LYNKUET
Generic: ELINZANETANT
Basic Information
Manufacturer
Bayer HealthCare Pharmaceuticals Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
ORAL
FDA Set ID
f42884ff-7dff-419c-8a0c-affe2ed73818
Indications & Usage
1 INDICATIONS AND USAGE LYNKUET is indicated for the treatment of moderate to severe vasomotor symptoms (VMS) due to menopause.
LYNKUET is a neurokinin 1 (NK1) and neurokinin 3 (NK3) receptor antagonist indicated for the treatment of moderate to severe vasomotor symptoms due to menopause.
( 1 )
LYNKUET is a neurokinin 1 (NK1) and neurokinin 3 (NK3) receptor antagonist indicated for the treatment of moderate to severe vasomotor symptoms due to menopause.
( 1 )
Adverse Reactions
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.
Similar adverse reactions were seen in OASIS 3.
Table 2 shows adverse reactions reported in at least 2% of women and more commonly in women taking LYNKUET than placebo in OASIS 3.
Table 2.
Common Adverse Reactions Reported in ≥ 2% in LYNKUET and Greater than Placebo, Weeks 1-52 (OASIS 3) Adverse Reaction LYNKUET N=313 n (%) Placebo N=314 n (%) Headache 30 (9.6) 22 (7.0) Fatigue Includes asthenia.
23 (7.3) 9 (2.9) Dizziness Includes balance disorder, presyncope, vertigo, vertigo CNS origin, vertigo positional, and vestibular neuronitis.
19 (6.1) 6 (1.9) Somnolence Includes lethargy.
16 (5.1) 4 (1.3) Abdominal pain Includes abdominal discomfort, abdominal pain lower/upper.
14 (4.5) 8 (2.5) Rash Includes dermatitis, urticaria.
13 (4.2) 5 (1.6) Diarrhea 12 (3.8) 3 (1.0) Muscle spasms Includes muscle tightness.
10 (3.2) 2 (0.6) Adverse Reactions Leading to Discontinuation In OASIS 3, adverse reactions leading to treatment discontinuation (≥1% in LYNKUET and greater than placebo) were abdominal pain (1.6%), fatigue (1.6%), depression (1.6%) and headache (1.3%).
Photosensitivity In the OASIS trials, mild to moderate events of photosensitivity occurred in 0.5% of patients receiving LYNKUET and 0.1% of patients receiving placebo.
Onset of photosensitivity reactions ranged from day 1 to day 290.
While discontinuation occurred in one patient, photosensitivity events in other patients resolved under continued treatment with LYNKUET [see Nonclinical Toxicology (13.2) ].
( 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.
Similar adverse reactions were seen in OASIS 3.
Table 2 shows adverse reactions reported in at least 2% of women and more commonly in women taking LYNKUET than placebo in OASIS 3.
Table 2.
Common Adverse Reactions Reported in ≥ 2% in LYNKUET and Greater than Placebo, Weeks 1-52 (OASIS 3) Adverse Reaction LYNKUET N=313 n (%) Placebo N=314 n (%) Headache 30 (9.6) 22 (7.0) Fatigue Includes asthenia.
23 (7.3) 9 (2.9) Dizziness Includes balance disorder, presyncope, vertigo, vertigo CNS origin, vertigo positional, and vestibular neuronitis.
19 (6.1) 6 (1.9) Somnolence Includes lethargy.
16 (5.1) 4 (1.3) Abdominal pain Includes abdominal discomfort, abdominal pain lower/upper.
14 (4.5) 8 (2.5) Rash Includes dermatitis, urticaria.
13 (4.2) 5 (1.6) Diarrhea 12 (3.8) 3 (1.0) Muscle spasms Includes muscle tightness.
10 (3.2) 2 (0.6) Adverse Reactions Leading to Discontinuation In OASIS 3, adverse reactions leading to treatment discontinuation (≥1% in LYNKUET and greater than placebo) were abdominal pain (1.6%), fatigue (1.6%), depression (1.6%) and headache (1.3%).
Photosensitivity In the OASIS trials, mild to moderate events of photosensitivity occurred in 0.5% of patients receiving LYNKUET and 0.1% of patients receiving placebo.
Onset of photosensitivity reactions ranged from day 1 to day 290.
While discontinuation occurred in one patient, photosensitivity events in other patients resolved under continued treatment with LYNKUET [see Nonclinical Toxicology (13.2) ].