WELIREG Aug 2025
SELECTED SAFETY INFORMATION
▼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 https://www.tga.gov.au/reporting-problems.
WELIREG is PBS listed for certain patients with von Hippel-Lindau (VHL) disease. Authority required. Criteria apply, see www.pbs.gov.au for further information.
Before prescribing, please review the Product Information available at: www.msdinfo.com.au/weliregpi
INDICATION:
WELIREG is indicated for the treatment of adult patients with von Hippel-Lindau (VHL) disease who require therapy for associated renal cell carcinoma (RCC), central nervous system (CNS) haemangioblastomas, or pancreatic neuroendocrine tumours (pNET), not requiring immediate surgery.
▼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 https://www.tga.gov.au/reporting-problems.
SELECTED SAFETY INFORMATION
PRECAUTIONS:
Anaemia
WELIREG can cause severe anaemia that can require blood transfusion.
Monitor for anaemia before initiation of and periodically throughout treatment.
Closely monitor patients who are dual UGT2B17 and CYP2C19 poor metabolisers due to potential increases in exposure that may increase the incidence or severity of anaemia.
In LITESPARK-004, Anaemia was reported in 55 patients (90.2%) and 6 patients (9.8%) had grade 3 anaemia.
Hypoxia
WELIREG can cause severe hypoxia that may require discontinuation, supplemental oxygen, or hospitalisation.
Monitor oxygen saturation with pulse oximetry before initiation of and periodically throughout treatment. Advise patients to report signs and symptoms of hypoxia immediately to a healthcare provider.
In LITESPARK-004, Grade 3 hypoxia occurred in 1 patient (1.6%).
Embryo-Fetal Toxicity
Verify the pregnancy status prior to initiation of WELIREG.
Exposure to WELIREG during pregnancy may cause embryo-fetal harm, including fetal loss, when administered to a pregnant woman; advise pregnant women of this potential risk.
Advise female and male patients of the potential risks to a fetus and the need for highly effective non-hormonal contraception during treatment and for 1 week after the last dose.
Effects on Ability to Drive and Use Machines
WELIREG can cause dizziness and fatigue. Patients should be advised not to drive and use machines until they are reasonably certain WELIREG does not affect them adversely.
CONTRAINDICATIONS: None.
ADVERSE EVENTS:
In LITESPARK-004 (n=61), all cause adverse events (AEs) occurring in ≥10% patients treated with WELIREG were anaemia, fatigue, peripheral oedema, headache, dizziness, nausea, constipation, abdominal pain, diarrhoea, dyspnea, upper respiratory tract infection, urinary tract infection, increased weight, increase alanine aminotransferase, increased aspartate aminotransferase, myalgia, arthralgia, back pain, blurred vision, hypertension, insomnia and anxiety. Serious adverse events occurred in 14 patients (23.0%), of which 4 were determined to be drug-related (anaemia, urinary tract infection, haemorrhage intracranial, and hypoxia).
In LITESPARK-004, the most common drug related AEs in patients treated with WELIREG were anaemia (90%), fatigue (70%), dizziness (44%) and nausea (36%).
Use in Pregnancy – Pregnancy Category D
Females and males of reproductive potential
Verify pregnancy status prior to initiating treatment with WELIREG.
Based on findings in animals, WELIREG may cause fetal harm, including fetal loss, when administered to a pregnant woman; advise pregnant women of this potential risk.
Advise patients of these risks to a fetus and to use highly effective non-hormonal contraception during treatment with WELIREG and for at least 1 week after the last dose as WELIREG may reduce the efficacy of hormonal contraceptives.
Effects on Fertility
WELIREG may impair fertility in males and females of reproductive potential. Advise patients of this potential risk.
Lactation
Due to the potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment with WELIREG and for 1 week after the last dose.
See full Product Information for further information.
AU-BEL-00107 v2. Issued September 2025.
WELIREG is PBS listed for certain patients with von Hippel-Lindau (VHL) disease. Authority required. Criteria apply, see www.pbs.gov.au for further information.
Before prescribing, please review the Product Information available at: www.msdinfo.com.au/weliregpi
INDICATION:
WELIREG is indicated for the treatment of adult patients with von Hippel-Lindau (VHL) disease who require therapy for associated renal cell carcinoma (RCC), central nervous system (CNS) haemangioblastomas, or pancreatic neuroendocrine tumours (pNET), not requiring immediate surgery.
▼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 https://www.tga.gov.au/reporting-problems.
SELECTED SAFETY INFORMATION
PRECAUTIONS:
Anaemia
WELIREG can cause severe anaemia that can require blood transfusion.
Monitor for anaemia before initiation of and periodically throughout treatment.
Closely monitor patients who are dual UGT2B17 and CYP2C19 poor metabolisers due to potential increases in exposure that may increase the incidence or severity of anaemia.
In LITESPARK-004, Anaemia was reported in 55 patients (90.2%) and 6 patients (9.8%) had grade 3 anaemia.
Hypoxia
WELIREG can cause severe hypoxia that may require discontinuation, supplemental oxygen, or hospitalisation.
Monitor oxygen saturation with pulse oximetry before initiation of and periodically throughout treatment. Advise patients to report signs and symptoms of hypoxia immediately to a healthcare provider.
In LITESPARK-004, Grade 3 hypoxia occurred in 1 patient (1.6%).
Embryo-Fetal Toxicity
Verify the pregnancy status prior to initiation of WELIREG.
Exposure to WELIREG during pregnancy may cause embryo-fetal harm, including fetal loss, when administered to a pregnant woman; advise pregnant women of this potential risk.
Advise female and male patients of the potential risks to a fetus and the need for highly effective non-hormonal contraception during treatment and for 1 week after the last dose.
Effects on Ability to Drive and Use Machines
WELIREG can cause dizziness and fatigue. Patients should be advised not to drive and use machines until they are reasonably certain WELIREG does not affect them adversely.
CONTRAINDICATIONS: None.
ADVERSE EVENTS:
In LITESPARK-004 (n=61), all cause adverse events (AEs) occurring in ≥10% patients treated with WELIREG were anaemia, fatigue, peripheral oedema, headache, dizziness, nausea, constipation, abdominal pain, diarrhoea, dyspnea, upper respiratory tract infection, urinary tract infection, increased weight, increase alanine aminotransferase, increased aspartate aminotransferase, myalgia, arthralgia, back pain, blurred vision, hypertension, insomnia and anxiety. Serious adverse events occurred in 14 patients (23.0%), of which 4 were determined to be drug-related (anaemia, urinary tract infection, haemorrhage intracranial, and hypoxia).
In LITESPARK-004, the most common drug related AEs in patients treated with WELIREG were anaemia (90%), fatigue (70%), dizziness (44%) and nausea (36%).
Use in Pregnancy – Pregnancy Category D
Females and males of reproductive potential
Verify pregnancy status prior to initiating treatment with WELIREG.
Based on findings in animals, WELIREG may cause fetal harm, including fetal loss, when administered to a pregnant woman; advise pregnant women of this potential risk.
Advise patients of these risks to a fetus and to use highly effective non-hormonal contraception during treatment with WELIREG and for at least 1 week after the last dose as WELIREG may reduce the efficacy of hormonal contraceptives.
Effects on Fertility
WELIREG may impair fertility in males and females of reproductive potential. Advise patients of this potential risk.
Lactation
Due to the potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment with WELIREG and for 1 week after the last dose.
See full Product Information for further information.
AU-BEL-00107 v2. Issued September 2025.