VAFSEO vadadustat 300 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

vadadustat, Quantity: 300 mg

Available from:

Adjutor Healthcare Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: sodium starch glycollate type A; microcrystalline cellulose; hypromellose; silicon dioxide; magnesium stearate; titanium dioxide; purified talc; iron oxide yellow; polyvinyl alcohol; macrogol 3350

Administration route:

Oral

Units in package:

28

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Vafseo is indicated for the treatment of anaemia associated with chronic kidney disease (CKD) in adults on chronic maintenance dialysis.

Product summary:

Visual Identification: Oval, yellow tablets debossed with 'VDT' on one side and '300' on the other side.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Registered

Authorization date:

2023-10-04

Patient Information leaflet

VAFSEO®
1
VAFSEO®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
See the full CMI on the following page for more information. If you
have concerns about taking 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.
1. WHY AM I USING VAFSEO?
Vafseo contains the active ingredient vadadustat. Vafseo is used to
TREAT ANAEMIA that is ASSOCIATED WITH CHRONIC KIDNEY DISEASE
(CKD) IN ADULTS WITH CHRONIC MAINTENANCE DIALYSIS. For more
information, see Section 1. Why am I using Vafseo? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE VAFSEO?
Do not use if you have ever had an allergic reaction to Vafseo 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 Vafseo? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Vafseo and affect how it works. 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 VAFSEO?
•
Always take Vafseo exactly as your doctor or pharmacist has told you.
•
Vafseo should be taken once every day with food or between meals.
•
Vafseo film-coated tablets are taken by mouth with water.
•
Take your Vafseo tablet whole and without chewing or crushing the
tablet.
More instructions can be found in Section 4. How do I use Vafseo? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING VAFSEO?
THINGS YOU SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
Vafseo.
•
Call your doctor straight away if you have headaches, especially
sudden, stabbing, migraine-
like headaches, bleeding from the nose, confusion, seizures or fits;
pain in the chest or other
parts of the body, feeling dizzy, shortness of breath or difficulty
breathing, feeling nauseous

Summary of Product characteristics

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 – VAFSEO
® (VADADUSTAT)
TABLETS
1
NAME OF THE MEDICINE
Vadadustat
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Vafseo 150 mg film-coated tablets
Each 150 mg film-coated tablet contains 150 mg of vadadustat
Vafseo 300 mg film-coated tablets
Each 300 mg film-coated tablet contains 300 mg of vadadustat
Vafseo 450 mg film-coated tablets
Each 450 mg film-coated tablet contains 450 mg of vadadustat
For the full list of excipients, see section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Film-coated tablet
Vafseo 150 mg film-coated tablets
Round, white tablets debossed with “VDT” on one side and “150”
on the other side.
Vafseo 300 mg film-coated tablets
Oval, yellow tablets debossed with “VDT” on one side and “300”
on the other side.
Vafseo 450 mg film-coated tablets
Oval, pink tablets debossed with “VDT” on one side and “450”
on the other side.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Vafseo is indicated for the treatment of anaemia associated with
chronic kidney disease (CKD)
in adults on chronic maintenance dialysis.
4.2
D
OSE AND METHOD OF ADMINISTRATION
▼
2
DOSAGE
Dose initiation
The recommended starting dose is 300 mg once daily. Do not increase
the dose more frequently
than once every 4 weeks. Decreases in dose can occur more frequently.
_Patients converting from an erythropoiesis-stimulating agent (ESA) _
When converting from an ESA to Vafseo, the recommended starting dose
is 300 mg once daily.
The ESA must be stopped before initiating Vafseo.
Those patients converting from a high baseline dose of ESA may
experience an initial decline in
Hb levels before gradually returning to baseline Hb levels by Weeks 16
to 20 (see section 5.1
Pharmacodynamic properties
for course Hb during treatment in indivi