VITRAKVI larotrectinib (as sulfate) 25 mg hard capsule bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

larotrectinib sulfate, Quantity: 30.7 mg

Available from:

Bayer Australia Ltd

Pharmaceutical form:

Capsule, hard

Composition:

Excipient Ingredients: Gelatin; propylene glycol; dimethicone 12500; brilliant blue FCF aluminium lake; titanium dioxide; Shellac; strong ammonia solution

Administration route:

Oral

Units in package:

56 capsules

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Vitrakvi (larotrectinib) has provisional approval in Australia for the treatment of adult and paediatric patients with locally advanced or metastatic solid tumours that:,? have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation, ? are metastatic or where surgical resection is likely to result in severe morbidity, and ? have either progressed following treatment or who have no satisfactory alternative therapy. The decision to approve this indication has been made on the basis of objective response rate (ORR) and duration of response from single arm clinical studies. The sponsor is required to submit further clinical data to confirm the clinical benefit of the medicine.

Product summary:

Visual Identification: White opaque hard gelatin capsule, size 2, with blue printing of BAYER cross and 25 mg on body of capsule; Container Type: Bottle; Container Material: HDPE; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Registered (Provisional)

Authorization date:

2020-09-07

Patient Information leaflet

VITRAKVI
®
CMI v2.0
1
VITRAKVI
®
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.
1.
WHY AM I USING VITRAKVI?
VITRAKVI contains the active ingredient larotrectinib. Vitrakvi
(larotrectinib) has provisional approval in Australia for the
treatment of adult and paediatric patients from 1 month old, with
locally advanced or metastatic solid tumours that:
• have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion
without a known acquired resistance mutation,
• are metastatic or where surgical resection is likely to result in
severe morbidity, and
• have either progressed following treatment or who have no
satisfactory alternative therapy.
These cancers can appear in many different parts of the body.
For more information, see Section 1. Why am I using VITRAKVI?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE VITRAKVI?
Do not use if you have ever had an allergic reaction to VITRAKVI or
any of the ingredients listed at the end of the CMI.
BEFORE STARTING THE THERAPY, A TEST WILL BE USED TO DETERMINE WHETHER
YOU HAVE NRTK GENE ALTERATION.
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
VITRAKVI?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with VITRAKVI and affect how it works.
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines including any that
you get without a prescription from your pharmacy,
supermarket, naturopath or health food shop such as vitamins, dietary
supplements or herbal medicine.
A list of these medicines is in Section 3. What if I am taking other
medicines?
in the full CMI.
4.
HOW DO I US

Summary of Product characteristics

Vitrakvi PI V3.0; CCDS V3.0
Page 1 of 24
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
VITRAKVI
®
1
NAME OF THE MEDICINE
Vitrakvi (larotrectinib)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Vitrakvi 25 mg hard capsules
Each capsule contains larotrectinib sulfate, equivalent to 25 mg of
larotrectinib
Vitrakvi 100 mg hard capsules
Each capsule contains larotrectinib sulfate, equivalent to 100 mg of
larotrectinib
Vitrakvi 20 mg/ml oral solution
Each ml oral solution contains larotrectinib sulfate, equivalent to 20
mg of larotrectinib
For a full list of excipients, see section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Vitrakvi 25 mg hard capsules
White opaque hard gelatin capsule, size 2, with blue printing of
“BAYER” cross and “25 mg”
on body of capsule
Vitrakvi 100 mg hard capsules
White opaque hard gelatin capsule, size 0, with blue printing of
“BAYER” cross and “100
mg” on body of capsule
Vitrakvi 20 mg/mL oral solution
100 mL clear yellow to orange liquid solution
[AUST R 320239]
Vitrakvi 20 mg/mL oral solution - new formulation
[AUST R 388084]
Colourless to yellow or orange or red or brownish liquid solution
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Vitrakvi (larotrectinib) has provisional approval in Australia for the
treatment of adult and
paediatric patients with locally advanced or metastatic solid tumours
that:
▼
Vitrakvi PI V3.0; CCDS V3.0
Page 2 of 24
•
have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion
without a known
acquired resistance mutation,
•
are metastatic or where surgical resection is likely to result in
severe morbidity, and
•
have either progressed following treatment or who have no satisfactory
alternative
therapy.
The decision to approve this indication has been made on the basis of
objective response rate
(ORR