insulin and/or other antihyperglycemic agents.
- deflazacort
lonapegsomatropin decreases effects of deflazacort by Other (see comment). Use Caution/Monitor. Comment: Growth hormone (GH) inhibits microsomal enzyme 11 beta-hydroxysteroid dehydrogenase type 1, which converts cortisone to its active metabolite, cortisol. Patients with untreated GH deficiency may have increases in serum cortisol, and initiation of lonapegsomatropin may result decreased serum cortisol. Patients with hypoadrenalism treated with glucocorticoids may require an increase glucocorticoid stress or maintenance doses following lonapegsomatropin initiation.
deflazacort decreases effects of lonapegsomatropin by Other (see comment). Use Caution/Monitor. Comment: Glucocorticoid therapy and supraphysiologic glucocorticoid treatment may attenuate the growth promoting effects of lonapegsomatropin in children. Carefully adjust glucocorticoid replacement dosing in children receiving glucocorticoid treatments to avoid both hypoadrenalism and an inhibitory effect on growth. - dexamethasone
lonapegsomatropin decreases effects of dexamethasone by Other (see comment). Use Caution/Monitor. Comment: Growth hormone (GH) inhibits microsomal enzyme 11 beta-hydroxysteroid dehydrogenase type 1, which converts cortisone to its active metabolite, cortisol. Patients with untreated GH deficiency may have increases in serum cortisol, and initiation of lonapegsomatropin may result decreased serum cortisol. Patients with hypoadrenalism treated with glucocorticoids may require an increase glucocorticoid stress or maintenance doses following lonapegsomatropin initiation.
dexamethasone decreases effects of lonapegsomatropin by Other (see comment). Use Caution/Monitor. Comment: Glucocorticoid therapy and supraphysiologic glucocorticoid treatment may attenuate the growth promoting effects of lonapegsomatropin in children. Carefully adjust glucocorticoid replacement dosing in children receiving glucocorticoid treatments to avoid both hypoadrenalism and an inhibitory effect on growth. - dienogest/estradiol valerate
dienogest/estradiol valerate will decrease the level or effect of lonapegsomatropin by Other (see comment). Use Caution/Monitor. Oral estrogens may reduce serum insulin-like growth factor-1 response to lonapegsomatropin. Patients receiving oral estrogen replacement may require higher lonapegsomatropin dosages.
- drospirenone
drospirenone will decrease the level or effect of lonapegsomatropin by Other (see comment). Use Caution/Monitor. Oral estrogens may reduce serum insulin-like growth factor-1 response to lonapegsomatropin. Patients receiving oral estrogen replacement may require higher lonapegsomatropin dosages.
- dulaglutide
lonapegsomatropin decreases effects of dulaglutide by Other (see comment). Use Caution/Monitor. Comment: Closely monitor blood glucose when treated with antidiabetic agents. Lonapegsomatropin may decrease insulin sensitivity, particularly at higher doses. Patients with diabetes mellitus may require adjustment of their doses of insulin and/or other antihyperglycemic agents.
- empagliflozin
lonapegsomatropin decreases effects of empagliflozin by Other (see comment). Use Caution/Monitor. Comment: Closely monitor blood glucose when treated with antidiabetic agents. Lonapegsomatropin may decrease insulin sensitivity, particularly at higher doses. Patients with diabetes mellitus may require adjustment of their doses of insulin and/or other antihyperglycemic agents.
- ertugliflozin
lonapegsomatropin decreases effects of ertugliflozin by Other (see comment). Use Caution/Monitor. Comment: Closely monitor blood glucose when treated with antidiabetic agents. Lonapegsomatropin may decrease insulin sensitivity, particularly at higher doses. Patients with diabetes mellitus may require adjustment of their doses of insulin and/or other antihyperglycemic agents.
- estrogens conjugated synthetic
estrogens conjugated synthetic will decrease the level or effect of lonapegsomatropin by Other (see comment). Use Caution/Monitor. Oral estrogens may reduce serum insulin-like growth factor-1 response to lonapegsomatropin. Patients receiving oral estrogen replacement may require higher lonapegsomatropin dosages.
- estrogens esterified
estrogens esterified will decrease the level or effect of lonapegsomatropin by Other (see comment). Use Caution/Monitor. Oral estrogens may reduce serum insulin-like growth factor-1 response to lonapegsomatropin. Patients receiving oral estrogen replacement may require higher lonapegsomatropin dosages.
- estropipate
estropipate will decrease the level or effect of lonapegsomatropin by Other (see comment). Use Caution/Monitor. Oral estrogens may reduce serum insulin-like growth factor-1 response to lonapegsomatropin. Patients receiving oral estrogen replacement may require higher lonapegsomatropin dosages.
- ethinylestradiol
ethinylestradiol will decrease the level or effect of lonapegsomatropin by Other (see comment). Use Caution/Monitor. Oral estrogens may reduce serum insulin-like growth factor-1 response to lonapegsomatropin. Patients receiving oral estrogen replacement may require higher lonapegsomatropin dosages.
- exenatide injectable solution
lonapegsomatropin decreases effects of exenatide injectable solution by Other (see comment). Use Caution/Monitor. Comment: Closely monitor blood glucose when treated with antidiabetic agents. Lonapegsomatropin may decrease insulin sensitivity, particularly at higher doses. Patients with diabetes mellitus may require adjustment of their doses of insulin and/or other antihyperglycemic agents.
- exenatide injectable suspension
lonapegsomatropin decreases effects of exenatide injectable suspension by Other (see comment). Use Caution/Monitor. Comment: Closely monitor blood glucose when treated with antidiabetic agents. Lonapegsomatropin may decrease insulin sensitivity, particularly at higher doses. Patients with diabetes mellitus may require adjustment of their doses of insulin and/or other antihyperglycemic agents.
- exenatide subdermal implant
lonapegsomatropin decreases effects of exenatide subdermal implant by Other (see comment). Use Caution/Monitor. Comment: Closely monitor blood glucose when treated with antidiabetic agents. Lonapegsomatropin may decrease insulin sensitivity, particularly at higher doses. Patients with diabetes mellitus may require adjustment of their doses of insulin and/or other antihyperglycemic agents.
- fludrocortisone
lonapegsomatropin decreases effects of fludrocortisone by Other (see comment). Use Caution/Monitor. Comment: Growth hormone (GH) inhibits microsomal enzyme 11 beta-hydroxysteroid dehydrogenase type 1, which converts cortisone to its active metabolite, cortisol. Patients with untreated GH deficiency may have increases in serum cortisol, and initiation of lonapegsomatropin may result decreased serum cortisol. Patients with hypoadrenalism treated with glucocorticoids may require an increase glucocorticoid stress or maintenance doses following lonapegsomatropin initiation.
fludrocortisone decreases effects of lonapegsomatropin by Other (see comment). Use Caution/Monitor. Comment: Glucocorticoid therapy and supraphysiologic glucocorticoid treatment may attenuate the growth promoting effects of lonapegsomatropin in children. Carefully adjust glucocorticoid replacement dosing in children receiving glucocorticoid treatments to avoid both hypoadrenalism and an inhibitory effect on growth. - glimepiride
lonapegsomatropin decreases effects of glimepiride by Other (see comment). Use Caution/Monitor. Comment: Closely monitor blood glucose when treated with antidiabetic agents. Lonapegsomatropin may decrease insulin sensitivity, particularly at higher doses. Patients with diabetes mellitus may require adjustment of their doses of insulin and/or other antihyperglycemic agents.
- glipizide
lonapegsomatropin decreases effects of glipizide by Other (see comment). Use Caution/Monitor. Comment: Closely monitor blood glucose when treated with antidiabetic agents. Lonapegsomatropin may decrease insulin sensitivity, particularly at higher doses. Patients with diabetes mellitus may require adjustment of their doses of insulin and/or other antihyperglycemic agents.
- glyburide
lonapegsomatropin decreases effects of glyburide by Other (see comment). Use Caution/Monitor. Comment: Closely monitor blood glucose when treated with antidiabetic agents. Lonapegsomatropin may decrease insulin sensitivity, particularly at higher doses. Patients with diabetes mellitus may require adjustment of their doses of insulin and/or other antihyperglycemic agents.
- hydrocortisone
lonapegsomatropin decreases effects of hydrocortisone by Other (see comment). Use Caution/Monitor. Comment: Growth hormone (GH) inhibits microsomal enzyme 11 beta-hydroxysteroid dehydrogenase type 1, which converts cortisone to its active metabolite, cortisol. Patients with untreated GH deficiency may have increases in serum cortisol, and initiation of lonapegsomatropin may result decreased serum cortisol. Patients with hypoadrenalism treated with glucocorticoids may require an increase glucocorticoid stress or maintenance doses following lonapegsomatropin initiation.
hydrocortisone decreases effects of lonapegsomatropin by Other (see comment). Use Caution/Monitor. Comment: Glucocorticoid therapy and supraphysiologic glucocorticoid treatment may attenuate the growth promoting effects of lonapegsomatropin in children. Carefully adjust glucocorticoid replacement dosing in children receiving glucocorticoid treatments to avoid both hypoadrenalism and an inhibitory effect on growth. - insulin aspart
lonapegsomatropin decreases effects of insulin aspart by Other (see comment). Use Caution/Monitor. Comment: Closely monitor blood glucose when treated with antidiabetic agents. Lonapegsomatropin may decrease insulin sensitivity, particularly at higher doses. Patients with diabetes mellitus may require adjustment of their doses of insulin and/or other antihyperglycemic agents.
- insulin aspart protamine/insulin aspart
lonapegsomatropin decreases effects of insulin aspart protamine/insulin aspart by Other (see comment). Use Caution/Monitor. Comment: Closely monitor blood glucose when treated with antidiabetic agents. Lonapegsomatropin may decrease insulin sensitivity, particularly at higher doses. Patients with diabetes mellitus may require adjustment of their doses of insulin and/or other antihyperglycemic agents.
- insulin degludec
lonapegsomatropin decreases effects of insulin degludec by Other (see comment). Use Caution/Monitor. Comment: Closely monitor blood glucose when treated with antidiabetic agents. Lonapegsomatropin may decrease insulin sensitivity, particularly at higher doses. Patients with diabetes mellitus may require adjustment of their doses of insulin and/or other antihyperglycemic agents.
- insulin degludec/insulin aspart
lonapegsomatropin decreases effects of insulin degludec/insulin aspart by Other (see comment). Use Caution/Monitor. Comment: Closely monitor blood glucose when treated with antidiabetic agents. Lonapegsomatropin may decrease insulin sensitivity, particularly at higher doses. Patients with diabetes mellitus may require adjustment of their doses of insulin and/or other antihyperglycemic agents.
- insulin detemir
lonapegsomatropin decreases effects of insulin detemir by Other (see comment). Use Caution/Monitor. Comment: Closely monitor blood glucose when treated with antidiabetic agents. Lonapegsomatropin may decrease insulin sensitivity, particularly at higher doses. Patients with diabetes mellitus may require adjustment of their doses of insulin and/or other antihyperglycemic agents.
- insulin glargine
lonapegsomatropin decreases effects of insulin glargine by Other (see comment). Use Caution/Monitor. Comment: Closely monitor blood glucose when treated with antidiabetic agents. Lonapegsomatropin may decrease insulin sensitivity, particularly at higher doses. Patients with diabetes mellitus may require adjustment of their doses of insulin and/or other antihyperglycemic agents.
- insulin glulisine
lonapegsomatropin decreases effects of insulin glulisine by Other (see comment). Use Caution/Monitor. Comment: Closely monitor blood glucose when treated with antidiabetic agents. Lonapegsomatropin may decrease insulin sensitivity, particularly at higher doses. Patients with diabetes mellitus may require adjustment of their doses of insulin and/or other antihyperglycemic agents.
- insulin inhaled
lonapegsomatropin decreases effects of insulin inhaled by Other (see comment). Use Caution/Monitor. Comment: Closely monitor blood glucose when treated with antidiabetic agents. Lonapegsomatropin may decrease insulin sensitivity, particularly at higher doses. Patients with diabetes mellitus may require adjustment of their doses of insulin and/or other antihyperglycemic agents.
- insulin isophane human/insulin regular human
lonapegsomatropin decreases effects of insulin isophane human/insulin regular human by Other (see comment). Use Caution/Monitor. Comment: Closely monitor blood glucose when treated with antidiabetic agents. Lonapegsomatropin may decrease insulin sensitivity, particularly at higher doses. Patients with diabetes mellitus may require adjustment of their doses of insulin and/or other antihyperglycemic agents.
- insulin lispro
lonapegsomatropin decreases effects of insulin lispro by Other (see comment). Use Caution/Monitor. Comment: Closely monitor blood glucose when treated with antidiabetic agents. Lonapegsomatropin may decrease insulin sensitivity, particularly at higher doses. Patients with diabetes mellitus may require adjustment of their doses of insulin and/or other antihyperglycemic agents.
- insulin lispro protamine/insulin lispro
lonapegsomatropin decreases effects of insulin lispro protamine/insulin lispro by Other (see comment). Use Caution/Monitor. Comment: Closely monitor blood glucose when treated with antidiabetic agents. Lonapegsomatropin may decrease insulin sensitivity, particularly at higher doses. Patients with diabetes mellitus may require adjustment of their doses of insulin and/or other antihyperglycemic agents.
- insulin NPH
lonapegsomatropin decreases effects of insulin NPH by Other (see comment). Use Caution/Monitor. Comment: Closely monitor blood glucose when treated with antidiabetic agents. Lonapegsomatropin may decrease insulin sensitivity, particularly at higher doses. Patients with diabetes mellitus may require adjustment of their doses of insulin and/or other antihyperglycemic agents.
- insulin regular human
lonapegsomatropin decreases effects of insulin regular human by Other (see comment). Use Caution/Monitor. Comment: Closely monitor blood glucose when treated with antidiabetic agents. Lonapegsomatropin may decrease insulin sensitivity, particularly at higher doses. Patients with diabetes mellitus may require adjustment of their doses of insulin and/or other antihyperglycemic agents.
- linagliptin
lonapegsomatropin decreases effects of linagliptin by Other (see comment). Use Caution/Monitor. Comment: Closely monitor blood glucose when treated with antidiabetic agents. Lonapegsomatropin may decrease insulin sensitivity, particularly at higher doses. Patients with diabetes mellitus may require adjustment of their doses of insulin and/or other antihyperglycemic agents.
- liraglutide
lonapegsomatropin decreases effects of liraglutide by Other (see comment). Use Caution/Monitor. Comment: Closely monitor blood glucose when treated with antidiabetic agents. Lonapegsomatropin may decrease insulin sensitivity, particularly at higher doses. Patients with diabetes mellitus may require adjustment of their doses of insulin and/or other antihyperglycemic agents.
- lixisenatide (DSC)
lonapegsomatropin decreases effects of lixisenatide (DSC) by Other (see comment). Use Caution/Monitor. Comment: Closely monitor blood glucose when treated with antidiabetic agents. Lonapegsomatropin may decrease insulin sensitivity, particularly at higher doses. Patients with diabetes mellitus may require adjustment of their doses of insulin and/or other antihyperglycemic agents.
- metformin
lonapegsomatropin decreases effects of metformin by Other (see comment). Use Caution/Monitor. Comment: Closely monitor blood glucose when treated with antidiabetic agents. Lonapegsomatropin may decrease insulin sensitivity, particularly at higher doses. Patients with diabetes mellitus may require adjustment of their doses of insulin and/or other antihyperglycemic agents.
- methylprednisolone
lonapegsomatropin decreases effects of methylprednisolone by Other (see comment). Use Caution/Monitor. Comment: Growth hormone (GH) inhibits microsomal enzyme 11 beta-hydroxysteroid dehydrogenase type 1, which converts cortisone to its active metabolite, cortisol. Patients with untreated GH deficiency may have increases in serum cortisol, and initiation of lonapegsomatropin may result decreased serum cortisol. Patients with hypoadrenalism treated with glucocorticoids may require an increase glucocorticoid stress or maintenance doses following lonapegsomatropin initiation.
methylprednisolone decreases effects of lonapegsomatropin by Other (see comment). Use Caution/Monitor. Comment: Glucocorticoid therapy and supraphysiologic glucocorticoid treatment may attenuate the growth promoting effects of lonapegsomatropin in children. Carefully adjust glucocorticoid replacement dosing in children receiving glucocorticoid treatments to avoid both hypoadrenalism and an inhibitory effect on growth. - miglitol
lonapegsomatropin decreases effects of miglitol by Other (see comment). Modify Therapy/Monitor Closely. Comment: Closely monitor blood glucose when treated with antidiabetic agents. Lonapegsomatropin may decrease insulin sensitivity, particularly at higher doses. Patients with diabetes mellitus may require adjustment of their doses of insulin and/or other antihyperglycemic agents.
- mometasone sinus implant
lonapegsomatropin decreases effects of mometasone sinus implant by Other (see comment). Use Caution/Monitor. Comment: Growth hormone (GH) inhibits microsomal enzyme 11 beta-hydroxysteroid dehydrogenase type 1, which converts cortisone to its active metabolite, cortisol. Patients with untreated GH deficiency may have increases in serum cortisol, and initiation of lonapegsomatropin may result decreased serum cortisol. Patients with hypoadrenalism treated with glucocorticoids may require an increase glucocorticoid stress or maintenance doses following lonapegsomatropin initiation.
mometasone sinus implant decreases effects of lonapegsomatropin by Other (see comment). Use Caution/Monitor. Comment: Glucocorticoid therapy and supraphysiologic glucocorticoid treatment may attenuate the growth promoting effects of lonapegsomatropin in children. Carefully adjust glucocorticoid replacement dosing in children receiving glucocorticoid treatments to avoid both hypoadrenalism and an inhibitory effect on growth. - nateglinide
lonapegsomatropin decreases effects of nateglinide by Other (see comment). Use Caution/Monitor. Comment: Closely monitor blood glucose when treated with antidiabetic agents. Lonapegsomatropin may decrease insulin sensitivity, particularly at higher doses. Patients with diabetes mellitus may require adjustment of their doses of insulin and/or other antihyperglycemic agents.
- pioglitazone
lonapegsomatropin decreases effects of pioglitazone by Other (see comment). Use Caution/Monitor. Comment: Closely monitor blood glucose when treated with antidiabetic agents. Lonapegsomatropin may decrease insulin sensitivity, particularly at higher doses. Patients with diabetes mellitus may require adjustment of their doses of insulin and/or other antihyperglycemic agents.
- pramlintide
lonapegsomatropin decreases effects of pramlintide by Other (see comment). Modify Therapy/Monitor Closely. Comment: Closely monitor blood glucose when treated with antidiabetic agents. Lonapegsomatropin may decrease insulin sensitivity, particularly at higher doses. Patients with diabetes mellitus may require adjustment of their doses of insulin and/or other antihyperglycemic agents.
- prednisolone
lonapegsomatropin decreases effects of prednisolone by Other (see comment). Use Caution/Monitor. Comment: Growth hormone (GH) inhibits microsomal enzyme 11 beta-hydroxysteroid dehydrogenase type 1, which converts cortisone to its active metabolite, cortisol. Patients with untreated GH deficiency may have increases in serum cortisol, and initiation of lonapegsomatropin may result decreased serum cortisol. Patients with hypoadrenalism treated with glucocorticoids may require an increase glucocorticoid stress or maintenance doses following lonapegsomatropin initiation.
prednisolone decreases effects of lonapegsomatropin by Other (see comment). Use Caution/Monitor. Comment: Glucocorticoid therapy and supraphysiologic glucocorticoid treatment may attenuate the growth promoting effects of lonapegsomatropin in children. Carefully adjust glucocorticoid replacement dosing in children receiving glucocorticoid treatments to avoid both hypoadrenalism and an inhibitory effect on growth. - prednisone
lonapegsomatropin decreases effects of prednisone by Other (see comment). Use Caution/Monitor. Comment: Growth hormone (GH) inhibits microsomal enzyme 11 beta-hydroxysteroid dehydrogenase type 1, which converts cortisone to its active metabolite, cortisol. Patients with untreated GH deficiency may have increases in serum cortisol, and initiation of lonapegsomatropin may result decreased serum cortisol. Patients with hypoadrenalism treated with glucocorticoids may require an increase glucocorticoid stress or maintenance doses following lonapegsomatropin initiation.
prednisone decreases effects of lonapegsomatropin by Other (see comment). Use Caution/Monitor. Comment: Glucocorticoid therapy and supraphysiologic glucocorticoid treatment may attenuate the growth promoting effects of lonapegsomatropin in children. Carefully adjust glucocorticoid replacement dosing in children receiving glucocorticoid treatments to avoid both hypoadrenalism and an inhibitory effect on growth. - repaglinide
lonapegsomatropin decreases effects of repaglinide by Other (see comment). Use Caution/Monitor. Comment: Closely monitor blood glucose when treated with antidiabetic agents. Lonapegsomatropin may decrease insulin sensitivity, particularly at higher doses. Patients with diabetes mellitus may require adjustment of their doses of insulin and/or other antihyperglycemic agents.
- rosiglitazone
lonapegsomatropin decreases effects of rosiglitazone by Other (see comment). Use Caution/Monitor. Comment: Closely monitor blood glucose when treated with antidiabetic agents. Lonapegsomatropin may decrease insulin sensitivity, particularly at higher doses. Patients with diabetes mellitus may require adjustment of their doses of insulin and/or other antihyperglycemic agents.
- saxagliptin
lonapegsomatropin decreases effects of saxagliptin by Other (see comment). Use Caution/Monitor. Comment: Closely monitor blood glucose when treated with antidiabetic agents. Lonapegsomatropin may decrease insulin sensitivity, particularly at higher doses. Patients with diabetes mellitus may require adjustment of their doses of insulin and/or other antihyperglycemic agents.
- segesterone/ethinyl estradiol
segesterone/ethinyl estradiol will decrease the level or effect of lonapegsomatropin by Other (see comment). Use Caution/Monitor. Oral estrogens may reduce serum insulin-like growth factor-1 response to lonapegsomatropin. Patients receiving oral estrogen replacement may require higher lonapegsomatropin dosages.
- semaglutide
lonapegsomatropin decreases effects of semaglutide by Other (see comment). Use Caution/Monitor. Comment: Closely monitor blood glucose when treated with antidiabetic agents. Lonapegsomatropin may decrease insulin sensitivity, particularly at higher doses. Patients with diabetes mellitus may require adjustment of their doses of insulin and/or other antihyperglycemic agents.
- sitagliptin
lonapegsomatropin decreases effects of sitagliptin by Other (see comment). Use Caution/Monitor. Comment: Closely monitor blood glucose when treated with antidiabetic agents. Lonapegsomatropin may decrease insulin sensitivity, particularly at higher doses. Patients with diabetes mellitus may require adjustment of their doses of insulin and/or other antihyperglycemic agents.
- tirzepatide
lonapegsomatropin decreases effects of tirzepatide by Other (see comment). Use Caution/Monitor. Comment: Closely monitor blood glucose when treated with antidiabetic agents. Lonapegsomatropin may decrease insulin sensitivity, particularly at higher doses. Patients with diabetes mellitus may require adjustment of their doses of insulin and/or other antihyperglycemic agents.
- tolazamide
lonapegsomatropin decreases effects of tolazamide by Other (see comment). Use Caution/Monitor. Comment: Closely monitor blood glucose when treated with antidiabetic agents. Lonapegsomatropin may decrease insulin sensitivity, particularly at higher doses. Patients with diabetes mellitus may require adjustment of their doses of insulin and/or other antihyperglycemic agents.
- tolbutamide
lonapegsomatropin decreases effects of tolbutamide by Other (see comment). Use Caution/Monitor. Comment: Closely monitor blood glucose when treated with antidiabetic agents. Lonapegsomatropin may decrease insulin sensitivity, particularly at higher doses. Patients with diabetes mellitus may require adjustment of their doses of insulin and/or other antihyperglycemic agents.
- triamcinolone acetonide extended-release injectable suspension
lonapegsomatropin decreases effects of triamcinolone acetonide extended-release injectable suspension by Other (see comment). Use Caution/Monitor. Comment: Growth hormone (GH) inhibits microsomal enzyme 11 beta-hydroxysteroid dehydrogenase type 1, which converts cortisone to its active metabolite, cortisol. Patients with untreated GH deficiency may have increases in serum cortisol, and initiation of lonapegsomatropin may result decreased serum cortisol. Patients with hypoadrenalism treated with glucocorticoids may require an increase glucocorticoid stress or maintenance doses following lonapegsomatropin initiation.
triamcinolone acetonide extended-release injectable suspension decreases effects of lonapegsomatropin by Other (see comment). Use Caution/Monitor. Comment: Glucocorticoid therapy and supraphysiologic glucocorticoid treatment may attenuate the growth promoting effects of lonapegsomatropin in children. Carefully adjust glucocorticoid replacement dosing in children receiving glucocorticoid treatments to avoid both hypoadrenalism and an inhibitory effect on growth. - triamcinolone acetonide injectable suspension
lonapegsomatropin decreases effects of triamcinolone acetonide injectable suspension by Other (see comment). Use Caution/Monitor. Comment: Growth hormone (GH) inhibits microsomal enzyme 11 beta-hydroxysteroid dehydrogenase type 1, which converts cortisone to its active metabolite, cortisol. Patients with untreated GH deficiency may have increases in serum cortisol, and initiation of lonapegsomatropin may result decreased serum cortisol. Patients with hypoadrenalism treated with glucocorticoids may require an increase glucocorticoid stress or maintenance doses following lonapegsomatropin initiation.
triamcinolone acetonide injectable suspension decreases effects of lonapegsomatropin by Other (see comment). Use Caution/Monitor. Comment: Glucocorticoid therapy and supraphysiologic glucocorticoid treatment may attenuate the growth promoting effects of lonapegsomatropin in children. Carefully adjust glucocorticoid replacement dosing in children receiving glucocorticoid treatments to avoid both hypoadrenalism and an inhibitory effect on growth.
Minor (0)
Adverse Effects
>10%
Elevated phosphate levels (44.2%)
Elevated alkaline phosphatase levels (19.2%)
Viral infection (15%)
Pyrexia (15%)
Cough (11%)
Nausea and vomiting (11%)
1-10%
Hemorrhage (7%)
Diarrhea (6%)
Abdominal pain (6%)
Arthralgia and arthritis (6%)
Postmarketing Reports
Severe systemic hypersensitivity reactions including anaphylactic reactions and angioedema
Warnings
Contraindications
Acute critical illness after open heart surgery, abdominal surgery, multiple accidental traumas, or those with acute respiratory failure
Hypersensitivity to somatropin or any of the excipients
Closed epiphyses
Active malignancy, owing to risk of malignancy progression
Active proliferative or severe nonproliferative diabetic retinopathy
Prader-Willi syndrome who are severely obese, have a history of upper airway obstruction or sleep apnea, or have severe respiratory impairment
Cautions
Increased mortality reported among patients with acute critical illness, owing to complications following open heart surgery, abdominal surgery, multiple accidental traumas, or those with acute respiratory failure; safety of continuing treatment in such patients receiving replacement doses has not been established
Serious systemic hypersensitivity reactions (eg, anaphylactic reactions, angioedema) reported; inform patients and caregivers that such reactions are possible and to seek immediate medical attention if allergic reaction occurs
May decrease insulin sensitivity, particularly at higher doses; previously undiagnosed impaired glucose tolerance and overt type 2 diabetes mellitus (DM) may be unmasked; closely monitor glucose levels when initiating and during treatment in patients with preexisting type 1 or type 2 DM or impaired glucose tolerance; adjust doses of antihyperglycemic drugs as needed
Fluid retention may occur; clinical manifestations of fluid retention (eg, edema, arthralgia, myalgia, nerve compression syndromes including carpal tunnel syndrome/paresthesia) are usually transient and dose-dependent
Undiagnosed or untreated hypothyroidism may prevent optimal treatment response; perform periodic thyroid function tests and initiate or appropriately adjust thyroid hormone replacement therapy when indicated
Reports of fatalities after initiating therapy with somatropin documented in pediatric patients with Prader-Willi syndrome who had ≥1 of the following risk factors: severe obesity, history of upper airway obstruction or sleep apnea, or unidentified respiratory infection; male patients with ≥1 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
Slipped capital femoral epiphysis may occur more frequently in patients undergoing rapid growth; evaluate patients with the onset of a limp or complaints of hip or knee pain
Pancreatitis reported; consider pancreatitis in patients who develop persistent severe abdominal pain
When somatropin is administered SC at same site over a long period, tissue atrophy may result; avoid by rotating injection site
Treated patients 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; patients treated with glucocorticoid replacement for previously diagnosed hypoadrenalism may require an increase in their maintenance or stress dose following initiation of treatment; monitor for reduced serum cortisol levels and/or need for glucocorticoid dose increases in those with known hypoadrenalism
Serum levels of phosphate, alkaline phosphatase, and parathyroid hormone may increase after treatment; monitor these laboratory tests if abnormal
Somatropin increases growth rate, and progression of existing scoliosis can occur in patients who experience rapid growth; somatropin has not been shown to increase occurrence of scoliosis; monitor patients with a history of scoliosis for disease progression
Increased risk of neoplasms
- Somatropin treatment may increase risk of malignancy progression in patients with active malignancy
- Any preexisting malignancy should be inactive and its treatment complete before initiating somatotropin; discontinue therapy if there is evidence of recurrent activity
- An increased risk of second neoplasm reported in childhood cancer survivors treated with somatropin; the most common second neoplasms were intracranial tumors (eg, meningiomas) in patients treated with radiation to the head for their first neoplasm
- Monitor all patients with a history of GH deficiency secondary to an intracranial neoplasm while on somatropin therapy for progression or recurrence of the tumor
- Because pediatric patients with certain rare genetic causes of short stature have an increased risk of developing malignancies, thoroughly consider the risks and benefits of starting treatment in these patients; monitor for development of neoplasms if initiating treatment
- Monitor for increased growth, or potential malignant changes of preexisting nevi; advise patients/caregivers to report marked changes in behavior, onset of headaches, vision disturbances, and/or changes in skin pigmentation or changes in the appearance of preexisting nevi
Intracranial hypertension
- Intracranial hypertension (IH) with papilledema, visual changes, headache, nausea, and/or vomiting reported
- In reported cases, IH-associated signs and symptoms rapidly resolved after discontinuing therapy or reducing the dose
- Perform funduscopic examination routinely before initiating treatment to exclude preexisting papilledema, and periodically thereafter
- If papilledema observed by fundoscopy, stop somatropin treatment
- If somatropin-induced IH is confirmed, restart treatment at a lower dose once IH-associated signs and symptoms resolve
Drug interaction overview
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Replacement glucocorticoid treatment
- Patients treated with glucocorticoid replacement for hypoadrenalism may require an increase in their maintenance or stress dose following initiation
- 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
- Initiating lonapegsomatropin may result in inhibition of 11βHSD-1 and reduced serum cortisol concentrations
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Pharmacologic glucocorticoid therapy and supraphysiologic glucocorticoid treatment
- Carefully adjust glucocorticoid replacement dosing in pediatric patients receiving glucocorticoid treatments to avoid both hypoadrenalism and an inhibitory effect on growth
- Pharmacologic glucocorticoid therapy and supraphysiologic glucocorticoid treatment may potentiate the growth-promoting effects of lonapegsomatropin in pediatric patients
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Cytochrome P450-metabolizing drugs
- Carefully monitor when used in combination with drugs metabolized by cytochrome P450 (CYP450) liver enzymes
- Limited published data indicate that somatropin treatment increases CYP450-mediated antipyrine clearance
- Lonapegsomatropin may alter clearance of compounds known to be metabolized by CYP450 liver enzymes
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Oral estrogen
- Patients receiving oral estrogen replacement may require higher lonapegsomatropin dosages
- Oral estrogens may reduce the serum insulinlike growth factor-1 response to lonapegsomatropin
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Insulin and/or other antihyperglycemic agents
- Patients with diabetes mellitus may require dosage adjustment of their insulin and/or other antihyperglycemic agents
- Lonapegsomatropin may decrease insulin sensitivity, particularly at higher doses
Pregnancy & Lactation
Pregnancy
There are no available data on use in pregnant females to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes
Available published data over several decades for somatropin, the active component of lonapegsomatropin, have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes
Lactation
No data are available on presence of lonapegsomatropin in human milk, effects on the breastfed infant, or effects on milk production
High-molecular–weight therapeutic proteins, including lonapegsomatropin, are expected to have low passage into human milk and limited systemic exposure in breastfed infants
No adverse effects on breastfed infants have been reported with somatropin
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 prodrug of somatropin (recombinant human GH)
Somatropin binds to GH receptor on target cells, resulting intracellular signal transduction and a host of pharmacodynamic effects
Somatropin stimulates skeletal growth in pediatric patients with GH deficiency as a result of effects on epiphyses of long bones
Absorption
AUC: 500 h⋅ng/mL
Peak plasma concentration
- Lonapegsomatropin: 1230 ng hGH/mL
- Somatotropin: 15.2 ng/mL
- Methoxypolyethylene glycol carrier: 13.1 mcg/L
Peak plasma time
- Lonapegsomatropin: 25 hr
- Somatropin: 12 hr
- Methoxypolyethylene glycol carrier: 36 hr
Distribution
Vd: 0.13 L/kg
Metabolism
Metabolism of somatropin involves protein catabolism in both the liver and kidneys
Methoxypolyethylene glycol carrier is cleared by the kidneys
Elimination
Clearance: 3.2 mL/h/kg
Half-life
- Lonapegsomatropin: 30.7 hr
- Somatropin: 25 hr
Administration
SC Preparation
Selection of appropriate cartridge is based on prescribed dose (mg/kg) and patient’s body weight (kg)
For a prescribed dose of 0.24 mg/kg/week and patient’s weight is 11.5-100 kg, follow the recommended dosing
- 11.5-13.9 kg: 3 mg/week
- 14-16.4 kg: 3.6 mg/week
- 16.5-19.9 kg: 4.3 mg/week
- 20-23.9 kg: 5.2 mg/week
- 24-28.9 kg: 6.3 mg/week
- 29-34.9 kg: 7.6 mg/week
- 35- 41.9 kg: 9.1 mg/week
- 42-50.9 kg: 11 mg/week
- 51-60.4 kg: 13.3 mg/week
- 60.5-69.9 kg: 15.2 mg/week (use 2 cartridges of 7.6 mg each)
- 70- 84.9 kg: 18.2 mg/week (use 2 cartridges of 9.1 mg each)
- 85-100 kg: 22 mg/week (use 2 cartridges of 11 mg each)
For a prescribed dose other than 0.24 mg/kg/week, calculate total weekly dose (in mg) and select appropriate cartridge as follows:
Total weekly dose (mg) = Prescribed weekly dose (mg/kg) x patient’s body weight (kg)
Round total weekly dose (mg) to closest cartridge dose while also considering treatment goals and clinical response
Cartridge has been designed for use only with autoinjector
If refrigerated, calibrate cartridge to room temperature for 15 minutes before use
Autoinjector provides a fully automated reconstitution of the lyophilized drug product, which is followed by a manual mixing step controlled by the device
Insert injection needle into skin; the device automatically delivers the drug
Built-in electronics and software assist the user during drug preparation and administration, and confirm dose delivery
SC Administration
Administer SC into abdomen, buttock, or thighs; rotate injection sites between and within regions to reduce the risk of lipoatrophy
Refer to Instructions for Use [www.Skytrofa.com/IFU] for complete administration instructions with illustrations
Diluted solution appears clear and colorless to opalescent and may occasionally contain air bubbles; do NOT inject if solution is cloudy or contains particulate matter
Use cartridges within 4 hr after reconstitution; discard reconstituted cartridges after 4 hours when stored at room temperature up to 86ºF (30ºC)
Missed doses
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≤2 days
- Administer as soon as possible
- Take 2 days before or after scheduled dosing day
- Resume once-weekly dosing for the next dose at previously scheduled dosing day
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>2 days
- Skip dose and administer the next dose on the regularly scheduled day
- At least 5 days should elapse between doses
Storage
Unopened cartridges
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For patients
- Store in outer carton to protect from light until expiration date
- May refrigerate at 2-8ºC (36-46ºF); do not freeze
- Alternatively, store at room temperature (up to 30ºC [86ºF]) for up to 6 months; may return to refrigeration within the 6 months
- Write date first removed from refrigerator on outer carton
- Do not use beyond the expiration date or 6 months after the date it was first removed from refrigeration (whichever is earlier)
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For pharmacy long-term storage
- Refrigerate at 2-8ºC (36-46ºF) in outer carton until expiration date; do not freeze
Reconstituted cartridges
- Store at room temperature up to 30ºC (86ºF); discard 4 hr after reconstitution
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.
