Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Herceptin there are no specific foods that you must exclude from your diet when receiving Herceptin.
Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you are being treated with:
- daunorubicin (Daunoxome, Cerubidine)
- doxorubicin (Doxil)
- epirubicin (Ellence)
- idarubicin (Idamycin)
- paclitaxel (Abraxane, Taxol)
This is not a complete list of Herceptin drug interactions. Ask your doctor or pharmacist for more information.
Herceptin is given intravenously (IV) by a healthcare provider in a medical setting (healthcare provider’s office, or hospital). The first dose is usually given over 90 minutes. Subsequent maintenance doses may be given over 30 minutes if the first dose is well-tolerated. Herceptin is given once a week or every three weeks, depending on the chosen dosing regimen.
Your doctor will monitor the side effects you experience and your response to therapy, as well as:
- how well your heart, kidneys and liver are functioning
- your complete blood count (CBC)
Herceptin is supplied in a multi‑use vial containing 440 mg trastuzumab as a lyophilized sterile powder, under vacuum. Each carton contains one vial Herceptin and one vial (20 mL) of Bacteriostatic Water for Injection (BWFI), USP, containing 1.1% benzyl alcohol as a preservative.
Active ingredient: trastuzumab
Inactive ingredients: trehalose dihydrate, histidine monohydrochloride, histidine, polysorbate 20, bacteriostatic water, benzyl alcohol.
While you are receiving Herceptin, your doctor may require you have certain lab tests to check your body’s response to Herceptin. Be certain to keep all appointments with your doctor and the laboratory.
The Herceptin dose you receive will depend upon the type and severity of cancer you have, your weight, as well as other factors. Your doctor will determine the best dose and regimen for you.
WARNING: CARDIOMYOPATHY, INFUSION REACTIONS, EMBRYO-FETAL TOXICITY, and PULMONARY TOXICITY
Cardiomyopathy
Herceptin administration can result in sub‑clinical and clinical cardiac failure. The incidence and severity was highest in patients receiving Herceptin 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 withhold Herceptin in patients with metastatic disease for clinically significant decrease in left ventricular function.
Infusion Reactions; Pulmonary Toxicity
Herceptin administration can result in serious and fatal infusion reactions and pulmonary toxicity. Symptoms usually occur during or within 24 hours of Herceptin administration. Interrupt Herceptin infusion for dyspnea or clinically significant hypotension. Monitor patients until symptoms completely resolve. Discontinue Herceptin for anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome.
Embryo Fetal Toxicity
Exposure to Herceptin during pregnancy can result in oligohydramnios and oligohydramnios sequence manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death.
Before taking Herceptin, tell your doctor if you have any other medical problems, especially heart disease, lung disease, or infection.
Tell your doctor if you have ever had an allergic reaction to this or any other medication. You should not receive Herceptin if you are allergic to medicines made from Chinese hamster ovary cell protein or those containing benzyl alcohol.
Tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. You should use birth control to prevent pregnancy during your treatment and for 6 months after your treatment.
If you are having surgery, including dental surgery, tell the doctor or dentist that you are receiving Herceptin.
Tell your doctor if you are allergic to any ingredient in Herceptin, medicines made from Chinese hamster ovary cell protein, benzyl alcohol, or any other medicines.
Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.
Tell your doctor if you have lung disease or heart disease.
Tell your doctor if you are pregnant or breastfeeding.
As with all medications Herceptin can have unwanted side effects. The most commonly reported side effects with Herceptin injections are pain, weakness, fever, nausea, chills, headache, and cough.
Less frequently, serious side effects have occurred during treatment with Herceptin. These include life-threatening heart problems, lung damage, as well as infusion reactions, and fetal harm or death when given to pregnant women. See Black Box Warning section.
Tell your doctor or nurse if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Let your doctor know 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.
Herceptin is a form of targeted cancer therapy known as a monoclonal antibody. It is a man-made protein designed to act just like the antibodies produced by our immune system, by seeking out a specific protein on a cell and attaching to it. Some types of breast cancer cells have a receptor being overexpressed, called HER2/neu, which causes the breast cancer to grow out of control. Herceptin finds and attaches to this receptor, essentially turning it off.
This medication is used to treat new cases of breast cancer or disease that has spread to other parts of the body. Other medicines that are used along with Herceptin often incude:
- Doxorubicin
- Cyclophosphamide
- Paclitaxel
- Doxetaxel
- Carboplatin
Herceptin is also used in combination with cisplatin and capecitabine or 5-fluorouracil to treat metastatic gastric cancer (stomach and esophagus cancer that has spread) with over expression of the HER2 protein.
Before you begin treatment with Herceptin, you and your doctor should talk about the benefits this medicine will have as well as the risks of using it.
This medicine is to be administered only by or under the immediate supervision of your doctor. Herceptin is injected into a vein (intravenous infusion) in a medical clinic or hospital.
Herceptin is a prescription medication used alone or in combination with other medications to treat certain types of breast cancer that has spread to other parts of the body. Herceptin is also used with other medications to treat stomach cancer that has spread to other parts of the body.
This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.
In case of overdose, contact your local poison control center.
There is no experience with overdosage in human clinical trials.
Nursing mothers taking Herceptin may want to stop nursing or stop Herceptin, depending on the importance of the drug to the mother. Talk to your doctor if you are breastfeeding or plan to breastfeed. It is not known if Herceptin is excreted in human breast milk or if it will harm your baby.
Adjuvant Breast Cancer
Herceptin is used for adjuvant (supplemental) treatment of HER2 overexpressing node positive or node negative (ER/PR negative or with one high risk feature breast cancer:
- As part of a treatment regimen consisting of doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel
- With docetaxel and carboplatin
- As a single agent following multi-modality anthracycline based therapy.
Metastatic Breast Cancer
Herceptin is used:
- In combination with paclitaxel for first-line treatment of HER2-overexpressing metastatic breast cancer
- As a single agent for treatment of HER2-overexpressing breast cancer in patients who have received one or more chemotherapy regimens for metastatic disease.
Metastatic Gastric Cancer
Herceptin is used, in combination with cisplatin and capecitabine or 5-fluorouracil, for the treatment of patients with HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma, who have not received prior treatment for metastatic disease.
WARNING: CARDIOMYOPATHY, INFUSION REACTIONS, EMBRYO-FETAL TOXICITY, and PULMONARY TOXICITY
Cardiomyopathy
Herceptin administration can result in sub‑clinical and clinical cardiac failure. The incidence and severity was highest in patients receiving Herceptin 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 withhold Herceptin in patients with metastatic disease for clinically significant decrease in left ventricular function. [see Warnings and Precautions (5.1) and Dosage and Administration (2.2)]
Infusion Reactions; Pulmonary Toxicity
Herceptin administration can result in serious and fatal infusion reactions and pulmonary toxicity. Symptoms usually occur during or within 24 hours of Herceptin administration. Interrupt Herceptin infusion for dyspnea or clinically significant hypotension. Monitor patients until symptoms completely resolve. Discontinue Herceptin for anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome. [see Warnings and Precautions (5.2, 5.4)]
Embryo Fetal Toxicity
Exposure to Herceptin during pregnancy can result in oligohydramnios and oligohydramnios sequence manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death. [see Warnings and Precautions (5.3), Use in Specific Populations (8.1)]
Active Ingredient: Trastuzumab
Always let your doctor know what other medications or supplements you may be taking. Always keep doctor’s appointments as they may need to check your laboratory tests.
Heart Problems
- Herceptin treatment can result in heart problems, including those without symptoms (such as reduced heart function) and those with symptoms (such as congestive heart failure). The risk and seriousness of these heart problems were highest in people who received both Herceptin and a certain type of chemotherapy (anthracycline). One patient died in an adjuvant (early) breast cancer trial of significantly weakened heart muscle.
- Herceptin can cause serious heart problems, including:
- A decline in heart function
- Irregular heartbeats
- High blood pressure
- Serious heart attack
- Death
- Your doctor will stop Herceptin therapy if you have weakening of the heart muscle or changes in the heart muscle structure.
Monitoring the Heart
- Your doctor will evaluate your heart function before and during treatment. For adjuvant breast cancer therapy, your doctor will also evaluate heart function after the end of treatment.
- Your doctor may run tests, such as an echocardiogram or a MUGA scan, and will review your health history to see how well the heart muscle is working.
- If you are taking Herceptin and have stopped treatment temporarily because of significant heart problems, your doctor should monitor your heart health more frequently.
Infusion Reactions
- Some patients have had serious infusion reactions and lung problems; infusion reactions leading to death have been reported
- Symptoms usually happen during or within 24 hours of taking Herceptin
- Your infusion should be temporarily stopped if you experience shortness of breath or very low blood pressure
- Your doctor should monitor you until these symptoms completely go away
- Your doctor may have you completely stop Herceptin treatment if you have:
- A severe allergic reaction
- Swelling
- Lung problems
- Swelling of the lungs
- Severe shortness of breath
- Infusion reaction symptoms consist of:
- Fever and chills
- Nausea
- Vomiting
- Pain (in some cases at tumor sites)
- Headache
- Dizziness
- Shortness of breath
- Very low blood pressure
- Rash
- Lack of energy and strength
Pregnancy
- Herceptin can cause harm to the fetus (unborn baby), in some cases death to the fetus, when taken by a pregnant woman
- You should use effective birth control methods while receiving Herceptin and for at least 6 months after you finish taking Herceptin
- Nursing mothers taking Herceptin may want to stop nursing or stop Herceptin, depending on the importance of the drug to the mother
Taking Herceptin Can Result in Serious and Potentially Deadly Lung Problems, Including:
- A severe shortness of breath
- Fluid in or around the lungs
- Weakening of the valve between the heart and the lungs
- Too little oxygen in the body
- Swelling of the lungs
- Scarring of the lungs
Problems like these may occur after an infusion reaction. If you have trouble breathing at rest due to existing lung disease, or large lung tumors appear, you may have more serious lung problems. Your doctor should stop Herceptin if you experience lung problems.
Additional Important Safety Information associated with Herceptin
Worsening of Low White Blood Cell Counts Due to Chemotherapy
- Worsening of low white blood cell counts to serious and life-threatening levels and associated fever were higher in patients taking Herceptin in combination with chemotherapy when compared with those who received chemotherapy alone. The likelihood that a patient will die from infection was similar among patients who received Herceptin and those who did not
HER2 Testing
- You must have a HER2 test to determine if your cancer is HER2-positive before taking Herceptin, as benefit has only been shown in patients whose tumors are HER2-positive
- You should contact your doctor immediately for any of the following:
- New onset or worsening shortness of breath
- Cough
- Swelling of the ankles/legs
- Swelling of the face
- Palpitations
- Weight gain of more than 5 pounds in 24 hours
- Dizziness or loss of consciousness
- If you are pregnant or of childbearing potential, you should know that Herceptin exposure can result in harm to the fetus (unborn baby)
- You should use effective birth control methods during treatment and for a minimum of six months following Herceptin
- If you are nursing your baby, you should stop taking Herceptin or stop nursing
- Herceptin can cause harm to the fetus (unborn baby), in some cases death to the fetus, when taken by a pregnant woman.
- You should use effective birth control methods while receiving Herceptin and for at least 6 months after you finish taking Herceptin.
Herceptin is a liquid to be injected into a vein by a doctor or nurse in a hospital or medical facility. It must be given slowly, so the IV tube must remain in place for at least 90 minutes. Herceptin is usually given once a week when used to treat breast cancer that has spread to other areas of the body. When Herceptin is used to prevent the return of breast cancer, it is sometimes given once every 3 weeks and is sometimes given once a week along with other chemotherapy medications, and then once every 3 weeks after treatment with the other medications is completed. The length of your treatment depends on how well your body responds to the medication and the side effects that you experience. If you are using Herceptin to prevent the return of breast cancer, your treatment may last up to 52 weeks.