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