One capsule, once daily

 

Recommended starting dose is one 5 mg capsule, once daily1

2.5 mg, 5 mg, 10 mg and 15 mg capsules
 
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
  • After the 12-week treatment initiation phase, patient response to CAMZYOS should continue to be monitored every 12 weeks
  • 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.*
algorithm

* Interrupt treatment if LVEF <50% at any clinic visit. May consider restarting treatment after 4 weeks if LVEF ≥50%.

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

Once an individualized maintenance dose is achieved, monitor patients every 12 weeks1:
  • oHCM symptoms
  • LVOT gradient with Valsalva manoeuvre
  • LVEF using echo assessments



Assessment of LVEF is also recommended if clinical status changes; in patients with an intercurrent illness; or presence of clinically relevant arrhythmias. Dose increases are not recommended if the patient is experiencing an intercurrent illness which may impair systolic function.1

 

 

Echocardiograms

Before treatment starts At 4 weeks after treatment is started At 8 weeks after treatment is started At 12 weeks after treatment is started Every 12 weeks thereafter
table of maintenance phase

Adapted from the Product Monograph.

Following treatment interruption of CAMZYOS due to LVEF <50%, monitor patients carefully to determine if treatment can be resumed.

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.

 

Dose modification

Concomitant therapy1

 

table of concomitant therapy

 

Special populations1

No 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

  • Systolic dysfunction is the most likely adverse effect (limited experience).
  • 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. Administration of activated charcoal may reduce absorption (not specifically studied).

 

 

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, February 14, 2024.