Pronunciation:

tras-TOOZ-oo-mab - strf

Brand Names:

• Hercessi

Dosage Forms:

• Powder for Solution

Warnings:

Administration of trastuzumab products can result in sub-clinical and clinical cardiac failure. The incidence and severity was highest in patients receiving trastuzumab with anthracycline-containing chemotherapy regimens. Evaluate left ventricular function in all patients prior to and during treatment with trastuzumab-strf. Discontinue trastuzumab-strf treatment in patients receiving adjuvant therapy and withhold trastuzumab-strf in patients with metastatic disease for clinically significant decrease in left ventricular function. Administration 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-strf infusion for dyspnea or clinically significant hypotension. Monitor patients until symptoms completely resolve. Discontinue trastuzumab-strf for anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome. Exposure 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-strf injection is used together with other cancer medicines (eg, doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel, or docetaxel and carboplatin) or used alone following anthracycline-based therapy to treat HER2-overexpressing node-positive or node-negative (ER/PR negative or with one high risk feature) breast cancer.

Trastuzumab-strf injection is also used to treat HER2-overexpressing metastatic (cancer that has spread) breast cancer in patients who have received one or more chemotherapy treatments. It is also used together with paclitaxel for the first-line treatment of HER2-overexpressing metastatic breast cancer.

Trastuzumab-strf injection is also used together with cisplatin and capecitabine or 5-fluorouracil to treat HER2-overexpressing metastatic (cancer that has spread to other parts of the body) stomach cancer called gastric or gastroesophageal junction (GEJ) adenocarcinoma in patients who have not previously received treatment.

Trastuzumab-strf 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-strf 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-strf, 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 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-strf 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-strf 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 not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Bacillus of Calmette and Guerin Vaccine, Live
• Dengue Tetravalent Vaccine, Live
• Measles Virus Vaccine, Live
• Mumps Virus Vaccine, Live
• Rubella Virus Vaccine, Live
• Smallpox Monkeypox Vaccine
• Typhoid Vaccine
• Varicella Virus Vaccine
• Yellow Fever Vaccine

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.

• Adenovirus Vaccine Type 4, Live
• Adenovirus Vaccine Type 7, Live
• Cholera Vaccine
• Daunorubicin
• Daunorubicin Citrate Liposome
• Daunorubicin Liposome
• Doxorubicin
• Doxorubicin Hydrochloride Liposome
• Ebola Zaire Vaccine, Live
• Epirubicin
• Idarubicin
• Influenza Virus Vaccine, Live
• Pirarubicin
• Pixantrone
• Rotavirus Vaccine, Live
• 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 problems (eg, interstitial pneumonitis, pulmonary fibrosis, tumor)—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 in a medical facility. It is given through an IV catheter that is placed into one of your veins. The medicine must be given slowly, so the IV will have to stay in place for at least 30 to 90 minutes. The injection is usually given every 3 weeks.

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 closely while receiving the medicine and at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it. Blood and urine tests may be needed to check for unwanted effects.

Receiving this medicine while you are pregnant can harm your unborn baby. If you can get pregnant, your doctor may do tests to make sure you are not pregnant before receiving this medicine. 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 receiving the medicine, tell your doctor right away.

Your doctor may test your heart before you start receiving trastuzumab-strf injection and while you are getting treatments with this medicine. This medicine may cause heart problems (eg, heart failure, heart rhythm problems, heart failure, heart muscle problems, and high blood pressure). Check with your doctor right away if you have blurred vision, chest pain or tightness, decreased urine output, dilated neck veins, dizziness, extreme fatigue, fainting, fast or slow heartbeat, headache, irregular breathing, irregular heartbeat, nervousness, pounding in the ears, swelling of the face, fingers, feet, or lower legs, trouble breathing, or weight gain.

This medicine may cause infusion reactions, which can be life threatening and require immediate medical attention. Check with your doctor right away if you have blurred vision, confusion, dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position, facial swelling, fever or chills, headache, nausea or vomiting, skin rash, sweating, trouble breathing, or unusual tiredness or weakness.

Check with your doctor right away if you have chest pain or tightness, confusion, cough, dizziness, fast heartbeat, fever, trouble breathing, or unusual tiredness or weakness. These may be symptoms of serious lung problems.

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 have 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 the 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.

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

bladder pain

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

bloody or cloudy urine

bone pain

chest pain or tightness

chills

cough

decreased urine output

difficult, burning, or painful urination

dilated neck veins

discouragement

fast, pounding, or irregular heartbeat or pulse

feeling sad or empty

fever

frequent urge to urinate

headache

increased thirst

irregular breathing

irritability

lack of appetite

loss of interest or pleasure

lower back or side pain

muscle aches

rapid weight gain

sore throat

sores, ulcers, or white spots in the mouth

stuffy or runny nose

swelling of the face, fingers, feet, or lower legs

tingling of the hands or feet

trouble breathing

trouble concentrating

trouble sleeping

unusual bleeding or bruising

unusual tiredness or weakness

unusual weight gain or loss

vomiting

Less common

Blurred vision

body aches or pain

diarrhea

dizziness

fainting

general feeling of discomfort or illness

joint pain

loss of voice

muscle pain

pain or tenderness around the eyes and cheekbones

pale skin

pounding in the ears

shivering

sneezing

sweating

swollen glands

Rare

Hives, itching, skin rash

joint stiffness or swelling

trouble swallowing

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

change in taste

cracked lips

difficulty in moving

lack or loss of strength

loss of taste

muscle stiffness

swelling or inflammation of the mouth

Less common

Acid or sour stomach

belching

bloody nose

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

constipation

discoloration of the fingernails or toenails

heartburn

indigestion

stomach discomfort, upset, or pain

swollen joints

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.