Mosunetuzumab

What is Mosunetuzumab?

• Mosunetuzumab (Lunsumio) is a bispecific CD20-directed CD3 T-cell engager.
• It is a humanized monoclonal anti-CD20xCD3 T-cell-dependent bispecific antibody of the immunoglobulin G1 (IgG1) isotype.
• Mosunetuzumab-axgb is produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology.

Immunoglobulin G1-kappa, anti-CD3E + anti-MS4A1 bispecific

What are the uses of this medicine?

• Mosunetuzumab (Lunsumio) is a prescription medicine used to treat adults with follicular lymphoma whose cancer has come back or did not respond to previous treatment, and who have already received two or more treatments for their cancer.

How does this medicine work?

• Mosunetuzumab-axgb is a T-cell engaging bispecific antibody that binds to the CD3 receptor expressed on the surface of T-cells and CD20 expressed on the surface of lymphoma cells and some healthy B-lineage cells.
• Upon administration,it binds to both T cells and CD20-expressing tumor B cells; this cross-links T cells to tumor cells, and may result in a potent cytotoxic T-lymphocyte (CTL) response against CD20-expressing tumor B cells.

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

What drug interactions can this medicine cause?

• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Be sure to mention any of the following:

• CYP450 substrates

Is this medicine FDA approved?

• Mosunetuzumab was approved for medical use in the United States in December 2022.
• The US Food and Drug Administration (FDA) considers it to be a first-in-class medication.

How should this medicine be used?

Premedicate to reduce risk of cytokine release syndrome and infusion-related reactions.

Recommended dosage:

• Cycle 1: Day 1 – 1 mg
• Cycle 1: Day 8 – 2 mg
• Cycle 1: Day 15 – 60 mg
• Cycle 2: Day 1 – 60 mg
• Cycle 3: Day 1 – 30 mg

Administration:

• Lunsumio will be given to you by your healthcare provider by infusion through a needle placed in a vein (intravenous infusion).
• After you complete the weekly "step-up dosing schedule" in Cycle 1, Lunsumio is given every 21 days.
• After Cycle 1 and Cycle 2, your healthcare provider will decide if you need to continue to take other medicines to help reduce side effects from Lunsumio during future cycles.
• Your healthcare provider will decide how many treatment cycles you will receive of Lunsumio.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form: As Injection:

• 1 mg/mL solution in a single-dose vial.
• 30 mg/30 mL (1 mg/mL) solution in a single-dose vial.

This medicine is available in fallowing brand namesː

• Lunsumio

What side effects can this medication cause?

The most common side effects of this medicine include:

• tiredness, rash, fever, and headache

Less common, but serious side effects may include:

• Cytokine Release Syndrome
• Neurologic problems
• Serious infections
• Low blood cell counts
• Tumor flare

What special precautions should I follow?

• Lunsumio can cause cytokine release syndrome (CRS), including serious or life-threatening reactions. Discuss the signs and symptoms associated with CRS, including fever, chills, hypotension, tachycardia, hypoxia, and headache. Counsel patients to seek immediate medical attention should signs or symptoms of CRS occur at any time.
• Lunsumio can cause serious neurologic toxicity, including Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS). Discuss the signs and symptoms associated with neurologic toxicity, including ICANS, headache, peripheral neuropathy, dizziness, or mental status changes. Advise patients to immediately contact their healthcare provider if they experience any signs or symptoms of neurologic toxicity. Advise patients who experience neurologic toxicity that impairs consciousness to refrain from driving or operating heavy or potentially dangerous machinery until neurologic toxicity resolves.
• Lunsumio can cause serious or fatal infections. Monitor patients for signs and symptoms of infection, including opportunistic infections, and treat as needed.
• Lunsumio can cause serious or severe cytopenias, including neutropenia, anemia, and thrombocytopenia. Discuss the signs and symptoms associated with cytopenias, including neutropenia and febrile neutropenia, anemia, and thrombocytopenia.
• Lunsumio can cause serious or severe tumor flare. Inform patients of the potential risk of tumor flare reaction and to report any signs and symptoms associated with this event to their healthcare provider for evaluation.
• Based on its mechanism of action, Lunsumio may cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential to use effective contraception during treatment with Lunsumio and for 3 months after the last dose.
• Advise women not to breastfeed during treatment with Lunsumio and for 3 months after the last dose.
• Do not drive, operate heavy machinery, or do other dangerous activities if you develop dizziness, confusion, tremors, sleepiness, or any other symptoms that impair consciousness until your signs and symptoms go away. These may be signs and symptoms of CRS or neurologic problems.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.
• In the event of overdose, general supportive measures should be instituted as necessary.
• Monitor the patient for adverse reactions.

Can this medicine be used in pregnancy?

• Based on the mechanism of action, Lunsumio may cause fetal harm when administered to a pregnant woman.
• Lunsumio may harm your unborn baby.
• Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with Lunsumio.

Can this medicine be used in children?

• It is not known if Lunsumio is safe and effective in children.

What are the active and inactive ingredients in this medicine?

• Active ingredient: mosunetuzumab-axgb
• Inactive ingredients: acetic acid, histidine, methionine, polysorbate 20, sucrose, and Water for Injection

Who manufactures and distributes this medicine?

Manufactured by:

• Genentech, Inc., A Member of the Roche Group, 1 DNA Way, South San Francisco, CA

What should I know about storage and disposal of this medication?

• Store refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light.
• Do not freeze.
• Do not shake.

• Dailymed label info on Mosunetuzumab
• FDA Mosunetuzumab

Mosunetuzumab Resources
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Mosunetuzumab Resources
Need Help Finding a Doctor? Need help finding a doctor or specialist anywhere in the world? Explore our world directory. WikiMD's DocFinder can assist you in locating millions of physicians.	Medical Knowledge Access the latest research - Most recent articles Ongoing trials.

Translate to: East Asian 中文, 日本, 한국어, South Asian हिन्दी, Urdu, বাংলা, తెలుగు, தமிழ், ಕನ್ನಡ,
Southeast Asian Indonesian, Vietnamese, Thai, မြန်မာဘာသာ, European español, Deutsch, français, русский, português do Brasil, Italian, polski