What is Herceptin (trastuzumab)
HERCEPTIN is a sterile, white to pale yellow, preservative-free lyophilized powder for intravenous
Generic name: Trastuzumab
Biosimilars: Herzuma®, Kanjinti®, Ogivri®
HERCEPTIN is available as a single-dose vial containing 60 mg or 150 mg of trastuzumab with the
- histidine hydrochloride
- trehalose dihydrate
- polysorbate 20.
Reconstitution of the 60 mg vial with 3.0 mL of sterile water for injection yields 3.1 mL of a single dose solution containing approximately 21 mg/mL trastuzumab, at a pH of approximately 6.0. A
volume overage of 7.5% ensures that the labeled dose can be withdrawn from each vial.
Reconstitution of the 150 mg vial with 7.2 mL of sterile water for injection yields 7.4 mL of a single dose solution containing approximately 21 mg/mL trastuzumab, at a pH of approximately 6.0. A
volume overage of 4% ensures that the labeled dose can be withdrawn from each vial.
Herceptin was the first HER2-targeted therapy for breast cancer. Herceptin is a monoclonal antibody that binds to HER2 receptors present on the surface of HER2-positive tumor cells, blocking them from receiving growth signals and flagging them for destruction by the immune system.
In the US, Europe and many other countries, Herceptin is approved in combination with chemotherapy for the adjuvant (post-surgery) treatment of HER2-positive early breast cancer, first-line treatment of advanced HER2-positive breast cancer and first-line treatment of advanced HER2-positive gastric cancer. In Europe and other countries, it is also approved in combination with chemotherapy for the neoadjuvant (pre-surgery) treatment of HER2-positive early breast cancer.
Herceptin can be given as an intravenous infusion or as a subcutaneous injection (SC). The SC formulation of Herceptin, which is approved in over 100 countries including in the US and Europe, can be administered in two to five minutes via an injection under the skin
A biosimilar is a biologic medical product that is almost an identical copy of an original medication that is manufactured by a different pharmaceutical company.
Chemocare.com uses generic names in all descriptions of drugs. Herceptin is the trade name for Trastuzumab. In some cases, health care professionals may use the trade name Herceptin when referring to the generic drug name Trastuzumab.
Drug type: Herceptin is a monoclonal antibody. (For more detail, see “How this drug works” section below).
What This Drug Is Used For:
- Trastuzumab is used to treat metastatic (spread) breast cancer. It is effective against tumors that overexpress the HER2/neu protein.
- As part of the chemotherapy regimen for adjuvant treatment of lymph-node positive, HER2/neu protein-positive breast cancer.
- Treatment of gastric (stomach) cancer
- It is not known whether or not trastuzumab may be effective in other cancers that may also have this HER-2/neu protein, including ovarian, colon, endometrial, lung, bladder, prostate, and salivary gland tumors.
Note: If a drug has been approved for one use, physicians may elect to use this same drug for other problems if they believe it may be helpful.
How This Drug Is Given:
- Trastuzumab is given through an infusion into a vein (intravenous, IV). The first dose is given over 90 minutes. If well-tolerated subsequent maintenance doses may be given over 30 minutes.
- The amount of trastuzumab that you will receive depends on many factors, including your height and weight, your general health or other health problems, and the type of cancer or condition being treated. Your doctor will determine your dose and schedule.
Important things to remember about the side effects of trastuzumab:
- Most people do not experience all of the side effects listed.
- Side effects are often predictable in terms of their onset and duration.
- Side effects are almost always reversible and will go away after treatment is complete.
- There are many options to help minimize or prevent side effects.
- There is no relationship between the presence or severity of side effects and the effectiveness of the medication.
- The side effects of trastuzumab and their severity depend on whether the drug is given in combination with other medications. In other words, trastuzumab given in combination with other chemotherapy drugs may produce more severe side effects.
The following side effects are common (occurring in greater than 30%) for patients taking trastuzumab. The frequency of side effects reported is based on single-agent trastuzumab:
- During the first infusion of this trastuzumab, you may develop chills or a fever. Your health care provider might prescribe medicine to prevent or treat these symptoms.
- Body pain
These side effects are less common side effects (occurring in about 10-29%) of patients receiving trastuzumab. The frequency of side effects reported is based on single-agent trastuzumab:
- Abdominal pain
- Back pain
- Flu-like symptoms
- Shortness of breath
- Rhinitis or pharyngitis (see cold symptoms)
- Insomnia (see sleep problems)
- Rash (see skin reactions)
- Swelling (usually of the feet, ankles or hands)
Infrequently, serious hypersensitivity reactions (anaphylaxis) (see allergic reactions), have been associated with trastuzumab. Most of these events occur within 24 hours of infusion. However, delayed reactions have occurred. Trastuzumab should be used with caution in people with lung problems. If a person experiences severe hypersensitivity reaction, trastuzumab may be discontinued.
A serious but uncommon side effect of trastuzumab can be interference with the pumping action of the heart. The incidence of heart problems (heart failure) increases in people with heart disease or other risk factors such as radiation to the chest, advancing age, and use of other heart-toxic drugs (such as doxorubicin and cyclophosphamide). Your doctor may check your heart function before you may take any trastuzumab and will monitor your heart closely during your treatment. Trastuzumab may be discontinued if symptoms of heart failure appear.
Not all side effects are listed above. Some that are rare (occurring in less than 10% of patients) are not listed here. However, you should always inform your health care provider if you experience any unusual symptoms.
When to contact your doctor or health care provider:
Seek emergency help immediately and notify your health care provider, it you experience the following symptoms:
- Shortness of breath, wheezing, difficulty breathing, closing up of the throat, swelling of facial features, hives (possible allergic reaction).
Contact your health care provider immediately, day or night, if you should experience any of the following symptoms:
- Shortness of breath or chest pain
The following symptoms require medical attention but are not an emergency. Contact your health care provider within 24 hours of noticing any of the following:
- Nausea (interferes with the ability to eat and unrelieved with prescribed medication)
- Vomiting (vomiting more than 4-5 times in a 24 hour period)
- Diarrhea (4-6 episodes in a 24-hour period)
- Swelling of the feet or ankles. Sudden weight gain
- Signs of infection such as redness or swelling, pain on swallowing, coughing up mucous, or painful urination.
- Pain that is unrelieved by prescribed medication
Always inform your health care provider if you experience any unusual symptoms.
- Before starting trastuzumab treatment, make sure you tell your doctor about any other medications you are taking (including prescription, over-the-counter, vitamins, herbal remedies, etc.).
- Inform your health care professional if you are pregnant or may be pregnant prior to starting this treatment. Pregnancy category B (there is no evidence of risk in humans based on negative animal studies. Use in pregnancy only if clearly needed).
- For both men and women: It is not recommended to conceive a child (get pregnant) while taking trastuzumab. Barrier methods of contraception, such as condoms, are recommended. Discuss with your doctor when you may safely become pregnant or conceive a child after therapy.
- Do not breastfeed while taking this medication.
- Drink at least two to three quarts of fluid every 24 hours, unless you are instructed otherwise.
- This medication causes little nausea. But if you should experience nausea, take anti-nausea medications as prescribed by your doctor, and eat small frequent meals. Sucking on lozenges and chewing gum may also help.
- You may experience drowsiness or dizziness; avoid driving or engaging in tasks that require alertness until your response to the drug is known.
- For flu-like symptoms, keep warm with blankets and drink plenty of liquids. There are medications that can help reduce the discomfort caused by chills.
- Acetaminophen or ibuprofen may help relieve discomfort from fever, headache, and/or generalized aches and pains. However, be sure to talk with your doctor before taking it.
- In general, drinking alcoholic beverages should be kept to a minimum or avoided completely. You should discuss this with your doctor.
- Get plenty of rest.
- Maintain good nutrition.
- If you experience symptoms or side effects, be sure to discuss them with your health care team. They can prescribe medications and/or offer other suggestions that are effective in managing such problems.
Monitoring and Testing:
You will be checked regularly by your health care professional while you are taking trastuzumab, to monitor side effects and check your response to therapy. Periodic blood work to monitor your complete blood count (CBC), as well as the function of other organs (such as your kidneys and liver), may also be ordered by your doctor. Your doctor will monitor your heart while you are taking trastuzumab.
How This Drug Works:
Monoclonal antibodies are a relatively new type of “targeted” cancer therapy. Antibodies are part of the immune system. Normally, the body creates antibodies in response to an antigen (such as a protein in a germ) entering the body. The antibodies attach to the antigen in order to mark it for destruction by the body’s immune system. In the laboratory, scientists analyze specific antigens on the surface of cancer cells (target) to determine a protein to match the antigen. Then, using animal and human proteins, scientists work to create a special antibody that will attach to the target antigen. Antibodies will attach to matching antigens like a key fits a lock. This technology allows treatment to target specific cells, causing less toxicity to healthy cells. Monoclonal antibody therapy can be done only for cancers in which antigens (and the respective antibodies) have been identified.
Trastuzumab works by targeting the HER2/neu receptor on cancer cells. The HER2 gene produces a protein receptor on the cell surface that signals normal cell growth by telling the cell to divide and multiply. Some cancerous breast tissue has too much HER2 (HER2/neu overexpression), triggering the cells to divide and multiply very rapidly. Trastuzumab attaches to the HER2 receptors to prevent cells from multiplying, preventing further cancer growth and slowing cancer progression. It may also work by stimulating an immune mechanism.
Note: We strongly encourage you to talk with your health care professional about your specific medical condition and treatments. The information contained in this website is meant to be helpful and educational but is not a substitute for medical advice.