Source: FDA, National Drug Code (US) Revision Year: 2024
WELIREG is 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.
WELIREG is indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC) following a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and a vascular endothelial growth factor tyrosine kinase inhibitor (VEGF-TKI).
The recommended dosage of WELIREG is 120 mg administered orally once daily until disease progression or unacceptable toxicity. WELIREG should be taken at the same time each day and may be taken with or without food.
Advise patients to swallow tablets whole. Do not chew, crush, or split WELIREG prior to swallowing.
If a dose of WELIREG is missed, it can be taken as soon as possible on the same day. Resume the regular daily dose schedule for WELIREG the next day. Do not take extra tablets to make up for the missed dose.
If vomiting occurs any time after taking WELIREG, do not retake the dose. Take the next dose on the next day.
Dosage modifications for WELIREG for adverse reactions are summarized in Table 1.
The recommended dose reductions are:
Table 1. Recommended Dosage Modifications for Adverse Reactions:
| Adverse Reaction | Severity | Dosage Modification |
|---|---|---|
| Anemia [see Warnings and Precautions (5.1)] | Hemoglobin <8 g/dL or transfusion indicated | • Withhold until hemoglobin ≥8g/dL. • Resume at the same or reduced dose; or discontinue depending on the severity of anemia. |
| Life-threatening or urgent intervention indicated | • Withhold until hemoglobin ≥8g/dL. • Resume at a reduced dose or permanently discontinue. | |
| Hypoxia [see Warnings and Precautions (5.2)] | Decreased oxygen saturation with exercise (e.g., pulse oximeter <88%) | • Consider withholding until resolved. • Resume at the same dose or at a reduced dose depending on the severity of hypoxia. |
| Decreased oxygen saturation at rest (e.g., pulse oximeter <88% or PaO2 ≤55 mm Hg) or urgent intervention indicated | • Withhold until resolved. • Resume at reduced dose or discontinue depending on the severity of hypoxia. | |
| Life-threatening or recurrent symptomatic hypoxia | • Permanently discontinue. | |
| Other Adverse Reactions [see Adverse Reactions (6)] | Grade 3 | • Withhold dosing until resolved to ≤ Grade 2. • Consider resuming at a reduced dose (reduce by 40 mg). • Permanently discontinue upon recurrence of Grade 3. |
| Grade 4 | • Permanently discontinue. |
There is no specific treatment for WELIREG overdose. In cases of suspected overdose, withhold WELIREG and institute supportive care. Grade 3 hypoxia occurred at dosages of 120 mg twice a day and Grade 4 thrombocytopenia occurred at dosages of 240 mg once daily (approximately 2 times the recommended dosage).
Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature].
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