Cardiology
Obstructive hypertrophic cardiomyopathy: the approved drugs compared for prescribers
Camzyos side by side on what each first fill waits on, what the label requires you to monitor and what an insurer asks to see, with FDA decisions, label changes and open trials for obstructive hypertrophic cardiomyopathy.
1prescribing companion
0FDA decisions pending
12open or opening studies
November 7, 2026last checked
The drugs side by side
Each cell is a summary of that drug's prescribing companion, which carries the full detail and a source on every line. Insurer thresholds are one public policy shown as an example; plans differ.
| Camzyosmavacamten | |
|---|---|
| Label dated | September 30, 2026 |
| Starting dose | 5mg once daily, swallowed whole, with or without food. Available doses after titration are 2.5mg, 5mg, 10mg and 15mg, moved only on echo results. A bottle holds 30 capsules; in the first year the pharmacy may dispense no more than a 35-day supply. |
| Dispensing gate | REMS-certified prescriber and pharmacy, Patient Enrollment Form carrying the baseline echo with LVEF 55% or higher, a negative pregnancy test where it applies, and the pharmacy's medication review; the REMS authorizes every fill |
| Required monitoring | Echocardiogram at weeks 4, 8 and 12, then every 3 to 6 months on a stable dose, plus 4 and 12 weeks after any dose change; a Patient Status Form to the REMS after each, or the pharmacy cannot ship |
| Example PA threshold | FEP example: obstructive HCM with NYHA class II or III symptoms, a beta blocker or calcium channel blocker failed, not tolerated or contraindicated, LVEF 55% or higher, REMS enrollment, an echo monitoring commitment |
| Support line | MyCAMZYOS, 1-855-226-9967, Patient Access Specialist, copay to $10 for commercial plans, a free 35-day first supply, a bridge supply after a 5-day delay, and an echo copay program |
Camzyos mavacamten
- Label dated
- September 30, 2026
- Starting dose
- 5mg once daily, swallowed whole, with or without food. Available doses after titration are 2.5mg, 5mg, 10mg and 15mg, moved only on echo results. A bottle holds 30 capsules; in the first year the pharmacy may dispense no more than a 35-day supply.
- Dispensing gate
- REMS-certified prescriber and pharmacy, Patient Enrollment Form carrying the baseline echo with LVEF 55% or higher, a negative pregnancy test where it applies, and the pharmacy's medication review; the REMS authorizes every fill
- Required monitoring
- Echocardiogram at weeks 4, 8 and 12, then every 3 to 6 months on a stable dose, plus 4 and 12 weeks after any dose change; a Patient Status Form to the REMS after each, or the pharmacy cannot ship
- Example PA threshold
- FEP example: obstructive HCM with NYHA class II or III symptoms, a beta blocker or calcium channel blocker failed, not tolerated or contraindicated, LVEF 55% or higher, REMS enrollment, an echo monitoring commitment
- Support line
- MyCAMZYOS, 1-855-226-9967, Patient Access Specialist, copay to $10 for commercial plans, a free 35-day first supply, a bridge supply after a 5-day delay, and an echo copay program
FDA decisions for obstructive hypertrophic cardiomyopathy
From the Trial Friend FDA decision calendar, which records each date from the sponsor's or the FDA's own announcement.
No pending or recent decisions on the calendar.
Recent label changes
What changed in each label revision, from the FDA's approval letters and the labels' own revision lists.
- September 2026Camzyos. Children weighing 30kg (about 66 lb) or more were added to the approved use, with a 1mg capsule and a 2.5mg starting dose for those under 45kg (about 99 lb). The adult dosing did not change. FDA letter
- April 2025Camzyos. The biggest loosening since approval. Moderate CYP2C19 blockers and strong CYP3A4 blockers moved from banned to allowed with a lower starting dose. The maintenance echo went from every 12 weeks to every 3 to 6 months and a post-exercise gradient check was added. The pharmacy limit after the first year rose from 35 to 90 days. FDA letter
- April 2024Camzyos. The FDA approved revised wording on combined hormonal contraceptives and a revised overdose section. The current label's rule, that one combined pill can be used and others need a backup method, dates from this revision. FDA letter
- December 2023Camzyos. A REMS change only. Certified pharmacies may now dispense early for extended travel or humanitarian reasons, and office staff can be registered to handle REMS paperwork for the cardiologist. FDA letter
- June 2023Camzyos. Results of the VALOR-HCM trial, in patients referred for septal reduction surgery, were added to the label. FDA letter
Open trials
12
Screen a patient against themstudies listing Familial Hypertrophic Cardiomyopathy are recruiting or about to open on ClinicalTrials.gov
Counted live, at most once a day
A reference for licensed professionals, checked on November 7, 2026. Labels and plan policies change; the label on DailyMed and the plan's current policy govern. Not medical advice. For patients: the Obstructive hypertrophic cardiomyopathy page and the first 90 days pages for Camzyos.