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DOPTELET is a brand name for Avatrombopag, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: DOPTELET (avatrombopag) is indicated for: • the treatment of severe thrombocytopenia in adult patients with chronic liver disease (CLD) who are scheduled to undergo an invasive procedure. • the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations • For CLD patients, obtain a platelet count prior to administration of DOPTELET therapy and on the day of a procedure to ensure an adequate increase in platelet count. 2 Recommended Dose and Dosage Adjustment, • Table 3 and Table 4).
• For chronic ITP patients, DOPTELET can be administered in addition to other ITP medications. 2 Recommended Dose and Dosage Adjustment, Table 2). 2 Recommended Dose and Dosage Adjustment Chronic Liver Disease Patients Scheduled to Undergo a Procedure Begin DOPTELET dosing with food 10 to 13 days prior to the scheduled procedure.
The recommended DOPTELET® (avatrombopag) - Product Monograph Page 5 of 36 daily dose of DOPTELET is based on the patient’s platelet count prior to the scheduled procedure (see Table 1). Patients should undergo their procedure 5 to 8 days after the last dose of DOPTELET.
1 Clinical Trials by Indication). DOPTELET should not be administered to patients with chronic liver disease in an attempt to normalize platelet counts. Chronic Immune Thrombocytopenia Patients Use the lowest dose of DOPTELET needed to achieve and maintain a platelet count greater than or equal to 50 x109/L as necessary to reduce the risk for bleeding.
Dose adjustments are based on platelet count response. Do not use DOPTELET to normalize platelet counts.
Initial Dose Regimen:
Begin DOPTELET at a starting dose of 20 mg (1 tablet) once daily with food for all patients except those taking moderate or strong dual inducers or moderate or strong dual inhibitors of CYP2C9 and CYP3A4 (see Table 2).
Table 2:
DOPTELET Recommended Starting Dose for Patients with Chronic Immune Thrombocytopenia Based on Concomitant Medications Concomitant Medications Recommended Starting Dose Moderate or strong dual inhibitors of CYP2C9 and CYP3A4 20 mg (1 tablet) three times a week Moderate or strong dual inducers of CYP2C9 and CYP3A4 40 mg (2 tablets) once daily Monitoring: After initiating therapy with DOPTELET, assess platelet counts weekly until a stable platelet count greater than or equal to 50 x109/L has been achieved, and then obtain platelet counts monthly thereafter to maintain platelet counts ≥ 50 ×109/L and ≤ 150 ×109/L.
1 Adverse Reaction Overview Patients with Chronic Liver Disease The safety of DOPTELET was evaluated in two international, identically designed, randomized, double- blind, placebo-controlled trials, ADAPT-1 and ADAPT-2, in which 430 patients with chronic liver disease and thrombocytopenia received either DOPTELET (n=274) or placebo (n=156) daily for 5 days prior to a scheduled procedure, and had 1 post-dose safety assessment.
Patients were divided into two groups based on their mean platelet count at baseline: • Low Baseline Platelet Count Cohort (less than 40 x109/L) who received DOPTELET 60 mg once daily for 5 days • High Baseline Platelet Count Cohort (40 to less than 50 x109/L) who received DOPTELET 40 mg once daily for 5 days The majority of patients were males (65%) and median subject age was 58 years (ranging from 19-86 years of age).
The racial and ethnic distribution was White (60%), Asian (33%), Black (3%), and Other (3%). The most common treatment-emergent adverse events (TEAEs) (those occurring in ≥3% of patients) in the DOPTELET-treated groups (60 mg or 40 mg) versus placebo, across the pooled data from the two trials, were pyrexia (10% vs 9%), abdominal pain (7% vs 6%), nausea (7% vs 7%), headache (6% vs 6%), fatigue (4% vs 3%) and edema peripheral (3% vs 2%) (Table 6Table 6).
DOPTELET® (avatrombopag) - Product Monograph Page 12 of 36 Patients with Chronic Immune Thrombocytopenia The safety of DOPTELET was evaluated in four clinical trials in patients with chronic immune thrombocytopenia: two Phase 3 trials (one randomized, double-blind, placebo-controlled trial and one randomized, double-blind, active-controlled trial) and two Phase 2 trials (one randomized, double- blind, placebo-controlled, dose-ranging trial and one open-label extension trial) in 161 patients with chronic immune thrombocytopenia in both the double-blind and open-label extension phases.
08/2024 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ............................................................................................
2 TABLE OF CONTENTS .............................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION ......................................................................
4 1 INDICATIONS ............................................................................................................... 4 2 CONTRAINDICATIONS .................................................................................................
4 4 DOSAGE AND ADMINISTRATION ................................................................................. 7 5 OVERDOSAGE..............................................................................................................
7 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................. 7 7 WARNINGS AND PRECAUTIONS .................................................................................. 11 8 ADVERSE REACTIONS ................................................................................................
18 9 DRUG INTERACTIONS ................................................................................................ 20 10 CLINICAL PHARMACOLOGY .......................................................................................
21 11 STORAGE, STABILITY AND DISPOSAL ......................................................................... 22 12 SPECIAL HANDLING INSTRUCTIONS ........................................................................... 22 PART II: SCIENTIFIC INFORMATION .......................................................................................
DOPTELET is contraindicated in: • patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITIONS AND PACKAGING, Table 5.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Obtain platelet counts weekly for at least 4 weeks following discontinuation of DOPTELET. Dose adjustment recommendations (see Table 3 and Table 4) are based on the platelet count response and were established using clinical and pharmacokinetic and pharmacodynamic modelling and simulation data.
Do not exceed a daily dose of 40 mg (2 tablets).
Table 3:
DOPTELET Dose Adjustments for Patients with Chronic Immune Thrombocytopenia Platelet Count (x109/L) Dose Adjustment or Action Less than 50 after at least 2 weeks of DOPTELET • Increase One Dose Level per Table 4. • Wait 2 weeks to assess the effects of this regimen and any subsequent dose adjustments.
Between 150 and 250 • Decrease One Dose Level per Table 4. DOPTELET® (avatrombopag) - Product Monograph Page 6 of 36 Platelet Count (x109/L) Dose Adjustment or Action • Wait 2 weeks to assess the effects of this regimen and any subsequent dose adjustments.
Greater than 250 • Stop DOPTELET. • Increase platelet monitoring to twice weekly. • When platelet count is less than 150 x109/L, decrease One Dose Level per Table 4 and reinitiate therapy. Less than 50 after 4 weeks of DOPTELET 40 mg once daily • Discontinue DOPTELET.
Greater than 250 after 2 weeks of DOPTELET 20 mg weekly • Discontinue DOPTELET.
Table 4:
DOPTELET Dose Levels for Titration in Patients with Chronic Immune Thrombocytopenia *Initial dose regimen for all patients except those taking moderate or strong dual inducers or moderate or strong dual inhibitors of CYP2C9 and CYP3A4 (see Table 2).
#Patients taking DOPTELET less frequently than once daily should take the medication in a consistent manner from week to week. g. g. g.
Monday Discontinuation:
Discontinue DOPTELET if the platelet count does not increase to greater than or equal to 50 x109/L after 4 weeks of dosing at the maximum dose of 40 mg once daily. Discontinue DOPTELET if the platelet count is greater than 250 x109/L after 2 weeks of dosing at 20 mg once weekly.
Special populations Renal impairment No dose adjustment is required in patients with mild or moderate renal impairment. Due to limited clinical data, DOPTELET should be used with caution in these patients. No clinical data are available for patients with CrCl < 30 mL/min.
Geriatrics (≥ 65 years of age) No dose adjustment is required for patients aged 65 years and older. Due to limited clinical data, DOPTELET should be used with caution in elderly patients with chronic ITP. Pediatrics (< 18 years of age) Health Canada has not authorized an indication for pediatric use.
4 Administration Chronic Liver Disease Patients […]
1 weeks and had one post-dose safety assessment. 5 years (ranging from 18-88 years of age). The racial and ethnic distribution was White (84%), Black (6%), Asian (6%) and Other (6%). The most common TEAEs (those occurring in ≥10% of patients) in the DOPTELET treatment group versus placebo were headache (31% vs 14%), fatigue (28% vs 9%), contusion (26% vs 18%), epistaxis (19% vs 18%), upper respiratory tract infection (15% vs 5%), arthralgia (13% vs 0%), gingival bleeding (13% vs 0%), petechiae (11% vs 9%) and nasopharyngitis (10% vs 0%) (Table 7).
2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials therefore may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. 1 For the Low Baseline Platelet Count Cohort, the incidence of treatment-emergent serious adverse events was 7% (11/159) in the 60 mg DOPTELET treatment group.
For the High Baseline Platelet Count Cohort, the incidence of serious adverse events was 8% (9/115) in the 40 mg DOPTELET treatment group. The most common serious adverse event reported with DOPTELET was hyponatremia. 7%) developed hyponatremia.
4% (1/274) of patients receiving DOPTELET. TEAEs resulting in discontinuation of DOPTELET occurred in two patients in the […]
23 13 PHARMACEUTICAL INFORMATION ............................................................................ 23 14 CLINICAL TRIALS ........................................................................................................
28 15 MICROBIOLOGY ........................................................................................................ 29 16 NON-CLINICAL TOXICOLOGY .....................................................................................
29 PATIENT MEDICATION INFORMATION .................................................................................. 32 DOPTELET® (avatrombopag) - Product Monograph Page 4 of 36 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS DOPTELET […]