Cidofovir — Discount Pricing

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What Cidofovir is approved for (FDA label)

Cidofovir injection is indicated for the treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS). THE SAFETY AND EFFICACY OF CIDOFOVIR INJECTION HAVE NOT BEEN ESTABLISHED FOR TREATMENT OF OTHER CMV INFECTIONS (SUCH AS PNEUMONITIS OR GASTROENTERITIS), CONGENITAL OR NEONATAL CMV DISEASE, OR CMV DISEASE IN NON-HIV-INFECTED INDIVIDUALS. DESCRIPTION OF CLINICAL TRIALS Three phase II/III controlled trials of cidofovir injection have been conducted in HIV-infected patients with CMV retinitis.

Source: Read the full FDA label on DailyMed. Label effective date: October 25, 2023.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Boxed warning for Cidofovir (FDA label)

WARNING RENAL IMPAIRMENT IS THE MAJOR TOXICITY OF CIDOFOVIR INJECTION. CASES OF ACUTE RENAL FAILURE RESULTING IN DIALYSIS AND/OR CONTRIBUTING TO DEATH HAVE OCCURRED WITH AS FEW AS ONE OR TWO DOSES OF CIDOFOVIR INJECTION. TO REDUCE POSSIBLE NEPHROTOXICITY, INTRAVENOUS PREHYDRATION WITH NORMAL SALINE AND ADMINISTRATION OF PROBENECID MUST BE USED WITH EACH CIDOFOVIR INFUSION. RENAL FUNCTION (SERUM CREATININE AND URINE PROTEIN) MUST BE MONITORED WITHIN 48 HOURS PRIOR TO EACH DOSE OF CIDOFOVIR INJECTION AND THE DOSE OF CIDOFOVIR INJECTION MODIFIED FOR CHANGES IN RENAL FUNCTION AS APPROPRIATE (SEE ION (SERUM CREATININE AND URINE PROTEIN) MUST BE MONITORED WITHIN 48 HOURS PRIOR TO EACH DOSE OF CIDOFOVIR INJECTION AND THE DOSE OF CIDOFOVIR INJECTION MODIFIED FOR CHANGES IN RENAL FUNCTION AS APPROPRIATE (SEE DOSAGE AND ADMINISTRATION ). CIDOFOVIR INJECTION IS CONTRAINDICATED IN PATIENTS WHO ARE RECEIVING OTHER NEPHROTOXIC AGENTS. NEUTROPENIA HAS BEEN OBSERVED IN ASSOCIATION WITH CIDOFOVIR INJECTION TREATMENT. THEREFORE, NEUTROPHIL COUNTS SHOULD BE MONITORED DURING CIDOFOVIR INJECTION THERAPY. CIDOFOVIR INJECTION IS INDICATED ONLY FOR THE TREATMENT OF CMV RETINITIS IN PATIENTS WITH ACQUIRED IMMUNODEFICIENCY SYNDROME. IN ANIMAL STUDIES CIDOFOVIR WAS CARCINOGENIC, TERATOGENIC AND CAUSED HYPOSPERMIA (SEE CARCINOGENESIS, MUTAGENESIS, & IMPAIRMENT OF FERTILITY ).

Source: FDA prescribing information (DailyMed). Set ID: 44966a7e-d777-40fb-956f-d0f31f737848. SPL document ID: 963405a6-8cd9-4d70-9de9-2afc6eab1488. Label effective date: October 25, 2023. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Adverse reactions for Cidofovir (FDA label)

Nephrotoxicity: Renal toxicity, as manifested by ≥2+ proteinuria, serum creatinine elevations of ≥0.4 mg/dL, or decreased creatinine clearance ≤55 mL/min, occurred in 79 of 135 (59%) patients receiving cidofovir injection at a maintenance dose of 5 mg/kg every other week. Maintenance dose reductions from 5 mg/kg to 3 mg/kg due to proteinuria or serum creatinine elevations were made in 12 of 41 (29%) patients who had not received prior therapy for CMV retinitis (Study 106) and in 19 of 74 (26%) patients who had received prior therapy for CMV retinitis (Study 107). Prior foscarnet use has been associated with an increased risk of nephrotoxicity; therefore, such patients must be monitored closely (see CONTRAINDICATIONS , WARNINGS , DOSAGE AND ADMINISTRATION ).

Source: FDA prescribing information (DailyMed). Set ID: 44966a7e-d777-40fb-956f-d0f31f737848. SPL document ID: 963405a6-8cd9-4d70-9de9-2afc6eab1488. Label effective date: October 25, 2023. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Contraindications for Cidofovir (FDA label)

Initiation of therapy with cidofovir injection is contraindicated in patients with a serum creatinine >1.5 mg/dL, a calculated creatinine clearance ≤55 mL/min, or a urine protein ≥100 mg/dL (equivalent to ≥2+ proteinuria). Cidofovir injection is contraindicated in patients receiving agents with nephrotoxic potential. Such agents must be discontinued at least seven days prior to starting therapy with cidofovir injection. Cidofovir injection is contraindicated in patients with hypersensitivity to cidofovir. Cidofovir injection is contraindicated in patients with a history of clinically severe hypersensitivity to probenecid or other sulfa-containing medications. Direct intraocular injection of cidofovir injection is contraindicated; direct injection of cidofovir has been associated with iritis, ocular hypotony, and permanent impairment of vision.

Source: FDA prescribing information (DailyMed). Set ID: 44966a7e-d777-40fb-956f-d0f31f737848. SPL document ID: 963405a6-8cd9-4d70-9de9-2afc6eab1488. Label effective date: October 25, 2023. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Drug interactions for Cidofovir (FDA label)

Probenecid Probenecid is known to interact with the metabolism or renal tubular excretion of many drugs (e.g., acetaminophen, acyclovir, angiotensin-converting enzyme inhibitors, aminosalicylic acid, barbiturates, benzodiazepines, bumetanide, clofibrate, methotrexate, famotidine, furosemide, nonsteroidal anti-inflammatory agents, theophylline, and zidovudine). Concomitant medications should be carefully assessed. Zidovudine should either be temporarily discontinued or decreased by 50% when coadministered with probenecid on the day of cidofovir infusion. Nephrotoxic agents Concomitant administration of cidofovir injection and agents with nephrotoxic potential [e.g., intravenous aminoglycosides (e.g., tobramycin, gentamicin, and amikacin), amphotericin B, foscarnet, intravenous pentamidine, vancomycin, and nonsteroidal anti-inflammatory agents] is contraindicated. Such agents must be discontinued at least seven days prior to starting therapy with cidofovir injection.

Source: FDA prescribing information (DailyMed). Set ID: 44966a7e-d777-40fb-956f-d0f31f737848. SPL document ID: 963405a6-8cd9-4d70-9de9-2afc6eab1488. Label effective date: October 25, 2023. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.