Vivitra

Vivitra Dosage/Direction for Use

trastuzumab

Manufacturer:

Zydus Cadila

Distributor:

Maxxcare

Marketer:

Mega Lifesciences
Full Prescribing Info
Dosage/Direction for Use
Prior to initiation of Trastuzumab therapy HER2 testing is compulsory. Vivitra should be administered as an intravenous infusion.
Do not administer Vivitra as an intravenous push or bolus.
Weekly schedule: Loading dose: The recommended initial loading dose is 4 mg per kg of body weight administered as a 90-minute intravenous infusion.
Patients should be observed for fever and chills or other symptoms related to infusion, because the stopping of infusion may help control such symptoms. The infusion may be restarted when symptoms subside.
Subsequent doses: The recommended weekly dose is 2 mg per kg of body weight. If the previous dose was well tolerated, the dose can be administered as a 30-minute infusion. Patients should be observed for fever and chills or other symptoms related to infusion.
Alternative 3-weekly schedule: First loading dose of 8 mg per kg of body weight administered as infusions over approximately 90 minutes, followed by 6 mg per kg of body weight repeated at 3 weekly intervals. If the initial dose was well tolerated, the subsequent doses can be administered as a 30-minute infusion.
If patient misses a dose of Vivitra by one week or less, then the usual dose of Vivitra (6 mg per kg of body weight) should be administered as soon as possible without waiting until the next planned cycle. Subsequent maintenance doses of 6 mg per kg of body weight should then be given every 3 weeks, according to the previous schedule.
If the patient misses a dose of Vivitra by more than one week, a re-loading dose of Vivitra of 8 mg per kg of body weight should be administered over approximately 90 minutes. Subsequent maintenance doses of 6 mg per kg of body weight should then be given every 3 weeks from that point.
Dose Modifications: Infusion reaction: Reduce the rate of infusion for mild to moderate infusion reactions.
Interrupt the infusion in patients with dyspnea or significant hypotension.
Discontinue Vivitra for severe and or life threatening infusion reactions.
Cardiomyopathy: Examine the patient for LVEF prior to Vivitra therapy and subsequently at regular interval after the treatment.
Withhold Vivitra treatment for atleast four weeks in case of following: ≥ 16% absolute reduction in LVEF from the pretreatment value; LVEF below the standard of care defined by the institute of the normal and 10% of absolute decrease in LVEF from pretreatment values.
Vivitra treatment may be resumed if within 4 to 8 weeks LVEF returns to normal limits and the absolute reduction from baseline is ≤ 15%. Permanently discontinue the treatment if there is a persistent (more than 8 weeks) LVEF decline or for suspension of Vivitra dosing on more than 3 occasions for cardiomyopathy.
Dose reduction: During the clinical study carried out with Vivitra reduction of dose was not required.
Patients may continue Vivitra therapy during periods of reversible, chemotherapy-induced myelosuppression, but they should be monitored carefully for complications of neutropenia during that time.
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