Macrilen
Generic: MACIMORELIN ACETATE
Basic Information
Manufacturer
Aeterna Zentaris GmbH
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
ORAL
FDA Set ID
aeb30f1a-4815-47ae-a2cb-b6b4e26372e1
Indications & Usage
1 INDICATIONS AND USAGE MACRILEN is indicated for the diagnosis of adult growth hormone deficiency (AGHD).
MACRILEN is a growth hormone (GH) secretagogue receptor agonist indicated for the diagnosis of adult growth hormone deficiency ( 1 ).
Limitations of Use : The safety and diagnostic performance has not been established for subjects with BMI > 40kg/m 2 ( 1 ).
Limitations of Use The safety and diagnostic performance of MACRILEN have not been established for subjects with a body mass index (BMI) > 40 kg/m 2 .
MACRILEN is a growth hormone (GH) secretagogue receptor agonist indicated for the diagnosis of adult growth hormone deficiency ( 1 ).
Limitations of Use : The safety and diagnostic performance has not been established for subjects with BMI > 40kg/m 2 ( 1 ).
Limitations of Use The safety and diagnostic performance of MACRILEN have not been established for subjects with a body mass index (BMI) > 40 kg/m 2 .
Adverse Reactions
6 ADVERSE REACTIONS to report suspected adverse reactions 1-800-332-1088 to report suspected adverse reactions , contact Aeterna Zentaris GmbH at 1-843-900-2332, or FDA at 1‑800-332-1088 or www.fda.gov/medwatch.
to report suspected adverse reactions 1-800-332-1088 to report suspected adverse reactions , contact Aeterna Zentaris GmbH at 1-843-900-2332, or FDA at 1‑800-332-1088 or www.fda.gov/medwatch.
The most common adverse reactions were dysgeusia, dizziness, headache, fatigue, nausea, hunger, diarrhea, upper respiratory tract infection, feeling hot, hyperhidrosis, nasopharyngitis, and sinus bradycardia ( 6.1 ).
6.1 Clinical Studies Experience to report suspected adverse reactions 1-800-332-1088 to report suspected adverse reactions , contact Aeterna Zentaris GmbH at 1-843-900-2332, or FDA at 1‑800-332-1088 or www.fda.gov/medwatch.
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trial of another drug and may not reflect the rates observed in practice.
The data in Table 1 are derived from an open-label, randomized, cross-over study that compared the diagnostic performance of MACRILEN to the insulin tolerance test (ITT) for the diagnosis of adult growth hormone deficiency [see Clinical Studies ( 14 )].
A total of 154 subjects with a high to low pre-test probability of having adult growth hormone deficiency received a single oral dose of 0.5 mg/kg MACRILEN.
Out of 154 subjects, 58% were male, 42% female, and 86% of white origin.
Median values were for age 41 years (range: 18 – 66 years) and body mass index was 27.5 kg/m 2 (range: 16 – 40 kg/m 2 ).
Common adverse reactions presented in Table 1 were adverse reactions that were not present at baseline and occurred during MACRILEN dosing in at least two individuals.
Table 1: Common Adverse Reactions Reported in at Least Two Individuals Dosed with MACRILEN in an Open-Label Study Number of Subjects (n = 154) Proportion of Subjects (%) Dysgeusia 7 4.5 Dizziness 6 3.9 Headache 6 3.9 Fatigue 6 3.9 Nausea 5 3.2 Hunger 5 3.2 Diarrhea 3 1.9 Upper respiratory tract infection 3 1.9 Feeling hot 2 1.3 Hyperhidrosis 2 1.3 Nasopharyngitis 2 1.3 Sinus bradycardia 2 1.3 The safety of Macrilen was evaluated in 126 pediatric patients.
The overall safety profile in the pediatric population was consistent with that observed in adults.
to report suspected adverse reactions 1-800-332-1088 to report suspected adverse reactions , contact Aeterna Zentaris GmbH at 1-843-900-2332, or FDA at 1‑800-332-1088 or www.fda.gov/medwatch.
The most common adverse reactions were dysgeusia, dizziness, headache, fatigue, nausea, hunger, diarrhea, upper respiratory tract infection, feeling hot, hyperhidrosis, nasopharyngitis, and sinus bradycardia ( 6.1 ).
6.1 Clinical Studies Experience to report suspected adverse reactions 1-800-332-1088 to report suspected adverse reactions , contact Aeterna Zentaris GmbH at 1-843-900-2332, or FDA at 1‑800-332-1088 or www.fda.gov/medwatch.
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trial of another drug and may not reflect the rates observed in practice.
The data in Table 1 are derived from an open-label, randomized, cross-over study that compared the diagnostic performance of MACRILEN to the insulin tolerance test (ITT) for the diagnosis of adult growth hormone deficiency [see Clinical Studies ( 14 )].
A total of 154 subjects with a high to low pre-test probability of having adult growth hormone deficiency received a single oral dose of 0.5 mg/kg MACRILEN.
Out of 154 subjects, 58% were male, 42% female, and 86% of white origin.
Median values were for age 41 years (range: 18 – 66 years) and body mass index was 27.5 kg/m 2 (range: 16 – 40 kg/m 2 ).
Common adverse reactions presented in Table 1 were adverse reactions that were not present at baseline and occurred during MACRILEN dosing in at least two individuals.
Table 1: Common Adverse Reactions Reported in at Least Two Individuals Dosed with MACRILEN in an Open-Label Study Number of Subjects (n = 154) Proportion of Subjects (%) Dysgeusia 7 4.5 Dizziness 6 3.9 Headache 6 3.9 Fatigue 6 3.9 Nausea 5 3.2 Hunger 5 3.2 Diarrhea 3 1.9 Upper respiratory tract infection 3 1.9 Feeling hot 2 1.3 Hyperhidrosis 2 1.3 Nasopharyngitis 2 1.3 Sinus bradycardia 2 1.3 The safety of Macrilen was evaluated in 126 pediatric patients.
The overall safety profile in the pediatric population was consistent with that observed in adults.