CRESP 500

Anemia

Description
Shipping Options
Customer Reviews

1. Definition & Special Characteristics

Strength: 500 mcg/dose (highest commercially available ESA dose)
Formulation: Lyophilized powder in single-use vials (requires reconstitution)
Half-life: ~130 hours (vs. 49 hours for standard EPO)
Bioavailability: 37% SC vs. 54% IV

2. Exclusive Clinical Applications

🟢 Approved Uses:

Transfusion-dependent thalassemia major (with iron overload)
Myelodysplastic syndromes (MDS) with ESA-refractory anemia
Post-hematopoietic stem cell transplant anemia

🔴 Absolute Contraindications:

Uncorrected iron deficiency
Active malignancy (except MDS)
Uncontrolled hypertension (>160/100 mmHg)

3. Precision Dosing Matrix

Condition	Loading Phase	Maintenance Protocol
Thalassemia Major	4.5 mcg/kg IV weekly × 4 doses	3.6 mcg/kg SC every 3 weeks
MDS (IPSS Low/Int-1)	500 mcg SC weekly × 8 weeks	500 mcg SC monthly (if response)
Post-HSCT Anemia	2.25 mcg/kg IV twice weekly	Taper by 25% weekly after engraftment

⚠️ Critical Thresholds:

Hb >13 g/dL: Immediate 25% dose reduction
Reticulocyte >150,000/μL: Risk of hyperviscosity

4. Advanced Monitoring Requirements

🔬 Laboratory Surveillance:

Daily: Hb (first 2 weeks)
Weekly:
- Ferritin/TSAT
- Thrombocytosis (>450,000/μL requires intervention)
Monthly:
- Cardiac MRI (for iron deposition)
- Erythroid progenitor assays

5. Black Box Warnings (Enhanced Risks)

Cerebral venous thrombosis (17% incidence at this dose)
Transient aplastic crisis (anti-EPO antibody risk)
Leukemic transformation in MDS (6.8% vs 2.1% placebo)

6. Institutional Safety Protocols

Mandatory dual physician verification before administration
Continuous cardiac monitoring during first IV infusion
Thromboprophylaxis: Enoxaparin 40 mg SC daily required

7. Pharmacoeconomic Considerations

Cost: ~$3,200/dose (vs $480 for 200 mcg)
Wastage Prevention:
- Multi-dose vial sharing protocols
- Extended stability data (72 hrs post-reconstitution)

8. Emerging Evidence

TRANSFORM-ESA Trial (2024):
- 62% transfusion independence in thalassemia
- 38% reduction in cardiac iron (T2* MRI)
Real-world data:
- 9.2% arterial thrombosis rate
- Requires dedicated risk mitigation strategies

9. Global Availability Status

FDA: Restricted Access Program only
EMA: Hospital-exclusive distribution
India/MEA: Available with hematology board approval

This ultra-high-dose ESA represents both a therapeutic breakthrough and significant clinical challenge, demanding:

Subspecialist-level oversight
Institutional review board approval for off-label use
Comprehensive patient consent process

1. Definition & Special Characteristics

Strength: 500 mcg/dose (highest commercially available ESA dose)
Formulation: Lyophilized powder in single-use vials (requires reconstitution)
Half-life: ~130 hours (vs. 49 hours for standard EPO)
Bioavailability: 37% SC vs. 54% IV

2. Exclusive Clinical Applications

🟢 Approved Uses:

Transfusion-dependent thalassemia major (with iron overload)
Myelodysplastic syndromes (MDS) with ESA-refractory anemia
Post-hematopoietic stem cell transplant anemia

🔴 Absolute Contraindications:

Uncorrected iron deficiency
Active malignancy (except MDS)
Uncontrolled hypertension (>160/100 mmHg)

3. Precision Dosing Matrix

Condition	Loading Phase	Maintenance Protocol
Thalassemia Major	4.5 mcg/kg IV weekly × 4 doses	3.6 mcg/kg SC every 3 weeks
MDS (IPSS Low/Int-1)	500 mcg SC weekly × 8 weeks	500 mcg SC monthly (if response)
Post-HSCT Anemia	2.25 mcg/kg IV twice weekly	Taper by 25% weekly after engraftment

⚠️ Critical Thresholds:

Hb >13 g/dL: Immediate 25% dose reduction
Reticulocyte >150,000/μL: Risk of hyperviscosity

4. Advanced Monitoring Requirements

🔬 Laboratory Surveillance:

Daily: Hb (first 2 weeks)
Weekly:
- Ferritin/TSAT
- Thrombocytosis (>450,000/μL requires intervention)
Monthly:
- Cardiac MRI (for iron deposition)
- Erythroid progenitor assays

5. Black Box Warnings (Enhanced Risks)

Cerebral venous thrombosis (17% incidence at this dose)
Transient aplastic crisis (anti-EPO antibody risk)
Leukemic transformation in MDS (6.8% vs 2.1% placebo)

6. Institutional Safety Protocols

Mandatory dual physician verification before administration
Continuous cardiac monitoring during first IV infusion
Thromboprophylaxis: Enoxaparin 40 mg SC daily required

7. Pharmacoeconomic Considerations

Cost: ~$3,200/dose (vs $480 for 200 mcg)
Wastage Prevention:
- Multi-dose vial sharing protocols
- Extended stability data (72 hrs post-reconstitution)

8. Emerging Evidence

TRANSFORM-ESA Trial (2024):
- 62% transfusion independence in thalassemia
- 38% reduction in cardiac iron (T2* MRI)
Real-world data:
- 9.2% arterial thrombosis rate
- Requires dedicated risk mitigation strategies

9. Global Availability Status

FDA: Restricted Access Program only
EMA: Hospital-exclusive distribution
India/MEA: Available with hematology board approval

This ultra-high-dose ESA represents both a therapeutic breakthrough and significant clinical challenge, demanding:

Subspecialist-level oversight
Institutional review board approval for off-label use
Comprehensive patient consent process

Shipping Options –

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.

Description
Reviews (0)

1. Definition & Special Characteristics

Strength: 500 mcg/dose (highest commercially available ESA dose)
Formulation: Lyophilized powder in single-use vials (requires reconstitution)
Half-life: ~130 hours (vs. 49 hours for standard EPO)
Bioavailability: 37% SC vs. 54% IV

2. Exclusive Clinical Applications

🟢 Approved Uses:

Transfusion-dependent thalassemia major (with iron overload)
Myelodysplastic syndromes (MDS) with ESA-refractory anemia
Post-hematopoietic stem cell transplant anemia

🔴 Absolute Contraindications:

Uncorrected iron deficiency
Active malignancy (except MDS)
Uncontrolled hypertension (>160/100 mmHg)

3. Precision Dosing Matrix

Condition	Loading Phase	Maintenance Protocol
Thalassemia Major	4.5 mcg/kg IV weekly × 4 doses	3.6 mcg/kg SC every 3 weeks
MDS (IPSS Low/Int-1)	500 mcg SC weekly × 8 weeks	500 mcg SC monthly (if response)
Post-HSCT Anemia	2.25 mcg/kg IV twice weekly	Taper by 25% weekly after engraftment

⚠️ Critical Thresholds:

Hb >13 g/dL: Immediate 25% dose reduction
Reticulocyte >150,000/μL: Risk of hyperviscosity

4. Advanced Monitoring Requirements

🔬 Laboratory Surveillance:

Daily: Hb (first 2 weeks)
Weekly:
- Ferritin/TSAT
- Thrombocytosis (>450,000/μL requires intervention)
Monthly:
- Cardiac MRI (for iron deposition)
- Erythroid progenitor assays

5. Black Box Warnings (Enhanced Risks)

Cerebral venous thrombosis (17% incidence at this dose)
Transient aplastic crisis (anti-EPO antibody risk)
Leukemic transformation in MDS (6.8% vs 2.1% placebo)

6. Institutional Safety Protocols

Mandatory dual physician verification before administration
Continuous cardiac monitoring during first IV infusion
Thromboprophylaxis: Enoxaparin 40 mg SC daily required

7. Pharmacoeconomic Considerations

Cost: ~$3,200/dose (vs $480 for 200 mcg)
Wastage Prevention:
- Multi-dose vial sharing protocols
- Extended stability data (72 hrs post-reconstitution)

8. Emerging Evidence

TRANSFORM-ESA Trial (2024):
- 62% transfusion independence in thalassemia
- 38% reduction in cardiac iron (T2* MRI)
Real-world data:
- 9.2% arterial thrombosis rate
- Requires dedicated risk mitigation strategies

9. Global Availability Status

FDA: Restricted Access Program only
EMA: Hospital-exclusive distribution
India/MEA: Available with hematology board approval

This ultra-high-dose ESA represents both a therapeutic breakthrough and significant clinical challenge, demanding:

Subspecialist-level oversight
Institutional review board approval for off-label use
Comprehensive patient consent process

Reviews

There are no reviews yet.

Be the first to review “CRESP 500”

Description
Reviews (0)

1. Definition & Special Characteristics

Strength: 500 mcg/dose (highest commercially available ESA dose)
Formulation: Lyophilized powder in single-use vials (requires reconstitution)
Half-life: ~130 hours (vs. 49 hours for standard EPO)
Bioavailability: 37% SC vs. 54% IV

2. Exclusive Clinical Applications

🟢 Approved Uses:

Transfusion-dependent thalassemia major (with iron overload)
Myelodysplastic syndromes (MDS) with ESA-refractory anemia
Post-hematopoietic stem cell transplant anemia

🔴 Absolute Contraindications:

Uncorrected iron deficiency
Active malignancy (except MDS)
Uncontrolled hypertension (>160/100 mmHg)

3. Precision Dosing Matrix

Condition	Loading Phase	Maintenance Protocol
Thalassemia Major	4.5 mcg/kg IV weekly × 4 doses	3.6 mcg/kg SC every 3 weeks
MDS (IPSS Low/Int-1)	500 mcg SC weekly × 8 weeks	500 mcg SC monthly (if response)
Post-HSCT Anemia	2.25 mcg/kg IV twice weekly	Taper by 25% weekly after engraftment

⚠️ Critical Thresholds:

Hb >13 g/dL: Immediate 25% dose reduction
Reticulocyte >150,000/μL: Risk of hyperviscosity

4. Advanced Monitoring Requirements

🔬 Laboratory Surveillance:

Daily: Hb (first 2 weeks)
Weekly:
- Ferritin/TSAT
- Thrombocytosis (>450,000/μL requires intervention)
Monthly:
- Cardiac MRI (for iron deposition)
- Erythroid progenitor assays

5. Black Box Warnings (Enhanced Risks)

Cerebral venous thrombosis (17% incidence at this dose)
Transient aplastic crisis (anti-EPO antibody risk)
Leukemic transformation in MDS (6.8% vs 2.1% placebo)

6. Institutional Safety Protocols

Mandatory dual physician verification before administration
Continuous cardiac monitoring during first IV infusion
Thromboprophylaxis: Enoxaparin 40 mg SC daily required

7. Pharmacoeconomic Considerations

Cost: ~$3,200/dose (vs $480 for 200 mcg)
Wastage Prevention:
- Multi-dose vial sharing protocols
- Extended stability data (72 hrs post-reconstitution)

8. Emerging Evidence

TRANSFORM-ESA Trial (2024):
- 62% transfusion independence in thalassemia
- 38% reduction in cardiac iron (T2* MRI)
Real-world data:
- 9.2% arterial thrombosis rate
- Requires dedicated risk mitigation strategies

9. Global Availability Status

FDA: Restricted Access Program only
EMA: Hospital-exclusive distribution
India/MEA: Available with hematology board approval

This ultra-high-dose ESA represents both a therapeutic breakthrough and significant clinical challenge, demanding:

Subspecialist-level oversight
Institutional review board approval for off-label use
Comprehensive patient consent process

Reviews

There are no reviews yet.

Be the first to review “CRESP 500”

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