Special Warning : אזהרת שימוש

4.4   Special warnings and precautions for use

Anaemia due to decreased erythropoietin
Anaemia occurred very commonly in patients receiving Welireg (see section 4.8). Patients should be monitored for anaemia before initiation of and periodically throughout treatment with belzutifan with more frequent monitoring within the first 6 months of treatment (see section 5.1). For patients who develop Grade 3 anaemia (Hb < 8 g/dL), belzutifan should be withheld and patients should be treated according to standard medical practice, including ESA administration until resolved to ≤ Grade 2 (Hb ≥ 8 g/dL). For recurrent Grade 3 anaemia, belzutifan should be discontinued. For patients who develop Grade 4 anaemia, the dose of belzutifan should be reduced or permanently discontinued (see section 4.2).

Hypoxia
Belzutifan can cause severe hypoxia that may require discontinuation, supplemental oxygen, or hospitalisation (see section 4.2).

Patients should be monitored for oxygen saturation with pulse oximetry before initiation of and periodically throughout treatment with belzutifan with more frequent monitoring within the first 6 months of treatment (see section 5.1). In light of the risk of hypoxia, smoking cessation is recommended.

For Grade 2 hypoxia, providing supplemental oxygen and continuing or withholding treatment should be considered. If withheld, belzutifan should be resumed at a reduced dose. For patients who have Grade 3 hypoxia, belzutifan should be withheld, hypoxia treated, and dose reduction should be considered. If Grade 3 hypoxia continues to recur, treatment should be discontinued. For Grade 4 hypoxia, treatment should be permanently discontinued (see section 4.2). Patients treated with belzutifan must be given the patient alert card.

Embryo-foetal toxicity
Based on findings in animals, belzutifan may cause foetal harm, including foetal loss, in humans. In a rat study, belzutifan caused embryo-foetal toxicity when administered during the period of organogenesis at maternal exposures that were lower than the human exposures at the recommended dose of 120 mg daily (see section 5.3).

Females of reproductive potential should be advised to use highly effective non-hormonal contraceptive methods during treatment with belzutifan and for 1 week after the last dose, since belzutifan can render some hormonal contraceptives ineffective (see sections 4.5 and 4.6). Advise male patients and their female partners of reproductive potential to use highly effective contraception during treatment with belzutifan and for 1 week after the last dose (see section 4.6). Advise male patients with female partners who are pregnant to use a barrier method of contraception during treatment with belzutifan and 1 week after the last dose.

Information about some of the ingredients
This medicine contains less than 1 mmol sodium (23 mg) per dosage unit, that is to say essentially ‘sodium-free’.

Effects on Driving

4.7   Effects on ability to drive and use machines

Belzutifan may have a minor influence on the ability to drive and use machines. Dizziness and fatigue may occur following administration of belzutifan (see section 4.8).

Patients should be advised not to drive and use machines, until they are reasonably certain belzutifan therapy does not affect them adversely.