Herzuma Dosage/Direction for Use

HER2 testing is mandatory prior to initiation of Herzuma therapy.
Substitution by any other biological medicinal product requires the consent of the prescribing physician. Herzuma should be administered by a qualified health care professional.
It is important to check the product labels to ensure that the drug about to be administered is consistent with what has been prescribed for the patient.
IV formulation (see Cautions for Usage and Storage): Herzuma IV formulation is not to be used for subcutaneous administration and should be administered as intravenous infusion.
Do not administer as an intravenous push or bolus.
Weekly schedule: The recommended initial loading dose is 4 mg/kg body weight Herzuma administered as a 90-minute IV infusion.
The recommended weekly dose of Herzuma is 2 mg/kg body weight. If the prior dose was well tolerated, the dose can be administered as a 30-minute infusion.
Alternative 3-weekly schedule: Initial loading dose of 8 mg/kg body weight, followed by 6 mg/kg body weight 3 weeks later and then 6 mg/kg repeated at 3-weekly intervals administered as infusions over approximately 90 minutes. If the prior dose was well tolerated, the dose can be administered as a 30-minute infusion.
Duration of treatment: Patients with MBC should be treated with Herzuma until progression of disease.
Patients with EBC should be treated for 1 year or until disease recurrence, whichever occurs first. Extending treatment in EBC beyond one year is not recommended (see Pharmacology: Pharmacodynamics: Clinical/ Efficacy Studies under Actions).
Patients with advanced gastric cancer should be treated with Herzuma IV until progression of disease.
Missed doses: If the patient has missed a dose of Herzuma by one week or less, then the usual maintenance dose (weekly regimen: 2 mg/kg; three-weekly regimen: 6 mg/kg) should be administered as soon as possible. Do not wait until the next planned cycle. Subsequent Herzuma maintenance doses should be administered 7 days or 21 days later according to the weekly or three-weekly schedules, respectively. If the patient has missed a dose of Herzuma by more than one week, a re-loading dose of Herzuma should be administered over approximately 90 minutes (weekly regimen: 4 mg/kg; 3-weekly regimen: 8 mg/kg) as soon as possible. Subsequent Herzuma maintenance doses (weekly regimen: 2 mg/kg; three-weekly regimen 6 mg/kg, respectively) should be administered 7 days or 21 days later according to the weekly or three-weekly schedules, respectively.
Dose reduction: No reductions in the dose of trastuzumab were made during clinical trials. Patients may continue Herzuma therapy during periods of reversible, chemotherapy-induced myelosuppression, but they should be monitored carefully for complications of neutropenia during this time. The specific instructions to reduce or hold the dose of chemotherapy should be followed.
Special Dosage Instructions: Elderly: Data suggest that the disposition of trastuzumab is not altered based on age (see Pharmacology: Pharmacokinetics: Pharmacokinetics in Special Populations under Actions). In clinical trials, elderly patients did not receive reduced doses of trastuzumab.
Children: The safety and efficacy of trastuzumab in paediatric patients have not been established.