- 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
|Prevention or management
|Impact of other drugs on CAMZYOS
Moderate to strong
Strong CYP3A4 inhibitors
Moderate to strong CYP2C19
Moderate to strong CYP3A4
Weak CYP2C19 inhibitors
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
- 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 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
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