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PrimeWell Pharmacy
Generic Prograf 0.5mg

Showing the 0.5mg medicine. Other strengths look different — the picture changes with the strength you select.

Prescription · monitored

Generic Prograf

Active ingredient: Tacrolimus

Strength
Pack size

$165.00

In stock (100 available)

This medicine needs close supervision

You can add this to your basket, but we cannot dispense it until you upload a valid prescription at checkout and our registered pharmacist approves it. Because this medicine requires ongoing monitoring, our pharmacist will also confirm counselling before it is released. Your card is authorized but not charged until then.

About this medicine

Boxed warning

WARNING: MALIGNANCIES AND SERIOUS INFECTIONS IN TRANSPLANT PATIENTS; AND INCREASED MORTALITY IN FEMALE LIVER TRANSPLANT PATIENTS Increased risk for developing serious infections and malignancies with tacrolimus extended-release capsulest or other immunosuppressants that may lead to hospitalization or death. [see Warnings and Precautions ( 5.1 , 5.2 )] Increased mortality in female liver transplant patients with tacrolimus extended-release capsulest. Tacrolimus extended-release capsulest is not approved for use in liver transplantation. [see Warnings and Precautions ( 5.3 )] WARNING: MALIGNANCI

What it is used for

1 INDICATIONS AND USAGE Tacrolimus extended-release capsules is indicated for the prophylaxis of organ rejection in kidney transplant patients in combination with other immunosuppressants in adult patients who can swallow capsules intact [see Clinical Studies ( 14.1 ), ( 14.2 )] . Pediatric use information is approved for Astellas Pharma US, Inc.'s ASTAGRAF XL (tacrolimus extended-release capsules). However, due to Astellas Pharma US, Inc.'s marketing exclusivity rights, this drug product is not labeled with that information. Tacrolimus extended-release capsules is a calcineurin-inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in kidney transplant patients in combination with other immunosuppressants in adult patients who can swallow capsules intact. ( 1 , 14.1 , 14.2 )

How it is taken

2 DOSAGE AND ADMINISTRATION Capsules must be taken whole. ( 2.1 ) Take consistently every morning at the same time on an empty stomach at least 1 hour before a meal or at least 2 hours after a meal. ( 2.1 ) Avoid eating grapefruit or drinking grapefruit juice or alcohol. ( 2.1 ) African-American patients and patients with severe hepatic impairment may require dosing adjustments. ( 2.3 ) Frequent monitoring of trough concentrations is recommended. ( 2.4 ) For complete dosing information, see Full Prescribing Information. MMF = Mycophenolate mofetil Recommended Tacrolimus Extended-Release Capsules Initial Dosage Patient Population Initial Oral Dosage Whole Blood Trough Concentration Range ADULT With basiliximab, MMF and steroids 0.15 mg/kg to 0.2 mg/kg once daily prior to reperfusion or within 48 hours of completion of transplant Month 1: 7 ng/mL to 15 ng/mL Month 2 to Month 6: 5 ng/mL to 15 ng/mL More than 6 Months: 5 ng/mL to 10 ng/mL With MMF and steroids, without basiliximab induction First dose (pre-operative): 0.1 mg/kg, within 12 hours prior to reperfusion Subsequent doses (post-operative): 0.2 mg/kg once daily at least 4 hours after pre-operative dose and within 12 hours afte

Warnings

5 WARNINGS AND PRECAUTIONS Not Interchangeable with Other Tacrolimus Products-Medication Errors: Instruct patients or caregivers to recognize the appearance of tacrolimus extended-release capsules. ( 5.4 ) New onset diabetes after transplant: Monitor blood glucose. ( 5.5 ) Nephrotoxicity (acute and/or chronic): May occur due to tacrolimus extended-release capsules, drug interactions, concomitant nephrotoxic drugs. Monitor renal function; consider dosage reduction. ( 5.6 ) Neurotoxicity: Including risk of posterior reversible encephalopathy syndrome (PRES), monitor for neurologic abnormalities; reduce dosage or discontinue tacrolimus extended-release capsules. ( 5.7 ) Hyperkalemia: Risk may be increased with other agents associated with hyperkalemia; monitor serum potassium levels. ( 5.8 ) Hypertension: May require antihypertensive therapy; monitor relevant drug interactions. ( 5.9 ) QT prolongation: Consider obtaining electrocardiograms and monitoring electrolytes in patients at high risk. ( 5.11 ) Immunizations: Avoid live vaccines. ( 5.12 ) Pure red cell aplasia: Consider discontinuation of tacrolimus extended-release capsules. ( 5.13 ) Thrombotic Microangiopathy, Including Hemol

Source: openFDA / DailyMed. Provided for information only — always follow the directions given by your own prescriber.