VERQUVO vericiguat 2.5 mg film-coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

vericiguat, Quantity: 2.5 mg

Available from:

Bayer Australia Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: magnesium stearate; croscarmellose sodium; lactose monohydrate; titanium dioxide; microcrystalline cellulose; purified talc; hypromellose; sodium lauryl sulfate

Administration route:

Oral

Units in package:

28 film coated tablets, 14 film coated tablets, 100 film coated tablets (hospital dispensing pack), 14 film coated tablets (starter pack)

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

VERQUVO? is indicated in addition to standard of care therapy for the treatment of symptomatic chronic heart failure in adult patients with reduced ejection fraction less than 45[percent] who are stabilised after a recent heart failure decompensation event requiring admission and/or IV diuretic therapy (see Section 5.1 Pharmacodynamic properties ? Clinical trials).

Product summary:

Visual Identification: Round, biconvex, white film-coated tablet with a diameter of 7 mm, debossed with 2.5 on one side and VC on the other side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2021-11-15

Patient Information leaflet

VERQUVO® CMI V1.0
1
VERQUVO®
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. Please report side effects. See the full CMI for
further details.
1.
WHY AM I USING VERQUVO®?
VERQUVO® contains the active ingredient vericiguat. VERQUVO® is used
to treat heart failure.
For more information, see Section 1. Why am I using VERQUVO®?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE VERQUVO®?
Do not use if you have ever had an allergic reaction to vericiguat or
any of the ingredients listed at the end of the CMI.
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
VERQUVO®?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with VERQUVO® and affect how it works.
Do not take VERQUVO® if you are taking riociguat, or
medicine for erectile dysfunction.
A list of these medicines is in Section 3. What if I am taking other
medicines?
in the full CMI.
4.
HOW DO I USE VERQUVO®?
Take one (1) tablet of VERQUVO® at the same time each day with food.
The usual recommended target dose of VERQUVO® is
10mg once a day. You will usually start by taking 2.5mg tablet once a
day for the first 2 weeks.
More instructions can be found in Section 4. How do I use VERQUVO®?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING VERQUVO®?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
VERQUVO®.
•
Call your doctor if you feel dizzy, lightheaded, or develop signs or
symptoms of an allergic reaction.
THINGS YOU
SHOULD NOT DO
•
Do not take VERQUVO® to treat any other complaints unless your doctor
tells you to.
•
Do not stop taking your medicine or lower the dose without checking
with your doctor.
DRIVING OR USING
MACHINES
•
Be careful befo

Summary of Product characteristics

VERQUVO
®
PI V2; CCDS 1
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 www.tga.gov.au/reporting-problems.
AUSTRALIAN PRODUCT INFORMATION
VERQUVO
® (VERICIGUAT) FILM-COATED TABLETS
1
NAME OF THE MEDICINE
Vericiguat
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
VERQUVO® 2.5 mg film-coated tablets
Each film-coated tablet contains 2.5 mg vericiguat.
VERQUVO® 5 mg film-coated tablets
Each film-coated tablet contains 5 mg vericiguat.
VERQUVO® 10 mg film-coated tablets
Each film-coated tablet contains 10 mg vericiguat.
Excipient with known effect
Each 2.5 mg film-coated tablet contains 58.14 mg lactose (as
monohydrate).
Each 5 mg film-coated tablet contains 55.59 mg lactose (as
monohydrate).
Each 10 mg film-coated tablet contains 111.15 mg lactose (as
monohydrate).
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Film-coated tablets.
VERQUVO® 2.5 mg film-coated tablets
Round, biconvex, white film-coated tablet with a diameter of 7 mm,
debossed with “2.5” on one side
and “VC” on the other side.
VERQUVO® 5 mg film-coated tablets
Round, biconvex, brown-red film-coated tablet with a diameter of 7 mm,
debossed with “5” on one
side and “VC” on the other side.
VERQUVO
®
PI V2; CCDS 1
2
VERQUVO® 10 mg film-coated tablets
Round, biconvex, yellow-orange film-coated tablet with a diameter of 9
mm, debossed with “10” on
one side and “VC” on the other side.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
VERQUVO® is indicated in addition to standard of care therapy for the
treatment of symptomatic
chronic heart failure in adult patients with reduced ejection fraction
less than 45% who are stabilised
after a recent heart failure decompensation event requiring admission
and/or IV diuretic therapy (see
Section 5.1 Pharmacodynamic properties – Clinical trials).
4.2
D
OSE AND METHOD OF ADMI