Welireg

— THERAPEUTIC CATEGORIES —
  • Bladder, kidney, and other urologic cancers
  • CNS cancers
  • Pancreatic, thyroid, and other endocrine cancers

Welireg Generic Name & Formulations

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

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

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