TAVNEOS avacopan 10 mg hard capsule bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

avacopan, Quantity: 10 mg

Available from:

Seqirus Pty Ltd

Pharmaceutical form:

Capsule, hard

Composition:

Excipient Ingredients: Shellac; iron oxide yellow; titanium dioxide; iron oxide red; Gelatin; potassium hydroxide; iron oxide black; PEG-40 hydrogenated castor oil; macrogol 4000; polysorbate 80

Administration route:

Oral

Units in package:

180, 30

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Tavneos, in combination with a rituximab or cyclophosphamide based regimen, is indicated for the treatment of adults with anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (granulomatosis with polyangiitis [GPA] and microscopic polyangiitis [MPA]).

Product summary:

Visual Identification: Capsules with light orange cap and yellow body with CCX168 in black ink on the capsule.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Registered

Authorization date:

2023-01-31

Patient Information leaflet

Tavneos 2023-01-31 AVA_AUS_CMI
1
TAVNEOS®
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 TAVNEOS?
Tavneos contains the active ingredient avacopan. Tavneos is used in
combination with other medicines to treat adults with
anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis
(granulomatosis with polyangiitis [GPA] and
microscopic polyangiitis [MPA]).
For more information, see Section 1. Why am I using Tayneos? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE TAVNEOS?
Do not use if you have ever had an allergic reaction to avacopan 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
Tavneos? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Tavneos 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 TAVNEOS?
•
Use as directed by your doctor. Check with your doctor or pharmacist
if you are not sure.
•
The recommended dose is 3 capsules, twice daily.
•
Take the capsules with food, in the morning and evening. Swallow the
capsules whole with water.
•
Do not crush, chew or open the capsules.
More instructions can be found in Section 4. How do I use Tavneos? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING TAVNEOS?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
Tavneos.
•
If you are pregnant or breast-feeding, think you may be pregnant or
are planning to have a baby, ask
your doctor or pharmacist for advice before taking this medicine.
Tavneos is not recommended for
us

Summary of Product characteristics

Tavneos 2023-01-31 AVA_AUS_PI
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 – TAVNEOS
® (AVACOPAN)
CAPSULES
1
NAME OF THE MEDICINE
Avacopan
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 10 mg of avacopan.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Hard capsule.
Capsules with yellow body and light orange cap with “CCX168” in
black ink.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Tavneos, in combination with a rituximab or cyclophosphamide based
regimen, is indicated
for the treatment of adults with anti-neutrophil cytoplasmic
autoantibody (ANCA)-associated
vasculitis (granulomatosis with polyangiitis [GPA] and microscopic
polyangiitis [MPA]).
4.2
DOSE AND METHOD OF ADMINISTRATION
Treatment should be initiated and monitored by healthcare
professionals experienced in the
diagnosis and treatment of GPA or MPA.
DOSAGE
The recommended dose of Tavneos is 30 mg (3 hard capsules of 10 mg
each) taken orally
twice daily, morning and evening, with food.
Tavneos should be administered in combination with rituximab or
cyclophosphamide.
Suitable dosing regimens for these combinations include:
▼
Tavneos 2023-01-31 AVA_AUS_PI
2
•
rituximab for 4 weekly intravenous doses or,
•
intravenous or oral cyclophosphamide for 13 or 14 weeks, followed by
oral
azathioprine or mycophenolate mofetil and,
•
glucocorticoids as clinically indicated.
For details on doses, concomitant glucocorticoids and data on efficacy
and safety for the
combinations, please see Sections 4.8 Adverse effects (Undesirable
effects) and 5.1
Pharmacodynamic properties.
Clinical study data are limited to 52 weeks of exposure followed by 8
weeks of observation.
_MISSED DOSES _
If a patient misses a dose, the missed dose is to be taken a