Tremelimumab-actl (Intravenous)

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

Tremelimumab-actl injection is also used 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 must be given only by your doctor or under their supervision.

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 ensure you are not pregnant. Use an effective form of birth control to prevent 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 (e.g., 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 (e.g., 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.

In deciding to use a medicine, you and your doctor must consider the risks of taking the medicine against the benefits it may provide. For this medicine, keep the following points in mind:

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 about any other allergies you have, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

There have not been suitable studies on the effects of tremelimumab-actl injection in children. Safety and effectiveness have not been proven.

Geriatric

Currently available studies have not shown any specific problems in older adults that would limit the use of tremelimumab-actl injection.

Breast Feeding

There are not enough studies in women to determine the risk to infants when using this medication while breastfeeding. Weigh the potential benefits against the possible risks before using this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together even if an interaction is possible. In such cases, your doctor may adjust 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 or around the time of eating food or specific types of food due to possible interactions. Using alcohol or tobacco with some medicines may also lead to interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may influence the use of this medicine. Be sure to inform your doctor if you have any other medical issues, particularly:

• Adrenal gland problems or
• Diabetes or
• Immune system problems (e.g., Crohn's disease, ulcerative colitis, lupus) or
• Kidney problems or
• Nervous system problems (e.g., Guillain-Barré syndrome, myasthenia gravis) or
• Thyroid problems—Use with caution. This may worsen these conditions.

Along with its needed effects, a medicine may cause some unwanted effects. Not all of these side effects may occur, but if they do, they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

• Bleeding gums
• body aches or pain
• bone pain
• chest pain or tightness
• chills
• constipation
• coughing up blood
• depressed mood
• difficulty swallowing
• dry skin and hair
• diarrhea
• dizziness
• ear congestion
• feeling cold
• hoarseness or husky voice
• headache
• increased menstrual flow or vaginal bleeding
• loss of voice
• muscle cramps, spasms, pain, stiffness, tenderness, or weakness
• nervousness
• nosebleeds
• paralysis
• prolonged bleeding from cuts
• red or dark brown urine
• red or black, tarry stools
• sensitivity to heat
• sleeplessness
• slow heartbeat
• sneezing
• sore throat
• stomach cramps, tenderness, or pain
• stuffy or runny nose
• swollen glands in the neck
• trouble breathing
• trouble sleeping
• unusual tiredness or weakness
• weight gain or loss

Less common

• Agitation
• bloating
• blood in the urine or stools
• bloody or cloudy urine
• coma
• confusion
• darkened urine
• darkening of the skin
• decreased urine output
• drowsiness
• hostility
• irritability
• lethargy
• lightheadedness
• muscle twitching
• fainting
• fast heartbeat
• fever
• general feeling of discomfort or illness
• indigestion
• loss of appetite
• mental depression
• nausea
• pains in the stomach, side, or abdomen, possibly radiating to the back
• pale skin
• pinpoint red spots on the skin
• rapid, shallow breathing
• rapid weight gain
• seizures
• skin rash
• stupor
• sweating
• swelling of the face, ankles, or hands
• swelling of the face, feet, or lower legs
• thickening of bronchial secretions
• unusual bleeding or bruising
• vomiting
• yellow eyes or skin

Rare

• Light-colored stools
• sudden severe weakness
• upper right abdominal or stomach pain

Incidence not known

• Anxiety
• back, leg, or stomach pain
• blistering, peeling, or loosening of the skin
• blue or pale skin
• blurred vision or other change in vision
• burning, tingling, numbness, or pain in the hands, arms, feet, or legs
• burning feeling in the chest or stomach
• chest discomfort
• difficulty in chewing or talking
• difficulty in moving
• double vision
• drooping eyelids
• eye pain, tearing
• facial swelling
• inability to move the arms and legs
• joint pain
• numbness or tingling in the fingers, face, or feet
• pain, swelling, or redness in the joints
• painful or difficult urination
• red irritated eyes
• red skin lesions, often with a purple center
• redness, soreness, or itching skin
• redness of the eye
• seeing flashes or sparks of light
• seeing floating spots before the eyes
• sensation of pins and needles
• sensitivity of the eye to light
• severe headache
• sores, ulcers, or white spots on the lips or in the mouth
• stabbing pain
• stiff neck or back
• stomach upset or discomfort
• sudden numbness and weakness in the arms and legs
• swollen, painful, or tender lymph glands in the neck, armpit, or groin
• swollen or painful glands
• 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. Your health care professional may also know 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

• Lack or loss of strength
• 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.

In the U.S.

• Imjudo

Available Dosage Forms:

• Solution

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Tremelimumab

Find detailed information on biosimilars for this medication.

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.