CAMZYOS

Camzyos Generic Name & Formulations

Legal Class

General Description

Mavacamten 2.5mg, 5mg, 10mg, 15mg; caps.

Pharmacological Class

Cardiac myosin inhibitor.

How Supplied

Caps—30

Manufacturer

Bristol Myers Squibb

Generic Availability

Mechanism of Action

Mavacamten is an allosteric and reversible inhibitor selective for cardiac myosin. Mavacamten modulates the number of myosin heads that can enter “on actin” (power-generating) states, thus reducing the probability of force-producing (systolic) and residual (diastolic) cross-bridge formation. Mavacamten shifts the overall myosin population towards an energy-sparing, recruitable, super-relaxed state. In HCM patients, myosin inhibition with mavacamten reduces dynamic left ventricular outflow tract (LVOT) obstruction and improves cardiac filling pressures.

Camzyos Indications

Indications

In adults with symptomatic New York Heart Association (NYHA) class II-III obstructive hypertrophic cardiomyopathy (HCM) to improve functional capacity and symptoms.

Camzyos Dosage and Administration

Adult

Swallow whole. Individualize. Initially 5mg once daily; allowable subsequent titration doses are 2.5mg, 5mg, 10mg or 15mg once daily. When initiating or titrating, first consider LVEF then consider the Valsalva LVOT gradient and patient clinical status to guide appropriate dosing; see full labeling. Concomitant with weak CYP2C19 or moderate CYP3A4 inhibitors: initially 5mg once daily (in those who are on stable therapy with a weak CYP2C19 or a moderate CYP3A4 inhibitor). Reduce Camzyos dose by one level (eg, 15mg to 10mg; 10mg to 5mg; or 5mg to 2.5mg) in those who are on Camzyos therapy and intend to initiate a weak CYP2C19 or a moderate CYP3A4 inhibitor; avoid in those who are on a stable treatment with Camzyos 2.5mg, as a lower dose is not available.

Children

Not established.

Camzyos Contraindications

Contraindications

Concomitant moderate to strong CYP2C19 inhibitors or strong CYP3A4 inhibitors. Concomitant moderate to strong inducers of CYP2C19 or CYP3A4.

Camzyos Boxed Warnings

Boxed Warning

Risk of heart failure.

Camzyos Warnings/Precautions

Warnings/Precautions

Risk of heart failure due to systolic dysfunction. Assess clinical status and LVEF prior to and during treatment; adjust dose accordingly. Asymptomatic LVEF reduction, intercurrent illnesses (eg, serious infection), arrhythmias; see full labeling. Initiation or up-titration in those with LVEF <55%: not recommended. Interrupt treatment if LVEF is <50% at any visit, if heart failure symptoms, or worsening clinical status develops. Severe hepatic impairment. Embryo-fetal toxicity. Advise females of reproductive potential to use effective contraception during and for 4 months after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers.

REMS

YES

Camzyos Pharmacokinetics

Distribution

Plasma protein bound: 97–98%.

Metabolism

CYP2C19 (major), CYP3A4, CYP2C9.

Elimination

Renal (85%), fecal (7%). Half-life: 6–9 days (CYP2C19 normal metabolizers); 23 days (CYP2C19 poor metabolizers).

Camzyos Interactions

Interactions

See Contraindications. Avoid concomitant drugs that reduce cardiac contractility (eg, disopyramide, ranolazine, verapamil+beta blocker, or diltiazem+beta blocker); if concomitant use with a negative inotrope is initiated or the dose increased, monitor LVEF until stable doses and clinical response are achieved. Potentiated by weak CYP2C19 inhibitors (eg, omeprazole) or moderate CYP3A4 inhibitors; see Adult. May antagonize substrates of CYP3A4, CYP2C19, or CYP2C9 (eg, progestin, ethinyl estradiol, midazolam, tolbutamide); monitor closely. Advise patients using combined hormonal contraceptives to use an alternative method (eg, IUDs) or add nonhormonal contraception (condoms).

Camzyos Adverse Reactions

Adverse Reactions

Dizziness, syncope.

Camzyos Clinical Trials

See Literature

Camzyos Note

Notes

Only available through the Camzyos REMS Program. For more information visit www.CamzyosREMS.com or call (833) 628-7367.

Camzyos Patient Counseling