Consumer medicine information

Welireg 40 mg Tablets

Belzutifan

BRAND INFORMATION

Brand name

Welireg

Active ingredient

Belzutifan

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Welireg 40 mg Tablets.

1. Why am I using WELIREG?


WELIREG contains the active ingredient belzutifan. WELIREG is used to treat adults with von-Hippel Lindau (VHL) disease who need treatment for multiple tumour types. For more information, see Section 1. Why am I using WELIREG? in the full CMI.

2. What should I know before I use WELIREG?


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 WELIREG? in the full CMI.

3. What if I am taking other medicines?


Some medicines may interfere with WELIREG and affect how it works.
For more information, see Section 3. What if I am taking other medicines? in the full CMI.

4. How do I take WELIREG?

  • Take your prescribed dose once per day. Take your prescribed dose at the same time each day. You can take WELIREG with or without food. Swallow the tablet whole. Do not break, crush or chew.

More instructions can be found in Section 4. How do I use WELIREG? in the full CMI.

5. What should I know while using WELIREG?

Things you should do
  • Tell your doctor if you get any symptoms of low red blood cell counts including tiredness, feeling cold, shortness of breath, chest pain, or fast heartbeat.
  • Tell your doctor or get medical help right away if you get symptoms of low oxygen in your body, including shortness of breath or fast heart rate.
  • For female patients who are able to become pregnant, your healthcare provider will do a pregnancy test before you start treatment with WELIREG. You should use an effective form of non-hormonal birth control (contraception) during treatment with WELIREG and for 1 week after your last dose.
  • Males with female partners who are able to become pregnant should use effective birth control (contraception) during treatment with WELIREG and for 1 week after your last dose.
Driving or using machines
  • The effect of WELIREG on driving or using machines is not known. Be careful before you drive or use any machines or tools until you know how WELIREG affects you.
Looking after your medicine
  • Store below 30°C

For more information, see Section 5. What should I know while using WELIREG? in the full CMI.

6. Are there any side effects?


Common side effects of WELIREG include: feeling tired, headache, feeling dizzy, nausea, and weight gain.
WELIREG may decrease the oxygen level in your blood and red blood cell level. This may cause serious side effects including shortness of breath, trouble breathing, chest pain, or a very fast heartbeat. Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

BRAND INFORMATION

Brand name

Welireg

Active ingredient

Belzutifan

Schedule

S4

 

1 Name of Medicine

Belzutifan.

2 Qualitative and Quantitative Composition

Each Welireg tablet contains 40 mg of belzutifan.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Welireg 40 mg tablet is a blue oval shaped, film-coated tablet debossed with "177" on one side and plain on the other side.

4 Clinical Particulars

4.9 Overdose

There is no specific treatment for Welireg overdose. In cases of suspected overdose, if necessary, consider withholding Welireg and instituting supportive care. The highest dose of Welireg studied clinically was 240 mg total daily dose (120 mg twice a day or 240 mg once a day). Grade 3 hypoxia occurred at 120 mg twice a day and Grade 4 thrombocytopenia occurred at 240 mg once daily.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

Pharmacotherapeutic group: not yet assigned, ATC code: not yet assigned.

5.3 Preclinical Safety Data

Genotoxicity. Belzutifan was not genotoxic in in vitro bacterial mutagenicity assay and micronucleus assay in human lymphocytes, and an in vivo rat micronucleus assay.
Carcinogenicity. Carcinogenicity studies have not been conducted with belzutifan.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Belzutifan is a white to light brown powder that is soluble in acetonitrile, dimethoxyethane and acetone, sparingly soluble in ethyl acetate, very slightly soluble in isopropanol and toluene, and insoluble in water.
Chemical structure. The chemical name of belzutifan is 3-[[(1S,2S,3R)-2,3-Difluoro-2,3-dihydro-1-hydroxy-7- (methylsulfonyl)-1H-inden-4-yl]oxy]-5-fluorobenzonitrile. The molecular formula is C17H12F3NO4S and the molecular weight is 383.34 Daltons.
The chemical structure is:
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSBELZUT.gif CAS number. 1672668-24-4.

7 Medicine Schedule (Poisons Standard)

Prescription only medicine (Schedule 4).

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/WELIREST.gif