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Drugs reference index «Herceptin»

Herceptin


Herceptin

Generic Name: trastuzumab (Intravenous route)

tras-too-zoo-mab

Intravenous routePowder for Solution
  • Cardiomyopathy
    • Trastuzumab can result in sub-clinical and clinical cardiac failure manifesting as congestive heart failure (CHF) and decreased left ventricular ejection fraction (LVEF). The incidence and severity of left ventricular cardiac dysfunction was highest in patients who received trastuzumab concurrently with anthracycline-containing chemotherapy regimens.
    • Evaluate left ventricular function in all patients prior to and during treatment with trastuzumab. Discontinue trastuzumab treatment in patients receiving adjuvant therapy and strongly consider discontinuation of trastuzumab treatment in patients with metastatic breast cancer for clinically significant decrease in left ventricular function.
  • Infusion Reactions/Pulmonary Toxicity
    • Trastuzumab 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 trastuzumab. Trastuzumab infusion should be interrupted for patients experiencing dyspnea or clinically significant hypotension. Patients should be monitored until signs and symptoms completely resolve. Discontinue trastuzumab for infusion reactions manifesting as anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome

Trastuzumab can result in sub-clinical and clinical cardiac failure manifesting as congestive heart failure (CHF), and decreased left ventricular ejection fraction (LVEF), with greatest risk when administered concurrently with anthracyclines. Evaluate cardiac function prior to and during treatment. Discontinue trastuzumab for cardiomyopathy. Discontinue trastuzumab for anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome .

Commonly used brand name(s):

In the U.S.

  • Herceptin

Available Dosage Forms:

  • Powder for Solution

Therapeutic Class: Immunological Agent

Pharmacologic Class: Monoclonal Antibody

Uses For Herceptin

Trastuzumab is a monoclonal antibody. It is used to treat new cases of breast cancer or disease that has spread to other parts of the body. Trastuzumab may prevent the growth of some breast tumors that produce extra amounts of a certain substance known as the HER2 protein. Trastuzumab should only be used in patients whose breast tumors have been shown to produce extra amounts of this protein. It can be used alone or with other cancer medicines (chemotherapy) such as doxorubicin, cyclophosphamide, paclitaxel, docetaxel, and carboplatin .

Trastuzumab is to be administered only by or under the immediate supervision of your doctor .

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, trastuzumab is used in certain patients with the following medical conditions:

  • Breast cancer, HER2-overexpressing disease, primary treatment in combination with chemotherapy, before surgery .

Before Using Herceptin

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of trastuzumab in the pediatric population. Safety and efficacy have not been established .

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of trastuzumab in the elderly. However, elderly patients are more likely to have age-related heart problems, which may require caution in patients receiving trastuzumab .

Pregnancy

Pregnancy CategoryExplanation
All TrimestersDStudies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Aclarubicin
  • Cyclophosphamide
  • Daunorubicin
  • Daunorubicin Citrate Liposome
  • Doxorubicin Hydrochloride
  • Doxorubicin Hydrochloride Liposome
  • Epirubicin
  • Idarubicin
  • Pirarubicin

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Warfarin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Heart disease or
  • Lung disease—May make these conditions worse .

Proper Use of Herceptin

A nurse or other trained health professional will give you this medicine. This medicine is given through a needle placed in one of your veins .

Precautions While Using Herceptin

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and to check for any unwanted effects .

Contact your doctor right away if you experience any chest pain, increased coughing, trouble with breathing, a sudden difficulty with breathing at night, or abnormal swelling in your ankles or legs. These could be symptoms of serious heart problems .

This medicine can cause harm to your unborn baby. Make sure your doctor knows if you are pregnant before taking this medicine. If you think you have become pregnant while using the medicine, tell your doctor right away .

Trastuzumab may cause a serious side effect called an infusion reaction. This can be life-threatening and require immediate medical attention. Tell your doctor or nurse right away if you have fever, chills, trouble with breathing, lightheadedness, fainting, chest pain, headache, dizziness, rash, pain, nausea, vomiting, or weakness within a few hours after you receive it .

This medicine can temporarily lower the number of white blood cells in your blood, which increases the chance of getting an infection. If this occurs, there are certain precautions you can take to reduce the risk of infection :

  • If you can, avoid people with infections. Check with your doctor right away if you think you are getting an infection or if you get a fever or chills, a cough or hoarseness, lower back or side pain, or have painful or difficult urination.
  • Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime .

Herceptin Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common
  • Dizziness
  • fever or chills
  • headache
  • muscle aches
  • nausea or vomiting
  • shortness of breath
  • skin rash
  • sore throat
  • stuffy or runny nose
  • unusual tiredness or weakness
Less common
  • Bloody nose
  • cough
  • diarrhea
  • difficult or labored breathing
  • ear congestion or pain
  • fast or irregular heartbeat
  • general feeling of discomfort or illness
  • head congestion
  • hoarseness or other voice changes
  • increased cough
  • joint pain
  • loss of appetite
  • nasal congestion
  • pain or tenderness around the eyes and cheekbones
  • shivering
  • sneezing
  • sweating
  • swelling of the feet or lower legs
  • tightness in the chest
  • trouble sleeping
  • vomiting
  • wheezing
Rare
  • Blue lips and fingernails
  • blurred vision
  • chest pain
  • confusion
  • cough or hoarseness, accompanied by fever or chills
  • faintness or lightheadedness when getting up from a lying or sitting position suddenly
  • itching
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, feet, or sex organs
  • lower back or side pain, accompanied by fever or chills
  • painful or difficult urination, accompanied by fever or chills
  • pale skin
  • redness of the skin
  • trouble with breathing
Incidence not known
  • Black, tarry stools
  • sores, ulcers, or white spots in the mouth
  • unusual bleeding or bruising

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Pain
Less common
  • Numbness or tingling of the hands or feet

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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  • Herceptin Prescribing Information (FDA)
  • Herceptin MedFacts Consumer Leaflet (Wolters Kluwer)
  • Herceptin Consumer Overview
  • Trastuzumab Professional Patient Advice (Wolters Kluwer)

See Also...