NGENLA® Drug Interactions

(somatrogon-ghla)

7 DRUG INTERACTIONS

Table 2 includes a list of drugs with clinically significant drug interactions when administered concomitantly with NGENLA and instructions for preventing or managing them.

Table 2  Clinically Significant Drug Interactions with NGENLA

Replacement Glucocorticoid Treatment

Clinical Impact:

Microsomal enzyme 11β-hydroxysteroid dehydrogenase type 1 (11βHSD-1) is required for conversion of cortisone to its active metabolite, cortisol, in hepatic and adipose tissue. Growth hormone inhibits 11βHSD-1. Consequently, individuals with untreated GH deficiency have relative increases in 11βHSD-1 and serum cortisol. Initiation of NGENLA may result in inhibition of 11βHSD-1 and reduced serum cortisol concentrations.

Intervention:

Patients treated with glucocorticoid replacement for hypoadrenalism may require an increase in their maintenance or stress doses following initiation of NGENLA [see Warnings and Precautions (5.7)].

Examples:

Cortisone acetate and prednisone may be affected more than others because conversion of these drugs to their biologically active metabolites is dependent on the activity of 11βHSD-1.

Supraphysiologic Glucocorticoid Treatment

Clinical Impact:

Supraphysiologic glucocorticoid treatment may attenuate the growth-promoting effects of NGENLA in pediatric patients.

Intervention:

Carefully adjust glucocorticoid replacement dosing in pediatric patients receiving glucocorticoid treatments to avoid hypoadrenalism and an inhibitory effect on growth.

Cytochrome P450-Metabolized Drugs

Clinical Impact:

Limited published data indicate that growth hormone treatment increases cytochrome P450 (CYP450)-mediated antipyrine clearance. NGENLA may alter the clearance of compounds known to be metabolized by CYP450 liver enzymes.

Intervention:

Careful monitoring is advisable when NGENLA is administered in combination with drugs metabolized by CYP450 liver enzymes.

Oral Estrogen

Clinical Impact:

Oral estrogens may reduce the serum IGF-1 response to NGENLA.

Intervention:

Patients receiving oral estrogen replacement may require higher NGENLA dosages.

Insulin and/or Other Antihyperglycemic Agents

Clinical Impact:

Treatment with NGENLA may decrease insulin sensitivity, particularly at higher doses.

Intervention:

Patients with diabetes mellitus may require adjustment of their doses of insulin and/or other antihyperglycemic agents [see Warnings and Precautions (5.4)].

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Drug Interactions

7 DRUG INTERACTIONS

Table 2 includes a list of drugs with clinically significant drug interactions when administered concomitantly with NGENLA and instructions for preventing or managing them.

Table 2  Clinically Significant Drug Interactions with NGENLA

Replacement Glucocorticoid Treatment

Clinical Impact:

Microsomal enzyme 11β-hydroxysteroid dehydrogenase type 1 (11βHSD-1) is required for conversion of cortisone to its active metabolite, cortisol, in hepatic and adipose tissue. Growth hormone inhibits 11βHSD-1. Consequently, individuals with untreated GH deficiency have relative increases in 11βHSD-1 and serum cortisol. Initiation of NGENLA may result in inhibition of 11βHSD-1 and reduced serum cortisol concentrations.

Intervention:

Patients treated with glucocorticoid replacement for hypoadrenalism may require an increase in their maintenance or stress doses following initiation of NGENLA [see Warnings and Precautions (5.7)].

Examples:

Cortisone acetate and prednisone may be affected more than others because conversion of these drugs to their biologically active metabolites is dependent on the activity of 11βHSD-1.

Supraphysiologic Glucocorticoid Treatment

Clinical Impact:

Supraphysiologic glucocorticoid treatment may attenuate the growth-promoting effects of NGENLA in pediatric patients.

Intervention:

Carefully adjust glucocorticoid replacement dosing in pediatric patients receiving glucocorticoid treatments to avoid hypoadrenalism and an inhibitory effect on growth.

Cytochrome P450-Metabolized Drugs

Clinical Impact:

Limited published data indicate that growth hormone treatment increases cytochrome P450 (CYP450)-mediated antipyrine clearance. NGENLA may alter the clearance of compounds known to be metabolized by CYP450 liver enzymes.

Intervention:

Careful monitoring is advisable when NGENLA is administered in combination with drugs metabolized by CYP450 liver enzymes.

Oral Estrogen

Clinical Impact:

Oral estrogens may reduce the serum IGF-1 response to NGENLA.

Intervention:

Patients receiving oral estrogen replacement may require higher NGENLA dosages.

Insulin and/or Other Antihyperglycemic Agents

Clinical Impact:

Treatment with NGENLA may decrease insulin sensitivity, particularly at higher doses.

Intervention:

Patients with diabetes mellitus may require adjustment of their doses of insulin and/or other antihyperglycemic agents [see Warnings and Precautions (5.4)].

Medication Guide

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