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Sparsentan

Also known as: Filspari

Endothelin Receptor AntagonistAngiotensin 2 Receptor BlockerEndothelin Receptor Antagonists

Route: Oral

5 interactions on record⛔ Black Box Warning

Sparsentan has 5 known drug interactions based on U.S. FDA drug labeling data. Of these, 2 are contraindicated combinations that should be avoided entirely. Notable interactions include combinations with Cyp3a Inducers, Mao Inhibitors, Agents Increasing Serum Potassium. Patients taking Sparsentan should inform their healthcare provider of all current medications — including over-the-counter drugs and supplements — to avoid potentially harmful combinations. Data sourced from OpenFDA and the NIH National Library of Medicine.

Total: 5
Contraindicated: 2
Moderate: 3

Contraindicated (2)

Sparsentan + Cyp3a Inducers— Avoid concomitant use. Decreased sparsentan exposure, which may reduce efficacy.
Sparsentan + Mao Inhibitors— Avoid concomitant use. Increased sparsentan exposure (2.7-12.3 fold), which may increase risk of adverse reactions.

Moderate (3)

Sparsentan + Agents Increasing Serum Potassium— Increased risk of hyperkalemia. Monitor serum potassium frequently.
Sparsentan + Nonsteroidal Anti-Inflammatory Drugs (Nsaids)— Monitor for signs of worsening renal function. Increased risk of kidney injury, especially in patients with volume deple…
Sparsentan + P-Gp Or Bcrp Substrates— Monitor for adverse reactions of P-gp substrates with narrow therapeutic indices. Increased exposure to substrates.

Sparsentan + Cyp3a Inducers⛔Contraindicated

Avoid concomitant use. Decreased sparsentan exposure, which may reduce efficacy.

Sparsentan + Mao Inhibitors⛔Contraindicated

Avoid concomitant use. Increased sparsentan exposure (2.7-12.3 fold), which may increase risk of adverse reactions.

Sparsentan + Agents Increasing Serum Potassium🟡Moderate

Increased risk of hyperkalemia. Monitor serum potassium frequently.

Sparsentan + Nonsteroidal Anti-Inflammatory Drugs (Nsaids)🟡Moderate

Monitor for signs of worsening renal function. Increased risk of kidney injury, especially in patients with volume depletion or impaired kidney function.

Sparsentan + P-Gp Or Bcrp Substrates🟡Moderate

Monitor for adverse reactions of P-gp substrates with narrow therapeutic indices. Increased exposure to substrates.

⛔ FDA Black Box Warning

WARNING: HEPATOTOXICITY and EMBRYO-FETAL TOXICITY Because of the risk of hepatotoxicity, FILSPARI is available only through a restricted program called the FILSPARI REMS. Under the FILSPARI REMS, prescribers, patients, and pharmacies must enroll in the program [see Warnings and Precautions ( 5.1 , 5.2 )] . Hepatotoxicity Some Endothelin Receptor Antagonists (ERAs) have caused elevations of aminotransferases, hepatotoxicity, and liver failure. In clinical studies, elevations in aminotransferases (ALT or AST) of at least 3-times the Upper Limit of Normal (ULN) have been observed in up to 3.5% of FILSPARI-treated patients, including cases confirmed with rechallenge. Measure transaminases and bilirubin before initiating treatment and then every 3 months during treatment. Interrupt treatment and closely monitor patients who develop aminotransferase elevations more than 3-times ULN [see Dosage and Administration ( 2.2 , 2.6 ), Warnings and Precautions ( 5.1 )] . FILSPARI should generally be avoided in patients with elevated aminotransferases (>3-times ULN) at baseline because monitoring for hepatotoxicity may be more difficult and these patients may be at increased risk for serious hepatotoxicity [see Dosage and Administration ( 2.2 , 2.6 ), Warnings and Precautions ( 5.1 )] . Embryo-Fetal Toxicity FILSPARI is contraindicated for use during pregnancy because it may cause fetal harm if used by pregnant patients. Therefore, in patients who can become pregnant, exclude pregnancy prior to initiation of FILSPARI. Advise use of effective contraception before the initiation of treatment, during treatment, and for two weeks after discontinuation of treatment with FILSPARI. When pregnancy is detected, discontinue FILSPARI as soon as possible [see Dosage and Administration ( 2.3 ), Contraindications ( 4 ), Warnings and Precautions ( 5.3 ), Use in Specific Populations ( 8.1 , 8.3 )]. WARNING: HEPATOTOXICITY and EMBRYO-FETAL TOXICITY See full prescribing information for complete boxe

Contraindications

4 CONTRAINDICATIONS Use of FILSPARI is contraindicated in patients who are pregnant [see Dosage and Administration ( 2.3 ), Warnings and Precautions ( 5.3 ), Use in Specific Populations ( 8.1 )] . Do not co-administer FILSPARI with ARBs, ERAs, or aliskiren [see Dosage and Administration ( 2.1 ), Drug Interactions ( 7.1 )]. • Pregnancy ( 4 ). • Concomitant use with angiotensin receptor blockers (ARBs), ERAs, or aliskiren ( 4 ).

Pregnancy & Breastfeeding

8.1 Pregnancy Risk Summary Based on data from animal reproductive toxicity studies, FILSPARI may cause fetal harm, including birth defects and fetal death, when administered to a pregnant patient and is contraindicated during pregnancy [see Contraindications ( 4 )] . Available data from reports of pregnancy in clinical trials with FILSPARI are insufficient to identify a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Available data from postmarketing reports and published literature over decades of use with ERA in the same class as FILSPARI have not identified an increased risk of fetal harm; however, these data are limited. Methodological limitations of these postmarketing reports and published literature include lack of a control group; limited information regarding dose, duration, and timing of drug exposure; and missing data. These limitations preclude establishing a reliable estimate of the risk of adverse fetal and neonatal outcomes with maternal ERA use. In animal reproduction studies, oral administration of sparsentan to pregnant rats throughout organogenesis at 10-times the maximum recommended human dose (MRHD) in mg/day caused teratogenic effects in rats, including craniofacial malformations, skeletal abnormalities, increased embryo-fetal lethality, and reduced fetal weights (see Data) . Advise pregnant patients 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 2-4% and 15-20%, respectively. Data Animal Data In embryo-fetal development studies in pregnant rats and rabbits, teratogenicity and/or developmental toxicity were observed, which were attributed to the antagonism of endothelin type A

Data sourced from U.S. FDA drug labeling via openFDA and the NIH National Library of Medicine, supplemented with a small number of well-established interactions from curated clinical references. For informational purposes only. Always consult your pharmacist or physician.