Pronunciation:

moe-sun-e-TOOZ-ue-mab - axgb

Brand Names:

• Lunsumio

Dosage Forms:

• Solution

Warnings:

Warning: Cytokine Release SyndromeCytokine release syndrome (CRS), including serious or life-threatening reactions, can occur in patients receiving mosunetuzumab-axgb. Initiate treatment with the mosunetuzumab-axgb step-up dosing schedule to reduce the risk of CRS. Withhold mosunetuzumab-axgb until CRS resolves or permanently discontinue based on severity .

Classifications:

Therapeutic—

Antineoplastic Agent

Pharmacologic—

Mosunetuzumab

Uses of This Medicine:

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

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

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

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

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

Children—

Appropriate studies have not been performed on the relationship of age to the effects of mosunetuzumab-axgb injection in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of mosunetuzumab-axgb injection in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Serious infections (eg, Epstein-Barr virus), history of—Use with caution. May make this condition worse.

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

Proper Use of This Medicine:

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.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure 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 do tests to make sure you are not pregnant before starting treatment. Use an effective form of birth control to keep from getting pregnant during treatment and for 3 months after the 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. This may be life-threatening and requires 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 with speaking, or slurred speech. These could be symptoms of a serious nerve problem.

This medicine may cause serious infections (eg, 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 serious or worsening of 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.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately 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 as to time, place, or person

cough

coughing that sometimes produce 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 occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or 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.