Pronunciation:

tras-TOOZ-oo-mab - dkst

Brand Names:

• Ogivri

Dosage Forms:

• Powder for Solution

Warnings:

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 .

Classifications:

Therapeutic—

Antineoplastic Agent

Pharmacologic—

Trastuzumab

Uses of This Medicine:

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

Trastuzumab-dkst 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-dkst 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-dkst 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-dkst, 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-dkst 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-dkst 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:

• Congestive heart failure or
• Heart disease (eg, cardiomyopathy) 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.

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.

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.

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 treatment with this medicine and for 7 months after the last dose. If you think you have become pregnant while using the medicine, tell your doctor right away.

Your doctor may test your heart before you start receiving trastuzumab-dkst 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, or 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.

Trastuzumab-dkst can temporarily lower the number of some types of blood cells in your body. Because of this, you may bleed or get infections more easily. To help with these problems, avoid being near people who are sick or have infections. Wash your hands often. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.

Do not use an anthracycline medicine for up to 7 months after stopping treatment with medicines containing trastuzumab.

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

blood in the urine or stools

chest pain

chills

cough

cracked lips

decreased frequency or amount of urine

diarrhea

difficult or labored breathing

difficulty in swallowing

dry mouth

fever

headache

hoarseness

increased blood pressure

increased thirst

irregular heartbeat

loss of appetite

lower back or side pain

mood changes

muscle aches, pain, or cramps

nausea

numbness or tingling in the hands, feet, or lips

painful or difficult urination

pale skin

peeling of the skin

pinpoint red spots on the skin

seizures

sore throat

sores, ulcers, or white spots on the lips, tongue, or inside the mouth

stuffy or runny nose

swelling of the face, fingers, or lower legs

swollen glands

tightness in the chest

troubled breathing

troubled breathing with exertion

unusual bleeding or bruising

unusual tiredness or weakness

vomiting

weight gain

Less common

Bladder pain

bloody nose

blurred vision

body aches or pain

burning or stinging of the skin

cloudy urine

dilated neck veins

dizziness

ear congestion

extreme tiredness or weakness

fainting

fast, irregular, pounding, or racing heartbeat or pulse

frequent urge to urinate

general feeling of discomfort or illness

irregular breathing

joint pain

loss of voice

nasal congestion

nervousness

pain or tenderness around the eyes and cheekbones

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

pounding in the ears

shivering

sneezing

sweating

trouble sleeping

Rare

Chest discomfort

hives, itching, skin rash

joint stiffness or swelling

neck tenderness or swelling

redness of the skin

tightness in the chest

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

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

difficulty in moving

feeling of warmth

muscle stiffness

redness of the face, neck, arms and occasionally, upper chest

sudden sweating

Less common

Acne

back pain

belching

bone pain

constipation

discoloration of the fingernails or toenails

heartburn

indigestion

lack or loss of strength

muscle spasm

stomach upset or pain

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.