Dosage & Administration
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Jesduvroq Prescribing Information
JESDUVROQ increases the risk of arterial and venous thrombotic events, that may be fatal, including myocardial infarction, stroke, venous thromboembolism and vascular access thrombosis
A rate of hemoglobin rise of greater than 1 g/dL over 2 weeks may contribute to these risks. Targeting a hemoglobin level of greater than 11 g/dL is expected to further increase the risk of death and arterial and venous thrombotic events, as occurs with ESAs, which also increase erythropoietin levels.
No trial has identified a hemoglobin target level, dose of JESDUVROQ, or dosing strategy that does not increase these risks. Use the lowest dose of JESDUVROQ sufficient to reduce the need for red blood transfusions. Adherence to dosing and hemoglobin monitoring recommendations is important to avoid excessive erythropoiesis
Advise patients to seek immediate medical attention if they develop signs or symptoms of myocardial infarction, stroke, venous thromboembolism, or thrombosis of vascular access. Evaluate and manage promptly if these occur.
JESDUVROQ increases the risk of arterial and venous thrombotic events, that may be fatal, including myocardial infarction, stroke, venous thromboembolism and vascular access thrombosis
A rate of hemoglobin rise of greater than 1 g/dL over 2 weeks may contribute to these risks. Targeting a hemoglobin level of greater than 11 g/dL is expected to further increase the risk of death and arterial and venous thrombotic events, as occurs with ESAs, which also increase erythropoietin levels.
No trial has identified a hemoglobin target level, dose of JESDUVROQ, or dosing strategy that does not increase these risks. Use the lowest dose of JESDUVROQ sufficient to reduce the need for red blood transfusions. Adherence to dosing and hemoglobin monitoring recommendations is important to avoid excessive erythropoiesis
Advise patients to seek immediate medical attention if they develop signs or symptoms of myocardial infarction, stroke, venous thromboembolism, or thrombosis of vascular access. Evaluate and manage promptly if these occur.
Following initiation of therapy and after each dose adjustment, monitor hemoglobin every 2 weeks for the first month and then every 4 weeks thereafter.
When adjusting doses of JESDUVROQ, consider hemoglobin rate of rise, rate of decline and hemoglobin variability. Do not increase the dose of JESDUVROQ more frequently than once every 4 weeks.
• If the dose of JESDUVROQ needs to be adjusted, increase or decrease by one dose level at a time (see Table 3).• Decrease the dose of JESDUVROQ if hemoglobin increases rapidly (e.g., greater than 1 g/dL over 2 weeks or greater than 2 g/dL over 4 weeks) or if the hemoglobin exceeds 11 g/dL.• If hemoglobin exceeds 12 g/dL,interrupt treatment with JESDUVROQ. When the hemoglobin is within the target range, treatment may be restarted at one dose level lower (see Table 3).• Treatment with JESDUVROQ should not be continued beyond 24 weeks of therapy if a clinically meaningful increase in hemoglobin level is not achieved. Alternative explanations for an inadequate response should be sought and treated before re-starting therapy.
Daily dose of JESDUVROQ | 1 mg | 2 mg | 4 mg | 6 mg | 8 mg | 12 mg | 16 mg | 24 mga |
a24 mg is the maximum recommended once daily dose.
Following initiation of therapy and after each dose adjustment, monitor hemoglobin every 2 weeks for the first month and then every 4 weeks thereafter.
When adjusting doses of JESDUVROQ, consider hemoglobin rate of rise, rate of decline and hemoglobin variability. Do not increase the dose of JESDUVROQ more frequently than once every 4 weeks.
• If the dose of JESDUVROQ needs to be adjusted, increase or decrease by one dose level at a time (see Table 3).• Decrease the dose of JESDUVROQ if hemoglobin increases rapidly (e.g., greater than 1 g/dL over 2 weeks or greater than 2 g/dL over 4 weeks) or if the hemoglobin exceeds 11 g/dL.• If hemoglobin exceeds 12 g/dL,interrupt treatment with JESDUVROQ. When the hemoglobin is within the target range, treatment may be restarted at one dose level lower (see Table 3).• Treatment with JESDUVROQ should not be continued beyond 24 weeks of therapy if a clinically meaningful increase in hemoglobin level is not achieved. Alternative explanations for an inadequate response should be sought and treated before re-starting therapy.
Daily dose of JESDUVROQ | 1 mg | 2 mg | 4 mg | 6 mg | 8 mg | 12 mg | 16 mg | 24 mga |
a24 mg is the maximum recommended once daily dose.
JESDUVROQ is indicated for the treatment of anemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis for at least four months.
JESDUVROQ has not been shown to improve quality of life, fatigue, or patient well-being.
JESDUVROQ is not indicated for use:
• As a substitute for red blood cell transfusions in patients who require immediate correction of anemia.• For treatment of anemia of chronic kidney disease in patients who are not on dialysis.
• Administer orally once daily, with or without food. (,2.2 Important Dosing InformationIndividualize dosing and use the lowest dose of JESDUVROQ sufficient to reduce the need for red blood cell transfusions. Do not target a hemoglobin higher than 11 g/dL.
JESDUVROQ can be taken with or without food, and without regard to concomitant administration of iron or phosphate binders
[see Clinical Pharmacology ].JESDUVROQ should be swallowed whole. Tablets should not be cut, crushed, or chewed.
JESDUVROQ can be administered without regard to the timing or type of dialysis
[see Clinical Pharmacology ].If a dose of JESDUVROQ is missed, it should be taken as soon as possible, unless it is the same day as the next dose. In this case, the missed dose should be skipped, and the next dose taken at the usual time. Double-doses should not be taken to make-up for a missed dose.
)2.3 Recommended Starting Dose of JESDUVROQAdults with Anemia Due to Chronic Kidney Disease Receiving Dialysis for at Least 4 MonthsAdults Not Being Treated with an ESA:For adults not being treated with an ESA, the starting dose of JESDUVROQ is based on the hemoglobin level (see Table 1). Dose modifications are needed for patients receiving concomitant treatment with a moderate CYP2C8 inhibitor or moderate hepatic impairment[see Dosage and Administration , Drug Interactions , Use in Specific Populations , Clinical Pharmacology ].Table 1: Starting Dose of JESDUVROQ for Adults on Dialysis not Receiving an Erythropoiesis-Stimulating Agent Pre-Treatment Hemoglobin Level (g/dL)Starting Dose of JESDUVROQ(Once Daily Dosing)a<9
4 mg
≥9 to ≤10
2 mg
>10
1 mg
aSee dosing modifications in Section 2.5 if the patient has moderate hepatic impairment and Section 2.6 if the patient is on a moderate CYP2C8 inhibitor.
Adults Being Switched from an ESA:For adults being switched from an ESA to JESDUVROQ, the starting dose of JESDUVROQ is based on the dose regimen of the ESA at the time of substitution (see Table 2). Dose modifications are needed for patients receiving concomitant treatment with a moderate CYP2C8 inhibitor or moderate hepatic impairment[see Dosage and Administration , Drug Interactions , Use in Specific Populations , Clinical Pharmacology ].Table 2: Starting Dose of JESDUVROQ for Adults on Dialysis Switching from an Erythropoiesis-Stimulating Agent Current Dose of ESADose of JESDUVROQaEpoetin AlfabIntravenous(units/week)Darbepoetin AlfaSubcutaneous/Intravenous(mcg/4 weeks)Methoxy PEG-Epoetin BetaSubcutaneous/Intravenous(mcg/month)Once DailyDosingLess than or equal to 2,000
20 to 30
30 to 40
4 mg
Greater than 2,000 to less than 10,000
Greater than
30 to 150
Greater than
40 to 180
6 mg
Greater than or equal to 10,000 to less than 20,000
Greater than
150 to 300
Greater than
180 to 360
8 mg
Greater than or equal to 20,000
Greater than 300
Greater than 360
12 mg
ESA = Erythropoiesis stimulating agent.
aSee dosing modifications in Section 2.5 if the patient has moderate hepatic impairment and Section 2.6 if the patient is on a moderate CYP2C8 inhibitor. bFor patients on subcutaneous epoetin alfa, convert the epoetin alfa subcutaneous dose to intravenous dose equivalent by multiplying the subcutaneous dose received per week by 1.42 to obtain the weekly intravenous dose.
• See Full Prescribing Information for starting dosage based on hemoglobin level, liver function and concomitant medications, and for dose titration and monitoring recommendations. (,2.3 Recommended Starting Dose of JESDUVROQAdults with Anemia Due to Chronic Kidney Disease Receiving Dialysis for at Least 4 MonthsAdults Not Being Treated with an ESA:For adults not being treated with an ESA, the starting dose of JESDUVROQ is based on the hemoglobin level (see Table 1). Dose modifications are needed for patients receiving concomitant treatment with a moderate CYP2C8 inhibitor or moderate hepatic impairment[see Dosage and Administration , Drug Interactions , Use in Specific Populations , Clinical Pharmacology ].Table 1: Starting Dose of JESDUVROQ for Adults on Dialysis not Receiving an Erythropoiesis-Stimulating Agent Pre-Treatment Hemoglobin Level (g/dL)Starting Dose of JESDUVROQ(Once Daily Dosing)a<9
4 mg
≥9 to ≤10
2 mg
>10
1 mg
aSee dosing modifications in Section 2.5 if the patient has moderate hepatic impairment and Section 2.6 if the patient is on a moderate CYP2C8 inhibitor.
Adults Being Switched from an ESA:For adults being switched from an ESA to JESDUVROQ, the starting dose of JESDUVROQ is based on the dose regimen of the ESA at the time of substitution (see Table 2). Dose modifications are needed for patients receiving concomitant treatment with a moderate CYP2C8 inhibitor or moderate hepatic impairment[see Dosage and Administration , Drug Interactions , Use in Specific Populations , Clinical Pharmacology ].Table 2: Starting Dose of JESDUVROQ for Adults on Dialysis Switching from an Erythropoiesis-Stimulating Agent Current Dose of ESADose of JESDUVROQaEpoetin AlfabIntravenous(units/week)Darbepoetin AlfaSubcutaneous/Intravenous(mcg/4 weeks)Methoxy PEG-Epoetin BetaSubcutaneous/Intravenous(mcg/month)Once DailyDosingLess than or equal to 2,000
20 to 30
30 to 40
4 mg
Greater than 2,000 to less than 10,000
Greater than
30 to 150
Greater than
40 to 180
6 mg
Greater than or equal to 10,000 to less than 20,000
Greater than
150 to 300
Greater than
180 to 360
8 mg
Greater than or equal to 20,000
Greater than 300
Greater than 360
12 mg
ESA = Erythropoiesis stimulating agent.
aSee dosing modifications in Section 2.5 if the patient has moderate hepatic impairment and Section 2.6 if the patient is on a moderate CYP2C8 inhibitor. bFor patients on subcutaneous epoetin alfa, convert the epoetin alfa subcutaneous dose to intravenous dose equivalent by multiplying the subcutaneous dose received per week by 1.42 to obtain the weekly intravenous dose.
,2.4 Monitoring Response to Therapy and Dose AdjustmentFollowing initiation of therapy and after each dose adjustment, monitor hemoglobin every 2 weeks for the first month and then every 4 weeks thereafter.
When adjusting doses of JESDUVROQ, consider hemoglobin rate of rise, rate of decline and hemoglobin variability. Do not increase the dose of JESDUVROQ more frequently than once every 4 weeks.
• If the dose of JESDUVROQ needs to be adjusted, increase or decrease by one dose level at a time (see Table 3).• Decrease the dose of JESDUVROQ if hemoglobin increases rapidly (e.g., greater than 1 g/dL over 2 weeks or greater than 2 g/dL over 4 weeks) or if the hemoglobin exceeds 11 g/dL.• If hemoglobin exceeds 12 g/dL,interrupt treatment with JESDUVROQ. When the hemoglobin is within the target range, treatment may be restarted at one dose level lower (see Table 3).• Treatment with JESDUVROQ should not be continued beyond 24 weeks of therapy if a clinically meaningful increase in hemoglobin level is not achieved. Alternative explanations for an inadequate response should be sought and treated before re-starting therapy.
Table 3: Dose Levels of JESDUVROQ Daily dose of JESDUVROQ
1 mg
2 mg
4 mg
6 mg
8 mg
12 mg
16 mg
24 mga
a24 mg is the maximum recommended once daily dose.
,2.5 Dosage Modification for Hepatic ImpairmentReduce the starting dose of JESDUVROQ by half (see Table 1and Table 2) in patients with moderate hepatic impairment (Child-Pugh Class B) except in patients whose starting dose is already 1 mg.
Use of JESDUVROQ in patients with severe hepatic impairment (Child-Pugh Class C) is not recommended
[see Use in Specific Populations , Clinical Pharmacology ].)2.6 Dosage Modification for Concomitant Treatment with Moderate CYP2C8 InhibitorsReduce the starting dose of JESDUVROQ by half (see Table 1and Table 2) in patients who are on clopidogrel or a moderate CYP2C8 inhibitor except in patients whose starting dose is already 1 mg
[see Drug Interactions , Clinical Pharmacology ].Monitor hemoglobin and adjust the dose of JESDUVROQ when initiating or stopping therapy with clopidogrel or a moderate CYP2C8 inhibitor during treatment with JESDUVROQ.
Tablets:
• 1 mg, gray, biconvex, round film-coated tablets debossed with “GS KF” on one face.• 2 mg, yellow, biconvex, round film-coated tablets debossed with “GS V7” on one face.• 4 mg, white, biconvex, round film-coated tablets debossed with “GS 13” on one face.• 6 mg, pink, biconvex, round film-coated tablets debossed with “GS IM” on one face.• 8 mg, orange, biconvex, round film-coated tablets debossed with “GS 5E” on one face.
• Pregnancy: May cause fetal harm. ()8.1 PregnancyRisk SummaryAvailable data with JESDUVROQ use in pregnant women are insufficient to establish a drug associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. There are risks to the mother and the fetus associated with CKD (
see Clinical Considerations).Daprodustat administered orally to pregnant rats and rabbits during the period of organogenesis was associated with adverse fetal outcomes, including embryonic and fetal loss and reduced fetal weight, at doses that caused maternal toxicity and polycythemia (see Data).Advise pregnant women of the potential risk to the fetus.The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Clinical ConsiderationsDisease-Associated Maternal and/or Embryo/Fetal Risk: CKD in pregnancy increases the risk for maternal hypertension, preeclampsia, miscarriage, stillbirth, preterm delivery, low birth weight infants, and polyhydramnios.
DataAnimal Data: Daprodustat was orally administered to pregnant rats at 0.5, 7, or 60 mg/kg/day from gestation day 6 to gestation day 17 during the period of organogenesis. No adverse effects were observed at doses less than or equal to 7 mg/kg/day (3 times the maximum recommended human dose [MRHD] based on body surface area). Daprodustat administration resulted in post-implantation loss, increased embryofetal death, and reduction in skeletal ossification in rats at a dose of 60 mg/kg/day (24 times the MRHD based on body surface area), which was associated with maternal toxicity (reduced body weight gain or weight loss). Maternal toxicity occurred at doses associated with polycythemia.Daprodustat was orally administered to pregnant rabbits at doses of 4, 30, or 60 mg/kg/day from gestation day 7 until gestation day 19 during the period of organogenesis. No adverse effects were observed at doses less than or equal to 30 mg/kg/day (24 times the MRHD based on body surface area). Daprodustat administration was associated with a low incidence of abortions and fetal skeletal malformations (irregularly shaped anterior fontanelle, manubrium, fused sternal centra, and microphthalmia) at a dose of 60 mg/kg/day (49 times the MRHD based on body surface area) in the presence of maternal toxicity (reduced body weight gain or weight loss) and polycythemia.
In a pre- and postnatal development study, pregnant rats were dosed orally with daprodustat from implantation until weaning (gestation day 6 to lactation day 21) at 0.8, 7, or 40 mg/kg/day concomitantly with 3 major human metabolites of daprodustat. No adverse effects were observed at doses less than or equal to 7 mg/kg/day (3 times the MRHD based on body surface area). Maternal toxicity (in the presence of polycythemia) was noted at 40 mg/kg/day (16 times the MRHD based on body surface area), which was associated with increased pup deaths and decreased pup weights.
• Lactation: Breastfeeding not recommended until one week after the final dose. ()8.2 LactationRisk SummaryThere are no data on the presence of daprodustat in human milk, the effects on the breastfed child, or the effects on milk production. Daprodustat is present in the milk of lactating rats
(see Data). When a drug is present in animal milk, it is likely that the drug will be present in human milk. Given the serious adverse reactions seen in adults treated with JESDUVROQ, such as thrombotic vascular events, advise patients not to breastfeed during treatment with JESDUVROQ, and for one week after the final dose.DataIn a pre- and postnatal development study in rats, when daprodustat was orally administered to maternal rats during the lactation period, the drug was detected in plasma of suckling pups on postnatal day 10. The plasma concentration of daprodustat in pups was 2.3% to 3.7% of daprodustat detected in the plasma of dams when dosed at 40 mg/kg/day.
• Hepatic Impairment: Reduce the starting dose in patients with moderate hepatic impairment (Child-Pugh Class B). JESDUVROQ not recommended in severe hepatic impairment (Child-Pugh Class C). ()8.6 Hepatic ImpairmentNo adjustment of the starting dose is required in patients with mild hepatic impairment (Child-Pugh Class A).
Reduce the starting dose of JESDUVROQ by half in patients with moderate hepatic impairment (Child-Pugh Class B) except in patients whose starting dose is already 1 mg
[see Clinical Pharmacology ].JESDUVROQ has not been studied in patients with severe hepatic impairment (Child-Pugh Class C). Therefore, JESDUVROQ is not recommended in patients with severe hepatic impairment.
JESDUVROQ is contraindicated in patients:
• Receiving a strong CYP2C8 inhibitor such as gemfibrozil[see Drug Interactions (.), Clinical Pharmacology (7.1 CYP2C8 InhibitorsConcomitant administration of strong CYP2C8 inhibitors (e.g., gemfibrozil) with JESDUVROQ is contraindicated due to a marked increase in daprodustat exposure
[see Contraindications , Clinical Pharmacology ]. Concomitant administration of moderate CYP2C8 inhibitors (e.g., clopidogrel) increases daprodustat exposure[see Clinical Pharmacology ]. Reduce the starting dose of JESDUVROQ by half when initiating treatment in patients on clopidogrel or a moderate CYP2C8 inhibitor except in patients whose starting dose is already 1 mg. Monitor hemoglobin and adjust the dose of JESDUVROQ when initiating or stopping therapy with clopidogrel or a moderate CYP2C8 inhibitor during treatment with JESDUVROQ[see Dosage and Administration ].)]12.3 PharmacokineticsDaprodustat exposure generally increases in a dose-proportional manner over the range of approved doses. Steady-state concentrations are achieved within 24-hours of dosing.
AbsorptionFollowing oral administration, daprodustat is readily absorbed with median time to peak concentration (Tmax) in healthy subjects ranging from 1 hour to 4 hours. The absolute bioavailability of daprodustat is 65%. Administration of JESDUVROQ with a high fat/high calorie meal did not significantly alter daprodustat exposure compared to administration in the fasted state.
DistributionDaprodustat has an approximately equal distribution between plasma and blood cells (blood:plasma ratio of 1.23). Following intravenous dosing, the volume of distribution at steady-state in healthy subjects is 14.3 L. In vitro, plasma protein binding of daprodustat is >99%.
EliminationThe terminal elimination half-life of daprodustat is approximately 1 hour to 4 hours.
Metabolism:In vitro, daprodustat is primarily metabolized by CYP2C8 (95% contribution), with a minor contribution by CYP3A4 (5%).Following oral or intravenous administration of radiolabeled daprodustat to healthy adults, approximately 40% of the total circulating radioactivity in plasma was daprodustat, and the remaining 60% was metabolites.
In patients treated with JESDUVROQ, the parent drug is the principal circulating component in plasma. Three metabolites, each accounting for more than 10% of circulating drug-related material, have been identified; in vitro and non-clinical data suggest that each may contribute to the pharmacologic response in vivo; however, the extent of this contribution is unknown.
Excretion:Mean clearance from plasma was 18.9 L/h, which correlates to blood clearance of 15 L/h and equates to a hepatic extraction of approximately 18%.Within seven days of an oral dose of radiolabeled daprodustat, 74% of the radioactivity was recovered in the feces, and 21% in the urine. Approximately 99.5% of the dose was excreted as oxidative metabolites, with the rest accounted for by daprodustat.
Specific PopulationsElderly:Population pharmacokinetic analyses in adults with CKD (22 years to 93 years) showed that age did not influence the pharmacokinetics of daprodustat.Renal Impairment:The steady-state exposure of daprodustat is similar in patients with normal renal function and those with varying degrees of renal impairment; daprodustat exposure is not significantly impacted by hemodialysis or peritoneal dialysis. The systemic exposure of daprodustat metabolites was higher in patients with Stage 3 to 5 CKD compared to those with normal renal function. Exposures of metabolites were higher on non-dialysis days compared to dialysis days.Hepatic Impairment:Following administration of a single JESDUVROQ 6 mg dose, mean daprodustat Cmaxand AUC increased by 2-fold and unbound exposure increased by 2.3-fold in subjects with moderate hepatic impairment (Child‑Pugh Class B) compared to subjects with normal hepatic and renal function. For those with mild hepatic impairment (Child‑Pugh Class A), mean daprodustat Cmaxwas similar while AUC increased by 1.5-fold and unbound Cmaxand AUC increased by 1.6 and 2.2-fold, respectively, compared to subjects with normal hepatic and renal function. The effect of severe hepatic impairment (Child‑Pugh Class C) on the pharmacokinetics of daprodustat is unknown as there have been no studies of JESDUVROQ in patients with severe hepatic impairment.Drug Interaction StudiesClinical Studies: Effect of CYP2C8 Inhibitors on the Pharmacokinetics of Daprodustat:The concomitant administration of gemfibrozil 600 mg twice a day for 5 days (strong CYP2C8 inhibitor) with a single 100 mg dose of JESDUVROQ on Day 4 of gemfibrozil administration resulted in an 18.6‑fold increase in AUC(0-∞)and a 3.9-fold increase in Cmaxof daprodustat[see Contraindications ].The concomitant administration of trimethoprim 200 mg twice a day for 5 days (CYP2C8 weak inhibitor) and 25 mg single dose of JESDUVROQ on Day 4 of trimethoprim administration resulted in a 1.5-fold increase in AUC(0-∞)and a 1.3‑fold increase in Cmaxof daprodustat.
Daprodustat AUC and Cmaxare expected to increase at least 4-fold and 3-fold, respectively, following concomitant administration of daprodustat with clopidogrel 75 mg once daily (moderate CYP2C8 inhibitor).
Following 4 weeks of JESDUVROQ dosing, hemoglobin changes from baseline were similar in subjects with and without concomitant use of clopidogrel.
Effect of Daprodustat on the Pharmacokinetics of Other Drugs:Clinical drug interaction studies showed that daprodustat inhibition of CYP2C8 and OATP1B1/OATP1B3 demonstrated no clinically significant effect on pioglitazone (CYP2C8 substrate) or rosuvastatin (OATP1B1/OATP1B3 substrate) Cmaxor AUC.In vitro studies:Some oxidative metabolites of daprodustat are substrates of Organic Anion Transporter (OAT)1 or OAT3; however, the clinical significance of this is unknown. Daprodustat is a substrate of Breast Cancer Resistance Protein (BCRP); however, the risk of significant drug interactions between daprodustat and BCRP inhibitors is considered low given the absorption and metabolism profile of daprodustat.Daprodustat is not an inducer of CYP1A2, CYP2B6 and CYP3A4. Daprodustat is not an inhibitor of P-glycoprotein (P-gp) and BCRP.
Daprodustat is not a substrate of CYP1A2, CYP2B6, CYP2C9, CYP2C19, CYP2D6 and P-gp. The major metabolites are not substrates of OATP1B1, OATP1B3, OATP2B1, Organic Cation Transporter (OCT)1, OCT2, Multidrug and Toxin Extrusion (MATE)1 and MATE2-K. Daprodustat and its major metabolites are not inhibitors of CYP1A2, CYP2A6, CYP2B6, CYP2C9, CYP2C19, CYP2D6, CYP3A4, OATP1B1, OATP1B3, OATP2B1, OCT1, OAT1, OAT3, OCT2, MATE1 and MATE2-K.
• With uncontrolled hypertension[see Warnings and Precautions (.)]5.3 HypertensionJESDUVROQ is contraindicated in patients with uncontrolled hypertension. In the ASCEND-D trial, worsening of hypertension occurred in 24% (12 per 100 PY) of patients receiving JESDUVROQ and 24% (12 per 100 PY) of patients receiving rhEPO
[see Adverse Reactions ]. Serious worsening of hypertension occurred in 3.1% of patients receiving JESDUVROQ and 3.1% of patients receiving rhEPO. Cases of hypertensive crisis including hypertensive encephalopathy and seizures have also been reported in patients receiving JESDUVROQ. Periodically monitor blood pressure and adjust or initiate anti-hypertensive therapy as needed.