Tacrolimus — Membership Pricing

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What Tacrolimus is approved for (FDA label)

Tacrolimus capsules are a calcineurin-inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult and pediatric patients receiving allogeneic liver, kidney or heart transplants, in combination with other immunosuppressants. ( 1.1 ) 1.1 Prophylaxis of Organ Rejection in Kidney, Liver or Heart Transplant Tacrolimus capsules are indicated for the prophylaxis of organ rejection, in adult and pediatric patients receiving allogeneic kidney transplant [see Clinical Studies ( 14.1 )] , liver transplant [see Clinical Studies ( 14.2 )] , or heart transplant [see Clinical Studies ( 14.3 )] in combination with other immunosuppressants. Additional information pertaining to use in adult and pediatric populations for lung transplantation is approved for Astellas Pharma US, Inc.'s Prograf® products.

Source: Read the full FDA label on DailyMed. Label effective date: July 17, 2026.

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

Boxed warning for Tacrolimus (FDA label)

WARNING: MALIGNANCIES AND SERIOUS INFECTIONS Increased risk for developing serious infections and malignancies with Tacrolimus or other immunosuppressants that may lead to hospitalization or death. ( 5.1 , 5.2 ) WARNING: MALIGNANCIES AND SERIOUS INFECTIONS See full prescribing information for complete boxed warning. Increased risk for developing serious infections and malignancies with tacrolimus or other immunosuppressants that may lead to hospitalization or death. ( 5.1 , 5.2 )

Source: FDA prescribing information (DailyMed). Set ID: 6b89e8a4-9f11-42e3-8e79-fe617e7c461f. SPL document ID: 53396094-b61b-4383-a680-82974cc9c159. Label effective date: July 17, 2026. Read the full label.

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

Dosage forms and strengths for Tacrolimus (FDA label)

Tacrolimus capsules USP, are hard gelatin capsules for oral administration containing anhydrous tacrolimus, USP as follows: Tacrolimus capsules USP, 0.5mg: Opaque light yellow color, size "4" hard gelatin capsules imprinted with "C5" "0.5mg" on cap with black ink, containing white to off white granular powder. Tacrolimus capsules USP, 1mg: Opaque white color, size "4" hard gelatin capsules imprinted with "C6" "1 mg" on cap with black ink, containing white to off white granular powder. Tacrolimus capsules USP, 5mg: Opaque grayish red color, size "4" hard gelatin capsules imprinted with "C7'' "5mg" on cap with black ink, containing white to off white granular powder. Capsules: 0.5 mg, 1 mg and 5 mg ( 3 )

Source: FDA prescribing information (DailyMed). Set ID: 6b89e8a4-9f11-42e3-8e79-fe617e7c461f. SPL document ID: 53396094-b61b-4383-a680-82974cc9c159. Label effective date: July 17, 2026. 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 Tacrolimus (FDA label)

The most common adverse reactions (≥ 15%) were abnormal renal function, hypertension, diabetes mellitus, fever, CMV infection, tremor, hyperglycemia, leukopenia, infection, anemia, bronchitis, pericardial effusion, urinary tract infection, constipation, diarrhea, headache, abdominal pain, insomnia, paresthesia, peripheral edema, nausea, hyperkalemia, hypomagnesemia, and hyperlipemia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Concord Biotech Limited at Telephone: 1-855-407-0586 or FDA at 1-800-FDA-1088 or www.fda.g ov/medwatch.

Source: FDA prescribing information (DailyMed). Set ID: 6b89e8a4-9f11-42e3-8e79-fe617e7c461f. SPL document ID: 53396094-b61b-4383-a680-82974cc9c159. Label effective date: July 17, 2026. Read the full label.

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

Contraindications for Tacrolimus (FDA label)

Hypersensitivity to tacrolimus or HCO-60 (polyoxyl 60 hydrogenated castor oil). ( 4 ) Tacrolimus capsules are contraindicated in patients with a hypersensitivity to tacrolimus. Tacrolimus injection is contraindicated in patients with a hypersensitivity to HCO-60 (polyoxyl 60 hydrogenated castor oil). Hypersensitivity symptoms reported include dyspnea, rash, pruritus, and acute respiratory distress syndrome [see Adverse Reactions (6) ] .

Source: FDA prescribing information (DailyMed). Set ID: 6b89e8a4-9f11-42e3-8e79-fe617e7c461f. SPL document ID: 53396094-b61b-4383-a680-82974cc9c159. Label effective date: July 17, 2026. Read the full label.

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

Warnings and precautions for Tacrolimus (FDA label)

Not Interchangeable with Extended-Release Tacrolimus Products- Medication Errors: Instruct patients or caregivers to recognize the appearance of tacrolimus capsules. ( 5.3 ) New Onset Diabetes After Transplant: Monitor blood glucose. ( 5.4 ) Nephrotoxicity (acute and/or chronic): Reduce the dose; use caution with other nephrotoxic drugs. ( 5.5 ) Neurotoxicity: Including risk of Posterior Reversible Encephalopathy Syndrome (PRES); monitor for neurologic abnormalities; reduce or discontinue tacrolimus capsules. ( 5.6 ) Hyperkalemia: Monitor serum potassium levels. Consider carefully before using with other agents also associated with hyperkalemia. ( 5.7 ) Hypertension: May require antihypertensive therapy.

Source: FDA prescribing information (DailyMed). Set ID: 6b89e8a4-9f11-42e3-8e79-fe617e7c461f. SPL document ID: 53396094-b61b-4383-a680-82974cc9c159. Label effective date: July 17, 2026. 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 Tacrolimus (FDA label)

Mycophenolic Acid Products: Can increase MPA exposure after crossover from cyclosporine to tacrolimus; monitor for MPA-related adverse reactions and adjust MMF or MPA dose as needed. ( 7.1 ) Nelfinavir and Grapefruit Juice: Increased tacrolimus concentrations via CYP3A inhibition; avoid concomitant use. ( 7.2 ) CYP3A Inhibitors: Increased tacrolimus concentrations; monitor concentrations and adjust tacrolimus dose as needed. ( 5.11 , 7.2 ) CYP3A4 Inducers: Decreased tacrolimus concentrations; monitor concentrations and adjust tacrolimus dose as needed. ( 5.11 , 7.2 ) Therapeutic drug monitoring and dose reduction for tacrolimus should be considered when tacrolimus is co-administered with cannabidiol ( 5.17 , 7.3 ). 7.1 Mycophenolic Acid When tacrolimus is prescribed with a given dose of a mycophenolic acid (MPA) product, exposure to MPA is higher with tacrolimus co-administration than with cyclosporine co-administration with MPA, because cyclosporine interrupts the enterohepatic recirculation of MPA while tacrolimus does not.

Source: FDA prescribing information (DailyMed). Set ID: 6b89e8a4-9f11-42e3-8e79-fe617e7c461f. SPL document ID: 53396094-b61b-4383-a680-82974cc9c159. Label effective date: July 17, 2026. Read the full label.

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