Mavacamten: Uses, Side Effects, Dosage - Drugvu

ℹ️ Compiled from public regulatory records · Last regulator revision: May 22, 2026🚩 Report this page

Mavacamten

Other Cardiac Preparations

Sold as Camzyos

GB MHRAEU EMACA Health Canada

Drug class: Other Cardiac Preparations
Availability: See label
Routes: Oral
Markets covered: 3
Products on record: 9

Overview

Mavacamten is an active pharmaceutical ingredient in the Other Cardiac Preparations group (C01EB). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.

Regulatory status by market

Market	Regulator	Products	Last revision
GB United Kingdom	MHRA	4	May 22, 2026
EU European Union	EMA	1	October 23, 2025
CA Canada	Health Canada	4	July 25, 2025

GBUnited Kingdom· MHRA

4 products

Uses

GBOfficial regulatory label· revised May 22, 2026[1]

1).

How to take

GBOfficial regulatory label· revised May 22, 2026

EUEuropean Union· EMA

1 product

Uses

EUOfficial regulatory label· revised October 23, 2025[2]

1).

How to take

EUOfficial regulatory label· revised October 23, 2025

CACanada· Health Canada

4 products

4 products on record with this regulator. Detailed label text (uses, dosage, side effects) is being ingested — the original document is linked under Sources [3].

Brands in Canada (1)

CAMZYOSBRISTOL-MYERS SQUIBB CANADA

Sources & citations

[1]MHRA (UK) · PLGB151050181 · revised May 22, 2026
[2]European Medicines Agency · EMEA/H/C/005457 · revised October 23, 2025
[3]Health Canada (DPD) · 02532549 · revised July 25, 2025

Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.

Treatment should be initiated under the supervision of a physician experienced in the management of patients with cardiomyopathy. 4). If LVEF is < 55%, treatment should not be initiated. 6). Patients should be genotyped for Cytochrome P450 (CYP) 2C19 (CYP2C19) in order to determine appropriate mavacamten dose.
2). If treatment initiation occurs prior to determination of CYP2C19 phenotype, patients should follow dosing instructions for poor metabolisers (see figure 1 and 3 and table 1) until CYP2C19 phenotype is determined. 5 mg, 5 mg, 10 mg or 15 mg).
5 mg orally once daily. The maximum dose is 5 mg once daily. The patient should be assessed for early clinical response by left ventricular outflow tract (LVOT) gradient with Valsalva manoeuvre 4 and 8 weeks after treatment initiation (see figure 1).
CYP2C19 intermediate, normal, rapid and ultra-rapid metaboliser phenotype The recommended starting dose is 5 mg orally once daily. The maximum dose is 15 mg once daily. The patient should be assessed for early clinical response by LVOT gradient with Valsalva manoeuvre 4 and 8 weeks after treatment initiation (see figure 2).
Once an individualised maintenance dose is achieved with LVEF ≥ 55%, patients should be assessed every 6 months. For patients with LVEF 50 - < 55% regardless of Valsalva LVOT gradient, patients should be assessed every 3 months (see figure 3).
If at any visit the patient’s LVEF is < 50%, the treatment should be interrupted for 4 weeks and until LVEF returns to ≥ 50% (see figure 4). 4). , no improvement in symptoms, quality of life, exercise capacity, LVOT gradient) after 4-6 months on the maximum tolerated dose.
Figure 1:
Treatment initiation in CYP2C19 poor metaboliser phenotype * Interrupt treatment if LVEF is < 50% at any clinical visit; restart treatment after 4 weeks if LVEF ≥ 50% (see figure 4). LVEF = left ventricular ejection fraction; LVOT = left ventricular outflow tract Week 12*Week 4* Week 8* Valsalva LVOT gradient Valsalva LVOT gradient ≥ 20 mmHg See maintenance phase in figure 3 < 20 mmHg 1.
5 mg once daily if LVEF ≥ 50%. 2. Recheck clinical status, Valsalva LVOT gradient and LVEF in 4 weeks and maintain the current dose for the next 8 weeks unless LVEF < 50%. 5 mg once daily ≥ 20 mmHg See maintenance phase in figure 3 Figure 2: Treatment initiation in CYP2C19 intermediate, normal, rapid and ultra- rapid metaboliser phenotype * Interrupt treatment if LVEF is < 50% at any clinical visit; restart treatment after 4 weeks if LVEF ≥ 50% (see figure 4).
5 mg once daily 5 mg once daily, initiate only if LVEF ≥ 55% Maintain 5 mg once daily ≥ 20 mmHg Valsalva LVOT gradient Valsalva LVOT gradient 1. 5 mg once daily if LVEF ≥ 50%. 2. Recheck clinical status, Valsalva LVOT gradient and LVEF in 4 weeks and maintain the current dose for the next 8 weeks unless LVEF < 50%.
< 20 mmHg Pause treatment Maintain 5 mg once daily Figure 3: Maintenance phase LVEF = left ventricular ejection fraction; LVOT = left ventricular outflow tract Figure 4: Treatment interruption at any clinic visit if LVEF < 50% LVEF = left ventricular ejection fraction; LVOT = left ventricular outflow tract Week 12 + subsequent visits Current dose (Treatment not paused) LVEF < 50% LVEF 50 - < 55%, regardless of Valsalva LVOT gradient LVEF ≥ 55% and Valsalva LVOT gradient ≥ 30 mmHg See figure 4.
Maintain on the current dose and follow up 3 months later. 1. 5 mg→5 mg; 5 mg→10 mg; 10 mg→15 mg 2. Recheck clinical status, Valsalva LVOT gradient and LVEF at week 4 after dose increase and maintain the current dose for the next 8 weeks unless LVEF < 50%.
3. Further up-titration is allowed after 3 months of treatment on the current dose level if LVEF ≥ 55%. Recheck at week 4. 4. Maximum daily dose is 15 mg.
For CYP2C19 poor metaboliser phenotype:
Maximum dose is 5 mg. 5 mg to 5 mg; follow-up 4 and 8 weeks later. LVEF < 50% 1. Interrupt treatment. 2. Recheck echocardiography parameters every 4 weeks until LVEF ≥ 50%. 5 mg daily. LVEF ≥ 50% 1. Restart treatment at next lower daily (mg) dose level.
5 mg 2. Recheck clinical status; Valsalva LVOT gradient and LVEF in 4 weeks and maintain the current dose for the next 8 weeks unless LVEF < 50%. 3. Follow figure 3. LVEF ≥ 55% and Valsalva LVOT gradient < 30 mmHg 1. Maintain on the current dose.
2. Recheck clinical status, […]

Side effects & warnings

GBOfficial regulatory label· Adverse reactions· revised May 22, 2026[1]

Summary of the safety profile The most commonly reported adverse reactions with mavacamten are dizziness (17%), dyspnoea (12%), systolic dysfunction (5%) and syncope (5%). Tabulated list of adverse reactions Adverse reactions reported in patients treated with mavacamten in two phase 3 studies (EXPLORER-HCM and VALOR-HCM) are tabulated below.
5 mg, 5 mg, 10 mg or 15 mg of mavacamten. 3 weeks). The adverse reactions included in table 3 are listed according to system organ class in MedDRA. Within each system organ class, the adverse reactions are presented in order of decreasing frequency and seriousness.
In addition, the corresponding frequency category for each adverse reaction is defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1 000 to < 1/100); rare (≥ 1/10 000 to < 1/1 000); very rare (< 1/10 000).
Table 3:
Adverse reactions System organ class Adverse reaction Frequency Dizziness Very common Nervous system disorders Syncope Common Cardiac disorders Systolic dysfunctiona Common Respiratory, thoracic and mediastinal disorders Dyspnoea Very common a Defined as LVEF < 50% with or without symptoms.
Description of selected adverse reactions Systolic dysfunction In Phase 3 clinical studies, 5% (9/179) of patients in the mavacamten group experienced reversible reductions in LVEF < 50% (median 45%: range: 35-49%) while on treatment.
In 56% (5/9) of these patients, reductions were observed without other clinical manifestations. 4). 7% of patients on placebo. 9) after last dose. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store

GBOfficial regulatory label· Warnings and precautions· revised May 22, 2026[1]

Systolic dysfunction defined as symptomatic LVEF < 50% Mavacamten reduces LVEF and may cause heart failure due to systolic dysfunction defined as symptomatic LVEF < 50%. 8). New or worsening dyspnoea, chest pain, fatigue, palpitations, leg oedema or elevations in N-terminal pro-B-type natriuretic peptide (NT-proBNP) may be signs and symptoms of systolic dysfunction and should prompt an evaluation of cardiac function.
LVEF should be measured prior to initiating treatment and closely monitored thereafter. 2). 5): Starting or increasing the dose of a strong or moderate CYP3A4 inhibitor or any CYP2C19 inhibitor may increase risk of heart failure due to systolic dysfunction.
Stopping or decreasing dose of any inhibitor of CYP3A4 or CYP2C19 may lead to a loss of therapeutic response to mavacamten. Starting a strong CYP3A4 or strong CYP2C19 inducer may lead to a loss of therapeutic response to mavacamten.
Stopping a strong CYP3A4 or strong CYP2C19 inducer may increase risk of heart failure due to systolic dysfunction. Prior to and during mavacamten treatment, the potential for interactions, including over the counter medicinal products (such as omeprazole or esomeprazole), should be considered.
3). 5). 5). Concomitant use of negative inotropes The safety of concomitant use of mavacamten with disopyramide, or use of mavacamten in patients taking beta blockers in combination with verapamil or diltiazem has not been established.
5). 3). Due to risk to the foetus, Mavacamten BMS is contraindicated during pregnancy and in women of childbearing potential not using effective contraception. 6). Sodium content This medicinal product contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially 'sodium-free'.

This is not medical advice. Consult a qualified healthcare professional.

Treatment should be initiated under the supervision of a physician experienced in the management of patients with cardiomyopathy. 4). If LVEF is < 55%, treatment should not be initiated. 6). Patients should be genotyped for Cytochrome P450 (CYP) 2C19 (CYP2C19) in order to determine appropriate mavacamten dose.
2). If treatment initiation occurs prior to determination of CYP2C19 phenotype, patients should follow dosing instructions for poor metabolisers (see figure 1 and 3 and table 1) until CYP2C19 phenotype is determined. 5 mg, 5 mg, 10 mg or 15 mg).
5 mg orally once daily. The maximum dose is 5 mg once daily. The patient should be assessed for early clinical response by left ventricular outflow tract (LVOT) gradient with Valsalva manoeuvre 4 and 8 weeks after treatment initiation (see figure 1).
CYP2C19 intermediate, normal, rapid and ultra-rapid metaboliser phenotype The recommended starting dose is 5 mg orally once daily. The maximum dose is 15 mg once daily. The patient should be assessed for early clinical response by LVOT gradient with Valsalva manoeuvre 4 and 8 weeks after treatment initiation (see figure 2).
Once an individualised maintenance dose is achieved with LVEF ≥ 55%, patients should be assessed every 6 months. For patients with LVEF 50 - < 55% regardless of Valsalva LVOT gradient, patients should be assessed every 3 months (see figure 3).
If at any visit the patient’s LVEF is < 50%, the treatment should be interrupted for 4 weeks and until LVEF returns to ≥ 50% (see figure 4). 4). , no improvement in symptoms, quality of life, exercise capacity, LVOT gradient) after 4-6 months on the maximum tolerated dose.
4 Figure 1: Treatment initiation in CYP2C19 poor metaboliser phenotype * Interrupt treatment if LVEF is < 50% at any clinical visit; restart treatment after 4 weeks if LVEF ≥ 50% (see figure 4). LVEF = left ventricular ejection fraction; LVOT = left ventricular outflow tract Week 12*Week 4* Week 8* Valsalva LVOT gradient Valsalva LVOT gradient ≥ 20 mmHg See maintenance phase in figure 3 < 20 mmHg 1.
5 mg once daily if LVEF ≥ 50%. 2. Recheck clinical status, Valsalva LVOT gradient and LVEF in 4 weeks and maintain the current dose for the next 8 weeks unless LVEF < 50%. 5 mg once daily ≥ 20 mmHg See maintenance phase in figure 3 5 Figure 2: Treatment initiation in CYP2C19 intermediate, normal, rapid and ultra-rapid metaboliser phenotype * Interrupt treatment if LVEF is < 50% at any clinical visit; restart treatment after 4 weeks if LVEF ≥ 50% (see figure 4).
5 mg once daily 5 mg once daily, initiate only if LVEF ≥ 55% Maintain 5 mg once daily ≥ 20 mmHg Valsalva LVOT gradient Valsalva LVOT gradient 1. 5 mg once daily if LVEF ≥ 50%. 2. Recheck clinical status, Valsalva LVOT gradient and LVEF in 4 weeks and maintain the current dose for the next 8 weeks unless LVEF < 50%.
3. < 20 mmHg Pause treatment Maintain 5 mg once daily 6 Figure 3: Maintenance phase LVEF = left ventricular ejection fraction; LVOT = left ventricular outflow tract Figure 4: Treatment interruption at any clinic visit if LVEF < 50% LVEF = left ventricular ejection fraction; LVOT = left ventricular outflow tract LVEF < 50% 1.
Interrupt treatment. 2. Recheck echocardiography parameters every 4 weeks until LVEF ≥ 50%. 5 mg daily. LVEF ≥ 50% 1. Restart treatment at next lower daily (mg) dose level. 5 mg 2. Recheck clinical status; Valsalva LVOT gradient and LVEF in 4 weeks and maintain the current dose for the next 8 weeks unless LVEF < 50%.
3. Follow figure 3. Week 12 + subsequent visits Current dose (Treatment not paused) LVEF < 50% LVEF 50 - < 55%, regardless of Valsalva LVOT gradient LVEF ≥ 55% and Valsalva LVOT gradient ≥ 30 mmHg See figure 4. Maintain on the current dose and follow up 3 months later.
1. 5 mg→5 mg; 5 mg→10 mg; 10 mg→15 mg 2. Recheck clinical status, Valsalva LVOT gradient and LVEF at week 4 after dose increase and maintain the current dose for the next 8 weeks unless LVEF < 50%. 3. Further up-titration is allowed after 3 months of treatment on the current dose level if LVEF ≥ 55%.
Recheck at week 4. 4. Maximum daily dose is 15 mg.
For CYP2C19 poor metaboliser phenotype:
Maximum dose is 5 mg. 5 mg to 5 mg; follow-up 4 and 8 weeks later. LVEF ≥ 55% and Valsalva LVOT gradient < 30 mmHg 1. Maintain on the current dose. 2. Recheck clinical […]