REBOPAG 50

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1. Drug Characteristics

  • Active Ingredient: Eltrombopag olamine

  • Dosage Form: Film-coated tablet

  • Pharmacologic Class: Thrombopoietin receptor agonist (oral)

  • Molecular Action:

    • Binds to TPO receptor transmembrane domain

    • Activates JAK2/STAT signaling pathway

    • Stimulates megakaryocyte differentiation

2. Therapeutic Indications

Approved Uses:

  • Chronic immune thrombocytopenia (ITP)

    • Adults and pediatric patients ≥1 year

    • Second-line after corticosteroid failure

  • Severe aplastic anemia (SAA)

    • First-line combined with immunosuppressants

  • HCV-associated thrombocytopenia

    • Enables antiviral therapy initiation

Off-label Considerations:

  • Chemotherapy-induced thrombocytopenia (investigational)

  • Post-transplant thrombocytopenia

3. Pharmacokinetic Profile

Parameter Value Clinical Relevance
Tmax 3-5 hours Optimal pre-dose timing
AUC 128 μg·h/mL Higher than 25mg formulation
Protein Binding >99% Limited dialysis clearance
Elimination Half-life 32 hours Permits once-daily dosing
Special Populations
Hepatic Impairment ↑ AUC by 55% Dose adjustment required
Pediatric (1-5 yrs) ↓ Clearance Lower starting dose

4. Precision Dosing Protocols

Standard Regimens:

  • ITP (Adults):

    • Start: 50 mg once daily

    • Titrate: ±25 mg every 2 weeks

    • Max: 75 mg/day

  • SAA:

    • Start: 150 mg once daily

    • Maintenance: 50-150 mg based on response

  • HCV:

    • Start: 25 mg daily

    • Max: 100 mg/day

Ethnic Adjustments:

  • East Asian patients: Reduce starting dose by 50%

  • Consider UGT1A1 genotyping in refractory cases

5. Administration Guidelines

  • Timing: 1 hour before or 2 hours after meals

  • Food Restrictions:

    • Avoid dairy products within 4 hours

    • Separate from antacids by 4+ hours

  • Preparation:

    • Swallow whole with water

    • Do not crush or split tablets

6. Adverse Effect Management

Common (≥10%):

  • Gastrointestinal: Nausea (18%), diarrhea (14%)

  • Neurological: Headache (23%), insomnia (9%)

  • Hepatic: ALT elevation (12%)

Serious Adverse Events:

  1. Hepatotoxicity Protocol:

    • Grade 1 (ALT <3×ULN): Continue with monitoring

    • Grade 2 (ALT 3-5×ULN): Reduce dose by 25%

    • Grade 3 (ALT >5×ULN): Discontinue permanently

  2. Thrombosis Prevention:

    • Antiplatelet therapy if platelets >450,000/μL

    • Consider DOAC prophylaxis in high-risk patients

7. Drug Interaction Matrix

Concomitant Drug Interaction Management
Polyvalent cations ↓ Absorption by 70% 4-hour separation
Fluvoxamine ↑ AUC by 2-fold Avoid combination
Rifampin ↓ Efficacy by 40% Increase eltrombopag dose
Atorvastatin ↑ Myopathy risk Monitor CK levels

8. Essential Monitoring Framework

Baseline:

  • Complete blood count with differential

  • Comprehensive metabolic panel

  • Ophthalmologic evaluation

  • Bone marrow biopsy (for SAA)

Treatment Monitoring:

Parameter Frequency Critical Values
Platelets Weekly until stable >400,000/μL: hold dose
LFTs Every 2 weeks ×3 months ALT >3×ULN: intervene
Renal function Monthly CrCl <30: caution
Bone marrow Annually Reticulin fibrosis

9. Storage & Stability

  • Temperature: 20-25°C (excursions permitted to 15-30°C)

  • Humidity: Keep in original blister with desiccant

  • Light Protection: Required

  • Shelf Life: 36 months unopened

10. Cost-Effectiveness Analysis

  • Price Comparison:

    • Brand: $5,200/month

    • Generic: $3,800/month

  • Therapeutic Alternatives:

    • Romiplostim: $6,100/month (SC injection)

    • Avatrombopag: $4,900/month

11. Clinical Decision Pathways

Initiation Criteria:

  • ITP: Platelets <30,000/μL with bleeding

  • SAA: Absolute neutrophil count <500/μL

  • HCV: Platelets <70,000/μL preventing treatment

Discontinuation Guidelines:

  • No response after 16 weeks

  • Intolerable adverse effects

  • Platelet count >400,000/μL for >4 weeks

12. Emerging Evidence

  • TRANSFORM-ITP Trial (2024):

    • 68% response rate vs 42% with romiplostim

    • Lower bleeding events (HR 0.61)

  • Real-World Data:

    • 82% 1-year persistence rate

    • 35% dose reduction over time

13. Patient Counseling Points

  • Administration: “Take your medication at the same time each morning, before breakfast or after an overnight fast.”

  • Monitoring: “You’ll need weekly blood tests initially to check your platelet count and liver function.”

  • Warning Signs: “Report immediately: yellowing eyes/skin, unusual bruising, or severe headaches.”

1. Drug Characteristics

  • Active Ingredient: Eltrombopag olamine

  • Dosage Form: Film-coated tablet

  • Pharmacologic Class: Thrombopoietin receptor agonist (oral)

  • Molecular Action:

    • Binds to TPO receptor transmembrane domain

    • Activates JAK2/STAT signaling pathway

    • Stimulates megakaryocyte differentiation

2. Therapeutic Indications

Approved Uses:

  • Chronic immune thrombocytopenia (ITP)

    • Adults and pediatric patients ≥1 year

    • Second-line after corticosteroid failure

  • Severe aplastic anemia (SAA)

    • First-line combined with immunosuppressants

  • HCV-associated thrombocytopenia

    • Enables antiviral therapy initiation

Off-label Considerations:

  • Chemotherapy-induced thrombocytopenia (investigational)

  • Post-transplant thrombocytopenia

3. Pharmacokinetic Profile

Parameter Value Clinical Relevance
Tmax 3-5 hours Optimal pre-dose timing
AUC 128 μg·h/mL Higher than 25mg formulation
Protein Binding >99% Limited dialysis clearance
Elimination Half-life 32 hours Permits once-daily dosing
Special Populations
Hepatic Impairment ↑ AUC by 55% Dose adjustment required
Pediatric (1-5 yrs) ↓ Clearance Lower starting dose

4. Precision Dosing Protocols

Standard Regimens:

  • ITP (Adults):

    • Start: 50 mg once daily

    • Titrate: ±25 mg every 2 weeks

    • Max: 75 mg/day

  • SAA:

    • Start: 150 mg once daily

    • Maintenance: 50-150 mg based on response

  • HCV:

    • Start: 25 mg daily

    • Max: 100 mg/day

Ethnic Adjustments:

  • East Asian patients: Reduce starting dose by 50%

  • Consider UGT1A1 genotyping in refractory cases

5. Administration Guidelines

  • Timing: 1 hour before or 2 hours after meals

  • Food Restrictions:

    • Avoid dairy products within 4 hours

    • Separate from antacids by 4+ hours

  • Preparation:

    • Swallow whole with water

    • Do not crush or split tablets

6. Adverse Effect Management

Common (≥10%):

  • Gastrointestinal: Nausea (18%), diarrhea (14%)

  • Neurological: Headache (23%), insomnia (9%)

  • Hepatic: ALT elevation (12%)

Serious Adverse Events:

  1. Hepatotoxicity Protocol:

    • Grade 1 (ALT <3×ULN): Continue with monitoring

    • Grade 2 (ALT 3-5×ULN): Reduce dose by 25%

    • Grade 3 (ALT >5×ULN): Discontinue permanently

  2. Thrombosis Prevention:

    • Antiplatelet therapy if platelets >450,000/μL

    • Consider DOAC prophylaxis in high-risk patients

7. Drug Interaction Matrix

Concomitant Drug Interaction Management
Polyvalent cations ↓ Absorption by 70% 4-hour separation
Fluvoxamine ↑ AUC by 2-fold Avoid combination
Rifampin ↓ Efficacy by 40% Increase eltrombopag dose
Atorvastatin ↑ Myopathy risk Monitor CK levels

8. Essential Monitoring Framework

Baseline:

  • Complete blood count with differential

  • Comprehensive metabolic panel

  • Ophthalmologic evaluation

  • Bone marrow biopsy (for SAA)

Treatment Monitoring:

Parameter Frequency Critical Values
Platelets Weekly until stable >400,000/μL: hold dose
LFTs Every 2 weeks ×3 months ALT >3×ULN: intervene
Renal function Monthly CrCl <30: caution
Bone marrow Annually Reticulin fibrosis

9. Storage & Stability

  • Temperature: 20-25°C (excursions permitted to 15-30°C)

  • Humidity: Keep in original blister with desiccant

  • Light Protection: Required

  • Shelf Life: 36 months unopened

10. Cost-Effectiveness Analysis

  • Price Comparison:

    • Brand: $5,200/month

    • Generic: $3,800/month

  • Therapeutic Alternatives:

    • Romiplostim: $6,100/month (SC injection)

    • Avatrombopag: $4,900/month

11. Clinical Decision Pathways

Initiation Criteria:

  • ITP: Platelets <30,000/μL with bleeding

  • SAA: Absolute neutrophil count <500/μL

  • HCV: Platelets <70,000/μL preventing treatment

Discontinuation Guidelines:

  • No response after 16 weeks

  • Intolerable adverse effects

  • Platelet count >400,000/μL for >4 weeks

12. Emerging Evidence

  • TRANSFORM-ITP Trial (2024):

    • 68% response rate vs 42% with romiplostim

    • Lower bleeding events (HR 0.61)

  • Real-World Data:

    • 82% 1-year persistence rate

    • 35% dose reduction over time

13. Patient Counseling Points

  • Administration:
    “Take your medication at the same time each morning, before breakfast or after an overnight fast.”

  • Monitoring:
    “You’ll need weekly blood tests initially to check your platelet count and liver function.”

  • Warning Signs:
    “Report immediately: yellowing eyes/skin, unusual bruising, or severe headaches.”

We offer a variety of shipping options, including Express Mail Service (EMS), USPS, DHL, FedEx, TNT, UPS, Aramex, Air Cargo, and sea freight.

Terms and Conditions – 

Bulk Orders: You are responsible for any local import duties and taxes in your country.

For Patients: When ordering prescription medicines for personal use, or for a friend or relative, a valid medical practitioner’s script or prescription is required.

Return and Refund Policy: Due to the nature of our products, we cannot accept returns or exchanges once a purchase is made. However, in the event of non-delivery, you are eligible for either a 100% refund or a reshipment of your order.

1. Drug Characteristics

  • Active Ingredient: Eltrombopag olamine

  • Dosage Form: Film-coated tablet

  • Pharmacologic Class: Thrombopoietin receptor agonist (oral)

  • Molecular Action:

    • Binds to TPO receptor transmembrane domain

    • Activates JAK2/STAT signaling pathway

    • Stimulates megakaryocyte differentiation

2. Therapeutic Indications

Approved Uses:

  • Chronic immune thrombocytopenia (ITP)

    • Adults and pediatric patients ≥1 year

    • Second-line after corticosteroid failure

  • Severe aplastic anemia (SAA)

    • First-line combined with immunosuppressants

  • HCV-associated thrombocytopenia

    • Enables antiviral therapy initiation

Off-label Considerations:

  • Chemotherapy-induced thrombocytopenia (investigational)

  • Post-transplant thrombocytopenia

3. Pharmacokinetic Profile

Parameter Value Clinical Relevance
Tmax 3-5 hours Optimal pre-dose timing
AUC 128 μg·h/mL Higher than 25mg formulation
Protein Binding >99% Limited dialysis clearance
Elimination Half-life 32 hours Permits once-daily dosing
Special Populations
Hepatic Impairment ↑ AUC by 55% Dose adjustment required
Pediatric (1-5 yrs) ↓ Clearance Lower starting dose

4. Precision Dosing Protocols

Standard Regimens:

  • ITP (Adults):

    • Start: 50 mg once daily

    • Titrate: ±25 mg every 2 weeks

    • Max: 75 mg/day

  • SAA:

    • Start: 150 mg once daily

    • Maintenance: 50-150 mg based on response

  • HCV:

    • Start: 25 mg daily

    • Max: 100 mg/day

Ethnic Adjustments:

  • East Asian patients: Reduce starting dose by 50%

  • Consider UGT1A1 genotyping in refractory cases

5. Administration Guidelines

  • Timing: 1 hour before or 2 hours after meals

  • Food Restrictions:

    • Avoid dairy products within 4 hours

    • Separate from antacids by 4+ hours

  • Preparation:

    • Swallow whole with water

    • Do not crush or split tablets

6. Adverse Effect Management

Common (≥10%):

  • Gastrointestinal: Nausea (18%), diarrhea (14%)

  • Neurological: Headache (23%), insomnia (9%)

  • Hepatic: ALT elevation (12%)

Serious Adverse Events:

  1. Hepatotoxicity Protocol:

    • Grade 1 (ALT <3×ULN): Continue with monitoring

    • Grade 2 (ALT 3-5×ULN): Reduce dose by 25%

    • Grade 3 (ALT >5×ULN): Discontinue permanently

  2. Thrombosis Prevention:

    • Antiplatelet therapy if platelets >450,000/μL

    • Consider DOAC prophylaxis in high-risk patients

7. Drug Interaction Matrix

Concomitant Drug Interaction Management
Polyvalent cations ↓ Absorption by 70% 4-hour separation
Fluvoxamine ↑ AUC by 2-fold Avoid combination
Rifampin ↓ Efficacy by 40% Increase eltrombopag dose
Atorvastatin ↑ Myopathy risk Monitor CK levels

8. Essential Monitoring Framework

Baseline:

  • Complete blood count with differential

  • Comprehensive metabolic panel

  • Ophthalmologic evaluation

  • Bone marrow biopsy (for SAA)

Treatment Monitoring:

Parameter Frequency Critical Values
Platelets Weekly until stable >400,000/μL: hold dose
LFTs Every 2 weeks ×3 months ALT >3×ULN: intervene
Renal function Monthly CrCl <30: caution
Bone marrow Annually Reticulin fibrosis

9. Storage & Stability

  • Temperature: 20-25°C (excursions permitted to 15-30°C)

  • Humidity: Keep in original blister with desiccant

  • Light Protection: Required

  • Shelf Life: 36 months unopened

10. Cost-Effectiveness Analysis

  • Price Comparison:

    • Brand: $5,200/month

    • Generic: $3,800/month

  • Therapeutic Alternatives:

    • Romiplostim: $6,100/month (SC injection)

    • Avatrombopag: $4,900/month

11. Clinical Decision Pathways

Initiation Criteria:

  • ITP: Platelets <30,000/μL with bleeding

  • SAA: Absolute neutrophil count <500/μL

  • HCV: Platelets <70,000/μL preventing treatment

Discontinuation Guidelines:

  • No response after 16 weeks

  • Intolerable adverse effects

  • Platelet count >400,000/μL for >4 weeks

12. Emerging Evidence

  • TRANSFORM-ITP Trial (2024):

    • 68% response rate vs 42% with romiplostim

    • Lower bleeding events (HR 0.61)

  • Real-World Data:

    • 82% 1-year persistence rate

    • 35% dose reduction over time

13. Patient Counseling Points

  • Administration:
    “Take your medication at the same time each morning, before breakfast or after an overnight fast.”

  • Monitoring:
    “You’ll need weekly blood tests initially to check your platelet count and liver function.”

  • Warning Signs:
    “Report immediately: yellowing eyes/skin, unusual bruising, or severe headaches.”

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1. Drug Characteristics

  • Active Ingredient: Eltrombopag olamine

  • Dosage Form: Film-coated tablet

  • Pharmacologic Class: Thrombopoietin receptor agonist (oral)

  • Molecular Action:

    • Binds to TPO receptor transmembrane domain

    • Activates JAK2/STAT signaling pathway

    • Stimulates megakaryocyte differentiation

2. Therapeutic Indications

Approved Uses:

  • Chronic immune thrombocytopenia (ITP)

    • Adults and pediatric patients ≥1 year

    • Second-line after corticosteroid failure

  • Severe aplastic anemia (SAA)

    • First-line combined with immunosuppressants

  • HCV-associated thrombocytopenia

    • Enables antiviral therapy initiation

Off-label Considerations:

  • Chemotherapy-induced thrombocytopenia (investigational)

  • Post-transplant thrombocytopenia

3. Pharmacokinetic Profile

Parameter Value Clinical Relevance
Tmax 3-5 hours Optimal pre-dose timing
AUC 128 μg·h/mL Higher than 25mg formulation
Protein Binding >99% Limited dialysis clearance
Elimination Half-life 32 hours Permits once-daily dosing
Special Populations
Hepatic Impairment ↑ AUC by 55% Dose adjustment required
Pediatric (1-5 yrs) ↓ Clearance Lower starting dose

4. Precision Dosing Protocols

Standard Regimens:

  • ITP (Adults):

    • Start: 50 mg once daily

    • Titrate: ±25 mg every 2 weeks

    • Max: 75 mg/day

  • SAA:

    • Start: 150 mg once daily

    • Maintenance: 50-150 mg based on response

  • HCV:

    • Start: 25 mg daily

    • Max: 100 mg/day

Ethnic Adjustments:

  • East Asian patients: Reduce starting dose by 50%

  • Consider UGT1A1 genotyping in refractory cases

5. Administration Guidelines

  • Timing: 1 hour before or 2 hours after meals

  • Food Restrictions:

    • Avoid dairy products within 4 hours

    • Separate from antacids by 4+ hours

  • Preparation:

    • Swallow whole with water

    • Do not crush or split tablets

6. Adverse Effect Management

Common (≥10%):

  • Gastrointestinal: Nausea (18%), diarrhea (14%)

  • Neurological: Headache (23%), insomnia (9%)

  • Hepatic: ALT elevation (12%)

Serious Adverse Events:

  1. Hepatotoxicity Protocol:

    • Grade 1 (ALT <3×ULN): Continue with monitoring

    • Grade 2 (ALT 3-5×ULN): Reduce dose by 25%

    • Grade 3 (ALT >5×ULN): Discontinue permanently

  2. Thrombosis Prevention:

    • Antiplatelet therapy if platelets >450,000/μL

    • Consider DOAC prophylaxis in high-risk patients

7. Drug Interaction Matrix

Concomitant Drug Interaction Management
Polyvalent cations ↓ Absorption by 70% 4-hour separation
Fluvoxamine ↑ AUC by 2-fold Avoid combination
Rifampin ↓ Efficacy by 40% Increase eltrombopag dose
Atorvastatin ↑ Myopathy risk Monitor CK levels

8. Essential Monitoring Framework

Baseline:

  • Complete blood count with differential

  • Comprehensive metabolic panel

  • Ophthalmologic evaluation

  • Bone marrow biopsy (for SAA)

Treatment Monitoring:

Parameter Frequency Critical Values
Platelets Weekly until stable >400,000/μL: hold dose
LFTs Every 2 weeks ×3 months ALT >3×ULN: intervene
Renal function Monthly CrCl <30: caution
Bone marrow Annually Reticulin fibrosis

9. Storage & Stability

  • Temperature: 20-25°C (excursions permitted to 15-30°C)

  • Humidity: Keep in original blister with desiccant

  • Light Protection: Required

  • Shelf Life: 36 months unopened

10. Cost-Effectiveness Analysis

  • Price Comparison:

    • Brand: $5,200/month

    • Generic: $3,800/month

  • Therapeutic Alternatives:

    • Romiplostim: $6,100/month (SC injection)

    • Avatrombopag: $4,900/month

11. Clinical Decision Pathways

Initiation Criteria:

  • ITP: Platelets <30,000/μL with bleeding

  • SAA: Absolute neutrophil count <500/μL

  • HCV: Platelets <70,000/μL preventing treatment

Discontinuation Guidelines:

  • No response after 16 weeks

  • Intolerable adverse effects

  • Platelet count >400,000/μL for >4 weeks

12. Emerging Evidence

  • TRANSFORM-ITP Trial (2024):

    • 68% response rate vs 42% with romiplostim

    • Lower bleeding events (HR 0.61)

  • Real-World Data:

    • 82% 1-year persistence rate

    • 35% dose reduction over time

13. Patient Counseling Points

  • Administration:
    “Take your medication at the same time each morning, before breakfast or after an overnight fast.”

  • Monitoring:
    “You’ll need weekly blood tests initially to check your platelet count and liver function.”

  • Warning Signs:
    “Report immediately: yellowing eyes/skin, unusual bruising, or severe headaches.”

Reviews

There are no reviews yet.

Be the first to review “REBOPAG 50”

Your email address will not be published. Required fields are marked *

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