Mosunetuzumab-axgb (Intravenous)

Mosunetuzumab-axgb injection is used to treat follicular lymphoma that has returned or did not respond to treatment in patients who have had at least 2 previous treatments.

Mosunetuzumab-axgb is an antineoplastic agent (cancer medicine). It disrupts the growth of cancer cells, which are eventually killed by the body.

This medicine should only be given by or under the direct supervision of your doctor.

It is very important for your doctor to check your progress during regular visits to ensure that this medicine is working properly. Blood tests are needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. If you are a woman who can get pregnant, your doctor may perform tests to make sure you are not pregnant before starting treatment. Use an effective form of birth control to avoid getting pregnant during treatment and for 3 months after your last dose. If you think you have become pregnant while using this medicine, tell your doctor right away.

This medicine may cause cytokine release syndrome (CRS) and infusion reactions. These can be life-threatening and require immediate attention. Tell your doctor right away if you have a fever, chills, headache, nausea, lightheadedness, dizziness, fainting, skin rash, trouble breathing, or tiredness or weakness.

Check with your doctor right away if you have seizures, loss of balance, loss of consciousness, confusion, disorientation, difficulty speaking, or slurred speech. These could be symptoms of a serious nerve problem.

This medicine may cause serious infections (e.g., pneumonia, sepsis, upper respiratory tract infection). Check with your doctor right away if you have chest pain or tightness, fever or chills, confusion, cough or hoarseness, dizziness, fainting, fast heartbeat, lightheadedness, lower back or side pain, painful or difficult urination, sneezing, sore throat, or trouble breathing.

This medicine lowers the number of some types of blood cells in your body. Because of this, you may bleed or get infections more easily. To help with these problems, avoid being near people who are sick or have infections. Wash your hands often. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.

This medicine may cause dizziness, confusion, tremors, or sleepiness. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

Check with your doctor right away if you have chest pain, cough, pain or swelling at the site of the tumor, tender or swollen lymph nodes, or trouble breathing. These may be symptoms of a serious or worsening tumor.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, you and your doctor must consider the risks against the benefits. For this medicine, keep the following in mind:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, tell your healthcare professional about any other allergies you have, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies have not been conducted to understand how age affects the use of mosunetuzumab-axgb injection in children. Safety and effectiveness have not been established.

Geriatric

Studies done so far have not shown any specific problems in older adults that would limit the usefulness of mosunetuzumab-axgb injection.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when this medication is used during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together even if an interaction might happen. In those cases, your doctor may want to adjust the dose, or other precautions may be needed. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around the time of eating food or certain types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also cause interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical issues may affect how you can use this medicine. Be sure to tell your doctor if you have any other medical problems, especially:

• Serious infections (e.g., Epstein-Barr virus), history of—Use with caution. May worsen this condition.

• Infection, active—Should not be used in patients with this condition.

Along with its intended effects, a medicine can cause some unwanted effects. Not all of these side effects may happen, but if they do, they may require medical attention.

Check with your doctor or nurse right away if any of the following side effects occur:

More common

• Abnormal or decreased touch sensation
• agitation
• back pain
• blue lips and fingernails
• blurred vision
• body aches or pain
• bone pain
• burning, crawling, itching, numbness, prickling, "pins and needles," or tingling feelings
• burning, numbness, tingling, or painful sensations
• chest pain or tightness
• chills
• confusion about time, place, or person
• cough
• coughing that sometimes produces a pink frothy sputum
• decrease in amount of urine
• difficulty in moving
• dizziness
• drowsiness
• ear congestion
• fast, noisy breathing
• fever
• frequent or painful urination
• hallucinations
• headache
• holding false beliefs that cannot be changed by fact
• increased sweating
• irritability
• joint pain
• loss of voice
• mental depression or anxiety
• muscle aches, cramps, pain, or stiffness
• neck pain
• nerve pain
• nightmares or unusually vivid dreams
• pain or tenderness around the eyes and cheekbones
• pale skin
• rapid or irregular heartbeat
• seizures
• sneezing
• sore throat
• stiff neck
• stomach pain
• stuffy or runny nose
• swelling
• swelling of the hands, ankles, feet, or lower legs
• swollen joints
• trembling and shaking of the hands
• trouble breathing
• trouble performing routine tasks
• trouble sleeping
• unsteadiness or awkwardness
• unusual excitement, nervousness, or restlessness
• unusual tiredness or weakness
• vomiting
• weakness in the arms, hands, legs, or feet
• weight gain

Incidence not known

• Black, tarry stools
• bleeding gums
• blood in the urine or stools
• lower back or side pain
• painful or difficult urination
• pinpoint red spots on the skin
• ulcers, sores, or white spots in the mouth
• unusual bleeding or bruising

Some side effects may happen that usually do not require medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your health care professional may also have ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue, are bothersome, or if you have any questions about them:

More common

• Diarrhea
• dry skin
• itching skin

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Lunsumio

Available Dosage Forms:

• Solution

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Mosunetuzumab

Find detailed information on biosimilars for this medication.

A nurse or other trained health professional will give you this medicine in a hospital or cancer treatment center. This medicine is given through a needle placed into one of your veins.

You will receive this medicine on a "step-up dosing schedule" on Day 1 and 8 of your first cycle. You will receive a higher dose on Day 15 of your first cycle treatment. After cycle 1, you will receive this medicine every 21 days.

Your doctor may also give you other medicines (eg, allergy medicine, fever medicine, steroids) 30 to 60 minutes before starting treatment with this medicine to help prevent unwanted side effects from the injection.

This medicine should come with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.