GAVRETO pralsetinib 100 mg hard capsule bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

pralsetinib, Quantity: 100 mg

Available from:

Roche Products Pty Ltd

Pharmaceutical form:

Capsule, hard

Composition:

Excipient Ingredients: sodium bicarbonate; microcrystalline cellulose; magnesium stearate; citric acid; pregelatinised starch; hypromellose; titanium dioxide; brilliant blue FCF; propylene glycol; butan-1-ol; isopropyl alcohol; purified water; Shellac; ethanol absolute; ammonia; potassium hydroxide

Administration route:

Oral

Units in package:

90 CAPSULES, 60 CAPSULES, 120 CAPSULES

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Non-Small Cell Lung Cancer (NSCLC),Gavreto has provisional approval in Australia for the treatment of adult patients with locally advanced or metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC). The decision to approve this indication has been made on the basis of overall response rate (ORR) and duration of response (DOR) in single-arm trials. Continued approval of this indication depends on verification and description of benefit in confirmatory trials. RET-Fusion Positive Thyroid Cancer,Gavreto has provisional approval in Australia for the treatment of adult patients with advanced or metastatic RET-fusion positive thyroid cancer that is refractory to (or unsuitable for) radioactive iodine and who have progressed on or are unable to tolerate lenvatinib or sorafenib. The decision to approve this indication has been made on the basis of overall response rate (ORR) and duration of response (DOR). Continued approval of this indication depends on verification and description of benefit in confirmatory trials.

Product summary:

Visual Identification: Size 0 light blue opaque HPMC capsule, printed in white ink with 'BLU-667' on the capsule shell body and '100 mg' on the capsule shell cap; Container Type: Bottle; Container Material: HDPE; Container Life Time: 30 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Registered (Provisional)

Authorization date:

2023-03-29

Patient Information leaflet

GAVRETO
®
G
A
V
R
E
T
O
®
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 GAVRETO?
GAVRETO contains the active ingredient pralsetinib. GAVRETO is used to
treat patients who have certain types of cancer - known
as rearranged during transfection (RET)-fusion positive lung cancer or
thyroid cancer.
For more information, see Section 1. Why am I using GAVRETO? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE GAVRETO?
Do not use if you have ever had an allergic reaction to GAVRETO 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. IT IS IMPORTANT TO TELL YOU DOCTOR IF
YOU HAVE A HISTORY OF LUNG AND/OR BREATHING PROBLEMS,
HIGH BLOOD PRESSURE, LIVER PROBLEMS OR BLEEDING PROBLEMS.
For more information, see Section 2. What should I know before I use
GAVRETO? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with GAVRETO 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 GAVRETO?
•
The recommended dose is 400 mg (4 capsules) taken by mouth once daily.
GAVRETO capsules should be swallowed whole
with a glass of water and must not be opened or chewed. If you get
side effects, your doctor may change your dose, temporarily
stop, or permanently stop treatment.
•
Take GAVRETO on an empty stomach. Do not eat for at least 2 hours
before and at least 1 hour after taking GAVRETO.
More instructions can be found in Section 4. How do I use GAVRETO? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING GAVRETO?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are t

Summary of Product characteristics

GAVRETO 20230406 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
GAVRETO
® (PRALSETINIB)
1.
GAVRETO
Pralsetinib
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 100 mg pralsetinib.
Gavreto (pralsetinib) 100 mg, light blue, opaque, immediate release,
hydroxypropyl
methylcellulose (HPMC) hard capsule printed with “BLU-667” on the
capsule shell body and
“100 mg” on the capsule shell cap.
For the full list of excipients, see section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Hard capsule.
Gavreto is a size 0 capsule with light blue body and cap and BLU-667
imprinted in white on
the body.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
NON-SMALL CELL LUNG CANCER (NSCLC)
Gavreto has
PROVISIONAL APPROVAL
in Australia for the treatment of adult patients with locally
advanced or metastatic rearranged during transfection (RET)
fusion-positive non-small cell
lung cancer (NSCLC). The decision to approve this indication has been
made on the basis of
overall response rate (ORR) and duration of response (DOR) in
single-arm trials. Continued
approval of this indication depends on verification and description of
benefit in confirmatory
trials.
RET-FUSION POSITIVE THYROID CANCER
Gavreto has
PROVISIONAL APPROVAL
in Australia for the treatment of adult patients with
advanced or metastatic RET-fusion positive thyroid cancer that is
refractory to (or unsuitable
for) radioactive iodine and who have progressed on or are unable to
tolerate lenvatinib or
sorafenib. The decision to approve this indication has been made on
the basis of overall
response rate (ORR) and duration of response (DOR). Continued approval
of this indication
depends on verification and description of benefit in confirmatory
trials.
4.2
DOSE AND METHOD OF ADMINISTRATION
GENERAL
Method of administrati