NEW
Tecentriq特善奇

Tecentriq

atezolizumab

Manufacturer:

Roche

Distributor:

DKSH
/
Agencia Lei Va Hong
Concise Prescribing Info
Contents
Atezolizumab
Indications/Uses
Monotherapy in adult patients w/ locally advanced or metastatic urothelial carcinoma after prior platinum-containing chemotherapy, or who are considered cisplatin ineligible & whose tumours have PD-L1 expression ≥5%. Monotherapy in adult patients w/ locally advanced or metastatic NSCLC after prior chemotherapy; patients w/ EGFR mutant or ALK-positive NSCLC should also have received targeted therapies before receiving Tecentriq. 840 mg/14 mL In combination w/ nab-paclitaxel for the treatment of adult patients w/ unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumours have PD-L1 expression ≥1% & who have not received prior chemotherapy for metastatic disease. 1,200 mg/20 mL In combination w/ bevacizumab, paclitaxel & carboplatin as 1st-line treatment of adult patients w/ metastatic non-squamous non-small cell lung cancer (NSCLC); indicated only after failure of appropriate targeted therapies in patients w/ EGFR mutant or ALK-positive NSCLC. In combination w/ nab-paclitaxel & carboplatin as 1st-line treatment of adult patients w/ metastatic non-squamous NSCLC who do not have EGFR mutant or ALK-positive NSCLC. In combination w/ carboplatin & etoposide as 1st-line treatment of adult patients w/ extensive-stage small cell lung cancer (ES-SCLC). In combination w/ bevacizumab for the treatment of adult patients w/ advanced or unresectable hepatocellular carcinoma (HCC) who have not received prior systemic therapy.
Dosage/Direction for Use
840 mg/14 mL vial Monotherapy 840 mg IV every 2 wk, or 1,680 mg IV every 4 wk. In combination w/ nab-paclitaxel in 1L mTNBC 840 mg by IV infusion, followed by nab-paclitaxel 100 mg/m2. For each 28-day cycle, Tecentriq is administered on days 1 & 15, & nab-paclitaxel is administered on days 1, 8, & 15. 1,200 mg/20 mL vial Monotherapy 1,200 mg by IV infusion over 60 min every 3 wk until loss of clinical benefit or unmanageable toxicity. If 1st infusion is tolerated, all subsequent infusions may be delivered over 30 min. In combination w/ bevacizumab, paclitaxel, & carboplatin for 1st-line non-squamous NSCLC Induction phase: 1,200 mg by IV infusion, followed by bevacizumab, paclitaxel, & then carboplatin every 3 wk for 4 or 6 cycles. Maintenance phase w/o chemotherapy: 1,200 mg Tecentriq followed by bevacizumab, administered by IV infusion every 3 wk. In combination w/ nab-paclitaxel & carboplatin for 1st-line non-squamous NSCLC Induction phase: 1,200 mg by IV infusion, followed by nab-paclitaxel & carboplatin every 3 wk for 4 or 6 cycles. For each 21-day cycle, Tecentriq, nab-paclitaxel, & carboplatin are administered on day 1. In addition, nab-paclitaxel is administered on days 8 & 15. Maintenance phase w/o chemotherapy: 1,200 mg Tecentriq administered by IV infusion every 3 wk. In combination w/ carboplatin & etoposide for 1st-line ES-SCLC Induction phase: 1,200 mg by IV infusion, followed by carboplatin, & then etoposide administered by IV infusion on day 1. Etoposide is also administered on days 2 & 3. Administer regimen every 3 wk for 4 cycles. Maintenance phase w/o chemotherapy: 1,200 mg Tecentriq by IV infusion every 3 wk. In combination w/ bevacizumab for HCC 1,200 mg followed by bevacizumab 15 mg/kg administered by IV infusion every 3 wk.
Contraindications
Special Precautions
Cases of pneumonitis; hepatitis; diarrhoea or colitis; hypothyroidism, hyperthyroidism, adrenal insufficiency, hypophysitis & type 1 DM including diabetic ketoacidosis; meningoencephalitis; myasthenic syndrome/myasthenia gravis, Guillain-Barré syndrome; pancreatitis including increased serum amylase & lipase levels; myocarditis; nephritis; myositis. Infusion-related reactions. Permanently discontinue for any Grade 3 immune-related adverse reaction that recurs & for any Grade 4 immune-related adverse reactions, except for endocrinopathies that are controlled w/ replacement hormone. Monitor AST, ALT & bilirubin prior to treatment initiation, periodically during treatment & as clinically indicated. Monitor thyroid function prior to & periodically during treatment. Monitor patients for changes in renal function. Carefully consider the combined risks of the 4-drug regimen of atezolizumab, bevacizumab, paclitaxel, & carboplatin before initiating treatment for metastatic non-squamous NSCLC. Occurrence of neutropenia & peripheral neuropathies when combined w/ nab-paclitaxel in metastatic triple negative breast cancer. Excluded from clinical trials: Patients w/ history of autoimmune disease, history of pneumonitis, active brain metastasis, HIV, HBV or HCV infection; significant CV disease; inadequate hematologic & end-organ function; patients who were administered a live, attenuated vaccine w/in 28 days prior to enrolment; systemic immunostimulatory agents w/in 4 wk or systemic immunosuppressive medicinal products w/in 2 wk prior to study entry; therapeutic oral or IV antibiotics w/in 2 wk prior to study treatment initiation; patients w/ ECOG performance status ≥2; patients w/ NSCLC that had clear tumour infiltration into the thoracic great vessels or clear cavitation of pulmonary lesions. Use in combination w/ bevacizumab, paclitaxel & carboplatin in EGFR+ patients w/ NSCLC who have previously progressed on erlotinib + bevacizumab. Use in urothelial carcinoma for previously untreated patients who are considered cisplatin ineligible. Risk of DM & increased risk of haemorrhage when combined w/ bevacizumab for HCC therapy. Minor influence on the ability to drive & use machines. Patients w/ severe renal impairment or severe hepatic impairment. HCC patients w/ Child-Pugh B or C liver disease. Women of childbearing potential must use effective contraception during & for 5 mth after treatment. Pregnancy & lactation. Childn & adolescents <18 yr.
Adverse Reactions
Fatigue, decreased appetite, nausea, diarrhoea, cough, rash. Monotherapy: Pyrexia, dyspnoea, musculoskeletal pain, back pain, vomiting, pruritus, asthenia, arthralgia, UTI, headache. In combination therapy: Anaemia, neutropenia, thrombocytopenia, alopecia, constipation, peripheral neuropathy.
Drug Interactions
Potential interference of systemic corticosteroids or immunosuppressants w/ the pharmacodynamic activity & efficacy of atezolizumab.
ATC Classification
L01XC32 - atezolizumab ; Belongs to the class of monoclonal antibodies, other antineoplastic agents. Used in the treatment of cancer.
Presentation/Packing
Form
Tecentriq concentrate for soln for infusion 840 mg/14 mL
Packing/Price
1's
Form
Tecentriq concentrate for soln for infusion 1,200 mg/20 mL
Packing/Price
1's
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