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APO-ELTROMBOPAG is a brand name for Eltrombopag, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: • APO-ELTROMBOPAG (eltrombopag) tablets are indicated for the treatment of chronic immune thrombocytopenia (ITP) to increase platelet counts in adult and pediatric patients one year and older who have had an insufficient response to corticosteroids or immunoglobulins. • APO-ELTROMBOPAG is indicated to increase…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations APO-ELTROMBOPAG is only available as tablets and cannot be used in patients who are unable to swallow APO-ELTROMBOPAG tablets whole. Chronic Immune Thrombocytopenia (ITP) APO-ELTROMBOPAG (eltrombopag) treatment should be initiated and maintained by a physician who is experienced in the treatment of haematological diseases, who understands the benefits and risks associated with the treatment of ITP, and who is experienced in counselling patients for whom APO-ELTROMBOPAG is indicated.
4 Administration below). APO-ELTROMBOPAG dosing regimens must be individualized based on the patient’s platelet counts. The objective of treatment with APO-ELTROMBOPAG should not be to normalize platelet counts but to maintain platelet counts above the level for hemorrhagic risk (>50 x 109/L), and generally below 150 to 200 x 109/L.
Use the lowest effective dosing regimen to maintain platelet counts, as clinically indicated. In most patients, measurable elevations in platelet counts take 1 to 2 weeks to occur (see 14 CLINICAL TRIALS). Chronic Hepatitis C-related Thrombocytopenia APO-ELTROMBOPAG is given in combination with pegylated interferon and ribavirin.
Reference should be made to the full Product Monographs for each respective co-administered medicinal product for comprehensive details of administration. The directions regarding the APO-ELTROMBOBAG Eltrombopag (as eltrombopag olamine) Page 6 of 74 dosage, dose adjustment guidelines in the event of toxicity and other relevant safety information or contraindications for pegylated interferon and ribavirin should be followed.
APO-ELTROMBOPAG should be used only in patients with chronic hepatitis C whose degree of thrombocytopenia prevents the initiation of interferon-based therapy and limits the ability to maintain interferon-based therapy. Use the lowest dose of APO-ELTROMBOPAG to achieve and maintain a platelet count necessary to initiate and maintain antiviral therapy.
Dose adjustments are based upon the patient’s platelet count response, see Table 2, below. Do not use APO- ELTROMBOPAG to normalize platelet counts. In clinical studies, platelet counts generally increased within 1 week of starting eltrombopag.
The safety and efficacy of eltrombopag have not been established in combination with direct acting antiviral agents used in the treatment of chronic hepatitis C virus infection. Severe Aplastic Anemia (SAA) Use the lowest dose of APO-ELTROMBOPAG to achieve and maintain a hematologic response.
1 Adverse Reaction Overview In the adult ITP clinical studies, hemorrhage was the most common serious adverse reaction and most hemorrhage reactions followed discontinuation of eltrombopag. Other serious adverse reactions included liver test abnormalities and thromboembolic complications.
Based on an analysis of adult chronic ITP patients receiving eltrombopag in 3 controlled and 2 uncontrolled clinical studies, the median duration of exposure to eltrombopag was 379 days and patient year’s exposure was 584 in this study population.
Based on a final analysis of adult chronic ITP patients receiving eltrombopag in one uncontrolled extension study, the median daily dose was 51 mg and the median duration of exposure was 865 days. The safety of eltrombopag in pediatric patients (aged 1 to 17 years) with previously treated chronic ITP has been demonstrated in a pooled safety population of 157 patients, 107 treated with eltrombopag and 50 treated with placebo.
The median exposure to eltrombopag in the randomized period was 91 days. The most common adverse reactions observed with eltrombopag (≥ 10% and greater than placebo) were upper respiratory tract infection and nasopharyngitis. 0%, eltrombopag versus placebo, respectively.
In the HCV clinical studies, the safety of eltrombopag in combination with interferon and ribavirin is supported by a clinical database of 1576 eltrombopag-treated adult patients enrolled in two pivotal, placebo-controlled, phase III studies and one supportive phase II study.
06. The most commonly reported adverse events were fatigue, headache, myalgia, fever, and rigors. The Product Monographs for both pegylated interferon and ribavirin should be consulted for relevant safety information. In the SAA pivotal phase II study (n=43), nausea, fatigue, cough, diarrhea, and headache were the most common adverse reactions reported.
, Hepatic/Biliary/Pancreatic, Hepatic Impairment and Hepatotoxicity). • APO-ELTROMBOPAG (eltrombopag) 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 of excipients (see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING). In patients with chronic hepatitis C virus (HCV) infection, the Product Monographs for both pegylated interferon and ribavirin should be consulted for relevant contraindications associated with the use of these products.
APO-ELTROMBOBAG Eltrombopag (as eltrombopag olamine) Page 5 of 74 3 SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions APO-ELTROMBOPAG should be used with caution in chronic hepatitis C patients with cirrhosis as it may increase the risk of hepatic decompensation and death when administered with pegylated interferon and ribavirin.
Patients with low albumin levels (<35 g/L) or Model for End-Stage Liver Disease (MELD) score ≥ 10 at baseline had a greater risk of hepatic decompensation. Patients with these characteristics should be closely monitored for signs and symptoms of hepatic decompensation (see 7 WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic, Hepatic Decompensation - Use with Interferon).
1 Dosing Considerations APO-ELTROMBOPAG is only available as tablets and cannot be used in patients who are unable to swallow APO-ELTROMBOPAG tablets whole. Chronic Immune Thrombocytopenia (ITP) APO-ELTROMBOPAG (eltrombopag) treatment should be initiated and maintained by a physician who is experienced in the treatment of haematological diseases, who understands the benefits and risks associated with the treatment of ITP, and who is experienced in counselling patients for whom APO-ELTROMBOPAG is indicated.
4 Administration below). APO-ELTROMBOPAG dosing regimens must be individualized based on the patient’s platelet counts. The objective of treatment with APO-ELTROMBOPAG should not be to normalize platelet counts but to maintain platelet counts above the level for hemorrhagic risk (>50 x 109/L), and generally below 150 to 200 x 109/L.
• APO-ELTROMBOPAG (eltrombopag) is contraindicated in patients with severe hepatic impairment (Child-Pugh Class C) (see 7 WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic, Hepatic Impairment and Hepatotoxicity). • APO-ELTROMBOPAG (eltrombopag) 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 of excipients (see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING). In patients with chronic hepatitis C virus (HCV) infection, the Product Monographs for both pegylated interferon and ribavirin should be consulted for relevant contraindications associated with the use of these products.
APO-ELTROMBOBAG Eltrombopag (as eltrombopag olamine) Page 5 of 74
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Dose adjustments are based upon the platelet count. Do not use APO- ELTROMBOPAG to normalize platelet counts (see 7 Hematologic, Thrombotic or thromboembolic complications). 1 Severe Aplastic Anemia). 2 Recommended Dose and Dosage Adjustment Chronic Immune Thrombocytopenia (ITP) Initial Dose Regimen Adults and Pediatric Patients Aged 6 years and above: The recommended starting dose of APO-ELTROMBOPAG is 50 mg once daily.
For ITP patients of East/Southeast-Asian ancestry aged 6 and above, initiate APO-ELTROMBOPAG at a reduced dose of 25 mg once daily (see 4 DOSAGE AND ADMINISTRATION).
Pediatric Patients Aged 1 to < 6 years:
The recommended starting dose of APO-ELTROMBOPAG is 25 mg once daily. g. 50 x 109/L), the dose may be increased to a maximum of 75 mg once daily (see Table 1). A dose reduction should be considered with platelet counts increasing to over 150 x 109/L.
At platelet counts over 200 x 109/L dose reduction is recommended (see Table 1). APO-ELTROMBOBAG Eltrombopag (as eltrombopag olamine) Page 7 of 74 APO-ELTROMBOPAG should be interrupted if platelet counts increase to > 300 x 109/L. Once the platelet count is < 150 x 109/L; reinitiate therapy at a reduced dose.
If platelet counts remain at > 300 x 109/L after 2 weeks of therapy of the lowest dose of APO-ELTROMBOPAG, discontinue treatment (see Table 1). Table 1 Dose Adjustments of APO-ELTROMBOPAG in ITP patients Platelet Count Result Dose Adjustment or Response < 50 x 109/L following at least 2 weeks of APO-ELTROMBOPAG Increase daily dose by 25 mg to a maximum of 75 mg/day For patients taking 25 mg once every other day, increase dose to 25 mg once daily.
≥ 50 x 109/L to ≤ 200 x 109/L Use lowest dose of APO-ELTROMBOPAG and/or concomitant ITP treatment to maintain platelet counts that avoid or reduce bleeding. > 200 x 109/L to ≤ 300 x 109/L at any time Decrease the daily dose by 25 mg.
Wait 2 weeks to assess the effects of this and any subsequent dose adjustments For patients taking 25 mg once daily, consideration should be given to dosing at 25 mg once every other day. > 300 x 109/L Stop APO-ELTROMBOPAG. Increase the frequency of platelet monitoring to twice weekly.
Once the platelet count is < 150 x 109/L, reinitiate therapy at a daily dose reduced by 25 mg. For patients taking 25 mg once daily, consideration should be given to reinitiating therapy at 25 mg once every other day. >300 x 109/L after 2 weeks of therapy at lowest dose of APO-ELTROMBOPAG Discontinue APO-ELTROMBOPAG The standard dose adjustment, whether decreased or increased, would be 25 mg once daily.
However, in a few patients an alternate dosing of different tablet strengths on different days may be required. After any APO-ELTROMBOPAG dose adjustment, platelet counts should be monitored at least once weekly for 2 to 3 weeks. Wait for at least 2 weeks to see the effect of any dose increase on the patient’s platelet […]
The most common serious adverse events reported were febrile neutropenia, sepsis and viral infection. 2 Clinical Trial Adverse Reactions Clinical trials were 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 is useful for identifying and approximating rates of adverse drug reactions in the real world use. Adult Chronic Immune Thrombocytopenia (ITP) The safety of eltrombopag has been demonstrated in two randomised, double-blind, placebo controlled studies in 211 adults with previously treated chronic ITP (see 14 CLINICAL TRIALS).
Most adverse reactions associated with eltrombopag were mild to moderate in severity, early in onset and rarely treatment limiting. The most common adverse events were nausea, vomiting, diarrhea and headache. The drug-related adverse events occurring in ≥ 1% of adult patients, and which were more common in the treatment group as compared to placebo in the Phase III, double-blind, placebo-controlled 6 week study, TRA100773B, and 6 month study, RAISE (TRA102537), are presented in Table 5 and Table 6, respectively.
APO-ELTROMBOBAG Eltrombopag (as eltrombopag olamine) Page 22 of 74 The safety of eltrombopag over long-term dosing was evaluated in one single arm, open- label, extension study, EXTEND (TRA105325), in 302 adult patients with previously treated chronic ITP who were previously enrolled in an eltrombopag study.
Overall, the safety data from this study reflect the known safety profile of eltrombopag. Drug-related adverse events occurring in ≥ 3% of patients are presented in Table 7. Table 5 Drug-Related Adverse Events ≥ 1% in Adult ITP Patients over 6 weeks (Study TRA100773B) Body System/Adverse Event Treatment Group, n (%) Eltrombopag N=76 Placebo N=38 Cardiac disorders Sinus tachycardia 1(1) 0 Gastrointestinal Nausea 4(5) 0 Vomiting 2(3) 0 Abdominal distension 1(1) 0 Constipation 1(1) 0 Diarrhea 1(1) 0 Hemorrhoids 1(1) 0 Hepatobiliary disorders Hepatic function abnormal 1(1) 0 General disorders and administration site conditions Fatigue 2(3) 0 Malaise 1(1) 0 Investigations Protein total increased 3(4) 1(3) ALT increased 2(3) 0 AST increased 2(3) 0 Metabolism and nutrition disorders Hypokalemia 1(1) 0 Musculoskeletal and connective tissue disorders APO-ELTROMBOBAG Eltrombopag (as eltrombopag olamine) Page 23 of 74 Body System/Adverse Event Treatment Group, n (%) Eltrombopag N=76 Placebo N=38 Myalgia 3(4) 0 Arthralgia 1(1) 0 Bone pain 1(1) 0 Nervous system disorders Headache 4(5) 1(3) Psychiatric disorders Sleep disorder 1(1) 0 Skin and subcutaneous tissue disorders Alopecia 1(1) 0 Night sweats 1(1) 0 Table 6 Drug-Related Adverse Events ≥ 1% in Adult ITP Patients over 6 months (RAISE) Body System/Adverse Event Treatment Group, n (%) Eltrombopag N=135 Placebo N=61 Eye disorders Dry eye 2(1) 0 Gastrointestinal Nausea 6(4) 0 Constipation 3(2) 1(2) Diarrhea 4(3) 0 Dry mouth 3(2) 0 Vomiting 2(1) 0 General Disorders and Administration Site Conditions Feeling hot 2(1) 0 Hepatobiliary disorders Hepatic function abnormal 2(1) 0 Investigations ALT increased 6(4) 2(3) APO-ELTROMBOBAG Eltrombopag (as eltrombopag olamine) Page 24 of 74 Body System/Adverse Event Treatment Group, n (%) Eltrombopag N=135 Placebo N=61 Hemoglobin increased 2(1) 0 Transaminases increased 2(1) 0 Musculoskeletal and connective tissue disorders Arthralgia 2(1) 0 Nervous system disorder Headache 15(11) 5(8) Paraesthesia 3(2) 0 Skin and subcutaneous tissue disorders Hyperhidrosis 3(2) 0 Rash 2(1) 0 EXTEND (TRA105325) Table 7 Drug-Related Adverse Events ≥ 3% in Adult Chronic ITP Patients in EXTEND (Safety Population) Preferred Term Eltrombopag N=302 Any AE; n (%) 133 (44) Headache 30 (10) Alanine aminotransferase increased 16 (5) […]
Use the lowest effective dosing regimen to maintain platelet counts, as clinically indicated. In most patients, measurable elevations in platelet counts take 1 to 2 weeks to occur (see 14 CLINICAL TRIALS). Chronic Hepatitis C-related Thrombocytopenia APO-ELTROMBOPAG is given in combination with pegylated interferon and ribavirin.
Reference should be made to the full Product Monographs for each respective co-administered medicinal product for comprehensive details of administration. The directions regarding the APO-ELTROMBOBAG Eltrombopag (as eltrombopag olamine) Page 6 of 74 dosage, dose adjustment guidelines in the event of toxicity and other relevant safety information or contraindications for pegylated interferon and ribavirin should be followed.
APO-ELTROMBOPAG should be used only in patients with chronic hepatitis C whose degree of thrombocytopenia prevents the initiation of interferon-based therapy and limits the ability to maintain interferon-based therapy. Use the lowest dose of APO-ELTROMBOPAG to achieve and maintain a platelet count necessary to initiate and maintain antiviral therapy.
Dose adjustments are based upon the patient’s platelet count response, see Table 2, below. Do not use APO- ELTROMBOPAG to normalize platelet counts. In clinical studies, platelet counts generally increased within 1 week of starting eltrombopag.
The safety and efficacy of eltrombopag have not been established in combination with direct acting antiviral agents used in the treatment of chronic hepatitis C virus infection. Severe Aplastic Anemia (SAA) Use the lowest dose of APO-ELTROMBOPAG to achieve and maintain a hematologic response.
Dose adjustments are based upon the platelet count. Do not use APO- ELTROMBOPAG to normalize platelet counts (see 7 Hematologic, Thrombotic or thromboembolic complications). 1 Severe Aplastic Anemia). 2 Recommended Dose and Dosage Adjustment Chronic Immune Thrombocytopenia (ITP) Initial Dose Regimen Adults and Pediatric Patients Aged 6 years and above: The recommended starting dose of APO-ELTROMBOPAG is 50 mg once daily.
For ITP patients of East/Southeast-Asian ancestry aged 6 and above, initiate APO-ELTROMBOPAG at a reduced dose of 25 mg once daily (see 4 DOSAGE AND ADMINISTRATION).
Pediatric Patients Aged 1 to < 6 years:
The recommended starting dose of APO-ELTROMBOPAG is 25 mg once daily. g. 50 x 109/L), the dose may be increased to a maximum of 75 mg once daily (see Table 1). A dose reduction should be considered with platelet counts increasing to over 150 x 109/L.
At platelet counts over 200 x 109/L dose reduction is recommended (see Table 1). APO-ELTROMBOBAG Eltrombopag (as eltrombopag olamine) Page 7 of 74 APO-ELTROMBOPAG should be interrupted if platelet counts increase to > 300 x 109/L. Once the platelet count is < 150 x 109/L; reinitiate therapy at a reduced dose.
If platelet counts remain at > 300 x 109/L after 2 weeks of therapy of the lowest dose of APO-ELTROMBOPAG, discontinue treatment (see Table 1). Table 1 Dose Adjustments of APO-ELTROMBOPAG in ITP patients Platelet Count Result Dose Adjustment or Response < 50 x 109/L following at least 2 weeks of APO-ELTROMBOPAG Increase daily dose by 25 mg to a […]