Tecentriq

/ Roche

The recommended dose is 1200 mg administered as an intravenous infusion over 60 minutes every 3 weeks until disease progression or unacceptable toxicity. If the first infusion is tolerated, all subsequent infusions may be delivered over 30 minutes.
Dose modification according to adverse drug reactions: No dose reductions of atezolizumab are recommended.
Pneumonitis Grade 2: Withhold dose until Grade 1 or resolved and corticosteroid dose is less than or equal to prednisone 10 mg per day (or
equivalent).
Pneumonitis Grade 3 or 4: Permanently discontinue.
AST or ALT more than 3 and up to 8 times the upper limit of normal or total bilirubin more than 1.5 and up to 3 times the upper limit of normal: Withhold dose until Grade 1 or resolved and corticosteroid dose is less than or equal to
prednisone 10 mg per day (or equivalent).
AST or ALT more than8 times the upper limit of normal or total bilirubin more than 3 times the upper limit of normal: Permanently discontinue.
Colitis or diarrhea Grade 2 or 3: Withhold dose until Grade 1 or resolved and corticosteroid dose is less than or equal to prednisone 10 mg per day (or equivalent).
Colitis or diarrhea Grade 4: Permanently discontinue.
Endocrinopathies (including but not limited to hypophysitis, adrenal insufficiency, hyperthyroidism, and type 1 diabetes mellitus) Grade 2, 3, or 4: Withhold dose until Grade 1 or resolved and clinically stable on hormone replacement therapy.
Other immune-mediated adverse reactions involving a major organ Grade 3: Withhold dose until Grade 1 or resolved and corticosteroid dose is less than or equal to prednisone 10 mg per day (or equivalent).
Other immune-mediated adverse reactions involving a major organ Grade 4: Permanently discontinue.
Infections Grade 3 or 4: Withhold dose until Grade 1 or resolved.
Infections Grade 1 or 2: Interrupt or slow the rate of infusion.
Infusion-Related Reactions Grade 3 or 4: Permanently discontinue
Grade 2 or 3 adverse reaction (excluding endocrinopathies) that does not
recover to Grade 0 or 1 within 12 weeks after last TECENTRIQ dose: Permanently discontinue.
Inability to reduce to less than or equal to prednisone 10 mg per day (or equivalent) within 12 weeks after last TECENTRIQ dose: Permanently discontinue.
Recurrent Grade 3 or 4 (severe or lifethreatening) adverse reaction: Permanently discontinue.
Administration: Administer the initial infusion over 60 minutes through an intravenous line with or without a sterile, non-pyrogenic, low-protein binding in-line filter (pore size of 0.2–0.22 micron). If the first infusion is tolerated, all subsequent infusions may be delivered over 30 minutes.
Do not co-administer other drugs through the same intravenous line.
Do not administer as an intravenous push or bolus.

Locally Advanced or Metastatic Urothelial Carcinoma: Treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible  for cisplatin-containing chemotherapy.
Treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following any platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant chemotherapy. Metastatic Non-Small Cell Lung Cancer: Treatment of patients with metastatic non-small cell lung cancer (NSCLC) who are naïve to anti-PD-L1 or anti-PD-1 therapies and have disease progression during or following platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on approved therapy for these aberrations prior to receiving atezolizumab.

Hypersensitivity to the active substance or to any of the excipients.

Immune-Mediated Pneumonitis: TECENTRIQ can cause immune-mediated pneumonitis or interstitial lung disease, defined as requiring use of corticosteroids, including fatal cases. Monitor patients for signs and symptoms of pneumonitis. Evaluate patients with suspected pneumonitis with radiographic imaging.
Administer corticosteroids, prednisone 1–2 mg/kg/day or equivalents, followed by a taper for Grade 2 or higher pneumonitis. Withhold or permanently discontinue TECENTRIQ based on the severity.
Immune-Mediated Hepatitis: TECENTRIQ can cause liver test abnormalities and immune-mediated hepatitis, defined as requiring use of corticosteroids. Fatal cases have been reported. Monitor patients for signs and symptoms of hepatitis, during and after discontinuation of TECENTRIQ, including clinical chemistry monitoring. Administer corticosteroids, prednisone 1–2 mg/kg/day or equivalents, followed by a taper for Grade 2 or higher elevations of ALT, AST and/or total bilirubin. Interrupt or permanently discontinue TECENTRIQ based on the severity.
Immune-Mediated Colitis: TECENTRIQ can cause immune-mediated colitis or diarrhea, defined as requiring use of corticosteroids. Monitor patients for signs and symptoms of diarrhea or colitis. Withhold treatment with TECENTRIQ for Grade 2 or 3 diarrhea or colitis. If symptoms persist for longer than 5 days or recur, administer corticosteroids, prednisone 1–2 mg/kg/day or equivalents,
followed by a taper for Grade 2 diarrhea or colitis. Interrupt or permanently discontinue TECENTRIQ based on the severity.
Immune-Mediated Endocrinopathies: TECENTRIQ can cause immune-mediated endocrinopathies, including thyroid disorders, adrenal insufficiency, and type 1 diabetes mellitus, including diabetic ketoacidosis, and hypophysitis/hypopituitarism.
Thyroid Disorders: Monitor thyroid function prior to and periodically during treatment with TECENTRIQ. Initiate hormone replacement therapy or medical management of hyperthyroidism as clinically indicated. Continue TECENTRIQ for hypothyroidism and interrupt for hyperthyroidism based on the severity.
Adrenal Insufficiency: Monitor patients for clinical signs and symptoms of adrenal insufficiency. For Grade 2 or higher adrenal insufficiency, initiate prednisone 1 to 2 mg/kg/day or equivalents, followed by a taper and hormone replacement as clinically indicated. Interrupt TECENTRIQ based on the severity.
Type 1 Diabetes Mellitus: Monitor patients for hyperglycemia or other signs and symptoms of diabetes. Initiate treatment with insulin as clinically indicated. Interrupt TECENTRIQ based on the severity.
Hypophysitis: For Grade 2 or higher hypophysitis, initiate prednisone 1-2 mg/kg/day or equivalents, followed by a taper and hormone replacement therapy as clinically indicated. Interrupt TECENTRIQ based on the severity.
See prescribing information for full details.

The most common adverse reactions (≥ 20%) were fatigue (52%), decreased appetite (24%), diarrhea (24%), and nausea (22%). The most common Grade 3–4 adverse reactions (≥ 2%) were fatigue, urinary tract infection, anemia, diarrhea, blood creatinine increase, intestinal obstruction, ALT increase, hyponatremia, decreased appetite, sepsis, back/neck pain, renal failure, and hypotension.
See prescribing information for full details.

The drug interaction potential of atezolizumab is unknown.

Pregnancy: Based on its mechanism of action, TECENTRIQ can cause fetal harm when administered to a pregnant woman. There are no available data on the use of TECENTRIQ in pregnant women. Advise females of reproductive
potential to use effective contraception during treatment with TECENTRIQ and for at least 5 months following the last dose.
Lactation: There is no information regarding the presence of atezolizumab in human milk, the effects on the breastfed infant, or the effects on milk production. As human IgG is excreted in human milk, the potential for absorption and harm to the infant is unknown. Because of the potential for serious adverse reactions in breastfed infants from TECENTRIQ, advise women not to breastfeed during treatment and for at least 5 months after the last dose.
See prescribing information for full details.

There is no information on overdose with this drug.

Storage: This product does not contain a preservative.
Administer immediately once prepared. If diluted TECENTRIQ infusion solution is not used immediately, it can be stored either:
– At ambient temperature (≤30°C) for no more than 8 hours from the time of preparation. This includes room temperature storage of the infusion in the infusion bag and time for administration for infusion.
– Under refrigeration at 2°C–8°C for no more than 24 hours.
Do not freeze. Do not shake.