One capsule, once daily

 

Recommended starting dose is one 5 mg capsule, once daily1

 
Images of 2.5 mg, 5 mg, 10 mg, 15 mg capsules
Administration

5 mg orally, once daily recommended starting dose with echo-guided titration
  • The patient’s individualized dose will be either 2.5, 5, 10 or 15 mg once daily

 

 

 


oHCM=obstructive hypertrophic cardiomyopathy
* Please see the Product Monograph for complete dosing and administration instructions.

 

 

Initiation1*

 

Individualized dosing and titration

 

Test before start

  • Assess LVEF by echocardiography. Initiation of treatment in patients with LVEF <55% is not recommended.

 

Titrate to maintenance dose

  • Individualized dosing and titration based on clinical status and echocardiographic assessment of patient response
  • Monitor treatment: If at any visit LVEF is <50%, interrupt treatment for at least 4 weeks.*

* Interrupt treatment if LVEF <50% at any clinic visit. Restart treatment after 4 weeks if LVEF ≥50%.
† For patients initiating CAMZYOS on stable therapy with a moderate CYP2C19 inhibitor or a strong CYP3A4 inhibitor, see Concomitant therapy for dosing instructions.

Adapted from the Product Monograph.


 

echo=echocardiogram; LVEF=left ventricular ejection fraction; LVOT=left ventricular outflow tract
Please see the Product Monograph for complete dosing and administration instructions.

 

Maintain and monitor

Treatment maintenance from Week 12 and subsequent visits

Monitor with at least
2 Echos a Year
In appropriate patients1*

The patient’s individualized dose will be either 2.5, 5, 10 or 15 mg once daily.1

Patients should be assessed at least every 12 weeks until an individual maintenance dose has been achieved. Subsequently, assessment should be done at least every 6 months1:

  • oHCM symptoms
  • LVOT gradient with Valsalva manoeuvre
  • LVEF using echo assessments

 

During the first 6-month cycle, check clinical status after ~3 months.1

For patients who initiated mavacamten treatment with a normal or near normal Valsalva LVOT gradient, but remain symptomatic during maintenance phase, post-exercise LVOT gradient may be additionally considered to guide titration.1

Assessment of LVEF is also recommended if clinical status changes or in patients with an intercurrent illness such as serious infections or with clinically relevant arrhythmias, including atrial fibrillation and other tachyarrhythmias. In these circumstances, the dose of CAMZYOS may need to be reduced or temporarily discontinued. Dose increases are not recommended if a patient is experiencing an intercurrent illness which may impair systolic function.1

 

table of maintenance phase

* For patients with normal or near-normal Valsalva LVOT gradient (approximately 30 mmHg) prior to initiating treatment with CAMZYOS, if LVEF ≥55% and post-exercise LVOT gradient is ≥30 mmHg the dose may be increased to the next higher daily (mg) dose level if symptoms persist.1

Adapted from the Product Monograph.

Following treatment interruption of CAMZYOS due to LVEF <50%, patients should be monitored carefully to determine if treatment can be resumed (see Following treatment interruption due to LVEF <50%).

echo=echocardiogram; LVEF=left ventricular ejection fraction; LVOT=left ventricular outflow tract; oHCM=obstructive hypertrophic cardiomyopathy
Please see the Product Monograph for complete dosing and administration instructions.

 

Treatment interruption

 

Treatment interruption flow

Adapted from the Product Monograph.

 

echo=echocardiogram; LVEF=left ventricular ejection fraction
Please see the Product Monograph for complete dosing and administration instructions.

 

 

Echocardiograms

 

echo=echocardiogram; LVEF=left ventricular ejection fraction; LVOT=left ventricular outflow tract
* For patients in maintenance phase and on a stable individualized dose of CAMZYOS.1

 

Please see the Product Monograph for complete dosing and administration instructions.

 

 

Dose modification

Concomitant therapy1

 

table of concomitant therapy

 

Special populations1

No specific dose adjustments recommended for:

  • patients aged ≥65 years
  • mild (eGFR 60 - <90 mL/min/1.73 m2) and moderate (eGFR 30 - <60 mL/min/1.73 m2) renal impairment; used with caution in patients with severe renal impairment (eGFR <30 mL/min/1.73 m2)
  • mild (Child-Pugh Class A) and moderate (Child-Pugh Class B) hepatic impairment; not recommended for patients with severe (Child-Pugh Class C) hepatic impairment

 

Missed dose1

  • Dose should be taken as soon as possible on the current day; next scheduled dose to be taken at the usual time the following day. Two separate doses should not be taken in a single day.

 

Management of overdosage1

  • Discontinue CAMZYOS treatment and start supportive measures to maintain hemodynamic status: initiation of inotropic support with adrenergic agents, if appropriate, along with close monitoring of vital signs and LVEF. Early (<6 hours after CAMZYOS dose) administration of activated charcoal with sorbitol may be considered.
  • There is no specific antidote to CAMZYOS.
  • For the most recent information on the management of a suspected drug overdose, contact your regional poison control centre or Health Canada's toll-free number, 1-844-764-7669.

 

eGFR=estimated glomerular filtration rate; LVEF=left ventricular ejection fraction
Please see the Product Monograph for complete dosing and administration instructions.

 

 

Reference: 1. CAMZYOS (mavacamten capsules) Product Monograph. Bristol Myers Squibb Canada.