CAMZYOS™ Dosing Guide

The CAMZYOS Dosing Guide provides considerations to assist doctors in determining the appropriate dose for each patient at key points in their treatment with CAMZYOS. The dosing guide follows the FDA-approved labeling, which can be viewed here.

Notes:

  • Prior to initiating CAMZYOS:
  • Confirm absence of pregnancy and usage of effective contraception in females of reproductive potential. Advise females of reproductive potential to use effective contraception until 4 months after the last dose. Use a contraceptive not affected by CAMZYOS’ CYP 450 enzyme induction or add nonhormonal contraception1
  • Assess LVEF by echocardiogram (echo). Do not initiate CAMZYOS in patients with LVEF <55%1
  • Consider Contraindications and Drug-Drug Interactions prior to and throughout treatment. Please see Important Safety Information for Contraindications, Risk of Heart Failure or Loss of Response due to Drug Interactions, and Drug Interactions
  • In order to prescribe CAMZYOS, you must be certified in the Risk Evaluation and Mitigation Strategy (REMS) program.1 If you are not certified, you can learn more here
  • Following initiation: Assess patient response to treatment, including Valsalva LVOT (VLVOT) gradient and LVEF, at weeks 4, 8, and 12 and every 12 weeks thereafter. Adjust the dose based on the figure below1
  • Patients may develop heart failure while taking CAMZYOS. Regular LVEF and VLVOT gradient assessment is required for careful dose titration to achieve an appropriate target VLVOT gradient while maintaining LVEF ≥50% and avoiding heart failure symptoms1
  • Do not up-titrate CAMZYOS in patients with LVEF <55%. Interrupt treatment if LVEF is <50% at any visit; restart treatment after 4 weeks if LVEF ≥50% at next lower daily (mg) dose level. See figure below1

CAMZYOS Is a Once-Daily Oral Medication1

Individualized dosing and titration

Downloadable Dosing Schematic

  • Delay dose increases when there is intercurrent illness (eg, serious infection) or arrhythmia (eg, atrial fibrillation or other uncontrolled tachyarrhythmia) that may impair systolic function. Consider interruption of CAMZYOS in patients with an intercurrent illness1
  • CAMZYOS can be taken without regard to food. If a dose is missed, it should be taken as soon as possible, and the next scheduled dose should be taken at the usual time the following day. Exact timing of dosing during the day is not essential, but 2 doses should not be taken on the same day. CAMZYOS capsules should be taken whole. Advise patients not to break, open, or chew the capsules1

LVEF=left ventricular ejection fraction; LVOT=left ventricular outflow tract.

Please review for additional information.

  • CAMZYOS is primarily metabolized by CYP2C19 and, to a lesser extent, by CYP3A4 and CYP2C9. Concomitant use of CAMZYOS with drugs that interact with these enzymes may lead to life-threatening drug interactions, such as heart failure or loss of effectiveness
  • The use of inducers and inhibitors of CYP2C19 and moderate to strong inducers and inhibitors of CYP3A4 may affect the exposures of CAMZYOS
  • Please see the table below for detailed descriptions of drug interactions, prevention and management strategies, and their clinical impact

Established and Potentially Significant Pharmacokinetic Drug Interactions with CAMZYOS1

Category Drug type Prevention or management Clinical impact
Impact of other drugs on CAMZYOS

Moderate to strong
CYP2C19 inhibitors
or
Strong CYP3A4 inhibitors

Moderate to strong CYP2C19
inducers
or
Moderate to strong CYP3A4
inducers

Weak CYP2C19 inhibitors
or
Moderate CYP3A4 inhibitors

Concomitant use is contraindicated.

Concomitant use is contraindicated.

  • Initiate CAMZYOS at the recommended starting dose of 5 mg orally once daily in patients who are on stable therapy with a weak CYP2C19 or moderate CYP3A4 inhibitor
  • Down-titrate CAMZYOS one level in patients who are on CAMZYOS treatment and intend to initiate a weak CYP2C19 or moderate CYP3A4 inhibitor. Schedule a clinical and echocardiographic assessment 4 weeks after inhibitor initiation. Up-titration should not occur until 12 weeks after the initiation of the inhibitor
  • Avoid the concomitant initiation of weak CYP2C19 inhibitors and moderate CYP3A4 inhibitors in patients who are on stable treatment with 2.5 mg of CAMZYOS because a lower dose is not available

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

  • Concomitant use decreases CAMZYOS exposure, which may reduce the efficacy of CAMZYOS
  • The risk of heart failure due to systolic dysfunction may increase with discontinuation of these inducers as the levels of induced enzyme normalizes

Concomitant use increases CAMZYOS exposure, which may increase the risk of adverse drug reactions.

Impact of CAMZYOS on other drugs

CYP3A4, CYP2C9,
and
CYP2C19 substrates

  • Closely monitor patients when CAMZYOS is used in combination with CYP3A4, CYP2C9, or CYP2C19 substrates, where decreases in the plasma concentrations of these drugs may reduce their activity
  • Advise patients to use a contraceptive method that is not affected by CYP450 enzyme induction (eg, an intrauterine system) or to add nonhormonal contraception (eg, condoms) during concomitant use and for 4 months after the last dose of CAMZYOS
  • CAMZYOS is an inducer of CYP3A4, CYP2C9, and CYP2C19
  • Concomitant use with CYP3A4, CYP2C9, or CYP2C19 substrates may reduce the plasma concentration of these drugs
  • Concomitant use of CAMZYOS with hormonal contraceptives (progestin and ethinyl estradiol), which are CYP3A4 substrates, may decrease exposures of ethinyl estradiol and progestin and lead to contraceptive failure or an increase in breakthrough bleeding

Impact of drugs
that reduce cardiac contractility

Drugs that reduce cardiac contractility

If concomitant therapy with a negative inotrope is initiated, or if the dose of a negative inotrope is increased, monitor LVEF closely until stable doses and clinical response have been achieved.

  • Expect additive negative inotropic effects of CAMZYOS and other drugs that reduce cardiac contractility
  • Avoid concomitant use of CAMZYOS with disopyramide in combination with verapamil or diltiazem because such use has been associated with left ventricular systolic dysfunction and heart failure symptoms
  • 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 were excluded from EXPLORER-HCM

Advise patients of the potential for drug interactions, including with over-the-counter medications (such as omeprazole, esomeprazole, or cimetidine). Advise patients to inform their healthcare providers of all concomitant products prior to and during treatment with CAMZYOS.1

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Reference:

  1. CAMZYOS [package insert]. Princeton, NJ: Bristol-Myers Squibb Company; 2022.