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Tacrolimus is an immunosuppressant medication that reduces your body's ability to combat infections and diseases. This can elevate your risk of infections and certain cancers, such as skin cancer and lymphoma. To minimize these risks, it is crucial to take the medication at the lowest effective dose as advised by your healthcare provider. It is also important to attend all scheduled medical and laboratory appointments.

Key Safety Information and Warnings:

• Cancer Risk: Long-term use or high doses of tacrolimus may increase your risk of developing skin or lymph node cancers, especially if you have a history of skin cancer or Epstein-Barr virus (EBV) infection. To reduce this risk, limit sun exposure, wear protective clothing, and use sunscreen. Regularly check your skin for any unusual changes and report them to your doctor immediately.

• Serious Infections: Tacrolimus can impair your immune response, making you more susceptible to serious infections, including those affecting the kidneys, liver, or brain. Your healthcare provider will monitor you for signs of infection. Inform your provider if you experience symptoms like fever, chills, or nausea.

• Increased Mortality Risk in Females After Liver Transplant: Females using Astagraf XL (a form of tacrolimus) after a liver transplant may face a higher risk of sudden death. Astagraf XL is only FDA-approved for kidney transplants.

• High Blood Sugar: This medication may elevate blood sugar levels, potentially leading to diabetes. Monitor for symptoms such as excessive thirst or frequent urination, and consult your provider for blood sugar monitoring.

• Kidney Problems: Tacrolimus can cause kidney issues, possibly leading to elevated potassium or uric acid levels. Regular lab tests are necessary to ensure safety and adjust the dosage if needed.

• Neurological Issues: High doses of tacrolimus can lead to neurological issues, including tremors, memory problems, or seizures. Report any changes in mood or movement to your provider.

• High Blood Pressure: Tacrolimus may cause or worsen high blood pressure. Regular monitoring is recommended, and certain blood pressure medications may interact with tacrolimus.

• Heart Rhythm Issues: Tacrolimus can affect heart rhythm, increasing the risk of QT prolongation. Your heart rhythm and blood work will be monitored. Seek emergency help if you experience chest pain or difficulty breathing.

• Blood Disorders: Some individuals may develop blood disorders, resulting in anemia or increased bleeding risk. Watch for unexplained bruising or fatigue.

• Pregnancy Risks: Tacrolimus may harm unborn babies and reduce sperm count. It is not recommended during pregnancy. Discuss birth control options with your provider and consider enrolling in the Transplantation Pregnancy Registry if you become pregnant while on this medication.

• Vaccine Interaction: Tacrolimus can affect your response to vaccines, particularly live vaccines, increasing the risk of infections. Avoid live vaccines and consult your provider about your vaccination history.

• Drug Interactions: Some drugs may alter how tacrolimus is processed in your body, affecting its efficacy and side effects. Always inform your provider about any other medications you are taking.

Contraindications:

• Avoid using tacrolimus if you have a known allergy to the medication or its components, such as polyoxyl 60 hydrogenated castor oil (HCO-60) in tacrolimus injections. Always consult your healthcare provider if you have any concerns or underlying health conditions before starting tacrolimus.

When taking this medication, some common side effects may occur, typically mild and manageable. These include shaking, headache, diarrhea, nausea, upset stomach, and trouble sleeping. In some cases, individuals might experience high blood pressure, changes in electrolyte levels, infections, increased creatinine levels, swelling of hands and feet, constipation, general pain, feeling weak, and low red blood cell count. While these effects are often not serious, consult your healthcare provider if they persist or worsen.

Some other side effects, though less common, include vomiting, fever, indigestion, joint pain, back pain, and a prickling sensation. Additionally, difficulty catching your breath can occur. If you experience any of these, especially if they are severe, it is important to contact your healthcare provider.

Serious side effects, although rare, demand immediate medical attention. These include abnormal heart rhythms, characterized by chest pounding and difficulty breathing, serious infections, and symptoms of heart attack or stroke. Sudden kidney injury and nerve problems, such as seizures or severe dizziness, are also significant concerns. If you notice signs of low blood cell counts, such as unusual bleeding, or symptoms of a heart attack or stroke, seek urgent medical care.

In rare cases, this medication can lead to a serious brain infection, known as progressive multifocal leukoencephalopathy. Symptoms include clumsiness, sudden changes in thinking, or problems with coordination and speech. Additionally, a very serious allergic reaction could occur, presenting symptoms like rash, swelling, or difficulty breathing. Immediate medical help is crucial if these occur. Always monitor for high blood sugar symptoms, such as increased thirst or frequent urination, as the medication might cause diabetes. Regular blood pressure checks are advised since this medication can elevate blood pressure levels. If you experience any unusual side effects not listed here, it is important to contact your healthcare provider for further guidance.

When taking Tacrolimus (Prograf), it's important to be aware of potential interactions with other medications and supplements. Inform your healthcare provider about all the medicines and supplements you use, including prescriptions, over-the-counter drugs, vitamins, and herbal products. Below are some key interactions:

1. Medications Not Recommended for Use with Tacrolimus:

   • Certain medicines such as Bepridil, Cisapride, Dronedarone, Lefamulin, Mesoridazine, Mifepristone, Nelfinavir, Pimozide, Piperaquine, Posaconazole, Ritonavir, Saquinavir, Sparfloxacin, Terfenadine, Thioridazine, and Ziprasidone should generally be avoided. Your doctor may choose to either not prescribe Tacrolimus or adjust other medications.

2. Medications Typically Not Recommended but May Be Necessary:

   • Some drugs might be used in combination with Tacrolimus if deemed necessary. These include, but are not limited to, Abametapir, Aceclofenac, Cyclosporine, and others. Your healthcare provider might adjust dosages if these are used together.

3. Medications that May Increase Side Effects:

   • Using Tacrolimus with drugs like Danazol, Ertapenem, Lansoprazole, Nifedipine, and Tigecycline may heighten certain side effects. If both drugs are needed, your doctor may modify how you take them.

Additionally, avoid alcohol as it can cause Tacrolimus to release too quickly, increasing the risk of side effects. Some medications can alter how Tacrolimus is removed from your body, affecting its effectiveness. These include azole antifungals (e.g., Itraconazole, Voriconazole), Cimetidine, and others. Always consult your healthcare provider before starting or stopping any medications while on Tacrolimus.