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Welireg 40mg Tablet
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Indications & Clinical Uses
- Welireg 40 mg tablets contain belzutifan, a hypoxia-inducible factor inhibitor taken by mouth once daily.
- In the US label it is approved for von Hippel-Lindau disease (for associated renal cell carcinoma, central nervous system hemangioblastomas and pancreatic neuroendocrine tumours that do not need immediate surgery); together with pembrolizumab as adjuvant treatment of adults with clear cell renal cell carcinoma at intermediate-high or high risk of recurrence after nephrectomy; on its own for adults with advanced clear cell renal cell carcinoma after a PD-1 or PD-L1 inhibitor and a VEGF tyrosine kinase inhibitor; and for adults and children aged 12 years and over with locally advanced, unresectable or metastatic pheochromocytoma or paraganglioma.
- The usual adult dose is 120 mg once daily, with or without food.
- It is a prescription cancer medicine.
Side Effects
- Very common effects (25% or more of patients in trials) include decreased haemoglobin, tiredness, raised creatinine, headache, dizziness, raised blood sugar, nausea, lowered lymphocyte counts and raised liver enzymes.
- In von Hippel-Lindau disease, decreased haemoglobin was seen in 93% of patients and fatigue in 64%.
- Serious effects are severe anaemia that can need a blood transfusion and severe hypoxia (low oxygen) that may require stopping treatment, oxygen or hospital care.
- BOXED WARNING: exposure during pregnancy can cause embryo-fetal harm; pregnancy status must be verified before starting, and effective non-hormonal contraception is required because Welireg can make some hormonal contraceptives ineffective.
- Report breathlessness, unusual tiredness, pale skin or a racing heart to your healthcare provider promptly.
Precautions & Warnings
- The label carries a boxed warning for embryo-fetal toxicity.
- Verify pregnancy status before starting Welireg.
- Females and males of reproductive potential should use effective non-hormonal contraception during treatment and for 1 week after the last dose, and you should not breastfeed during treatment or for 1 week after the last dose.
- Your healthcare provider will check haemoglobin before and during treatment and monitor oxygen saturation, and dose changes or stopping may be needed for anaemia or hypoxia.
- There are no labelled contraindications.
- Children aged 12 and over take 120 mg if they weigh 40 kg or more and 80 mg if they weigh less.
- Store the tablets at 20°C to 25°C in the original child-resistant bottle.
Avoid Interactions
- Medicines that increase Welireg exposure: inhibitors of UGT2B17 or CYP2C19 raise belzutifan levels, so your healthcare provider will watch more closely for anaemia and hypoxia.
- Medicines whose effect Welireg reduces: sensitive CYP3A4 substrates (concentrations fall by roughly 40 to 70%), which should be avoided, and hormonal contraceptives, which may fail; use effective non-hormonal contraception instead during treatment and for 1 week afterwards.
- Tell your healthcare provider about all prescription medicines, over-the-counter products and herbal supplements you use, and before starting any new one, so that the contraception plan and any interaction risks can be reviewed before and during treatment.
References
Frequently Asked Questions
Welireg (belzutifan) treats von Hippel-Lindau disease tumours, clear cell renal cell carcinoma (with pembrolizumab after surgery, or alone when advanced) and pheochromocytoma or paraganglioma (from age 12). It is a once-daily tablet. Which use applies to you depends on your diagnosis and previous treatment.
Take Welireg (belzutifan) by mouth once daily, with or without food. The usual adult dose is 120 mg, which is three 40 mg tablets. Children aged 12 and over take 120 mg if they weigh 40 kg or more and 80 mg if they weigh less.
Common Welireg side effects include low haemoglobin, tiredness, higher creatinine, headache, dizziness, high blood sugar and nausea. Serious ones are severe anaemia, which can need a transfusion, and severe low oxygen (hypoxia). Report breathlessness, unusual tiredness or pale skin to your healthcare provider quickly.
Avoid pregnancy and avoid relying on hormonal birth control while taking Welireg (belzutifan), because it can make hormonal contraceptives ineffective. Use non-hormonal contraception during treatment and for 1 week after. Avoid sensitive CYP3A4 substrate medicines, and tell your healthcare provider about all medicines and supplements you take.
Store Welireg (belzutifan) tablets at room temperature, 20°C to 25°C, in the original child-resistant bottle. Short excursions between 15°C and 30°C are allowed. Keep the bottle closed and out of reach of children, and take the tablets exactly as prescribed.
No. Welireg (belzutifan) carries a boxed warning: exposure during pregnancy can cause embryo-fetal harm. Your pregnancy status must be checked before you start. Males and females should use effective non-hormonal contraception during treatment and for 1 week after the last dose, and should not breastfeed during that time.
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