Version October 2024
Vadadustat increases the risk of thrombotic vascular events, including major adverse cardiovascular events (MACE). Targeting a hemoglobin level greater than 11 g/dL is expected to further increase the risk of death and arterial and venous thrombotic events, as occurs with erythropoietin stimulating agents (ESAs), which also increase erythropoietin levels. No trial has identified a hemoglobin target level, dose of vadadustat, or dosing strategy that does not increase these risks. Use the lowest dose of vadadustat sufficient to reduce the need for red blood cell transfusions.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in adults.
>10%:
Cardiovascular: Hypertension (14%; including hypertensive crisis, hypertensive encephalopathy)
Gastrointestinal: Diarrhea (13%)
1% to 10%:
Cardiovascular: Arteriovenous fistula-site complication (thrombosis: 6%)
Gastrointestinal: Abdominal pain (7%), gastrointestinal erosion (6%; including gastrointestinal hemorrhage, gastrointestinal perforation, gastrointestinal ulcer), nausea (8%), vomiting (7%; including hematemesis)
Hematologic & oncologic: Malignant neoplasm (2%)
Hepatic: Increased serum alanine aminotransferase (2%), increased serum aspartate aminotransferase (2%)
Nervous system: Dizziness (6%), fatigue (8%), headache (9%), seizure (2%)
Respiratory: Dyspnea (6%)
<1%: Hepatic: Hepatotoxicity, increased serum bilirubin
Frequency not defined:
Cardiovascular: Acute myocardial infarction, arterial thrombosis, deep vein thrombosis, pulmonary embolism, shunt thrombosis, venous thromboembolism
Nervous system: Cerebrovascular accident
Hypersensitivity to vadadustat or any component of the formulation; uncontrolled hypertension.
Vafseo: FDA approved March 2024; availability anticipated January 2025.
Anemia due to chronic kidney disease (dialysis-dependent): Treatment of anemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis for ≥3 months.
Limitations of use: Has not been shown to improve quality of life, fatigue, or patient well-being; not indicated as a substitute for RBC transfusions in patients who require immediate correction of anemia or treatment of anemia of CKD in patients who are not on dialysis.
Substrate of OAT1/3; Inhibits BCRP/ABCG2, OAT1/3
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.
Alpelisib: BCRP/ABCG2 Inhibitors may increase the serum concentration of Alpelisib. Management: Avoid coadministration of BCRP/ABCG2 inhibitors and alpelisib due to the potential for increased alpelisib concentrations and toxicities. If coadministration cannot be avoided, closely monitor for increased alpelisib adverse reactions. Risk D: Consider therapy modification
Androgens: Hypertension-Associated Agents may enhance the hypertensive effect of Androgens. Risk C: Monitor therapy
BCRP/ABCG2 Substrates (Clinically Relevant with Inhibitors): Vadadustat may increase the serum concentration of BCRP/ABCG2 Substrates (Clinically Relevant with Inhibitors). Risk C: Monitor therapy
Berotralstat: BCRP/ABCG2 Inhibitors may increase the serum concentration of Berotralstat. Management: Decrease the berotralstat dose to 110 mg daily when combined with BCRP inhibitors. Risk D: Consider therapy modification
Cefaclor: Vadadustat may increase the serum concentration of Cefaclor. Risk C: Monitor therapy
Ceftizoxime: Vadadustat may increase the serum concentration of Ceftizoxime. Risk C: Monitor therapy
Cladribine: BCRP/ABCG2 Inhibitors may increase the serum concentration of Cladribine. Management: Avoid concomitant use of BCRP inhibitors during the 4 to 5 day oral cladribine treatment cycles whenever possible. If combined, consider dose reduction of the BCRP inhibitor and separation in the timing of administration. Risk D: Consider therapy modification
Darbepoetin Alfa: Vadadustat may enhance the adverse/toxic effect of Darbepoetin Alfa. Management: For adult patients treated with vadadustat who require temporary darbepoetin alfa rescue therapy, interrupt vadadustat treatment during darbepoetin alfa therapy. Do not restart vadadustat until 7 days after the last darbepoetin alfa dose. Risk X: Avoid combination
Erythropoiesis-Stimulating Agents: Vadadustat may enhance the adverse/toxic effect of Erythropoiesis-Stimulating Agents. Management: For adult patients treated with vadadustat who require temporary erythropoiesis-stimulating agent (ESA) rescue therapy, interrupt vadadustat treatment during ESA therapy. Do not restart vadadustat until 2 days after the last epoetin dose. Risk X: Avoid combination
Famotidine: Vadadustat may increase the serum concentration of Famotidine. Risk C: Monitor therapy
Fexinidazole: May increase the serum concentration of OAT1/3 Substrates (Clinically Relevant). Management: Avoid use of fexinidazole with OAT1/3 substrates when possible. If combined, monitor for increased OAT1/3 substrate toxicities. Risk D: Consider therapy modification
HMG-CoA Reductase Inhibitors (Statins): Vadadustat may increase the serum concentration of HMG-CoA Reductase Inhibitors (Statins). Risk C: Monitor therapy
Iron Preparations: May decrease the serum concentration of Vadadustat. Management: Administer vadadustat at least 1 hour before oral iron supplements. Risk D: Consider therapy modification
Ketoprofen: Vadadustat may increase the serum concentration of Ketoprofen. Ketoprofen may increase the serum concentration of Vadadustat. Risk C: Monitor therapy
Leflunomide: May increase the serum concentration of OAT1/3 Substrates (Clinically Relevant). Risk C: Monitor therapy
Methoxy Polyethylene Glycol-Epoetin Beta: Vadadustat may enhance the adverse/toxic effect of Methoxy Polyethylene Glycol-Epoetin Beta. Management: For patients treated with vadadustat who require temporary methoxy polyethylene glycol-epoetin beta rescue therapy, interrupt vadadustat treatment and do not restart vadadustat until 14 days after the last methoxy polyethylene glycol-epoetin beta dose. Risk X: Avoid combination
Nitisinone: May increase the serum concentration of OAT1/3 Substrates (Clinically Relevant). Risk C: Monitor therapy
OAT1/3 Inhibitors: May increase the serum concentration of Vadadustat. Risk C: Monitor therapy
OAT1/3 Substrates (Clinically Relevant): Vadadustat may increase the serum concentration of OAT1/3 Substrates (Clinically Relevant). Risk C: Monitor therapy
PAZOPanib: BCRP/ABCG2 Inhibitors may increase the serum concentration of PAZOPanib. Risk X: Avoid combination
Penicillin G (Parenteral/Aqueous): Vadadustat may increase the serum concentration of Penicillin G (Parenteral/Aqueous). Risk C: Monitor therapy
Penicillin G Benzathine: Vadadustat may increase the serum concentration of Penicillin G Benzathine. Risk C: Monitor therapy
Penicillin G Procaine: Vadadustat may increase the serum concentration of Penicillin G Procaine. Risk C: Monitor therapy
Phosphate Binders: May decrease the serum concentration of Vadadustat. Management: Administer vadadustat at least 1 hour before or 2 hours after phosphate binders. Risk D: Consider therapy modification
Pretomanid: May increase the serum concentration of OAT1/3 Substrates (Clinically Relevant). Risk C: Monitor therapy
Rosuvastatin: Vadadustat may increase the serum concentration of Rosuvastatin. Management: Do not exceed rosuvastatin doses of 5 mg daily and monitor for rosuvastatin adverse effects (eg, myopathy) during coadministration with vadadustat. Risk D: Consider therapy modification
Simvastatin: Vadadustat may increase the serum concentration of Simvastatin. Management: Initiate simvastatin at 5 mg daily and no not exceed 20 mg daily during coadministration with vadadustat. Monitor patients for simvastatin adverse effects (eg, myopathy) during any combined use. Risk D: Consider therapy modification
SITagliptin: Vadadustat may enhance the hypoglycemic effect of SITagliptin. Risk C: Monitor therapy
Solriamfetol: May enhance the hypertensive effect of Hypertension-Associated Agents. Risk C: Monitor therapy
Sucroferric Oxyhydroxide: May decrease the serum concentration of Vadadustat. Management: Administer vadadustat at least 1 hour before oral sucroferric oxyhydroxide. Risk D: Consider therapy modification
Talazoparib: BCRP/ABCG2 Inhibitors may increase the serum concentration of Talazoparib. Risk C: Monitor therapy
Taurursodiol: May increase the serum concentration of OAT1/3 Substrates (Clinically Relevant). Risk X: Avoid combination
Teriflunomide: May increase the serum concentration of OAT1/3 Substrates (Clinically Relevant). Risk C: Monitor therapy
Topotecan: BCRP/ABCG2 Inhibitors may increase the serum concentration of Topotecan. Risk X: Avoid combination
Ubrogepant: BCRP/ABCG2 Inhibitors may increase the serum concentration of Ubrogepant. Management: Use an initial ubrogepant dose of 50 mg and second dose (at least 2 hours later if needed) of 50 mg when used with a BCRP inhibitor. Risk D: Consider therapy modification
Vaborbactam: May increase the serum concentration of OAT1/3 Substrates (Clinically Relevant). Risk C: Monitor therapy
آیا می خواهید مدیلیب را به صفحه اصلی خود اضافه کنید؟
