Your first 90 days
Your first 90 days on Camzyos for obstructive HCM
What happens before the first fill, the days that matter, the label's rules and who to call, from the label, the drugmaker's own program and one insurer's written rules.
Camzyos is the busiest start of any drug on this site. It cannot be filled until a heart ultrasound and a signed REMS form are on file, and the label adds a pregnancy test for anyone who can become pregnant. Once it starts, 3 more echocardiograms fall inside the first 90 days, with a refill gate on each one. This page lays out that stretch from the FDA label, the REMS program's own forms, Bristol Myers Squibb's support program and one insurer's written rules.
What has to happen before the first bottle ships
Camzyos is a specialty drug under a REMS, so the first fill waits on an echocardiogram, a signed form and an insurance approval, not on a pharmacy counter. These are the 5 things in the way, in order.
An echocardiogram showing an ejection fraction of 55% or more
The boxed warning says Camzyos is not recommended for anyone whose left ventricular ejection fraction is under 55%. The cardiologist records the echo date and result on the REMS enrollment form, and the pharmacy will not be authorized to ship without it. A recent echo may count, so ask whether the one you have will do.FDA label
The REMS patient brochure, a conversation and your signature
The REMS asks the cardiologist to give you the patient brochure and walk through the risk of heart failure, its warning signs, the drug interactions and the echo schedule. You then sign the Patient Enrollment Form. Your doctor must be certified in the program too, and the form says the start date can be set up to 90 days after it is submitted.Camzyos REMS
A pregnancy test, and a plan for contraception
The label requires confirming there is no pregnancy before the first dose and effective contraception during treatment and for 4 months after the last dose. Camzyos can make some hormonal birth control less effective, and the label names the one combined pill it does not affect. That is a conversation to have before day 1 rather than after.FDA label
A medicine review with the pharmacist
Camzyos is cleared by 2 liver enzymes, and medicines that block or speed them can tip it into heart failure or make it stop working. Strong CYP2C19 blockers, and moderate or strong inducers of either enzyme, are banned outright. Common heartburn pills such as omeprazole, esomeprazole and cimetidine are on the label's list to disclose. The certified pharmacy reviews every prescription and supplement with you before each fill and files a checklist with the REMS.FDA label
The insurance approval, and MyCAMZYOS
Most plans require prior authorization. Enrolling in MyCAMZYOS gives you a Patient Access Specialist who explains your coverage and costs, and a free 35-day first supply for first-time patients. Its bridge program supplies the drug at no cost if a commercial plan's decision is delayed 5 days. The REMS also says to tell your doctor if the first dose is delayed more than 7 days after the pharmacy delivers it.MyCAMZYOS
The days that matter
Counted from the first dose, with the 3 echocardiograms the REMS requires in the first 12 weeks, the monthly refill that depends on each one, and the cadence after that. Type your first-dose date and the tiles become real dates you can add to your calendar.
The tiles below count days from a first dose. Enter the date of yours, or the date you expect, and each tile becomes a real date on your calendar.
The date stays on your device. It is not sent to Trial Friend or anyone else. The calendar file works with Apple, Google and Outlook calendars.Echo, pregnancy test, forms signed
The baseline echocardiogram, the pregnancy test where it applies, the REMS Patient Enrollment Form and the MyCAMZYOS enrollment. The cardiologist's office submits the REMS form with the echo result on it.
The certified pharmacy calls
It confirms with the REMS that your doctor is certified and you are enrolled, reviews your medicine list with you, and sets a delivery window. The REMS asks you to tell your doctor if you do not take the first dose within 7 days of delivery.
First dose, 5mg once a day
One capsule, swallowed whole, at any time of day, with or without food. The label says exact timing does not matter but 2 doses must never fall on the same day. A bottle holds 30 capsules.
Echocardiogram, week 4
The first of 3 required echoes in the first 12 weeks. The cardiologist checks the ejection fraction and the outflow gradient, files a Patient Status Form with the REMS, and decides whether the dose stays, drops or pauses. Below 50% means a pause.
Refill, then about every 30 days
A 30-capsule bottle runs out here. In the first year the pharmacy may dispense no more than a 35-day supply at a time. It calls the REMS for authorization before every fill, so a missing echo result holds the box.
Echocardiogram, week 8
Same check, same form. If the dose was changed at week 4, the REMS schedule also calls for echoes 4 and 12 weeks after any dose change.
Refill, number 2
Echocardiogram, week 12
The last of the initiation echoes. After this, on a stable dose, the REMS calls for an echo every 3 to 6 months depending on the results. The pharmacy can move to a 90-day supply after the first year.
Refill, number 3
The label, revision by revision
The FDA lists which sections changed in each revision of a label. These are the revisions the current Camzyos label records, dated by the FDA, with a plain note on what each one meant for a patient. Older references and handouts can lag these by months.
Label dated September 30, 2026, read on DailyMed. FDA label
- September 2026
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 2025
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 2024
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 2023
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 2023
Results of the VALOR-HCM trial, in patients referred for septal reduction surgery, were added to the label.FDA letter
How the label says to take it
The parts of the prescribing information and the patient leaflet that come up in the first 3 months, in plain words.
- Once a day, any time, swallowed whole
The label says 5mg once daily without regard to food, swallowed whole, never broken, opened or chewed. The allowed doses after titration are 2.5mg, 5mg, 10mg and 15mg, and the cardiologist moves between them only on echo results.FDA label
- If you miss a dose
Take it as soon as possible that day, and take the next dose at the usual time the following day. The label says exact timing is not essential but 2 doses must not be taken on the same day.FDA label
- Heartburn pills and other over-the-counter medicines
The label singles out omeprazole, esomeprazole and cimetidine, which are sold without a prescription, as medicines to tell your doctor and pharmacist about. The Medication Guide adds grapefruit juice. A new medicine, even for a week, can change the dose or pause the drug, so the rule is to ask before taking anything new.FDA label
- Medicines that are banned outright
Strong CYP2C19 inhibitors, and moderate to strong inducers of CYP2C19 or CYP3A4, are contraindicated. The label also says to avoid disopyramide, ranolazine, and verapamil or diltiazem combined with a beta blocker, because they weaken the heart's squeeze in the same direction.FDA label
- If you get a serious infection or an irregular heartbeat
The label says a serious illness such as an infection, or an arrhythmia such as atrial fibrillation, raises the risk of heart failure on Camzyos. It tells prescribers to delay dose increases and consider pausing the drug. Tell the cardiologist's office the day it happens.FDA label
- Pregnancy and birth control
No pregnancy at the start, and effective contraception during treatment and for 4 months after the last dose. The label says the combined pill of ethinyl estradiol and norethindrone can be used, and that other hormonal methods may need a backup such as condoms. The label asks that any pregnancy on Camzyos, or within 4 months of the last dose, be reported to Bristol Myers Squibb's pregnancy safety study at 1-800-721-5072.FDA label
- Storage, and children
Room temperature. The label's overdose section records an infant death after accidental ingestion of three 15mg capsules, so this bottle stays out of reach.FDA label
What the label says to act on
The symptoms the label singles out, and what it tells patients and prescribers to do about each. If any of these happen, the label's instruction is the one to follow, with your care team.
Signs the label ties to heart failure
New or worse shortness of breath, swelling in the legs, chest pain, a racing or pounding heart, fatigue, or rapid weight gain. The Medication Guide says to tell your doctor right away, and the label says these should prompt an echo rather than wait for the next scheduled one.FDA label
Dizziness and fainting
In the EXPLORER-HCM trial, dizziness occurred in 27% of patients on Camzyos against 18% on placebo, and fainting in 6% against 2%. Fainting was the only side effect that led anyone to stop the drug. Either one is worth reporting the same day.FDA label
A drop in ejection fraction
In the trial, 6% of patients on Camzyos had their ejection fraction fall below 50%, against 2% on placebo, and in every case it recovered after the drug was paused. That is what the week 4, 8 and 12 echoes are for, and why a missed echo is not a paperwork problem.FDA label
Why the pharmacy or the insurer says no, and what fixes it
Most first-fill delays are one of these. Knowing which one tells you who to call.
- The REMS has not authorized the fillThe pharmacy must get authorization from the REMS before every dispense. The usual gap is a Patient Status Form the cardiologist's office has not yet filed after an echo. The REMS line is 1-833-628-7367, and the office can file the form online.Camzyos REMS
- The prescription went to a pharmacy that is not certifiedOnly REMS-certified pharmacies can dispense Camzyos, and Bristol Myers Squibb says no local pharmacy can. The prescriber's office resends it to a certified pharmacy. This is a routing error, not a denial.Camzyos REMS
- Prior authorization pending or deniedInsurers ask for the criteria below, most often the diagnosis, the symptom class, an ejection fraction of 55% or more, and REMS enrollment. Many also want a beta blocker or calcium channel blocker tried first. If a commercial plan's decision is delayed 5 days, the MyCAMZYOS bridge program supplies the drug at no cost while it is sorted out.FEP Blue policy
- A copay you cannot payCommercial insurance: the MyCAMZYOS copay program, as little as $10 a month, with program maximums. Medicare, TRICARE and VA: the copay program is closed to you by its terms. Bristol Myers Squibb says Medicare patients pay about $38 a month on average, under Part D's yearly cap. Our help paying page lists charity funds.MyCAMZYOS
- The echocardiograms themselves cost moneyThe REMS requires them. The MyCAMZYOS echo copay program covers the out-of-pocket cost for eligible commercially insured patients up to $2,500 a year, except in Massachusetts, Minnesota and Rhode Island.MyCAMZYOS
Blue Cross Blue Shield Federal Employee Program prior authorization policy, July 1, 2026
- Age 18 or older, with obstructive hypertrophic cardiomyopathy
- Symptoms at NYHA class II or III, meaning limited by shortness of breath or fatigue with ordinary activity
- A beta blocker or calcium channel blocker did not work well enough, was not tolerated or could not be used
- Prescribed by or on the advice of a cardiologist
- Ejection fraction of 55% or more
- The prescriber agrees to monitor echocardiograms, ECG, ejection fraction and the outflow gradient during treatment
- Patient and prescriber enrolled in the Camzyos REMS
- For anyone who can become pregnant, no pregnancy confirmed and contraception advised during treatment and for 4 months after
Approval length. A year at a time, renewed if symptoms improved or stabilized and the same monitoring promises are made, with a limit of 90 capsules per 90 days.
This policy was last reviewed in June 2026, before the FDA extended Camzyos to children weighing 30kg (about 66 lb) or more, so it still says adults only. Other plans set their own criteria and some ask for the outflow gradient figure. It is here as an example of what a plan asks for, not as a rule. FEP Blue policy
Who to call, and what they can do
The drugmaker's program handles most of the first-fill problems above. Charity funds and foundation help are on the help paying page.
- Patient Access Specialists who explain your coverage and out-of-pocket costs
- A copay program for commercial insurance, as little as $10 per 30-day supply, with monthly, annual or per-claim maximums, not open to Medicare, TRICARE, VA or cash payers
- A one-time free 35-day supply for first-time patients, regardless of insurance type, and a bridge supply at no cost when a commercial plan's decision is delayed 5 days
- An echo copay program for commercial insurance, as little as $0 for required echocardiograms up to $2,500 a year
- Educational emails through the first 3 to 4 months and text reminders, plus a finder for REMS-certified cardiologists
Trial Friend takes no money from this program. MyCAMZYOS
Five questions for the pharmacist or the support line
- Has the REMS authorized this fill, and if not, which form is it waiting on from my cardiologist?
- I take these heartburn pills and supplements. Which of them are on the Camzyos interaction list?
- If my doctor changes the dose after an echo, do you ship the new strength right away or at the next refill?
- In my first year, how many days of supply can you send at once, and when do you call the REMS for the next one?
- If I get a cold or an infection and want to take something for it, who do I call first?
Questions people ask in the first weeks
How long does it take to get Camzyos after it is prescribed?
There is no fixed number. The echo, the REMS enrollment, the prior authorization and the pharmacy's REMS authorization each take their own time. The REMS lets the cardiologist set a start date up to 90 days after the enrollment form. The MyCAMZYOS free first supply and bridge program exist because the insurance step is often the slow one.
Can I pick up Camzyos at my regular pharmacy?
No. The REMS allows only certified pharmacies to dispense it, and Bristol Myers Squibb says it is filled by mail from a specialty pharmacy after the REMS authorizes each fill.
How often do I need an echocardiogram on Camzyos?
Before the first dose, then 4, 8 and 12 weeks after it, then every 3 to 6 months on a stable dose. Any dose change adds echoes 4 and 12 weeks later. The pharmacy cannot ship a refill until the REMS has the result for the current interval.
What if I miss a dose of Camzyos?
The label says to take it as soon as possible that day and the next dose at the usual time the following day. Two doses are never taken in one day.
Can I take omeprazole or Prilosec with Camzyos?
The label lists omeprazole, esomeprazole and cimetidine as over-the-counter medicines to tell your doctor and pharmacist about, because they slow the enzyme that clears Camzyos. Whether a particular one is fine at your dose is a question for the cardiologist. The label says a new interacting medicine can mean a lower dose and an echo 4 weeks later.
Why was Camzyos denied by my insurance?
Most often because the plan wants the diagnosis, the symptom class, an ejection fraction of 55% or more, or proof of REMS enrollment. Many also want a documented trial of a beta blocker or calcium channel blocker. The cardiologist's records usually resolve it, and a Patient Access Specialist at MyCAMZYOS can explain what the plan is asking for.
Is Camzyos approved for children?
Since September 30, 2026, yes, for children weighing 30kg (about 66 lb) or more with symptomatic obstructive HCM, with a new 1mg capsule and a lower starting dose for those under 45kg (about 99 lb). The REMS, the echo schedule and the pregnancy rules apply to them too.
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Sources
- CAMZYOS (mavacamten) prescribing information and Medication Guide, revised September 2026, Bristol Myers Squibb, via DailyMed, September 30, 2026.
- CAMZYOS REMS Program, patient page, Patient Enrollment Form, Patient Status Form and pharmacy page, Bristol Myers Squibb, September 1, 2026.
- MyCAMZYOS Patient Support, affordability and support, Bristol Myers Squibb, November 6, 2026.
- Pharmacy Policy 5.40.033, Camzyos (mavacamten), Blue Cross Blue Shield Federal Employee Program, July 1, 2026.
- NDA 214998/S-013 approval letter, pediatric indication and 1mg capsule, FDA, September 30, 2026.
- NDA 214998/S-010 approval letter, interaction, monitoring and dispensing changes, FDA, April 17, 2025.
- NDA 214998/S-009 approval letter, contraception and overdosage labeling, FDA, April 30, 2024.
- NDA 214998/S-008 REMS modification letter, FDA, December 19, 2023.
- NDA 214998/S-001 approval letter, VALOR-HCM results, FDA, June 15, 2023.
This page explains what the FDA label, the drugmaker's support program and an insurer policy say. It is not medical advice and does not tell anyone to start, stop or change a medicine. Dosing, test timing and restarts after a gap are decisions for the prescribing cardiologist. Found an error? Use the report link in the footer and it will be checked against the source.