Description and Brand Names

Drug information provided by: Merative, Micromedex®

US Brand Name

1. Imjudo

Descriptions

Tremelimumab-actl injection is used in combination with durvalumab to treat liver cancer that cannot be removed by surgery (unresectable hepatocellular carcinoma or uHCC).

Tremelimumab-actl injection is also used in combination with durvalumab to treat non-small cell lung cancer (NSCLC) that has spread to other parts of the body in patients whose tumors do not have an abnormal EGFR or ALK gene.

This medicine is to be given only by or under the 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 tremelimumab-actl 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 tremelimumab-actl 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:

• Adrenal gland problems or
• Diabetes or
• Immune system problems (eg, Crohn's disease, ulcerative colitis, lupus) or
• Kidney problems or
• Nervous system problems (eg, Guillain-Barré syndrome, myasthenia gravis) or
• Thyroid problems—Use with caution. May make these conditions worse.

Proper Use

Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.

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

This medicine should come 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 or forget to use your medicine, call your doctor or pharmacist 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 do tests before receiving 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 at least 3 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 (eg, pneumonitis).

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, a loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Colitis (inflammation of the bowels) may occur with this medicine. Tell your doctor right away if you have stomach pain or tenderness, watery or bloody diarrhea, or fever after receiving the medicine.

Adrenal, pituitary, or thyroid gland problems may occur while you are receiving this medicine. Tell your doctor if you have changes in mood or behavior, constipation, dry skin or hair, feeling cold, sensitivity to heat, sweating, trouble sleeping, or weight changes.

Check with your doctor right away if you have bloody urine, a decrease in frequency or amount of urine, an increase in blood pressure, increased thirst, loss of appetite, lower back or side pain, nausea, swelling of the face, fingers, or lower legs, trouble breathing, unusual tiredness or weakness, vomiting, or weight gain. These could be symptoms of a serious kidney problem.

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

Check with 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 (myocardium) 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 with breathing, swallowing, or talking, muscle weakness, severe tiredness, or sudden numbness and weakness in the arms or legs. These could be symptoms of a nervous system problem.

Pancreatitis (swelling of the pancreas) may occur while you are receiving this medicine. Tell your doctor right away if you have sudden and severe stomach pain, chills, constipation, nausea, vomiting, fever, or lightheadedness.

This medicine may cause a rare but serious type of allergic reaction called an infusion reaction, which can be life-threatening and requires immediate medical attention. Tell your doctor right away if you start to have a skin rash, dizziness, trouble breathing, chest tightness, swelling in your face or hands, fever, or chills while you are receiving this medicine.

Serious skin reactions (eg, exfoliative dermatitis, Stevens-Johnson syndrome, drug rash with eosinophilia and systemic syndrome (DRESS), or 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 a skin rash, sore throat, sores or ulcers on the skin, mouth, or lips, swollen glands, unusual bleeding or bruising, or unusual tiredness or weakness after receiving this medicine.

Call your doctor right away if you have fever, joint pain, muscle tenderness, weakness, pain, or cramps, skin rash, unusual tiredness or weakness, or weight loss. These could be symptoms of a muscle problem.

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 gums
2. body aches or pain
3. bone pain
4. chest pain or tightness
5. chills
6. constipation
7. coughing up blood
8. depressed mood
9. difficulty swallowing
10. dry skin and hair
11. diarrhea
12. dizziness
13. ear congestion
14. feeling cold
15. hoarseness or husky voice
16. headache
17. increased menstrual flow or vaginal bleeding
18. loss of voice
19. muscle cramps, spasms, pain, stiffness, tenderness, or weakness
20. nervousness
21. nosebleeds
22. paralysis
23. prolonged bleeding from cuts
24. red or dark brown urine
25. red or black, tarry stools
26. sensitivity to heat
27. sleeplessness
28. slow heartbeat
29. sneezing
30. sore throat
31. stomach cramps, tenderness, or pain
32. stuffy or runny nose
33. swollen glands in the neck
34. trouble breathing
35. trouble sleeping
36. unusual tiredness or weakness
37. weight gain or loss

Less common

1. Agitation
2. bloating
3. blood in the urine or stools
4. bloody or cloudy urine
5. coma
6. confusion
7. darkened urine
8. darkening of the skin
9. decreased urine output
10. drowsiness
11. hostility
12. irritability
13. lethargy
14. lightheadedness
15. muscle twitching
16. fainting
17. fast heartbeat
18. fever
19. general feeling of discomfort or illness
20. indigestion
21. loss of appetite
22. mental depression
23. nausea
24. pains in the stomach, side, or abdomen, possibly radiating to the back
25. pale skin
26. pinpoint red spots on the skin
27. rapid, shallow breathing
28. rapid weight gain
29. seizures
30. skin rash
31. stupor
32. sweating
33. swelling of the face, ankles, or hands
34. swelling of the face, feet, or lower legs
35. thickening of bronchial secretions
36. unusual bleeding or bruising
37. vomiting
38. yellow eyes or skin

Rare

1. Light-colored stools
2. sudden severe weakness
3. upper right abdominal or stomach pain

Incidence not known

1. Anxiety
2. back, leg, or stomach pain
3. blistering, peeling, or loosening of the skin
4. blue or pale skin
5. blurred vision or other change in vision
6. burning, tingling, numbness, or pain the hands, arms, feet, or legs
7. burning feeling the chest or stomach
8. chest discomfort
9. difficulty in chewing or talking
10. difficulty in moving
11. double vision
12. drooping eyelids
13. eye pain, tearing
14. facial swelling
15. inability to move the arms and legs
16. joint pain
17. numbness or tingling in the fingers, face, or feet
18. pain, swelling, or redness in the joints
19. painful or difficult urination
20. red irritated eyes
21. red skin lesions, often with a purple center
22. redness, soreness, or itching skin
23. redness of the eye
24. seeing flashes or sparks of light
25. seeing floating spots before the eyes
26. sensation of pins and needles
27. sensitivity of the eye to light
28. severe headache
29. sores, ulcers, or white spots on the lips or in the mouth
30. stabbing pain
31. stiff neck or back
32. stomach upset or discomfort
33. sudden numbness and weakness in the arms and legs
34. swollen, painful, or tender lymph glands in the neck, armpit, or groin
35. swollen or painful glands
36. veil or curtain appearing across part of vision

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. Lack or loss of strength
2. loss or thinning of the hair

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/tremelimumab-actl-intravenous-route/side-effects/drg-20541333