Pronunciation:

a-te-zoe-LIZ-ue-mab

Brand Names:

• Tecentriq

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Antineoplastic Agent

Pharmacologic—

Monoclonal Antibody

Uses of This Medicine:

Atezolizumab injection is used alone to help prevent non-small cell lung cancer (NSCLC) from coming back in patients whose tumor has been removed by surgery and who have received other cancer medicines (eg, platinum). It is given to patients who have stage 2 to stage 3A NSCLC and whose tumors express PD-L1. Your doctor will perform a test to check for the PD-L1 tumor before you receive this medicine.

Atezolizumab injection is also used alone as first-line treatment for metastatic (cancer that has already spread) non-small cell lung cancer (NSCLC) in patients whose tumors express high PD-L1 and do not have an abnormal EGFR or ALK gene. Your doctor will perform a test to check for the PD-L1 tumor before you receive this medicine. It is used together with other cancer medicines (eg, bevacizumab, paclitaxel, and carboplatin combination, or paclitaxel protein-bound and carboplatin combination) as first-line treatment to metastatic non-squamous non-small cell lung cancer in patients whose tumor does not have an abnormal EGFR or ALK gene. It is also used to treat metastatic non-small cell lung cancer with or without an EGFR or ALK gene in patients who have tried treatment for EGFR or ALK tumors and received cancer medicines containing platinum that did not work well.

Atezolizumab injection is also used together with carboplatin and etoposide as first-line treatment for extensive-stage (cancer that has spread) small cell lung cancer (ES-SCLC).

Atezolizumab injection is also used together with bevacizumab to treat a type of liver cancer called hepatocellular carcinoma (HCC) that has spread throughout the body (metastatic) or cannot be removed by surgery (unresectable) in patients who have not received other cancer medicines by mouth or injection.

Atezolizumab injection is also used together with cobimetinib and vemurafenib to treat melanoma (a type of skin cancer) that has spread or cannot be removed by surgery. It is used in patients whose skin cancer have the abnormal gene. Your doctor will perform a test to check for this gene before you receive this medicine.

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 atezolizumab 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 atezolizumab 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. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Dexlansoprazole
• Esomeprazole
• Lansoprazole
• Omeprazole
• Pantoprazole
• Rabeprazole

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:

• Diabetes or
• Immune system problems (eg, Crohn's disease, ulcerative colitis, lupus) or
• Infection or
• Liver problems or
• Lung or breathing problems or
• Nervous system problems (eg, Guillain-Barré syndrome, myasthenia gravis) or
• Organ transplant, recent or
• Pancreatitis (inflammation of the pancreas) or
• Thyroid problems—Use with caution. May make these conditions worse.

• Kidney disease, severe or
• Liver disease, severe—Use has not been studied in patients with these conditions.

• 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 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 30 to 60 minutes every 2, 3, or 4 weeks. Your doctor will decide how many treatments you will need.

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 female and able to get pregnant, your doctor may give you a pregnancy test before you start 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 5 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, interstitial lung disease).

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.

This medicine may affect blood sugar levels. Check with your doctor 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 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.

Tell your doctor right away if you have blurred vision, eye pain or redness, or other vision problems while you are receiving this medicine.

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.

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

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.

This medicine may cause kidney problems (eg, nephritis). Check with your doctor right away if you have bloody or cloudy urine, difficulty in breathing, drowsiness, headache, nausea or vomiting, 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), 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.

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

Talk with your doctor before receiving this medicine if you plan to have children. Some women who receive this medicine have become infertile (unable to have children).

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

Black, tarry stools

bladder pain

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

bloody or cloudy urine

blurred vision

body aches or pain

chest tightness

chills

constipation

cough

diarrhea

difficult, burning, or painful urination

difficulty in breathing

dizziness

ear congestion

fever

frequent urge to urinate

general feeling of tiredness and weakness

headache

hoarseness

loss of appetite

loss of voice

lower back or side pain

muscle aches

nausea

nervousness

nosebleed

pain

pale skin

pounding in the ears

rapid weight gain

slow or fast heartbeat

sneezing

sore throat

stomach cramps

stuffy or runny nose

tenderness

tingling of the hands or feet

ulcers, sores, or white spots in the mouth

unusual bleeding or bruising

unusual tiredness or weakness

unusual weight gain or loss

vomiting

watery or bloody diarrhea

Less common

Anxiety

burning, tingling, numbness or pain in the hands, arms, feet, or legs

chest pain

confusion

dark urine

decreased urine

depressed mood

difficulty with chewing, swallowing, or talking

double vision

drooping eyelids

drowsiness

dry skin and hair

facial swelling

feeling cold

general feeling of discomfort or illness

increased thirst

inability to move the arms and legs

irritability

light-colored stools

lightheadedness

muscle cramp, stiffness, or weakness

numbness in the hands, feet, or lips

rapid, shallow breathing

seizures

sensation of pins and needles

sensitivity to heat

skin rash

stabbing pain

stiff neck or back

sudden numbness and weakness in the arms and legs

sweating

swelling of the face, ankles, hands, or feet

thickening of bronchial secretions

trouble sleeping

upper right abdominal or stomach pain

yellow eyes and skin

Rare

Blistering, peeling, or loosening of the skin

darkening of the skin

fainting

hives, itching

indigestion

joint pain, stiffness, or swelling

muscle pain

pains in the stomach, side, or abdomen, possibly radiating to the back

red skin lesions, often with a purple center

red, irritated eyes

redness of the skin

swelling of the eyelids or lips

swollen glands

Incidence not known

Blue or pale skin

chest pain, possibly moving to the left arm, neck, or shoulder

flushed, dry skin

fruit-like breath odor

increased hunger

increased urination

trouble breathing

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

Back, neck, arm, or leg pain

difficulty in moving

loss of or change in taste

thinning of the hair or hair loss

unsteadiness or awkwardness

weakness in the arms, hands, legs, or feet

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.