Welireg Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Manufacturer
Generic Availability
Mechanism of Action
Welireg Indications
Indications
In adults 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. In adults 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).
Welireg Dosage and Administration
Adult
Children
Welireg Contraindications
Not Applicable
Welireg Boxed Warnings
Boxed Warning
Welireg Warnings/Precautions
Warnings/Precautions
Monitor for anemia, oxygen saturation prior to initiation and periodically during therapy. Withhold for hemoglobin <8g/dL or transfusion indicated until resolved; resume at reduced dose or permanently discontinue based on severity of anemia. For life-threatening anemia or when urgent intervention is indicated; withhold until hemoglobin ≥8g/dL; resume at reduced dose or permanently discontinue. Consider withholding therapy for decreased oxygen saturation with exercise (eg, pulse oximeter <88% or PaO2 ≤55mmHg) until resolved, then resume at same or reduced dose. Withhold for decreased oxygen saturation at rest (eg, pulse oximeter <88% or PaO2 ≤55mmHg) or urgent intervention indicated until resolved; resume at reduced dose or discontinue based on severity of hypoxia. Permanently discontinue if life-threatening or recurrent symptomatic hypoxia occurs. Poor metabolizers (dual UGT2B17/CYP2C19): monitor closely. Severe renal impairment (eGFR 15–29mL/min/1.73m2). Moderate or severe hepatic impairment (total bilirubin >1.5×ULN and any AST). Embryo-fetal toxicity. Advise females of reproductive potential and males (w. female partners) to use effective non-hormonal contraception during and for 1 week after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 1 week after the last dose).
Welireg Pharmacokinetics
Absorption
Median Tmax: 1 to 2 hours.
Distribution
Volume of distribution: 119 L. Plasma protein bound: 45%.
Elimination
Fecal (51.7%), renal (49.6%). Half-life (mean): 14 hours. Clearance: 6.0 L/hr.
Welireg Interactions
Interactions
Welireg Adverse Reactions
Adverse Reactions
Decreased hemoglobin, fatigue, increased creatinine; anemia, hypoxia, anaphylaxis reaction, retinal disorders. Also for VHL disease: headache, dizziness, increased glucose, nausea; also for advanced RCC: musculoskeletal pain, decreased lymphocytes, increased alanine aminotransferase, decreased sodium, increased potassium, increased aspartate aminotransferase.
Welireg Clinical Trials
See Literature
Welireg Note
Not Applicable
Welireg Patient Counseling
See Literature
Welireg Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Manufacturer
Generic Availability
Mechanism of Action
Welireg Indications
Indications
In adults 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 Dosage and Administration
Adult
Children
Welireg Contraindications
Not Applicable
Welireg Boxed Warnings
Boxed Warning
Welireg Warnings/Precautions
Warnings/Precautions
Monitor for anemia, oxygen saturation prior to initiation and periodically during therapy. Withhold for hemoglobin <8g/dL or transfusion indicated until resolved; resume at reduced dose or permanently discontinue based on severity of anemia. For life-threatening anemia or when urgent intervention is indicated; withhold until hemoglobin ≥8g/dL; resume at reduced dose or permanently discontinue. Consider withholding therapy for decreased oxygen saturation with exercise (eg, pulse oximeter <88% or PaO2 ≤55mmHg) until resolved, then resume at same or reduced dose. Withhold for decreased oxygen saturation at rest (eg, pulse oximeter <88% or PaO2 ≤55mmHg) or urgent intervention indicated until resolved; resume at reduced dose or discontinue based on severity of hypoxia. Permanently discontinue if life-threatening or recurrent symptomatic hypoxia occurs. Poor metabolizers (dual UGT2B17/CYP2C19): monitor closely. Severe renal impairment (eGFR 15–29mL/min/1.73m2). Moderate or severe hepatic impairment (total bilirubin >1.5×ULN and any AST). Embryo-fetal toxicity. Advise females of reproductive potential and males (w. female partners) to use effective non-hormonal contraception during and for 1 week after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 1 week after the last dose).
Welireg Pharmacokinetics
Absorption
Median Tmax: 1 to 2 hours.
Distribution
Volume of distribution: 119 L. Plasma protein bound: 45%.
Elimination
Fecal (51.7%), renal (49.6%). Half-life (mean): 14 hours. Clearance: 6.0 L/hr.
Welireg Interactions
Interactions
Welireg Adverse Reactions
Adverse Reactions
Decreased hemoglobin, fatigue, increased creatinine; anemia, hypoxia, anaphylaxis reaction, retinal disorders. Also for VHL disease: headache, dizziness, increased glucose, nausea; also for advanced RCC: musculoskeletal pain, decreased lymphocytes, increased alanine aminotransferase, decreased sodium, increased potassium, increased aspartate aminotransferase.
Welireg Clinical Trials
See Literature
Welireg Note
Not Applicable
Welireg Patient Counseling
See Literature
Welireg Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Manufacturer
Generic Availability
Mechanism of Action
Welireg Indications
Indications
In adults 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 Dosage and Administration
Adult
Children
Welireg Contraindications
Not Applicable
Welireg Boxed Warnings
Boxed Warning
Welireg Warnings/Precautions
Warnings/Precautions
Monitor for anemia, oxygen saturation prior to initiation and periodically during therapy. Withhold for hemoglobin <8g/dL or transfusion indicated until resolved; resume at reduced dose or permanently discontinue based on severity of anemia. For life-threatening anemia or when urgent intervention is indicated; withhold until hemoglobin ≥8g/dL; resume at reduced dose or permanently discontinue. Consider withholding therapy for decreased oxygen saturation with exercise (eg, pulse oximeter <88% or PaO2 ≤55mmHg) until resolved, then resume at same or reduced dose. Withhold for decreased oxygen saturation at rest (eg, pulse oximeter <88% or PaO2 ≤55mmHg) or urgent intervention indicated until resolved; resume at reduced dose or discontinue based on severity of hypoxia. Permanently discontinue if life-threatening or recurrent symptomatic hypoxia occurs. Poor metabolizers (dual UGT2B17/CYP2C19): monitor closely. Severe renal impairment (eGFR 15–29mL/min/1.73m2). Moderate or severe hepatic impairment (total bilirubin >1.5×ULN and any AST). Embryo-fetal toxicity. Advise females of reproductive potential and males (w. female partners) to use effective non-hormonal contraception during and for 1 week after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 1 week after the last dose).
Welireg Pharmacokinetics
Absorption
Median Tmax: 1 to 2 hours.
Distribution
Volume of distribution: 119 L. Plasma protein bound: 45%.
Elimination
Fecal (51.7%), renal (49.6%). Half-life (mean): 14 hours. Clearance: 6.0 L/hr.
Welireg Interactions
Interactions
Welireg Adverse Reactions
Adverse Reactions
Decreased hemoglobin, fatigue, increased creatinine; anemia, hypoxia, anaphylaxis reaction, retinal disorders. Also for VHL disease: headache, dizziness, increased glucose, nausea; also for advanced RCC: musculoskeletal pain, decreased lymphocytes, increased alanine aminotransferase, decreased sodium, increased potassium, increased aspartate aminotransferase.
Welireg Clinical Trials
See Literature
Welireg Note
Not Applicable
Welireg Patient Counseling
See Literature