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Mavacamten

Also known as: Camzyos

Cardiac Myosin InhibitorCardiac Myosin Inhibitors

Route: Oral

4 interactions on record⛔ Black Box Warning

Mavacamten has 4 known drug interactions based on U.S. FDA drug labeling data. Of these, 2 are contraindicated combinations that should be avoided entirely. 2 are classified as major interactions requiring close medical supervision. Notable interactions include combinations with Mao Inhibitors, Moderate To Strong Cyp2c19 Inducers, Disopyramide. Patients taking Mavacamten should inform their healthcare provider of all current medications — including over-the-counter drugs and supplements — to avoid potentially harmful combinations. Data sourced from OpenFDA and the NIH National Library of Medicine.

Total: 4
Contraindicated: 2
Major: 2

Contraindicated (2)

Mavacamten + Mao Inhibitors— Concomitant use increases mavacamten exposure, which may increase the risk of heart failure due to systolic dysfunction.…
Mavacamten + Moderate To Strong Cyp2c19 Inducers— Concomitant use decreases mavacamten exposure and may reduce efficacy. Risk of heart failure may increase upon discontin…

Major (2)

Mavacamten + Disopyramide— Avoid concomitant use of CAMZYOS in patients on disopyramide, ranolazine, verapamil with a beta blocker, or diltiazem wi…
Mavacamten + Negative Inotropes— Close medical supervision and LVEF monitoring recommended if a negative inotrope is initiated or dose increased. Avoid c…

Mavacamten + Mao Inhibitors⛔Contraindicated

Concomitant use increases mavacamten exposure, which may increase the risk of heart failure due to systolic dysfunction. Contraindicated.

Mavacamten + Moderate To Strong Cyp2c19 Inducers⛔Contraindicated

Concomitant use decreases mavacamten exposure and may reduce efficacy. Risk of heart failure may increase upon discontinuation. Contraindicated.

Mavacamten + Disopyramide⚠️Major

Avoid concomitant use of CAMZYOS in patients on disopyramide, ranolazine, verapamil with a beta blocker, or diltiazem with a beta blocker as these medications and combinations increase the risk of left ventricular systolic dysfunction and heart failure symptoms and clinical experience is limited [see Warnings and Precautions (5.1) ] .

Mavacamten + Negative Inotropes⚠️Major

Close medical supervision and LVEF monitoring recommended if a negative inotrope is initiated or dose increased. Avoid certain combinations of negative inotropes.

⛔ FDA Black Box Warning

WARNING: RISK OF HEART FAILURE CAMZYOS reduces left ventricular ejection fraction (LVEF) and can cause heart failure due to systolic dysfunction [see Warnings and Precautions (5.1) ] . Echocardiogram assessments of LVEF are required prior to and during treatment with CAMZYOS. Initiation of CAMZYOS in patients with LVEF <55% is not recommended. Interrupt CAMZYOS if LVEF is <50% at any visit or if the patient experiences heart failure symptoms or worsening clinical status [see Dosage and Administration (2.1) and Warnings and Precautions (5.1) ] . Concomitant use of CAMZYOS with certain cytochrome P450 inhibitors or discontinuation of certain cytochrome P450 inducers may increase the risk of heart failure due to systolic dysfunction; therefore, the use of CAMZYOS is contraindicated with the following [see Contraindications (4) and Warnings and Precautions (5.2) ] : • Strong CYP2C19 inhibitors • Moderate to strong CYP2C19 inducers or moderate to strong CYP3A4 inducers Because of the risk of heart failure due to systolic dysfunction, CAMZYOS is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called CAMZYOS REMS PROGRAM [see Warnings and Precautions (5.3) ]. WARNING: RISK OF HEART FAILURE See full prescribing information for complete boxed warning. • CAMZYOS can cause heart failure due to systolic dysfunction. ( 5.1 ) • Echocardiogram assessments of left ventricular ejection fraction (LVEF) required before and during CAMZYOS use. ( 2.1 ) • Initiation in patients with LVEF <55% not recommended. Interrupt if LVEF <50% or if worsening clinical status. ( 2.1 , 5.1 ) • Certain CYP450 inhibitors and inducers are contraindicated in patients taking CAMZYOS because of an increased risk of heart failure. ( 4 , 5.2 , 7 ) • CAMZYOS is available only through a restricted program called the CAMZYOS REMS Program. ( 5.3 )

Contraindications

4 CONTRAINDICATIONS CAMZYOS is contraindicated with concomitant use of: • Strong CYP2C19 inhibitors [see Warnings and Precautions (5.2) , Drug Interactions (7.1) ] • Moderate to strong CYP2C19 inducers or moderate to strong CYP3A4 inducers [see Warnings and Precautions (5.2) , Drug Interactions (7.1) ] • Strong CYP2C19 inhibitors. ( 4 , 5.2 ) • Moderate to strong CYP2C19 inducers or moderate to strong CYP3A4 inducers. ( 4 , 5.2 )

Pregnancy & Breastfeeding

8.1 Pregnancy Risk Summary Based on animal data, CAMZYOS may cause fetal harm when administered to a pregnant female. There are no human data on the use of CAMZYOS during pregnancy to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. The underlying maternal condition during pregnancy poses a risk to the mother and fetus (see Clinical Considerations ) . Advise pregnant females about the potential risk to the fetus with maternal exposure to CAMZYOS during pregnancy. In animal embryo-fetal development studies, mavacamten-related decreases in mean fetal body weight, reductions in fetal ossification of bones, and increases in post-implantation loss (early and/or late resorptions) were observed in rats and increases in visceral and skeletal malformations were observed in both rabbits and rats at dose exposures similar to that achieved at the maximum recommended human dose (MRHD) (see Data ) . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. There is a pregnancy safety study for CAMZYOS. If CAMZYOS is administered during pregnancy, or if a patient becomes pregnant while receiving CAMZYOS or within 4 months after the last dose of CAMZYOS, healthcare providers should report CAMZYOS exposure by contacting Bristol-Myers Squibb at 1-800-721-5072 or www.bms.com. Clinical Considerations Disease-Associated Maternal and Embryo-Fetal Risk Obstructive HCM in pregnancy has been associated with increased risk for preterm birth. Data Animal Data When mavacamten was administered orally to pregnant rats (0.3 to 1.5 mg/kg/day) during the period of organogenesis, increases in post-implantation loss,

Data sourced from U.S. FDA drug labeling via openFDA and the NIH National Library of Medicine. For informational purposes only. Always consult your pharmacist or physician.