Tislelizumab-jsgr injection

WHY is this medicine prescribed?

Tislelizumab-jsgr injection is used to treat a certain type of esophageal cancer (cancer of the tube that connects your throat to your stomach) and a certain type of gastric cancer (cancer of the stomach). Tislelizumab-jsgr is in a class of medications called monoclonal antibodies. It works by helping the immune system to slow or stop the growth of cancer cells.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Tislelizumab-jsgr injection comes as a solution (liquid) to be given intravenously (into the vein) by a doctor or nurse at a hospital or clinic. It is given once every 3 weeks. Your first dose will be given over 60 minutes but may be given over 30 minutes for doses after that if you tolerate it.

You may have a reaction during or immediately following treatment with tislelizumab-jsgr injection. If you experience any of the following symptoms, tell or call your doctor or nurse immediately: chills, shaking, itching, rash, flushing, shortness of breath or wheezing, dizziness, feeling faint or like you may pass out, fever, back or neck pain.

Your doctor will decide how many treatments of tislelizumab-jsgr that you need.

You will be given the Medication Guide when you begin treatment with tislelizumab-jsgr injection and each time you refill yourprescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. Youcan also visit https://www.fda.gov/Drugs/DrugSafety/ucm085729.htm to obtain the Medication Guide.

What SPECIAL PRECAUTIONS should I follow?

Before receiving tislelizumab-jsgr,

• tell your doctor and pharmacist if you are allergic to this drug, any part of this drug, or any other drugs, food, or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.

• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.

• tell your doctor if you have ever had an organ or tissue transplant, including corneal transplant, a bone marrow (stem cell) transplant, or if you have or ever had had radiation therapy to your chest area. Also, tell your doctor if you have or have ever had an autoimmune disease (condition in which the immune system attacks a healthy part of the body) such as Crohn's disease (a condition in which the body attacks the lining of the digestive tract, causing pain, diarrhea, weight loss, and fever), ulcerative colitis, (condition which causes swelling and sores in the lining of the colon [large intestine] and rectum), or lupus (condition in which the immune system attacks many tissues and organs including the skin, joints, blood, and kidneys); a nervous system disorder such as myasthenia gravis (a disorder of the nervous system that causes muscle weakness) or Guillain-Barré syndrome (weakness, tingling, and possible paralysis due to sudden nerve damage); any type of lung disease or breathing problems; diabetes; thyroid problems; or kidney or liver disease.

• tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while you are receiving tislelizumab-jsgr injection. IYou may be asked take a pregnancy test before you start treatment, You should use birth control to prevent pregnancy during your treatment and for 4 months after your final dose.If you become pregnant while receiving tislelizumab-jsgr, call your doctor immediately. Tislelizumab-jsgr may harm the fetus.

• tell your doctor if you are breastfeeding or plan to breastfeed. You should not breastfeed while you are receiving tislelizumab-jsgr and for 4 months after your final dose.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

If you miss an appointment to receive a dose of tislelizumab-jsgr injection, call your doctor right away.

What SIDE EFFECTS can this medicine cause?

Tislelizumab-jsgr may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• tiredness
• fever
• muscle, bone and joint pain
• weight loss
• nausea
• vomiting
• decreased appetite

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

• cough, chest pain, or shortness of breath
• diarrhea; severe stomach pain or tenderness; or, black, tarry or sticky stools
• yellowing of the skin or whites of the eyes, nausea or vomiting, pain on the right side of your abdomen, dark urine, or bruising easily
• headaches that do not go way, sensitivity to light, feeling like your heart is racing, sweating more than usual, exhaustion, unexpected changes in weight, increase in hunger or thirst, increased urgency or need to urinate, hair loss, feeling cold, constipation, dizziness or fainting, or changes in mood or behavior
• decrease in the amount of urine or blood in your urine, ankle swelling, loss of appetite
• rash; itching; blistering or peeling skin; sores or ulcers in your mouth, throat, nose, or genital area; swollen lymph nodes; or fever or flu-like symptoms
• irregular heartbeat, chest pain, shortness of breath or swelling of ankles
• confusion, sleepiness, memory problems, changes in mood or behavior, stiff neck, balance problems, tingling or numbness of arms or legs
• double vision, blurry vision, sensitivity to light, eye pain or changes in eyesight
• persistent or severe muscle pain, weakness

Tislelizumab-jsgr may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and laboratory. Your doctor may order a lab test before you begin your treatment to see whether your cancer can be treated with tislelizumab-jsgr injection. Your doctor may order certain lab tests to check your body's response to tislelizumab-jsgr.

Ask your pharmacist any questions you have about tislelizumab-jsgr injection.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.