Pronunciation:

tras-TOOZ-oo-mab

Brand Names:

• Herceptin
• Herzuma
• Kanjinti
• Ogivri
• Ontruzant
• Trazimera

Dosage Forms:

• Powder for Solution

Warnings:

Trastuzumab can result in subclinical and clinical cardiac failure, with the greatest risk and severity upon concurrent administration with anthracyclines. Evaluate cardiac function prior to and during treatment. Discontinue trastuzumab in patients receiving adjuvant therapy and withhold trastuzumab for a clinically significant decrease in left ventricular function. Serious and fatal infusion reactions and pulmonary toxicity may occur during or within 24 hours after administration. Discontinue trastuzumab if signs of anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome are noted. Exposure during pregnancy can result in oligohydramnios, in some cases complicated by pulmonary hypoplasia, skeletal abnormalities, and neonatal death. Advise patients of these risks and the need for effective contraception .

CardiomyopathyAdministration of trastuzumab products can result in subclinical and clinical cardiac failure. The incidence and severity were highest in patients receiving trastuzumab with anthracycline-containing chemotherapy regimens. Evaluate left ventricular function in all patients prior to and during treatment with trastuzumab-qyyp. Discontinue trastuzumab-qyyp treatment in patients receiving adjuvant therapy and withhold trastuzumab-qyyp in patients with metastatic disease for clinically significant decrease in left ventricular function.Infusion Reactions, Pulmonary ToxicityAdministration of trastuzumab products can result in serious and fatal infusion reactions and pulmonary toxicity. Symptoms usually occur during or within 24 hours of administration. Interrupt trastuzumab-qyyp infusion for dyspnea or clinically significant hypotension. Monitor patients until symptoms completely resolve. Discontinue trastuzumab-qyyp for anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome.Embryo-Fetal ToxicityExposure to trastuzumab products during pregnancy can result in oligohydramnios and oligohydramnios sequence manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death. Advise patients of these risks and the need for effective contraception .

Administration of trastuzumab products can result in subclinical and clinical cardiac failure, with the greatest risk and severity upon concurrent administration with anthracyclines. Evaluate cardiac function prior to and during treatment. Discontinue trastuzumab-dkst in patients receiving adjuvant therapy and withhold trastuzumab-dkst for a clinically significant decrease in left ventricular function. Serious and fatal infusion reactions and pulmonary toxicity may occur during or within 24 hours after administration. Discontinue trastuzumab-dkst if signs of anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome are noted. Exposure during pregnancy can result in oligohydramnios, in some cases complicated by pulmonary hypoplasia, skeletal abnormalities, and neonatal death. Advise patients of these risks and the need for effective contraception .

CardiomyopathyAdministration of trastuzumab products can result in subclinical and clinical cardiac failure. The incidence and severity were highest in patients receiving trastuzumab with anthracycline-containing chemotherapy regimens. Evaluate left ventricular function in all patients prior to and during treatment with trastuzumab-pkrb. Discontinue trastuzumab-pkrb treatment in patients receiving adjuvant therapy and withhold trastuzumab-pkrb in patients with metastatic disease for clinically significant decrease in left ventricular function.Infusion Reactions, Pulmonary ToxicityAdministration of trastuzumab products can result in serious and fatal infusion reactions and pulmonary toxicity. Symptoms usually occur during or within 24 hours of administration. Interrupt trastuzumab-pkrb infusion for dyspnea or clinically significant hypotension. Monitor patients until symptoms completely resolve. Discontinue trastuzumab-pkrb for anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome.Embryo-Fetal ToxicityExposure to trastuzumab products during pregnancy can result in oligohydramnios and oligohydramnios sequence manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death. Advise patients of these risks and the need for effective contraception .

Trastuzumab products can result in subclinical and clinical cardiac failure manifesting as CHF and decreased LVEF, with the greatest risk upon concurrent administration with anthracyclines. Evaluate cardiac function prior to and during treatment. Discontinue trastuzumab-anns in patients receiving adjuvant therapy and withhold trastuzumab for a clinically significant decrease in left ventricular function. Serious and fatal infusion reactions and pulmonary toxicity may occur during or within 24 hours after administration. Discontinue trastuzumab-anns if signs of anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome are noted. Exposure during pregnancy can result in oligohydramnios, in some cases complicated by pulmonary hypoplasia, skeletal abnormalities, and neonatal death. Advise patients of these risks and the need for effective contraception .

CardiomyopathyAdministration of trastuzumab products can result in subclinical and clinical cardiac failure. The incidence and severity were highest in patients receiving trastuzumab with anthracycline-containing chemotherapy regimens. Evaluate left ventricular function in all patients prior to and during treatment with trastuzumab-dttb. Discontinue trastuzumab-dttb treatment in patients receiving adjuvant therapy and withhold trastuzumab-dttb in patients with metastatic disease for clinically significant decrease in left ventricular function.Infusion Reactions, Pulmonary ToxicityAdministration of trastuzumab products can result in serious and fatal infusion reactions and pulmonary toxicity. Symptoms usually occur during or within 24 hours of administration. Interrupt trastuzumab-dttb infusion for dyspnea or clinically significant hypotension. Monitor patients until symptoms completely resolve. Discontinue trastuzumab-dttb for anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome.Embryo-Fetal ToxicityExposure to trastuzumab products during pregnancy can result in oligohydramnios and oligohydramnios sequence manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death. Advise patients of these risks and the need for effective contraception .

Classifications:

Therapeutic—

Antineoplastic Agent

Pharmacologic—

Monoclonal Antibody

Uses of This Medicine:

Trastuzumab injection is used to treat HER2-overexpressing new or metastatic (cancer that has spread) breast cancer. It can be used alone or with other cancer medicines (eg, carboplatin, cyclophosphamide, docetaxel, doxorubicin, paclitaxel).

Trastuzumab injection is also used in combination with cisplatin and capecitabine or 5-fluorouracil to treat HER2-overexpressing metastatic (cancer that has spread) stomach and gastroesophageal (stomach and esophagus) cancer.

Trastuzumab prevents the growth of some tumors that produce extra amounts of a certain substance known as the HER2 protein. It should only be used in patients whose tumors have been shown to produce extra amounts of this protein (HER2 overexpression).

Trastuzumab is a monoclonal antibody. It interferes with the growth of cancer cells, which are eventually destroyed by the body. Since the growth of normal body cells may also be affected by trastuzumab, other effects will also occur. Some of these may be serious and must be reported to your doctor. Other effects, such as a skin rash, may not be serious but may cause concern. Some effects do not occur until months or years after the medicine is used.

This medicine is to be given only by or under the immediate supervision of your doctor.

Before Using This Medicine:

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.

Children—

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

Older adults—

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

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.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

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.

• Daunorubicin
• Daunorubicin Citrate Liposome
• Daunorubicin Liposome
• Doxorubicin
• Doxorubicin Hydrochloride Liposome
• Epirubicin
• Idarubicin
• Pirarubicin
• Pixantrone
• Valrubicin

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

Other interactions—

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 (eg, cardiomyopathy, heart failure) or
• Heart rhythm problems (eg, arrhythmia) or
• Hypertension (high blood pressure) or
• Lung disease (eg, interstitial pneumonitis, pulmonary fibrosis)—Use with caution. May make these conditions worse.

• Infection—May decrease your body's ability to fight infection.

Proper Use of This Medicine:

Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.

A doctor or other trained health professional will give you this medicine. It is given through a needle placed into one of your veins. It must be given slowly, so the needle should remain in place for at least 90 minutes.

Missed dose—

This medicine needs to be given on a fixed schedule. If you miss a dose, call your doctor, home health caregiver, or treatment clinic for instructions.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Your doctor may test your heart before you start receiving trastuzumab injection and while you are getting treatments with this medicine. Contact your doctor right away if you experience any chest pain, increased coughing, trouble with breathing, a sudden difficulty with breathing at night, rapid weight gain, or abnormal swelling in your ankles or legs. These could be symptoms of a serious heart problem.

This medicine may cause infusion-related reactions, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you start to have a fever, chills or shaking, dizziness, trouble breathing, itching or rash, lightheadedness or fainting after receiving this medicine.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant during therapy and for 7 months after the last dose of this medicine. If you think you have become pregnant while using the medicine, tell your doctor right away.

Serious lung or breathing problems may occur after you receive this medicine. Call your doctor right away if have changes in your breathing, chest tightness, or any type of breathing problem.

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.
• Check with your doctor immediately if you notice any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, or pinpoint red spots on your skin.
• 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.

Side Effects of This Medicine:

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 or nurse immediately if any of the following side effects occur:

More common

Dizziness

fever or chills

headache

muscle aches

nausea or vomiting

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 with sleeping

vomiting

Rare

Blue lips and fingernails

blurred vision

chest pain

confusion

cough or hoarseness, accompanied by fever or chills

faintness or lightheadedness when suddenly getting up from a lying or sitting position

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

Incidence not known

Black, tarry stools

bloody or cloudy urine

sores, ulcers, or white spots in the mouth

unusual bleeding or bruising

weight gain

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

Difficulty in moving

metallic taste in the tongue

muscle pain or stiffness

pain

weight loss

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.