Herceptin/Herceptin SC Dosage/Direction for Use

General: HER2 testing is mandatory prior to initiation of Herceptin therapy.
Substitution by any other biological medicinal product requires the consent of the prescribing physician. The benefit-risk of alternating or switching between Herceptin and products that are biosimilar but not deemed interchangeable needs to be carefully considered when the safety and efficacy of alternating or switching has not been established.
Herceptin should be administered by a qualified health care professional.
It is important to check the product labels to ensure that the correct formulation (Herceptin IV or Herceptin SC) is being administered to the patient as prescribed.
Switching treatment between Herceptin IV and Herceptin SC and vice versa, using a three-weekly (q3w) dosing regimen, was investigated in study MO22982 (see Clinical Trials under Adverse Reactions).
In order to prevent medication errors it is important to check the vial labels to ensure that the drug being prepared and administered is Herceptin (trastuzumab) and not Kadcyla (trastuzumab emtansine).
Herceptin IV (see Storage and Cautions for Usage): Herceptin IV 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: Loading dose: The recommended initial loading dose is 4 mg/kg body weight Herceptin IV administered as a 90-minute IV infusion.
Subsequent doses: The recommended weekly dose of Herceptin IV 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 Herceptin IV 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.
Herceptin SC (see Storage and Cautions for Usage): Herceptin SC is not to be used for intravenous administration and must be administered as a subcutaneous injection only.
No loading dose is required.
The recommended fixed dose of Herceptin SC is 600 mg every three weeks irrespective of the patient's body weight. The injection site should be alternated between the left and right thigh. New injections should be given at least 1 inch/2.5 cm from the previous site and never into areas where the skin is red, bruised, tender, or hard. During the treatment course with Herceptin SC, other medications for SC administration should preferably be injected at different sites.
When administering Herceptin SC Vial, the dose should be administered over 2-5 minutes every three weeks.
Duration of treatment: Patients with MBC should be treated with Herceptin until progression of disease or unmanageable toxicity.
Patients with EBC should be treated for 1 year or until disease recurrence or unmanageable toxicity, 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 Herceptin IV until progression of disease or unmanageable toxicity.
Missed doses: Herceptin IV: If the patient has missed a dose of Herceptin IV 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 Herceptin IV 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 Herceptin IV by more than one week, a re-loading dose of Herceptin IV should be administered over approximately 90 minutes (weekly regimen: 4 mg/kg; three-weekly regimen: 8 mg/kg) as soon as possible. Subsequent Herceptin IV 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.
Herceptin SC: If one dose of Herceptin SC is missed, it is recommended to administer the next 600 mg dose (i.e. the missed dose) as soon as possible. The interval between subsequent Herceptin SC doses should not be less than three weeks.
Dose modification: If the patient develops an infusion-related reaction (IRR), the infusion rate of Herceptin IV may be slowed or interrupted (see Precautions).
No reductions in the dose of Herceptin SC were made during clinical trials. Patients may continue Herceptin SC 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: Geriatric use: Data suggest that the disposition of Herceptin is not altered based on age (see Pharmacology: Pharmacokinetics: Pharmacokinetics in Special Populations under Actions). In clinical trials, patients ≥ 65 years of age did not receive reduced doses of Herceptin.
Paediatric use: The safety and efficacy of Herceptin in paediatric patients < 18 years of age have not been established.
Route of Administration: Herceptin IV: Intravenous infusion.
Herceptin SC: Subcutaneous injection.