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 into separate similar volume injections and administer across separate injection sites. Reconstitute the appropriate number of Reblozyl vials to achieve the desired dose.
• 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.
• 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

DOSING MODIFICATION

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:

• 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 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

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 &
Administration Guides.

These guides include all the information found here, as well as the full steps for reconstitution of Reblozyl^®, plus storage information:

• Reconstitution Guide (French)
• Reconstitution Guide (Dutch)
• Administration Guide (French)
• Administration Guide (Dutch)

Sample calculation for subcutaneous administration of Reblozyl^®

• Average adult male 65 years old and weighing 89 kg
• 1 mg of Reblozyl^® per 1 kg = 89 mg starting dose

Administering Reblozyl^®1

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