Welireg Drug Information
Generic name: BELZUTIFAN
Hypoxia-inducible Factor Inhibitor [EPC]
Uses of Welireg
Advanced Renal Cell Carcinoma (RCC)
WELIREG is indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC) with a clear cell component 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).
Pheochromocytoma or Paraganglioma (PPGL)
WELIREG is indicated for the treatment of adult and pediatric patients 12 years and older with locally advanced, unresectable, or metastatic pheochromocytoma or paraganglioma (PPGL).
Dosage & Administration of Welireg
| Anemia | Hemoglobin <8 g/dL or transfusion indicated |
|---|---|
| Life-threatening or urgent intervention indicated |
|
| Hypoxia | Decreased oxygen saturation with exercise (e.g., pulse oximeter <88%) |
| Decreased oxygen saturation at rest (e.g., pulse oximeter <88% or PaO2 ≤55 mm Hg) or urgent intervention indicated |
|
| Life-threatening or recurrent symptomatic hypoxia |
|
| Other Adverse Reactions | Grade 3 |
| Grade 4 |
|
Side Effects of Welireg
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. von Hippel-Lindau (VHL) disease LITESPARK-004 The safety of WELIREG was evaluated in an open-label clinical trial (LITESPARK-004) in 61 patients with VHL disease who had at least one measurable solid tumor localized to the kidney . Patients received WELIREG 120 mg orally once daily until disease progression or unacceptable toxicity. The median duration of exposure to WELIREG was 68 weeks (range: 8.4 to 104.7 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). Permanent discontinuation of WELIREG due to adverse reactions occurred in 3.3% of patients. Adverse reactions which resulted in permanent discontinuation of WELIREG were dizziness and opioid overdose (1.6% 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.
Table 2 summarizes the adverse reactions reported in patients treated with WELIREG in LITESPARK-004. Table 2: Adverse Reactions Occurring in ≥10% of Patients Who Received WELIREG in LITESPARK-004 Adverse Reaction WELIREG (n=61) All Grades Graded per NCI CTCAE v4.0 (%) Grade 3-4 (%) General Fatigue Includes other related terms 64 5 Nervous system Headache 39 0 Dizziness 38 0 Gastrointestinal Nausea 31 0 Constipation 13 0 Abdominal pain 13 0 Eye Disorders Visual impairment Includes visual impairment, vision blurred, central retinal vein occlusion and retinal detachment 21
Infections Upper respiratory tract infection 21 0 Respiratory, Thoracic and Mediastinal Dyspnea
20
Musculoskeletal and Connective Tissue Arthralgia 18 0 Myalgia 16 0 Vascular Hypertension
13
Metabolism and Nutrition Weight increased 12 1.6 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. WELIREG (n=61) Grades 1-4 % Grades 3-4 % Hematology Decreased hemoglobin 93 7 Decreased leukocytes 11 0 Chemistry Increased creatinine 64 0 Increased glucose 34
Increased
ALT 20 0 Increased AST 16 0 Decreased calcium (corrected) 10 0 Decreased phosphate 10
Advanced Renal Cell Carcinoma (RCC)
LITESPARK-005 The safety of WELIREG was evaluated in a randomized, active-controlled study (LITESPARK- 005) in 732 patients with advanced RCC with a clear cell component that has progressed after prior PD-1 or PD-L1 checkpoint inhibitor and VEGF receptor targeted therapies . Patients received 120 mg WELIREG (n=372) or 10 mg everolimus (n=360) orally once daily until disease progression or unacceptable toxicity. The median duration of exposure to WELIREG was 7.6 months (range 0.1 to 28.5 months). Serious adverse reactions occurred in 38% of patients who received WELIREG. Serious adverse reactions in ≥2% of patients treated with WELIREG were hypoxia (7%), anemia (5%), pneumonia (3.5%), hemorrhage (3%), and pleural effusion (2.2%). Fatal adverse reactions occurred in 3.2% of patients who received WELIREG, including sepsis (0.5%) and hemorrhage (0.5%). Permanent discontinuation of WELIREG due to adverse reactions occurred in 6% of patients. Adverse reactions which resulted in permanent discontinuation (≥0.5%) of WELIREG were hypoxia (1.1%), anemia (0.5%), and hemorrhage (0.5%). 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 anemia (8%), hypoxia (5%), COVID-19 (4.3%), fatigue (3.2%), and hemorrhage (2.2%). Dose reductions of WELIREG due to an adverse reaction occurred in 13% of patients. Adverse reactions which required dose reduction in ≥1% of patients were hypoxia (5%) and anemia (3.2%). 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. Table 4: Adverse Reactions (≥10%) in Patients with Advanced RCC Receiving WELIREG in LITESPARK-005 Adverse Reaction WELIREG (n=372) Everolimus (n=360) All Grades Graded per NCI CTCAE v5.0 (%) Grade 3-4 (%) All Grades (%) Grade 3-4 (%) General Fatigue Includes other related terms 43 3.2 41 6 Edema 20 0.5 23
Musculoskeletal and Connective Tissue Musculoskeletal Pain 34 1.1 27 2.2 Gastrointestinal Nausea
17 0.5 11
Constipation 15 0 8 0 Vomiting 11 0.8 8 0.8 Diarrhea 11
1.3 19
Abdominal Pain 10 0.8 8 0.3 Respiratory, Thoracic, and Mediastinal Dyspnea 16
1.6 16
Hypoxia 15 10 1.4 1.4 Metabolism and Nutrition Decreased Appetite 13 1.1
16 0 Nervous Systems Headache 12 0.5 8
Dizziness 11 0 1.9 0 Clinically relevant adverse reactions in <10% of
patients who received WELIREG in LITESPARK-005 included hemorrhage (9%), rash (8%), hypertension (6%), visual impairment (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). WELIREG Everolimus All Grades Graded per NCI CTCAE v5.0 % Grades 3-4 % All Grades % Grades 3-4 % Hematology Decreased hemoglobin 88 29 76 17 Decreased lymphocytes 34 8 53 20 Chemistry Increased creatinine 34 4.7 43
Increased potassium 29 2.5 20 2.8 Increased aspartate aminotransferase 27 2.2 38
2 Decreased glucose 22 1.1 19
Decreased calcium 21 1.1 45 3.1 Pheochromocytoma or Paraganglioma
LITESPARK-015 The safety of WELIREG was evaluated in an open-label clinical trial (LITESPARK-015) in 72 patients with locally advanced, unresectable, or metastatic pheochromocytoma or paraganglioma (PPGL) . Patients received WELIREG 120 mg orally once daily until disease progression or unacceptable toxicity. The median duration of exposure to WELIREG was 20 months (range: 0.3 to 32.5 months). Serious adverse reactions occurred in 36% of patients who received WELIREG. Serious adverse reactions occurring in ≥2% of patients treated with WELIREG were anemia and hypertension (4.2% each) and pyelonephritis, pneumonia, hypoxia, dyspnea and hemorrhage (2.8% each). Permanent discontinuation of WELIREG due to adverse reactions occurred in 2 patients (2.8%). Adverse reactions which resulted in permanent discontinuation of WELIREG were increased alanine aminotransferase and paraparesis (1.4% each). Dosage interruptions of WELIREG due to an adverse reaction occurred in 40% of patients. Adverse reactions which required dosage interruption in >3% of patients were hypoxia, nausea and fatigue (4.2% each). Dose reductions of WELIREG due to an adverse reaction occurred in 14% of patients.
The most frequently reported adverse reaction which required dose reduction was hypoxia (4.2%). 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. Table 6: Adverse Reactions Occurring in ≥10% of Patients with PPGL Who Received WELIREG in LITESPARK-015 Adverse Reaction WELIREG (n=72) All Grades Graded per NCI CTCAE v5.0 (%) Grade 3-4 (%) Blood and Lymphatic Anemia 96 22 General Fatigue Includes other related terms 56 10 Edema 24 0 Musculoskeletal and Connective Tissue Musculoskeletal pain 56 6 Muscle spasms 13 0 Muscle weakness 13
Respiratory, Thoracic, and Mediastinal Dyspnea 33 1.4 Cough 15 0 Hypoxia 13
10 Nasal congestion 10 0 Nervous System Headache 29
Dizziness 26 2.8 Peripheral neuropathy 13 0 Gastrointestinal Nausea 25 1.4 Constipation
24
Diarrhea 15 0 Abdominal Pain 13 1.4 Vomiting 10 1.4 Vascular Disorders
Hypertension 21 13 Hypotension 10
Hemorrhage 10 2.8 Infections
COVID-19 17
Metabolism and Nutrition Disorders Decreased appetite 14 2.8 Investigations Weight increased 13
7 Cardiac Disorders Arrhythmia 11
Palpitations 10 0 Table 7 summarizes the laboratory abnormalities in
LITESPARK-015. Table 7: Select Laboratory Abnormalities (≥20%) That Worsened from Baseline in Patients with PPGL Who Received WELIREG in LITESPARK-015 Laboratory Abnormality WELIREG (n=72) All Grades % Grades 3 or 4 % Hematology Decreased hemoglobin 90 21 Decreased lymphocytes 54 14 Decreased leukocytes 30 0 Decreased neutrophils 24
Decreased platelets 21 1.4 Chemistry Increased
ALT 51
Increased
AST 42
Increased calcium 34 0 Increased potassium 31 2.8 Increased alkaline phosphatase 25
0 Increased creatinine 24
Warnings & Cautions for Welireg
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.
For life threatening anemia or when urgent intervention is indicated, withhold WELIREG until hemoglobin ≥8g/dL, then resume at a reduced dose or permanently discontinue WELIREG . von Hippel-Lindau (VHL) disease In LITESPARK-004, decreased hemoglobin occurred in 93% of patients and 7% had Grade 3 events . Median time to onset of anemia was 31 days (range: 1 day to 8.4 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.
Advanced Renal Cell Carcinoma (RCC) In LITESPARK-005, decreased hemoglobin occurred in 88% of patients and 29% had Grade 3 events . Median time to onset of anemia was 29 days (range: 1 day to 16.6 months). Of the patients with anemia, 22% received transfusions only, 20% of patients received ESAs only and 12% received both transfusion and ESAs. Pheochromocytoma or Paraganglioma (PPGL) In LITESPARK-015, anemia occurred in 96% of patients and 22% had Grade 3 events . Median time to onset of anemia was 29 days (range: 1 day to 22.1 months). Of the patients with anemia, 20% received transfusions only, 26% received ESAs only, and 6% received both transfusion and ESAs.
Hypoxia
WELIREG can cause severe hypoxia that may require discontinuation, supplemental oxygen, or hospitalization. Monitor oxygen saturation before initiation of, and periodically throughout, treatment with WELIREG. For decreased oxygen saturation with exercise (e.g., 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. For decreased oxygen saturation at rest (e.g., pulse oximeter <88% or PaO2 ≤55 mm Hg) or urgent intervention indicated, withhold WELIREG until resolved and resume at a reduced dose or discontinue.
For life-threatening hypoxia or for recurrent symptomatic hypoxia, permanently discontinue WELIREG . Advise patients to report signs and symptoms of hypoxia immediately to a healthcare provider. von Hippel-Lindau (VHL) disease In LITESPARK- 004, hypoxia occurred in 1.6% of patients . Advanced Renal Cell Carcinoma (RCC) In LITESPARK- 005, hypoxia occurred in 15% of patients and 10% had Grade 3 events . Of the patients with hypoxia, 69% were treated with oxygen therapy. Median time to onset of hypoxia was 30.5 days (range: 1 day to 21.1 months). Pheochromocytoma or Paraganglioma (PPGL) In LITESPARK-015, hypoxia occurred in 13% of patients and 10% had Grade 3 hypoxia . Median time to onset of hypoxia was 35 days (range: 6 days to 23.9 months). Of the patients with hypoxia, 67% were treated with oxygen therapy.
Embryo-Fetal Toxicity
Based on findings in animals, WELIREG can cause fetal harm when administered to a pregnant woman. In an animal reproduction study, oral administration of belzutifan to pregnant rats during the period of organogenesis caused embryo-fetal lethality, reduced fetal body weight, and fetal skeletal malformations at maternal exposures ≥0.2 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.
Advise females of reproductive potential to use effective non-hormonal contraception during treatment with WELIREG and for 1 week after the last dose, since WELIREG can render some hormonal contraceptives ineffective. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with WELIREG and for 1 week after the last dose .
Drug Interactions with Welireg
Effects of Other Drugs on
WELIREG UGT2B17 or CYP2C19 Inhibitors Monitor for anemia and hypoxia and reduce the dosage of WELIREG as recommended . Coadministration of WELIREG with inhibitors of UGT2B17 or CYP2C19 increases belzutifan exposure , which may increase the risk of adverse reactions of WELIREG.
Effect of
WELIREG on Other Drugs CYP3A4 Substrates Avoid coadministration of WELIREG with sensitive CYP3A4 substrates, for which minimal decrease in concentration may lead to therapeutic failures of the substrate. If coadministration cannot be avoided, increase the sensitive CYP3A4 substrate dosage in accordance with its Prescribing Information. Coadministration of WELIREG with CYP3A4 substrates decreases concentrations of CYP3A substrates , which may reduce the efficacy of these substrates.
The magnitude of this decrease may be more pronounced in patients who are dual UGT2B17 and CYP2C19 poor metabolizers. Hormonal Contraceptives Coadministration of WELIREG with hormonal contraceptives may lead to contraceptive failure or an increase in breakthrough bleeding .
Pregnancy Safety for Welireg
Pregnancy Risk Summary Based on findings in animal studies, WELIREG can cause fetal harm when administered to a pregnant woman. There are no available data on the use of WELIREG in pregnant women to inform the drug-associated risk. In an animal reproduction study, oral administration of belzutifan to pregnant rats during the period of organogenesis caused embryo-fetal lethality, reduced fetal body weight, and fetal skeletal malformations at maternal exposures ≥0.2 times the human exposure (AUC) at the recommended dose of 120 mg daily ( see Data ). Advise pregnant women and females of reproductive potential of the potential risk to a fetus.
The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2–4% and 15–20%, respectively. Data Animal Data In a pilot embryo-fetal development study, pregnant rats received oral doses of 6, 60, or 200 mg/kg/day of belzutifan during the period of organogenesis.
Belzutifan caused embryo-fetal lethality at doses ≥60 mg/kg/day (approximately 1 time the human exposure at the recommended dose based on AUC). Reduced fetal body weights, fetal rib malformations, and reduced skeletal ossification occurred at doses of 6 and 60 mg/kg/day (approximately ≥0.2 times the human exposure at the recommended dose based on AUC).
Pediatric Use of Welireg
Pediatric Use The safety and effectiveness of WELIREG have been established in pediatric patients aged 12 years and older for the treatment of locally advanced, unresectable, or metastatic pheochromocytoma or paraganglioma. Use of WELIREG in pediatric patients aged 12 years and older is supported by evidence from an adequate and well-controlled study of WELIREG in adults with additional pharmacokinetic data demonstrating that belzutifan exposure is predicted to be within range of that observed in adults, and that the course of locally advanced, unresectable, or metastatic pheochromocytoma or paraganglioma is sufficiently similar in adults and pediatric patients to allow extrapolation of data in adults to pediatric patients. The safety and effectiveness of WELIREG have not been established in pediatric patients younger than 12 years of age.
Overdosage Information for Welireg
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).
Clinical Studies of Welireg
Advanced Renal Cell Carcinoma (RCC)
The efficacy of WELIREG was evaluated in LITESPARK-005 (NCT04195750), an open-label, randomized, active-controlled clinical trial in 746 patients with unresectable, locally advanced or metastatic clear cell RCC that progressed following PD-1 or PD-L1 checkpoint inhibitor and VEGF receptor targeted therapies either in sequence or in combination. Patients could have received up to 3 prior treatment regimens and were required to have measurable disease per RECIST v1.1. Patients were randomized in a 1:1 ratio to receive 120 mg WELIREG or 10 mg everolimus orally once daily until disease progression or unacceptable toxicity. Randomization was stratified by IMDC risk categories (favorable versus intermediate versus poor) and number of prior VEGF receptor targeted therapies (1 versus 2-3). Patients were evaluated radiologically at Week 9 from the date of randomization, then every 8 weeks through Week 49, and every 12 weeks thereafter.
The study population characteristics were: median age 63 years, 42% age 65 or older; 78% male; 79% White; 12% Asian; 1% Black or African American; 11% Hispanic or Latino; 44% ECOG performance status 0 and 55% ECOG performance status 1. Prior therapies: 13% patients had 1 prior line of therapy, 43% had 2 prior lines of therapy and 43% had 3 prior lines of therapy; 49% received 2 to 3 prior VEGF receptor targeted therapies. Patient distribution by IMDC risk categories was 22% favorable, 66% intermediate, and 12% poor. Common sites of metastasis in patients were 65% lung, 59% lymph nodes, and 49% bone.
The major efficacy endpoints were Progression Free Survival (PFS) measured by BICR using RECIST v1.1 and Overall Survival (OS). Additional efficacy endpoint included objective response rate (ORR) by BICR using RECIST v1.1. The trial demonstrated a statistically significant improvement in PFS for patients randomized to WELIREG compared with everolimus. Table 10 and Figure 1 summarize the efficacy results for LITESPARK-005. Table 10: Efficacy Results for Advanced RCC (IRC assessment) for LITESPARK-005 Efficacy Outcome Measure WELIREG n=374 Everolimus n=372 NS – not statistically significant Progression-Free Survival (PFS) Number of events, n (%) 257 (69%) 262 (70%) Progressive disease 234 (63%) 222 (60%) Death 23 (6%) 40 (11%) Median in months (95% CI) From product-limit (Kaplan-Meier) method for censored data 5.6
Hazard ratio
Based on the stratified Cox proportional hazard model. (95% CI) 0.75 p-Value One-sided p-Value based on stratified log-rank test compared with the significance boundary of 0.0021. 0.0008 Overall Survival (OS) Number of events, n (%) 254 (68%) 259 (70%) Median in months (95% CI) 21 18 Hazard ratio (95% CI) 0.92 p-Value Based on stratified log-rank test. NS Confirmed Objective Response Rate Number of patients with measurable disease at baseline 373 364 ORR % (n) (95% CI) 22% 4% Complete response 3% 0% Partial response 19% 4% p-Value One-sided p-value based on stratified Miettinen and Nurminen (M&N) method. <0.0001 Among the 82 patients treated with WELIREG who achieved a confirmed response based on BICR per RECIST 1.1, 25 (30%) patients had a duration of response ≥12 months. Figure 1: Kaplan-Meier Curve for Progression-Free Survival in LITESPARK-005 Figure 1
Pheochromocytoma or Paraganglioma
The efficacy of WELIREG was evaluated in LITESPARK-015 (NCT04924075), an open-label, multi-cohort clinical trial in 72 patients in Cohort A1 who had measurable disease verified by BICR per RECIST v1.1, documented histopathological diagnosis of pheochromocytoma or paraganglioma (PPGL), locally advanced or metastatic disease that was not amenable to surgery or curative treatment, and adequately controlled blood pressure (defined as BP <150/90 mm Hg, <135/85 mm Hg for adolescents) with no change in antihypertensive medications for patients with concomitant hypertension for at least 2 weeks prior to start of study treatment. Patients with carcinomatous meningitis were excluded. Patients received WELIREG 120 mg orally once daily until disease progression or unacceptable toxicity.
The study population characteristics were: median age 52 years, 13% age 65 or older; 58% male; 93% White; 4.2% Black or African-American; 1.4% Asian; 6% Hispanic or Latino; 54% had an ECOG PS of 0 and 46% had an ECOG PS of 1. The median number of prior therapies was 1: (range: 0 to 5). A total of 50% of patients received prior chemotherapy, 44% received prior radiopharmaceuticals, and 25% received prior VEGF-TKIs. No patients had a history of VHL disease. The major efficacy outcome measure for the treatment of locally advanced PPGL was objective response rate (ORR) measured by BICR using RECIST v1.1. Additional efficacy outcome measures were duration of response (DOR), time to response (TTR), and the proportion of patients who had a reduction in at least one antihypertensive medication by at least 50% maintained for at least six months.
Table 11 summarizes the efficacy results for PPGL in LITESPARK-015. Table 11: Efficacy Results in Patients with PPGL in LITESPARK-015 Efficacy Outcome Measure WELIREG n=72 NR = not reached + = Denotes ongoing response. Data cut-off: October 23, 2024 Confirmed Objective Response Rate Based on BICR., All responses were partial responses. ORR, % (95% CI) 26% Duration of Response Median in months (95% CI) Based on Kaplan-Meier estimates. 20.4 (8.3, NR) Range 5.6+, 29.6+ % with duration ≥ 12 months 53% Reduction in at least one antihypertensive medication by at least 50% maintained for at least 6 months Number of patients 19 Proportion of patients (95% CI Calculated using the Clopper-Pearson method. ) Based on the number of patients who were on antihypertensive medications at baseline (N=60). 32% For PPGL, the median TTR was 11.0 months (range 1.7 to 24.8).
Drug information sourced from the FDA. This content is for informational purposes only and does not constitute medical advice. Consult a healthcare professional before making any medication decisions.
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