Molecule
Tacrolimus is a calcineurin inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult and pediatric patients receiving allogeneic liver, kidney, heart, or lung transplants, in combination with other immunosuppressants. MedsAcross supplies Tacrolimus for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
PROGRAF is a calcineurin-inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult and pediatric patients receiving allogeneic liver, kidney, heart, or lung transplants, in combination with other immunosuppressants.
Source: US FDA prescribing information
Tacrolimus binds to an intracellular protein, FKBP-12. A complex of tacrolimus-FKBP-12, calcium, calmodulin, and calcineurin (a ubiquitous mammalian intracellular enzyme) is then formed, after which the phosphatase activity of calcineurin is inhibited. Such inhibition prevents the dephosphorylation and translocation of various factors such as the nuclear factor of activated T-cells (NF-AT), and nuclear factor kappa-light-chain enhancer of activated B-cells (NF-κB). Tacrolimus inhibits the expression and/or production of several cytokines that include interleukin (IL)-1 beta, IL-2, IL-3, IL-4, IL-5, IL-6, IL-8, IL-10, gamma interferon, tumor necrosis factor-alpha, and granulocyte macrophage colony-stimulating factor.
Source: US FDA prescribing information
• Intravenous (IV) use recommended for patients who cannot tolerate oral formulations (capsules or suspension). • Administer capsules or suspension consistently with or without food. • Therapeutic drug monitoring is recommended. • Avoid eating grapefruit or drinking grapefruit juice. • See dosage adjustments for African-American patients, hepatic and renal impaired. • For complete dosing information, see Full Prescribing Information.
Source: US FDA prescribing information
PROGRAF is contraindicated in patients with a hypersensitivity to tacrolimus. PROGRAF 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. • Hypersensitivity to tacrolimus or HCO-60 (polyoxyl 60 hydrogenated castor oil).
Source: US FDA prescribing information
Boxed warning (malignancies and serious infections): Increased risk for developing serious infections and malignancies with PROGRAF or other immunosuppressants that may lead to hospitalization or death. • Not Interchangeable with Extended-Release Tacrolimus Products - Medication Errors: Instruct patients or caregivers to recognize the appearance of PROGRAF capsules. • New Onset Diabetes After Transplant: Monitor blood glucose. • Nephrotoxicity (acute and/or chronic): Reduce the dose, use caution with other nephrotoxic drugs. • Neurotoxicity: Including risk of Posterior Reversible Encephalopathy Syndrome (PRES), monitor for neurologic abnormalities, reduce or discontinue PROGRAF. • Hyperkalemia: Monitor serum potassium levels. Consider carefully before using with other agents also associated with hyperkalemia. • Hypertension: May require antihypertensive therapy.
Source: US FDA prescribing information
The following serious and otherwise important adverse drug reactions are discussed in greater detail in other sections of labeling: • Lymphoma and Other Malignancies • Serious Infections • New Onset Diabetes After Transplant • Nephrotoxicity • Neurotoxicity • Hyperkalemia • Hypertension • Anaphylactic Reactions with PROGRAF Injection • Myocardial Hypertrophy • Pure Red Cell Aplasia • Thrombotic Microangiopathy, Including Hemolytic Uremic Syndrome and Thrombotic Thrombocytopenic Purpura 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.
Source: US FDA prescribing information
• Mycophenolic Acid Products: Can increase MPA exposure after crossover from cyclosporine to PROGRAF, monitor for MPA-related adverse reactions and adjust MMF or MPA dose as needed. • Nelfinavir and Grapefruit Juice: Increased tacrolimus concentrations via CYP3A inhibition, avoid concomitant use. • CYP3A Inhibitors: Increased tacrolimus concentrations, monitor concentrations and adjust tacrolimus dose as needed. • CYP3A4 Inducers: Decreased tacrolimus concentrations, monitor concentrations and adjust tacrolimus dose as needed. • Therapeutic drug monitoring and dose reduction for PROGRAF should be considered when PROGRAF is co-administered with cannabidiol.
Source: US FDA prescribing information
Store and Dispense Store at 20°C to 25°C (68°F to 77°F), excursions permitted 15°C to 30°C (59°F to 86°F). f f f PROGRAF (tacrolimus) Injection (for Intravenous infusion only) NDC 0469-3016-01 Product Code 301601 5 mg/mL (equivalent of 5 mg of anhydrous tacrolimus USP per mL) supplied as a sterile solution in a 1 mL ampule, in boxes of 10 ampules Store and Dispense Store between 5°C and 25°C (41°F and 77°F).
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
21 presentations of Tacrolimus, sorted by availability.
3 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Conditions linked to Tacrolimus in public data. This is not a list of approved uses, see the clinical information.
Yes, on request. MedsAcross lists 21 presentations of Tacrolimus and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 3 brand names for Tacrolimus, including Astagraf XL, Envarsus XR, Prograf.
Yes. The US FDA first approved Tacrolimus on 8 April 1994, according to Drugs@FDA.
Yes. Tacrolimus has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
No listed presentation of Tacrolimus is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Tacrolimus is classified under ATC code D11AH01 (Tacrolimus).
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.