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What kind of drug is Herceptin (trastuzumab), and how does it work?
- Herceptin is an intravenous drug that is part of a
chemotherapy regimen that is used to prevent recurrence of
breast cancer, and
for the treatment breast cancer that has spread beyond the breast
(metastasized). - It belongs to a class of drugs called monoclonal antibodies.
Other monoclonal antibodies include
rituximab (Rituxan) and gemtuzumab
ozogamicin (Mylotarg). - A cancer cell has various receptors on its
surface. Chemicals bind to these receptors and cause changes within the
cancer
cell. One of the receptors that occurs in about one-third of all breast cancers
is called HER2. HER2 is known to control the growth and development of the
cancer cells, and the production of new cancer cells. If HER2 receptors are
present in large numbers on the cancer cells (often referred to as
overexpression of HER2), then the cancer cells may multiply and grow quickly.
Normally, the immune system produces antibodies that will detect and attack HER2
receptors to slow the growth of cancer cells; however, if HER2 is present in
large numbers, the immune system may be unable to control HER2. Trastuzumab is a
man-made antibody developed using molecular cloning and recombinant DNA
technology. Trastuzumab is thought to block the HER2 receptors when there is
overexpression, thereby blocking growth of the cancer.
What brand names are available for trastuzumab?
- Herceptin is the brand name available for trastuzumab in the US.
What are the uses for Herceptin (trastuzumab)?
- Trastuzumab is used for preventing recurrence (adjuvant treatment) of HER2
overexpressing breast cancer. - It also is used for treatment of metastatic breast cancer, metastatic gastric, or gastroesophageal junction adenocarcinoma among patients
who overexpress HER2. - It may be used alone or combined with other
chemotherapy drugs.
What are the side effects of Herceptin (trastuzumab)?
BLACK BOX WARNING
- Trastuzumab can cause
heart failure, especially when it is combined with
cyclophosphamide and anthracycline-containing
chemotherapy regimens. Left ventricular function should
be monitored prior to and during treatment. - It should be stopped in
patients receiving adjuvant therapy, and withheld in patients with metastatic
cancer if the function of the heart decreases significantly.
Herceptin (trasuzumab) side effects
Common side effects include:
-
Diarrhea (25% of patients)
- A prickling or burning sensation in the skin (9% of patients)
- Either an upper respiratory or a catheter-related infection (26% of patients)
- Increased cough (26% of patients)
- Nausea and vomiting (23%-33% of patients)
- Rash (18% of patients)
- infusion-related side effects including mild
to moderate chills and/or fever (40% of patients) - Insomnia
- Weight loss
- Stomatitis
- Shortness of breath
- Distortion of taste
- Fatigue
- Pain
- Cough
- Dizziness
Other side effects include:
- Bone pain
- Joint pain
- Muscle pain
- Increased heart rate
- Body swelling (edema)
- Headache
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What is the dosage for Herceptin (trastuzumab)?
- Trastuzumab is administered by intravenous infusion over 30 to 90
minutes.
Herceptin for adjuvant treatment
- The recommended dose of trastuzumab during and following paclitaxel (Taxol), docetaxel
(Taxotere), or docetaxel/carboplatin (Paraplatin) treatment is 4 mg per kilogram
of body weight followed by a weekly dose of 2 mg per kilogram of body weight for
12 weeks or 18 weeks. - When it is used alone the dose is 8 mg/kg initially followed by 6 mg/kg every 3
weeks.
Herceptin for Metastatic breast cancer treatment
- Trastuzumab 4 mg/kg is administered alone or in combination with paclitaxel
followed by once weekly doses of 2 mg/kg until there is disease progression.
Herceptin Metastatic Gastric Cancer
- The initial dose of trastuzumab is 8 mg/kg then 6 mg/kg every 3 weeks until there is disease
progression.
What else should I know about Herceptin (trastuzumab)?
What preparations of trastuzumab are available?
- Trastuzumab is available as a powder in a vial containing 440 mg of the drug.
It must be mixed with a liquid before intravenous injection.
How should I keep it stored?
- Trastuzumab should be stored at 2 C to 8 C (36F to 46 F), and should
not be frozen.
When was XYZ approved by the FDA?
- Trastuzumab was approved by the FDA in 1998.