Elinzanetant: uses, dosing, side effects & brands

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…

LYNKUET is contraindicated in pregnancy. Exposure to LYNKUET may cause pregnancy loss or stillbirth when administered during pregnancy [see Use in Specific Populations (8.1 , 8.3) ] . Pregnancy. ( 4 )

Strong CYP3A4 Inhibitors and grapefruit (juice): Avoid concomitant use with LYNKUET. ( 7.1 ) Moderate CYP3A4 Inhibitors: Reduce LYNKUET dosage to 60 mg once daily. ( 2.2 , 7.1 ) Strong and Moderate CYP3A4 Inducers: Avoid concomitant use with LYNKUET. ( 7.1 ) 7.1 Effects of Other Drugs on LYNKUET Elinzanetant is primarily metabolized via CYP3A4 enzyme. Table 3 describes drug interactions where concomitant use of another drug affects LYNKUET. Table 3: Drug Interactions: Concomitant Use of Other Drugs Affect the Use of LYNKUET Strong and Moderate CYP3A4 Inhibitors See www.fda.gov/CYPandTransporterInteractingDrugs for examples of strong and moderate CYP3A4 inhibitors, and CYP3A4 inducers. Prevention or Management Strong CYP3A4 Inhibitors and grapefruit (juice): Avoid concomitant use. Moderate CYP3A4 Inhibitors: Reduce the LYNKUET dosage [see Dosage and Administration (2.2) ]. Clinical Effect(s) Strong and moderate CYP3A4 inhibitors increase elinzanetant exposure, which may increase the risk of LYNKUET-associated adverse reactions [see Clinical Pharmacology (12.3) ]. Strong and Moderate CYP3A4 Inducers Prevention or Management Strong and moderate CYP3A4 inducers: Avoid concomitant use. Clinical Effect(s) Strong and moderate CYP3A4 inducers decrease elinzanetant exposure, which may reduce the effectiveness of LYNKUET. 7.2 Effects of LYNKUET on Other Drugs CYP3A4 Substrates Avoid concomitant use unless otherwise recommended in the Prescribing Information for CYP3A4 substrates where minimal concentration changes may lead to serious adverse reactions. See www.fda.gov/CYPandTransporterInteractingDrugs for examples of CYP3A4 substrates. Elinzanetant is a weak inhibitor of CYP3A4. Concomitant use of LYNKUET increases exposure of CYP3A4 substrates [see Clinical Pharmacology (12.3) ] , which may increase the risk of adverse reactions related to these substrates.