PROGRAF (TACROLIMUS)

Pograf is FDA-cleared medicine given by doctors to patients who have had heart, kidney, lung, or liver transplants, to avoid rejection of their transplanted organs. It is prescribed along with other medications. Its active ingredient or main content is Tacrolimus, previously known as FK506.

Prograf (Tacrolimus) belongs to the pharmacological class: Calcineurin inhibitors/immunosuppressants. Calcineurin inhibitors are the class of medications that inhibit the activity of calcineurin enzymes. Calcineurin has a role in T-cell activation which takes part in cell-mediated immunity. As Prograf acts to suppress cell-mediated immunity by blocking calcineurin and further prevent rejection of the transplanted organ, it comes under the drug class of immunosuppressants and calcineurin inhibitors which are even called anti-rejection drugs.

Prograf capsules are hard and oblong. They come in three strengths:

• 0.5mg: Its light-yellow capsule with a shell containing titanium dioxide USP, ferric oxide NF, and gelatin NF. The capsule cap has “0.5mg” and the capsule body has “f607” imprinted in red.
• 1mg: It’s a white capsule with a shell containing titanium dioxide USP and gelatin NF. The capsule cap has “1mg” and the capsule body has “f617” imprinted in red.
• 5mg: It’s a greyish-red capsule with a shell containing titanium dioxide USP, ferric oxide NF, and gelatin NF. The capsule cap has “0.5mg” and the capsule body has “f657” imprinted in white.

Prograf capsule is meant for immunosuppression and anti-rejection of transplanted organs. Its usage is concomitant with adrenal corticosteroids, for prevention of organ rejection in cases where allogeneic kidney, heart, or liver transplantation has been done.

• The recommended initial dosing in case of an adult kidney transplant is 0.2mg/kg/day when combined with azathioprine.
• The recommended initial dosing in case of an adult kidney transplant is 0.1mg/kg/day when combined with MMF/IL-2 receptor antagonist.
• The recommended initial dosing in case of an adult liver transplant is 0.10-0.15mg/kg/day while for a pediatric live transplant, it is 0.15-0.20mg/kg/day.
• The recommended initial dosing in case of an adult heart transplant is 0.075mg/kg/day.
• Every recommended dosage is divided into two and needs to be taken every 12 hours.
• Renal and hepatic impaired patients should lower their initial recommended dosing while black patients should increase their dosing to have comparable whole blood trough concentrations.

Prograf is available in the form of capsules meant for oral administration. Swallow the capsule with a glass full of water, daily at the same time with or without food. Do not open, chew, or crush it.

Some reported side effects of taking Prograf capsules are:

• A general sick feeling, a swelling or pain close to the transplanted organ.
• Stomach issues like diarrhea, constipation, stomach ache, nausea, and loss of appetite.
• Insomnia
• Nervous system problems like tremors, headaches, tingling sensation or numbness in hands and feet, and others.
• Signs of high levels of blood sugar and hypertension.
• Signs of low levels of phosphate and magnesium in the blood.
• Bronchitis
• Pain
• Weakness
• Fever
• Fluid accumulation around the heart.
• Swelling in legs, ankles, hands, or feet.

Here is a non-exhaustive list of drugs and supplements known to interact with Prograf capsules:

• Medications to treat bacterial and viral infections, osteoporosis, bowel disorders, hypertension, arthritis, pain, and cancer.
• Birth control pills or hormone-based drugs.
• Other medicines or immunosuppressants that prevent organ transplant rejections like Mycophenolate mofetil and Sirolimus.
• Diuretics (water pills)
• HIV medicines
• Antacids containing Aluminium or Magnesium.
• Seizure medicine
• Calcium channel blockers
• St John’s wort
• Potassium supplements

Prograf capsule intake is not meant for:

• Patients with known allergy or hypersensitivity to components of Prograf capsule.
• Pregnant and lactating women.
• Patients previously diagnosed with kidney, heart, or liver disease or problems not related to transplant.
• Patients with a family history of long QT syndrome.
• Patients scheduled to receive a vaccine.

Take note of the following precautions while taking Prograf:

• Avoid drug/disease interactions with Prograf by sharing information about your current intake of drugs, and illnesses (if any) with your doctor.
• Avoid sudden discontinuation of intake of Prograf, its overdose, or arbitrarily skipping the dose.
• Inform the doctor beforehand if pregnant, planning childbearing, or breastfeeding.
• Take Prograf as per the doctor’s advice and instructions on the label.
• Avoid getting vaccinated.
• Avoid consuming grapefruit or its products.
• Avoid direct sunlight exposure, UV light exposure, and tanning beds.

• Store the supply bottle of Prograf capsules at controlled room temperature, preferably at 20-25℃.
• Keep it away from light, heat, and moisture, and out of reach of small children.
• For short periods such as when transporting the medicine, Prograf can be exposed to temperatures between 15 to 30℃.

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