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

Reblozyl offers stepwise dose increases to achieve
individual patient response¹

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

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

Reblozyl is supplied as a lyophilized powder for reconstitution before use

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