Your first 90 days
Your first 90 days on Myqorzo 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.
Myqorzo is the second drug of its kind for obstructive HCM, after Camzyos, and its first months are built around echocardiograms. The first fill waits on a heart ultrasound and a signed REMS form. After that, each dose step brings another echo a few weeks later, and the pharmacy ships a month at a time until the dose settles. This page lays out that stretch from the FDA label, the REMS program's own forms, Cytokinetics' support program and one insurer's written rules.
What has to happen before the first bottle ships
Myqorzo is a specialty drug under a REMS, so the first fill waits on an echocardiogram, a signed enrollment 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 starting Myqorzo is not recommended when the left ventricular ejection fraction is under 55%. The cardiologist reviews this echo before the first dose and confirms it on the REMS Patient Enrollment Form. Ask whether a recent echo you already had will count.FDA label
The REMS Patient Guide, a conversation and your signature
Your cardiologist must be certified in the MYQORZO REMS, which includes passing a knowledge test. They walk you through the Patient Guide on heart failure risk and its warning signs, then you both sign the Patient Enrollment Form. Treatment must start within 3 months of that form, or a new one is needed.REMS Document
A medicine review
The label bans one medicine with Myqorzo, the antibiotic rifampin. Fluconazole for more than 3 days, voriconazole, fluvoxamine and strong CYP2C9 blockers can raise Myqorzo levels and change the dose. The Medication Guide asks you to list every prescription, over-the-counter medicine, vitamin and herbal supplement before you start.FDA label
Pregnancy and breastfeeding, raised before day 1
The label has no pregnancy test or birth control requirement, which sets it apart from Camzyos. It says the risk in pregnancy is unknown, and animal studies at higher exposures showed birth defects. Tell the cardiologist if you are pregnant, planning a pregnancy or breastfeeding.FDA label
The insurance approval, and MYQORZO & You
Your plan may require prior authorization, and MYQORZO & You can explain your coverage and what you may pay. With commercial insurance, its Bridge Program may supply Myqorzo at no cost for up to 12 months after an initial denial. Government-insured patients new to Myqorzo may get up to a 60-day supply free, though TRICARE, VA and military plans are excluded.MYQORZO & You terms
The days that matter
Counted from the first dose, with the echo after each dose step, the 30-day refills while the dose is set, and the REMS form deadline. 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, Patient Guide, forms signed
The baseline echocardiogram, the REMS conversation using the Patient Guide, and the Patient Enrollment Form signed by you and the cardiologist. The cardiologist's office sends the signed form to the REMS to enroll you.
The certified pharmacy calls
Only specialty pharmacies certified in the REMS can dispense Myqorzo to you. The REMS Patient Guide says the pharmacy will contact you to fill the prescription and ship it to your home.
First dose, 5mg once a day
One tablet, swallowed whole, with or without food, at about the same time each day. Each bottle holds 30 tablets, which is a 30-day supply. The label says 2 doses must never be taken on the same day.
First echocardiogram on treatment
The label calls for an echo 2 to 8 weeks after the first dose. If the ejection fraction is 55% or more and the outflow gradient is still 30 mmHg or higher, the dose can go up by 5mg.
Refill, then about every 30 days
The first 30-tablet bottle runs out around here. While you start or change doses, the pharmacy may send no more than a 30-day supply. It asks the REMS to authorize every fill before it ships.
REMS form deadline
The REMS must receive a Patient Monitoring Form from the cardiologist within 60 days of the first dose. Without it the pharmacy cannot ship again until the form arrives. Each later dose change starts a new 60-day clock for the next form.
Refill, number 2
Toward a settled dose
Each dose step brings another echo 2 to 8 weeks later, up to 20mg. Once the dose holds, echoes fall every 6 months, or every 3 months when the ejection fraction is 50% to under 55%. The pharmacy can then send up to 90 days at a time.
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 Myqorzo 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.
Current label dated December 16, 2025, read from the FDA's label database today. FDA label
- February 2026
A REMS change only, and the label did not change. The FDA approved REMS materials reworded to match the label on what happens at an ejection fraction from 40% to under 50%, and on the approved use.FDA letter
- December 2025
The FDA approved Myqorzo for adults with symptomatic obstructive HCM on December 19th, with the boxed warning and the REMS. The approval requires a pregnancy outcomes study and a breast milk study after approval.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, about the same time, swallowed whole
The label says 5mg once daily to start, with or without meals, at about the same time each day, swallowed whole. The tablets come in 5mg, 10mg, 15mg and 20mg, and the cardiologist moves between them on echo results.FDA label
- If you miss a dose
The label says to take it as soon as possible on the same day, with the next dose at the usual time the following day. It says 2 doses must never be taken on the same day.FDA label
- Rifampin is banned
Rifampin is the only medicine the label says must never be taken with Myqorzo. The label predicts it lowers Myqorzo levels by about 79%, which may make Myqorzo work less well.FDA label
- Medicines that change the dose, starting or stopping
Starting fluconazole for more than 3 days, voriconazole, fluvoxamine or a strong CYP2C9 blocker raises Myqorzo levels and can mean a lower dose or avoiding the combination. Stopping carbamazepine or a similar CYP3A inducer has the same effect. The label then calls for an echo 2 to 8 weeks later.FDA label
- Tell the cardiologist before any change
The Medication Guide says not to stop or change the dose of a medicine, or start a new one, without telling your healthcare provider. That rule covers over-the-counter medicines, vitamins and herbal supplements as well as prescriptions.FDA label
- If you get a serious infection or an irregular heartbeat
The label says a serious illness such as a severe infection or COVID-19, or new atrial fibrillation, raises the risk of heart failure. It tells prescribers to consider checking the ejection fraction and not to raise the dose until it settles.FDA label
- Pregnancy and breastfeeding
The label says the risk in pregnancy is unknown and that there is a pregnancy safety study. Tell the cardiologist about a pregnancy during treatment or within 3 weeks after the last dose. Whether the drug passes into breast milk is also unknown.FDA label
- Storage, and too many tablets
Room temperature, 68 to 77 degrees Fahrenheit (20 to 25 Celsius), in the bottle with its child-resistant cap. For an overdose, the Medication Guide gives Poison Control at 1-800-222-1222 or the nearest emergency room.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, a racing heart, fatigue, chest pain or rapid weight gain. The Medication Guide says to tell your healthcare provider or get medical help right away.FDA label
Higher blood pressure
High blood pressure was the most common side effect in the SEQUOIA-HCM trial, in 8% of patients against 2% on placebo. A top reading of 160 or more was seen in about 16% against 8%. The label links the rise to relief of the blockage.FDA label
A drop in ejection fraction
In the trial, 4% of patients on Myqorzo had their ejection fraction fall below 50%, against 1% on placebo. Each drop reversed without a pause in treatment and without heart failure. Catching such a drop is what the echoes are for.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 needs authorization from the REMS before every single dispense. The usual gap is a Patient Monitoring Form not yet filed after an echo, due within 60 days of the start or a dose change. The REMS call center is at 1-844-285-7367 for questions.REMS Document
- The enrollment form has lapsedThe first authorization lasts 3 months from the Patient Enrollment Form. If treatment did not start in that window, the cardiologist submits a new form.REMS Document
- The prescription went to a pharmacy that is not certifiedCytokinetics says Myqorzo is only available through REMS-certified specialty pharmacies that ship each month. The prescriber's office resends it to a certified pharmacy, so this is a routing error rather than a denial.Myqorzo REMS page
- Prior authorization pending or deniedThe Cigna policy below, one example, asks for the symptom class, wall thickness and outflow gradient. It also wants an ejection fraction of 55% or more and a beta blocker or calcium channel blocker tried first. With commercial insurance, the MYQORZO & You Bridge Program may cover the gap after an initial denial.Cigna policy
- A copay you cannot payCommercial insurance: the copay program, as little as $5 a month up to $15,000 a year. Medicare, Medicaid, TRICARE and VA are excluded from it by its terms. A Patient Assistance Program gives free drug to people who meet its financial criteria.MYQORZO & You terms
- The echocardiograms themselves cost moneyThe MYQORZO & You echo copay program covers out-of-pocket echo costs for eligible commercially insured patients, as little as $0 up to $2,500 a year. It is not available in Massachusetts, Minnesota or Rhode Island.MYQORZO & You terms
Cigna prior authorization policy, April 1, 2026
- Age 18 or older, with at least one symptom of obstructive hypertrophic cardiomyopathy
- Heart failure symptoms at New York Heart Association (NYHA) class II or III
- Maximal heart wall thickness of 15mm or more, or 13mm or more with familial HCM
- An outflow gradient of 30 mmHg or more at rest, or 50 mmHg or more after Valsalva or exercise
- Ejection fraction of 55% or more
- A beta blocker or non-dihydropyridine calcium channel blocker tried for at least 3 months, or one the prescriber says cannot be used
- Prescribed by a cardiologist
Approval length. A year at a time. Renewal needs at least a year on therapy and a measured benefit or stable symptoms, still prescribed by a cardiologist.
This policy was revised in April 2026, after the December 2025 label, to add the beta blocker or calcium channel blocker step. Its summary says therapy is interrupted below 50% and that certain drugs acting on liver enzymes are contraindicated. The label instead lowers the dose from 40% to under 50%, pauses it below 40%, and bans only rifampin. It is here as an example of what a plan asks for, not as a rule. Cigna 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.
- MYQORZO Navigators who help you start and stay on track, reached at 833-MYQORZO
- A copay program for commercial insurance, as little as $5 a month up to $15,000 a year, not valid with Medicare, Medicaid, TRICARE, VA or other government coverage
- An echocardiogram copay program for commercial insurance, as little as $0 up to $2,500 a year, except in Massachusetts, Minnesota and Rhode Island
- A Bridge Program for commercial insurance, Myqorzo at no cost for up to 12 months after an initial insurance denial or until coverage is approved
- A Free Trial Offer of up to a 60-day supply for government-insured patients new to Myqorzo, excluding TRICARE, VA and military plans, and a Patient Assistance Program for those who meet financial criteria
Details as the drugmaker publishes them. MYQORZO & You
Five questions for the pharmacist or the support line
- Has the REMS authorized this fill, and if not, is it waiting on a Patient Monitoring Form from my cardiologist?
- I take these medicines and supplements. Are any of them on the Myqorzo interaction list, or do any change my dose?
- If my doctor changes the dose after an echo, do you ship the new strength right away or at the next refill?
- How many days can you send at once now, and when does that change to 90 days?
- If another doctor prescribes fluconazole or an antibiotic, who should I call first?
Questions people ask in the first weeks
How long does it take to get Myqorzo after it is prescribed?
There is no fixed number of days for this. The echo, the REMS enrollment, the prior authorization and the pharmacy's REMS check each take their own time. The REMS gives a 3-month window from the enrollment form to start treatment. The MYQORZO & You Bridge Program exists because the insurance step is often the slow one.
Can I pick up Myqorzo at my regular pharmacy?
No, not a regular drugstore. Cytokinetics says Myqorzo is only available through REMS-certified specialty pharmacies, which ship it to your home each month after the REMS authorizes each fill.
How often do I need an echocardiogram on Myqorzo?
Before the first dose, then 2 to 8 weeks after starting and after every dose change. Once the dose is settled, every 6 months, or every 3 months if the ejection fraction is 50% to under 55%. The cardiologist files a REMS form after each one, and a missing form can hold a refill.
What if I miss a dose of Myqorzo?
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 on the same day to make up for a missed one.
Can I take fluconazole with Myqorzo?
The label says fluconazole for more than 3 days raises Myqorzo levels. At 15mg or 20mg it calls for dropping to 5mg, and at 5mg or 10mg it says to avoid the combination. The label measured no change with 2 doses of 150mg taken 48 hours apart. The cardiologist decides, and an echo follows 2 to 8 weeks later.
Why was Myqorzo denied by my insurance?
Cigna's policy, one example, asks for the symptom class, the wall thickness and the outflow gradient. It also asks for an ejection fraction of 55% or more and a documented beta blocker or calcium channel blocker trial. The cardiologist's records usually resolve it, and a MYQORZO Navigator can explain what the plan is asking for.
How is Myqorzo different from Camzyos?
Both are cardiac myosin inhibitors with a heart failure boxed warning and a REMS. Myqorzo's label sets echoes 2 to 8 weeks after each dose step rather than at fixed weeks. At an ejection fraction from 40% to under 50%, it lowers the dose instead of pausing it. It bans only rifampin, and requires no pregnancy test or birth control. Its main trial compared it with placebo, not with Camzyos, so neither label shows which works better.
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Sources
- MYQORZO (aficamten) tablet, film coated: prescribing information and Medication Guide, revised December 2025, Cytokinetics, via DailyMed, December 16, 2025.
- Approved Risk Evaluation and Mitigation Strategies (REMS): Myqorzo (aficamten), NDA 219083, FDA, March 26, 2026.
- MYQORZO (aficamten) REMS Document, Cytokinetics, approved by FDA, March 26, 2026.
- MYQORZO REMS Patient Guide, Cytokinetics, approved by FDA, March 26, 2026.
- MYQORZO REMS Patient Monitoring Form, Cytokinetics, approved by FDA, March 26, 2026.
- MYQORZO REMS Program | MYQORZO™ (aficamten), Cytokinetics, November 7, 2026.
- MYQORZO and You Patient Support | MYQORZO™ (aficamten), Cytokinetics, November 7, 2026.
- MYQORZO & You program terms and conditions (US-MYQ-00242 05/2026), Cytokinetics, November 7, 2026.
- Cardiology – Myqorzo Prior Authorization with Step Therapy Policy, Cigna, April 1, 2026.
- CAMZYOS (mavacamten) prescribing information and Medication Guide, revised September 2026, Bristol Myers Squibb, via DailyMed, September 30, 2026.
- NDA 219083/S-001 supplement approval letter, REMS modification, FDA, February 5, 2026.
- NDA 219083 approval letter, FDA, December 19, 2025.
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.