Imruza Tablet

Imruza Tablet is used for: Rheumatoid arthritis, Prevention of rejection in organ and tissue transplantation, Auto-immune diseases, Renal homotransplantation

Oral Rheumatoid Arthritis 1 mg/kg/day PO initially in single daily dose or divided q12hr; may be increased by 0.5 mg/kg/day after 6-8 weeks, then by 0.5 mg/kg/day every 4 weeks; not to exceed 2.5 mg/kg/day Maintenance: Reduce daily dose by 0.5 mg/kg every 4 weeks until the lowest effective dosage is reached Kidney Transplantation Prevention of transplant rejection 3-5 mg/kg/day PO initially on day of transplant or 3 days before transplant (rare) Maintenance: 1-3 mg/kg/day PO Auto-immune diseases 1-3 mg/kg/day. Hepatic Impairment Reduce dose.

Oral Juvenile Idiopathic Arthritis 1 mg/kg/day PO initially in single daily dose or divided q12hr; may be increased by 0.5 mg/kg/day after 6-8 weeks, then by 0.5 mg/kg/day every 4 weeks; not to exceed 2.5 mg/kg/day Maintenance: Reduce daily dose by 0.5 mg/kg every 4 weeks until the lowest effective dosage is reached

RENAL IMPAIRMENT Dose adjustments Reduce dose.

May be taken with or without food. Preferably taken w/ or after meals to reduce GI discomfort.

Hypersensitivity Pregnant patients receiving therapy for rheumatoid arthritis Patients with rheumatoid arthritis previously treated with alkylating agents (eg, cyclophosphamide, chlorambucil, melphalan, or others) due to increased risk of malignancy

Chronic immunosuppression may increase the risk of malignancy Posttransplant lymphoma and hepatosplenic T-cell lymphoma (HSTCL) in patients with inflammatory bowel disease have been reported Prescribing physicians should be familiar with mutagenic potential and with possible hematologic toxicities Malignancy Patients on immunosuppressants have an increased risk of developing lymphoma and other malignancies (eg, skin cancers) with azathioprine therapy Instruct patients to wear protective clothing and use sunscreen with a high protection factor Transplant recipients Renal transplant patients have an increased risk of malignancy (eg, skin cancer and reticulum cell or lymphomatous tumors) Patients with rheumatoid arthritis Patients with rheumatoid arthritis may have an increased risk of malignancy (eg, acute myelogenous leukemia and solid tumors) Patients with inflammatory bowel disease (IBS) Patients with IBS may have an increased risk of malignancy (eg, hepatosplenic T-cell lymphoma) Hepatosplenic T-cell lymphoma (HSTCL) HSTCL is an aggressive, rare type of T-cell lymphoma that is usually fatal Rare postmarketing cases of HSTCL were reported primarily in adolescent and young adult patients with Crohn disease and ulcerative colitis treated with tumor necrosis factor (TNF) blockers Cytopenias Severe myelosuppression (eg, leukopenia, thrombocytopenia, anemia/macrocytic anemia, pancytopenia) may occur Hematologic toxicity is dose-related and may be delayed Myelosuppression may be more severe in renal transplant patients whose homograft is undergoing rejection Promptly reduce the dosage or withhold therapy withdrawal if there is a rapid decline in or persistently low leukocyte count or other evidence of myelotoxicity Patients with TPMT or NUDT15 deficiency may have an increased risk of severe and life-threatening myelotoxicity at usual dosages Serious infections Patients on immunosuppressants have an increased risk of developing infection (eg, bacterial, viral, fungal, protozoal, opportunistic infection), including reactivation of latent infection GI hypersensitivity reactions can occur; severe nausea and vomiting have been reported Avoid use during pregnancy; fetal harm may occur if administered to pregnant patients Monitoring Parameters Monitor for toxicity throughout treatment. Monitor complete blood counts weekly during the first month, twice monthly for the second and third months, and then monthly, or more frequently if dosage alterations or other therapy changes are necessary Monitor LFT periodically. Blood tests and monitoring for signs of myelosuppression are essential in long-term treatment.

Pregnancy Use is contraindicated in pregnant patients receiving therapy for rheumatoid arthritis Fetal harm may occur if administered during pregnancy; avoid use in pregnant patients Carefully weigh the risk of fetal harm with the benefits of therapy in pregnant patients or patients of reproductive potential Intrahepatic cholestasis of pregnancy (ICP) has been reported; discontinue therapy if ICP develops during pregnancy Patients of reproductive potential should avoid pregnancy Azathioprine or its metabolites are transferred through the placenta at low levels Human data Limited immunologic and other abnormalities were reported in a few infants born of renal allograft recipients receiving azathioprine Lymphopenia diminished IgG and IgM levels, CMV infection, and a decreased thymic shadow were noted in an infant born to a mother receiving azathioprine 150 mg and prednisone 30 mg daily during pregnancy; most features were normalized at 10 weeks Pancytopenia and severe immune deficiency were reported in a preterm infant whose mother received azathioprine 125 mg and prednisone 12.5 mg daily during pregnancy Preaxial polydactyly occurred in an infant born to a mother receiving azathioprine 200 mg and prednisone 20 mg every other day during pregnancy Large myelomeningocele in the upper lumbar region, bilateral dislocated hips, and bilateral talipes equinovarus were reported in an infant whose father was receiving long-term azathioprine therapy Animal data Teratogenicity (eg, skeletal malformations, visceral anomalies) has been observed in rabbits and mice who received doses equivalent to human doses (5 mg/kg/day) Fertility Animal data Temporary depression in spermatogenesis and reduction in sperm count and viability were reported in mice at doses 10x times the human therapeutic dose Reduced rate of fertile mating occurred in mice who received 5 mg/kg Lactation Use not recommended in nursing patients; discontinue breastfeeding or discontinue therapy while breastfeeding Azathioprine or its metabolites are transferred in breast milk at low levels

Increased risk of haematotoxicity with aminosalicylates, drugs that affect myelopoesis e.g. co-trimoxazole or trimethoprim. Increased risk of infections with intra-uterine devices and live vaccines. Increased risk of leucopenia with ACE inhibitors. Concurrent use may reduce the anticoagulant effect of vitamin K antagonists e.g. warfarin. Increased risk of myelosuppressive effects when used with drugs that inhibit TPMT (thiopurine methyltransferase) or xanthine oxidase e.g. olsalazine, allopurinol. Potentially Fatal: Increased risk of serious haematotoxicity or hepatotoxicity with leflunomide. Increased risk of bone marrow suppression with mycophenolate mofetil. Increased risk of infections and malignancies with efalizumab. Contraindicated (2) febuxostat upadacitinib

Side effects of Azathioprine : >10% Leukopenia (28-50%),Infection (20%) <1% Lymphoma Frequency Not Defined Fever, chills; bone marrow depression, thrombocytopenia or anaemia; anorexia, nausea, diarrhoea; arthralgias; secondary infections; hepatotoxicity, rash, alopoecia. Potentially Fatal: Myelosuppression, mutagenicity and carcinogenicity; veno-occlussive liver disease.

Azathioprine is an imidazolyl derivative of mercaptopurine, which inhibits DNA, RNA and protein synthesis and antagonises purine synthesis. It also inhibits mitosis and interferes with cellular metabolism of susceptible organisms. Azathioprine inj should be converted to oral therapy as soon as the drug can be tolerated.

Imruza 25 mg Tablet manufactured by Beacon Pharmaceuticals Ltd.. Its generic name is Azathioprine. Imruza is availble in Bangladesh. Farmaco BD drug index information on Imruza Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.