Toripalimab-tpzi Injection

Toripalimab-tpzi injection is used alone to treat nasopharyngeal carcinoma (NPC; a type of throat cancer) that has spread to nearby tissues or to other parts of the body or has returned after treatment with other chemotherapy medications and cannot be removed by surgery. Toripalimab-tpzi injection is also used in combination with other chemotherapy medications as a first treatment of NPC that has spread to nearby tissues or to other parts of the body. Toripalimab-tpzi is in a class of medications called monoclonal antibodies. It works by helping your immune system to slow or stop the growth of cancer cells.

Toripalimab-tpzi injection comes as a solution (liquid) to be injected intravenously (into a vein) over 30 or 60 minutes by a doctor or nurse in a hospital or medical facility. It is usually given once every 2 or 3 weeks for as long as your doctor recommends that you receive treatment.

Toripalimab-tpzi injection may cause serious reactions during the infusion of the medication. If you experience any of the following symptoms, tell your doctor immediately: flushing, fever, chills, shaking, dizziness, feeling faint, shortness of breath, difficulty breathing, back pain, itching, rash, or hives.

Your doctor may need to slow down your infusion, or interrupt or stop your treatment with toripalimab-tpzi injection depending on your response to the medication and any side effects that you experience. Talk to your doctor about how you are feeling during and after your treatment.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with toripalimab-tpzi injection and each time you receive a dose. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.

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

Before receiving toripalimab-tpzi injection,

• tell your doctor and pharmacist if you are allergic to toripalimab-tpzi, any other medications, or any of the ingredients in toripalimab-tpzi injection. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have ever had an organ or bone marrow transplant and if you have or have ever had radiation therapy to your chest area; an autoimmune disease (condition in which the immune system attacks a healthy part of the body) such as Crohn's disease (condition in which the immune system 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); diabetes; thyroid problems; any type of lung disease or breathing problems; any condition that affects your nervous system 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); or kidney or liver disease.
• tell your doctor if you are pregnant or plan to become pregnant. You will have to take a pregnancy test before starting treatment. You should not become pregnant while you are receiving toripalimab-tpzi injection and for 4 months after your final dose. Talk to your doctor about birth control methods that will work for you. If you become pregnant while receiving toripalimab-tpzi injection, call your doctor immediately. Toripalimab-tpzi injection may harm the fetus.
• tell your doctor if you are breastfeeding or plan to breastfeed. Your doctor may tell you not to breastfeed while receiving toripalimab-tpzi injection, and for 4 months after your final dose.

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

If you miss an appointment to receive toripalimab-tpzi injection, call your doctor as soon as possible.

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

• nausea
• vomiting
• constipation
• muscle or bone pain
• difficulty falling asleep or staying asleep

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

• blisters or peeling skin, rash, or itching
• painful sores or ulcers in mouth or nose, throat, or genital area
• fever or flu-like symptoms
• swollen glands
• shortness of breath
• chest pain
• new or worsening cough
• diarrhea; stools that are black, tarry, sticky, or have blood or mucus; or abdominal pain or tenderness
• increased or decreased appetite
• increased thirst
• yellowing of the eyes or skin, severe nausea or vomiting, unusual bleeding or bruising, or pain or discomfort in right upper stomach area
• tiredness or weakness
• headaches, including those that are unusual or will not go away
• feeling cold
• hair loss
• deepening of voice or hoarseness
• rapid or irregular heartbeat
• increased sweating
• changes in weight (gain or loss)
• stiff neck
• confusion, sleepiness, or changes in mood or behavior (decreased sex drive, irritability, or forgetfulness)
• balance problems
• pain, burning, tingling, or numbness in the hands or feet
• double vision, blurry vision, eye sensitivity to light, eye pain, or changes in vision
• change in amount or color of urine
• swelling of feet, ankles, or lower legs
• persistent muscle pain or weakness or muscle cramps

Toripalimab-tpzi injection 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).

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to toripalimab-tpzi 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.

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