Dosing & Uses
See pediatric dosing
Dosage Forms & Strengths
injection, solution
- 24mg/1.2mL (20mg/mL) prefilled pen; delivers dose in 0.2-mg increments
- 60mg/1.2mL (50mg/mL) prefilled pen; delivers dose in 0.5-mg increments
Growth Hormone Deficiency
- Indicated for pediatric patients aged ≥3 years who have growth failure owing to inadequate secretion of endogenous growth hormone
- 0.66 mg/kg (actual body weight) SC qWeek
- Individualize dosage for each patient based on growth response
Dosage Modifications
Renal or hepatic impairment
- Not studied
Dosing Considerations
Perform fundoscopic examination before initiating to exclude preexisting papilledema; if papilledema identified, evaluate the etiology and treat underlying cause before initiating somatrogon
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (0)
Serious - Use Alternative (1)
- macimorelin
somatrogon, macimorelin. unspecified interaction mechanism. Avoid or Use Alternate Drug. Drugs that may blunt the growth hormone (GH) response to macrimorelin may impact the accuracy of the diagnostic test. Discontinue GH products at least 1 week before administering macimorelin. .
Monitor Closely (104)
- acarbose
somatrogon decreases effects of acarbose by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Growth hormone (GH) analogs may decrease insulin sensitivity, particularly at higher doses. Antidiabetic agents may require dose adjustment after initiating growth hormone.
- albiglutide
somatrogon decreases effects of albiglutide by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Growth hormone (GH) analogs may decrease insulin sensitivity, particularly at higher doses. Antidiabetic agents may require dose adjustment after initiating growth hormone.
- alfentanil
somatrogon will decrease the level or effect of alfentanil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Limited published data indicate that growth hormone treatment increases cytochrome P450 (CYP450)-mediated antipyrine clearance. Caution with sensitive CYP substrates
- alogliptin
somatrogon decreases effects of alogliptin by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Growth hormone (GH) analogs may decrease insulin sensitivity, particularly at higher doses. Antidiabetic agents may require dose adjustment after initiating growth hormone.
- alosetron
somatrogon will decrease the level or effect of alosetron by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor. Limited published data indicate that growth hormone treatment increases cytochrome P450 (CYP450)-mediated antipyrine clearance. Caution with sensitive CYP substrates
- bendamustine
somatrogon will decrease the level or effect of bendamustine by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor. Limited published data indicate that growth hormone treatment increases cytochrome P450 (CYP450)-mediated antipyrine clearance. Caution with sensitive CYP substrates
- betamethasone
betamethasone decreases effects of somatrogon by pharmacodynamic antagonism. Use Caution/Monitor. Supraphysiologic glucocorticoid treatment may attenuate growth-promoting effects of growth hormone (GH). Microsomal enzyme 11-beta-hydroxysteroid dehydrogenase type 1 (11-beta-HSD-1) is required for conversion of cortisone to its active metabolite, cortisol, in hepatic and adipose tissue. GH inhibits 11-beta-HSD-1. Consequently, individuals with untreated GH deficiency have relative increases in 11-beta-HSD-1 and serum cortisol. Initiation of GH analogs may result in inhibition of 11-beta-HSD-1 and reduced serum cortisol concentrations.
- bexagliflozin
somatrogon decreases effects of bexagliflozin by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Growth hormone (GH) analogs may decrease insulin sensitivity, particularly at higher doses. Antidiabetic agents may require dose adjustment after initiating growth hormone.
- canagliflozin
somatrogon decreases effects of canagliflozin by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Growth hormone (GH) analogs may decrease insulin sensitivity, particularly at higher doses. Antidiabetic agents may require dose adjustment after initiating growth hormone.
- carbamazepine
somatrogon will decrease the level or effect of carbamazepine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Limited published data indicate that growth hormone treatment increases cytochrome P450 (CYP450)-mediated antipyrine clearance. Caution with sensitive CYP substrates
- chlorpropamide
somatrogon decreases effects of chlorpropamide by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Growth hormone (GH) analogs may decrease insulin sensitivity, particularly at higher doses. Antidiabetic agents may require dose adjustment after initiating growth hormone.
- clomipramine
somatrogon will decrease the level or effect of clomipramine by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor. Limited published data indicate that growth hormone treatment increases cytochrome P450 (CYP450)-mediated antipyrine clearance. Caution with sensitive CYP substrates
- clonidine
somatrogon will decrease the level or effect of clonidine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Limited published data indicate that growth hormone treatment increases cytochrome P450 (CYP450)-mediated antipyrine clearance. Caution with sensitive CYP substrates
- clozapine
somatrogon will decrease the level or effect of clozapine by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor. Limited published data indicate that growth hormone treatment increases cytochrome P450 (CYP450)-mediated antipyrine clearance. Caution with sensitive CYP substrates
- colchicine
somatrogon decreases effects of colchicine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Limited published data indicate that growth hormone treatment increases cytochrome P450 (CYP450)-mediated antipyrine clearance. Caution with sensitive CYP substrates.
- corticotropin
corticotropin decreases effects of somatrogon by pharmacodynamic antagonism. Use Caution/Monitor. Supraphysiologic glucocorticoid treatment may attenuate growth-promoting effects of growth hormone (GH). Microsomal enzyme 11-beta-hydroxysteroid dehydrogenase type 1 (11-beta-HSD-1) is required for conversion of cortisone to its active metabolite, cortisol, in hepatic and adipose tissue. GH inhibits 11-beta-HSD-1. Consequently, individuals with untreated GH deficiency have relative increases in 11-beta-HSD-1 and serum cortisol. Initiation of GH analogs may result in inhibition of 11-beta-HSD-1 and reduced serum cortisol concentrations.
- cortisone
cortisone decreases effects of somatrogon by pharmacodynamic antagonism. Use Caution/Monitor. Supraphysiologic glucocorticoid treatment may attenuate growth-promoting effects of growth hormone (GH). Microsomal enzyme 11-beta-hydroxysteroid dehydrogenase type 1 (11-beta-HSD-1) is required for conversion of cortisone to its active metabolite, cortisol, in hepatic and adipose tissue. GH inhibits 11-beta-HSD-1. Consequently, individuals with untreated GH deficiency have relative increases in 11-beta-HSD-1 and serum cortisol. Initiation of GH analogs may result in inhibition of 11-beta-HSD-1 and reduced serum cortisol concentrations.
- cyclosporine
somatrogon decreases effects of cyclosporine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Limited published data indicate that growth hormone treatment increases cytochrome P450 (CYP450)-mediated antipyrine clearance. Caution with sensitive CYP substrates.
- dapagliflozin
somatrogon decreases effects of dapagliflozin by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Growth hormone (GH) analogs may decrease insulin sensitivity, particularly at higher doses. Antidiabetic agents may require dose adjustment after initiating growth hormone.
- deflazacort
deflazacort decreases effects of somatrogon by pharmacodynamic antagonism. Use Caution/Monitor. Supraphysiologic glucocorticoid treatment may attenuate growth-promoting effects of growth hormone (GH). Microsomal enzyme 11-beta-hydroxysteroid dehydrogenase type 1 (11-beta-HSD-1) is required for conversion of cortisone to its active metabolite, cortisol, in hepatic and adipose tissue. GH inhibits 11-beta-HSD-1. Consequently, individuals with untreated GH deficiency have relative increases in 11-beta-HSD-1 and serum cortisol. Initiation of GH analogs may result in inhibition of 11-beta-HSD-1 and reduced serum cortisol concentrations.
- dexamethasone
dexamethasone decreases effects of somatrogon by pharmacodynamic antagonism. Use Caution/Monitor. Supraphysiologic glucocorticoid treatment may attenuate growth-promoting effects of growth hormone (GH). Microsomal enzyme 11-beta-hydroxysteroid dehydrogenase type 1 (11-beta-HSD-1) is required for conversion of cortisone to its active metabolite, cortisol, in hepatic and adipose tissue. GH inhibits 11-beta-HSD-1. Consequently, individuals with untreated GH deficiency have relative increases in 11-beta-HSD-1 and serum cortisol. Initiation of GH analogs may result in inhibition of 11-beta-HSD-1 and reduced serum cortisol concentrations.
- dienogest/estradiol valerate
dienogest/estradiol valerate will decrease the level or effect of somatrogon by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Oral estrogens may reduce serum insulin-like growth factor I (IGF-1) response to growth hormone (GH) analogs. Higher GH dose may be required
- dihydroergotamine
somatrogon decreases effects of dihydroergotamine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Limited published data indicate that growth hormone treatment increases cytochrome P450 (CYP450)-mediated antipyrine clearance. Caution with sensitive CYP substrates.
- disopyramide
somatrogon decreases effects of disopyramide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Limited published data indicate that growth hormone treatment increases cytochrome P450 (CYP450)-mediated antipyrine clearance. Caution with sensitive CYP substrates.
- divalproex sodium
somatrogon will decrease the level or effect of divalproex sodium by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Limited published data indicate that growth hormone treatment increases cytochrome P450 (CYP450)-mediated antipyrine clearance. Caution with sensitive CYP substrates
- drospirenone
drospirenone will decrease the level or effect of somatrogon by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Oral estrogens may reduce serum insulin-like growth factor I (IGF-1) response to growth hormone (GH) analogs. Higher GH dose may be required
- dulaglutide
somatrogon decreases effects of dulaglutide by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Growth hormone (GH) analogs may decrease insulin sensitivity, particularly at higher doses. Antidiabetic agents may require dose adjustment after initiating growth hormone.
- duloxetine
somatrogon will decrease the level or effect of duloxetine by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor. Limited published data indicate that growth hormone treatment increases cytochrome P450 (CYP450)-mediated antipyrine clearance. Caution with sensitive CYP substrates
- empagliflozin
somatrogon decreases effects of empagliflozin by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Growth hormone (GH) analogs may decrease insulin sensitivity, particularly at higher doses. Antidiabetic agents may require dose adjustment after initiating growth hormone.
- ergotamine
somatrogon decreases effects of ergotamine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Limited published data indicate that growth hormone treatment increases cytochrome P450 (CYP450)-mediated antipyrine clearance. Caution with sensitive CYP substrates.
- ertugliflozin
somatrogon decreases effects of ertugliflozin by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Growth hormone (GH) analogs may decrease insulin sensitivity, particularly at higher doses. Antidiabetic agents may require dose adjustment after initiating growth hormone.
- ethinylestradiol
ethinylestradiol will decrease the level or effect of somatrogon by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Oral estrogens may reduce serum insulin-like growth factor I (IGF-1) response to growth hormone (GH) analogs. Higher GH dose may be required
- ethosuximide
somatrogon decreases effects of ethosuximide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Limited published data indicate that growth hormone treatment increases cytochrome P450 (CYP450)-mediated antipyrine clearance. Caution with sensitive CYP substrates.
- everolimus
somatrogon decreases effects of everolimus by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Limited published data indicate that growth hormone treatment increases cytochrome P450 (CYP450)-mediated antipyrine clearance. Caution with sensitive CYP substrates.
- exenatide injectable solution
somatrogon decreases effects of exenatide injectable solution by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Growth hormone (GH) analogs may decrease insulin sensitivity, particularly at higher doses. Antidiabetic agents may require dose adjustment after initiating growth hormone.
- exenatide injectable suspension
somatrogon decreases effects of exenatide injectable suspension by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Growth hormone (GH) analogs may decrease insulin sensitivity, particularly at higher doses. Antidiabetic agents may require dose adjustment after initiating growth hormone.
- exenatide subdermal implant
somatrogon decreases effects of exenatide subdermal implant by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Growth hormone (GH) analogs may decrease insulin sensitivity, particularly at higher doses. Antidiabetic agents may require dose adjustment after initiating growth hormone.
- fentanyl
somatrogon will decrease the level or effect of fentanyl by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Limited published data indicate that growth hormone treatment increases cytochrome P450 (CYP450)-mediated antipyrine clearance. Caution with sensitive CYP substrates
- fludrocortisone
fludrocortisone decreases effects of somatrogon by pharmacodynamic antagonism. Use Caution/Monitor. Supraphysiologic glucocorticoid treatment may attenuate growth-promoting effects of growth hormone (GH). Microsomal enzyme 11-beta-hydroxysteroid dehydrogenase type 1 (11-beta-HSD-1) is required for conversion of cortisone to its active metabolite, cortisol, in hepatic and adipose tissue. GH inhibits 11-beta-HSD-1. Consequently, individuals with untreated GH deficiency have relative increases in 11-beta-HSD-1 and serum cortisol. Initiation of GH analogs may result in inhibition of 11-beta-HSD-1 and reduced serum cortisol concentrations.
- fluvoxamine
somatrogon will decrease the level or effect of fluvoxamine by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor. Limited published data indicate that growth hormone treatment increases cytochrome P450 (CYP450)-mediated antipyrine clearance. Caution with sensitive CYP substrates
- fosphenytoin
somatrogon will decrease the level or effect of fosphenytoin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Limited published data indicate that growth hormone treatment increases cytochrome P450 (CYP450)-mediated antipyrine clearance. Caution with sensitive CYP substrates
- glimepiride
somatrogon decreases effects of glimepiride by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Growth hormone (GH) analogs may decrease insulin sensitivity, particularly at higher doses. Antidiabetic agents may require dose adjustment after initiating growth hormone.
- glipizide
somatrogon decreases effects of glipizide by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Growth hormone (GH) analogs may decrease insulin sensitivity, particularly at higher doses. Antidiabetic agents may require dose adjustment after initiating growth hormone.
- glyburide
somatrogon decreases effects of glyburide by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Growth hormone (GH) analogs may decrease insulin sensitivity, particularly at higher doses. Antidiabetic agents may require dose adjustment after initiating growth hormone.
- hydrocortisone
hydrocortisone decreases effects of somatrogon by pharmacodynamic antagonism. Use Caution/Monitor. Supraphysiologic glucocorticoid treatment may attenuate growth-promoting effects of growth hormone (GH). Microsomal enzyme 11-beta-hydroxysteroid dehydrogenase type 1 (11-beta-HSD-1) is required for conversion of cortisone to its active metabolite, cortisol, in hepatic and adipose tissue. GH inhibits 11-beta-HSD-1. Consequently, individuals with untreated GH deficiency have relative increases in 11-beta-HSD-1 and serum cortisol. Initiation of GH analogs may result in inhibition of 11-beta-HSD-1 and reduced serum cortisol concentrations.
- insulin aspart
somatrogon decreases effects of insulin aspart by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Growth hormone (GH) analogs may decrease insulin sensitivity, particularly at higher doses. Antidiabetic agents may require dose adjustment after initiating growth hormone.
- insulin aspart protamine/insulin aspart
somatrogon decreases effects of insulin aspart protamine/insulin aspart by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Growth hormone (GH) analogs may decrease insulin sensitivity, particularly at higher doses. Antidiabetic agents may require dose adjustment after initiating growth hormone.
- insulin degludec
somatrogon decreases effects of insulin degludec by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Growth hormone (GH) analogs may decrease insulin sensitivity, particularly at higher doses. Antidiabetic agents may require dose adjustment after initiating growth hormone.
- insulin degludec/insulin aspart
somatrogon decreases effects of insulin degludec/insulin aspart by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Growth hormone (GH) analogs may decrease insulin sensitivity, particularly at higher doses. Antidiabetic agents may require dose adjustment after initiating growth hormone.
- insulin detemir
somatrogon decreases effects of insulin detemir by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Growth hormone (GH) analogs may decrease insulin sensitivity, particularly at higher doses. Antidiabetic agents may require dose adjustment after initiating growth hormone.
- insulin glargine
somatrogon decreases effects of insulin glargine by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Growth hormone (GH) analogs may decrease insulin sensitivity, particularly at higher doses. Antidiabetic agents may require dose adjustment after initiating growth hormone.
- insulin glulisine
somatrogon decreases effects of insulin glulisine by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Growth hormone (GH) analogs may decrease insulin sensitivity, particularly at higher doses. Antidiabetic agents may require dose adjustment after initiating growth hormone.
- insulin inhaled
somatrogon decreases effects of insulin inhaled by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Growth hormone (GH) analogs may decrease insulin sensitivity, particularly at higher doses. Antidiabetic agents may require dose adjustment after initiating growth hormone.
- insulin isophane human/insulin regular human
somatrogon decreases effects of insulin isophane human/insulin regular human by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Growth hormone (GH) analogs may decrease insulin sensitivity, particularly at higher doses. Antidiabetic agents may require dose adjustment after initiating growth hormone.
- insulin lispro
somatrogon decreases effects of insulin lispro by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Growth hormone (GH) analogs may decrease insulin sensitivity, particularly at higher doses. Antidiabetic agents may require dose adjustment after initiating growth hormone.
- insulin lispro protamine/insulin lispro
somatrogon decreases effects of insulin lispro protamine/insulin lispro by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Growth hormone (GH) analogs may decrease insulin sensitivity, particularly at higher doses. Antidiabetic agents may require dose adjustment after initiating growth hormone.
- insulin NPH
somatrogon decreases effects of insulin NPH by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Growth hormone (GH) analogs may decrease insulin sensitivity, particularly at higher doses. Antidiabetic agents may require dose adjustment after initiating growth hormone.
- insulin regular human
somatrogon decreases effects of insulin regular human by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Growth hormone (GH) analogs may decrease insulin sensitivity, particularly at higher doses. Antidiabetic agents may require dose adjustment after initiating growth hormone.
- levonorgestrel oral/ethinylestradiol/ferrous bisglycinate
levonorgestrel oral/ethinylestradiol/ferrous bisglycinate will decrease the level or effect of somatrogon by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Oral estrogens may reduce serum insulin-like growth factor I (IGF-1) response to growth hormone (GH) analogs. Higher GH dose may be required
- linagliptin
somatrogon decreases effects of linagliptin by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Growth hormone (GH) analogs may decrease insulin sensitivity, particularly at higher doses. Antidiabetic agents may require dose adjustment after initiating growth hormone.
- liraglutide
somatrogon decreases effects of liraglutide by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Growth hormone (GH) analogs may decrease insulin sensitivity, particularly at higher doses. Antidiabetic agents may require dose adjustment after initiating growth hormone.
- metformin
somatrogon decreases effects of metformin by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Growth hormone (GH) analogs may decrease insulin sensitivity, particularly at higher doses. Antidiabetic agents may require dose adjustment after initiating growth hormone.
- methylprednisolone
methylprednisolone decreases effects of somatrogon by pharmacodynamic antagonism. Use Caution/Monitor. Supraphysiologic glucocorticoid treatment may attenuate growth-promoting effects of growth hormone (GH). Microsomal enzyme 11-beta-hydroxysteroid dehydrogenase type 1 (11-beta-HSD-1) is required for conversion of cortisone to its active metabolite, cortisol, in hepatic and adipose tissue. GH inhibits 11-beta-HSD-1. Consequently, individuals with untreated GH deficiency have relative increases in 11-beta-HSD-1 and serum cortisol. Initiation of GH analogs may result in inhibition of 11-beta-HSD-1 and reduced serum cortisol concentrations.
- mexiletine
somatrogon will decrease the level or effect of mexiletine by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor. Limited published data indicate that growth hormone treatment increases cytochrome P450 (CYP450)-mediated antipyrine clearance. Caution with sensitive CYP substrates
- midazolam
somatrogon will decrease the level or effect of midazolam by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Limited published data indicate that growth hormone treatment increases cytochrome P450 (CYP450)-mediated antipyrine clearance. Caution with sensitive CYP substrates
- miglitol
somatrogon decreases effects of miglitol by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Growth hormone (GH) analogs may decrease insulin sensitivity, particularly at higher doses. Antidiabetic agents may require dose adjustment after initiating growth hormone.
- mometasone sinus implant
mometasone sinus implant decreases effects of somatrogon by pharmacodynamic antagonism. Use Caution/Monitor. Supraphysiologic glucocorticoid treatment may attenuate growth-promoting effects of growth hormone (GH). Microsomal enzyme 11-beta-hydroxysteroid dehydrogenase type 1 (11-beta-HSD-1) is required for conversion of cortisone to its active metabolite, cortisol, in hepatic and adipose tissue. GH inhibits 11-beta-HSD-1. Consequently, individuals with untreated GH deficiency have relative increases in 11-beta-HSD-1 and serum cortisol. Initiation of GH analogs may result in inhibition of 11-beta-HSD-1 and reduced serum cortisol concentrations.
- nateglinide
somatrogon decreases effects of nateglinide by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Growth hormone (GH) analogs may decrease insulin sensitivity, particularly at higher doses. Antidiabetic agents may require dose adjustment after initiating growth hormone.
- olanzapine
somatrogon will decrease the level or effect of olanzapine by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor. Limited published data indicate that growth hormone treatment increases cytochrome P450 (CYP450)-mediated antipyrine clearance. Caution with sensitive CYP substrates
- pacritinib
somatrogon will decrease the level or effect of pacritinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Limited published data indicate that growth hormone treatment increases cytochrome P450 (CYP450)-mediated antipyrine clearance. Caution with sensitive CYP substrates
- phenobarbital
somatrogon will decrease the level or effect of phenobarbital by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Limited published data indicate that growth hormone treatment increases cytochrome P450 (CYP450)-mediated antipyrine clearance. Caution with sensitive CYP substrates
- phenytoin
somatrogon will decrease the level or effect of phenytoin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Limited published data indicate that growth hormone treatment increases cytochrome P450 (CYP450)-mediated antipyrine clearance. Caution with sensitive CYP substrates
- pimozide
somatrogon will decrease the level or effect of pimozide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Limited published data indicate that growth hormone treatment increases cytochrome P450 (CYP450)-mediated antipyrine clearance. Caution with sensitive CYP substrates
- pioglitazone
somatrogon decreases effects of pioglitazone by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Growth hormone (GH) analogs may decrease insulin sensitivity, particularly at higher doses. Antidiabetic agents may require dose adjustment after initiating growth hormone.
- pirfenidone
somatrogon will decrease the level or effect of pirfenidone by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor. Limited published data indicate that growth hormone treatment increases cytochrome P450 (CYP450)-mediated antipyrine clearance. Caution with sensitive CYP substrates
- pomalidomide
somatrogon will decrease the level or effect of pomalidomide by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor. Limited published data indicate that growth hormone treatment increases cytochrome P450 (CYP450)-mediated antipyrine clearance. Caution with sensitive CYP substrates
- pramlintide
somatrogon decreases effects of pramlintide by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Growth hormone (GH) analogs may decrease insulin sensitivity, particularly at higher doses. Antidiabetic agents may require dose adjustment after initiating growth hormone.
- prednisolone
prednisolone decreases effects of somatrogon by pharmacodynamic antagonism. Use Caution/Monitor. Supraphysiologic glucocorticoid treatment may attenuate growth-promoting effects of growth hormone (GH). Microsomal enzyme 11-beta-hydroxysteroid dehydrogenase type 1 (11-beta-HSD-1) is required for conversion of cortisone to its active metabolite, cortisol, in hepatic and adipose tissue. GH inhibits 11-beta-HSD-1. Consequently, individuals with untreated GH deficiency have relative increases in 11-beta-HSD-1 and serum cortisol. Initiation of GH analogs may result in inhibition of 11-beta-HSD-1 and reduced serum cortisol concentrations.
- prednisone
prednisone decreases effects of somatrogon by pharmacodynamic antagonism. Use Caution/Monitor. Supraphysiologic glucocorticoid treatment may attenuate growth-promoting effects of growth hormone (GH). Microsomal enzyme 11-beta-hydroxysteroid dehydrogenase type 1 (11-beta-HSD-1) is required for conversion of cortisone to its active metabolite, cortisol, in hepatic and adipose tissue. GH inhibits 11-beta-HSD-1. Consequently, individuals with untreated GH deficiency have relative increases in 11-beta-HSD-1 and serum cortisol. Initiation of GH analogs may result in inhibition of 11-beta-HSD-1 and reduced serum cortisol concentrations.
- primidone
somatrogon will decrease the level or effect of primidone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Limited published data indicate that growth hormone treatment increases cytochrome P450 (CYP450)-mediated antipyrine clearance. Caution with sensitive CYP substrates
- quinidine
somatrogon will decrease the level or effect of quinidine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Limited published data indicate that growth hormone treatment increases cytochrome P450 (CYP450)-mediated antipyrine clearance. Caution with sensitive CYP substrates
- quinine
somatrogon will decrease the level or effect of quinine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Limited published data indicate that growth hormone treatment increases cytochrome P450 (CYP450)-mediated antipyrine clearance. Caution with sensitive CYP substrates
- ramelteon
somatrogon will decrease the level or effect of ramelteon by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor. Limited published data indicate that growth hormone treatment increases cytochrome P450 (CYP450)-mediated antipyrine clearance. Caution with sensitive CYP substrates
- rasagiline
somatrogon will decrease the level or effect of rasagiline by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor. Limited published data indicate that growth hormone treatment increases cytochrome P450 (CYP450)-mediated antipyrine clearance. Caution with sensitive CYP substrates
- repaglinide
somatrogon decreases effects of repaglinide by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Growth hormone (GH) analogs may decrease insulin sensitivity, particularly at higher doses. Antidiabetic agents may require dose adjustment after initiating growth hormone.
somatrogon will decrease the level or effect of repaglinide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Limited published data indicate that growth hormone treatment increases cytochrome P450 (CYP450)-mediated antipyrine clearance. Caution with sensitive CYP substrates - ropinirole
somatrogon will decrease the level or effect of ropinirole by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor. Limited published data indicate that growth hormone treatment increases cytochrome P450 (CYP450)-mediated antipyrine clearance. Caution with sensitive CYP substrates
- rosiglitazone
somatrogon decreases effects of rosiglitazone by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Growth hormone (GH) analogs may decrease insulin sensitivity, particularly at higher doses. Antidiabetic agents may require dose adjustment after initiating growth hormone.
- saxagliptin
somatrogon decreases effects of saxagliptin by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Growth hormone (GH) analogs may decrease insulin sensitivity, particularly at higher doses. Antidiabetic agents may require dose adjustment after initiating growth hormone.
- semaglutide
somatrogon decreases effects of semaglutide by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Growth hormone (GH) analogs may decrease insulin sensitivity, particularly at higher doses. Antidiabetic agents may require dose adjustment after initiating growth hormone.
- sirolimus
somatrogon will decrease the level or effect of sirolimus by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Limited published data indicate that growth hormone treatment increases cytochrome P450 (CYP450)-mediated antipyrine clearance. Caution with sensitive CYP substrates
- sitagliptin
somatrogon decreases effects of sitagliptin by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Growth hormone (GH) analogs may decrease insulin sensitivity, particularly at higher doses. Antidiabetic agents may require dose adjustment after initiating growth hormone.
- tacrolimus
somatrogon will decrease the level or effect of tacrolimus by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Limited published data indicate that growth hormone treatment increases cytochrome P450 (CYP450)-mediated antipyrine clearance. Caution with sensitive CYP substrates
- tasimelteon
somatrogon will decrease the level or effect of tasimelteon by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor. Limited published data indicate that growth hormone treatment increases cytochrome P450 (CYP450)-mediated antipyrine clearance. Caution with sensitive CYP substrates
- theophylline
somatrogon will decrease the level or effect of theophylline by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor. Limited published data indicate that growth hormone treatment increases cytochrome P450 (CYP450)-mediated antipyrine clearance. Caution with sensitive CYP substrates
somatrogon will decrease the level or effect of theophylline by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Limited published data indicate that growth hormone treatment increases cytochrome P450 (CYP450)-mediated antipyrine clearance. Caution with sensitive CYP substrates - thioridazine
somatrogon will decrease the level or effect of thioridazine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Limited published data indicate that growth hormone treatment increases cytochrome P450 (CYP450)-mediated antipyrine clearance. Caution with sensitive CYP substrates
- tirzepatide
somatrogon decreases effects of tirzepatide by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Growth hormone (GH) analogs may decrease insulin sensitivity, particularly at higher doses. Antidiabetic agents may require dose adjustment after initiating growth hormone.
- tizanidine
somatrogon will decrease the level or effect of tizanidine by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor. Limited published data indicate that growth hormone treatment increases cytochrome P450 (CYP450)-mediated antipyrine clearance. Caution with sensitive CYP substrates
- tolazamide
somatrogon decreases effects of tolazamide by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Growth hormone (GH) analogs may decrease insulin sensitivity, particularly at higher doses. Antidiabetic agents may require dose adjustment after initiating growth hormone.
- tolbutamide
somatrogon decreases effects of tolbutamide by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Growth hormone (GH) analogs may decrease insulin sensitivity, particularly at higher doses. Antidiabetic agents may require dose adjustment after initiating growth hormone.
- triamcinolone acetonide extended-release injectable suspension
triamcinolone acetonide extended-release injectable suspension decreases effects of somatrogon by pharmacodynamic antagonism. Use Caution/Monitor. Supraphysiologic glucocorticoid treatment may attenuate growth-promoting effects of growth hormone (GH). Microsomal enzyme 11-beta-hydroxysteroid dehydrogenase type 1 (11-beta-HSD-1) is required for conversion of cortisone to its active metabolite, cortisol, in hepatic and adipose tissue. GH inhibits 11-beta-HSD-1. Consequently, individuals with untreated GH deficiency have relative increases in 11-beta-HSD-1 and serum cortisol. Initiation of GH analogs may result in inhibition of 11-beta-HSD-1 and reduced serum cortisol concentrations.
- triamcinolone acetonide injectable suspension
triamcinolone acetonide injectable suspension decreases effects of somatrogon by pharmacodynamic antagonism. Use Caution/Monitor. Supraphysiologic glucocorticoid treatment may attenuate growth-promoting effects of growth hormone (GH). Microsomal enzyme 11-beta-hydroxysteroid dehydrogenase type 1 (11-beta-HSD-1) is required for conversion of cortisone to its active metabolite, cortisol, in hepatic and adipose tissue. GH inhibits 11-beta-HSD-1. Consequently, individuals with untreated GH deficiency have relative increases in 11-beta-HSD-1 and serum cortisol. Initiation of GH analogs may result in inhibition of 11-beta-HSD-1 and reduced serum cortisol concentrations.
- triazolam
somatrogon will decrease the level or effect of triazolam by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Limited published data indicate that growth hormone treatment increases cytochrome P450 (CYP450)-mediated antipyrine clearance. Caution with sensitive CYP substrates
- valproic acid
somatrogon will decrease the level or effect of valproic acid by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Limited published data indicate that growth hormone treatment increases cytochrome P450 (CYP450)-mediated antipyrine clearance. Caution with sensitive CYP substrates
- warfarin
somatrogon will decrease the level or effect of warfarin by affecting hepatic enzyme CYP2C9/10 metabolism. Use Caution/Monitor. Limited published data indicate that growth hormone treatment increases cytochrome P450 (CYP450)-mediated antipyrine clearance. Caution with sensitive CYP substrates
Minor (0)
Adverse Effects
Comparative Incidence
Incidence is less than compared with daily somatropin injection denoted with an asterisk*
>10%
Injection site reactions (42.2%)
Nasopharyngitis (33%)
Headache (16.5%)*
Pyrexia (16.5%)
Elevated eosinophil levels (29%)
1-10%
Anemia (8.3%)
Cough (8.3%)
Vomiting (7.3%)*
Hypothyroidism (6.4%)
Abdominal pain (6.4%) *
Rash (5.5%)*
Oropharyngeal pain (5.5%)
Arthralgia (4.6%)*
Otitis media (4.6%)*
Bronchitis (2.8%)*
Warnings
Contraindications
Acute critical illness after open heart surgery, abdominal surgery, or multiple accidental trauma, or those with acute respiratory failure owing to risk of increased mortality with somatropin
Hypersensitivity to somatrogon or excipients
Closed epiphyses
Active malignancy owing to risk of malignancy progression
Active proliferative or severe non-proliferative diabetic retinopathy
Prader-Willi syndrome in patients who are severely obese, have a history of upper airway obstruction or sleep apnea, or have severe respiratory impairment owing to risk of sudden death
Cautions
Fluid retention may occur, including clinical manifestations (eg, edema, nerve compression syndromes including carpal tunnel syndrome/paresthesia) are usually transient and dose dependent
Slipped capital femoral epiphysis may occur more frequently in patients undergoing rapid growth; evaluate patients with onset of a limp or complaints of persistent hip or knee pain
Somatrogon increases growth rate, and progression of preexisting scoliosis can occur in patients who experience rapid growth; growth hormone treatment has not been shown to increase occurrence of scoliosis; monitor patients with history of scoliosis for disease progression
Pancreatitis reported; risk may be greater in pediatric patients compared with adults; consider pancreatitis in patients who develop persistent severe abdominal pain
Lipoatrophy may occur when administered SC at the same site over a long period of time; rotate injection sites to reduce risk
Serum levels of phosphorus, alkaline phosphatase, and parathyroid hormone may increase; monitor as appropriate
Increased mortality with acute critical illness
- Increased mortality in patients with acute critical illness owing to complications following open heart surgery, abdominal surgery, or multiple accidental trauma, or those with acute respiratory failure has been reported
- Safety of continuing treatment in patients who concurrently develop these illnesses has not been established
Hypersensitivity
- Severe hypersensitivity reactions, including anaphylaxis and angioedema, reported
- Inform patients and/or caregivers about possibility of hypersensitivity and to seek prompt medical attention if an allergic reaction occurs
Risk of neoplasms
-
Active malignancy
- Increased risk of malignancy progression
- Any preexisting malignancy should be inactive, and its treatment completed before initiating therapy
- Discontinue somatrogon with evidence of recurrent malignancy
-
Risk of second neoplasm
- Increased risk of second neoplasm reported in childhood cancer survivors treated with radiation to the brain/head for their first neoplasm and who developed subsequent growth hormone deficiency (GHD) and were treated with somatropin
- Intracranial tumors, in particular meningiomas, were the most common of these second neoplasms
- Monitor for progression or recurrence of the tumor in all patients who have history of GHD secondary to an intracranial neoplasm while on somatrogon
-
New malignancy during treatment
- Consider risks and benefits in children with certain rare genetic causes of short stature since these children have an increased risk of developing malignancies
- If treatment is initiated, carefully monitor for development of neoplasms
- Monitor for increased growth or potential malignant changes of preexisting nevi
- Advise patients and/or 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
Glucose intolerance and diabetes mellitus
- Growth hormone treatment may decrease insulin sensitivity, particularly at higher doses
- New-onset type 2 diabetes mellitus reported in patients receiving growth hormone.
- Patients with undiagnosed prediabetes and diabetes mellitus may experience worsened glycemic control and become symptomatic
- Monitor glucose levels periodically in all patients, especially those with risk factors for diabetes mellitus (eg, obesity, Turner syndrome, family history of diabetes mellitus)
- Monitor patients with preexisting type 1 or type 2 diabetes mellitus or pre-diabetes closely
- Doses of antidiabetic agents may require adjustment when initiating somatrogon
Intracranial hypertension
- Intracranial hypertension (IH) with papilledema, visual changes, headache, nausea, and/or vomiting reported
- Symptoms usually occurred within 8 weeks after initiating
- In all reported cases, IH-associated signs and symptoms rapidly resolved after cessation of therapy or a reduction of somatropin dose
- Perform fundoscopic examination before initiating treatment to exclude preexisting papilledema and periodically thereafter
- If papilledema identified before initiating, evaluate the etiology and treat underlying cause before initiating
- Temporarily discontinue in patients with clinical or fundoscopic evidence of IH
- If IH confirmed, restart treatment at a lower dose after IH-associated signs and symptoms have resolved
Hypoadrenalism
- 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 doses following initiation of somatrogon treatment
- Monitor for reduced serum cortisol levels and/or need for glucocorticoid dose increases in those with known hypoadrenalism
Hypothyroidism
- Undiagnosed/untreated hypothyroidism may prevent an optimal response to somatrogon
- In patients with GHD, central (secondary) hypothyroidism may first become evident or worsen during treatment with growth hormone therapy
- Initiate periodic thyroid function tests and thyroid hormone replacement therapy or appropriately adjust treatment when indicated
Sudden death in patients with Prader-Willi syndrome
- Sudden death reported after initiating therapy 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 may be at greater risk than females
- Not indicated for treatment of pediatric patients who have growth failure owing to genetically confirmed Prader-Willi syndrome
Drug interaction overview
-
Replacement glucocorticoid treatment
- Dosage modification/monitor of glucocorticoid
- Microsomal enzyme 11-beta-hydroxysteroid dehydrogenase type 1 (11-betaHSD-1) is required for conversion of cortisone to its active metabolite, cortisol, in hepatic and adipose tissue
- Growth hormone inhibits 11-betaHSD-1; consequently, individuals with untreated GHD have relative increases in 11-betaHSD-1 and serum cortisol
- Initiation of somatrogon may inhibit 11-betaHSD-1 and reduce serum cortisol concentrations
- Patients treated with glucocorticoid replacement for hypoadrenalism may require increased maintenance or stress doses after initiating somatrogon
- Cortisone acetate and prednisone may be affected more than others because conversion of these drugs to their biologically active metabolites depends on 11-betaHSD-1
-
Supraphysiologic glucocorticoid treatment
- Dosage modification/monitor of glucocorticoid
- Supraphysiologic glucocorticoid treatment may attenuate growth-promoting effects of somatrogon
- Carefully adjust glucocorticoid replacement dosing in patients receiving glucocorticoid treatments to avoid hypoadrenalism and an inhibitory effect on growth
-
CYP450 substrates
- Monitor
- Limited data indicate growth hormone treatment increases cytochrome P450 (CYP450)-mediated antipyrine clearance
- Somatrogon may alter clearance of compounds known to be metabolized by CYP450 liver enzymes
-
Oral estrogen
- Modify dose of somatrogon
- Oral estrogens may reduce serum insulin-like growth factor 1 (IGF-1) response to somatrogon
- Patients receiving oral estrogen replacement may require higher somatrogon dosages
-
Insulin/antihyperglycemic agents
- Modify dose/monitor
- Treatment with somatrogon 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
Pregnancy & Lactation
Pregnancy
Data are unavailable on use in pregnant females to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes
Pregnancy testing
- Although somatrogon did not interfere with human chorionic gonadotropin (hCG) pregnancy testing in a limited number of commercial tests, interference with hCG blood and urine pregnancy testing in patients receiving somatrogon may be possible, leading to either false-positive or false-negative results
- Alternative methods (ie, not reliant on hCG) are recommended to determine pregnancy
Animal studies
- In pregnant rats, there was no evidence of embryo-fetal toxicity following administration of somatrogon SC during organogenesis at doses up to 45 times the maximum recommended human dose based on exposure
Lactation
Data are unavailable on presence of somatrogon in human or animal milk, effects on breastfed infants, or effects on milk production
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Long-acting human growth hormone derivative
Binds to growth hormone (GH) receptor and initiates a signal transduction cascade culminating in changes in growth and metabolism
This binding leads to activation of STAT5b signaling pathway and increases serum concentration of IGF-1
GH and IGF-1 stimulate metabolic changes, linear growth, and enhance growth velocity in pediatric patients with GHD
Absorption
Peak plasma time: 11 hr (range 6-25 hr)
Peak plasma concentration (steady state): 495 ng/mL
Distribution
Vd: 0.342 L/kg (central); 0.671 L/kg (peripheral)
Metabolism
Believed to be classic protein catabolism, with subsequent recovery of amino acids and return to systemic circulation
Elimination
Half-life: 37.7 hr
Clearance: 0.0398 L/hr/kg
Excretion: Not evaluated
Administration
SC Preparation
May use pen straight from refrigerator, or for a more comfortable injection, leave pen at room temperature for up to 30 minutes
Inspect visually for particulate matter and discoloration before administration
Discard if flakes, particles, or discoloration observed
Do not shake; shaking can damage product
See Prescribing Information for complete patient instructions for self or caregiver administration
SC Administration
Administer once weekly by SC injection on the same day each week, at any time of the day
Administer in abdomen, thighs, buttocks, or upper arms; rotate injection site weekly
If more than 1 injection required to deliver a complete dose, administer each injection at a different injection site
Switching administration day
- Day of weekly administration can be changed if necessary as long as time between 2 doses is ≥3 days
- After selecting new dosing day, continue once-weekly dosing
Switching from daily growth hormone
- When switching from daily growth hormone, initiate once-weekly somatrogon on the day following last daily injection
Missed dose
- Administer as soon as possible within 3 days after missed dose
- If >3 days have passed, skip missed dose and administer next dose on regularly scheduled day
Storage
Before first use (unused pens)
- Refrigerate between 36-46ºF (2-8ºC) in original carton to protect from light
- Do not freeze pen or expose it to heat
- Do not use pen if it has been frozen or stored in direct sunlight
After first use
- Refrigerate between 36-46ºF (2-8ºC) and protect from direct sunlight
- Keep pen cap on pen when not in use
- Do not store pen with needle attached
- Discard if >28 days after first use
Images
Formulary
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