Pronunciation:

dur-VAL-ue-mab

Brand Names:

• Imfinzi

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Antineoplastic Agent

Pharmacologic—

Monoclonal Antibody

Uses of This Medicine:

Durvalumab injection is used to treat non-small cell lung cancer (NSCLC) that has not spread and cannot be removed by surgery in patients who have received other cancer medicines (eg, platinum) and radiation treatment for their NSCLC. This medicine is also used in combination with etoposide and either carboplatin or cisplatin as first-line treatment for extensive-stage small cell lung cancer (ES-SCLC). It is also used in combination with tremelimumab-actl 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.

Durvalumab injection is also used in combination with other cancer medicines (eg, gemcitabine, cisplatin) to treat biliary tract cancer (BTC) that has spread to nearby tissues or to other parts of the body.

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

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 durvalumab 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 durvalumab 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 or
• Infection or
• Kidney problems or
• Liver problems or
• Lung or breathing problems or
• Thyroid problems—Use with caution. May make these conditions worse.

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

Proper Use of This Medicine:

Medicines used to treat cancer are very strong and can have many side effects. Before using 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. 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 every 2, 3, or 4 weeks.

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

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 to make sure you are not pregnant before receiving this medicine. 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 colon) 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.

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.

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 with this medicine.

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

Call your doctor right away if you start to have a cough that won't go away, weight loss, night sweats, fever, chills, painful or difficult urination, or flu-like symptoms, such as a runny or stuffy nose, headache, blurred vision, or feeling generally ill. These may be signs that you have an infection.

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.

This medicine may cause thrombocytopenic purpura. Check with your doctor right away if you have black, tarry stools, blood in the urine, bloody nose, fever, heavier menstrual periods, pinpoint red spots on the skin, skin rash, unusual bleeding or bruising or unusual tiredness or weakness.

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.

This medicine may cause a rare but serious type of an allergic reaction called an infusion reaction. This 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.

This medicine may increase your risk for possible organ transplant rejection. Talk to your doctor about this risk.

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

Bladder pain

bloating or swelling of the face, arms, hands, lower legs, or feet

bloody or cloudy urine

body aches or pain

chest pain or tightness

chills

cough

depressed mood

difficult, burning, or painful urination

difficulty having a bowel movement

dry skin and hair

ear congestion

feeling cold

fever

frequent urge to urinate

general feeling of discomfort or illness

headache

hoarseness, husky, or loss of voice

lower back or side pain

muscle cramps and stiffness

nervousness

runny or stuffy nose

sensitivity to heat

slowed heartbeat

sneezing

sore throat

stomach cramps

sweating

tenderness

thickening of bronchial secretions

tingling of the hands or feet

trouble breathing

trouble sleeping

unusual tiredness or weakness

unusual weight gain or loss

watery or bloody diarrhea

Less common

Back, leg, or stomach pains

black, tarry stools

bleeding gums

bloody nose

blurred vision or other changes in vision

dark urine

eye redness, irritation, or pain

general body swelling

heavier menstrual periods

light-colored stools

loss of appetite

nausea

nosebleeds

pale skin

pinpoint red spots on the skin

sensitivity of the eye to light

skin rash

stiff neck or back

tearing

unusual bleeding or bruising

upper right abdominal or stomach pain

vomiting

yellow eyes and skin

Rare

Blistering, peeling, or loosening of the skin

dizziness

drowsiness

fainting

joint or muscle pain

red skin lesions, often with a purple center

sores, ulcers, or white spots in the mouth or on the lips

swollen glands

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

Constipation

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.