GNH USA

USA — NDC

Prograf .5 mg/1

GNH USA supplies Prograf 0.5mg (tacrolimus) capsules, a calcineurin-inhibitor immunosuppressant for prevention of organ transplant rejection.

Tacrolimus
Prograf
CAPSULE, GELATIN COATED
.5 mg/1

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1
Pack/s

What is Tacrolimus?

Tacrolimus, the active ingredient in Prograf 0.5mg, is a calcineurin-inhibitor immunosuppressant supplied as gelatin-coated capsules taken twice daily. It prevents the immune system rejecting a transplanted organ and is licensed for adults and children receiving liver, kidney, heart, or lung transplants, always alongside other immunosuppressive medicines. The 0.5mg strength allows fine dose adjustment. GNH USA supplies Prograf 0.5mg as a licensed, GDP-compliant international pharmaceutical supplier serving transplant centres worldwide.

What is Tacrolimus used for?

Tacrolimus is used to prevent rejection after solid organ transplantation, given in combination with other immunosuppressants. - Prevention of kidney transplant rejection: a mainstay of maintenance immunosuppression after renal transplantation. - Prevention of liver transplant rejection: used shortly after surgery and continued long term. - Prevention of heart transplant rejection: given as part of a combination regimen. - Prevention of lung transplant rejection: included in the licensed indications alongside other immunosuppressants. - Paediatric transplantation: used in children, who often need higher weight-adjusted doses than adults. - Fine dose titration: the 0.5mg strength allows small adjustments to hit the target blood level.

What are the side effects of Tacrolimus?

Kidney function, blood pressure, blood sugar, and potassium all need regular monitoring throughout treatment. Common Side Effects: - Tremor and headache: common neurological effects, often dose-related. - Reduced kidney function: rising creatinine is frequent and prompts dose review. - Raised blood sugar and new-onset diabetes: common enough to require routine glucose monitoring. - High blood potassium and high blood pressure: both frequently need treatment in their own right. Serious or Rare Side Effects: - Serious and opportunistic infections: including BK virus nephropathy and, rarely, progressive multifocal leukoencephalopathy; report fever or persistent illness. - Lymphoma and skin cancer: immunosuppression raises the risk of post-transplant lymphoproliferative disorder and skin malignancy; report new lumps or skin lesions. - Neurotoxicity, QT prolongation, or thrombotic microangiopathy: seek urgent care for seizures, confusion, visual disturbance, or palpitations.

What precautions apply to Tacrolimus?

Tacrolimus has a narrow therapeutic range and carries boxed warnings, so it must be prescribed and monitored by transplant specialists. - Prescribe only under specialist supervision: treatment requires physicians experienced in immunosuppression and facilities with full laboratory support. - Monitor blood levels routinely: trough concentrations guide dosing, since both under-exposure and over-exposure cause serious harm. - Take doses consistently: give the capsules the same way each time in relation to food, since food alters how much drug is absorbed. - Avoid grapefruit entirely: grapefruit and its juice raise tacrolimus levels and the risk of toxicity. - Protect against skin cancer: limit sun and ultraviolet exposure, use high-factor sunscreen, and wear protective clothing. - Do not switch formulations casually: immediate-release and extended-release tacrolimus are not interchangeable and errors have caused graft rejection.

What does Tacrolimus interact with?

Tacrolimus is metabolised by CYP3A4 and interacts with a long list of medicines, so review the full list before any change. Major Interactions (Avoid): - Strong CYP3A4 inhibitors (ketoconazole, voriconazole, clarithromycin, ritonavir): these sharply raise tacrolimus levels and the risk of kidney and neurological toxicity. - Strong CYP3A4 inducers (rifampicin, carbamazepine, St John’s wort): these lower levels and can allow graft rejection. Moderate Interactions (Monitor Closely): - Nephrotoxic drugs (aminoglycosides, amphotericin B, NSAIDs): the combined load on the kidneys raises the risk of injury. - Cannabidiol: raises tacrolimus concentrations, so monitor levels and consider a dose reduction. - Potassium-sparing diuretics and potassium supplements: these add to the risk of high blood potassium.

Frequently asked questions

What is Prograf 0.5mg used for?+
Prograf 0.5mg contains tacrolimus, an immunosuppressant that stops the body rejecting a transplanted organ. It is licensed for adults and children who have received a liver, kidney, heart, or lung transplant, and is always used alongside other immunosuppressive medicines. The 0.5mg strength is the smallest capsule and allows small, precise adjustments to reach the right blood level.
How does tacrolimus work?+
Tacrolimus quietens the T-cells that would otherwise attack a transplanted organ. Inside the cell it binds a protein called FKBP-12, and together they block an enzyme called calcineurin. The cell needs calcineurin in order to produce interleukin-2, the signal that tells T-cells to multiply and attack. Without it, the immune response against the graft is suppressed.
What is the boxed warning for Prograf?+
Prograf carries a boxed warning for malignancies and serious infections. Because it suppresses the immune system, patients face an increased risk of bacterial, viral, fungal, and protozoal infections, including opportunistic infections, and of cancers such as lymphoma and skin cancer. Both risks relate to the intensity and duration of immunosuppression, and either can lead to hospitalisation or death.
Should Prograf be taken with or without food?+
The important point is consistency. Prograf capsules should be taken the same way each time, either always with food or always without, because food reduces how much tacrolimus the body absorbs. Changing the routine changes blood levels, which is significant for a medicine with such a narrow safe range. Grapefruit and grapefruit juice must be avoided entirely.
Why does tacrolimus need blood level monitoring?+
Tacrolimus has a narrow therapeutic range, meaning the gap between too little and too much is small. Too little allows the immune system to attack the transplanted organ and cause rejection. Too much causes kidney damage, tremor, high blood sugar, and other toxicity. Regular trough blood tests let the transplant team keep levels within the target range and adjust the dose.
How do I order Prograf 0.5mg from GNH USA?+
You can request Prograf 0.5mg through the product page at gnh-usa.com by submitting an enquiry with your required quantity. GNH USA supplies hospitals, transplant centres, and procurement teams across international markets and will ask you to confirm trade or institutional credentials. The team then replies with pricing, availability, shipping arrangements, and the documentation needed for import into your country.
How is tacrolimus different from ciclosporin?+
Both are calcineurin inhibitors that block the same enzyme and prevent T-cells activating, but they bind different intracellular proteins and differ in potency and side effect profile. Tacrolimus is generally more potent and is more associated with tremor, high blood sugar, and new-onset diabetes, while ciclosporin more often causes gum overgrowth and increased hair growth. They are not interchangeable.
How should Prograf 0.5mg be stored?+
Prograf capsules should be stored at room temperature in the original container, away from moisture, heat, and direct sunlight, and out of the reach of children. Keep the bottle tightly closed and handle the capsules with clean, dry hands. Do not use them after the printed expiry date, and do not open or crush the capsules unless a pharmacist directs otherwise.
Why should sun exposure be limited on tacrolimus?+
Long-term immunosuppression raises the risk of skin cancer, and ultraviolet light adds to that risk. Transplant patients on tacrolimus are advised to limit time in strong sunlight, cover up with protective clothing, and use a high-factor sunscreen routinely. Regular skin checks are also recommended, and any new, changing, or non-healing skin lesion should be reported promptly.
Who should not take Prograf?+
Prograf is contraindicated in anyone with hypersensitivity to tacrolimus, and the injection form is contraindicated in those sensitive to polyoxyl 60 hydrogenated castor oil. Caution is needed in patients with existing kidney impairment, uncontrolled infection, or a history of malignancy. Because dosing depends on blood levels, it is prescribed only by clinicians experienced in transplant immunosuppression.
Information provided on this page is for educational use by procurement and clinical professionals. Always consult a licensed healthcare provider for medical advice and prescribing decisions. GNH USA supplies this product subject to applicable regulatory and licensing requirements.

Product details

Drug
Tacrolimus
Brand
Prograf
Strength
.5 mg/1
Form
CAPSULE, GELATIN COATED
Route
ORAL
Pack size
1 BOTTLE in 1 CARTON (0469-0607-73) / 100 CAPSULE, GELATIN COATED in 1 BOTTLE
Manufacturer
Astellas Pharma US, Inc.
Origin
USA

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