Dasanix Tablet
Dasatinib
100mg
Beacon Pharmaceuticals Ltd.
| Pack size | 30's pack |
|---|---|
| Dispensing mode | |
| Source | |
| Agent | |
| Retail Price | 400.00 AED |
Available as:
Indications
Dasanix Tablet is used for:
Chronic Myeloid Leukaemia, Acute Lymphoblastic Leukemia
Adult Dose
Oral
Acute Lymphoblastic Leukemia (ALL)
Indicated for the treatment of Philadelphia chromosome-positive (Ph+) ALL in adults with resistance or intolerance to prior therapy
Initial, 140 mg once daily; may increase to 180 mg once daily if hematologic or cytogenetic response not achieved with initial dosage
Chronic Myeloid Leukemia (CML)
Newly diagnosed CML in chronic phase
100 mg once daily; may increase to 140 mg orally once daily if hematologic or cytogenetic response not achieved with initial dosage
Therapy was continued until disease progression or until no longer tolerated in clinical studies
Previously treated CML
Indicated for treatment of chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML in adults with resistance or intolerance to prior therapy including imatinib
Initial, 140 mg orally once daily; may increase to 180 mg once daily if hematologic or cytogenetic response not achieved with initial dosage
Child Dose
Acute Lymphoblastic Leukemia (ALL)
Indicated in pediatric patients aged >1 years with newly diagnosed Philadelphia chromosome-positive (Ph+) ALL in combination with chemotherapy
Begin therapy on or before day 15 of induction chemotherapy
<10 kg: Not recommended
10 to <20 kg: 40 mg PO daily
20 to <30 kg: 60 mg PO daily
30 to <45 kg: 70 mg PO daily
>45 kg: 100 mg PO daily
Continue dasatinib therapy for 2 years
Chronic Myeloid Leukemia (CML)
Indicated in pediatric patients aged >1 years with Ph+ CML in chronic phase
Dosage may be escalated if hematologic or cytogenetic response not achieved with recommended starting dosage
<10 kg: Not recommended
10 to <20 kg: initial, 40 mg PO daily; may increase to 50 mg PO daily
20 to <30 kg: initial, 60 mg PO daily; may increase to 70 mg PO daily
30 to <45 kg: initial, 70 mg PO daily; may increase to 90 mg PO daily
>45 kg: initial, 100 mg PO daily; may increase to 120 mg PO daily
Therapy was continued until disease progression or until no longer tolerated in clinical studies
Renal Dose
Renal impairment
CrCl 21.6-342.3 mL/min: No significant impact on pharmacokinetics
Administration
May be taken with or without food.
Swallow whole, do not break/crush/cut.
Contra Indications
Precautions
Myelosuppression and Bleeding Events: Severe thrombocytopenia, neutropenia, and anemia may occur. Use caution if used concomitantly with medications that inhibit platelet function or anticoagulants. Transfuse and interrupt Dasatinib when indicated.
Fluid Retention: Fluid retention, sometimes severe, including pleural effusions. Manage with supportive care measures and/or dose modification.
Cardiovascular Toxicity: Monitor patients for signs or symptoms and treat appropriately.
Pulmonary Arterial Hypertension (PAH): Dasatinib may increase the risk of developing PAH which may be reversible on discontinuation. Consider baseline risk and evaluate patients for signs and symptoms of PAH during treatment. Stop Dasatinib if PAH is confirmed.
QT Prolongation: Use Dasatinib with caution in patients who have or may develop prolongation of the QT interval.
Severe Dermatologic Reactions: Individual cases of severe mucocutaneous dermatologic reactions have been reported.
Tumor Lysis Syndrome: Tumor lysis syndrome has been reported.
Maintain adequate hydration and correct uric acid levels prior to initiating therapy with Dasatinib.
Embryo-Fetal Toxicity: Can cause fetal harm. Advise patients of the reproductive potential of the potential risk to the fetus and to use effective contraception.
Effects on Growth and Development in Pediatric Patients: Epiphyses delayed fusion, osteopenia, growth retardation, and gynecomastia have been reported.
Hepatotoxicity: Assess liver function before initiation of treatment and monthly thereafter or as clinically indicated.
Monitor complete blood counts regularly.
Monitor liver function when combined with chemotherapy known to be associated with liver dysfunction.
Monitor bone growth and development in pediatric patients.
Monitor patients for signs or symptoms of Cardiovascular Toxicity and treat appropriately.
Pregnancy-Lactation
Pregnancy
Based on limited human data, dasatinib can cause fetal harm when administered to a pregnant woman; adverse pharmacologic effects (eg, hydrops fetalis, fetal leukopenia, and fetal thrombocytopenia) have been reported with maternal exposure to dasatinib
Animal reproduction studies in rats have demonstrated extensive mortality during organogenesis, the fetal period, and in neonates; skeletal malformations were observed in a limited number of surviving rat and rabbit conceptuses; these findings occurred at dasatinib plasma concentrations below those in humans receiving therapeutic doses of dasatinib
Advise a pregnant woman of the potential risk to a fetus
Transplacental transfer of dasatinib has been reported
Advise females of reproductive potential to avoid pregnancy, which may include the use of effective contraceptive methods, during treatment with dasatinib and for 30 days after the final dose
Based on animal data, dasatinib may result in damage to female and male reproductive tissues
Lactation
No data are available regarding the presence of dasatinib in human milk, the effects of the drug on the breastfed child, or the effects of the drug on milk production
However, dasatinib is present in the milk of lactating rats
Interactions
Concomitant use w/ drugs that have narrow therapeutic index (e.g. alfentanil, cisapride, ciclosporin, fentanyl, pimozide, quinidine, simvastatin, sirolimus, tacrolimus, ergot alkaloids) as it may increase the serum levels of these drugs.
Increased risk of bleeding and thrombocytopenia w/ antiplatelet drugs, anticoagulants, and NSAIDs.
Dasatinib is a sensitive CYP3A substrate
Strong CYP3A inhibitors
Avoid coadministration
Risk of increased dasatinib exposure and adverse effects (eg, QTc prolongation)
If coadministration cannot be avoided, consider dasatinib dose reduction
Strong CYP3A inducers
Avoid coadministration; consider alternate agent
Risk of decreased dasatinib exposure and reduced efficacy
If coadministration cannot be avoided, consider dasatinib dose increase
Other QT prolongation agents
Use caution
Risk of additive QT prolongation
Antacids
Coadministration decreases dasatinib plasma concentrations
Avoid coadministration with short-acting antacids (eg, calcium carbonate); separate administration by at least 2 hours if concomitant use cannot be avoided
PPIs or H2 blockers
Avoid coadministration due to risk of decreased dasatinib exposure and reduced efficacy
Potentially Fatal: May reduce plasma levels w/ antacids, administer antacid 2 hr apart from the admin of dasatinib. May increase plasma levels w/ CYP3A4 inhibitors (e.g. atazanavir, clarithromycin, erythromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin or voriconazole). May reduce plasma levels w/ CYP3A4 inducers (e.g. carbamazepine, dexamethasone, phenytoin, phenobarbital or rifampicin).
Adverse Effects
Side effects of Dasatinib :
>10%
Fluid retention, incl CHF, pulm edema, pleural effusion (50%),Diarrhea (49%),Headache (40%),Hemorrhage (40%),Fatigue (39%),Pyrexia (39%),Skin rash (35%),Infection (34%),Nausea (34%),Dyspnea (32%),Cough (28%),Pain (26%),Abdominal pain (25%),Vomiting (22%),Anorexia (19%),Arthralgia (19%),Asthenia (19%),Constipation (14%),Dizziness (14%),Musculoskeletal pain (14%),Weight loss (14%),Chest pain (13%),Neuropathy (13%),Myalgia (12%),Abdominal distention (11%),Arrhythmia (11%),Chills (11%),Pneumonia (11%),Pruritus (11%),Weight gain (11%)
1-10% (selected)
Anemia,Febrile neutropenia,Thrombocytopenia,Mucosal inflammation
Vascular disorders: Thrombosis/embolism (including pulmonary embolism, deep vein thrombosis)
Respiratory, thoracic, and mediastinal disorders: Interstitial lung disease, pulmonary arterial hypertension
Dermatologic reactions: Stevens-Johnson syndrome, erythema multiforme
Mechanism of Action
Dasatinib is an inhibitor of multiple tyrosine kinases. It is used for the treatment of all phases of chronic myeloid leukaemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukaemia (ALL) in adults who have resistance or intolerance to previous therapy, including imatinib.
Note
Dasanix 100mg Tablet manufactured by Beacon Pharmaceuticals Ltd.. Its generic name is Dasatinib. Dasanix is availble in Bangladesh.
Farmaco BD drug index information on Dasanix Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.