Tislelizumab-jsgr injection

WHY is this medicine prescribed?

Tislelizumab-jsgr injection is used to treat esophageal squamous cell carcinoma (cancer of the cells lining the throat) that cannot be operated on or has spread to other parts of the body and has not responded to certain other types of treatments. Tislelizumab-jsgr is in a class of medications called monoclonal antibodies. It works by altering the immune system to slow tumor growth.

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 usually 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. 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.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

What SPECIAL PRECAUTIONS should I follow?

Before receiving tislelizumab-jsgr,

• tell your doctor and pharmacist if you are allergic to tislelizumab-jsgr, any other medications, or any of the ingredients in tislelizumab-jsgr injection. Ask your pharmacist or check the Medication Guide for a list of the ingredients.

• 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 or have ever had an disorder that impacts your immune system such as Crohn's disease, ulcerative colitis or lupus; have ever received an organ transplant, have received or plan to receive a stem cell transplant; have received radiation treatment to your chest; have a nervous system disorder such as myasthenia gravis or Guillain-Barré syndrome.

• tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while you are receiving tislelizumab-jsgr. If you are female, you will need to take a pregnancy test before you start treatment and use birth control to prevent pregnancy during your treatment with tislelizumab-jsgr and for 4 months after your final dose. If you become pregnant while receiving tislelizumab-jsgr, call your doctor immediately. Tislelizumab-jsgr can cause fetal harm.

• tell your doctor if you are breastfeeding. 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 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
• cough
• 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, 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 (http://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 certain lab tests to check your body's response to tislelizumab-jsgr.

Make sure you do not miss any scheduled appointments to receive tislelizumab-jsgr. If you do, call your doctor or nurse right away.

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

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.