Lunsumio

About Lunsumio 

• Lunsumio received approval from the US FDA administration on December 22, 2022.
• Lunsumio is an antineoplastic,which belongs to the class of B-Cell lymphoma inhibitors. It works by activating and redirecting the T cells to engage and eliminate the target B cells.
• Lunsumio is a prescription medication for adults with follicular lymphoma, a cancer affecting the lymphatic system. It targets the transformation of B lymphocytes into cancerous cells, leading to their accumulation in lymph node ‘follicles.’ 
• This type of lymphoma is the most common slow-growing non-Hodgkin’s lymphoma. Specifically prescribed for adults with relapsed or refractory follicular lymphoma, who have undergone at least two prior treatments, Lunsumio’s safety and effectiveness in children are unknown.
• Lunsumio carries the risk of causing Cytokine Release Syndrome (CRS), a serious and common side effect during treatment that can be severe or life-threatening. If you experience any signs or symptoms of CRS at any point, seek medical assistance promptly. 
• These symptoms include a fever of 100.4°F (38°C) or higher, chills, low blood pressure, fast or irregular heartbeat, fatigue, difficulty breathing, headache, confusion, anxiety, dizziness, light-headedness, nausea, and vomiting. Immediate medical attention is crucial to address these potential complications.

Strength

Injection: 1 mg/mL; 30 mg/30 mL (1 mg/mL) solution in a single-dose vial

Recommended Dosage

Administering intravenous (IV) injections is a medical procedure that should be conducted by trained healthcare professionals. Proper aseptic technique, including handwashing, glove usage, and site cleaning, is imperative during equipment handling and injection administration. Continuous monitoring of patients for any adverse reactions is vital throughout and after the injection. Ensure the correct disposal of all used materials following medical waste disposal guidelines.

• The recommended dosage varies throughout the treatment cycles. 
• In the first cycle, on Day 1, administer 1 mg, on Day 8, administer 2 mg, and on Day 15, administer 60 mg. 
• For the subsequent cycles, on Day 1 of Cycle 2, administer 60 mg, and from Cycle 3 onwards, on Day 1, administer 30 mg.

Important

Administer Lunsumio to well-hydrated patients and premedicate before each dose in Cycle 1 and Cycle 2. Use a dedicated infusion line for intravenous infusion, avoiding the use of an in-line filter. Drip chamber filters are suitable for administering Lunsumio. Ensure that a qualified healthcare professional, with appropriate medical support, administers Lunsumio to manage severe reactions like cytokine release syndrome and neurologic toxicity.

Warnings & Precautions

• Lunsumio can lead to serious neurologic toxicity, including Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS). It’s crucial to monitor patients for signs and symptoms of neurologic toxicity throughout treatment. Depending on the severity, your healthcare provider may recommend withholding or permanently discontinuing Lunsumio.
• Lunsumio may cause serious or fatal infections. Regular monitoring for signs and symptoms of infection, including opportunistic infections, is essential. Prompt treatment may be required. 
• Monitoring complete blood cell counts during treatment is crucial to manage cytopenias effectively. 
• Lunsumio can cause serious tumor flare reactions. Patients at risk for complications of tumor flare should be closely monitored.

Common Lunsumio Side Effects:

• Cytokine release syndrome
• Fatigue
• Rash
• Pyrexia
• Headache
• Decreased lymphocyte count
• Decreased phosphate
• Increased glucose
• Decreased neutrophil count
• Increased uric acid
• Decreased white blood cell count
• Decreased hemoglobin
• Decreased platelets

Use in Specific Population

• REZLIDHIA may potentially harm a developing fetus based on animal studies. Inform your doctor if you are pregnant, planning pregnancy, or suspect pregnancy before starting treatment. 
• There is no data on mosunetuzumab-axgb in human milk, its effects on the breastfed child, or milk production. 
• Do not breastfeed during Lunsumio treatment and for 3 months after the last dose due to potential B-cell depletion. 
• Females of reproductive potential should use effective contraception during Lunsumio treatment and for 3 months after the last dose. 
• Safety and efficacy in pediatric patients are not established. Always consult your doctor before starting treatment for personalized guidance.

Storage and Handling

• Store Lunsumio at room temperature of 2°C to 8°C (36°F to 46°F).
• Do not store Lunsumio in the bathroom or in other areas where it may be exposed to heat or humidity.
• Do not freeze or shake the injection.
• Protect Lunsumio from light and moisture.
• Keep Lunsumio out of the reach of children and pets.