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 adverse reaction is discussed in other sections of the labeling: • Heart failure [see Warnings and Precautions (5.1) ] Adverse reactions occurring in >5% of patients and more commonly on CAMZYOS than on placebo were dizziness (27%) and syncope (6%).
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Bristol-Myers Squibb at 1-800-721-5072 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 practice.
The safety of CAMZYOS was evaluated in EXPLORER-HCM, a Phase 3, double-blind, randomized, placebo-controlled trial [see Clinical Studies (14) ] .
Of the 251 adults with obstructive HCM, 123 patients were treated with CAMZYOS 2.5-15 mg daily and 128 were treated with placebo.
CAMZYOS-treated patients had a median duration of exposure of 30 weeks (range: 2-40 weeks).
Syncope (0.8%) was the only adverse drug reaction leading to discontinuation in patients receiving CAMZYOS.
Adverse reactions occurring in >5% of patients and more commonly on CAMZYOS than on placebo were dizziness (27% vs.
18%) and syncope (6% vs.
The safety of CAMZYOS in patients was further evaluated in VALOR-HCM, a Phase 3, double-blind, randomized, placebo-controlled trial [see Clinical Studies (14) ] .
5 WARNINGS AND PRECAUTIONS • Heart Failure : Consider interruption of CAMZYOS in patients with intercurrent illness.
( 2.1 , 5.1 ) • Drug Interactions Leading to Heart Failure or Loss of Effectiveness : Advise patients of the potential for drug interactions including with over-the-counter medications.
( 4 , 5.2 , 17 ) • Embryo-Fetal Toxicity : May cause fetal harm.
Advise females of reproductive potential to use effective contraception until 4 months after the last dose.
Avoid concomitant use with a combined hormonal contraceptive that contains a progestin other than norethindrone.
Like all medications, Camzyos 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: