Tibisan

Tibisan

imatinib

Manufacturer:

Sanbe

Marketer:

Sanbe
Concise Prescribing Info
Contents
Imatinib
Indications/Uses
Newly diagnosed Philadelphia chromosome (Bcr-abl) positive (Ph+) chronic myeloid leukaemia (CML) as well as patients w/ Ph+ CML in chronic phase after failure of interferon-α therapy, or in blast crisis, accelerated phase. Adult & ped >1 yr w/ newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemaia (Ph+ ALL) integrated chemotherapy. Adult patients w/ relapsed or refractory Ph+ ALL as monotherapy. Adult patients w/ myelodysplastic/myeloproliferative disease (MDS/MPD) associated w/ platelet-derived growth factor receptor (PDGFR) gene re-arrangements. Adult patients w/ systemic mastocytosis (SM) w/o the D816V c-Kit mutation or w/ c-Kit mutational status unknown. Adult patients w/ hypereosinophilic syndrome (HES) &/or chronic eosinophilic leukemia (CEL). Adult patients w/ unresectable, recurrent &/or metastatic dermatofibrosarcoma protuberans (DFSP).
Dosage/Direction for Use
CML Chronic phase: 400 mg daily. Accelerated phase or blast crisis: 600 mg daily. Max: 800 mg daily. Adult Ph+ ALL 600 mg daily. MDS/MPD, SM, HES/CEL 400 mg daily. DFSP 800 mg daily. Non-haematological AR Reduce dose from 400 mg to 300 mg, or from 600 mg to 400 mg or 800 mg to 600 mg. Childn Ph+ ALL Chronic & advanced phase: 340 mg/m2 daily. Max: 600 mg daily. Mild, moderate or severe liver dysfunction 400 mg daily. Renal insufficiency 400 mg daily.
Administration
Should be taken with food: Take w/ meal & large glass of water to minimise risk of GI disturbance. For patients w/ difficulty swallowing, may disperse tab in a glass of water/apple juice (approx 50 mL for 100-mg tab) then stir. Take susp immediately after complete disintegration of tab.
Contraindications
Special Precautions
Monitor TSH levels in thyroidectomy patients undergoing levothyroxine replacement. Weigh patients regularly. Evaluate & treat patients w/ cardiac disease or risk factors for cardiac failure & any patient w/ signs or symptoms consistent w/ cardiac failure. Perform ECG & serum troponin level determination in HES/CEL/MDS/MPD, or SM associated w/ high eosinophil levels; if either is abnormal, consider prophylactic use of systemic steroids for 1-2 wk concomitantly w/ imatinib at the start of therapy; CBC regularly during therapy. Correct significant dehydration & treatment of high uric acid level prior to therapy. Test patients for hepatitis B infection prior to treatment. Patients may experience undesirable effects eg, dizziness, blurred vision or somnolence during treatment. Carefully monitor peripheral blood counts & liver enzymes in patients w/ hepatic dysfunction. Monitor hepatic function particularly when combined w/ chemotherapy regimens known to be associated w/ hepatic dysfunction. Women of child-bearing potential should use highly effective contraception. Pregnancy. Women taking imatinib should not breastfeed. Closely monitor growth in childn.
Adverse Reactions
Neutropenia, thrombocytopenia, anemia; headache; nausea, diarrhea, vomiting, dyspepsia, abdominal pain; periorbital edema, dermatitis/eczema/rash; muscle spasm & cramps, musculoskeletal pain including myalgia, arthralgia, bone pain; fluid retention & edema, fatigue; increased wt; pain in extremity, spinal pain. Pancytopenia, febrile neutropenia; anorexia; insomnia; dizziness, paresthesia, taste disturbance, hypoesthesia; eyelid edema, increased lacrimation, conjunctival hemorrhage, conjunctivitis, dry eye, blurred vision; flushing, hemorrhage; dyspnea, epistaxis, cough; flatulence, abdominal distension, GERD, constipation, dry mouth, gastritis; increased hepatic enzymes; pruritus, face edema, dry skin, erythema, alopecia, night sweats, photosensitivity reaction; joint swelling; weakness, pyrexia, anasarca, chills, rigors; decreased wt.
Drug Interactions
Decreased plasma conc w/ CYP3A4 inducers eg, dexamethasone, phenytoin, carbamazepine, rifampicin, phenobarb, or Hypericum perforatum (St. John's wort). Increased plasma conc w/ CYP3A4 inhibitors eg, ketoconazole, itraconazole, erythromycin, clarithromycin. May increase plasma conc of triazolobenzodiazepines, dihydropyridine Ca channel blockers, certain HMG-CoA reductase inhibitors ie, statins. Co-administration w/ CYP3A4 substrates w/ narrow therapeutic window eg, cyclosporine or pimozide. Inhibits CYP2C9 & CYP2C19 activity.
MIMS Class
Targeted Cancer Therapy
ATC Classification
L01EA01 - imatinib ; Belongs to the class of BCR-ABL tyrosine kinase inhibitors. Used in the treatment of cancer.
Presentation/Packing
Form
Tibisan FC tab 100 mg
Packing/Price
4 × 15's (Rp10,250,000/boks)
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