Warnings:

Mosunetuzumab may cause a certain serious (sometimes fatal) side effect known as cytokine release syndrome-CRS. You will be given this medication in a hospital or clinic so your doctor can watch for serious side effects and quickly provide treatment if needed. Tell your doctor right away if you develop symptoms such as fever, chills, headache, nausea, vomiting, stomach/abdominal pain, trouble breathing, skin rash, tiredness, or low blood pressure.

How to use Lunsumio 1 Mg/Ml Intravenous Solution Antineoplastic - Immunotherapy, T-Cell Engager

Read the Medication Guide provided by your pharmacist before you start using mosunetuzumab and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

This medication is given by injection into a vein as directed by your doctor. The injection is given by a health care professional. The first 3 doses are usually given over at least 4 hours. If you can take this medication, the following doses may be given over less time (such as 2 hours). The dosage is based on your medical condition and response to treatment.

Infusion reactions may happen during or soon after the infusion of this drug. Your doctor may prescribe other medications (such as acetaminophen, dexamethasone, diphenhydramine) before each treatment to help prevent these side effects. Tell your doctor right away if you have any symptoms of infusion reactions such as flushing, chills, fever, fast/pounding heartbeat, dizziness, or shortness of breath.

Use this medication regularly to get the most benefit from it. To help you remember, it may help to mark your calendar with a reminder.

Side Effects

See also Warning and How to Use sections.

Tiredness, dizziness, diarrhea, nausea, muscle/joint pain, or headache may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

People using this medication may have serious side effects. However, you have been prescribed this drug because your doctor has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.

Tell your doctor right away if you have any serious side effects, including: easy bruising/bleeding, mental/mood changes (such as confusion, trouble understanding things, forgetting who or where you are), trouble speaking, reading, or writing, numbness/tingling of arms/legs, drowsiness or trouble sleeping (insomnia), loss of balance or trouble walking.

This medication may lower your ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. Tell your doctor right away if you have any signs of infection (such as sore throat that doesn't go away, fever, chills, cough).

This medication sometimes causes side effects due to the rapid destruction of cancer cells (tumor lysis syndrome). To lower your risk, your doctor may add a medication and tell you to drink plenty of fluids. Tell your doctor right away if you have symptoms such as: low back/side pain (flank pain), signs of kidney problems (such as painful urination, pink/bloody urine, change in the amount of urine), muscle spasms/weakness.

People taking this medication may have worsening of their symptoms (tumor flare). Tell your doctor right away if you have symptoms of tumor flare such as: tender or swollen lymph nodes, chest pain, cough, trouble breathing, or pain or swelling at the site of the tumor.

Mosunetuzumab can commonly cause a rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe reaction. Get medical help right away if you develop any rash.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before using mosunetuzumab, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: past/current/recent infections (including Epstein-Barr virus).

This drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

This medication can make you more likely to get infections or may make current infections worse. Stay away from anyone who has an infection that may easily spread (such as chickenpox, COVID-19, measles, flu). Talk to your doctor if you have been exposed to an infection or for more details.

Tell your health care professional that you are using mosunetuzumab before having any immunizations/vaccinations. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using mosunetuzumab. Mosunetuzumab may harm an unborn baby. Your doctor should order a pregnancy test before you start this medication. Ask about reliable forms of birth control while using this medication and for 3 months after the last dose. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.

It is unknown if this medication passes into breast milk. Because of the possible risk to the infant, breastfeeding is not recommended while using this medication and for 3 months after the last dose. Consult your doctor before breastfeeding.

Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

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Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Notes Notes

Lab and/or medical tests (such as complete blood count) should be done while you are using this medication. Keep all medical and lab appointments.

Missed Dose Missed Dose

It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.

Storage Storage

Not applicable. This medication is given in a hospital or clinic or doctor's office and will not be stored at home.

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Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, except as may be authorized by the applicable terms of use.

CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.