PROGRAF® (Tacrolimus) 0.5 mg, 50 capsules

What is PROGRAF?

PROGRAF® (tacrolimus) is an immunosuppressive medicine used to help prevent organ rejection in individuals who have undergone kidney, liver, heart, or lung transplants. It works by suppressing the immune system to prevent it from attacking the transplanted organ. PROGRAF is available in different formulations, such as capsules and granules, and should not be confused with other tacrolimus extended-release versions.

How does PROGRAF work?

Tacrolimus, the active ingredient in PROGRAF, inhibits T-cell activation, a key process in the immune response. By binding to specific proteins in the body, it prevents the immune system from recognizing the transplanted organ as foreign, thus reducing the risk of organ rejection.

What are the key safety concerns with PROGRAF?

Cancer risk: People taking PROGRAF have an increased risk of developing certain cancers, including skin cancer and lymphoma.

Infection risk: PROGRAF suppresses the immune system, which may reduce its ability to fight infections. Serious infections, potentially life-threatening, can occur during treatment. It's important to contact a healthcare provider if symptoms like fever, muscle aches, or flu-like symptoms appear.

Other concerns: You should not take PROGRAF if you're allergic to tacrolimus or any of the ingredients in this medication.

What should I tell my healthcare provider before taking PROGRAF?

Inform your healthcare provider if you:

• Have or have had liver, kidney, heart, or lung problems.
• Are pregnant, planning to become pregnant, or breastfeeding. PROGRAF may harm an unborn baby, and it passes into breast milk.
• Plan to receive any vaccines. Live vaccines should be avoided while taking PROGRAF.
• Take other medications. PROGRAF can interact with many drugs, such as certain antibiotics, antivirals, antifungals, and medications for high blood pressure.

How should I take PROGRAF?

• Take PROGRAF exactly as prescribed, at the same time every day, 12 hours apart, to maintain consistent drug levels in your body.
• You can take PROGRAF with or without food, but it’s important to choose one method and stick with it.
• Do not open or crush the capsules. If you miss a dose, contact your healthcare provider.

What side effects should I expect while taking PROGRAF?

Common side effects include:

• Tremors, headache, and trouble sleeping.
• High blood sugar, leading to symptoms like frequent urination and increased thirst.
• Kidney problems, which may be monitored by regular blood tests.
• High blood pressure, which may require medication to control.

Other side effects include diarrhea, stomach pain, and numbness or tingling in the hands and feet.

How should I store PROGRAF?

Store PROGRAF capsules in their original packaging at a temperature no higher than 25°C (77°F).

Keep the medicine out of reach of children and dispose of it properly if it expires.

Can I take PROGRAF with food?

Yes, but you should either always take it with food or always take it on an empty stomach for consistent absorption.

What should I avoid while taking PROGRAF?

• Sun exposure: PROGRAF may increase sensitivity to sunlight, so use sunscreen and wear protective clothing.
• Grapefruit: Avoid eating grapefruit or drinking grapefruit juice, as it can interfere with how your body processes PROGRAF.
• Live vaccines: Do not receive live vaccines during treatment, as PROGRAF weakens your immune system.

What should I do in case of an overdose?

If you suspect you have taken too much PROGRAF, contact your healthcare provider or visit the nearest emergency room immediately.