Herceptin side effects, herceptin dosing, herceptin administration
Source of information: herceptin package insert September 2011

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Drugs listed in this website for chemotherapy:
Xeloda, Avastin, Herceptin,  Tykerb,
website is for reference only. Please, discuss with your doctor before taking any medicine or supplement. All rights reserved 2011.
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Herceptin is indicated for [1] adjuvant HER2 overexpressing node positive or node negative (ER/PR metastatic
gastric cancer.

Herceptin Dosing and Herceptin Administration

Recommended Doses and Schedules
Do not administer as an intravenous push or bolus. Do not mix Herceptin with other drugs.

Adjuvant Treatment, Breast Cancer:

Administer according to one of the following dosing method and schedules for a total of 52 weeks of Herceptin

A. During and following paclitaxel, docetaxel, or docetaxel/carboplatin:

   a. Initial dosing of 4 mg/kg as an intravenous infusion over 90 minutes then at 2 mg/kg as an
       intravenous infusion over 30 minutes weekly during chemotherapy for the first 12 weeks
       (paclitaxel or docetaxel) or 18 weeks (docetaxel/carboplatin).

   b. One week following the last weekly dosing of Herceptin, administer Herceptin at 6 mg/kg as an
       intravenous infusion over 30–90 minutes every three weeks.

B. As a single agent within three weeks following completion of multi‑modality, anthracycline‑based
chemotherapy regimens:

a. Initial dosing at 8 mg/kg as an intravenous infusion over 90 minutes
b. Subsequent doses at 6 mg/kg as an intravenous infusion over 30–90 minutes every three weeks.

Metastatic Treatment, Breast Cancer:
* Administer Herceptin, alone or in combination with paclitaxel, at an initial dosing of 4 mg/kg as a 90 minute
intravenous infusion followed by subsequent once weekly doses of 2 mg/kg as 30 minute intravenous infusions
until disease progression.

Metastatic Gastric Cancer
*  Administer Herceptin at an initial dosing of 8 mg/kg as a 90 minute intravenous infusion followed by
subsequent doses of 6 mg/kg as an intravenous infusion over 30-90 minutes every three weeks until disease
progression [see Dose Modifications (2.2)].

Dose Modifications

Infusion Reactions
* Decrease the rate of infusion for mild or moderate infusion reactions
* Interrupt the infusion in patients with dyspnea or clinically significant hypotension
* Discontinue Herceptin for severe or life‑threatening infusion reactions.

Assess left ventricular ejection fraction (LVEF) prior to initiation of Herceptin and at regular intervals during
treatment. Withhold Herceptin dosing for at least 4 weeks for either of the following:

* ≥ 16% absolute decrease in LVEF from pre‑treatment values
* LVEF below institutional limits of normal and ≥ 10% absolute decrease in LVEF from pretreatment values.

Herceptin may be resumed if, within 4–8 weeks, the LVEF returns to normal limits and the absolute decrease
from baseline is ≤ 15%.

Permanently discontinue Herceptin for a persistent ( > 8 weeks) LVEF decline or for suspension of Herceptin
dosing on more than 3 occasions for cardiomyopathy.

Preparation for Administration
Reconstitute each 440 mg vial of Herceptin with 20 mL of Bacteriostatic Water for Injection (BWFI), USP,
containing 1.1% benzyl alcohol as a preservative to yield a multi‑dose solution containing 21 mg/mL
trastuzumab. In patients with known hypersensitivity to benzyl alcohol, reconstitute with 20 mL of Sterile Water for
Injection (SWFI) without preservative to yield a single use solution.

Use appropriate aseptic technique when performing the following reconstitution steps:

* Using a sterile syringe, slowly inject the 20 mL of diluent into the vial containing the lyophilized cake of
Herceptin. The stream of diluent should be directed into the lyophilized cake.
* Swirl the vial gently to aid reconstitution. DO NOT SHAKE.
* Slight foaming of the product may be present upon reconstitution. Allow the vial to stand undisturbed for
approximately 5 minutes.
* Parenteral drug products should be inspected visually for particulate matter and discoloration prior to
administration, whenever solution and container permit. Inspect visually for particulates and discoloration.
The solution should be free of visible particulates, clear to slightly opalescent and colorless to pale yellow.
* Store reconstituted Herceptin at 2–8° C; discard unused Herceptin after 28 days. If Herceptin is
reconstituted with SWFI without preservative, use immediately and discard any unused portion.

* Determine the dose (mg) of Herceptin [see Dosage and Administration (2.1)]. Calculate the volume of the
21 mg/mL reconstituted Herceptin solution needed, withdraw this amount from the vial and add it to an
infusion bag containing 250 mL of 0.9% Sodium Chloride Injection, USP.
* Gently invert the bag to mix the solution.

Herceptin Side Effects
The most common adverse side effects in patients receiving Herceptin in the adjuvant and metastatic breast
cancer setting are fever, nausea, vomiting, infusion reactions, diarrhea, infections, increased cough, headache,
fatigue, dyspnea, rash, neutropenia, anemia, and myalgia. Adverse side effects requiring interruption or
discontinuation of Herceptin treatment include CHF, significant decline in left ventricular cardiac function, severe
infusion reactions, and pulmonary toxicity

In the metastatic gastric cancer setting, the most common side effects (≥ 10%) that were increased (≥ 5%
difference) in the Herceptin arm as compared to the chemotherapy alone arm were neutropenia, diarrhea,
fatigue, anemia, stomatitis, weight loss, upper respiratory tract infections, fever, thrombocytopenia, mucosal
inflammation, nasopharyngitis, and dysgeusia. The most common adverse side effects which resulted in
discontinuation of treatment on the Herceptin-containing arm in the absence of disease progression were
infection, diarrhea, and febrile neutropenia.

When Herceptin is combined with another drug in use, the side effect incidence is raised slight. For example,
pain 47% (Herceptin as a single agent), 61% (Herceptin + Paclitaxel) and 62% (Paclitaxel Alone), Fever 36%
(Herceptin as a single agent), 49% (Herceptin + Paclitaxel) and 57% (Paclitaxel) etc.

The above information is based on product insert, September 06, 2011. Please, review product insert or consult
with your doctor for details.
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report the adverse side effects to the manufacturer, you should be able to find the contact information on the label.