Atezolizumab and hyaluronidase-tqjs Injection

WHY is this medicine prescribed?

Atezolizumab and hyaluronidase-tqjs injection is used alone or with other chemotherapy medications to treat certain types of non-small cell lung cancer (NSCLC). Atezolizumab and hyaluronidase-tqjs injection is also used in combination with other chemotherapy medications to treat certain types of small cell lung cancer (SCLC), hepatocellular carcinoma (HCC; a type of liver cancer), and melanoma (a type of skin cancer). Atezolizumab is also used alone to treat certain types of alveolar soft tissue sarcomas (cancer that forms in muscles, fat, or nerves). Atezolizumab 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. Hyaluronidase-tqus is an endoglycosidase. It helps to keep atezolizumab in the body longer so that the medication will have a greater effect.

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 and hyaluronidase-tqjs injection comes as a solution (liquid) to be injected under the skin in the thigh over approximately 7 minutes. Atezolizumab and hyaluronidase-tqjs injection is given by a doctor or nurse in a hospital or medical facility. It is usually injected once every 3 weeks. The length of your treatment will be decided by your doctor and depends on how well your body responds to the medication, and the side effects that you experience.

Atezolizumab and hyaluronidase-tqjs injection may cause serious reactions while you receive 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, or back or neck pain.

Your doctor may temporarily or permanently stop your treatment. This depends on how well the medication works for you and the side effects you experience. Be sure to tell your doctor how you are feeling during your treatment with atezolizumab and hyaluronidase-tqjs injection.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with atezolizumab and hyaluronidase-tqjs 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 (https://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 and hyaluronidase-tqjs injection,

• tell your doctor and pharmacist if you are allergic to atezolizumab, hyaluronidase, any other medications, or any of the ingredients in atezolizumab and hyaluronidase-tqjs 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.

• 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 and hyaluronidase-tqjs 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 and hyaluronidase-tqjs injection, call your doctor immediately. Atezolizumab and hyaluronidase-tqjs may harm the fetus.

• tell your doctor if you are breastfeeding or plan to breastfeed. 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 and hyaluronidase-tqjs injection.

What SPECIAL DIETARY instructions should I follow?

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

What should I do IF I FORGET to take a dose?

If you miss an appointment to receive atezolizumab and hyaluronidase-tqjs injection, call your doctor as soon as possible.

What SIDE EFFECTS can this medicine cause?

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

• tiredness or weakness
• muscle, joint, or bone pain
• decreased appetite
• nausea
• vomiting
• constipation
• dizziness

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

• new or worsening cough which may be bloody, shortness of breath, or chest pain
• diarrhea; stools that are black, tarry, sticky, or have blood or mucus; or stomach pain or tenderness
• yellowing of the skin or eyes, extreme tiredness, nausea or vomiting, pain in the upper right part of the stomach, dark (tea-colored) urine, decreased appetite
• unusual bruising or bleeding
• headaches that won't go away or unusual headaches; extreme tiredness; fast heartbeat; 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
• decreased urination, blood in urine, swelling in your ankles or feet, or loss of appetite
• rash; itching, blistering or peeling skin; swollen glands; or painful sores in mouth, nose, throat, or genital area
• chest pain, shortness of breath, fast or irregular heartbeat, or swelling of ankles
• persistent muscle pain, cramping, or weakness
• blurry or double vision, sensitivity to light, eye pain, or or other vision problems
• confusion, sleepiness, memory problems, changes in mood or behavior, stiff neck, balance problems, or tingling or numbness of arms or legs

Atezolizumab and hyaluronidase-tqjs injection may cause other side effects. Call your doctor if you have any unusual problems while taking 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 (https://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 and hyaluronidase-tqjs injection to check your body's response to the medication.

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.