Pronunciation:

tre-mel-IM-ue-mab - actl

Brand Names:

• Imjudo

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Antineoplastic Agent

Pharmacologic—

Tremelimumab

Uses of This Medicine:

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.

Before Using This Medicine:

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.

Children—

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.

Older adults—

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

Breast-feeding—

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.

Other medicines—

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 of This Medicine:

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 While Using This Medicine:

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 of This Medicine:

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

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 the hands, arms, feet, or legs

burning feeling 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. 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

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.