Description and Brand Names

Drug information provided by: Merative, Micromedex®

US Brand Name

1. Loqtorzi

Descriptions

Toripalimab-tpzi injection is used in combination with cisplatin and gemcitabine as first-line treatment of nasopharyngeal carcinoma (nose and throat cancer) that has spread throughout the body (metastatic) or has returned. It is also used alone to treat nasopharyngeal carcinoma in patients who have received other cancer medicines (eg, platinum) that did not work well, or whose cancer has returned, cannot be removed by surgery, or has spread.

Toripalimab-tpzi 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.

This product is available in the following dosage forms:

• Solution

Before Using

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.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of toripalimab-tpzi injection in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of toripalimab-tpzi injection in the elderly.

Breastfeeding

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.

Drug Interactions

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's disease, ulcerative colitis, or lupus) or
• Muscle or nerve problems (eg, 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 make these conditions worse.

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

• Patients who have had allogeneic hematopoietic stem cell transplant (HSCT)—Use with caution. May cause side effects to become worse.

Proper Use

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.

Precautions

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 get pregnant, 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 the 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 symptoms (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, or 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 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

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

1. Arm or leg pain
2. back pain
3. blistering, peeling, or loosening of the skin
4. blurred vision
5. body aches or pain
6. bone pain
7. burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
8. chest pain or tightness
9. chills
10. constipation
11. cough
12. cough producing mucus
13. cracks in the skin
14. depressed mood
15. diarrhea
16. difficulty moving
17. dizziness
18. dry skin and hair
19. ear congestion
20. enlarged pupils
21. feeling cold
22. fever
23. hair loss
24. headache
25. hoarseness or husky voice
26. increased sensitivity of the eyes to light
27. increased sweating, possibly with fever or cold, clammy skin
28. joint pain
29. loss of voice
30. muscle aches, cramps, pain, and stiffness
31. neck pain
32. nerve pain
33. nervousness
34. pain or tenderness around the eyes and cheekbones
35. pounding in the ears
36. red, swollen skin
37. red irritated eyes
38. red skin lesions, often with a purple center
39. slow or fast heartbeat
40. sneezing
41. sore throat
42. sores, ulcers, or white spots in the mouth or on the lips
43. stiff or sore neck
44. stuffy or runny nose
45. sweating
46. swollen joints
47. tender, swollen glands in neck
48. trouble breathing
49. trouble swallowing
50. trouble sleeping
51. unsteadiness or awkwardness
52. unusual tiredness or weakness
53. weakness in arms, hands, legs, or feet
54. weight gain or loss

Less common

1. General feeling of discomfort or illness
2. thickening of bronchial secretions

Rare

1. Anxiety
2. black, tarry stools
3. bleeding gums
4. bloating
5. blue or pale skin
6. burning feeling in the chest or stomach
7. change in vision
8. chest discomfort
9. confusion
10. dark urine
11. darkening of the skin
12. double vision
13. drooping eyelids
14. drowsiness
15. dry mouth
16. eye pain
17. fainting
18. flushed, dry skin
19. fruit-like breath odor
20. general feeling of illness
21. heavier menstrual periods
22. inability to move the arms and legs
23. increased hunger
24. increased thirst
25. increased urination
26. indigestion
27. irritability
28. loss of appetite
29. loss of consciousness
30. muscle aches or weakness
31. nausea or vomiting
32. nosebleeds
33. numbness or tingling in the fingers, face, or feet
34. pains in the stomach, side, or abdomen, possibly radiating to the back
35. pale skin
36. pinpoint red spots on the skin
37. seeing flashes or sparks of light
38. seeing floating spots before the eyes, or a veil or curtain appearing across part of vision
39. seizures
40. stomach pain, upset, or cramps
41. sudden numbness and weakness in the arms and legs
42. swollen, painful, or tender lymph glands in the neck, armpit, or groin
43. tearing
44. tenderness
45. unusual bleeding or bruising
46. watery or bloody diarrhea
47. 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

1. 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.

Portions of this document last updated: Feb. 01, 2024

Original article: https://www.mayoclinic.org/drugs-supplements/toripalimab-tpzi-intravenous-route/description/drg-20559739