Tacrolimus

DRUG INFORMATION

  ADULT
    - Dose at 0.1 mg/kg/day if antibody induction treatment is administered. 2.1
      Important Administration Instructions Tacrolimus capsules should not be used
      without supervision by a physician with experience in immunosuppressive therapy.
      Source: US FDA label for tacrolimus (Tacrolimus), section 'dosage and
      administration', retrieved 2026-08-29
    - In a second smaller trial, the initial dose of tacrolimus was 0.15 to 0.2
      mg/kg/day and observed tacrolimus concentrations were 6 to 16 ng/mL. during month
      1 to 3 and 5 to 12 ng/mL during month 4 to 12 [see Clinical Studies ( 14.1 )].
      Source: US FDA label for tacrolimus (Tacrolimus), section 'dosage and
      administration', retrieved 2026-08-29
    - The recommended starting dose of tacrolimus injection is 0.03 to 0.05 mg/kg/day in
      kidney or liver transplant, 0.01 mg/kg/day in heart transplant, given as a
      continuous intravenous infusion.
      Source: US FDA label for tacrolimus (Tacrolimus), section 'dosage and
      administration', retrieved 2026-08-29

  CHILD
    - Safety and effectiveness have been established in pediatric liver, kidney, and
      heart transplant patients. Liver Transplantation Safety and efficacy using
      tacrolimus in pediatric de novo liver transplant patients less than 16 years of
      age are based on evidence from active controlled studies that included 56
      pediatric patients, 31 of which received tacrolimus, and supported by two
      pharmacokinetic and safety studies in 151 children who received tacrolimus.
      Source: US FDA label for tacrolimus (Tacrolimus), section 'pediatric use',
      retrieved 2026-08-29
    - Intravenous (IV) use recommended for patients who cannot tolerate oral
      formulations (capsules). ( 2.1 , 2.2 ) Administer capsules consistently with or
      without food. ( 2.1 ) Therapeutic drug monitoring is recommended. ( 2.1 , 2.6 )
      Avoid eating grapefruit or drinking grapefruit juice. ( 2.1 ) See dosage
      adjustments for African-American patients ( 2.2 ), hepatic and renal impaired.
      Source: US FDA label for tacrolimus (Tacrolimus), section 'dosage and
      administration', retrieved 2026-08-29
    - Dose at 0.1 mg/kg/day if antibody induction treatment is administered. 2.1
      Important Administration Instructions Tacrolimus capsules should not be used
      without supervision by a physician with experience in immunosuppressive therapy.
      Source: US FDA label for tacrolimus (Tacrolimus), section 'dosage and
      administration', retrieved 2026-08-29

  RENAL IMPAIRMENT
    - However, due to Astellas Pharma US, Inc.’s marketing exclusivity rights, this drug
      product is not labeled with that information. 2.4 Dosage Modification for Patients
      with Renal Impairment Due to its potential for nephrotoxicity, consider dosing
      tacrolimus capsules at the lower end of the therapeutic dosing range in patients
      who have received a liver, or heart transplant, and have pre-existing renal
      impairment.
      Source: US FDA label for tacrolimus (Tacrolimus), section 'dosage and
      administration', retrieved 2026-08-29
    - The use of tacrolimus capsules in liver transplant recipients experiencing post-
      transplant hepatic impairment may be associated with increased risk of developing
      renal insufficiency related to high whole blood concentrations of tacrolimus.
      Source: US FDA label for tacrolimus (Tacrolimus), section 'dosage and
      administration', retrieved 2026-08-29
    - In general, dose selection for an elderly patient should be cautious, usually
      starting at the low end of the dosing range, reflecting the greater frequency of
      decreased hepatic, renal, or cardiac function, and of concomitant disease or other
      drug therapy. 8.6 Renal Impairment The pharmacokinetics of tacrolimus in patients
      with renal impairment was similar to that in healthy volunteers with normal renal
      function.
      Source: US FDA label for tacrolimus (Tacrolimus), section 'use in specific
      populations', retrieved 2026-08-29

  HEPATIC IMPAIRMENT
    - In kidney transplant patients with post-operative oliguria, the initial dose of
      tacrolimus capsules should be administered no sooner than 6 hours and within 24
      hours of transplantation, but may be delayed until renal function shows evidence
      of recovery [see Dosage and Administration ( 2.2 ), Warnings and Precautions ( 5.5
      ), Use in Specific Populations ( 8.6 ), and Clinical Pharmacology ( 12.3 )] .
      Source: US FDA label for tacrolimus (Tacrolimus), section 'dosage and
      administration', retrieved 2026-08-29
    - The use of tacrolimus capsules in liver transplant recipients experiencing post-
      transplant hepatic impairment may be associated with increased risk of developing
      renal insufficiency related to high whole blood concentrations of tacrolimus.
      Source: US FDA label for tacrolimus (Tacrolimus), section 'dosage and
      administration', retrieved 2026-08-29
    - Further reductions in dose below the targeted range may be required [see Dosage
      and Administration ( 2.4 ) and Clinical Pharmacology ( 12.3 )] . 8.7 Hepatic
      Impairment The mean clearance of tacrolimus was substantially lower in patients
      with severe hepatic impairment (mean Child-Pugh score: >10) compared to healthy
      volunteers with normal hepatic function.
      Source: US FDA label for tacrolimus (Tacrolimus), section 'use in specific
      populations', retrieved 2026-08-29

  PREGNANCY
    - Pregnancy Exposure Registry There is a pregnancy registry that monitors pregnancy
      outcomes in women exposed to tacrolimus during pregnancy.
      Source: US FDA label for tacrolimus (Tacrolimus), section 'pregnancy', retrieved
      2026-08-29
    - The Transplantation Pregnancy Registry International (TPRI) is a voluntary
      pregnancy exposure registry that monitors outcomes of pregnancy in female
      transplant recipients and those fathered by male transplant recipients exposed to
      immunosuppressants including tacrolimus.
      Source: US FDA label for tacrolimus (Tacrolimus), section 'pregnancy', retrieved
      2026-08-29
    - Healthcare providers are encouraged to advise their patients to register by
      contacting the Transplantation Pregnancy Registry International at 1-877-955-6877
      or https://www.transplantpregnancyregistry.org/ .
      Source: US FDA label for tacrolimus (Tacrolimus), section 'pregnancy', retrieved
      2026-08-29

  BREASTFEEDING
    - Contraception Tacrolimus can cause fetal harm when administered to pregnant women.
      Source: US FDA label for tacrolimus (Tacrolimus), section 'nursing mothers',
      retrieved 2026-08-29
    - Advise female and male patients of reproductive potential to speak to their
      healthcare provider on family planning options including appropriate contraception
      prior to starting treatment with tacrolimus [see Use in Specific Populations ( 8.1
      ) and Nonclinical Toxicology ( 13.1 )] .
      Source: US FDA label for tacrolimus (Tacrolimus), section 'nursing mothers',
      retrieved 2026-08-29
    - Infertility Based on findings in animals, male and female fertility may be
      compromised by treatment with tacrolimus [see Nonclinical Toxicology ( 13.1 )].
      Source: US FDA label for tacrolimus (Tacrolimus), section 'nursing mothers',
      retrieved 2026-08-29