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 following clinically significant adverse reactions are described elsewhere in the labeling: Central Nervous System (CNS) Depressant Effect and Daytime Impairment [see Warnings and Precautions (5.1) ] Hepatic Transaminase Elevations [see Warnings and Precautions (5.2) ] The most frequently reported (≥5%) adverse reactions were headache, fatigue, dizziness and somnolence.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Bayer HealthCare Pharmaceuticals Inc.
at 1-888-842-2937 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials 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 trials of another drug and may not reflect the rates observed in clinical practice.
The safety of LYNKUET was evaluated in three randomized, double-blind, placebo-controlled, multicenter clinical trials (OASIS 1, OASIS 2, OASIS 3 ) in 1420 women .
In OASIS 1 and OASIS 2 combined, 793 women received LYNKUET or placebo for 12 weeks.
After the first 12 weeks, 341 women randomized to LYNKUET continued to receive LYNKUET for another 14 weeks, with a total treatment duration of up to 26 weeks.
In OASIS 1 and OASIS 2 combined, 349 women received placebo for the first 12 weeks and 348 women switched to LYNKUET for the next 14 weeks.
In OASIS 3, 627 women received LYNKUET or placebo for up to 52 weeks to evaluate long-term safety [see Clinical Studies (14) ] .
Common Adverse Reactions In OASIS 1 and 2 combined, through the first 12 weeks, commonly reported adverse reactions in the LYNKUET group (≥2% and greater than in placebo) were headache, fatigue, gastroesophageal reflux disease, dizziness, nausea, and somnolence.
5 WARNINGS AND PRECAUTIONS CNS Depressant Effect and Daytime Impairment: Advise patients about the potential for somnolence and other nervous system effects.
Advise patients who experience these effects to refrain from driving or engaging in hazardous occupations or activities until the effects have resolved ( 5.1 ) Hepatic Transaminase Elevations: Perform bloodwork prior to initiation of LYNKUET to evaluate for hepatic function and injury.
Do not start therapy if serum transaminase concentration is equal to or exceeds two times the upper limit of normal (ULN).
Perform follow-up evaluations of hepatic transaminase concentration 3 months after initiation.
Do not start therapy if serum transaminase concentration is equal to or exceeds two times the ULN or if the total bilirubin is equal to or exceeds two times the ULN.
Like all medications, Lynkuet 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: