Welireg Generic Name & Formulations
Legal Class
Rx
General Description
Belzutifan 40mg; tabs.
Pharmacological Class
Hypoxia-inducible factor inhibitor.
How Supplied
Tabs—90
Manufacturer
Generic Availability
NO
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
Swallow whole. Take at the same time each day. 120mg once daily until disease progression or unacceptable toxicity. Dose modifications for adverse reactions: see full labeling.
Children
Not established.
Welireg Contraindications
Not Applicable
Welireg Boxed Warnings
Boxed Warning
Embryo-fetal toxicity.
Welireg Warnings/Precautions
Warnings/Precautions
Monitor for anemia, oxygen saturation prior to initiation and periodically during therapy. Withhold for hemoglobin <9g/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 resolved; 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
See Literature
Welireg Interactions
Interactions
Potentiated by UGT2B17 or CYP2C19 inhibitors; monitor and reduce belzutifan dose. Antagonizes CYP3A4 substrates (esp. in dual UGT2B17/CYP2C19 poor metabolizers). Avoid concomitant sensitive CYP3A4 substrates; if unavoidable, increase the dose of these substrates. May antagonize hormonal contraceptives.
Welireg Adverse Reactions
Adverse Reactions
Decreased hemoglobin, anemia, fatigue, increased creatinine, headache, dizziness, increased glucose, nausea; hypoxia, anaphylaxis reaction, retinal disorders.
Welireg Clinical Trials
See Literature
Welireg Note
Not Applicable
Welireg Patient Counseling
See Literature
Welireg Generic Name & Formulations
Legal Class
Rx
General Description
Belzutifan 40mg; tabs.
Pharmacological Class
Hypoxia-inducible factor inhibitor.
How Supplied
Tabs—90
Manufacturer
Generic Availability
NO
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
Swallow whole. Take at the same time each day. 120mg once daily until disease progression or unacceptable toxicity. Dose modifications for adverse reactions: see full labeling.
Children
Not established.
Welireg Contraindications
Not Applicable
Welireg Boxed Warnings
Boxed Warning
Embryo-fetal toxicity.
Welireg Warnings/Precautions
Warnings/Precautions
Monitor for anemia, oxygen saturation prior to initiation and periodically during therapy. Withhold for hemoglobin <9g/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 resolved; 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
See Literature
Welireg Interactions
Interactions
Potentiated by UGT2B17 or CYP2C19 inhibitors; monitor and reduce belzutifan dose. Antagonizes CYP3A4 substrates (esp. in dual UGT2B17/CYP2C19 poor metabolizers). Avoid concomitant sensitive CYP3A4 substrates; if unavoidable, increase the dose of these substrates. May antagonize hormonal contraceptives.
Welireg Adverse Reactions
Adverse Reactions
Decreased hemoglobin, anemia, fatigue, increased creatinine, headache, dizziness, increased glucose, nausea; hypoxia, anaphylaxis reaction, retinal disorders.
Welireg Clinical Trials
See Literature
Welireg Note
Not Applicable
Welireg Patient Counseling
See Literature
Welireg Generic Name & Formulations
Legal Class
Rx
General Description
Belzutifan 40mg; tabs.
Pharmacological Class
Hypoxia-inducible factor inhibitor.
How Supplied
Tabs—90
Manufacturer
Generic Availability
NO
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
Swallow whole. Take at the same time each day. 120mg once daily until disease progression or unacceptable toxicity. Dose modifications for adverse reactions: see full labeling.
Children
Not established.
Welireg Contraindications
Not Applicable
Welireg Boxed Warnings
Boxed Warning
Embryo-fetal toxicity.
Welireg Warnings/Precautions
Warnings/Precautions
Monitor for anemia, oxygen saturation prior to initiation and periodically during therapy. Withhold for hemoglobin <9g/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 resolved; 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
See Literature
Welireg Interactions
Interactions
Potentiated by UGT2B17 or CYP2C19 inhibitors; monitor and reduce belzutifan dose. Antagonizes CYP3A4 substrates (esp. in dual UGT2B17/CYP2C19 poor metabolizers). Avoid concomitant sensitive CYP3A4 substrates; if unavoidable, increase the dose of these substrates. May antagonize hormonal contraceptives.
Welireg Adverse Reactions
Adverse Reactions
Decreased hemoglobin, anemia, fatigue, increased creatinine, headache, dizziness, increased glucose, nausea; hypoxia, anaphylaxis reaction, retinal disorders.
Welireg Clinical Trials
See Literature
Welireg Note
Not Applicable
Welireg Patient Counseling
See Literature