Generic Prograf

Introduction

Prograf is an oral immunosuppressant that contains the active compound tacrolimus. It is primarily prescribed to prevent organ rejection after kidney, liver, or heart transplantation. In the United Kingdom, Prograf is marketed by Astellas Pharma Ltd and classified under the general health medication group. Tacrolimus also has recognised secondary uses such as the treatment of certain dermatological conditions (e.g., severe atopic dermatitis) and the management of autoimmune nephritis, although these indications are less common and often off‑label.

What is Prograf?

Prograf is a brand‑name formulation of tacrolimus, a macrolide immunosuppressant first approved by the European Medicines Agency (EMA) in 1995. The tablet delivers tacrolimus in immediate‑release form, enabling rapid absorption after oral administration. While Prograf is the original product, the same active ingredient is available as generic tacrolimus and as extended‑release variants (e.g., Advagraf®, Envarsus®). Our online pharmacy provides this generic alternative as a cost‑effective treatment option for patients who need long‑term immunosuppression.

How Prograf Works

Tacrolimus binds to the intracellular protein FKBP‑12 (FK506‑binding protein). The tacrolimus‑FKBP‑12 complex inhibits calcineurin, a phosphatase required for activation of the transcription factor NF‑AT (nuclear factor of activated T‑cells). By blocking NF‑AT, the drug suppresses the production of interleukin‑2 and other cytokines that drive T‑cell proliferation. The net effect is a reduction in the immune response that would otherwise target a transplanted organ.

Onset of action occurs within 1–2 hours after ingestion, with peak plasma concentrations at 1.5–3 hours. The drug’s half‑life in adults ranges from 8 to 12 hours, necessitating twice‑daily dosing for most immediate‑release formulations. Tacrolimus is metabolised primarily by hepatic CYP3A4 and CYP3A5 enzymes and eliminated in the bile.

Conditions Treated with Prograf

• Renal (kidney) transplantation – Over 4,000 kidney transplants are performed annually in the UK; tacrolimus‑based regimens are standard because they lower acute rejection rates compared with older agents such as cyclosporine.
• Liver transplantation – Tacrolimus improves graft survival and is recommended by the British Transplantation Society for most adult liver recipients.
• Heart transplantation – Evidence from the UK and European transplant registries shows reduced rejection episodes when tacrolimus is used as part of triple‑therapy (tacrolimus, mycophenolate, steroids).
• Severe atopic dermatitis – In selected patients unresponsive to topical steroids, oral tacrolimus can be used off‑label to control inflammation.
• Autoimmune nephritis (e.g., lupus nephritis) – Small‑scale UK studies indicate tacrolimus may be added to standard therapy for refractory disease, though this remains an off‑label indication.

The drug’s effectiveness stems from its targeted inhibition of T‑cell activation, the central mechanism underlying transplant rejection and many autoimmune processes.

Who is Prograf For?

• Adult transplant recipients – Patients who have undergone kidney, liver, or heart transplantation and require lifelong immunosuppression.
• Individuals with refractory dermatological or renal autoimmune disease – When conventional therapies fail, tacrolimus may be considered under specialist supervision.
• Patients with stable liver function – Because tacrolimus is metabolised hepatically, those with severe hepatic impairment may need dose adjustment or an alternative agent.
• Patients without contraindicating infections – Active uncontrolled infections (e.g., cytomegalovirus, tuberculosis) are a relative contraindication, as immunosuppression could exacerbate disease.

Prograf is not appropriate for patients with known hypersensitivity to tacrolimus, those with severe uncontrolled hypertension, or individuals taking strong CYP3A4 inhibitors (e.g., ketoconazole) without dose modification.

Risks, Side Effects, and Interactions

Common

• Tremor
• Headache
• Nausea or abdominal discomfort
• Diarrhoea
• Elevated blood glucose (possible new‑onset diabetes after transplantation)

Rare

• Hyperlipidaemia
• Peripheral neuropathy
• Hypertension worsening
• Hepatotoxicity (elevated liver enzymes)

Serious

• Nephrotoxicity – tacrolimus can cause dose‑dependent reductions in glomerular filtration rate; regular renal function monitoring is essential.
• Neurotoxicity – seizures, posterior reversible encephalopathy syndrome (PRES) have been reported, particularly at high trough levels.
• Infections – opportunistic infections (e.g., CMV, fungal) are more frequent due to immunosuppression.
• Malignancy – long‑term use is associated with an increased risk of skin cancers and post‑transplant lymphoproliferative disorder.

Clinically Relevant Drug Interactions

• CYP3A4 inhibitors (ketoconazole, itraconazole, clarithromycin, ritonavir) – increase tacrolimus concentrations; dose reductions of 30–50 % may be required.
• CYP3A4 inducers (rifampicin, carbamazepine, St. John’s wort) – lower tacrolimus levels; dose escalation may be necessary.
• Calcium channel blockers (diltiazem, verapamil) – may raise tacroline levels modestly.
• Antacids containing aluminium or magnesium – can reduce absorption if taken simultaneously; separate administration by at least 2 hours is advised.

Patients should disclose all prescribed, over‑the‑counter, and herbal products to their healthcare team.

Practical Use: Dosing, Missed Dose, Overdose

• Standard dosing – The typical adult dose for immediate‑release Prograf is .1 mg/kg twice daily, adjusted to maintain trough concentrations of 5–15 ng/mL (kidney) or 10–20 ng/mL (liver/heart). Dosing is individualised based on therapeutic drug monitoring (TDM).
• Missed dose – If a dose is forgotten within 6 hours, take it as soon as remembered. If more than 6 hours have passed, skip the missed dose and resume the regular schedule; do not double‑dose.
• Overdose – Symptoms may include severe tremor, confusion, or renal dysfunction. Seek urgent medical attention; supportive care and possible haemodialysis are recommended in extreme cases.
• Food and alcohol – High‑fat meals can increase tacrolimus absorption; consistency in meal composition helps maintain stable drug levels. Moderate alcohol consumption is acceptable, but excessive intake may exacerbate hepatotoxicity.
• Comorbidities – Patients with diabetes, hypertension, or chronic kidney disease require closer monitoring of blood glucose, blood pressure, and serum creatinine while on Prograf.

Buying Prograf from Our Online Pharmacy

Prograf can be purchased from our online pharmacy in the UK with a focus on safety, affordability, and privacy.

• Affordable pricing – We negotiate directly with licensed overseas suppliers to offer prices close to the manufacturer’s cost, making generic tacrolimus accessible for long‑term users.
• Verified quality – Every batch is sourced from GMP‑certified facilities and undergoes independent testing for potency and purity before shipment.
• Guaranteed delivery – Discreet packaging is dispatched via express service (typically 7 days) or standard airmail (approximately 3 weeks), with tracking available for all orders.
• Pharmacy broker service – We act as an intermediary between patients and internationally licensed pharmacies, ensuring compliance with UK import regulations while protecting patient confidentiality.

For patients who encounter limited stock or high prices at local pharmacies, our service provides a reliable alternative without compromising safety or legal standards.

FAQ

• Is Prograf available in both brand‑name and generic forms in the UK?
  Yes. The original brand‑name product is Prograf®, manufactured by Astellas. Generic tacrolimus tablets contain the same active ingredient and are approved by the Medicines and Healthcare products Regulatory Agency (MHRA). Generic versions are usually less expensive while offering identical therapeutic effect when taken at equivalent doses.

• Does Prograf require refrigeration?
  No. Immediate‑release Prograf tablets are stable at room temperature (15‑30 °C). They should be kept in the original container, away from moisture, direct sunlight, and heat sources such as radiators.

• What does the packaging of Prograf look like when ordered online?
  Tablets are supplied in blister packs of 30 units, each blister sealed individually to protect against moisture. The outer box bears the product name, strength (e.g., 1 mg), batch number, expiry date, and a MHRA registration number for verification.

• Can Prograf be imported into the UK for personal use?
  Under the UK’s “personal import” scheme, individuals may receive up to a three‑month supply of a prescription‑only medication for personal use, provided the product is authorised in the country of origin and is not a controlled substance. Our online pharmacy ensures that all shipments meet these legal criteria.

• Are there specific warnings for Asian populations taking tacrolimus?
  Genetic polymorphisms in the CYP3A5 enzyme are more prevalent among individuals of Asian descent, leading to higher tacrolimus clearance. Consequently, Asian patients often require higher maintenance doses to achieve target trough levels, as documented in MHRA‑approved prescribing guidelines.

• How does the immediate‑release formulation differ from the extended‑release versions (e.g., Advagraf, Envarsus)?
  Immediate‑release Prograf requires twice‑daily dosing because it reaches peak concentrations quickly and is cleared within 12 hours. Extended‑release formulations are designed for once‑daily administration, providing steadier blood concentrations and potentially improving adherence. The choice of formulation depends on the transplant centre’s protocol and the patient’s pharmacokinetic profile.

• What is the typical shelf life of Prograf tablets?
  The manufacturer assigns a shelf life of 24 months from the date of manufacture, provided the product is stored at controlled room temperature and the packaging remains intact. Expiry dates are printed on each blister pack and must be respected.

• Does tacrolimus interfere with drug testing for employment or sport?
  Tacrolimus is not listed on standard occupational drug‑screening panels and is not prohibited by the World Anti‑Doping Agency (WADA). However, therapeutic drug monitoring uses specialized assays that could be detected in a clinical laboratory setting.

• Can food composition affect tacrolimus blood levels?
  Yes. High‑fat meals can increase tacroline absorption, potentially raising trough concentrations by 20–30 %. Consistency in meal timing and composition is recommended, and any intentional dietary changes should be discussed with a clinician to adjust dosing if necessary.

• What was the historical development of tacrolimus?
  Tacrolimus was isolated in 1984 from the soil bacterium Streptomyces tsukubaensis by Fujisawa (now Astellas). Early trials demonstrated superior graft‑survival rates compared with cyclosporine, leading to its approval for transplantation in the mid‑199s. Since then, the molecule has been reformulated into various release profiles and investigated for autoimmune and dermatological applications.

• How does therapeutic drug monitoring improve safety with Prograf?
  Because tacrolimus has a narrow therapeutic window, regular measurement of trough blood concentrations (C) helps clinicians maintain efficacy while avoiding nephrotoxicity and neurotoxicity. Target ranges differ by organ transplanted; adjusting the dose based on TDM reduces the risk of rejection and adverse events.

• Is there a risk of developing resistance to tacrolimus?
  Long‑term use can lead to reduced responsiveness due to up‑regulation of drug efflux pumps (e.g., P‑glycoprotein) or changes in calcineurin expression. In such cases, clinicians may add or switch to alternative immunosuppressants, underscoring the importance of ongoing clinical assessment.

Glossary

Calcineurin

An intracellular enzyme that activates T‑cells by dephosphorylating NF‑AT; inhibition by tacrolimus suppresses immune responses.

Therapeutic window

The plasma concentration range in which a drug is effective without causing unacceptable toxicity; for tacrolimus this range is relatively narrow and requires monitoring.

CYP3A4/5

Liver enzymes that metabolise many drugs, including tacrolimus; variations in these enzymes affect drug levels and dosing requirements.

Trough concentration (C)

The lowest concentration of a drug in the bloodstream, measured just before the next dose; used to guide tacrolimus dosing in transplant patients.

⚠️ Disclaimer

The information provided about Prograf is for general knowledge only. It does not replace professional medical consultation. All treatment decisions should be made under the supervision of a qualified healthcare provider. We assume all readers are responsible adults capable of making informed decisions about their health. Our online pharmacy offers access to Prograf for individuals who may have limited availability through traditional pharmacies, prescription‑based insurance schemes, or who are seeking affordable generic alternatives. Always consult your doctor before starting, changing, or discontinuing any medication.