Initial US Approval:
2021
Key Clinical Studies:
LITESPARK-015 (NCT04924075)
Drug Class/Description:
Hypoxia-inducible factor inhibitor
WARNING: EMBRYO-FETAL TOXICITY
See full prescribing information for complete boxed warning.
- Exposure to WELIREG during pregnancy can cause embryo-fetal harm.
- Verify pregnancy status prior to the initiation of WELIREG.
- Advise patients of these risks and the need for effective non-hormonal contraception. WELIREG can render some hormonal contraceptives ineffective.
Indications and Usage:
WELIREG is a hypoxia-inducible factor inhibitor indicated for treatment of adult patients with von Hippel-Lindau (VHL) disease who require therapy for associated renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas, or pancreatic neuroendocrine tumors (pNET), not requiring immediate surgery.
Dosage and Administration:
The recommended dosage of WELIREG is 120 mg administered orally once daily with or without food.
Dosage Forms and Strengths:
Tablets: 40 mg
Contraindications:
None.
Warnings and Precautions:
- Anemia: Monitor for anemia before initiation of and periodically throughout treatment with WELIREG. Withhold WELIREG until hemoglobin ≥9g/dL, then resume at reduced dose or discontinue. For life threatening anemia, or for anemia requiring urgent intervention, withhold WELIREG until hemoglobin ≥9g/dL and resume at a reduced dose or permanently discontinue WELIREG.
- Hypoxia: Monitor oxygen saturation before initiation of, and periodically throughout, treatment with WELIREG. For hypoxia at rest, withhold until resolved, resume at reduced dose, or discontinue depending on severity. For life-threatening hypoxia, permanently discontinue WELIREG.
Adverse Reactions:
Most common (≥ 25%) adverse reactions, including laboratory abnormalities, were decreased hemoglobin, anemia, fatigue, increased creatinine, headache, dizziness, increased glucose, and nausea.
Drug Interactions:
UGT2B17 or CYP2C19 Inhibitors: Monitor for signs and symptoms of anemia and hypoxia and reduce the dosage of WELIREG as recommended.
Use in Specific Populations:
- Lactation: Advise not to breastfeed.
- Infertility: May impair fertility in males and females.
Adapted From:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/215383s000lbl.pdf
Every health-care provider should make their own determination regarding specific safe and appropriate patient care practices, including drug dosages and indications. The provider should always consult the most recent prescribing/product information. FDA Focus information is not guaranteed to be accurate, complete, or current. JADPRO and its editors, authors, reviewers, and commentators cannot be held responsible for any liability incurred as a consequence of the application of any of the information listed within.
