Trastuzumab and hyaluronidase-oysk (Subcutaneous)

Trastuzumab and hyaluronidase-oysk combination injection is used along with other cancer medicines (e.g., doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel, docetaxel and carboplatin, or after anthracycline medicine) to treat breast cancer that has a high level of HER2 (HER2-overexpressing) and is either node-positive or node-negative (ER/PR negative or with one high risk feature).

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

Trastuzumab and hyaluronidase-oysk combination stops the growth of some tumors that make too much of a substance called the HER2 protein. It should only be used in patients whose tumors have been confirmed to make too much of this protein (HER2 overexpression).

This medicine should only be given by your doctor or under their direct supervision.

It is very important for your doctor to check your progress at regular visits to ensure 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 prevent pregnancy 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, sudden difficulty with breathing at night, rapid weight gain, or abnormal swelling in your ankles or legs. These could be signs of a serious heart problem.

Serious lung or breathing problems may occur after you receive this medicine. Call your doctor right away if you 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.

In deciding to use a medicine, you and your doctor need to consider the risks and benefits. Here are some important points to think about for this medicine:

Allergies

Let your doctor know if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, inform your healthcare professional about any other allergies you may have, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies have not been done to see how age affects the use of trastuzumab and hyaluronidase-oysk combination injection in children. Safety and effectiveness have not been established.

Geriatric

Studies conducted so far have not shown any specific problems in older adults that would limit the usefulness of trastuzumab and hyaluronidase-oysk combination injection. However, older patients may be more likely to have heart problems related to aging, which may require caution when using this medicine.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Weigh the potential benefits against the risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together, while others can be used together, even if an interaction might happen. In these cases, your doctor may adjust the dose or take other precautions. It is especially important that your healthcare professional knows if you are taking any of the medicines listed below. The following interactions are significant but not a complete list.

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may change the dose or frequency for one or both 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 increase the risk of certain side effects, but using both may be the best treatment for you. If both medicines are prescribed together, your doctor may adjust the dose or frequency for one or both medicines.

• Warfarin

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around mealtime or with certain foods due to possible interactions. Drinking alcohol or using tobacco with certain medicines may also cause interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical issues may affect the use of this medicine. Be sure to inform your doctor if you have any other medical problems, especially:

• Congestive heart failure or
• Heart disease (e.g., cardiomyopathy) or
• Heart rhythm problems (e.g., arrhythmia) or
• Hypertension (high blood pressure) or
• Lung disease (e.g., interstitial pneumonitis, pulmonary fibrosis, tumor) — Use with caution. May worsen these conditions.

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects will happen, but if they do, they may require medical attention.

Check with your doctor or nurse right away 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 happen that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your health care professional may also have ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue, 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.

In the U.S.

• Herceptin Hylecta

Available Dosage Forms:

• Solution

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Monoclonal Antibody

Find detailed information on biosimilars for this medication.

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.

• What is Herceptin? Is Herceptin a chemo drug? How does it work?