Herceptin (Trastuzumab)
Information (FAQ)
Frequently Asked Questions

(HI VALERIE 4-29-08 Send me your data on Hercepin asap.   Go Camp Carefree.  Brian  )
 

Welcome to my compendium website about

Herceptin (Trastuzumab): Beter known as  HER2-positive which is a Breast Cancer Treatment.

Herceptin Audio Track Explanation Video Click Here and Listen While you Surf.

Why do I have a page about this?   I have  kept a journal www.IamFightingCancer.com  of my very detailed medical journey which started with electrical shocks to the head. After a year assuming that it was Trigeminal Neuralgia one of the most painful disorders know to the medical field it was determined that I have a parotid gland tumor too deep to operate on. This is the salivary gland that is in your jaw on both sides of the face. If your body did not create saliva you can not eat. I have been there with a feeding tube for 4 months. Eventually after 33 radiations and 3 infusions of chemotherapy my tumor that  was too deep to operate on was  gone. I have added a lot since this site was originally  made

Then for about a year I had quarterly checkups  with no discovery of further cancer. Then I developed a persistent  cough for which the  GP Doctor could not find a cause. I was sent  for a CT Scan. I went to MD Anderson because they have all of my records. So now I have tumor metastasized in my lung along with increase fluid. A biopsy indicated it was the same type of cell that is treated with  Herceptin in patients with breast cancer. I also was diagnosed with lesions on my spinal cord. These are being treated with a monthly dose After some chemo treatments it was determined that I had excessive liver enzymes 10 times more than normal. The chemo was cut off so other than a monthly dose for my bone structure I am not taking anything for my cancer except the herceptin.  The last report showed the tumor slightly shrinking. Was this reduction cause by the herceptin treatment or was it caused by the  chemo that I did have recently or was it from the nutrition diet change or ingredients in Immuno Power. The only pill I was taking was Zoloft  for depression as my only medical pill so I was taken off that since the reduction of the chemo did not show a benefit in my liver problem. I went off the Zoloft cold turkey. My liver enzymes went down. The oncologist as assured it was due to the fact that the Zoloft was eliminated.

So I want to learn more about the Herceptin. This compendium  site will give a lot of information about Herceptin. I hope you learn something from this site. If that occurs please let me know.

Brian Nelson 713-467-3025 Click: E-mail me

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 Brian Nelson. Owner   31 Gessner Rd. ,  Houston, TX 77024   713-467-3025  Fax 713-467-3192  Click: E-mail meImportant words found on this political website. Herceptin, Trastuzumab, Her2 Positive, Breast Cancer Treatment, Fighting,
Misspelled words used to find this page 1 of 5.The important words found on this site include:
 You can find this site again by typing in the Google search engine  the very unique word " 1nitpecreH  "  which is  " Herceptin1 " backwards.      Article Word Count __________ MSW  _____   1 YouTube.com   2 Alt Tags , 3 MSW  4 Metas/Title, Keywords  Description 5 BB4/FormLetter  6 BB3/NIDAS,   7 BB1 & BB2  Follow Ups in NI.  8 URLChannelAdSense All Urls Completed. Delete 25. Old Low Ones
Herceptin® (Trastuzumab) is the only FDA-approved therapeutic for HER2 protein overexpressing metastatic breast cancer. Herceptin is a therapy for women with metastatic breast cancer whose tumors have too much HER2 protein. For patients with this disease, Herceptin is approved for first-line use in combination with paclitaxel, and as a single agent for those who have received one or more chemotherapy regimens.

Herceptin is not chemotherapy. It is a monoclonal antibody (sometimes called biologic therapy).
  • Antibodies are part of the body's normal defense against bacteria, viruses, and abnormal cells such as cancer cells.
  • Monoclonal antibodies are mass-produced in a laboratory. Their name comes from the fact that they are identical and produced from a single cell (clones).

Therapy with monoclonal antibodies is generally a more targeted form of therapy than chemotherapy.
 
Important Safety Information

Herceptin treatment can result in reduced heart function and congestive heart failure. The risk of these heart problems was higher in people who received both Herceptin and a certain type of chemotherapy (anthracycline). Your doctor may need to stop or strongly consider stopping Herceptin if you have a significant drop in your heart function.

Patients receiving Herceptin should be evaluated before and frequently monitored throughout treatment for any drop in heart function. Patients with pre-existing heart problems should be monitored more frequently. Monitoring will not identify all patients who will develop heart problems.

Serious infusion reactions and lung problems have also been seen; rarely these have been fatal. Treatment may be stopped if you begin to have a severe allergic reaction, swelling, lung problems, inflammation of the lung, or severe shortness of breath.

The worsening of low white blood cell counts associated with chemotherapy has also occurred. The most common side effects associated with Herceptin were fever, nausea, vomiting, infusion reactions, diarrhea, infections, increased cough, headache, fatigue, shortness of breath, rash, low white and red blood cells, and muscle pain.

Because everyone is different, it is not possible to predict what side effects any one person will have. If you have questions or concerns about side effects, talk to your doctor.
7 New type of chemotherapy drug approves for breast cancer

Today's topics include: Trastuzumab improves outcome in women with aggressive breast cancer, New type of chemotherapy drug approves for breast cancer treatment, Breast MRI detects more Ductal carcinoma in situ

Adding Trastuzumab commmercially called  Herceptin to chemotherapy appears to completeley eradicate tumors better than chemotherapy alon in women with HER2 positive inflammatory breast cancer. HER2 is a protein receptor that is present in certain in breast cancer. The researchers found a complete disappearance of the tumor was found in 55 percent of the women women who received trastuzumab and chemotherapy compared to 19% of women with inflammatory HER2 positive breast cancer who did not receive trastuzmab. Trastuzumab or herceptin is a member of a new category of drugs called targeted therapy agents. The food and drug association (FDA) recently approved a new chemotherapy agent  Ixabepilone  that does  does not respond to standard chemotherapy agents. Ixabepilone is the first of tne nex classification of chemotherapy agents called epothilone.  Ixabepilone is given every three weeks as a singe agent or in combinatioin with another chemotherapy drug called capecitabine.

 

One a of the main side effects of the drugs is reversible peripheral nerve damage. Other side effects include a drop in blood count, muscles and joints pain, diarrhea and fatique. Ixabepilone is marketed commercially by Bristol-Myers Squib as lexmpra.

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Herceptin Audio Track Explanation Video Click Here and Listen While you Surf.
About Herceptin | How Does Herceptin Work?
This video presentation details how targeted therapy provides ongoing suppression for HER2 overexpressing breast cancer.

This presentation is intended to be used in its entirety to ensure that fair balance and safety information are covered.
 
 

ased on preclinical research, Herceptin is proposed to have up to 3 different types of activity:
1. May block tumor cell growth
Herceptin binds to HER2-positive cancer cells and may block them from dividing and growing.

 

2. May target the cell for destruction by the immune system
Herceptin attaches to the HER2-positive cancer cells and may signal the body's immune system to destroy the cell.
3. May work with chemotherapy
Along with chemotherapy (paclitaxel), Herceptin may work to destroy HER2-positive cancer cells.
Important Safety Information

Herceptin treatment can result in reduced heart function and congestive heart failure. The risk of these heart problems was higher in people who received both Herceptin and a certain type of chemotherapy (anthracycline). Your doctor may need to stop or strongly consider stopping Herceptin if you have a significant drop in your heart function.

Patients receiving Herceptin should be evaluated before and frequently monitored throughout treatment for any drop in heart function. Patients with pre-existing heart problems should be monitored more frequently. Monitoring will not identify all patients who will develop heart problems.

Serious infusion reactions and lung problems have also been seen; rarely these have been fatal. Treatment may be stopped if you begin to have a severe allergic reaction, swelling, lung problems, inflammation of the lung, or severe shortness of breath.

The worsening of low white blood cell counts associated with chemotherapy has also occurred. The most common side effects associated with Herceptin were fever, nausea, vomiting, infusion reactions, diarrhea, infections, increased cough, headache, fatigue, shortness of breath, rash, low white and red blood cells, and muscle pain.

Because everyone is different, it is not possible to predict what side effects any one person will have. If you have questions or concerns about side effects, talk to your doctor.
 
 How Do You Take Herceptin?

Herceptin is given through an intravenous (IV) infusion at your doctor's office or clinic.
 
  • The first infusion usually takes about 90 minutes but may be slowed or stopped if you have discomfort from side effects.
  • Infusions after that will only last about 30 minutes, as long as the prior infusion was well tolerated.
Important Safety Information

Herceptin treatment can result in reduced heart function and congestive heart failure. The risk of these heart problems was higher in people who received both Herceptin and a certain type of chemotherapy (anthracycline). Your doctor may need to stop or strongly consider stopping Herceptin if you have a significant drop in your heart function.

Patients receiving Herceptin should be evaluated before and frequently monitored throughout treatment for any drop in heart function. Patients with pre-existing heart problems should be monitored more frequently. Monitoring will not identify all patients who will develop heart problems.

Serious infusion reactions and lung problems have also been seen; rarely these have been fatal. Treatment may be stopped if you begin to have a severe allergic reaction, swelling, lung problems, inflammation of the lung, or severe shortness of breath.

The worsening of low white blood cell counts associated with chemotherapy has also occurred. The most common side effects associated with Herceptin were fever, nausea, vomiting, infusion reactions, diarrhea, infections, increased cough, headache, fatigue, shortness of breath, rash, low white and red blood cells, and muscle pain.

Because everyone is different, it is not possible to predict what side effects any one person will have. If you have questions or concerns about side effects, talk to your doctor.

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About Herceptin | What to Expect
How Do You Take Herceptin?

Herceptin is given through an intravenous (IV) infusion at your doctor's office or clinic.
 
  • The first infusion usually takes about 90 minutes but may be slowed or stopped if you have discomfort from side effects.
  • Infusions after that will only last about 30 minutes, as long as the prior infusion was well tolerated.
Important Safety Information

Herceptin treatment can result in reduced heart function and congestive heart failure. The risk of these heart problems was higher in people who received both Herceptin and a certain type of chemotherapy (anthracycline). Your doctor may need to stop or strongly consider stopping Herceptin if you have a significant drop in your heart function.

Patients receiving Herceptin should be evaluated before and frequently monitored throughout treatment for any drop in heart function. Patients with pre-existing heart problems should be monitored more frequently. Monitoring will not identify all patients who will develop heart problems.

Serious infusion reactions and lung problems have also been seen; rarely these have been fatal. Treatment may be stopped if you begin to have a severe allergic reaction, swelling, lung problems, inflammation of the lung, or severe shortness of breath.

The worsening of low white blood cell counts associated with chemotherapy has also occurred. The most common side effects associated with Herceptin were fever, nausea, vomiting, infusion reactions, diarrhea, infections, increased cough, headache, fatigue, shortness of breath, rash, low white and red blood cells, and muscle pain.

Because everyone is different, it is not possible to predict what side effects any one person will have. If you have questions or concerns about side effects, talk to your doctor.
  About Herceptin | Possible Benefits of Herceptin
In the Herceptin clinical trial, some people received chemotherapy plus Herceptin, while others received just chemotherapy. People who received Herceptin plus chemotherapy benefited in important ways.

While results may vary, on average, people who received Herceptin plus chemotherapy:
  • Lived longer than those who received chemotherapy alone.
  • Their cancer was kept from growing for a longer time compared with those who received chemotherapy alone.
  • Tumors shrank in size more often than those who received chemotherapy alone.

Herceptin does have possible side effects. In clinical trials, some people receiving Herceptin in combination with chemotherapy experienced serious side effects.

It's important to discuss treatment benefits and risks with your doctor and to have realistic expectations of Herceptin therapy.
 
Important Safety Information
Herceptin treatment can result in reduced heart function and congestive heart failure. The risk of these heart problems was higher in people who received both Herceptin and a certain type of chemotherapy (anthracycline). Your doctor may need to stop or strongly consider stopping Herceptin if you have a significant drop in your heart function.

Patients receiving Herceptin should be evaluated before and frequently monitored throughout treatment for any drop in heart function. Patients with pre-existing heart problems should be monitored more frequently. Monitoring will not identify all patients who will develop heart problems.

Serious infusion reactions and lung problems have also been seen; rarely these have been fatal. Treatment may be stopped if you begin to have a severe allergic reaction, swelling, lung problems, inflammation of the lung, or severe shortness of breath.

The worsening of low white blood cell counts associated with chemotherapy has also occurred. The most common side effects associated with Herceptin were fever, nausea, vomiting, infusion reactions, diarrhea, infections, increased cough, headache, fatigue, shortness of breath, rash, low white and red blood cells, and muscle pain.

Because everyone is different, it is not possible to predict what side effects any one person will have. If you have questions or concerns about side effects, talk to your doctor.
 
Here are some other questions you may want to ask your cancer care team. If you have more questions, write them down. These notes can help you remember what to ask during your next visit.
 
1 What is my tumor's HER2 status?
2 Is Herceptin a treatment option for me?
3 How is Herceptin different than other therapies?
4 Does Herceptin interact with any medications I'm currently taking?
5 What should I do to be ready for treatment?
6 How frequently will I take Herceptin and for how long?
7 Will the treatment be painful? Will I have any scars?
8 Is there anything that I can do to manage side effects?
9 Are there any symptoms that I should notify you about immediately?
10 Will I need to be on a special diet during and after treatment?
11 Are there any limitations on my activities or amount of exercise?
12 How will you monitor my progress?
13 How will I know if the cancer is growing?
14 What symptoms should I watch for?
15 Will I have to have more imaging tests in the future such as CT scans or MRI scans?
16 What blood tests will be needed?
17 What are my options if the cancer starts growing?
18 How will you know if the treatment is working?
 
About Herceptin | What Have Studies with Herceptin Found?
Related Links
National Cancer Institute (NCI)
NCI's Clinical Studies Support Center
National Institutes of Health (NIH)
American Cancer Society (ACS)
Clinical Trial Information

What is a clinical trial for patients with cancer?
A clinical trial is medical research in a clinic that tests potential cancer treatments to see if they can help people with cancer. Before a cancer treatment is studied in people, researchers may test their ideas for years in a laboratory. A clinical trial involving people is one of the many steps in a long and careful process. These studies, which include cancer patients, are used to determine whether potential treatments are safe and effective.

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Why are clinical trials important?
Clinical trials are important because they help doctors learn more about cancer and can lead to better treatments and care. Doctors may use the results of clinical trials when they decide on a cancer treatment. If a potential treatment works well in a clinical trial, it may go on to become a FDA approved treatment that may help patients.

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What are the types of clinical trials?
Clinical trials are done in a series of steps, called phases.
Phase I
These are early studies to find out what amount of the potential drug (the dose) can be given safely.
Phase II
A Phase II trial also tests the safety of the potential treatment and tries to find out whether the treatment may be effective. If the treatment is effective, doctors may plan a Phase III study.
Phase III
The goals of Phase III trials are to find out whether the potential treatment is safe and effective compared to a standard of care.
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What is a randomized trial?
A randomized trial is a study in which patients are put into a treatment group by chance. Patients in a randomized trial may or may not receive the potential drug being studied. A randomized trial aims to avoid what is called bias.

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What is a double-blind trial?
In a double-blind trial, neither the patient nor the doctor knows which potential treatment is being given. There is also something called a single-blind trial in which the doctor knows which group the patient is in but the patient doesn't.

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"What are eligibility/exclusion criteria?"
Every clinical trial has a list of rules that decides who can or cannot participate. These rules, called "eligibility/exclusion criteria," are a list of characteristics a patient must have to join the trial. These may include age, gender (male or female), and type of cancer.

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Should I take part in a clinical trial?
Once you know you have qualified for a trial, only you can decide whether to participate. Before you decide, you should

  • Learn as much as possible about your disease.
  • Find out what clinical trials are open to you by asking your doctor. You can also visit the website for the National Cancer Institute (NCI), National Institutes of Health (NIH), or American Cancer Society (ACS).
  • Discuss your feelings about clinical trials with your doctor and/or nurse, family members, and friends to help you decide what is right for you.
  • Learn all about the specific details of the trial you and your doctor may be considering.

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What are the potential benefits and risks of clinical trials?
You may or may not benefit from a clinical trial. Depending on the trial design, you may:

  • Receive a potential drug or other treatments that is often not available except in clinical trials because it is not yet FDA approved.
  • Get specific medical care from a team that includes doctors and nurses.
  • Be carefully watched for any side effects of the potential treatment.
  • Be among the first to experience whether the potential treatment being studied is effective.
  • Help identify potential treatments that may become FDA approved for cancer patients.

Clinical trials may also have some risks:

  • Potential treatments may have side effects that doctors don't yet know about. This is especially true in early phases of clinical trials.
  • New treatments may not work at all or as well as currently FDA approved treatments.
  • Even if a potential treatment helps others, it may not work for you.
  • Those in "randomized trials" will not be able to choose the treatment they get.
  • Health insurance may not pay for the study.
  • You may have to make more visits to the doctor than you would if you weren't in a clinical trial.

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Where do clinical trials take place?
Clinical trials take place all over the country. If you were in a clinical trial, you might receive the potential drug at a cancer center, a university hospital, a veterans or military hospital, a local medical center, or your physician's office.

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What happens during a trial?
If you decide to be in a clinical trial, you will work with a research team. Team members may include doctors, nurses, social workers, and dieticians. They will provide your care, watch you closely, and give you exact instructions about the study. Being in a clinical trial may mean that you will have more tests and doctor visits than if you weren't in the study. Team members also may continue to stay in touch with you after the trial ends. It is important to follow the research team's instructions.

  Back to topCould I be given a placebo?
A placebo, also called a "sugar pill," contains sugar or salt but looks exactly like the drug being used in some studies. Cancer clinical trials rarely use placebos. Most often the potential treatment is compared against current standard medical care for that condition.

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What happens when a clinical trial is over?
After a Phase I or II trial is completed, researchers look carefully at the results and decide whether to move on to the next phase of clinical trial. Or, stop studying the potential treatment because it has not been shown to be safe or effective.

When a Phase III trial ends, researchers look at the results and decide whether or not to apply for FDA approval.

If a potential approach is determined safe and effective by the FDA, the drug may be approved by the FDA and made available for patient use.

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What are my rights in a clinical trial?

  • Before and during a clinical trial, you have a number of rights. Knowing these rights can help you make informed decisions.
  • Being in a clinical trial is up to you. Talk with your doctor. Together, you can make the best choice for you.
  • If you decide to participate in a clinical trial, doctors and nurses will follow you very carefully to determine how the potential treatment affects you throughout the entire study.
  • If you experience a serious side effect, you may be taken off the study.
  • You have the right to stop participating in a study at any time.

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What is informed consent?
Informed consent is one of the most important rights someone in a clinical trial has. You must be told all the facts about a study before you decide whether to participate. You will be provided with a written consent form explaining the study that you can take home to read and discuss. The consent form will include information about:

  • How the study is designed
  • The potential treatments given in the trial
  • Possible risks and benefits
  • Tests you may be given

You have the right to ask your doctor any questions you might have. People who agree to be in the study are asked to sign the informed consent form.

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Who can answer my questions about clinical trials?
People with cancer and their families have a lot of questions when they are thinking about joining a clinical trial. It is important to discuss all of your questions with your doctor, a cancer specialist (oncologist), and the clinical trial team. Always remember that when it comes to your medical care, no question is silly.

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What have studies with Herceptin found?
In the Herceptin clinical trial, some people received chemotherapy plus Herceptin, while others received just chemotherapy. People who received Herceptin plus chemotherapy benefited in important ways. While results may vary, on average, people who received Herceptin plus chemotherapy:

  • Lived longer than those who received chemotherapy alone.
  • Their cancer was kept from growing for a longer time compared with those who received chemotherapy alone.
  • Their tumors shrank in size more often than those who received chemotherapy alone.


 Back to top

Important Safety Information

Herceptin treatment can result in reduced heart function and congestive heart failure. The risk of these heart problems was higher in people who received both Herceptin and a certain type of chemotherapy (anthracycline). Your doctor may need to stop or strongly consider stopping Herceptin if you have a significant drop in your heart function.

Patients receiving Herceptin should be evaluated before and frequently monitored throughout treatment for any drop in heart function. Patients with pre-existing heart problems should be monitored more frequently. Monitoring will not identify all patients who will develop heart problems.

Serious infusion reactions and lung problems have also been seen; rarely these have been fatal. Treatment may be stopped if you begin to have a severe allergic reaction, swelling, lung problems, inflammation of the lung, or severe shortness of breath.

The worsening of low white blood cell counts associated with chemotherapy has also occurred. The most common side effects associated with Herceptin were fever, nausea, vomiting, infusion reactions, diarrhea, infections, increased cough, headache, fatigue, shortness of breath, rash, low white and red blood cells, and muscle pain.

Because everyone is different, it is not possible to predict what side effects any one person will have. If you have questions or concerns about side effects, talk to your doctor.

To find additional clinical trials for Herceptin, please visit www.clinicaltrials.gov

 

WARNING
CARDIOMYOPATHY, INFUSION REACTIONS and PULMONARY TOXICITY

Cardiomyopathy

Herceptin can result in sub-clinical and clinical cardiac failure manifesting as CHF and decreased LVEF. The incidence and severity of left ventricular cardiac dysfunction was highest in patients who received Herceptin concurrently with anthracycline-containing chemotherapy regimens.

Evaluate left ventricular function in all patients prior to and during treatment with Herceptin. Discontinue Herceptin treatment in patients receiving adjuvant therapy and strongly consider discontinuation of Herceptin treatment in patients with metastatic breast cancer for clinically significant decrease in left ventricular function. [see WARNINGS and PRECAUTIONS and DOSAGE AND ADMINISTRATION]

Infusion Reactions; Pulmonary Toxicity

Herceptin administration can result in serious infusion reactions and pulmonary toxicity. Fatal infusion reactions have been reported. In most cases, symptoms occurred during or within 24 hours of administration of Herceptin. Herceptin infusion should be interrupted for patients experiencing dyspnea or clinically significant hypotension. Patients should be monitored until signs and symptoms completely resolve. Discontinue Herceptin for infusion reactions manifesting as anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome. [see WARNINGS and PRECAUTIONS]

DRUG DESCRIPTION

Herceptin (Trastuzumab) is a humanized IgG1 kappa monoclonal antibody that selectively binds with high affinity to the extracellular domain of the human epidermal growth factor receptor 2 protein, HER2. Trastuzumab is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary) culture containing the antibiotic gentamicin. Gentamicin is not detectable in the final product.

Herceptin is a sterile, white to pale yellow, preservative-free lyophilized powder for intravenous administration. Each multi-use vial of Herceptin contains 440 mg Trastuzumab, 400 mg α,α-trehalose dihydrate, 9.9 mg L-histidine HCl, 6.4 mg L-histidine, and 1.8 mg polysorbate 20, USP. Reconstitution with 20 mL of the appropriate diluent (BWFI or SWFI) yields a solution containing 21 mg/mL Trastuzumab, at a pH of approximately 6.

 

Trastuzumab can cause heart damage. Tell your doctor if you are taking cyclophosphamide (Cytoxan, Neosar), daunorubicin (DaunoXome), doxorubicin (Adriamycin, Rubex), or idarubicin (Idamycin). Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your response to trastuzumab.

Trastuzumab may cause severe or fatal allergic reactions. Usually this reaction occurs within 24 hours of receiving treatment, but it may occur days after treatment.

You should call for help or go to an emergency room immediately if you experience difficulty breathing; swelling of the lips, throat, or inside of your mouth; dizziness or fainting; hives; or a severe skin rash.

About your treatment   Return to top

Your doctor has ordered the drug trastuzumab to help treat your illness. The drug is given by injection into a vein.This medication is used to treat metastatic breast cancer.

Trastuzumab is in a class of drugs known as monoclonal antibodies. Antibodies are substances that the body produces to help fight infection or other foreign particles. Trastuzumab recognizes and attaches to certain cancer cells. The body's immune system can recognize and kill the cancer cells to which trastuzumab is attached. The length of treatment depends on the types of drugs you are taking, how well your body responds to them, and the type of cancer you have.

This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for information.

Precautions   Return to top

Before administering trastuzumab,

  • tell your doctor and pharmacist if you are allergic to trastuzumab, Chinese hamster ovary cell proteins, benzyl alcohol, or any other drugs.
  • tell your doctor and pharmacist what prescription and nonprescription medications you are taking, including the medications listed in the IMPORTANT WARNING section, paclitaxel (Taxol), valrubicin (Valstar), and vitamins and herbal products.
  • tell your doctor if you have or have ever had heart disease, asthma, or emphysema and if you have ever had radiation treatment.
  • tell your doctor if you are pregnant or breast-feeding. You should not plan to have children while receiving chemotherapy or for a while after treatments. (Talk to your doctor for more details.) Use a reliable method of birth control to prevent pregnancy.
  • do not have any vaccinations (e.g., measles or flu shots) without talking to your doctor.

Side effects   Return to top

Side effects from trastuzumab are common and usually occur while the drug is being infused. Your doctor may stop your treatment or may give you medications to treat these symptoms. They include:

  • chills or shaking chills
  • nausea
  • vomiting
  • pain at tumor site or in the abdomen or back
  • shortness of breath
  • muscle weakness or stiffness
  • rash
  • headache

 

Tell your doctor if any of these symptoms are severe or last for several hours:

  • loss of appetite
  • diarrhea
  • sleeplessness
  • runny nose
  • sore throat
  • sinus pain
  • headache
  • fatigue
  • abdominal pain

 

If you experience any of the following symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately:

  • unusual bruising or bleeding
  • swelling of the feet or ankles
  • rapid heartbeat
  • difficulty breathing
  • wheezing while sleeping
  • fever
  • upper respiratory tract infection
  • chills or shaking chills
  • excessive coughing

 

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/MedWatch/index.html] or by phone [1-800-332-1088].

Storage conditions   Return to top

In most cases, your health care provider will bring a dose of trastuzumab to your home right before the dose is scheduled. If your pharmacy gives you doses to store, you should keep the container in the refrigerator. Talk to your pharmacist about the proper disposal of containers that are outdated or no longer needed.

In case of emergency/overdose   Return to top

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Brand names   Return to top

  • Herceptin®
 
Application
Supplement Number 103792
Box Warning
Boxed Warning CARDIOMYOPATHY: HERCEPTIN administration can result in the development of ventricular dysfunction and congestive heart failure. Left ventricular function should be evaluated in all patients prior to and during treatment with HERCEPTIN. Discontinuation of HERCEPTIN treatment should be strongly considered in patients who develop a clinically significant decrease in left ventricular function. The incidence and severity of cardiac dysfunction was particularly high in patients who received HERCEPTIN in combination with anthracyclines and cyclophosphamide. (See WARNINGS.)
Complete Label
Formatted in PDF HERCEPTIN
Description
Mechanism of Action HERCEPTIN (Trastuzumab) is a recombinant DNA-derived humanized monoclonal antibody that selectively binds with high affinity in a cell-based assay (Kd = 5 nM) to the extracellular domain of the human epidermal growth factor receptor2 protein, HER2.1,2 The antibody is an IgG1 kappa that contains human framework regions with the complementarity-determining regions of a murine antibody (4D5) that binds to HER2. The humanized antibody against HER2 is produced by a mammalian cell (Chinese Hamster Ovary) [CHO] suspension culture in a nutrient medium containing the antibiotic gentamicin. Gentamicin is not detectable in the final product. HERCEPTIN is a sterile, white to pale yellow, preservative-free lyophilized powder for intravenous (IV) administration. Each vial of HERCEPTIN contains 440mg Trastuzumab, 9.9mg L-histidineHCl, 6.4mg L-histidine, 400 mg-trehalose dihydrate, and 1.8 mg polysorbate 20, USP. Reconstitution with 20 mL of the supplied Bacteriostatic Water for Injection, (BWFI) USP, containing 1.1% benzyl alcohol as a preservative, yields 21mL of a multi-dose solution containing 21mg/mL Trastuzumab, at a pH of approximately 6 .
Generic Drug Name trastuzumab
Manufacturer
Manufacturer Genentech, Inc. 1 DNA Way South San Francisco, CA 94080-4990
Clinical Pharmacology
Summary General The HER2 (or c-erbB2) proto-oncogene encodes a transmembrane receptor protein of 185kDa, which is structurally related to the epidermal growth factor receptor.1 HER2 protein overexpression is observed in 25%–30% of primary breast cancers. HER2 protein overexpression can be determined using an immunohistochemistrybased assessment of fixed tumor blocks.3 Trastuzumab has been shown, in both in vitro assays and in animals, to inhibit the proliferation of human tumor cells that overexpress HER2.4-6 Trastuzumab is a mediator of antibody-dependent cellular cytotoxicity (ADCC).7,8 In vitro, HERCEPTINmediated ADCC has been shown to be preferentially exerted on HER2 overexpressing cancer cells compared with cancer cells that do not overexpress HER2. Pharmacokinetics The pharmacokinetics of Trastuzumab were studied in breast cancer patients with metastatic disease. Short duration intravenous infusions of 10 to 500 mg once weekly demonstrated dose-dependent pharmacokinetics. Mean half-life increased and clearance decreased with increasing dose level. The half-life averaged 1.7 and 12 days at the 10 and 500 mg dose levels, respectively. Trastuzumab’s volume of distribution was approximately that of serum volume (44 mL/kg). At the highest weekly dose studied (500 mg), mean peak serum concentrations were 377 microgram/mL. In studies using a loading dose of 4 mg/kg followed by a weekly maintenance dose of 2 mg/kg, a mean halflife of 5.8 days (range = 1 to 32 days) was observed. Between weeks 16 and 32, Trastuzumab serum concentrations reached a steady-state with a mean trough and peak concentrations of approximately 79microgram/mL and 123 microgram/mL, respectively. Detectable concentrations of the circulating extracellular domain of the HER2 receptor (shed antigen) are found in the serum of some patients with HER2 overexpressing tumors. Determination of shed antigen in baseline serum samples revealed that 64% (286/447) of patients had detectable shed antigen, which ranged as high as 1880 ng/mL (median = 11 ng/mL). Patients with higher baseline shed antigen levels were more likely to have lower serum trough concentrations. However, with weekly dosing, most patients with elevated shed antigen levels achieved target serum concentrations of Trastuzumab by week 6. Data suggest that the disposition of Trastuzumab is not altered based on age or serum creatinine (up to 2.0 mg/dL). No formal interaction studies have been performed. Mean serum trough concentrations of Trastuzumab, when administered in combination with paclitaxel, were consistently elevated approximately 1.5-fold as compared with serum concentrations of Trastuzumab used in combination with anthracycline plus cyclophosphamide. In primate studies, administration of Trastuzumab with paclitaxel resulted in a reduction in Trastuzumab clearance. Serum levels of Trastuzumab in combination with cisplatin, doxorubicin or epirubicin plus cyclophosphamide did not suggest any interactions; no formal drug interaction studies were performed.
Clinical Studies
Summary CLINICAL STUDIES The safety and efficacy of HERCEPTIN were studied in a randomized, controlled clinical trial in combination with chemotherapy (469patients) and an open-label single agent clinical trial (222 patients). Both trials studied patients with metastatic breast cancer whose tumors overexpressthe HER2 protein. Patients were eligible if they had 2+ or 3+ levels of overexpression (based on a 0–3+ scale) by immunohistochemical assessment of tumor tissue performed by a central testing lab. A multicenter, randomized, controlled clinical trial was conducted in 469patients with metastatic breast cancer who had not been previously treated with chemotherapy for metastatic disease. Patients were randomized to receive chemotherapy alone or in combination with HERCEPTIN given intravenously as a 4 mg/kg loading dose followed by weekly doses of HERCEPTIN at 2mg/kg. For those who had received prior anthracycline therapy in the adjuvant setting, chemotherapy consisted of paclitaxel (175 m g / m2 over 3hours every 21 days for at least six cycles); for all other patients, chemotherapy consisted of anthracycline plus cyclophosphamide (AC: doxorubicin 60 m g / m2 or epirubicin 75 m g / m2 plus 600 m g / m2 cyclophosphamide every 21 days for six cycles). Compared with patients in the AC subgroups (n = 281), patients in the paclitaxel subgroups (n = 188) were more likely to have had the following: poor prognostic factors (premenopausal status, estrogen or progesterone receptor negative tumors, positive lymph nodes), prior therapy (adjuvant chemotherapy, myeloablative chemotherapy, radiotherapy), and a shorter disease-free interval. Compared with patients randomized to chemotherapy alone, the patients randomized to HERCEPTIN and chemotherapy experienced a significantly longer time to disease progression, a higher overall response rate (ORR), a longer median duration of response, and a higher one-year survival rate. (See Table1.) These treatment effects were observed both in patients who received HERCEPTIN plus paclitaxel and in those who received HERCEPTIN plus AC, however the magnitude of the effects was greater in the paclitaxel subgroup. The degree of HER2 overexpression was a predictor of treatment effect. (See CLINICAL STUDIES: HER2 pro - tein overexpression.) (Table) HERCEPTIN was studied as a single agent in a multicenter, open-label, single-arm clinical trial inpatients with HER2 overexpressing metastatic breast cancer who had relapsed following one or two prior chemotherapy regimens for metastatic disease. Of 222 patients enrolled, 66% had received prior adjuvant chemotherapy, 68% had received two prior chemotherapy regimens for metastatic disease, and 25% had received prior myeloablative treatment with hematopoietic rescue. Patients were treated with a loading dose of 4 mg/kg IV followed by weekly doses of HERCEPTIN (Trastuzumab) at 2mg/kg IV. The ORR (complete response+ p a rtial response), as determined by an independent Response Evaluation Committee, was 14%, with a 2% complete response rate and a 12% partial response rate. Complete responses were observed only in patients with disease limited to skin and lymph nodes. The degree of HER2 overexpression was a predictor of treatment effect. (See CLINICAL STUDIES: HER2 protein overexpression.) HER2 protein overexpression Relationship to Response: In the clinical studies described, patient eligibility was determined by testing tumor specimens for overexpression of HER2 protein. Specimens were tested with a research-use-only immunohistochemical assay (referred to as the Clinical Trial Assay, CTA) and scored as 0, 1+, 2+, or 3+ with 3+ indicating the strongest positivity. Only patients with 2+ or 3+ positive tumors were eligible (about 33% of those screened). Data from both efficacy trials suggest that the beneficial treatment effects were largely limited to patients with the highest level of HER2 protein overexpression (3+). (See Table 2.) Immunohistochemical Detection: In clinical trials, the Clinical Trial Assay (CTA) was used for immunohistochemical detection of HER2 protein overexpression. The DAKO HercepTestTM, another immunohistochemical test for HER2 protein overexpression, has not been directly studied for its ability to predict HERCEPTIN treatment effect, but has been compared to the CTA on over 500 breast cancer histology specimens obtained from the National Cancer Institute Cooperative Breast Cancer Tissue Resource. Based upon these results and an expected incidence of 33% of 2+ or 3+ HER2 overexpression in tumors from women with metastatic breast cancer, one can estimate the correlation of the HercepTestT M results with CTA results. Of specimens testing 3+ (strongly positive) on the HercepTestTM, 94% would be expected to test at least 2+ on the CTA (i.e., meeting the study entry criterion) including 82% which would be expected to test 3+ on the CTA (i.e., the reading most associated with clinical benefit). Of specimens testing 2+ (weakly positive) on the HercepTestT M, only 34% would be expected to test at least 2+ on the CTA, including 14% which would be expected to test 3+ on the CTA.
Indications and Usage
Summary HERCEPTIN as a single agent is indicated for the treatment of patients with metastatic breast cancer whose tumors overexpress the HER2 protein and who have received one or more chemotherapy regimens for their metastatic disease. HERCEPTIN in combination with paclitaxel is indicated for treatment of patients with metastatic breast cancer whose tumors overexpress the HER2 protein and who have not received chemotherapy for their metastatic disease. HERCEPTIN should only be used in patients whose tumors have HER2 protein overexpression. (See CLINICAL STUDIES: HER2 protein overexpression for information regarding HER2 protein testing and the relationship between the degree of overexpression and the treatment effect.)
Contraindications
Summary None known.
Warnings
Summary Cardiotoxicity: Signs and symptoms of cardiac dysfunction, such as dyspnea, increased cough, paroxysmal nocturnal dyspnea, peripheral edema, S3 gallop, or reduced ejection fraction, have been observed in patients treated with HERCEPTIN. Congestive heart failure associated with HERCEPTIN therapy may be severe and has been associated with disabling cardiac failure, death, and mural thrombosis leading to stroke. The clinical status of patients in the trials who developed congestive heart failure were classified for severity using the New York. Heart Association classification system (I?IV, where IV is the most severe level of cardiac failure). (SeeTable 3.) Candidates for treatment with HERCEPTIN should undergo thorough baseline cardiac assessment including history and physical exam and one or more of the following: EKG, echocardiogram, and MUGA scan. There are no data regarding the most appropriate method of evaluation for the identification of patients at risk for developing cardiotoxicity. Monitoring may not identify all patients who will develop cardiac dysfunction. Extreme caution should be exercised in treating patients with pre-existing cardiac dysfunction. Patients receiving HERCEPTIN should undergo frequent monitoring for deteriorating cardiac function. The probability of cardiac dysfunction was highest in patients who received HERCEPTIN concurrently with anthracyclines. The data suggest that advanced age may increase the probability of cardiac dysfunction. Pre-existing cardiac disease or prior cardiotoxic therapy (e.g., anthracycline or radiation therapy to the chest) may decrease the ability to tolerate HERCEPTIN therapy; however, the data are not adequate to evaluate the correlation between HERCEPTIN-induced cardiotoxicity and these factors. Discontinuation of HERCEPTIN therapy should be strongly considered in patients who develop clinically significant congestive heart failure. In the clinical trials, most patients with cardiac dysfunction responded to appropriate medical therapy often including discontinuation of HERCEPTIN. The safety of continuation or resumption of HERCEPTIN in patients who have previously experienced cardiac toxicity has not been studied. There are insufficient data regarding discontinuation of HERCEPTIN therapy in patients with asymptomatic decreases in ejection fraction; such patients should be closely monitored for evidence of clinical deterioration.
Precautions
Summary General: HERCEPTIN therapy should be used with caution in patients with known hypersensitivity to Trastuzumab, Chinese Hamster Ovary cell proteins, or any component of this product. Benzyl Alcohol: For patients with a known hypersensitivity to benzyl alcohol (the preservative in Bacteriostatic Water for Injection) reconstitute HERCEPTIN (Trastuzumab) with Sterile Water for Injection (SWFI), USP. DISCARD THE SWFI-RECONSTITUTED HERCEPTIN VIAL FOLLOWING A SINGLE USE. Immunogenicity: Of 903 patients who have been evaluated, human anti-human antibody (HAHA) to Trastuzumab was detected in onepatient, who had no allergic manifestations. Carcinogenesis, Mutagenesis, Impairment of Fertility: Carcinogenesis ?HERCEPTIN has not been tested for its carcinogenic potential. Mutagenesis ?No evidence of mutagenic activity was observed in Ames tests using six different test strains of bacteria, with and without metabolic activation, at concentrations of up to 5000 ?g/mL Trastuzumab. Human peripheral blood lymphocytes treated i nv i t r o at concentrations of up to 5000 g/plate Trastuzumab, with and without metabolic activation, revealed no evidence of mutagenic potential. In an i nv i v o mutagenic assay (the micronucleus assay), no evidence of chromosomal damage to mouse bone marrow cells was observed following bolus intravenous doses of up to 118 mg/kg Trastuzumab. Impairment of Fertility ?A fertility study has been conducted in female cynomolgus monkeys at doses up to 25times the weekly human maintenance dose of 2mg/kg HERCEPTIN and has revealed no evidence of impaired fertility. Pregnancy Category B: Reproduction studies have been conducted in cynomolgus monkeys at doses up to 25 times the weekly human maintenance dose of 2 mg/kg HERCEPTIN and have revealed no evidence of impaired fertility or harm to the fetus. However, HER2 protein expression is high in many embryonic tissues including cardiac and neural tissues; in mutant mice lacking HER2, embryos died in early gestation.9 Placental transfer of HERCEPTIN during the early (Days 20–50 of gestation) and late (Days 120–150 of gestation) fetal development period was observed in monkeys. There are, however, no adequate and wellcontrolled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Nursing Mothers: A study conducted in lactating cynomolgus monkeys at doses 25times the weekly human maintenance dose of 2mg/kg HERCEPTIN demonstrated that Trastuzumab is secreted in the milk. The presence of Trastuzumab in the serum of infant monkeys was not associated with any adverse effects on their growth or development from birth to 3 months of age. It is not known whether HERCEPTIN is excreted in human milk. Because human IgG is excreted in human milk, and the potential for absorption and harm to the infant is unknown, women should be advised to discontinue nursing during HERCEPTIN therapy and for 6 months after the last dose of HERCEPTIN. Pediatric Use: The safety and effectiveness of HERCEPTIN in pediatric patients have not been established. Geriatric Use: HERCEPTIN has been administered to 133 patients who were 65 years of age or over. The risk of cardiac dysfunction may be increased in geriatric patients. The reported clinical experience is not adequate to determine whether older patients respond differently from younger patients.
Drug Interactions
Summary Drug Interactions: There have been no formal drug interaction studies performed with HERCEPTIN in humans. Administration of paclitaxel in combination with HERCEPTIN resulted in a two-fold decrease in HERCEPTIN clearance in a non-human primate study and in a 1.5-fold increase in HERCEPTIN serum levels in clinical studies (see Pharmacokinetics).
Adverse Reactions
Summary A total of 958 patients have received HERCEPTIN alone or in combination with chemotherapy. Data in the table below are based on the experience with the recommended dosing regimen for HERCEPTIN in the randomized controlled clinical trial in 234 patients who received HERCEPTIN in combination with chemotherapy and four open-label studies of HERCEPTIN as a single agent in 352 patients at doses of 10–500 mg administered weekly. Cardiac Failure/Dysfunction: For a description of cardiac toxicities, see WARNINGS. Anemia and Leukopenia: An increased incidence of anemia and leukopenia was observed in the treatment group receiving HERCEPTIN and chemotherapy, especially in the HERCEPTIN and ACsubgroup, compared with the treatment group receiving chemotherapy alone. The majority of these cytopenic events were mild or moderate in intensity, reversible, and none resulted in discontinuation of therapy with HERCEPTIN. Hematologic toxicity is infrequent following the administration of HERCEPTIN as a single agent, with an incidence of Grade III toxicities for WBC, platelets, hemoglobin all<1%. No Grade IV toxicities were observed. Diarrhea : Of patients treated with HERCEPTIN as a single agent, 25% experienced diarrhea. An increased incidence of diarrhea, primarily mild to moderate in severity, was observed in patients receiving HERCEPTIN in combination with chemotherapy. Infection: An increased incidence of infections, primarily mild upper respiratory infections of minor clinical significance or catheter infections, was observed in patients receiving HERCEPTIN in combination with chemotherapy. Infusion-Associated Symptoms: During the first infusion with HERCEPTIN, a symptom complex most commonly consisting of chills and/or fever was observed in about 40% of patients. The symptoms were usually mild to moderate in severity and were treated with acetaminophen, diphenhydramine, and meperidine (with or without reduction in the rate of HERCEPTIN infusion). HERCEPTIN discontinuation was infrequent. Other signs and/or symptoms may include nausea, vomiting, pain (in some cases at tumor sites), rigors, headache, dizziness, dyspnea, hypotension, rash, and asthenia. The symptoms occurred infrequently with subsequent HERCEPTIN infusions. Table 4 Other serious adverse events The following other serious adverse events occurred in at least one of the 958 patients treated with HERCEPTIN (Trastuzumab): Body as a Whole: cellulitis, anaphylactoid reaction, ascites, hydrocephalus, radiation injury, deafness, amblyopia Cardiovascular: vascular thrombosis, pericardial effusion, heart arrest, hypotension, syncope, hemorrhage, shock arrhythmia Digestive : hepatic failure, gastroenteritis, hematemesis, ileus, intestinal obstruction, colitis, esophageal ulcer, stomatitis, pancreatitis, hepatitis Endocrine: hypothyroidism Hematological: pancytopenia, acute leukemia, coagulation disorder, lymphangitis Metabolic : hypercalcemia, hypomagnesemia, hyponatremia, hypoglycemia, growth retardation, weight loss Musculoskeletal: pathological fractures, bone necrosis, myopathy Nervous: convulsion, ataxia, confusion, manic reaction Respiratory: apnea, pneumothorax, asthma, hypoxia, laryngitis Skin: herpes zoster, skin ulceration Urogenital : hydronephrosis, kidney failure, cervical cancer, hematuria, hemorrhagic cystitis, pyelonephritis
Overdosage
Summary There is no experience with overdosage in human clinical trials. Single doses higher than 500 mg have not been tested.
Dosage and Administration
Summary Usual Dose The recommended initial loading dose is 4 mg/kg Trastuzumab administered as a 90-minute infusion. The recommended weekly maintenance dose is 2 m g / k g Trastuzumab and can be administered as a 30-minute infusion if the initial loading dose was well tolerated. HERCEPTIN may be administered in an outpatient setting. DO NOT ADMINISTER AS AN IV PUSH OR BOLUS (see ADMINISTRATION). Preparation for Administration Use appropriate aseptic technique. Each vial of HERCEPTIN should be reconstituted with 20mL of BWFI, USP, 1.1% benzyl alcohol preserved, as supplied, to yield a multi-dose solution containing 21 m g / m L Trastuzumab. Immediately upon reconstitution with BWFI, the vial of HERCEPTIN must be labeled in the area marked “Do not use after:” with the future date that is 28 days from the date of reconstitution. If the patient has known hypersensitivity to benzyl alcohol, HERCEPTIN must be reconstituted with Sterile Water for Injection (see PRECAUTIONS). HERCEPTIN WHICH HAS BEEN RECONSTITUTED WITH SWFI MUST BE USED IMMEDIATELY AND ANY UNUSED PORTION DISCARDED. USE OF OTHER RECONSTITUTION DILUENTS SHOULD BE AVOIDED. Determine the number of mg of Trastuzumab needed, based on a loading dose of 4 m g Trastuzumab/kg body weight or a maintenance dose of 2 mg Trastuzumab/kg body weight. Calculate the volume of 21 mg/mL Trastuzumab solution and withdraw this amount from the vial and add it to an infusion bag containing 250 m L of 0.9%sodium chloride, USP. DEXTROSE (5%) SOLUTION SHOULD NOT BE USED. Gently invert the bag to mix the solution. The reconstituted preparation results in a colorless to pale yellow transparent solution. Parenteral drug products should be inspected visually for particulates and discoloration prior to administration. No incompatibilities between HERCEPTIN and polyvinylchloride or polyethylene bags have been observed. Administration Treatment may be administered in an outpatient setting by administration of a 4 mg/kg Trastuzumab loading dose by intravenous (IV) infusion over 90 minutes. DO NOT ADMINISTER AS AN IV PUSH OR BOLUS . Patients should be observed for fever and chills or other infusion-associated symptoms (see ADVERSE REACTIONS). If prior infusions are well tolerated, subsequent weekly doses of 2 mg / k g Trastuzumab may be administered over 30 minutes. HERCEPTIN should not be mixed or diluted with other drugs. HERCEPTIN infusions should not be administered or mixed with Dextrose solutions. Stability and Storage Vials of HERCEPTIN are stable at 2–8°C (36–46°F) prior to reconstitution. Do not use beyond the expiration date stamped on the vial. A vial of HERCEPTIN reconstituted with BWFI, as supplied, is stable for 28days after reconstitution when stored refrigerated at 2–8°C (36–46°F), and the solution is preserved for multiple use. Discard any remaining multi-dose reconstituted solution after 28days. If unpreserved SWFI (not supplied) is used, the reconstituted HERCEPTIN solution should be used immediately and any unused portion must be discarded. DO NOT FREEZE HERCEPTIN THAT HAS BEEN RECONSTITUTED. The solution of HERCEPTIN for infusion diluted in polyvinylchloride or polyethylene bags containing 0.9% Sodium Chloride for Injection, USP, may be stored at 2–8°C (36–46°F) for up to 24 hours prior to use. Diluted HERCEPTIN has been shown to be stable for up to 24 hours at room temperature (2–25°C). However, since diluted HERCEPTIN contains no effective preservative, the reconstituted and diluted solution should be stored refrigerated (2–8°C).
How Supplied
Summary HERCEPTIN is supplied as a lyophilized, sterile powder containing 440mg Trastuzumab per vial under vacuum. Each carton contains one vial of 440mg HERCEPTIN(Trastuzumab) and one 30mL vial of Bacteriostatic Water for Injection, USP, 1.1% benzyl alcohol. NDC 50242-134-60.

 

 
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