Ogivri

Adjuvant treatment of HER2-overexpressing node +ve or -ve (ER/PR -ve or w/ 1 high risk feature) breast cancer as part of regimen consisting of doxorubicin, cyclophosphamide, & either paclitaxel or docetaxel; as part of regimen w/ docetaxel & carboplatin; as single agent following multi-modality anthracycline based therapy. In combination w/ paclitaxel for 1st-line treatment of HER2-overexpressing metastatic breast cancer or as single agent for treatment of HER2-overexpressing breast cancer in patients who have received ≥1 chemotherapy regimens for metastatic disease. In combination w/ cisplatin & capecitabine or 5-fluorouracil for the treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma in patients who have not received prior treatment for metastatic disease.

IV infusion Adjuvant breast cancer treatment During & following paclitaxel, docetaxel, or docetaxel/carboplatin: Initially 4 mg/kg over 90 min then 2 mg/kg over 30 min wkly during chemotherapy for the 1st 12 wk (paclitaxel or docetaxel) or 18 wk (docetaxel/carboplatin). 1 wk following the last wkly dose of Ogivri, administer 6 mg/kg over 30-90 min every 3 wk. As single agent w/in 3 wk following completion of multi-modality, anthracycline based chemotherapy regimens: Initially 8 mg/kg over 90 min. Subsequent doses at 6 mg/kg over 30-90 min every 3 wk. Metastatic breast cancer treatment Initially 4 mg/kg over 90 min followed by subsequent once wkly doses of 2 mg/kg over 30 min until disease progression, as single agent or in combination w/ paclitaxel. Metastatic gastric cancer Initially 8 mg/kg for 90 min followed by subsequent doses of 6 mg/kg over 30-90 min every 3 wk until disease progression.

Can cause left ventricular cardiac dysfunction, arrhythmias, HTN, disabling cardiac failure, cardiomyopathy, cardiac death & asymptomatic decline in left ventricular ejection fraction (LVEF). Conduct thorough cardiac assessment, including history, physical exam & LVEF determination by echocardiogram or MUGA prior to & during therapy. Avoid anthracycline-based therapy for up to 7 mth after stopping therapy. Interrupt treatment in patients experiencing dyspnea & clinically significant hypotension & administer intervention of medical therapy; evaluate & monitor until complete resolution of signs & symptoms. Consider permanent discontinuation of treatment in case of severe infusion reactions. Can result in serious & fatal pulmonary toxicity. Exacerbation of chemotherapy-induced neutropenia. Patients w/ rare hereditary problems of fructose intolerance should not take this medicine. Can cause fetal harm when administered to pregnant women. Verify pregnancy status prior to initiation; advise the use of effective contraception during treatment & for 7 mth after the last dose. Monitor women exposed during pregnancy or w/in 7 mth before conception for oligohydramnios. In lactating women, consider benefits of breastfeeding along w/ the mother's clinical need for treatment & any potential adverse effects on the breastfed child from treatment or from the underlying maternal condition, as well as trastuzumab wash-out period of 7 mth. Safety & effectiveness in ped patients have not been established. Increased risk of cardiac dysfunction in geriatric patients.

Fever, diarrhea, fatigue, neutropenia, anemia. Adjuvant & metastatic breast cancer: Nausea, vomiting, infusion reactions, infections, increased cough, headache, dyspnea, rash, myalgia. Metastatic gastric cancer: Stomatitis, wt loss, URTI, thrombocytopenia, mucosal inflammation, nasopharyngitis, dysgeusia.

Increased risk of cardiac dysfunction w/ anthracycline.

Targeted Cancer Therapy

L01FD01 - trastuzumab ; Belongs to the class of HER2 (Human Epidermal Growth Factor Receptor 2) inhibitors. Used in the treatment of cancer.

Rx