Meda Pharma
Concise Prescribing Info
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.
Ogivri powd for inj 150 mg
((lyo)) 1's
Ogivri powd for inj 440 mg
((lyo)) 1's
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