Description and Brand Names

Drug information provided by: Merative, Micromedex®

US Brand Name

1. Tevimbra

Descriptions

Tislelizumab-jsgr injection is used to treat esophageal cancer that has spread or cannot be removed by surgery. It is given to patients who have received cancer medicines that did not contain a PD-L1 inhibitor.

Tislelizumab-jsgr 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.

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 tislelizumab-jsgr 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 tislelizumab-jsgr 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 disease, ulcerative colitis, lupus) or
• Nephritis (inflammation of the kidneys) or
• Nervous system problems (eg, myasthenia gravis, Guillain-Barré syndrome) 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) or tissue transplant (eg, cornea transplant), recent—Use with caution. May increase risk for organ or tissue 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 an IV catheter placed into one of your veins. It must be given slowly, so the IV will have to remain in place for at least 30 to 60 minutes. The infusion will be given once every 3 weeks.

This medicine comes with a Medication Guide. Read and follow these instructions carefully. Ask your doctor 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 bear children, 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 this 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 syndrome (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, 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.

Tell your doctor right away if you have a headache, confusion, seizures, stiff neck, or vomiting while receiving this medicine. These may be symptoms of encephalitis.

Tell your doctor right away if you have a severe headache, drowsiness, confusion, general feeling of illness, or stiff neck or back while receiving this medicine. These may be symptoms of meningitis.

This medicine may cause inflammation of the heart muscle called myocarditis. Check with your doctor right away if you have chest pain or discomfort, fever, chills, a fast heartbeat, or trouble breathing.

Call your doctor right away if you have difficulty swallowing or talking, or if you have muscle weakness, severe tiredness, or sudden numbness and weakness in the arms or legs. These could be symptoms of a nervous system problem.

Tell your doctor right away if you have blurred vision, eye pain or redness, or other vision problems while you are 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. Bleeding from rectum or bloody stools
2. bleeding gums
3. chest pain or tightness
4. constipation
5. cough
6. coughing up blood
7. depressed mood
8. dizziness
9. dry skin and hair
10. feeling cold
11. fever or chills
12. hair loss
13. headache
14. hoarseness or husky voice
15. increased menstrual flow or vaginal bleeding
16. muscle cramps and stiffness
17. nosebleeds
18. pale skin
19. paralysis
20. prolonged bleeding form cuts
21. red or dark brown urine
22. red or black, tarry stools
23. slowed heartbeat
24. sneezing
25. sore throat
26. trouble breathing
27. unusual bleeding or bruising
28. unusual tiredness or weakness
29. vomiting of blood or material that looks like coffee grounds
30. weight gain

Less common

1. Dark urine
2. light-colored stools
3. nausea and vomiting
4. upper right abdominal or stomach pain
5. yellow eyes or skin

Rare

1. Back or leg pain
2. bloating
3. blurred vision or other change in vision
4. burning, tingling, numbness or pain in the hands, arms, feet, or legs
5. chest discomfort
6. confusion
7. darkening of the skin
8. difficulty in chewing, swallowing, or talking
9. difficulty in moving
10. double vision
11. drooping eyelids
12. drowsiness
13. eye pain
14. fainting
15. fast heartbeat
16. general body swelling
17. heavier menstrual periods
18. inability to move the arms and legs
19. irritability
20. loss of appetite
21. mental depression
22. muscle aches or weakness
23. nervousness
24. numbness or tingling in the fingers, face, or feet
25. pain, swelling, or redness in the joints
26. pains in stomach, side, or abdomen, possibly radiating to the back
27. pinpoint red spots on the skin
28. redness, soreness, or itching skin
29. redness of the eye
30. seeing flashes or sparks of light
31. seeing floating spots before the eyes, or a veil or curtain appearing across part of vision
32. seizures
33. sensation of pins and needles
34. sensitivity of the eye to light
35. sensitivity to heat
36. skin rash
37. stabbing pain
38. stiff neck or back
39. stomach cramps or pain
40. sudden numbness and weakness in the arms and legs
41. sweating
42. swollen, painful, or tender lymph glands in neck, armpit, or groin
43. tearing
44. tenderness
45. trouble sleeping
46. watery or bloody diarrhea
47. weight loss

Incidence not known

1. Blistering, peeling, or loosening of the skin
2. dry mouth
3. flushed, dry skin
4. flushing
5. fruit-like breath odor
6. increased hunger
7. increased thirst
8. increased urination
9. loss of consciousness
10. painful or difficult urination
11. red irritated eyes
12. red skin lesions, often with a purple center
13. sores, ulcers, or white spots in the mouth or on the lips
14. swollen glands
15. unexplained weight loss

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. Arm or leg pain
2. neck pain

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: July 01, 2024

Original article: https://www.mayoclinic.org/drugs-supplements/tislelizumab-jsgr-intravenous-route/proper-use/drg-20565521