Pronunciation:

tras-TOOZ-oo-mab, hye-al-ure-ON-i-dase - oysk

Brand Names:

• Herceptin Hylecta

Dosage Forms:

• Solution

Warnings:

Cardiomyopathy: Trastuzumab/hyaluronidase-oysk can result in subclinical and clinical cardiac failure manifesting as congestive heart failure, and decreased left ventricular ejection fraction, with greatest risk when administered concurrently with anthracyclines. Evaluate cardiac function prior to and during treatment. Discontinue trastuzumab/hyaluronidase-oysk for cardiomyopathy.Pulmonary Toxicity: Discontinue trastuzumab/hyaluronidase-oysk for anaphylaxis, angioedema, interstitial pneumonitis or acute respiratory distress syndrome.Embryo-Fetal Toxicity: Exposure to trastuzumab/hyaluronidase-oysk during pregnancy can result in oligohydramnios, in some cases complicated by pulmonary hypoplasia 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 and hyaluronidase-oysk combination injection is used together with other cancer medicines (eg, doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel, docetaxel and carboplatin, or after anthracycline medicine) to treat HER2-overexpressing node-positive or node-negative (ER/PR negative or with one high risk feature) breast cancer.

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

Trastuzumab and hyaluronidase-oysk combination 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).

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 and hyaluronidase-oysk combination 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 and hyaluronidase-oysk combination 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, 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 as a shot under your skin for at least 2 to 5 minutes once every 3 weeks.

If you miss a dose of this medicine, you must receive a dose as soon as possible. The doses should not be less than three weeks from each other.

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.

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 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 and hyaluronidase-oysk combination 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.

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 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.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after receiving this medicine.

Do not receive an anthracycline medicine for up to 7 months after stopping treatment with this medicine.

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

blurred vision

body aches or pain

chest pain or tightness

chills

cough

decreased urine output

diarrhea

difficulty in breathing

dilated neck veins

dizziness

ear congestion

extreme tiredness or weakness

fast heartbeat

fever

general feeling of discomfort or illness

headache

hives, itching, skin rash

hoarseness

irregular breathing

irritation

joint pain, stiffness, or swelling

loss of appetite

loss of voice

lower back or side pain

muscle aches and pains

nausea

nervousness

nosebleed

painful or difficult urination

pale skin

pounding in the ears

redness of the skin

runny nose or stuffy nose

shivering

slow, fast, or irregular heartbeat

sneezing

sore throat

sores, ulcers, or white spots on the lips or in the mouth

sweating

swelling of the eyelids, face, lips, hands, or feet

swollen glands

trouble sleeping

troubled swallowing

troubled breathing with exertion

unusual bleeding or bruising

unusual tiredness or weakness

vomiting

weight gain

Less common

Bladder pain

bloody or cloudy urine

difficult, burning, or painful urination

fainting

fast, pounding, or irregular heartbeat or pulse

frequent urge to urinate

Incidence not known

Bleeding gums

bluish color of the fingernails, lips, skin, palms, or nail beds

confusion

increased thirst

mood or mental changes

muscle cramps in the hands, arms, feet, legs, or face

numbness and tingling around the mouth, fingertips, or feet

pinpoint red spots on the skin

seizures

stomach cramps or pain

tremor

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

Arm, back, or leg pain

belching

bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

bone pain

burning, numbness, tingling, or painful sensations

difficulty in moving

discoloration of fingernails or toenails

feeling of warmth

hair loss or thinning of hair

heartburn

indigestion

lack or loss of strength

loss or change in taste

muscle stiffness

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

skin discoloration

stomach discomfort or upset

swelling or inflammation of the mouth

unsteadiness or awkwardness

weakness in the arms, hands, legs, or feet

Less common

Nasal discomfort

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.