Reblozyl 75mg Inj, 1 Vial
It is used to treat anemia in certain people.
Drug Class
Erythroid maturation agent
Pharmacologic Class
Recombinant fusion protein; Activin receptor ligand trap
Pregnancy Category
Not available
FDA Approved
Nov 2019
DEA Schedule
Not Controlled
Overview
What is this medicine?
Reblozyl is a medicine given by injection under the skin that helps your body make more healthy red blood cells. It is used to treat anemia (low red blood cell count) in adults with certain blood disorders like beta-thalassemia or myelodysplastic syndromes (MDS) who need regular blood transfusions. By helping your body make more red blood cells, it can reduce your need for blood transfusions.
How to Use This Medicine
To use this medication correctly, follow your doctor's instructions and carefully read all accompanying information. Take this medication exactly as directed, and adhere to all provided guidelines. This medication is administered via injection into the fatty tissue under the skin.
For storage and disposal, consult with your doctor, nurse, or pharmacist to determine the best approach for storing this medication at home, if necessary.
If you miss a dose, contact your doctor promptly to receive guidance on the appropriate course of action.
For storage and disposal, consult with your doctor, nurse, or pharmacist to determine the best approach for storing this medication at home, if necessary.
If you miss a dose, contact your doctor promptly to receive guidance on the appropriate course of action.
Lifestyle & Tips
- Maintain regular follow-up appointments and blood tests as instructed by your doctor.
- Report any new or worsening symptoms immediately to your healthcare provider.
- Stay hydrated unless otherwise advised by your doctor.
- Be aware of potential side effects like dizziness or fatigue, and avoid driving or operating machinery if affected.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
1 mg/kg subcutaneously every 3 weeks. May increase to 1.25 mg/kg, then 1.5 mg/kg, then 1.75 mg/kg based on response and tolerability. Max single dose 1.75 mg/kg or 337.5 mg.
Dose Range:
1 - 1.75 mg
Condition-Specific Dosing:
Beta-thalassemia:
Initial 1 mg/kg subcutaneously every 3 weeks. May increase to 1.25 mg/kg after 2 doses if no reduction in transfusion burden. Max 1.25 mg/kg.
MDS-associated anemia:
Initial 1 mg/kg subcutaneously every 3 weeks. May increase to 1.33 mg/kg after 2 doses if no reduction in transfusion burden. May further increase to 1.75 mg/kg after 2 more doses if needed. Max 1.75 mg/kg.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
For beta-thalassemia: 1 mg/kg subcutaneously every 3 weeks for patients 6 years and older. May increase to 1.25 mg/kg after 2 doses if no reduction in transfusion burden. Max 1.25 mg/kg.
Adolescent:
For beta-thalassemia: 1 mg/kg subcutaneously every 3 weeks. May increase to 1.25 mg/kg after 2 doses if no reduction in transfusion burden. Max 1.25 mg/kg.
Dose Adjustments
Renal Impairment:
Mild:
No dose adjustment needed
Moderate:
No dose adjustment needed
Severe:
No dose adjustment needed
Dialysis:
No dose adjustment needed
Hepatic Impairment:
Mild:
No dose adjustment needed
Moderate:
No dose adjustment needed
Severe:
No dose adjustment needed
Pharmacology
Mechanism of Action
Luspatercept is a recombinant fusion protein that acts as an erythroid maturation agent. It binds to select transforming growth factor-beta (TGF-β) superfamily ligands (e.g., GDF11, Activin B), thereby reducing SMAD2/3 signaling. This action mitigates ineffective erythropoiesis by promoting the maturation of late-stage red blood cell precursors, leading to increased hemoglobin levels and reduced red blood cell transfusion burden.
Pharmacokinetics
Absorption:
Bioavailability:
Not applicable (subcutaneous administration, relative bioavailability not explicitly stated as a percentage but well absorbed)
Tmax:
Approximately 7 days (range: 4-11 days)
FoodEffect:
Not applicable
Distribution:
Vd:
Approximately 7.1 L
ProteinBinding:
Not applicable (large protein)
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 11 days (range: 8-14 days)
Clearance:
Approximately 0.49 L/day
ExcretionRoute:
Protein degradation and subsequent elimination of amino acids
Unchanged:
Not applicable (protein degradation)
Pharmacodynamics
OnsetOfAction:
Clinical response (reduction in transfusion burden) typically observed within the first few doses (e.g., 12 weeks)
PeakEffect:
Peak effect on hemoglobin levels and transfusion independence can vary, often observed after several months of treatment.
DurationOfAction:
Effects persist for the duration of treatment; half-life of 11 days supports every 3-week dosing.
Confidence:
Medium
Safety & Warnings
Side Effects
Important Side Effects to Report to Your Doctor Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you experience any of the following symptoms, seek medical attention immediately:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high blood pressure, including:
+ Severe headache
+ Dizziness
+ Passing out
+ Changes in eyesight
Signs of kidney problems, such as:
+ Inability to pass urine
+ Changes in urine output
+ Blood in the urine
+ Sudden weight gain
Signs of a urinary tract infection (UTI), including:
+ Blood in the urine
+ Burning or pain while passing urine
+ Frequent or urgent need to pass urine
+ Fever
+ Lower stomach pain
+ Pelvic pain
Fast heartbeat
Swelling in the arms or legs
Confusion
Weakness on one side of the body
Trouble speaking or thinking
Changes in balance
Drooping on one side of the face
Blurred eyesight
If you have beta thalassemia, be aware of the risk of EMH masses. Seek medical attention immediately if you experience:
+ Pain, burning, or stiffness in the neck or back
+ Numbness or cramping in the arms, hands, legs, or feet
+ Trouble walking or standing up
+ Loss of coordination
+ Decreased sexual ability
+ Inability to control passing urine or stools
Signs of a blood clot, including:
+ Chest pain or pressure
+ Coughing up blood
+ Shortness of breath
+ Swelling, warmth, numbness, change of color, or pain in a leg or arm
+ Trouble speaking or swallowing
High uric acid levels can occur with this medication. Seek medical attention immediately if you experience:
+ Pain, redness, heat, tenderness, stiffness, or swelling in the big toe or any other joint
Other Possible Side Effects
Most people do not experience severe side effects, and some may only have minor side effects. However, if you experience any of the following side effects, or if they bother you or do not go away, contact your doctor:
Headache
Bone, joint, or muscle pain
Feeling dizzy, tired, or weak
Cough
Stomach pain or diarrhea
Upset stomach
Decreased appetite
Flu-like symptoms
Signs of a common cold
* Irritation at the injection site
Reporting Side Effects
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you experience any of the following symptoms, seek medical attention immediately:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high blood pressure, including:
+ Severe headache
+ Dizziness
+ Passing out
+ Changes in eyesight
Signs of kidney problems, such as:
+ Inability to pass urine
+ Changes in urine output
+ Blood in the urine
+ Sudden weight gain
Signs of a urinary tract infection (UTI), including:
+ Blood in the urine
+ Burning or pain while passing urine
+ Frequent or urgent need to pass urine
+ Fever
+ Lower stomach pain
+ Pelvic pain
Fast heartbeat
Swelling in the arms or legs
Confusion
Weakness on one side of the body
Trouble speaking or thinking
Changes in balance
Drooping on one side of the face
Blurred eyesight
If you have beta thalassemia, be aware of the risk of EMH masses. Seek medical attention immediately if you experience:
+ Pain, burning, or stiffness in the neck or back
+ Numbness or cramping in the arms, hands, legs, or feet
+ Trouble walking or standing up
+ Loss of coordination
+ Decreased sexual ability
+ Inability to control passing urine or stools
Signs of a blood clot, including:
+ Chest pain or pressure
+ Coughing up blood
+ Shortness of breath
+ Swelling, warmth, numbness, change of color, or pain in a leg or arm
+ Trouble speaking or swallowing
High uric acid levels can occur with this medication. Seek medical attention immediately if you experience:
+ Pain, redness, heat, tenderness, stiffness, or swelling in the big toe or any other joint
Other Possible Side Effects
Most people do not experience severe side effects, and some may only have minor side effects. However, if you experience any of the following side effects, or if they bother you or do not go away, contact your doctor:
Headache
Bone, joint, or muscle pain
Feeling dizzy, tired, or weak
Cough
Stomach pain or diarrhea
Upset stomach
Decreased appetite
Flu-like symptoms
Signs of a common cold
* Irritation at the injection site
Reporting Side Effects
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Signs of a blood clot (thromboembolic event) such as chest pain, shortness of breath, pain or swelling in an arm or leg, sudden numbness or weakness on one side of the body, sudden severe headache, or problems with vision or speech.
- Signs of high blood pressure (hypertension) such as severe headache, blurred vision, or dizziness.
- Signs of an allergic reaction such as rash, itching, hives, swelling of the face, lips, tongue, or throat, or difficulty breathing.
- Unusual bleeding or bruising.
- Severe or persistent bone pain or joint pain.
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
If you have extramedullary hematopoietic (EMH) masses, which are abnormal growths.
If you are breastfeeding or plan to breastfeed. You should not breastfeed while taking this medication or for 3 months after your last dose.
If the patient is a child, as this medication is not intended for pediatric use.
Additionally, this medication may interact with other medications or health conditions. To ensure safe use, it is crucial to:
Inform your doctor and pharmacist about all medications you are taking, including prescription and over-the-counter drugs, natural products, and vitamins.
Discuss your health problems with your doctor to determine if it is safe to take this medication.
* Never start, stop, or change the dose of any medication without first consulting your doctor to avoid potential interactions or complications.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
If you have extramedullary hematopoietic (EMH) masses, which are abnormal growths.
If you are breastfeeding or plan to breastfeed. You should not breastfeed while taking this medication or for 3 months after your last dose.
If the patient is a child, as this medication is not intended for pediatric use.
Additionally, this medication may interact with other medications or health conditions. To ensure safe use, it is crucial to:
Inform your doctor and pharmacist about all medications you are taking, including prescription and over-the-counter drugs, natural products, and vitamins.
Discuss your health problems with your doctor to determine if it is safe to take this medication.
* Never start, stop, or change the dose of any medication without first consulting your doctor to avoid potential interactions or complications.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Regular blood tests will be necessary, as directed by your doctor, to monitor your condition. Be sure to discuss any concerns or questions with your doctor.
You will need to have your blood pressure checked regularly, as prescribed by your doctor, since this medication can cause high blood pressure.
There is a risk of blood clots associated with this medication, particularly in individuals with beta thalassemia. Certain factors, such as smoking, spleen removal, hormone therapy, or birth control, may increase this risk. If you have concerns about your risk of developing blood clots, consult with your doctor.
This medication may affect your ability to become pregnant. Discuss any questions or concerns with your doctor.
Additionally, this medication can harm an unborn baby. To ensure your safety, a pregnancy test will be conducted before you start taking this medication to confirm that you are not pregnant. If you may become pregnant, it is crucial to use birth control while taking this medication and for a specified period after the last dose. Your doctor will advise you on the duration of birth control use. If you become pregnant while taking this medication, contact your doctor immediately.
You will need to have your blood pressure checked regularly, as prescribed by your doctor, since this medication can cause high blood pressure.
There is a risk of blood clots associated with this medication, particularly in individuals with beta thalassemia. Certain factors, such as smoking, spleen removal, hormone therapy, or birth control, may increase this risk. If you have concerns about your risk of developing blood clots, consult with your doctor.
This medication may affect your ability to become pregnant. Discuss any questions or concerns with your doctor.
Additionally, this medication can harm an unborn baby. To ensure your safety, a pregnancy test will be conducted before you start taking this medication to confirm that you are not pregnant. If you may become pregnant, it is crucial to use birth control while taking this medication and for a specified period after the last dose. Your doctor will advise you on the duration of birth control use. If you become pregnant while taking this medication, contact your doctor immediately.
Overdose Information
Overdose Symptoms:
- Symptoms of overdose are not well-established. High doses may lead to increased red blood cell counts (polycythemia) and potential hyperviscosity, increasing the risk of thromboembolic events.
What to Do:
There is no specific antidote. In case of suspected overdose, seek immediate medical attention. Management should be supportive and aimed at monitoring for and treating any adverse effects, particularly those related to hyperviscosity or thromboembolic events. Call 1-800-222-1222 (Poison Control).
Drug Interactions
Monitoring
Baseline Monitoring
Complete Blood Count (CBC) with differential
Rationale: To assess baseline hemoglobin, red blood cell counts, and other hematologic parameters.
Timing: Prior to initiation of treatment
Transfusion history and burden
Rationale: To establish baseline transfusion requirements and assess response to therapy.
Timing: Prior to initiation of treatment
Iron overload status (e.g., ferritin, transferrin saturation)
Rationale: To guide iron chelation therapy, especially in beta-thalassemia patients.
Timing: Prior to initiation of treatment
Routine Monitoring
Complete Blood Count (CBC) with differential
Frequency: Prior to each dose and as clinically indicated
Target: Individualized based on patient's condition and treatment goals (e.g., reduction in transfusion burden, increase in hemoglobin)
Action Threshold: Hold dose if hemoglobin is âĨ11.5 g/dL (MDS) or âĨ11 g/dL (beta-thalassemia) and re-evaluate in 3 weeks. If hemoglobin remains high, delay or discontinue. Monitor for signs of hyperviscosity.
Transfusion burden
Frequency: Continuously throughout treatment
Target: Reduction in red blood cell transfusion units or transfusion independence
Action Threshold: Assess response after 2 doses (6 weeks). If no clinical benefit, consider dose escalation. If no benefit after maximum dose, consider discontinuation.
Blood pressure
Frequency: Regularly, especially at the start of treatment
Target: Normotensive
Action Threshold: Manage hypertension as clinically indicated; consider dose modification or discontinuation if severe or uncontrolled.
Signs and symptoms of thromboembolic events (TEEs)
Frequency: Continuously throughout treatment
Target: Absence of TEEs
Action Threshold: Promptly evaluate and manage any suspected TEEs. Consider discontinuation if a TEE occurs.
Symptom Monitoring
- Fatigue
- Dizziness
- Nausea
- Diarrhea
- Headache
- Bone pain
- Arthralgia
- Hypertension (e.g., headache, blurred vision)
- Thromboembolic events (e.g., chest pain, shortness of breath, swelling/pain in limb, sudden numbness/weakness, vision changes, slurred speech)
- Allergic reactions (e.g., rash, itching, swelling, severe dizziness, trouble breathing)
Special Patient Groups
Pregnancy
Luspatercept may cause fetal harm when administered to a pregnant woman. Animal studies have shown adverse developmental outcomes. Advise pregnant women of the potential risk to a fetus. For females of reproductive potential, advise use of effective contraception during treatment and for at least 3 months after the last dose.
Trimester-Specific Risks:
First Trimester:
Potential for fetal harm based on animal data.
Second Trimester:
Potential for fetal harm based on animal data.
Third Trimester:
Potential for fetal harm based on animal data.
Lactation
It is unknown if luspatercept is excreted in human milk. Due to the potential for serious adverse reactions in a breastfed infant, advise women not to breastfeed during treatment and for 3 months after the last dose.
Infant Risk:
Risk unknown; potential for serious adverse reactions.
Pediatric Use
Approved for beta-thalassemia in patients 6 years and older. Safety and effectiveness in pediatric patients with MDS have not been established.
Geriatric Use
No overall differences in safety or effectiveness were observed between elderly patients (âĨ65 years) and younger patients. No specific dose adjustment is required based on age.
Clinical Information
Clinical Pearls
- Reblozyl is administered subcutaneously by a healthcare professional. Patients should not self-administer.
- Monitor patients for signs and symptoms of thromboembolic events (TEEs), especially those with beta-thalassemia who have undergone splenectomy or have other risk factors for TEEs.
- Monitor blood pressure regularly, as hypertension is a reported adverse reaction.
- Dose adjustments are based on hemoglobin levels and transfusion burden, not on body weight changes after the initial dose.
- Patients should be adequately transfused prior to starting Reblozyl to ensure a stable baseline for assessing response.
Alternative Therapies
- Red blood cell transfusions (supportive care)
- Iron chelation therapy (for iron overload)
- Erythropoiesis-stimulating agents (ESAs) like epoetin alfa or darbepoetin alfa (less direct mechanism for ineffective erythropoiesis)
- Immunosuppressive therapy (for certain MDS subtypes)
- Allogeneic hematopoietic stem cell transplantation (curative option for select patients)
- Gene therapy (emerging for beta-thalassemia)
Cost & Coverage
Average Cost:
Highly variable, typically >$10,000 per vial
Insurance Coverage:
Specialty Tier (requires prior authorization, may have high co-pay/co-insurance)
General Drug Facts
If your symptoms or health problems persist or worsen, it is essential to contact your doctor for further guidance. To ensure safe use, never share your medication with others, and do not take medication prescribed for someone else. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion. Dispose of unused or expired medications properly. Unless instructed to do so by a healthcare professional, do not flush medications down the toilet or pour them down the drain. If you are unsure about the proper disposal method, consult your pharmacist for advice. Many communities have drug take-back programs, which your pharmacist can help you locate. Some medications may come with an additional patient information leaflet; check with your pharmacist to see if this applies to your prescription. If you have any questions or concerns about your medication, discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. Be prepared to provide information about the medication taken, the amount, and the time it was taken to ensure prompt and effective treatment.