Pronunciation:

a-fam-i-TRES-jeen aw-toe-LOO-sel

Brand Names:

• Tecelra

Dosage Forms:

• Suspension

Warnings:

Cytokine Release Syndrome (CRS), which may be severe or life-threatening, occurred in patients receiving afamitresgene autoleucel. At the first sign of CRS, immediately evaluate patient for hospitalization and institute treatment with supportive care. Ensure that healthcare providers administering afamitresgene autoleucel have immediate access to medications and resuscitative equipment to manage CRS .

Classifications:

Therapeutic—

Antineoplastic Agent

Uses of This Medicine:

Afamitresgene autoleucel injection is used to treat synovial sarcoma that has spread throughout the body (metastatic) or cannot be removed by surgery (unresectable) and whose tumors express MAGE-A4 antigen in patients who have received previous treatment that did not work well.

Afamitresgene autoleucel injection is an antineoplastic (cancer) medicine that is made from your own white blood cells, which have been modified to recognize and attack your cancer cells. Before you begin treatment, talk to your doctor about the benefits of this medicine as well as the possible risks of receiving it.

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 afamitresgene autoleucel 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 afamitresgene autoleucel 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. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Bacillus of Calmette and Guerin Vaccine, Live
• Dengue Tetravalent Vaccine, Live
• Measles Virus Vaccine, Live
• Mumps Virus Vaccine, Live
• Rubella Virus Vaccine, Live
• Smallpox Monkeypox Vaccine
• Typhoid Vaccine
• Varicella Virus Vaccine
• Yellow Fever Vaccine

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Adenovirus Vaccine Type 4, Live
• Adenovirus Vaccine Type 7, Live
• Cholera Vaccine
• Ebola Zaire Vaccine, Live
• Influenza Virus Vaccine, Live
• Rotavirus Vaccine, Live

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:

• Allergy to dimethyl sulfoxide (DMSO)—Use with caution. May increase the risk of an allergic reaction.

• Heart disease or
• Heart rhythm problems (eg, tachycardia) or
• Hypotension (low blood pressure) or
• Infections (eg, hepatitis B), active or history of or
• Kidney disease or
• Lung or breathing problems or
• Seizures, history of or
• Stroke, history of—Use with caution. May cause side effects to become worse.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine in a hospital or cancer center. It is given through an IV catheter that is placed into one of your veins. This medicine must be given slowly, so your IV will need to stay in place for at least 60 minutes. It is given after receiving treatment with other cancer medicines (eg, fludarabine, cyclophosphamide).

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

You may also receive other medicines (eg, allergy medicine, fever medicine) 30 to 60 minutes before starting treatment with this medicine.

Your doctor will check you for unwanted effects at least daily for 7 days. Your doctor will also want you to stay close to the hospital or center for at least 4 weeks after your infusion.

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.

If you can get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment.

This medicine may cause cytokine release syndrome (CRS) and nervous system problems, including immune effector cell-associated neurotoxicity syndrome (ICANS). These may be life-threatening and require immediate attention. Tell your doctor right away if you have agitation, back pain, blurred vision, burning, throbbing, or stabbing pain, confusion, double vision, drowsiness, restlessness, fever, chills, hallucinations, headache, hearing loss, irritability, jerking movements, mood or mental changes, muscle spasms, nausea, lightheadedness, dizziness, fainting, rigid muscles, seizures, skin rash, stiff neck, tremor, trouble breathing, trouble speaking, unusual tiredness or weakness, or vomiting.

This medicine may cause dizziness or fainting. Do not drive or do anything else that could be dangerous for at least 4 weeks after treatment, until you know how this medicine affects you.

This medicine lowers the number of some types of blood cells in your body. Because of this, you may bleed more easily. 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 serious infections. Avoid being near people who are sick or have infections. Wash your hands often. Check with your doctor right away if you have a fever or chills, confusion, cough or hoarseness, lower back or side pain, or painful or difficult urination.

This medicine may increase your risk of getting other cancers. Talk to your doctor if you have questions about these risks.

Check with your doctor right away if you have a rash, itching, dizziness, fainting, fast heartbeat, trouble breathing or swallowing, or chest tightness while you are using this medicine. These may be symptoms of serious allergic reactions, including anaphylaxis, which may be life-threatening and require immediate medical attention.

Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of some tests may be affected by this medicine.

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

Black, tarry stools

bleeding gums

blood in the urine or stools

blurred vision

chest pain

chills

confusion

cough

cough or hoarseness

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

fast, pounding, or irregular heartbeat or pulse

fever

headache

lower back or side pain

nervousness

painful or difficult urination

pale skin

pinpoint red spots on the skin

pounding in the ears

sore throat

sweating

swelling

trembling and shaking of the hands

trouble breathing

ulcers, sores, or white spots in the mouth

unusual bleeding or bruising

unusual tiredness or weakness

Incidence not known

Chest tightness

defects in intelligence, short-term memory, learning ability, and attention

difficulty swallowing

hives, itching, skin rash

nausea

problems with speech or speaking

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

seizures

shakiness and unsteady walk

unsteadiness. trembling, or other problems with muscle control or coordination

vomiting

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

Arm or leg pain

back pain

constipation

decreased appetite

diarrhea

lack or loss of strength

loss or thinning of the hair

weight decreased

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.