Ogivri

Ogivri

trastuzumab

Manufacturer:

Biocon

Distributor:

DKSH

Marketer:

Meda Pharma
Concise Prescribing Info
Contents
Trastuzumab
Indications/Uses
For adjuvant treatment of HER2 overexpressing node positive or node negative or w/ 1 high risk feature breast cancer as part of treatment regimen w/ doxorubicin, cyclophosphamide & either paclitaxel or docetaxel; w/ docetaxel & carboplatin; as single agent following multi-modality anthracycline based therapy. For 1st-line treatment of HER2-overexpressing metastatic breast cancer in combination w/ paclitaxel. For treatment of HER2-overexpressing breast cancer as single agent in patients who have received ≥1 chemotherapy regimens for metastatic disease. For treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma in patients who have not received prior treatment for metastatic disease in combination w/ cisplatin & capecitabine or 5-fluorouracil.
Dosage/Direction for Use
Select patient based on HER2 protein overexpression or HER2 gene amplification in tumor specimens. Adjuvant breast cancer Administer 1 of the following doses & schedules for a total of 52 wk: During & following paclitaxel, docetaxel, or docetaxel/carboplatin: Initially 4 mg/kg over 90-min IV infusion then at 2 mg/kg over 30-min IV infusion wkly during chemotherapy for the first 12 wk w/ paclitaxel or docetaxel, or first 18 wk w/ docetaxel/carboplatin. After 1 wk of last wkly dose, administer 6 mg/kg over 30-90 min IV infusion every 3 wk. As monotherapy: Initially 8 mg/kg over 90-min IV infusion w/in 3 wk following completion of multi-modality, anthracycline-based chemotherapy regimens. Subsequently, 6 mg/kg over 30-90 min IV infusion every 3 wk. Do not extend adjuvant treatment >1 yr. Metastatic breast cancer As monotherapy or in combination w/ paclitaxel: Initially 4 mg/kg via 90-min IV infusion followed by subsequent dose of 2 mg/kg as 30-min IV infusion once wkly until disease progression. Metastatic gastric cancer Initially 8 mg/kg via 90-min IV infusion then followed by subsequent dose of 6 mg/kg over 30-90 min IV infusion every 3 wk until disease progression.
Special Precautions
Do not administer as IV push or bolus. Do not mix w/ other drugs. Do not substitute for or w/ ado-trastuzumab emtansine. Cardiomyopathy. Assess left ventricular ejection fraction (LVEF) prior to initiation of therapy at regular intervals during treatment. Withhold use for at least 4 wk if ≥16% absolute decrease in LVEF from pre-treatment values, or LVEF below institutional limits of normal & ≥10% absolute decrease in LVEF from pretreatment values; permanently discontinue if persistent (>8 wk) LVEF decline or suspension on >3 occasions for cardiomyopathy. Perform baseline LVEF measurement prior to initiation of therapy; LVEF measurements every 3 mth during & upon completion of Ogivri; repeat LVEF measurement at 4 wk intervals if treatment is withheld for significant LVEF cardiac dysfunction; LVEF measurements every 6 mth for at least 2 yr following completion of adjuvant therapy. Interrupt in patients w/ dyspnea & clinically significant hypotension. Permanently discontinue for severe infusion reactions. Serious & fatal pulmonary toxicity. Exacerbation of chemotherapy-induced neutropenia. Fructose intolerance. May cause fetal harm. Monitor women during pregnancy or w/in 7 mth prior to conception for oligohydramnios. Advise females of reproductive potential to use effective contraception during treatment & for 7 mth following last dose. Lactation. Ped patients.
Adverse Reactions
Diarrhea, fatigue, fever, neutropenia, anemia, infections. Adjuvant & metastatic breast cancer: Nausea, vomiting, infusion reactions (including severe), increased cough, headache, dyspnea, rash, myalgia, CHF, significant decline in left ventricular cardiac function & pulmonary toxicity. Metastatic gastric cancer: Stomatitis, wt loss, upper resp tract infections, thrombocytopenia, mucosal inflammation, nasopharyngitis, dysgeusia, febrile neutropenia.
Drug Interactions
Increased risk of cardiac dysfunction w/ anthracycline.
MIMS Class
Targeted Cancer Therapy
ATC Classification
L01XC03 - trastuzumab ; Belongs to the class of monoclonal antibodies, other antineoplastic agents. Used in the treatment of cancer.
Presentation/Packing
Form
Ogivri powd for inj 150 mg
Packing/Price
((lyo)) 1's
Form
Ogivri powd for inj 440 mg
Packing/Price
((lyo)) 1's
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