Tacrolimus - Warnings and Precautions
The following warnings and precautions are taken directly from the US FDA-approved drug label for Tacrolimus. This is the same information dispensing pharmacists read.
\u26a0\ufe0f Boxed Warning (Highest FDA Alert)
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 )
5 WARNINGS AND PRECAUTIONS • Not Interchangeable with Extended-Release Tacrolimus Products- Medication Errors: Instruct patients or caregivers to recognize the appearance of tacrolimus 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 tacrolimus. • Hyperkalemia: Monitor serum potassium levels.
Consider carefully before using with other agents also associated with hyperkalemia. • Hypertension: May require antihypertensive therapy.
Monitor relevant drug-drug interactions. • Anaphylactic Reactions with IV formulation: Observe patients receiving tacrolimus injection for signs and symptoms of anaphylaxis. • Not recommended for use with sirolimus: Not recommended in liver and heart transplant due to increased risk of serious adverse reactions. • Myocardial Hypertrophy: Consider dose reduction/discontinuation. • Immunizations: Avoid live vaccines. • Pure Red Cell Aplasia: Consider discontinuation of tacrolimus. • Thrombotic Microangiopathy, Including Hemolytic Uremic Syndrome and Thrombotic Thrombocytopenic Purpura: May occur, especially in patients with infections and certain concomitant medications.
5.1 Lymphoma and Other Malignancies Patients receiving immunosuppressants, including tacrolimus, are at increased risk of developing lymphomas and other malignancies, particularly of the skin.
The risk appears to be related to the intensity and duration of immunosuppression rather than to the use of any specific agent.
As usual for patients with increased risk for skin cancer, examine patients for skin changes; exposure to sunlight and UV light should be limited by wearing protective clothing and using a broad-spectrum sunscreen with a high protection factor.
Post-transplant lymphoproliferative disorder (PTLD) has been reported in immunosuppressed organ transplant recipients.
The majority of PTLD events appear related to Epstein-Barr Virus (EBV) infection.
The risk of PTLD appears greatest in those individuals who are EBV seronegative, a population which includes many young children.
Monitor EBV serology during treatment.
5.2 Serious Infections Patients receiving immunosuppressants, including tacrolimus, are at increased risk of developing bacterial, viral, fungal, and protozoal infections, including opportunistic infections.
These infections may lead to serious, including fatal, outcomes.
Serious viral infections reported include: • Polyomavirus-associated nephropathy (PVAN), mostly due to BK virus infection • JC virus-associated progressive multifocal leukoencephalopathy (PML) • Cytomegalovirus infections: CMV seronegative transplant patients who receive an organ from a CMV seropositive donor disease are at higher risk of developing CMV viremia and CMV disease.
Monitor for the development of infection and adjust the immunosuppressive regimen to balance the risk of rejection with the risk of infection [see Adverse Reactions ( 6.1 , 6.2) ] .
5.3 Not Interchangeable with Extended-Release Tacrolimus Products - Medication Errors Medication errors, including substitution and dispensing errors, between tacrolimus immediate-release products and tacrolimus extended-release products were reported outside the U.S.
This led to serious adverse reactions, including graft rejection, or other adverse reactions due to under-or overexposure to tacrolimus.
Tacrolimus capsules are not interchangeable or substitutable for tacrolimus extended-release products.
Changes between tacrolimus immediate-release and extended-release dosage forms must occur under physician supervision.
Instruct patients and caregivers to recognize the appearance of tacrolimus capsules dosage forms [see Dosage Forms and Strengths ] and to confirm with the healthcare provider if a different product is dispensed.
5.4 New Onset Diabetes After Transplant Tacrolimus was shown to cause new onset diabetes mellitus in clinical trials of kidney, liver, or heart transplantation.
New onset diabetes after transplantation may be reversible in some patients.
African-American and Hispanic kidney transplant patients are at an increased risk.
Blood glucose concentrations should be monitored closely in patients using tacrolimus [see Adverse Reactions ] .
5.5 Nephrotoxicity due to Tacrolimus and Drug Interactions Tacrolimus, like other calcineurin inhibitors, can cause acute or chronic nephrotoxicity in transplant patients due to its vasoconstrictive effect on renal vasculature, toxic tubulopathy and tubular-interstitial effects.
Nephrotoxicity was reported in clinical trials [see Adverse Reactions ] .
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