Toripalimab-tpzi (Intravenous)

Toripalimab-tpzi injection is used together with cisplatin and gemcitabine as the first treatment for nasopharyngeal carcinoma (cancer of the nose and throat) that has spread throughout the body (metastatic) or has come back. It can also be used on its own to treat nasopharyngeal carcinoma in patients who have already had other cancer treatments (such as platinum) that did not work well, or in cases where the cancer has returned, cannot be removed by surgery, or has spread.

Toripalimab-tpzi is a monoclonal antibody that helps the immune system control the growth of cancer cells.

This medicine should only be given by your doctor or under their direct supervision.

It is very important that your doctor checks your progress during regular visits to ensure 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 get pregnant, your doctor may give you a pregnancy test before you start using this medicine to confirm that you are not pregnant. Use an effective form of birth control to prevent getting pregnant during treatment with this medicine and for 4 months after the last dose. If you think you might be pregnant while receiving the medicine, tell your doctor right away.

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

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

Check with your doctor immediately 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 ongoing or unusual headaches, changes in mood or behavior (e.g., being irritable or forgetful), lightheadedness, dizziness, or fainting, unusual sluggishness, or weight gain.

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 (e.g., nephritis, kidney failure). Tell your doctor immediately if you have bloody or cloudy urine, nausea, vomiting, trouble breathing, swelling of the face, feet, or lower legs, unusual tiredness or weakness, or significant weight gain.

Serious skin reactions (e.g., exfoliative dermatitis, Stevens-Johnson syndrome, drug rash with eosinophilia and systemic symptoms (DRESS), and toxic epidermal necrolysis) can occur with this medicine. Check with your doctor immediately 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.

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

In deciding to use a medicine, you and your doctor need to consider the risks of the medicine against the benefits it may provide. Here are some important points to think about for this medicine:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

Studies have not been done to find out how age affects the effects of toripalimab-tpzi injection in children. Safety and effectiveness have not been established.

Geriatric

Current studies have not shown any specific problems in older adults that would limit the usefulness of toripalimab-tpzi injection in elderly patients.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication while breastfeeding. Consider the potential benefits and risks of taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should never be used together, while others can be used together even if there might be an interaction. In these cases, your doctor may change the dose or take other precautions. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicines.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken at the same time as eating food or specific types of food due to possible interactions. Consuming alcohol or tobacco with certain medicines may also lead to interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical issues may impact the use of this medicine. Make sure to 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 (e.g., Crohn's disease, ulcerative colitis, or lupus) or
• Muscle or nerve problems (e.g., myasthenia gravis, Guillain-Barré syndrome) or
• Nephritis (inflammation of the kidneys) or
• Pneumonitis (inflammation of the lungs) or
• Type 1 diabetes—Use with caution. May worsen these conditions.

• Recent organ transplant (e.g., kidney or liver transplant)—Use with caution. May increase the risk of organ transplant rejection.

• Patients who have had an allogeneic hematopoietic stem cell transplant (HSCT)—Use with caution. May worsen side effects.

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

• Arm or leg pain
• back pain
• blistering, peeling, or loosening of the skin
• blurred vision
• body aches or pain
• bone pain
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• chest pain or tightness
• chills
• constipation
• cough
• cough producing mucus
• cracks in the skin
• depressed mood
• diarrhea
• difficulty moving
• dizziness
• dry skin and hair
• ear congestion
• enlarged pupils
• feeling cold
• fever
• hair loss
• headache
• hoarseness or husky voice
• increased sensitivity of the eyes to light
• increased sweating, possibly with fever or cold, clammy skin
• joint pain
• loss of voice
• muscle aches, cramps, pain, and stiffness
• neck pain
• nerve pain
• nervousness
• pain or tenderness around the eyes and cheekbones
• pounding in the ears
• red, swollen skin
• red irritated eyes
• red skin lesions, often with a purple center
• slow or fast heartbeat
• sneezing
• sore throat
• sores, ulcers, or white spots in the mouth or on the lips
• stiff or sore neck
• stuffy or runny nose
• sweating
• swollen joints
• tender, swollen glands in neck
• trouble breathing
• trouble swallowing
• trouble sleeping
• unsteadiness or awkwardness
• unusual tiredness or weakness
• weakness in arms, hands, legs, or feet
• weight gain or loss

Less common

• General feeling of discomfort or illness
• thickening of bronchial secretions

Rare

• Anxiety
• black, tarry stools
• bleeding gums
• bloating
• blue or pale skin
• burning feeling in the chest or stomach
• change in vision
• chest discomfort
• confusion
• dark urine
• darkening of the skin
• double vision
• drooping eyelids
• drowsiness
• dry mouth
• eye pain
• fainting
• flushed, dry skin
• fruit-like breath odor
• general feeling of illness
• heavier menstrual periods
• inability to move the arms and legs
• increased hunger
• increased thirst
• increased urination
• indigestion
• irritability
• loss of appetite
• loss of consciousness
• muscle aches or weakness
• nausea or vomiting
• nosebleeds
• numbness or tingling in the fingers, face, or feet
• pains in the stomach, side, or abdomen, possibly radiating to the back
• pale skin
• pinpoint red spots on the skin
• seeing flashes or sparks of light
• seeing floating spots before the eyes, or a veil or curtain appearing across part of vision
• seizures
• stomach pain, upset, or cramps
• sudden numbness and weakness in the arms and legs
• swollen, painful, or tender lymph glands in the neck, armpit, or groin
• tearing
• tenderness
• unusual bleeding or bruising
• watery or bloody diarrhea
• yellow eyes or skin

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

• Swelling or inflammation of the mouth

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.

In the U.S.

• Loqtorzi

Pharmacologic Class: Toripalimab

Find detailed information on biosimilars for this medication.

A nurse or other trained health professional will give you this medicine. It is given through a needle placed into one of your veins. It must be given slowly, so the IV will have to remain in place for at least 30 or 60 minutes.

This medicine comes with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist 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.

• What are Monoclonal Antibodies and how do they work?
• What is the MOA of Loqtorzi (toripalimab)?
• How Accurate is Screening for Nasopharyngeal Carcinoma?