PHARMACEUTICAL FORM AND COMPOSITION:
UJVIRATM Injection is lyophilized powder for concentrate for solution for infusion. 160 mg single dose lyophilized powder for infusion & 100 mg single dose lyophilized powder for infusion.
THERAPEUTIC INDICATION:
UJVIRATM is indicated for the treatment of patients with HER2-positive, unresectable locally advanced or metastatic breast cancer who had previously received trastuzumab and a taxane, separately or in combination. It is also indicated for the adjuvant treatment of patients with HER2-positive early breast cancer with residual invasive disease in the breast and/or lymph nodes after receiving neo-adjuvant taxane-based and HER2-targeted therapy.
POSOLOGY AND METHOD OF ADMINISTRATION:
UJVIRATM should be administered as an intravenous infusion. Do not administer as an intravenous push or bolus. It should be given at a dose of 3.6 mg / kg body weight with 3 weekly intervals (21 Day cycle). The first dose should be administered over 90 minutes intravenous infusion. Patients should be observed for fever and chills or other symptoms related to infusion.
SUBSEQUENT DOSES:
If the previous dose was well tolerated, the 3.6 mg / kg body weight dose can be administered over 30 minutes intravenous infusion. If dose reduction is done due to drug related adverse effect, then the dose should not be re-escalated in subsequent cycles.
CONTRAINDICATIONS:
There are no known contraindications to UJVIRATM.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE:
There are no known contraindications to UJVIRATM.
