Tacrolimus

The label describes tacrolimus capsules for preventing organ rejection in adults and children receiving allogeneic kidney, liver or heart transplants. It is used in combination with other immunosuppressants.

• Kidney transplant
• Liver transplant
• Heart transplant

The label says tacrolimus binds to a protein called FKBP-12 and blocks calcineurin. This stops activation of T-cells and lowers production of several immune signalling chemicals.

This page covers the US label for tacrolimus capsules taken by mouth, with the dosing the label gives for adults and, where the label says so, children.

This is label-level information, not personal advice. Indian pack labels may differ, and your prescriber's instruction always comes first.

The label describes doses by weight, divided into two doses every 12 hours. For example, adult kidney transplant starts at 0.2 mg/kg/day with azathioprine, or 0.1 mg/kg/day with MMF or an IL-2 receptor antagonist. Liver is 0.1 to 0.15 mg/kg/day and heart 0.075 mg/kg/day.

Children start at 0.3 mg/kg/day for kidney and heart, and 0.15 to 0.2 mg/kg/day for liver. Capsules are taken consistently with or without food. Blood trough levels are monitored, and grapefruit and grapefruit juice are avoided.

The label notes adjustments for African-American patients and for liver or kidney impairment.

• Dose by weight, split every 12 hours
• Same way each day, with or without food
• Blood level monitoring
• Avoid grapefruit

The boxed warning says tacrolimus and other immunosuppressants raise the risk of serious infections and cancers, which can lead to hospitalization or death. Skin cancer risk means sun exposure should be limited.

It is contraindicated in people with hypersensitivity to tacrolimus. Pregnant women face fetal harm risk, including prematurity and birth defects. The label also advises avoiding live vaccines and warns about nerve toxicity, high potassium and kidney damage.

• Serious infections and cancers
• Kidney and nerve toxicity
• High potassium and blood sugar
• Not for those allergic to tacrolimus
• Fetal harm in pregnancy
• Avoid live vaccines

• CYP3A inhibitors and grapefruit
• CYP3A4 inducers
• Mycophenolic acid products
• Sirolimus and cannabidiol
• The label says CYP3A inhibitors, nelfinavir and grapefruit raise tacrolimus levels, while CYP3A4 inducers lower them.
• Levels need monitoring and dose changes.
• Mycophenolic acid exposure can rise, cannabidiol may need dose reduction, and use with sirolimus is not recommended in liver and heart transplant.

No match in this label text. Ask your pharmacist about any medicine you take.

The label gives a storage range of 20 to 25 degrees C.

Follow the storage line on your own pack, and keep medicines out of the reach of children.

We did not find tacrolimus in the Drugs Rules 1945 Schedule H, H1, X or G rows we checked, so we cannot state its Indian prescription status from our lists. Ask your pharmacist or doctor.

Tacrolimus is on the National List of Essential Medicines 2022. Listed forms include: Capsule 1 mg (page 83); Capsule 2 mg (page 83).

NPPA lists ceiling prices for scheduled tacrolimus formulations. The table shows the rows we found. Check NPPA directly for the current list.

The Jan Aushadhi (PMBJP) list we checked has 4 product rows that mention tacrolimus. We did not capture prices for them.

NPPA ceiling prices set the most a seller can charge per unit for the listed formulations, before local taxes. They are ceilings, not the price you will always pay.

Jan Aushadhi lists tacrolimus products including Tacrolimus Ointment 0.1% w/w None; Tacrolimus Capsule IP 2 mg 2 mg; Tacrolimus Capsule IP 1 mg 1 mg; Tacrolimus Capsule IP 0.25 mg 0.25 mg. We have not shown a price for them. Check the pack and the seller for the actual price.