Renograf

Tacrolimus monohydrate

Prophylaxis of transplant rejection in adult kidney or liver allograft recipients. Allograft rejection resistant to treatment w/ other immunosuppressive medicinal products in adult patients.

Prophylaxis of kidney transplant rejection Initially 0.20-0.30 mg/kg once daily in the morning w/in 24 hr after the completion of surgery. Prophylaxis of liver transplant rejection Initially 0.10-0.20 mg/kg once daily in the morning approx 12-18 hr after the completion of surgery. Allograft rejection after kidney or liver transplantation Begin w/ the initial oral dose recommended in kidney & liver transplantation respectively for prophylaxis of transplant rejection. Allograft rejection after heart transplantation Adult 0.15 mg/kg once daily in the morning. Allograft rejection after transplantation of other allografts Lung-transplanted patient Initially 0.10-0.15 mg/kg daily. Pancreas-transplanted patients Initially 0.20 mg/kg daily. Intestinal transplantation Initially 0.30 mg/kg daily.

Should be taken on an empty stomach.

Hypersensitivity to tacrolimus or other macrolides.

Graft rejection or other side effects which could be a consequence of either under- or overexposure to tacrolimus. Prophylaxis of transplant rejection in adult heart allograft recipients. Suspected symptoms or signs of GI perforation. Cardiomyopathies may occur. May prolong the QT interval & cause Torsades de Pointes. Patients w/ risk factors for QT prolongation including those w/ personal or family history of QT prolongation, CHF, bradyarrhythmias & electrolyte abnormalities; diagnosed or suspected to have congenital long QT syndrome or acquired QT prolongation, or on concomitant medications known to prolong the QT interval, induce electrolyte abnormalities or known to increase exposure. Development of EBV-associated lymphoproliferation disorders or posterior reversible encephalopathy syndrome. Limit exposure to sunlight & UV light due to risk of malignant skin changes. Eye disorders (sometimes progressive to loss of vision). Increased risk for infections including opportunistic infections eg, BK virus associated nephropathy & JC virus associated progressive multifocal leukoencephalopathy; viral hepatitis. Pure red cell aplasia. Non-Caucasian patients & patients at elevated immunological risk (eg, retransplantation, evidence of panel reactive Abs). Monitor BP, ECG, neurological & visual status, fasting blood glucose levels, electrolytes (particularly K), liver & renal function tests, haematology parameters, coagulation values, & plasma protein determinations during the initial post-transplant period; blood level conc during episodes of diarrhea. Monitor high-risk patients receiving substantial immunosuppression using echocardiography or ECG pre- & post-transplant (eg, initially at 3 mth & then at 9-12 mth) & reduce dose if abnormalities develop. Combination w/ strong CYP3A4 inhibitors (eg, telaprevir, boceprevir, ritonavir, ketoconazole, voriconazole, itraconazole, telithromycin or clarithromycin) or inducers (eg, rifampicin, rifabutin); w/ medicinal products known to have nephrotoxic or neurotoxic effects; immunosuppressives eg, antilymphocytic Abs (eg, basiliximab, daclizumab). Avoid herbal prep containing St. John's wort or other herbal prep; ciclosporin; high K intake or K-sparing diuretics; live attenuated vaccines. May enhance visual & neurological disturbance w/ alcohol. Severe liver impairment. Reduced sperm counts & motility in male. Pregnancy. Do not use during lactation. Not recommended for use in childn <18 yr.

Increased risk for infections (viral, bacterial, fungal, protozoal), aggravate preexisting infections, generalized & localized infections, BK virus associated w/ nephropathy, JC virus associated w/ progressive multifocal leukoencephalopathy; increased risk of developing malignancies, benign & malignant neoplasms including EBV-associated lymphoproliferative disorders & skin malignancies; allergic & anaphylactoid reactions. Hyperglycemic conditions, DM, hyperkalemia; insomnia; headache, tremor; HTN; diarrhea, nausea; renal impairment; abnormal LFTs. Anemia, leukopenia, thrombocytopenia, leukocytosis, abnormal RBC analyses; hypomagnesaemia, hypophosphatemia, hypokalemia, hypocalcemia, hyponatremia, fluid overload, hyperuricemia, decreased appetite, metabolic acidosis, hyperlipidemia, hypercholesterolemia, hypertriglyceridemia, other electrolyte abnormalities; anxiety symptoms, confusion & disorientation, depression, depressed mood, mood disorders & disturbances, nightmare, hallucination, mental disorders; nervous system disorders, seizures, disturbances in consciousness, peripheral neuropathies, dizziness, paresthesias & dysesthesia, impaired writing; blurred vision, photophobia, eye disorders; tinnitus; ischemic coronary artery disorders, tachycardia; hemorrhage, thromboembolic & ischemic events, peripheral vascular disorders, vascular hypotensive disorders; dyspnea, parenchymal lung disorders, pleural effusion, pharyngitis, cough, nasal congestion & inflammations; GI inflammatory conditions, GI ulceration & perforation, GI hemorrhages, stomatitis & ulceration, ascites, vomiting, GI & abdominal pains dyspeptic signs & symptoms, constipation, flatulence, bloating & distension, loose stools, GI signs & symptoms; bile duct disorders, hepatocellular damage & hepatitis, cholestasis & jaundice; pruritus, rash, alopecia, acne, increased sweating; arthralgia, back pain, muscle spasms, pain in extremity; renal failure, acute renal failure, oliguria, renal tubular necrosis, toxic nephropathy, urinary abnormalities, bladder & urethral symptoms; asthenic conditions, febrile disorders, edema, pain & discomfort, disturbed body temp perception; increased blood alkaline & wt; primary graft dysfunction.

May affect metabolism w/ medicinal products or herbal remedies known to inhibit or induce CYP3A4. Increased blood levels w/ antifungals (eg, ketoconazole, fluconazole, itraconazole, voriconazole, & isavuconazole), erythromycin, HIV PIs (eg, ritonavir, nelfinavir, saquinavir), HCV PIs (eg, telaprevir, boceprevir, & the combination of ombitasvir & paritaprevir w/ ritonavir, used w/ & w/o dasabuvir), letermovir, cobicistat, nilotinib & imatinib; grapefruit juice; medicinal products w/ high affinity for plasma proteins (eg, NSAIDs, oral anticoagulants, or oral antidiabetics). Potential inhibited metabolism w/ bromocriptine, cortisone, dapsone, ergotamine, gestodene, lidocaine, mephenytoin, miconazole, midazolam, nilvadipine, norethisterone, quinidine, tamoxifen, troleandomycin; lansoprazole & ciclosporin. May increase systemic exposure w/ prokinetic agents (eg, metoclopramide & cisapride), cimetidine & Mg-Al hydroxide. Decreased blood levels w/ rifampicin, phenytoin or St. John's wort; phenobarb; corticosteroids. Increased or decreased blood levels w/ high dose prednisolone or methylprednisolone. Decreased conc w/ carbamazepine, metamizole & INH. Synergistic/additive nephrotoxic effects w/ ciclosporin. Increased blood level of phenytoin. May reduce clearance of steroid-based contraceptives. Decreased clearance & increased t½ of pentobarbital & phenazone. Potential to reduce the plasma level & efficacy of mycophenolic acid. May increase nephrotoxic or neurotoxic effects w/ aminoglycosides, gyrase inhibitors, vancomycin, sulfamethoxazole + trimethoprim, NSAIDs, ganciclovir or aciclovir. Enhanced nephrotoxicity w/ amphotericin B & ibuprofen. Hyperkalemia or may increase preexisting hyperkalemia w/ high K intake or K-sparing diuretics (eg, amiloride, triamterene, or spironolactone). May affect response to vaccines.

Immunosuppressants

L04AD02 - tacrolimus ; Belongs to the class of calcineurin inhibitors. Used as immunosuppressants.

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