Reblozyl 25mg Inj, 1 Vial

Luspatercept is a recombinant fusion protein that acts as a ligand trap for select transforming growth factor-beta (TGF-β) superfamily ligands. By binding to these ligands (e.g., GDF11, activin B), luspatercept diminishes Smad2/3 signaling, which is aberrantly elevated in ineffective erythropoiesis conditions like beta-thalassemia and MDS. This action promotes late-stage erythroid maturation and differentiation, leading to increased red blood cell production.

Serious Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or 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 help right away 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, changes in color, or pain in a leg or arm
+ Trouble speaking or swallowing
High uric acid levels can occur with this medication. Seek medical help right away if you experience:
+ Pain, redness, heat, tenderness, stiffness, or swelling in your big toe or any other joint

Other Side Effects

Like all medications, this drug can cause side effects. Many people may not experience any side effects or may only have mild ones. If you notice any of the following side effects, or if they bother you or do not go away, contact your doctor or seek medical help:

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 a comprehensive list of all 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.

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, tell your doctor and pharmacist about:

All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Your health problems, including any medical conditions or concerns

It is crucial to verify that it is safe to take this medication with all your other medications and health conditions. Do not start, stop, or change the dose of any medication without first consulting your doctor.

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.

Use of this drug may lead to high blood pressure. To monitor this potential side effect, your doctor will instruct you on how frequently to have your blood pressure checked.

There is a risk of blood clots associated with this medication, particularly in individuals with beta thalassemia. Certain factors, such as smoking, prior spleen removal, or the use of hormone therapy or birth control, may increase this risk. If you have questions or concerns about your specific risk for blood clots, consult with your doctor.

This medication may affect fertility, making it more difficult to become pregnant. Discuss this potential side effect with your doctor.

Additionally, this drug may cause harm to an unborn baby. To ensure your safety and the safety of your potential pregnancy, a pregnancy test will be conducted before initiating treatment to confirm that you are not pregnant. If you are of childbearing potential, it is crucial to use birth control while taking this medication and for a specified period after the final dose. Your doctor will advise you on the duration of birth control use. If you become pregnant while taking this drug, notify your doctor immediately.

• Fatigue
• Musculoskeletal pain
• Dizziness
• Nausea
• Diarrhea
• Injection site reactions (erythema, swelling, pain)
• Headache
• Hypertension (e.g., headache, blurred vision)
• Signs of thromboembolic events (e.g., chest pain, shortness of breath, leg swelling, sudden vision changes, slurred speech)

There are no adequate and well-controlled studies of Reblozyl in pregnant women. Animal studies have shown embryo-fetal toxicity (e.g., skeletal malformations, reduced fetal weight) at exposures higher than clinical. Use during pregnancy should only be considered if the potential benefit justifies the potential risk to the fetus.

It is not known whether luspatercept is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in breastfed infants, a decision should be made whether to discontinue breastfeeding or to discontinue the drug, taking into account the importance of the drug to the mother.

Safety and efficacy have not been established in pediatric patients younger than 12 years of age. Approved for beta-thalassemia in patients 12 years and older.

No overall differences in safety or effectiveness were observed between elderly patients (≥65 years) and younger patients, but greater sensitivity of some older individuals cannot be ruled out. No dose adjustment is required based on age.

• Reblozyl is administered subcutaneously. Patients or caregivers can be trained to administer the injection at home after proper instruction.
• Monitor for signs and symptoms of thromboembolic events (TEEs), especially in patients with beta-thalassemia, as the risk is increased in this population and with luspatercept treatment.
• Blood pressure should be monitored regularly, as hypertension is a common adverse effect.
• Dose escalation is based on clinical response (reduction in transfusion burden or increase in hemoglobin) and tolerability.
• Discontinue treatment if no clinical benefit is observed after 9 weeks at the maximum dose (1.75 mg/kg).

• Red blood cell transfusions (supportive care)
• Erythropoiesis-stimulating agents (ESAs) (e.g., epoetin alfa, darbepoetin alfa) for MDS (if not failed)
• Iron chelation therapy (for iron overload in beta-thalassemia)
• Hydroxyurea (for beta-thalassemia or MDS, depending on subtype)
• Immunosuppressive therapy (for certain MDS subtypes)
• Allogeneic hematopoietic stem cell transplantation (curative for some MDS/thalassemia patients)

If your symptoms or health problems persist or worsen, it is essential to contact your doctor promptly. 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, avoid flushing medications down the toilet or pouring them down the drain. If you are unsure about the proper disposal method, consult your pharmacist, who can also inform you about potential drug take-back programs in your area. Some medications may come with an additional patient information leaflet, which your pharmacist can provide. 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 medical attention. Be prepared to provide information about the medication taken, the amount, and the time of the incident.