Pronunciation:

tis-le-LIZ-ue-mab - jsgr

Brand Names:

• Tevimbra

Classifications:

Pharmacologic—

Tislelizumab

Uses of This Medicine:

Tislelizumab-jsgr injection is used to treat esophageal cancer that has spread or cannot be removed by surgery. It is given to patients who have received cancer medicines that did not contain a PD-L1 inhibitor.

Tislelizumab-jsgr is a monoclonal antibody that changes the immune system to help control the growth of cancer cells.

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 tislelizumab-jsgr 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 tislelizumab-jsgr 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:

• Colitis (inflammation of the bowels) or
• Diabetic ketoacidosis or
• Hepatitis (inflammation of the liver) or
• Hyperthyroidism (high levels of thyroid hormone) or
• Hypophysitis (inflammation of the pituitary gland) or
• Hypothyroidism (low levels of thyroid hormone) or
• Immune system problems (eg, Crohn disease, ulcerative colitis, lupus) or
• Nephritis (inflammation of the kidneys) or
• Nervous system problems (eg, myasthenia gravis, Guillain-Barré syndrome) or
• Pneumonitis (inflammation of the lungs) or
• Type 1 diabetes—Use with caution. May make these conditions worse.

• Organ transplant (eg, kidney or liver transplant) or tissue transplant (eg, cornea transplant), recent—Use with caution. May increase risk for organ or tissue transplant rejection.

• Patients who have had allogeneic hematopoietic stem cell transplant (HSCT)—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. It is given through an IV catheter placed into one of your veins. It must be given slowly, so the IV will have to remain in place for at least 30 to 60 minutes. The infusion will be given once every 3 weeks.

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

Missed dose—

This medicine needs to be given on a fixed schedule. If you miss a dose, call your doctor, home health caregiver, or treatment clinic for instructions.

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 and urine tests may be needed to check for unwanted effects.

Receiving this medicine while you are pregnant can harm your unborn baby. If you are a woman who can bear children, your doctor may give you a pregnancy test before you start using this medicine to make sure you are not pregnant. Use an effective form of birth control to keep from getting pregnant during treatment with this medicine and for 4 months after the last dose. If you think you have become pregnant while receiving the medicine, tell your doctor right away.

Tell your doctor right away if you have a cough, chest tightness, or any type of breathing problem with this medicine. These could be symptoms of a serious lung problem.

Colitis (swelling of the colon or bowel) may occur with this medicine. Tell your doctor right away if you have stomach pain or tenderness, watery or bloody diarrhea, or a fever after receiving this medicine.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Serious problems with the adrenal, pituitary, or thyroid glands (hormone glands) may occur while you are receiving this medicine. Tell your doctor if you start having continuing or unusual headaches, changes in mood or behavior (eg, being irritable or forgetful), lightheadedness, dizziness, or fainting, unusual sluggishness, or an increase in weight.

This medicine may affect blood sugar levels. If you notice a change in the results of your blood or urine sugar tests or if you have any questions, check with your doctor.

This medicine may cause serious kidney problems (eg, nephritis, kidney failure). Tell your doctor right away if you have bloody or cloudy urine, nausea, vomiting, trouble breathing, swelling of the face, feet, or lower legs, unusual tiredness or weakness, or unusual weight gain.

Serious skin reactions (eg, exfoliative dermatitis, Stevens-Johnson syndrome, drug rash with eosinophilia and systemic syndrome (DRESS), and toxic epidermal necrolysis) can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loosening of the skin, chills, cough, diarrhea, itching, joint or muscle pain, red irritated eyes, red skin lesions, often with a purple center, severe acne or skin rash, sores or ulcers on the skin, mouth or lips, swollen glands, unusual bleeding or bruising, or unusual tiredness or weakness with this medicine.

Tell your doctor right away if you have changes in your eyesight, severe or persistent muscle or joint pain, or severe muscle weakness after receiving this medicine.

Tell your doctor right away if you have a headache, confusion, seizures, stiff neck, or vomiting while receiving this medicine. These may be symptoms of encephalitis.

Tell your doctor right away if you have a severe headache, drowsiness, confusion, general feeling of illness, or stiff neck or back while receiving this medicine. These may be symptoms of meningitis.

This medicine may cause inflammation of the heart muscle called myocarditis. Check with your doctor right away if you have chest pain or discomfort, fever, chills, a fast heartbeat, or trouble breathing.

Call your doctor right away if you have difficulty swallowing or talking, or if you have muscle weakness, severe tiredness, or sudden numbness and weakness in the arms or legs. These could be symptoms of a nervous system problem.

Tell your doctor right away if you have blurred vision, eye pain or redness, or other vision problems while you are receiving this medicine.

This medicine may cause infusion-related reactions. These can be life-threatening and require immediate medical attention. Tell your doctor right away if you start to have a fever, chills or shaking, dizziness, trouble breathing, itching or rash, lightheadedness or fainting after receiving 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

Bleeding from rectum or bloody stools

bleeding gums

chest pain or tightness

constipation

cough

coughing up blood

depressed mood

dizziness

dry skin and hair

feeling cold

fever or chills

hair loss

headache

hoarseness or husky voice

increased menstrual flow or vaginal bleeding

muscle cramps and stiffness

nosebleeds

pale skin

paralysis

prolonged bleeding form cuts

red or dark brown urine

red or black, tarry stools

slowed heartbeat

sneezing

sore throat

trouble breathing

unusual bleeding or bruising

unusual tiredness or weakness

vomiting of blood or material that looks like coffee grounds

weight gain

Less common

Dark urine

light-colored stools

nausea and vomiting

upper right abdominal or stomach pain

yellow eyes or skin

Rare

Back or leg pain

bloating

blurred vision or other change in vision

burning, tingling, numbness or pain in the hands, arms, feet, or legs

chest discomfort

confusion

darkening of the skin

difficulty in chewing, swallowing, or talking

difficulty in moving

double vision

drooping eyelids

drowsiness

eye pain

fainting

fast heartbeat

general body swelling

heavier menstrual periods

inability to move the arms and legs

irritability

loss of appetite

mental depression

muscle aches or weakness

nervousness

numbness or tingling in the fingers, face, or feet

pain, swelling, or redness in the joints

pains in stomach, side, or abdomen, possibly radiating to the back

pinpoint red spots on the skin

redness, soreness, or itching skin

redness of the eye

seeing flashes or sparks of light

seeing floating spots before the eyes, or a veil or curtain appearing across part of vision

seizures

sensation of pins and needles

sensitivity of the eye to light

sensitivity to heat

skin rash

stabbing pain

stiff neck or back

stomach cramps or pain

sudden numbness and weakness in the arms and legs

sweating

swollen, painful, or tender lymph glands in neck, armpit, or groin

tearing

tenderness

trouble sleeping

watery or bloody diarrhea

weight loss

Incidence not known

Blistering, peeling, or loosening of the skin

dry mouth

flushed, dry skin

flushing

fruit-like breath odor

increased hunger

increased thirst

increased urination

loss of consciousness

painful or difficult urination

red irritated eyes

red skin lesions, often with a purple center

sores, ulcers, or white spots in the mouth or on the lips

swollen glands

unexplained weight loss

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

neck pain

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.