CAMZYOS CAPSULES 15MG

PATHEON INC. - CANADAANDERSONBRECON INC. (PRIMARY PACKAGER AND SECONDARY PACKAGER) (UNITED STATES)🇸🇬 Health Sciences Authority

Approval Date: Jun 14, 2023
Approval ID: b7d6f10400c3aa6e
Company: PATHEON INC. - CANADAANDERSONBRECON INC. (PRIMARY PACKAGER AND SECONDARY PACKAGER) (UNITED STATES)
Type: Therapeutic

Approval Details

Approval Id: b7d6f10400c3aa6e
Drug Name: CAMZYOS CAPSULES 15MG
Product Name: CAMZYOS CAPSULES 15MG
Approval Number: SIN16807P
Approval Date: 2023-06-14
Registrant: BRISTOL-MYERS SQUIBB (SINGAPORE) PTE. LTD.
Licence Holder: BRISTOL-MYERS SQUIBB (SINGAPORE) PTE. LTD.
Drug Type: Therapeutic
Forensic Classification: PRESCRIPTION ONLY MEDICINES
Dosage Form: CAPSULE
Dosage: 2. DOSAGE AND ADMINISTRATION 2.1. Initiation, Maintenance, and Interruption of Treatment Confirm absence of pregnancy and usage of effective contraception in females of reproductive potential [see Warnings and Precautions (5.4) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information]. Initiation or up-titration of CAMZYOS in patients with LVEF <55% is not recommended. The recommended starting dose is 5 mg once daily without regard to food; allowable subsequent doses with titration are 2.5, 5, 10, or 15 mg once daily. Patients may develop heart failure while taking CAMZYOS. Regular LVEF and Valsalva left ventricular outflow tract (LVOT) gradient assessment is required for careful titration to achieve an appropriate target Valsalva LVOT gradient, while maintaining LVEF ≥50% and avoiding heart failure symptoms (see Figure 1 and Figure 2). Additional assessment of LVEF is recommended if clinical status changes or in patients with a serious intercurrent illness such as infection or arrhythmia (including atrial fibrillation or other uncontrolled tachyarrhythmia). Daily dosing takes weeks to reach steady-state drug levels and therapeutic effects, and genetic variation in metabolism and drug interactions can cause large differences in exposure [see Contraindications (4), Warnings and Precautions (5.2), Drug Interactions (7.1) and Clinical Pharmacology (12.3) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information]. When initiating or titrating CAMZYOS, first consider LVEF then consider the Valsalva LVOT gradient and patient clinical status to guide appropriate CAMZYOS dosing. Assessment of post-exercise LVOT gradient may be considered in symptomatic patients with normal or near normal Valsava gradients (approximately 30mmHg) prior to initiating treatment with CAMZYOS. Follow the algorithms for Initiation (Figure 1) and Maintenance (Figure 2) for appropriate CAMZYOS dosing and monitoring schedules. If LVEF <50% while taking CAMZYOS, interrupt treatment. Follow the algorithm for Interruption (Figure 3) for guidance on interrupting, restarting, or discontinuing CAMZYOS. If interrupted at 2.5 mg, either restart at 2.5 mg or discontinue permanently. <img src="/TGIF/Camzyos-Figure1_040825.png" alt="Camzyos Dosage Figure 1" /> <img src="/TGIF/Camzyos-Figure2_040825.png" alt="Camzyos Dosage Figure 2" /> <img src="/TGIF/Camzyos-Figure3_040825.png" alt="Camzyos Dosage Figure 3" /> Delay dose increases when there is intercurrent illness (e.g., serious infection) or arrhythmia (e.g., atrial fibrillation or other uncontrolled tachyarrhythmia) that may impair systolic function. Consider interruption of CAMZYOS in patients with intercurrent illness [see Warnings and Precautions (5.1) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information]. Missed or delayed doses If a dose is missed, it should be taken as soon as possible, and the next scheduled dose should be taken at the usual time the following day. Exact timing of dosing during the day is not essential, but two doses should not be taken on the same day. Swallow capsules whole. Do not break, open, or chew the capsules. 2.2. Concomitant Administration of Weak to Moderate CYP2C19 or Moderate to Strong CYP3A4 Inhibitors Initiate CAMZYOS at the recommended starting dosage of 5 mg orally once daily in patients who are on stable therapy with a weak CYP2C19 inhibitor or a moderate CYP3A4 inhibitor (see Figure 1). In patients who are on stable therapy with a moderate CYP2C19 inhibitor or a strong CYP3A4 inhibitor, initiate CAMZYOS at 2.5 mg orally once daily. Interrupt CAMZYOS treatment if Valsalva LVOT gradient is <20 mm Hg at Week 4 or Week 8. Treatment may be resumed after 4 weeks at 2.5 mg once daily if LVEF is ≥50%. If treatment is resumed at Week 12, recheck clinical status, Valsalva LVOT gradient and LVEF in 4 weeks, and maintain the current dose for the next 8 weeks unless LVEF is <50%. In patients who initiate a weak to moderate CYP2C19 inhibitor or a moderate to strong CYP3A4 inhibitor. reduce dosage of CAMZYOS to the next lower daily (mg) dose level (i.e., 15 mg to 10 mg; 10 mg to 5 mg; or 5 mg to 2.5 mg). Schedule clinical and echocardiographic assessment 4 weeks after inhibitor initiation, and do not up-titrate to the next higher daily (mg) dose level of CAMZYOS until 12 weeks after inhibitor initiation. Avoid initiation of concomitant weak CYP2C19 to moderate and moderate to strong CYP3A4 inhibitors in patients who are on stable treatment with 2.5 mg of CAMZYOS because a lower CAMZYOS once-daily dose is not available [see Dosage and Administration (2.1), Drug Interactions (7.1) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information]. For short-term use (e.g., 1 week), interrupt CAMZYOS for the duration of treatment with a weak to moderate inhibitor of CYP2C19 or a moderate to strong inhibitor of CYP3A4. Mavacamten may be reinitiated at the previous dose immediately on discontinuation of concomitant therapy.
Route Of Administration: ORAL
Indication Info: 1. INDICATIONS AND USAGE CAMZYOS® is indicated for the treatment of adults with symptomatic New York Heart Association (NYHA) class II–III obstructive hypertrophic cardiomyopathy (HCM) to improve functional capacity and symptoms.
Contraindications: 4. CONTRAINDICATIONS CAMZYOS is contraindicated with concomitant use of: <ul> <li>Strong CYP2C19 inhibitors [see Warnings and Precautions (5.2), Drug Interactions (7.1) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information]</li> <li>Moderate to strong CYP2C19 inducers or moderate to strong CYP3A4 inducers [see Warnings and Precautions (5.2), Drug Interactions (7.1) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information]</li> </ul>
Atc Code: C01EB24
Atc Item Name: mavacamten
Pharma Manufacturer Name: LIANBIO DEVELOPMENT (SG) PTE. LTD.

Active Ingredients

Mavacamten

15.0mg

MAVACAMTEN

15 MG

Approved

Quick Info

Agency

HSA

Country

🇸🇬

Approval Date

Jun 14, 2023

Approval ID

b7d6f10400c3aa6e

Type

Therapeutic

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