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Tazatred

Tazatred

dasatinib

Manufacturer:

Dr. Reddy's Lab

Distributor:

DKSH
Concise Prescribing Info
Contents
Dasatinib
Indications/Uses
Adults ≥18 yr w/ chronic, accelerated, myeloid or lymphoid blast phase chronic myeloid leukemia (CML) resistant or intolerant to prior therapy including imatinib; Philadelphia chromosome +ve acute lymphoblastic leukemia (Ph+ ALL) resistant or intolerant to prior therapy.
Dosage/Direction for Use
Chronic phase CML 100 mg once daily, may be increased to 140 mg once daily in patient who did not achieve response. Accelerated phase CML, myeloid or lymphoid blast phase CML, Ph+ ALL 70 mg bd, may be increased to 100 mg bd in patient who did not achieve response. Concomitant use w/ strong CYP3A4 inhibitor Decrease dose to 20 mg daily.
Administration
May be taken with or without food: Swallow whole, do not crush/cut.
Contraindications
Special Precautions
Permanently discontinue use if pulmonary arterial HTN is confirmed; thrombotic microangiopathy; severe mucocutaneous reaction occurs. Myelosuppression; bleeding; fluid retention, chylothorax; QT prolongation, congenital long QT syndrome; cardiac adverse reactions, history of cardiac disease, uncontrolled or significant CV disease; HBV reactivation. Correct hypokalaemia or hypomagnesaemia prior to therapy. Perform CBC every 2 wk for 12 wk then every 3 mth thereafter or as clinically indicated for chronic phase CML & wkly for 1st 2 mth then mthly thereafter or as clinically indicated for advanced phase CML or Ph+ ALL. Promptly evaluate chest X-ray or additional diagnostic imaging if symptoms suggestive of pleural effusion or other fluid retention eg, new or worsened dyspnoea, pleuritic chest pain or dry cough develops. Screen for HBV prior to therapy. Concomitant use w/ medications inhibiting platelet function or anticoagulants; arrhythmics, QT prolonging-medicinal products, cumulative high-dose anthracycline therapy. May affect ability to drive & use machines. Hepatic impairment. Pregnancy. Not to be used during lactation. Elderly ≥65 yr.
Adverse Reactions
Myelosuppression; headache; pleural effusion, dyspnoea; diarrhoea, vomiting, nausea, abdominal pain; skin rash; musculoskeletal pain; infections; haemorrhage; peripheral & face oedema, fatigue, pyrexia. Increased/decreased wt; CHF/cardiac dysfunction, pericardial effusion, arrhythmia, palpitations; febrile neutropenia; neuropathy, dizziness, dysgeusia, somnolence; visual disorders, dry eye; tinnitus; pulmonary oedema & HTN, lung infiltration, pneumonitis, cough; GI disorders; alopecia, dermatitis, pruritus, acne, dry skin, urticaria, hyperhidrosis; arthralgia, myalgia, muscular weakness, musculoskeletal stiffness, muscle spasm; appetite disturbances, hyperuricaemia; contusion; HTN, flushing; asthenia, pain, chest pain, generalised oedema, chills; depression, insomnia.
Drug Interactions
Increased plasma conc w/ CYP3A4 inhibitors eg, ketoconazole; simvastatin. Decreased plasma conc w/ CYP3A4 inducers eg, rifampin; H2-antagonists or PPIs eg, famotidine, omeprazole. Avoid simultaneous administration w/ Al- & Mg hydroxide-containing antacids. Concomitant use of CYP3A4 substrates w/ narrow therapeutic index eg, alfentanil, astemizole, terfenadine, cisapride, cyclosporine, fentanyl, pimozide, quinidine, sirolimus, tacrolimus or ergot alkaloids.
MIMS Class
Targeted Cancer Therapy
ATC Classification
L01EA02 - dasatinib ; Belongs to the class of BCR-ABL tyrosine kinase inhibitors. Used in the treatment of cancer.
Presentation/Packing
Form
Tazatred FC tab 50 mg
Packing/Price
6 × 10's
Form
Tazatred FC tab 70 mg
Packing/Price
6 × 10's
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