Pronunciation:

tras-TOOZ-oo-mab - dttb

Brand Names:

• Ontruzant

Dosage Forms:

• Powder for Solution

Warnings:

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—

Trastuzumab

Uses of This Medicine:

Trastuzumab-dttb injection is used to treat HER2-overexpressing node positive or node negative (ER/PR negative or with one high risk feature) breast cancer. It can be used alone after a previous treatment with an anthracycline medicine or with other cancer medicines (eg, carboplatin, cyclophosphamide, docetaxel, doxorubicin, paclitaxel).

Trastuzumab-dttb injection is also used alone to treat HER2-overexpressing metastatic (cancer that has spread) breast cancer in patients who have previously received one or more cancer treatments or as first-line treatment together with paclitaxel to treat HER2-overexpressing metastatic breast cancer.

Trastuzumab-dttb 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-dttb 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). Your doctor will test for the presence of this protein.

Trastuzumab-dttb 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-dttb, other effects will also occur. Some of these may be serious and must be reported to your doctor.

This medicine is to be given only by or under the direct 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-dttb 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-dttb 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 30 to 90 minutes.

Avoid using other cancer medicines (eg, anthracyclines) for up to 7 months after stopping treatment with trastuzumab-dttb injection. If you are receiving an anthracycline medicine, your doctor may need to check for heart problems regularly.

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 and urine tests may be needed to check for unwanted effects.

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

Your doctor may test your heart before you start receiving trastuzumab-dttb 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.

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, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
• Check with your doctor immediately if you notice any unusual bleeding or bruising, black, tarry stools, blood in urine or stools, or pinpoint red spots on your skin.
• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
• 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.
• Be careful not to cut yourself when you are using sharp objects, such as a safety razor or fingernail or toenail cutters.
• Avoid contact sports or other situations where bruising or injury could occur.

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

Black, tarry stools

bleeding gums

bloating or swelling of the face, arms, hands, lower legs, or feet

bloody urine

body aches or pain

chest pain

chills

cough

decreased frequency or amount of urine

diarrhea

difficulty in breathing

dilated neck veins

dry mouth

dryness or soreness of the throat

ear congestion

extreme tiredness or weakness

fever

general feeling of discomfort or illness

headache

hoarseness

increased blood pressure

increased cough

increased thirst

irregular breathing

irregular heartbeat

joint pain

loss of appetite

loss of voice

lower back or side pain

mood changes

muscle pain or cramps

nausea

numbness or tingling in the hands, feet, or lips

pain or tenderness around the eyes and cheekbones

painful or difficult urination

pale skin

pinpoint red spots on the skin

rapid weight gain

seizures

shivering

sneezing

sore throat

stuffy or runny nose

sweating

tender, swollen glands in the neck

tightness in the chest

trouble in swallowing

trouble sleeping

troubled breathing with exertion

ulcers, sores, or white spots in the mouth

unusual bleeding or bruising

unusual tiredness or weakness

unusual weight gain or loss

voice changes

vomiting

Less common

Bladder pain

blindness or vision changes

blurred vision

burning of the face or mouth

burning, crawling, itching, numbness, painful, prickling, "pins and needles", or tingling feelings

cloudy urine

clumsiness or unsteadiness

dizziness

fast, pounding, or irregular heartbeat or pulse

frequent urge to urinate

nervousness

nosebleed

painful cold sores or blisters on the lips, nose, eyes, or genitals

pounding in the ears

slow heartbeat

weakness in the hands or feet

Rare

Decreased ability to exercise

fainting

hives, itching, skin rash

irritation

joint stiffness or swelling

neck tenderness or swelling

redness of the skin

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

Back pain

bone pain

change in or loss of taste

cracked lips

depression

difficulty in moving

lack or loss of strength

stomach pain

swelling or inflammation of the mouth

trouble sleeping

weight decreased

Less common

Belching

heartburn

indigestion

muscle spasm

stabbing pain

stomach discomfort or upset

upper stomach pain

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.