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WELIREG is a brand name for Belzutifan. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 1 INDICATIONS AND USAGE WELIREG is a hypoxia-inducible factor inhibitor indicated: von Hippel-Lindau (VHL) disease 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…
Verbatim from this product's FDA label. Tap a section to expand.
2 DOSAGE AND ADMINISTRATION The recommended dosage of WELIREG in adult patients is 120 mg administered orally once daily with or without food. 1 Recommended Dosage The recommended dosage of WELIREG in adult patients is 120 mg administered orally once daily.
The recommended dosage of WELIREG in pediatric patients 12 years and older is based on bodyweight: Patients weighing ≥ 40 kg: 120 mg orally once daily Patients weighing < 40 kg: 80 mg orally once daily Continue WELIREG 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. 2 Dosage Modifications for Adverse Reactions Dosage modifications for WELIREG for adverse reactions are summarized in Table 1 .
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. , pulse oximeter <88%) Consider withholding until resolved. Resume at the same dose or at a reduced dose depending on the severity of hypoxia. , pulse oximeter <88% or PaO 2 ≤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.
2) ] VHL disease : Most common (≥25%) adverse reactions, including laboratory abnormalities, were decreased hemoglobin, fatigue, increased creatinine, headache, dizziness, increased glucose, and nausea. 1 ) Advanced RCC : Most common (≥25%) adverse reactions, including laboratory abnormalities were decreased hemoglobin, fatigue, musculoskeletal pain, increased creatinine, decreased lymphocytes, increased alanine aminotransferase, decreased sodium, increased potassium, and increased aspartate aminotransferase.
1 ) PPGL : Most common (≥25%) adverse reactions, including laboratory abnormalities were anemia, fatigue, musculoskeletal pain, decreased lymphocytes, increased alanine aminotransferase, increased aspartate aminotransferase, increased calcium, dyspnea, increased potassium, decreased leukocytes, headache, increased alkaline phosphatase, dizziness, and nausea.
gov/medwatch . 1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
1) ] . Patients received WELIREG 120 mg orally once daily until disease progression or unacceptable toxicity. 7 weeks). Serious adverse reactions occurred in 15% of patients who received WELIREG, including anemia, hypoxia, anaphylaxis reaction, retinal detachment, and central retinal vein occlusion (1 patient each).
3% of patients. 6% each). Dosage interruptions of WELIREG due to an adverse reaction occurred in 39% of patients. Adverse reactions which required dosage interruption in >2% of patients were fatigue, decreased hemoglobin, anemia, nausea, abdominal pain, headache, and influenza-like illness.
Dose reductions of WELIREG due to an adverse reaction occurred in 13% of patients. The most frequently reported adverse reaction which required dose reduction was fatigue (7%). The most common (≥25%) adverse reactions, including laboratory abnormalities, that occurred in patients who received WELIREG were decreased hemoglobin, fatigue, increased creatinine, headache, dizziness, increased glucose, and nausea.
5 WARNINGS AND PRECAUTIONS Anemia : Monitor for anemia before initiation of and periodically throughout treatment with WELIREG. Withhold WELIREG until hemoglobin ≥8g/dL, then resume at the same or reduced dose or discontinue. For life threatening anemia, or for anemia requiring urgent intervention, withhold WELIREG until hemoglobin ≥8g/dL and resume at a reduced dose or permanently discontinue WELIREG.
1 ) 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.
1 Anemia WELIREG can cause severe anemia that can require blood transfusion. Monitor for anemia before initiation of, and periodically throughout, treatment with WELIREG. Transfuse patients as clinically indicated. For patients with hemoglobin <8g/dL, withhold WELIREG until ≥8g/dL, then resume at the same or reduced dose or permanently discontinue WELIREG, depending on the severity of anemia.
2) ] . 1) ] . 4 months). The safety of erythropoiesis stimulating agents (ESAs) for treatment of anemia in patients with VHL disease treated with WELIREG has not been established. Randomized controlled trials in patients with cancer receiving myelosuppressive chemotherapy with ESAs have shown that ESAs increased the risks of death and serious cardiovascular reactions, and decreased progression-free survival and/or overall survival.
See the prescribing information for ESAs for more information. 1) ] . 6 months). Of the patients with anemia, 22% received transfusions only, 20% of patients received ESAs only and 12% received both transfusion and ESAs. 1) ] . 1 months).
Of the patients with anemia, 20% received transfusions only, 26% received ESAs only, and 6% received both transfusion and ESAs. 2) ]. Monitor oxygen saturation before initiation of, and periodically throughout, treatment with WELIREG.
4 CONTRAINDICATIONS None. None. ( 4 )
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Table 2 summarizes the adverse reactions reported in patients treated with WELIREG in LITESPARK-004. 6 Table 3 summarizes the laboratory abnormalities in LITESPARK-004.
Table 3:
Select Laboratory Abnormalities (≥10%) That Worsened from Baseline in Patients Who Received WELIREG in LITESPARK-004 Laboratory Abnormality The denominator used to calculate the rate is based on all patients in the safety analysis population.
2) ] . Patients received 120 mg WELIREG (n=372) or 10 mg everolimus (n=360) orally once daily until disease progression or unacceptable toxicity. 5 months). Serious adverse reactions occurred in 38% of patients who received WELIREG. 2%).
5%). Permanent discontinuation of WELIREG due to adverse reactions occurred in 6% of patients. 5%). Dosage interruptions of WELIREG due to an adverse reaction occurred in 39% of patients. 2%). Dose reductions of WELIREG due to an adverse reaction occurred in 13% of patients.
2%). The most common (≥25%) adverse reactions, including laboratory abnormalities, that occurred in patients who received WELIREG were decreased hemoglobin, fatigue, musculoskeletal pain, increased creatinine, decreased lymphocytes, increased alanine aminotransferase, decreased sodium, increased potassium, and increased aspartate aminotransferase.
Table 4 summarizes the adverse reactions in LITESPARK-005. 3%)] (6%) and increased weight (5%). Table 5 summarizes the laboratory abnormalities in LITESPARK-005.
Table 5:
Select Laboratory Abnormalities (≥20%) That Worsened from Baseline In Patients with Advanced RCC who Received WELIREG in LITESPARK-005 Laboratory Test Each test incidence is based on the number of patients who had both baseline and at least one on-study laboratory measurement available WELIREG (range: 359 to 366 patients), and everolimus (range: 351 to 356 patients).
3) ] . Patients received WELIREG 120 mg orally once daily until disease progression or unacceptable toxicity. 5 months). Serious adverse reactions occurred in 36% of patients who received WELIREG. 8% each). 8%). 4% each). Dosage interruptions of WELIREG due to an adverse reaction occurred in 40% of patients.
2% each). Dose reductions of WELIREG due to an adverse reaction occurred in 14% of patients. 2%). The most common (≥25%) adverse reactions, including laboratory abnormalities, that occurred in patients who received WELIREG were anemia, fatigue, musculoskeletal pain, decreased lymphocytes, increased alanine aminotransferase, increased aspartate aminotransferase, increased calcium, dyspnea, increased potassium, decreased leukocytes, headache, increased alkaline phosphatase, dizziness, and nausea.
Table 6 summarizes the adverse reactions reported in patients treated with WELIREG in LITESPARK-015. 8 Palpitations 10 0 Table 7 summarizes the laboratory abnormalities in LITESPARK-015. 4 Decreased sodium 21 0
, pulse oximeter <88% or P a O 2 ≤55 mm Hg), consider withholding WELIREG until pulse oximetry with exercise is greater than 88%, then resume at the same dose or at a reduced dose. , pulse oximeter <88% or PaO2 ≤55 mm Hg) or urgent intervention indicated, withhold WELIREG until resolved and resume at a reduced dose or discontinue.
2) ] . Advise patients to report signs and symptoms of hypoxia immediately to a healthcare provider. 1) ] . 1) ] . Of the patients with hypoxia, 69% were treated with oxygen therapy. 1 months). 1) ] . 9 months). Of the patients with hypoxia, 67% were treated with oxygen therapy.
3 Embryo-Fetal Toxicity Based on findings in animals, WELIREG can cause fetal harm when administered to a pregnant woman. 2 times the human exposures (AUC) at the recommended dose of 120 mg daily. Advise pregnant women and females of reproductive potential of the potential risk to the fetus.
1) ]. 3) ] .