Trastuzumab-pkrb (Intravenous)

Trastuzumab-pkrb injection is used along with other cancer medicines (for example, doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel, or docetaxel and carboplatin) or by itself after anthracycline-based therapy to treat HER2-overexpressing node-positive or node-negative (ER/PR negative or with one high-risk feature) breast cancer.

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

Trastuzumab-pkrb injection is also used with cisplatin and capecitabine or 5-fluorouracil to treat HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma (stomach or esophagus cancer) in patients who have not had treatment before.

Trastuzumab-pkrb prevents the growth of some tumors that make extra amounts of a substance known as the HER2 protein. It should only be used in patients whose tumors have been shown to make extra amounts of this protein (HER2 overexpression).

Trastuzumab-pkrb is a monoclonal antibody. It interferes with the growth of cancer cells, which are eventually destroyed by the body. Because the growth of normal body cells may also be affected by trastuzumab-pkrb, other effects may also occur. Some of these effects can be serious and must be reported to your doctor.

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

It is very important for your doctor to check your progress at regular visits to ensure that this medicine is working properly. Blood and urine tests may be needed to look for unwanted effects.

Receiving this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to prevent 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, inform your doctor right away.

Your doctor may test your heart before you start receiving trastuzumab-pkrb injection and while you are undergoing treatments with this medicine. Contact your doctor immediately if you experience any chest pain, increased coughing, trouble breathing, sudden difficulty breathing at night, rapid weight gain, or abnormal swelling in your ankles or legs. These could be signs of a serious heart problem.

This medicine may cause infusion reactions, which can be life-threatening and require immediate medical attention. Notify 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 immediately if you have changes in your breathing, chest tightness, or any type of breathing problem.

Trastuzumab-pkrb 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 issues, avoid being near people who are sick or have infections. Wash your hands often. Stay away from rough sports or situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be cautious when using sharp objects, including razors and fingernail clippers.

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

In deciding to use a medicine, the risks of taking it must be compared to the benefits it will provide. This is a decision you will make with your doctor. 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 inform your healthcare professional if you have any other allergies, 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 assess the effects of trastuzumab-pkrb injection in children. Safety and effectiveness have not been established.

Geriatric

Studies have not shown any specific problems in older adults that would limit the usefulness of trastuzumab-pkrb injection in this age group. However, older patients are more likely to have heart problems related to aging, which may require caution when receiving this medicine.

Breast Feeding

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

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction might occur. In these situations, your doctor may need to adjust the dose or take other precautions. When receiving this medicine, it is especially important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions are noted for 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 necessary in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use 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 change the dose or how often you use one or both medicines.

• Warfarin

Interactions with Food/Tobacco/Alcohol

Some medicines should not be used around the time of eating certain foods, as interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical problems may affect the use of this medicine. Be sure to tell your doctor if you have any other medical conditions, 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 may happen, but if they do, they may need medical attention.

Check with your doctor or nurse right away if any of the following side effects occur:

More common

• Back pain
• black, tarry stools
• body aches or pain
• chest discomfort or pain
• chills
• cough
• decreased urine output
• diarrhea
• difficulty breathing
• dilated neck veins
• dizziness
• dryness or soreness of the throat
• extreme tiredness or weakness
• fainting
• fast, irregular, or pounding heartbeat
• feeling of warmth
• fever
• general feeling of discomfort or illness
• headache
• hoarseness
• irregular breathing
• joint pain
• loss of appetite
• lower back or side pain
• muscle aches and pains
• nausea
• pain or tenderness around the eyes and cheekbones
• painful or difficult urination
• pale skin
• redness of the face, neck, arms, and occasionally, the upper chest
• shivering
• skin rash
• sneezing
• sore throat
• stuffy or runny nose
• sweating
• swelling of the face, fingers, feet, or lower legs
• tender, swollen glands in the neck
• tightness in the chest
• trouble swallowing
• trouble sleeping
• troubled breathing with exertion
• ulcers, sores, or white spots in the mouth
• unusual bleeding or bruising
• unusual tiredness or weakness
• voice changes
• vomiting
• weight gain

Less common

• Bladder pain
• bloody or cloudy urine
• burning or stinging of the skin
• frequent urge to urinate
• hives, itching
• painful cold sores or blisters on the lips, nose, eyes, or genitals
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over the affected area
• tingling of the hands or feet
• unusual weight gain or loss

Incidence not known

• Bleeding gums
• nosebleeds
• numbness or tingling in the face, arms, or legs
• pinpoint red spots on the skin
• vision problems

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. Your health care professional may also 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, are bothersome, or if you have any questions about them:

More common

• Bone pain
• depression
• difficulty moving
• lack or loss of strength
• loss of appetite
• muscle stiffness
• stomach pain

Less common

• Acne

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.

• Herzuma

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Trastuzumab

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 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.

• How soon can you start chemo after port placement?
• How long can you stay on Herceptin and Perjeta?
• What happens after Herceptin treatment?
• How long can I stay on Herceptin?
• What is TDM1 chemotherapy?
• What are biologic drugs and how do they work?
• What biosimilars have been approved in the United States?
• What is Herceptin? Is Herceptin a chemo drug? How does it work?
• How long does Herceptin stay in your body?

View more FAQ