Herceptin

DRUG DESCRIPTION

Herceptin (trastuzumab) is a humanized IgGl 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 (trastuzumab) 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 ?,?-trehalose dihydrate, 9.9 mg L-histidine HC1, 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.

What are the possible side effects of trastuzumab (Herceptin)?

Some people receiving a trastuzumab injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you feel dizzy, nauseated, light-headed, weak, itchy, or short of breath during the injection.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • chest pain or heavy feeling,...

Read All Potential Side Effects and See Pictures of Herceptin

What are the precautions when taking trastuzumab (Herceptin)?

Before using trastuzumab, tell your doctor or pharmacist if you are allergic to it; or to other mouse protein medications; or if you have any other allergies. This product may contain inactive ingredients (such as benzyl alcohol), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: previous cancer treatments (including radiation therapy to the chest), current infection, virus infection with returning symptoms (e.g., herpes, shingles), heart disease, high blood pressure, lung problems, previous severe reaction to monoclonal antibody treatment.

Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact...

Read All Potential Precautions of Herceptin


Herceptin Consumer (continued)

SIDE EFFECTS: Diarrhea, redness/irritation at injection (IV) site, muscle/joint/back pain, stomach/abdominal pain, trouble sleeping, nausea, vomiting, mouth sores, and loss of appetite may occur. Nausea and vomiting can be severe. In some cases, your doctor may prescribe medication to prevent or relieve nausea and vomiting. Eating several small meals, not eating before treatment, or limiting activity may help lessen some of these effects. If these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: bone pain, increased coughing, swelling of the hands/ankles/feet, trouble breathing, unusual tiredness, severe headache, severe dizziness, tingling/numbness (e.g., in the hands, feet, leg), mental/mood changes, fast/pounding heartbeat.

Seek immediate medical attention if any of these rare but very serious side effects occur: weakness on one side of the body, slurred speech, vision changes, confusion.

This medication can lower the body's ability to fight an infection. Tell your doctor promptly if you develop any signs of an infection such as fever, chills, or persistent sore throat.

This medication can sometimes cause a serious infusion (IV) reaction. Immediately tell your doctor of the following side effects that occur while this drug is being given or within 24 hours after your treatment is finished, such as chills, fever, flushing, nausea, headache, dizziness, fainting, rash, and weakness. (See also Warning section.)

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using trastuzumab, tell your doctor or pharmacist if you are allergic to it; or to other mouse protein medications; or if you have any other allergies. This product may contain inactive ingredients (such as benzyl alcohol), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: previous cancer treatments (including radiation therapy to the chest), current infection, virus infection with returning symptoms (e.g., herpes, shingles), heart disease, high blood pressure, lung problems, previous severe reaction to monoclonal antibody treatment.

Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received oral polio vaccine or flu vaccine inhaled through the nose.

Wash your hands well to prevent the spread of infections.

To lower your risk of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Caution is advised when using this drug in the elderly because they may be at greater risk for heart problems (e.g., heart failure).

This medication is not recommended during pregnancy because of the possible risk of harm to an unborn baby. Trastuzumab should only be used during pregnancy if the benefits outweigh these risks. Use 2 effective forms of birth control (e.g., condoms and birth control pills/patch/ring) while using this medication and for 6 month after treatment has stopped. Consult your doctor for more details and to discuss reliable forms of birth control. See also Warning section.

It is not known whether this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding is not recommended while using this drug or for 6 months after the last dose.


Herceptin Patient Information Including Side Effects

Brand Names: Herceptin

Generic Name: trastuzumab (Pronunciation: tras TOO zoo mab)

  • What is trastuzumab (Herceptin)?
  • What are the possible side effects of trastuzumab (Herceptin)?
  • What is the most important information I should know about trastuzumab (Herceptin)?
  • What should I discuss with my health care provider before receiving trastuzumab (Herceptin)?
  • How is trastuzumab given (Herceptin)?
  • What happens if I miss a dose (Herceptin)?
  • What happens if I overdose (Herceptin)?
  • What should I avoid while receiving trastuzumab (Herceptin)?
  • What other drugs will affect trastuzumab (Herceptin)?
  • Where can I get more information?

What is trastuzumab (Herceptin)?

Trastuzumab is a cancer medication. It interferes with the growth of cancer cells and slows their growth and spread in your body.

Trastuzumab is used to treat breast cancer that has progressed after treatment with other chemotherapy.

Trastuzumab may also be used for other purposes not listed in this medication guide.

What are the possible side effects of trastuzumab (Herceptin)?

Some people receiving a trastuzumab injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you feel dizzy, nauseated, light-headed, weak, itchy, or short of breath during the injection.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
  • fast or pounding heartbeats;
  • feeling short of breath, even with mild exertion;
  • swelling, rapid weight gain;
  • cough or wheezing;
  • white patches or sores inside your mouth or on your lips; or
  • fever, chills, body aches, flu symptoms.

Less serious side effects are more likely to occur, such as:

  • nausea, vomiting, diarrhea;
  • sore throat, sinus pain;
  • joint or muscle pain, back pain;
  • headache; or
  • tired feeling.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about trastuzumab (Herceptin)?

Do not use this medication without telling your doctor if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment.

Before receiving trastuzumab, tell your doctor if you have heart disease, congestive heart failure, a history of heart attack, or any allergies or breathing problems. You may not be able to receive trastuzumab, or you may need a dosage adjustment or special tests during treatment.

Some people receiving a trastuzumab injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you feel dizzy, nauseated, light-headed, weak, itchy, or short of breath during the injection.

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