DOSING & ADMINISTRATION

Starting with Reblozyl

Reblozyl should be initiated and monitored under the supervision of a physician experienced in the treatment of hematological diseases.1

START1:

  • Hemoglobin (Hb) should be assessed prior to each Reblozyl administration. In case of a red blood cell (RBC) transfusion occurring prior to dosing, the pre‑transfusion Hb level must be considered for dosing purposes
  • After reconstitution, Reblozyl solution should be injected subcutaneously (into the upper arm, thigh, or abdomen) every 3 weeks
    • The recommended maximum volume of Reblozyl per injection
      site is 1.2 mL. With reconstituted volumes larger than 1.2 mL, divide doses and administer across separate injection sites
  • If a scheduled injection is delayed or missed, administer Reblozyl as soon as possible and continue dosing as prescribed with at least 3 weeks between doses
  • No starting dose adjustments are required in:
    • Elderly patients
    • Patients with hepatic impairment who have a total bilirubin >upper limit of normal (ULN) and/or alanine aminotransferase or aspartate aminotransferase <3x ULN
    • Patients with mild to moderate renal impairment (estimated glomerular filtration rate [eGFR] <90 and ≥30 mL/min/1.73 m2)

MONITOR1:

  • If Hb is ≥11.5 g/dL in the absence of transfusion for at least 3 weeks, delay dosing until the Hb is ≤11 g/dL. If there is also a concomitant rapid increase in Hb (>2 g/dL within 3 weeks in absence of transfusion), a dose reduction to one step down (minimum 0.8 mg/kg) should be considered after the dose delay 
  • In case of Hb increase >2 g/dL within 3 weeks of luspatercept treatment in absence of transfusion, the Reblozyl dose should be reduced by one dose level. Dose should not be reduced below 0.8 mg/kg
  • If treatment-related Grade 3 or higher adverse reactions occur persistently, delay treatment until toxicity has improved or returned to baseline. After a dose delay, re-start patient at previous dose or at a reduced dose as per dose reduction guidance
  • If there is a loss of response to Reblozyl, assess causative factors (eg, a bleeding event). If typical causes for a loss of hematological response are excluded, consider a dose increase

INDIVIDUALIZE1:

  • Dosing with Reblozyl is customized by patient response. Dosing modifications may be needed to balance efficacy and safety
The Starting Dose With Reblozyl Is 1.0 Mg/Kg Administered Subcutaneously Every 3 Weeks

Start1

  • The recommended starting dose is 1.0 mg/kg administered subcutaneously every 3 weeks
  • Assess hemoglobin (Hb) prior to each Reblozyl administration
When Starting Reblozyl, Monitor For Treatment-Related Grade 3 Or Higher Adverse Reactions And For Loss Of Clinical Benefit

Monitor1

  • Monitor Hb and for adverse drug reactions, in the event a dose delay is needed or there is a loss of response
Dosing With Reblozyl Is Customized By Patient Response; Dosing Modifications May Be Needed

Individualize1

  • Dosing is customized by patient response; dosing modifications may be needed

Dosing modifications may be needed to

balance efficacy and safety1

Starting with Reblozyl

Reblozyl should be initiated and monitored under the supervision of a physician experienced in the treatment of hematological diseases.1

The Starting Dose With Reblozyl Is 1.0 Mg/Kg Administered Subcutaneously Every 3 Weeks

Start1

  • Hemoglobin (Hb) should be assessed prior to each Reblozyl administration. In case of a red blood cell (RBC) transfusion occurring prior to dosing, the pre‑transfusion Hb level must be considered for dosing purposes.
  • After reconstitution, Reblozyl solution should be injected subcutaneously (into the upper arm, thigh, or abdomen) every 3 weeks.
    • The recommended maximum volume of Reblozyl per injection site is 1.2 mL. With reconstituted volumes larger than 1.2 mL, divide doses and administer across separate injection sites
  • If a scheduled injection is delayed or missed, administer Reblozyl as soon as possible and continue dosing as prescribed with at least 3 weeks between doses
  • No starting dose adjustments are required in:
    • Elderly patients
    • Patients with hepatic impairment who have a total bilirubin >upper limit of normal (ULN) and/or alanine aminotransferase or aspartate aminotransferase <3x ULN
    • Patients with mild to moderate renal impairment (estimated glomerular filtration rate [eGFR] <90 and ≥30 mL/min/1.73 m2)
When Starting Reblozyl, Monitor For Treatment-Related Grade 3 Or Higher Adverse Reactions And For Loss Of Clinical Benefit

Monitor1

  • If Hb is ≥11.5 g/dL in the absence of transfusion for at least 3 weeks, delay dosing until the Hb is ≤11 g/dL. If there is also a concomitant rapid increase in Hb (>2 g/dL within 3 weeks in absence of transfusion), a dose reduction to one step down (minimum 0.8 mg/kg) should be considered after the dose delay 
  • In case of Hb increase >2 g/dL within 3 weeks of luspatercept treatment in absence of transfusion, the Reblozyl dose should be reduced by one dose level. Dose should not be reduced below 0.8 mg/kg
  • If treatment-related Grade 3 or higher adverse reactions occur persistently, delay treatment until toxicity has improved or returned to baseline. After a dose delay, re-start patient at previous dose or at a reduced dose as per dose reduction guidance
  • If there is a loss of response to Reblozyl, assess causative factors (eg, a bleeding event). If typical causes for a loss of hematological response are excluded, consider a dose increase
Dosing With Reblozyl Is Customized By Patient Response; Dosing Modifications May Be Needed

Individualize1

  • Dosing with Reblozyl is customized by patient response. Dosing modifications may be needed to balance efficacy and safety

Reference:

1. Reblozyl® (luspatercept) Summary of Product Characteristics (SmPC). Celgene 2020.

Dosing Modifications

Dosing with Reblozyl is customized by patient response. The recommended starting dose of Reblozyl is 1.0 mg/kg once every 3 weeks.1

INCREASE DOSE1:

  • Consider a dose increase in patients who have not achieved a reduction in RBC transfusion burden after at least 2 consecutive doses at the prior dose
  • In patients who do not achieve a response, defined as a reduction in RBC transfusion burden of at least a third after ≥ 2 consecutive doses (6 weeks), at the 1.0 mg/kg starting dose, the dose should be increased to 1.25 mg/kg
  • The dose should not be increased beyond the maximum dose of 1.25 mg/kg every 3 weeks
  • If patients experience a loss of response to Reblozyl, causative factors (eg, a bleeding event) should be assessed. If typical causes for a loss of hematological response are excluded, dose increase should be considered as described above for the respective indication being treated

REDUCE DOSE1:

  • In case of Hb increase ≥2 g/dL within 3 weeks, in absence of transfusions, reduce Reblozyl dose by one dose level1
  • If the Hb is ≥11.5 g/dL in the absence of transfusion for at least 3 weeks, the dose should be delayed until the Hb is ≤11.0 g/dL
  • If there is also a concomitant rapid increase in Hb (> 2 g/dL within 3 weeks in absence of transfusion), a dose reduction to one step down (minimum 0.8 mg/kg) should be considered after the dose delay
  • Dose should not be reduced below 0.8 mg/kg

DISCONTINUE1:

  • Reblozyl should be discontinued if patients do not experience a reduction in transfusion burden after 9 weeks of treatment (3 doses) at the maximum dose level if no alternative explanations for response failure are found (e.g. bleeding, surgery, other concomitant illnesses) or if unacceptable toxicity occurs at any time

Reblozyl offers stepwise dose increases to achieve
individual patient response1

INCREASE DOSE1

Reblozyl Offers Stepwise Dose Increases in ß-Thalassemia To Achieve Individual Patient Response
The dose should not be increased beyond the maximum of 1.25 mg/kg every 3 weeks.1

Reduce DOSE1

Dose reductions for β-thalassemia1
CURRENT DOSE DOSE REDUCTION
1.25 mg/kg 1 mg/kg
1 mg/kg 0.8 mg/kg

Dose should not be reduced below 0.8 mg/kg.

Discontinue1

Reblozyl should be discontinued

if patients do not experience a reduction in transfusion burden after 9 weeks of treatment (3 doses) at the maximum dose level1

Dosing Modifications

Dosing with Reblozyl is customized by patient response. The recommended starting dose of Reblozyl is 1.0 mg/kg once every 3 weeks.1

Reblozyl offers stepwise dose increases to achieve
individual patient response1

Reblozyl Offers Stepwise Dose Increases in ß-Thalassemia To Achieve Individual Patient Response

The dose should not be increased beyond the maximum of 1.25 mg/kg every 3 weeks.1

INCREASE DOSE1:

  • Consider a dose increase in patients who have not achieved a reduction in RBC transfusion burden after at least 2 consecutive administrations (6 weeks) at the prior dose
  • In patients who do not achieve a response, defined as a reduction in RBC transfusion burden of at least a third after ≥ 2 consecutive doses (6 weeks), at the 1.0 mg/kg starting dose, the dose should be increased to 1.25 mg/kg
  • The dose should not be increased beyond the maximum dose of 1.25 mg/kg every 3 weeks
  • If patients experience a loss of response to Reblozyl, causative factors (e.g. a bleeding event) should be assessed. If typical causes for a loss of hematological response are excluded, dose increase should be considered as described above for the respective indication being treated

REDUCE DOSE1:

  • In case of Hgb increase ≥2 g/dL within 3 weeks, in absence of transfusions, reduce Reblozyl dose by one dose level1
  • If the Hb is ≥11.5 g/dL in the absence of transfusion for at least 3 weeks, the dose should be delayed until the Hb is ≤11.0 g/dL
  • If there is also a concomitant rapid increase in Hb (> 2 g/dL within 3 weeks in absence of transfusion), a dose reduction to one step down (minimum 0.8 mg/kg) should be considered after the dose delay
  • Dose should not be reduced below 0.8 mg/kg

DISCONTINUE1:

  • Reblozyl should be discontinued if patients do not experience a reduction in transfusion burden after 9 weeks of treatment (3 doses) at the maximum dose level if no alternative explanations for response failure are found (e.g. bleeding, surgery, other concomitant illnesses) or if unacceptable toxicity occurs at any time
DOSE REDUCTIONS FOR
β-THALASSEMIA
CURRENT DOSE DOSE REDUCTION
1.25 mg/kg 1 mg/kg
1 mg/kg 0.8 mg/kg

Reference:

1. Reblozyl® (luspatercept) Summary of Product Characteristics (SmPC). Celgene 2020.

INCREASE DOSE1

 

Reblozyl Offers Stepwise Dose Increases in ß-Thalassemia To Achieve Individual Patient Response

 

The dose should not be increased beyond the maximum of 1.25 mg/kg every 3 weeks.1

Preparation &
administration

Reconstitution1

Reblozyl must be reconstituted gently prior to administration. Aggressive shaking should be avoided.

The appropriate number of Reblozyl vials should be reconstituted to achieve the desired dose. A syringe with appropriate graduations must be used for reconstitution to ensure accurate dosage.

After reconstitution, each mL of solution contains 50 mg of Reblozyl. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.1

Download the Dosing & Reconstitution Guide. This guide includes all the information found here, as well as the full steps for reconstitution of Reblozyl, plus storage information.

Sample calculation for subcutaneous administration of Reblozyl1
  • Average adult male 30 years of age and weighing 89 kg
  • 1 mg of Reblozyl per 1 kg = 89 starting dose

Reblozyl is available in 2 strengths as single-dose vials for reconstitution1

Reblozyl is supplied as a lyophilized powder for reconstitution before use.
Water for injections (WFI) should be used when reconstituting Reblozyl1:
25 mg vial After reconstitution with 0.68 mL WFI, each 25 mg single-dose vial will deliver at least 0.5 mL of 50 mg/mL Reblozyl
75 mg vial After reconstitution with 1.6 mL WFI, each 75 mg single-dose vial will deliver at least 1.5 mL of 50 mg/mL Reblozyl

Sample calculation for subcutaneous administration of Reblozyl1

TOTAL VOLUME OF RECONSTITUTED 50 MG/ML SOLUTION
NEEDED TO ADMINISTER 89 MG: 1.78 ML
(Average adult male 30 years old and weighing 89 kg)
NUMBER
OF VIALS
REBLOZYL CONCENTRATION AFTER
RECONSTITUTION
VOLUME OF RECONSTITUTED SOLUTION FOR ADMINISTRATION MG
IN SOLUTION
1 75 mg vial 75 mg/1.5 mL (50 mg/mL) Use 1.5 mL 75 mg
1 25 mg vial 25 mg/0.5 mL (50 mg/mL) Use 0.28 mL 14 mg
  Total volume needed
1.78 mL
89 mg

Dividing doses and administering with reconstituted volumes larger than 1.2 mL:

Injection 1: 0.89 mL – in upper arm     Injection 2: 0.89 mL – in thigh or abdomen

Administering Reblozyl1
  • Prior to administration, allow solution to reach room temperature for a more comfortable injection

Reblozyl is administered subcutaneously every 3 weeks1

STEP 1
Verify correct dose for the patient1

Calculate the exact total dosing volume required for the patient (See sample calculation chart above)

STEP 2
Plan and prep
for injection1

Slowly withdraw the dosing volume of the reconstituted Reblozyl solution from the single-dose vial(s) into a syringe.

The recommended maximum volume of medicinal product per injection site is 1.2 mL. Divide doses requiring larger reconstituted volumes into separate similar volume injections and administer across separate sites.

If multiple injections are required, use a new syringe and needle for each subcutaneous injection.

STEP 3
Administer
subcutaneously1

Prior to injection, allow solution to reach room temperature for a more comfortable injection.

Administer the SC injection(s) into the upper arm, thigh, and/or abdomen.

Steps For Administering Reblozyl

Do not administer more than 1 dose from a vial
Do not mix with other medications
Do not pool unused portions from the vials
Discard any unused portion

Preparation & Administration

Reblozyl is available in 2 strengths as single-dose vials for reconstitution1

Reblozyl is supplied as a lyophilized powder for reconstitution before use

Water for injections (WFI) should be used when reconstituting Reblozyl1:
25 mg vial After reconstitution with 0.68 mL WFI, each 25 mg single-dose vial will deliver at least 0.5 mL of 50 mg/mL Reblozyl
75 mg vial After reconstitution with 1.6 mL  WFI, each 75 mg single-dose vial will deliver at least 1.5 mL of 50 mg/mL Reblozyl

Reblozyl must be reconstituted gently prior to administration. Aggressive shaking should be avoided.

The appropriate number of Reblozyl vials should be reconstituted to achieve the desired dose. A syringe with appropriate graduations must be used for reconstitution to ensure accurate dosage.

Download the Dosing & Reconstitution Guide. This guide includes all the information found here, as well as the full steps for reconstitution of Reblozyl, plus storage information.

After reconstitution, each mL of solution contains 50 mg of Reblozyl. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.1

Sample calculation for subcutaneous administration of Reblozyl1

  • Average adult male 30 years of age and weighing 89 kg
  • 1 mg of Reblozyl per 1 kg = 89 starting dose
TOTAL VOLUME OF RECONSTITUTED SOLUTION NEEDED TO ADMINISTER 89 MG: 1.78 ML1
# OF VIALS 1 1
REBLOZYL 75 mg
vial
25 mg
vial
CONCENTRATION
AFTER
RECONSTITUTION
75 mg/1.5 mL
(50 mg/mL)
25 mg/0.5 mL
(50 mg/mL)
VOLUME OF RECONSTITUTED SOLUTION FOR ADMINISTRATION Use 1.5 mL Use 0.28 mL
MG IN
SOLUTION
75 mg 14 mg
  Total volume needed 1.78 mL 89 mg

Dividing doses and administering with reconstituted volumes larger than 1.2 mL:

  • Injection 1: 0.89 mL –in upper arm
  • Injection 2: 0.89 mL –in thigh or abdomen

Administering Reblozyl

Reblozyl is conveniently administered subcutaneously every 3 weeks

  • Prior to administration, allow solution to reach room temperature for a more comfortable injection
STEP 1

Verify correct dose for the patient1

Calculate the exact total dosing volume required for the patient

STEP 2

Plan and prep for injection1

Slowly withdraw the dosing volume of the reconstituted Reblozyl solution from the single-dose vial(s) into a syringe

Divide doses requiring larger reconstituted volumes (ie, >1.2 mL) into separate similar volume injections and administer across separate sites

STEP 3

Administer subcutaneously1

If multiple injections are required, use a new syringe and needle for each SC injection

Administer the SC injection into the upper arm, thigh, and/or abdomen Steps For Administering Reblozyl

Do not administer more than 1 dose from a vial

Do not mix with other medications

Do not pool unused portions from the vials

Discard any unused portion

Reference:

1. Reblozyl® (luspatercept) Summary of Product Characteristics (SmPC). Celgene 2020.

 

This site is not intended for US or UK healthcare professionals.

The product has received European Medicines Agency approval. The registration status and approved product labels of Reblozyl may vary from country to country. The information on this website is not country-specific and may not be applicable to your country. For more information, please refer to your local Prescribing Information.
IMPORTANT: The information on this website is based on the European Summary of Product Characteristics (EU SmPC).
This site is not intended for US or UK healthcare professionals. View the US site.
The information provided on this website is intended for use by a healthcare professional qualified to prescribe and supply medications, thus requiring specific scientific knowledge and training to interpret it correctly.
I am a European Healthcare Professional (UK excluded)
I am NOT a European Healthcare Professional
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See Section 4.8 in the EU Summary of Product Characteristics for more information. Before prescribing Reblozyl, please refer to the
EU Summary of Product Characteristics.