Atezolizumab Injection

WHY is this medicine prescribed?

Atezolizumab injection is used alone or with other chemotherapy medications to treat certain types of non-small cell lung cancer (NSCLC) in adults. Atezolizumab injection is also used in combination with other chemotherapy medications to treat certain types of small cell lung cancer (SCLC), hepatocellular carcinoma (HCC), and melanoma (a type of skin cancer) in adults. Atezolizumab is also used alone to treat certain types of alveolar soft tissue sarcomas (cancer that forms in muscles, fat, or nerves) in adults and children 2 years of age or older. Atezolizumab injection is in a class of medications called monoclonal antibodies. It works by blocking the action of a certain protein in cancer cells. This helps the person's immune system to fight against the cancer cells, and helps to slow tumor growth.

Your doctor will review your specific type of cancer and past treatment history and other available treatments to determine if atezolizumab injection is right for you.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Atezolizumab injection comes as a solution (liquid) to be injected into a vein over 30 to 60 minutes by a doctor or nurse in a hospital or medical facility. It is usually injected once every 2, 3, or 4 weeks depending on your dose. The length of your treatment will be decided by your doctor and depends on the type of cancer being treated, how well your body responds to the medication, and the side effects that you experience.

Atezolizumab injection may cause serious reactions during the infusion of the medication. A doctor or nurse will monitor you carefully while you are receiving the medication. If you experience any of the following symptoms, tell your doctor immediately: flushing, fever, chills, shaking, dizziness, feeling faint, shortness of breath, wheezing, difficulty breathing, itching, rash, back or neck pain, or swelling of the face or lips.

Your doctor may need to slow down your infusion, delay or stop your treatment, or treat you with other medications if you experience certain side effects. Be sure to tell your doctor how you are feeling during your treatment with atezolizumab injection.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with atezolizumab injection and each time you receive the medication. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.

What SPECIAL PRECAUTIONS should I follow?

Before receiving atezolizumab injection,

• tell your doctor and pharmacist if you are allergic to atezolizumab, any other medications, or any of the ingredients in atezolizumab injection. Ask your pharmacist or check the Medication Guide for a list of the ingredients.

• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor if you have or have ever had an organ or bone marrow transplant or radiation therapy to your chest area; lung or breathing problems; any condition that affects your nervous system such as myasthenia gravis (a disorder of the nervous system that causes muscle weakness) or Guillain-Barré syndrome (weakness, tingling, and possible paralysis due to sudden nerve damage); an autoimmune disease (condition in which the immune system attacks a healthy part of the body) such as Crohn's disease (condition in which the immune system attacks the lining of the digestive tract causing pain, diarrhea, weight loss, and fever), ulcerative colitis (condition that causes swelling and sores in the lining of the colon [large intestine] and rectum) or lupus (condition in which the immune system attacks many tissues and organs including the skin, joints, blood, and kidneys); diabetes; thyroid problems;or kidney or liver disease. Also tell your doctor if you have or have ever had cytomegalovirus (CMV; a viral infection that may cause symptoms in patients with weak immune systems).

• tell your doctor if you are pregnant, or plan to become pregnant. You will have to take a pregnancy test before starting treatment. You should not become pregnant while you are receiving atezolizumab injection and for 5 months after your last dose. Talk to your doctor about birth control methods that you can use during your treatment. If you become pregnant while receiving atezolizumab injection, call your doctor immediately. Atezolizumab may harm the fetus.

• tell your doctor if you are breastfeeding. Your doctor will probably tell you not to breastfeed during your treatment and for 5 months after your last dose.

• you should know that this medication may decrease fertility in women. Talk to your doctor about the risks of receiving atezolizumab injection.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What SIDE EFFECTS can this medicine cause?

Atezolizumab injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• back, neck, or joint pain
• pale skin
• swelling of arms
• loss of appetite
• nausea
• vomiting
• constipation
• hair loss
• stuffy or runny nose

Some side effects can be serious. If you experience any of these symptoms call your doctor immediately or get emergency medical treatment:

• diarrhea, stomach pain, blood or mucus in the stool, or black tarry, sticky, stools
• ongoing pain that begins in the upper left or middle of the stomach but may spread to the back, fever, nausea, vomiting
• fever, sore throat, cough, chills, flu-like symptoms, frequent, urgent, difficult, or painful urination, or other signs of infection
• decreased urination, blood in urine, swelling in your ankles or feet, or loss of appetite
• new or worsening cough which may be bloody, shortness of breath, or chest pain
• yellowing of the skin or eyes, extreme tiredness, bleeding or bruising easily, nausea or vomiting, pain in the upper right part of the stomach, dark (tea-colored) urine, decreased appetite
• headaches that won't go away or unusual headaches; extreme tiredness; rapid heartbeat; constipation; increased sweating; feeling cold; deepening of voice; hair loss; feeling more hungry or thirsty than usual; dizziness or fainting; increased urination; weight loss or gain; vision changes; changes in mood or behavior such as decreased sex drive or feeling irritable, confused, or forgetful
• rash or itching, blistering or peeling skin
• sores in mouth, nose, throat, or genital area
• persistent muscle pain, cramping, or weakness; neck stiffness
• numbness or tingling in the arms or legs
• blurry or double vision, sensitivity to light, or other vision problems, eye pain or redness
• feeling more hungry or thirsty than usual, increased urination, extreme tiredness, weakness, breath that smells fruity
• chest pain, shortness of breath, fast or irregular heartbeat, swelling of ankles

Atezolizumab injection may cause other side effects. Call your doctor if you have any unusual problems while receiving this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests before and during your treatment with atezolizumab injection to check your body's response to the medication. For some conditions, your doctor will order a lab test before you begin your treatment to see whether your cancer can be treated with atezolizumab.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.