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APO-DASATINIB is a brand name for Dasatinib, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: APO-DASATINIB TABLETS (dasatinib tablets) is indicated for the treatment of adults with: • Newly diagnosed Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. Clinical effectiveness of dasatinib tablets treatment in patients with newly diagnosed Ph+ CML in chronic phase is based on…
Verbatim from this product's HC label. Tap a section to expand.
Note:
APO-DASATINIB TABLETS manufactured by Apotex Inc. is NOT available in the 140 mg strength. 4 Drug-Drug Interactions, Table 8). CYP3A4 inhibitors such as ketoconazole may increase dasatinib tablets plasma concentrations. If possible, an alternative concomitant medication with no or minimal enzyme inhibition potential should be selected.
If APO-DASATINIB TABLETS must be administered with a strong CYP3A4 inhibitor, consider a dose APO-DASATINIB TABLETS (Dasatinib Tablets) Page 6 of 76 decrease to: 40 mg daily for patients taking APO-DASATINIB TABLETS 140 mg daily. 20 mg daily for patients taking APO-DASATINIB TABLETS 100 mg daily.
20 mg daily for patients taking APO-DASATINIB TABLETS 70 mg daily. For patients taking APO-DASATINIB TABLETS 60 mg or 40 mg daily, consider interrupting APO- DASATINIB TABLETS until the inhibitor is discontinued. Allow a washout period of approximately 1 week after the inhibitor is stopped before reinitiating APO-DASATINIB TABLETS.
The reduced doses of dasatinib tablets are predicted to adjust the area under the curve (AUC) to the range observed without CYP3A4 inhibitors; however, clinical data are not available with these dose adjustments in patients receiving strong CYP3A4 inhibitors.
If APO-DASATINIB TABLETS is not tolerated after dose reduction, either discontinue the strong CYP3A4 inhibitor or stop APO-DASATINIB TABLETS until the inhibitor is discontinued. Allow a washout period of approximately 1 week after the inhibitor is stopped before the APO-DASATINIB TABLETS dose is increased.
2 Recommended Dose and Dosage Adjustment • The recommended starting dosage of APO-DASATINIB TABLETS for chronic phase CML is 100 mg administered orally once daily (OD), either in the morning or in the evening. • The recommended starting dosage of APO-DASATINIB TABLETS for accelerated phase CML, or myeloid or lymphoid blast CML, is 140 mg/day administered orally once daily (140 mg QD) either in the morning or in the evening.
• The recommended starting dosage of APO-DASATINIB TABLETS for Ph+ ALL is 140 mg administered orally once daily (140 mg QD) either in the morning or in the evening. Dosing recommendations in patients with imatinib resistant or intolerant CML and Ph+ ALL are based on the results of two randomized Phase III dose-optimization studies (see 14 CLINICAL TRIALS).
), patients who ingested more than the recommended dosage should be closely monitored for myelosuppression and appropriate supportive treatment given. 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table 2 - Dosage Forms, Strengths, Composition and Packaging Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients Oral Tablet / 20 mg, 50 mg, 70 mg, 80 mg and 100 mg Colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, titanium dioxide and triethyl citrate.
APO-DASATINIB TABLETS 20 mg is white to off-white, round shape, biconvex coated tablet. Engraved "APO" on one side, "DA" over "20" on the other side. APO-DASATINIB TABLETS 50 mg is white to off-white, oval shape, biconvex beveled-edge coated tablet.
Engraved "APO" on one side, "DAS5O" on the other side. APO-DASATINIB TABLETS 70 mg is white to off-white, round shape, biconvex coated tablet. Engraved "APO" on one side, "DA" over "70" on the other side. APO-DASATINIB TABLETS 80 mg is white to off-white, round shape, biconvex coated tablet.
For the most recent information in the management of a suspected drug overdose, contact your regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1- 844-764-7669). APO-DASATINIB TABLETS (Dasatinib Tablets) Page 10 of 76 Engraved "APO" on one side, "DAS" over "80" on the other side.
APO-DASATINIB TABLETS 100 mg is white to off-white, oval shape, biconvex beveled-edge coated tablet. Engraved "APO" on one side, "DAS100" on the other side. APO-DASATINIB TABLETS film coated tablets, 20 mg, 50 mg, 70 mg, 80 mg and 100 mg are supplied in blisters of 30 tablets.
7 WARNINGS AND PRECAUTIONS Please see 3 SERIOUS WARNINGS AND PRECAUTIONS BOX. Carcinogenesis and Mutagenesis Please see 16 NON-CLINICAL TOXICOLOGY Cardiovascular The Phase III clinical study in patients with newly diagnosed CML in chronic phase excluded patients with uncontrolled or significant cardiovascular disease.
, Hematologic). • Hemorrhage, including fatal outcomes (see 7 WARNINGS AND PRECAUTIONS, Hemorrhage). • Fluid retention, pleural effusion, pulmonary edema and pericardial effusion (see 7 WARNINGS AND PRECAUTIONS, Respiratory). • Congestive heart failure (see 7 WARNINGS AND PRECAUTIONS, Cardiovascular ).
• Pulmonary arterial hypertension (see 7 WARNINGS AND PRECAUTIONS, Respiratory below) 4 DOSAGE AND ADMINISTRATION Note: APO-DASATINIB TABLETS manufactured by Apotex Inc. is NOT available in the 140 mg strength. 4 Drug-Drug Interactions, Table 8).
CYP3A4 inhibitors such as ketoconazole may increase dasatinib tablets plasma concentrations. If possible, an alternative concomitant medication with no or minimal enzyme inhibition potential should be selected. If APO-DASATINIB TABLETS must be administered with a strong CYP3A4 inhibitor, consider a dose APO-DASATINIB TABLETS (Dasatinib Tablets) Page 6 of 76 decrease to: 40 mg daily for patients taking APO-DASATINIB TABLETS 140 mg daily.
20 mg daily for patients taking APO-DASATINIB TABLETS 100 mg daily. 20 mg daily for patients taking APO-DASATINIB TABLETS 70 mg daily. For patients taking APO-DASATINIB TABLETS 60 mg or 40 mg daily, consider interrupting APO- DASATINIB TABLETS until the inhibitor is discontinued.
Allow a washout period of approximately 1 week after the inhibitor is stopped before reinitiating APO-DASATINIB TABLETS. The reduced doses of dasatinib tablets are predicted to adjust the area under the curve (AUC) to the range observed without CYP3A4 inhibitors; however, clinical data are not available with these dose adjustments in patients receiving strong CYP3A4 inhibitors.
If APO-DASATINIB TABLETS is not tolerated after dose reduction, either discontinue the strong CYP3A4 inhibitor or stop APO-DASATINIB TABLETS until the inhibitor is discontinued. Allow a washout period of approximately 1 week after the inhibitor is stopped before the APO-DASATINIB TABLETS dose is increased.
2 Breast-feeding). • Use of APO-DASATINIB TABLETS is contraindicated in patients with hypersensitivity to dasatinib or to any other component of APO-DASATINIB TABLETS.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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In clinical studies, treatment with dasatinib tablets was continued until disease progression or until no longer tolerated by the patient. The effect of stopping treatment on long-term disease outcome after the achievement of a complete cytogenetic response ([CCyR]) or major molecular response (MMR) has not been investigated.
Dose Escalation In clinical studies of adult CML and Ph+ ALL patients, dose escalation to 140 mg once daily APO-DASATINIB TABLETS (Dasatinib Tablets) Page 7 of 76 (chronic phase CML) or 180 mg once daily (advanced phase CML and Ph+ ALL) was allowed in patients who did not achieve a hematologic or cytogenetic response at the recommended dosage.
Dose Adjustment for Adverse Reactions Myelosuppression In clinical studies, myelosuppression was managed by dose interruption, dose reduction, or discontinuation of study therapy. Hematopoietic growth factor has been used in patients with resistant myelosuppression.
Guidelines for dose modifications are summarized in Table 1. 5 × 109/L and/or Platelets <50 × 109/L 1. 0 × 109/L and platelets ≥50 × 109/L. 2. Resume treatment with APO- DASATINIB TABLETS at the original starting dose. 3. 5× 109/L for >7 days, repeat Step 1 and resume APO-DASATINIB TABLETS at a reduced dose of 80 mg once daily for second episode.
For third episode, further reduce dose to 50 mg once daily (for newly diagnosed patients) or discontinue APO-DASATINIB TABLETS (for patients resistant or intolerant to prior therapy including imatinib). 5 × 109/L and/or Platelets <10 × 109/L 1.
Check if cytopenia is related to leukemia (marrow aspirate or biopsy). 2. 0 × 109/L and platelets ≥20 × 109/L and resume at the original starting dose. 3. If recurrence of cytopenia, repeat Step 1 and resume APO-DASATINIB TABLETS at a reduced dose of 100 mg once daily (second episode) or 80 mg once daily (third episode).
4. If cytopenia is related to leukemia, consider dose escalation to 180 mg once daily. APO-DASATINIB TABLETS (Dasatinib Tablets) Page 8 of 76 *ANC: absolute neutrophil count Non-hematological adverse reactions If a moderate (Grade 2) non-hematological adverse reaction develops with APO-DASATINIB TABLETS, treatment should be interrupted until the adverse reaction has resolved or returned to baseline.
The same dose should be resumed if this is the first occurrence and the dose should be reduced if this is a recurrent adverse reaction. If a severe (Grade 3 or 4) non-hematological adverse reaction develops with APO-DASATINIB TABLETS use, treatment must be withheld until the event has resolved or improved.
Thereafter, treatment can be resumed as appropriate at a reduced dose depending on the initial severity of the event. However, in patients diagnosed with pulmonary arterial hypertension (PAH), APO-DASATINIB TABLETS should be permanently discontinued.
Patients with chronic CML who received 100 mg once daily, dose reduction to 80 mg once daily with further reduction from 80 mg once daily to 50 mg once daily, if needed, is recommended. For adult patients with advanced phase CML or Ph+ ALL who […]
6 % of patients with prior cardiac disease and 24% with baseline cardiovascular risk factors. Cardiac adverse reactions of congestive heart failure/cardiac dysfunction, pericardial effusion, arrhythmias, palpitations, QT prolongation, and myocardial infarction (including fatal) were reported in patients taking dasatinib tablets (see 8 ADVERSE REACTIONS).
4%) were also reported in patients. Adverse cardiac events were more frequent in patients with cardiovascular risk factors or a previous medical history of cardiac disease (see 8 ADVERSE REACTIONS). Patients with risk factors or a history of cardiac disease should be evaluated at baseline and monitored carefully for clinical signs or symptoms consistent with cardiac dysfunction (such as chest pain, shortness of breath, and diaphoresis) during routine follow up.
In the Phase III clinical trials in patients with resistance or intolerance to prior imatinib therapy, patients were excluded from enrolment for a broad range of cardiac events or conditions. A significantly abnormal ECG at screening was also an exclusion criterion.
No prospective evaluation of cardiac function was carried out. In all clinical trials with patients resistant or intolerant to prior imatinib therapy, congestive heart failure/cardiac dysfunction was reported in 96 (4%) of subjects, of which 49 (2%) were considered to be severe.
In some cases, the event was triggered by an acute volume load, including transfusion of blood products. QT Prolongation In vitro data suggest that dasatinib and its N-dealkylated metabolite, BMS- 582691 have the APO-DASATINIB TABLETS (Dasatinib Tablets) Page 11 of 76 potential to prolong cardiac ventricular repolarization (QT interval, see Safety Pharmacology).
In 865 patients with leukemia treated with dasatinib tablets in Phase II clinical studies, the mean changes from baseline in QTcF interval were 4 to 6 msec; the upper 95% confidence intervals for all mean changes from baseline were <7 msec.
Of the 2182 patients with resistance or intolerance to prior imatinib therapy who received dasatinib tablets in clinical studies, 21 patients (<1%) experienced a QTcF >500 msec. In the Phase III clinical study in patients with newly diagnosed CML in chronic phase, patients with baseline QTcF interval > 450 msec were excluded.
After 5 years of follow-up, QTc prolongation was reported in one patient (<1%) who experienced a QTcF >500 msec and discontinued dasatinib tablets treatment. APO-DASATINIB TABLETS should be administered with caution in patients who have or may develop prolongation of QTc.
These include patients with hypokalemia or hypomagnesemia, patients with congenital long QT syndrome, patients taking anti arrhythmic medicines or other medicinal products that lead to QT prolongation, and cumulative high-dose anthracycline therapy.
Hypokalemia or hypomagnesemia should be corrected prior to administration of APO- DASATINIB TABLETS. (See
2 Recommended Dose and Dosage Adjustment • The recommended starting dosage of APO-DASATINIB TABLETS for chronic phase CML is 100 mg administered orally once daily (OD), either in the morning or in the evening. • The recommended starting dosage of APO-DASATINIB TABLETS for accelerated phase CML, or myeloid or lymphoid blast CML, is 140 mg/day administered orally once daily (140 mg QD) either in the morning or in the evening.
• The recommended starting dosage of APO-DASATINIB TABLETS for Ph+ ALL is 140 mg administered orally once daily (140 mg QD) either in the morning or in the evening. Dosing recommendations in patients with imatinib resistant or intolerant CML and Ph+ ALL are based on the results of two randomized Phase III dose-optimization studies (see 14 CLINICAL TRIALS).
In clinical studies, treatment with dasatinib tablets was continued until disease progression or until no longer tolerated by the patient. The effect of stopping treatment on long-term disease outcome after the achievement of a complete cytogenetic response ([CCyR]) or major molecular response (MMR) has not been investigated.
Dose Escalation In clinical studies of adult CML and Ph+ ALL patients, dose escalation to 140 mg once daily APO-DASATINIB TABLETS (Dasatinib Tablets) Page 7 of 76 (chronic phase CML) or 180 mg once daily (advanced phase CML and Ph+ ALL) was allowed in patients who did not achieve a hematologic or cytogenetic response at the recommended dosage.
Dose Adjustment for Adverse Reactions Myelosuppression In clinical studies, myelosuppression was managed by dose interruption, dose reduction, or discontinuation of study therapy. Hematopoietic growth factor has been used in patients with resistant myelosuppression.
Guidelines for dose modifications are summarized in Table 1. 5 × 109/L and/or Platelets <50 × 109/L 1. 0 × 109/L and platelets ≥50 × 109/L. 2. Resume treatment with APO- DASATINIB TABLETS at the original starting dose. 3. 5× 109/L for >7 days, repeat Step 1 and resume APO-DASATINIB TABLETS at a reduced dose of 80 mg once daily for second episode.
For third episode, further reduce dose to 50 mg once daily (for newly diagnosed patients) or discontinue APO-DASATINIB TABLETS (for patients resistant or intolerant to prior therapy including imatinib). 5 × 109/L and/or Platelets <10 × 109/L 1.
Check if cytopenia is related to leukemia (marrow aspirate or biopsy). 2. 0 × 109/L and platelets ≥20 × 109/L and resume at the original starting dose. 3. If recurrence of cytopenia, repeat Step 1 and resume APO-DASATINIB TABLETS at a reduced dose of 100 mg once daily (second episode) or 80 mg once daily (third episode).
4. If cytopenia is related to leukemia, consider dose escalation to 180 mg once daily. APO-DASATINIB TABLETS (Dasatinib Tablets) Page 8 of 76 *ANC: absolute neutrophil count Non-hematological adverse reactions If a moderate (Grade 2) non-hematological adverse reaction develops with APO-DASATINIB TABLETS, treatment should be interrupted until the adverse reaction has resolved or returned to baseline.
The same dose should be resumed if this is the first occurrence and the dose should be reduced if this is a recurrent adverse reaction. If a severe (Grade 3 or 4) non-hematological adverse reaction develops with APO-DASATINIB TABLETS use, treatment must be withheld until the event has resolved or improved.
Thereafter, treatment can be resumed as appropriate at a reduced dose depending […]