This site is intended for U.S. healthcare professionals.

REBLOZYL dosing information1

Assess and review hemoglobin (Hgb) results prior to each administration1

  • Start patients at the recommended starting dose of 1 mg/kg by SC injection once every 3 weeks
  • If an RBC transfusion occurred prior to dosing, the pretransfusion Hgb level must be considered for dosing purposes
  • If the pre-dose Hgb is ≥11.5 g/dL and the Hgb level is not influenced by recent transfusion, delay dosing until the Hgb is ≤11 g/dL

Continue treatment as long as reduction in transfusion burden from baseline is observed1

REBLOZYL® Dosing Instructions.
REBLOZYL® Dosing Instructions.
  • Overall, 53% of patients in the BELIEVE trial had their dose increased to 1.25 mg/kg (46% REBLOZYL, n = 223; 66% placebo, n = 109)

If a planned administration of REBLOZYL is delayed or missed, administer REBLOZYL as soon as possible and continue dosing as prescribed, with at least 3 weeks between doses

Continuation and discontinuation recommendations1

  • If a patient experienced a response followed by a lack of or lost response to REBLOZYL, initiate a search for causative factors (eg, a bleeding event)
  • If typical causes for a lack or loss of hematologic response are excluded, follow dosing recommendations for management of patients with an insufficient response to REBLOZYL therapy
  • Discontinue REBLOZYL if a patient does not experience a decrease in transfusion burden after 9 weeks of treatment (administration of 3 doses) at the maximum dose level or if unacceptable toxicity occurs at any time
  • Do not increase the dose beyond the maximum dose of 1.25 mg/kg

REBLOZYL dosing and administration video

Reconstituting REBLOZYL

REBLOZYL should be reconstituted and administered by a healthcare professional1

  • Reconstitute REBLOZYL with Sterile Water for Injection, USP only

Reconstitution volumes1

Vial size Amount of Sterile Water for Injection, USP required for reconstitution Final concentration Deliverable volume
25 mg vial 0.68 mL 25 mg/0.5 mL 0.5 mL
75 mg vial 1.6 mL 75 mg/1.5 mL
(50 mg/mL)
1.5 mL

Important considerations for REBLOZYL reconstitution1

  • Reconstitute the number of REBLOZYL vials to achieve the appropriate dose based on the patient’s weight
  • Use a syringe with suitable graduations for reconstitution to ensure accurate dosage

Adhere to the following steps to properly reconstitute REBLOZYL1

Reconstitution instructions for REBLOZYL for SC injection

Reconstitute REBLOZYL with Sterile Water for Injection, USP only.

1. Add Sterile Water for Injection, USP.

Reconstitute with Sterile Water for Injection, USP using volumes described in the reconstitution volumes table above with the stream directed onto the lyophilized powder. Allow to stand for 1 minute.

Discard the needle and syringe used for reconstitution.

2. Discard the needle and syringe used for reconstitution.

The needle and syringe used for reconstitution should not be used for SC injections.

Gently swirl in a vial for 30 seconds. Let vial sit upright for 30 seconds.

3. Mix and wait.

Gently swirl the vial in a circular motion for 30 seconds. Stop swirling and let the vial sit in an upright position for 30 seconds.

Inspect the vial for undissolved particles in the solution. Repeat last step if undissolved powder is observed.

4. Inspect.

Inspect the vial for undissolved particles in the solution. If undissolved powder is observed, repeat step 3 until the powder is completely dissolved.

Invert the vial and gently swirl in an inverted position for 30 seconds. Let vial sit upright for 30 seconds.

5. Mix and wait.

Invert the vial and gently swirl in an inverted position for 30 seconds. Bring the vial back to the upright position, and let it sit for 30 seconds.

Repeat step 5 seven more times.

6. Repeat.

Repeat step 5 seven more times to ensure complete reconstitution of material on the sides of the vial.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Do not use if undissolved product or foreign particulate matter is observed.

7. Inspect.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. REBLOZYL is a colorless to slightly yellow, clear to slightly opalescent solution, which is free of foreign particulate matter. Do not use if undissolved product or foreign particulate matter is observed.

REBLOZYL reconstitution video

Instructions for administration

REBLOZYL is administered subcutaneously and is available in 2 vial sizes (25 mg and 75 mg)1

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

REBLOZYL should be reconstituted and administered by a healthcare professional1

Step 1

Verify correct dose for the patient1

  • Calculate the exact total dosing volume of 50 mg/mL solution 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 inject into separate sites

Step 3

Subcutaneous administration1

  • 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

Subcutaneous administration.
Subcutaneous administration.

NOTE: Discard any unused portion. Do not pool unused portions from the vials.
Do not administer more than 1 dose from a vial.1

  • Do not mix with other medications

Sample calculation for SC administration of REBLOZYL1

  • Average adult male aged 30 years and weighing 197 pounds (89 kg)
  • 1 mg of REBLOZYL per 1 kg = 89 mg starting dose

Total volume of reconstituted solution needed to administer
89 mg: 1.78 mL

Number of vials REBLOZYL Concentration after reconstitution Solution needed for administration Milligrams 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 Use 0.28 mL 14 mg
Total volume needed 1.78 mL 89 mg

Doses with reconstituted volumes larger than 1.2 mL should be divided into separate, similar-volume syringes for injection and injected into separate sites (upper arm, thigh, and/or abdomen)

Injection 1: 0.89 mL – upper arm

Injection 2: 0.89 mL – thigh or abdomen

REBLOZYL requires cold storage1

Storage of unreconstituted Reblozyl® vial

STORAGE OF UNRECONSTITUTED VIAL

  • Store unreconstituted vials refrigerated at 2°C to 8°C (36°F to 46°F) in original carton to protect from light
  • Do not freeze
Storage of reconstituted Reblozyl® solution

STORAGE OF RECONSTITUTED SOLUTION

  • If the reconstituted solution is not used immediately, store at room temperature at 20°C to 25°C (68°F to 77°F) in the original vial for up to 8 hours. Discard if not used within 8 hours of reconstitution
  • Alternatively, store refrigerated at 2°C to 8°C (36°F to 46°F) for up to 24 hours in the original vial
    • Remove from refrigerated condition 15 to 30 minutes prior to injection to allow solution to reach room temperature for a more comfortable injection
    • Discard if not used within 24 hours of reconstitution
  • Do not freeze the reconstituted solution
Expand

Indication

REBLOZYL is indicated for the treatment of anemia in adult patients with beta thalassemia who require regular red blood cell (RBC) transfusions.

REBLOZYL is not indicated for use as a substitute for RBC transfusions in patients who require immediate correction of anemia.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Thrombosis/Thromboembolism: Thromboembolic events (TEE) were reported in 8/223 (3.6%) REBLOZYL-treated patients. TEEs included deep vein thrombosis, pulmonary embolus, portal vein thrombosis, and ischemic stroke. Patients with known risk factors for thromboembolism (splenectomy or concomitant use of hormone replacement therapy) may be at further increased risk of thromboembolic conditions. Consider thromboprophylaxis in patients at increased risk of TEE. Monitor patients for signs and symptoms of thromboembolic events and institute treatment promptly.

Hypertension

Hypertension was reported in 10.7% (61/571) of REBLOZYL-treated patients. Across clinical studies, the incidence of Grade 3 to 4 hypertension ranged from 1.8% to 8.6%. In patients with beta thalassemia with normal baseline blood pressure, 13 (6.2%) patients developed systolic blood pressure (SBP) >130 mm Hg and 33 (16.6%) patients developed diastolic blood pressure (DBP) >80 mm Hg. Monitor blood pressure prior to each administration. Manage new or exacerbations of preexisting hypertension using anti-hypertensive agents.

Embryo-Fetal Toxicity

REBLOZYL may cause fetal harm when administered to a pregnant woman. REBLOZYL caused increased post-implantation loss, decreased litter size, and an increased incidence of skeletal variations in pregnant rat and rabbit studies. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment and for at least 3 months after the last dose.

ADVERSE REACTIONS

Serious adverse reactions occurring in 1% of patients included cerebrovascular accident and deep vein thrombosis. A fatal adverse reaction occurred in 1 patient treated with REBLOZYL who died due to an unconfirmed case of acute myeloid leukemia (AML).

Most common adverse reactions (at least 10% for REBLOZYL and 1% more than placebo) were headache (26% vs 24%), bone pain (20% vs 8%), arthralgia (19% vs 12%), fatigue (14% vs 13%), cough (14% vs 11%), abdominal pain (14% vs 12%), diarrhea (12% vs 10%) and dizziness (11% vs 5%).

LACTATION

It is not known whether REBLOZYL is excreted into human milk or absorbed systemically after ingestion by a nursing infant. REBLOZYL was detected in milk of lactating rats. When a drug is present in animal milk, it is likely that the drug will be present in human milk. Because many drugs are excreted in human milk, and because of the unknown effects of REBLOZYL in infants, a decision should be made whether to discontinue nursing or to discontinue treatment. Because of the potential for serious adverse reactions in the breastfed child, breastfeeding is not recommended during treatment and for 3 months after the last dose.

Please see full Prescribing Information for REBLOZYL.

Reference: 1. REBLOZYL [Prescribing Information]. Summit, NJ: Celgene Corporation; 2019.