atezolizumab (Tecentriq)

Tecentriq is a prescription medicine used to treat adults with:

• a type of bladder and urinary tract cancer called urothelial carcinoma. Tecentriq may be used when your bladder cancer has spread or cannot be removed by surgery, and if you have any one of the following conditions:
  • you are not able to take chemotherapy that contains a medicine called cisplatin, and your cancer tests positive for “PD-L1”, or
  • you are not able to take chemotherapy that contains any platinum regardless of “PD-L1” status, or
  • you have tried chemotherapy that contains platinum, and it did not work or is no longer working.
• a type of lung cancer called non-small cell lung cancer (NSCLC).
  • Tecentriq may be used with bevacizumab and the chemotherapy medicines carboplatin and paclitaxel as your first treatment when your lung cancer:
    • has spread or grown, and
    • is a type of lung cancer called “non-squamous NSCLC
    • your tumor does not have an abnormal “EGFR” or “ALK” gene
• Tecentriq may be used alone when your lung cancer:
  • has spread or grown, and
  • you have tried chemotherapy that contains platinum, and it did not work or is no longer working.
  • if your tumor has an abnormal “EGFR” or “ALK” gene, you should have also tried an FDA-approved therapy for tumors with these abnormal genes, and it did not work or is no longer working.
• a type of breast cancer called triple-negative breast cancer (TNBC). Tecentriq may be used with the medicine paclitaxel protein-bound when your breast cancer:
  • has spread or cannot be removed by surgery, and
  • your cancer tests positive for “PD-L1”.
• a type of lung cancer called small cell lung cancer (SCLC). Tecentriq may be used with the chemotherapy medicines carboplatin and etoposide as your first treatment when your lung cancer is a type called “extensive-stage SCLC,” which means that it has spread or grown.

It is not known if Tecentriq is safe and effective in children.

WARNING

Immune-Mediated Pneumonitis: Withhold or permanently discontinue based on severity of pneumonitis.

• Immune-Mediated Hepatitis: Monitor for changes in liver function. Withhold or permanently discontinue based on severity of transaminase or total bilirubin elevation.
• Immune-Mediated Colitis: Withhold or permanently discontinue based on severity of colitis.
• Immune-Mediated Endocrinopathies:
  • Hypophysitis: Withhold based on severity of hypophysitis.
  • Thyroid Disorders: Monitor for changes in thyroid function. Withhold based on severity of hyperthyroidism.
  • Adrenal Insufficiency: Withhold based on severity of adrenal insufficiency.
  • Type 1 Diabetes Mellitus: Withhold based on severity of hyperglycemia.
  • Infections: Withhold for severe or life-threatening infection.
• Infusion-Related Reactions: Interrupt, slow the rate of infusion, or permanently discontinue based on severity of infusion reactions.
• Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and use of effective contraception.

Tecentriq can cause serious side effects, including:

• feeling tired or weak
• nausea
• cough
• shortness of breath
• decreased appetite

The most common side effects of Tecentriq when used in lung cancer with other anti-cancer medicines include:

• feeling tired or weak
• nausea
• hair loss
• constipation
• diarrhea
• decreased appetite

The most common side effects of Tecentriq when used in triple-negative breast cancer with paclitaxel protein-bound include:

• hair loss
• tingling or numbness in hands or feet
• feeling tired
• nausea
• diarrhea
• low red blood cells (anemia)
• constipation
• cough
• headache
• low white blood cells
• vomiting
• decreased appetite

Tecentriq may cause fertility problems in females, which may affect the ability to have children. Talk to your healthcare provider if you have concerns about fertility.

These are not all the possible side effects of Tecentriq. Ask your healthcare provider or pharmacist for more information. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Administer Tecentriq as an intravenous infusion over 60 minutes. If the first infusion is tolerated, all subsequent infusions may be delivered over 30 minutes.

Your healthcare provider will give you Tecentriq into your vein through an intravenous (IV) line over 30 to 60 minutes.

• Tecentriq is usually given every 2, 3, or 4 weeks.
• Your healthcare provider will decide how many treatments you need.
• Your healthcare provider will test your blood to check you for certain side effects.
• If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment.

Urothelial Carcinoma

• Administer Tecentriq as:
  • 840 mg every 2 weeks, 1200 mg every 3 weeks, or 1680 mg every 4 weeks

NSCLC

• Administer Tecentriq as a single agent as:
  • 840 mg every 2 weeks, 1200 mg every 3 weeks, or 1680 mg every 4 weeks
• When administering in combination with bevacizumab and paclitaxel and carboplatin, administer Tecentriq 1200 mg every 3 weeks prior to chemotherapy or other antineoplastic drugs.
• Following completion of 4-6 cycles of paclitaxel and carboplatin, and if bevacizumab is discontinued, administer Tecentriq as:
  • 840 mg every 2 weeks, 1200 mg every 3 weeks, or 1680 mg every 4 weeks

Metastatic Treatment of TNBC

Administer Tecentriq 840 mg, followed by 100 mg/m2 paclitaxel proteinbound. For each 28-day cycle, Tecentriq is administered on days 1 and 15, and paclitaxel protein-bound is administered on days 1, 8, and 15.

Small Cell Lung Cancer

• When administering with carboplatin and etoposide, administer Tecentriq 1200 mg every 3 weeks prior to chemotherapy.
• Following completion of 4 cycles of carboplatin and etoposide, administer Tecentriq as:
  • 840 mg every 2 weeks, 1200 mg every 3 weeks, or 1680 mg every 4 weeks

Tecentriq can harm your unborn baby. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with Tecentriq.

Females who are able to become pregnant:

• Your healthcare provider should do a pregnancy test before you start treatment with Tecentriq.
• You should use an effective method of birth control during your treatment and for at least 5 months after the last dose of Tecentriq.
• It is not known if Tecentriq passes into your breast milk. Do not breastfeed during treatment and for at least 5 months after the last dose of Tecentriq.