Atezolizumab

Name: Atezolizumab

Uses of Atezolizumab

Atezolizumab is a prescription medication used to treat urothelial carcinoma, a type of bladder and urinary tract cancer. This medication may be given to those:

  • whose cancer has spread or cannot be removed by surgery (advanced urothelial carcinoma), and
  • who are not able to take chemotherapy that contains a medicine called cisplatin, or
  • who have tried chemotherapy that contains platinum, and it did not work or is no longer working

Atezolizumab may be given to those who cannot receive chemotherapy that contains platinum as well as for those whose cancer has spread after chemotherapy that contains platinum as well as those whose cancer has spread within 12 months of receiving chemotherapy before surgery or after surgery.

Atezolizumab is also approved to treat non-small cell lung cancer (NSCLC) that has spread to other parts of the body and has progressed during or after receiving chemotherapy containing platinum. For those with a tumor that has an abnormal EGFR or ALK gene, atezolizumab can be given if an FDA-approved therapy for tumors with these abnormal genes has been tried and it did not work or is no longer working

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

What is atezolizumab?

Atezolizumab is a monoclonal antibody that affects the actions of the body's immune system. Atezolizumab strengthens your immune system to help your body fight against tumor cells.

Atezolizumab is used to treat a certain type of bladder cancer that has spread to other parts of the body or cannot be removed by surgery.

Atezolizumab is also used to treat non-small cell lung cancer that has spread to other parts of the body.

Atezolizumab is usually given after other cancer medicines have been tried without success.

Atezolizumab may also be used for purposes not listed in this medication guide.

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your atezolizumab injection.

Atezolizumab side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some side effects may occur during the injection. Tell your caregiver right away if you feel dizzy, light-headed, chilled or feverish, itchy, or have neck pain, back pain, trouble breathing, or swelling in your face.

Call your doctor at once if you have:

  • new or worsening cough, chest pain, feeling short of breath;

  • diarrhea, bloody or tarry stools;

  • nausea or vomiting;

  • severe stomach pain (especially in your upper stomach or spreading to your back);

  • a light-headed feeling, like you might pass out;

  • blurred vision, double vision, eye pain or redness;

  • signs of infection--fever, flu symptoms, cough, painful or frequent urination;

  • liver problems--loss of appetite, drowsiness, easy bruising or bleeding, dark urine, jaundice (yellowing of the skin or eyes);

  • nervous system problems--neck stiffness, increased sensitivity to light, confusion, severe muscle weakness, numbness or tingling in your hands or feet; or

  • signs of a hormonal disorder--frequent or unusual headaches, feeling light-headed or very tired, mood or behavior changes, hoarse or deepened voice, increased hunger or thirst, increased urination, nausea, vomiting, constipation, hair loss, feeling cold, weight gain, or weight loss.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common side effects may include:

  • nausea, loss of appetite;

  • constipation;

  • tiredness; or

  • urination problems.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of lung or breathing problems like shortness of breath or other trouble breathing, cough, or fever.
  • Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
  • Signs of thyroid, pituitary, or adrenal gland problems. Some signs may be change in mood or the way you act, change in weight, constipation, deeper voice, dizziness, fainting, feeling cold, feeling very tired, hair loss, headache that lasts or is very bad, or lowered interest in sex.
  • Signs of a pancreas problem (pancreatitis) like very bad stomach pain, very bad back pain, or very bad upset stomach or throwing up.
  • Signs of nervous system problems like change in mood or actions, feeling confused, fever, numbness or tingling in the hands or feet, stiff neck, bright lights bother your eyes, or very bad muscle weakness.
  • Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
  • Signs of low sodium levels like headache, trouble focusing, memory problems, feeling confused, weakness, seizures, or change in balance.
  • Swelling in the arms or legs.
  • Blood in the urine.
  • Feeling very tired or weak.
  • Chest pain.
  • Any unexplained bruising or bleeding.
  • Change in eyesight, eye pain, or very bad eye irritation.

Consumer Information Use and Disclaimer

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else's drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Check with your pharmacist about how to throw out unused drugs.
  • This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time this medicine is refilled. If you have any questions about atezolizumab, please talk with the doctor, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about atezolizumab. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using atezolizumab.

Review Date: October 4, 2017

Pronunciation

(a te zoe LIZ ue mab)

Reconstitution

Withdraw 1,200 mg (20 mL) from vial and dilute into 250 mL of NS in a polyvinyl chloride (PVC), polyethylene (PE), or polyolefin (PO) infusion bag. Dilute only with NS. Mix by gently inverting; do not shake.

Storage

Store intact vials at 2°C to 8°C (36°F to 46°F). Do not freeze. Do not shake. Store in original carton to protect from light. Solutions diluted in NS for infusion should be used immediately after preparation; if not used immediately, may be stored for up to 6 hours (including administration time) at room temperature or 24 hours refrigerated at 2°C to 8°C (36°F to 46°F). Do not freeze.

Dose Adjustments

No adjustment recommended

Precautions

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Atezolizumab Breastfeeding Warnings

Because this drug is a large protein molecule with a molecular weight of 145,000, the amount in breastmilk is likely to be very low and absorption is unlikely as it is probably destroyed in the infant GI tract.

Use should be avoided. Excreted into human milk: Unknown Excreted into animal milk: Data not available Comments: -The effects in the nursing infant are unknown. -Lactating women should not breastfeed during treatment and for at least 5 months after the last dose.

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