Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS 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 ).
To report SUSPECTED ADVERSE REACTIONS, contact Novo Nordisk Inc.
at 1-800-727-6500, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Studies Experience 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
5 WARNINGS AND PRECAUTIONS • QT Prolongation: QT prolongation can lead to development of torsade de pointes-type ventricular tachycardia.
Avoid the concomitant use of MACRILEN with drugs that are known to prolong QT interval ( 5.1 , 7.1 ).
• Potential for False Positive Test Results with Use of Strong CYP3A4 Inducers: Discontinue and washout strong CYP3A4 inducers before testing ( 5.2 , 7.2 ).
• Potential for False Negative Test Results in Recent Onset Hypothalamic Disease: Consider repeat testing if indicated ( 5.3 ).
5.1 QT Prolongation MACRILEN causes an increase of about 11 msec in the corrected QT (QTc) interval [see Clinical Pharmacology ( 12.2 )] .
Like all medications, Macrilen can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: