CAMZYOS mavacamten 2.5 mg capsule blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

mavacamten, Quantity: 2.5 mg

Available from:

Bristol-Myers Squibb Australia Pty Ltd

Pharmaceutical form:

Capsule, hard

Composition:

Excipient Ingredients: magnesium stearate; hypromellose; croscarmellose sodium; Gelatin; silicon dioxide; iron oxide black; mannitol; titanium dioxide; iron oxide red; propylene glycol; ethanol; butan-1-ol; purified water; isopropyl alcohol; Shellac; strong ammonia solution; potassium hydroxide

Administration route:

Oral

Units in package:

28 capsules

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

CAMZYOS is indicated for the treatment of adults with symptomatic NYHA class II-III obstructive hypertrophic cardiomyopathy.

Product summary:

Visual Identification: Light purple opaque cap imprinted with '2.5 mg' in black and white opaque body imprinted with 'Mava' in black. Capsule size 2.; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Registered

Authorization date:

2022-09-19

Patient Information leaflet

CAMZYOS
®
C
A
M
Z
Y
O
S
®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
▼
This medicine is new or being used differently. Please report side
effects. See the full CMI for further details.
WARNING: Important safety information is provided in a boxed warning
in the full CMI. Read before using this medicine.
1.
WHY AM I USING CAMZYOS?
Camzyos contains the active ingredient mavacamten. Camzyos is used to
treat adults with symptomatic obstructive hypertrophic
cardiomyopathy. This is a type of heart disease with a thickened
muscle in the heart which makes it harder for blood to leave the
heart. For more information, see Section 1. Why am I using Camzyos? in
the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE CAMZYOS?
DO NOT USE IF YOU HAVE EVER HAD AN ALLERGIC REACTION TO CAMZYOS OR ANY
OF THE INGREDIENTS LISTED AT THE END OF THE CMI.
SOME MEDICINES SHOULD NOT BE USED WITH CAMZYOS. The risk of heart
failure is increased when Camzyos is taken with certain
other medicines. Tell your doctor about the medicines you take,
including prescription, non-prescription and herbal medicines,
before and during treatment with Camzyos. TALK TO YOUR DOCTOR IF YOU
HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER
MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE
BREASTFEEDING. For more information, see Section 2. What
should I know before I use Camzyos? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines can increase the levels of Camzyos in your body and
make it more likely for you to get new side effects that are
possibly severe. Some medicines can decrease the levels of Camzyos in
your body which can reduce its beneficial effects.
It is important to check the list of medicines in Section 3. What if I
am taking other medicines? in the full CMI.
4.
HOW DO I USE CAMZYOS?
Your doctor will tell you how much Camzyos to take. Camzyos should be
taken once a day, by mouth (orally), and

Summary of Product characteristics

AU_PI_CAMZYOS_V1.0
1
▼This medicinal product is subject to additional monitoring in
Australia. This will allow quick
identification of new safety information. Healthcare professionals are
asked to report any suspected
adverse events at https://www.tga.gov.au/reporting-problems.
AUSTRALIAN PRODUCT INFORMATION
CAMZYOS
®
(MAVACAMTEN)
WARNING: CAMZYOS REDUCES LEFT VENTRICULAR EJECTION FRACTION (LVEF)
PRIOR TO AND DURING TREATMENT WITH CAMZYOS REGULAR CLINICAL AND
ECHOCARDIOGRAM
MONITORING ARE REQUIRED TO APPROPRIATELY TITRATE AND MAINTAIN THE
OPTIMAL PATIENT DOSE.
INITIATION OF CAMZYOS IN PATIENTS WITH LVEF <55% IS NOT RECOMMENDED.
INTERRUPT
CAMZYOS IF LVEF IS <50% AT ANY VISIT (_SEE SECTION 4.2 DOSE AND METHOD
OF _
_ADMINISTRATION AND SECTION 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR
USE_)_. _
CONCOMITANT
USE
OF
CAMZYOS
WITH
CERTAIN
CYTOCHROME
P450
INHIBITORS
OR
DISCONTINUATION OF CERTAIN CYTOCHROME P450 INDUCERS MAY INCREASE THE
RISK OF HEART
FAILURE DUE TO SYSTOLIC DYSFUNCTION; THEREFORE, THE USE OF CAMZYOS IS
CONTRAINDICATED
WITH THE FOLLOWING (_SEE SECTION 4.3 CONTRAINDICATIONS _AND_ SECTION
4.4 SPECIAL WARNINGS AND _
_PRECAUTIONS FOR USE)_
:
•
MODERATE TO STRONG CYP2C19 INHIBITORS OR STRONG CYP3A4 INHIBITORS
•
MODERATE TO STRONG CYP2C19 INDUCERS OR MODERATE TO STRONG CYP3A4
INDUCERS
1
NAME OF THE MEDICINE
Mavacamten
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 2.5 mg hard capsule contains 2.5 mg mavacamten.
Each 5 mg hard capsule contains 5 mg mavacamten.
Each 10 mg hard capsule contains 10 mg mavacamten.
Each 15 mg hard capsule contains 15 mg mavacamten.
For the full list of excipients, see section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
Hard capsule (capsule).
CAMZYOS 2.5 mg capsules
Light purple opaque cap imprinted with “2.5 mg” in black, and
white opaque body imprinted with
“Mava” in black, both in radial direction. Capsule size: 2.
CAMZYOS 5 mg capsules
Yellow opaque cap imprinted with “5 mg” in black, and white opaque
body imprinted with “Mava” in
black, both in radial dire