Herzuma (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 breast cancer that overexpresses HER2 and is either node-positive or node-negative (ER/PR negative or with one high-risk feature).

Trastuzumab-pkrb injection is also used to treat metastatic breast cancer (cancer that has spread) that overexpresses HER2 in patients who have already had one or more chemotherapy treatments. It is also combined 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 (cancer of the stomach or esophagus) in patients who have not received treatment before.

Trastuzumab-pkrb prevents the growth of some tumors that make extra amounts of a substance called 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-pkrb is a monoclonal antibody. It disrupts the growth of cancer cells, which the body eventually destroys. Since trastuzumab-pkrb may also affect the growth of normal body cells, other effects can occur. Some of these effects may be serious and should 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 during regular visits to ensure that this medicine is working properly. Blood and urine tests may be needed to look for unwanted effects.

Taking 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 your last dose. If you think you might be pregnant while receiving this medicine, tell your doctor right away.

Your doctor may test your heart before you start receiving trastuzumab-pkrb injection and while you are getting 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 unusual 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. 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 happen after you receive this medicine. Call your doctor right away if you notice changes in your breathing, chest tightness, or any type of breathing problem.

Trastuzumab-pkrb can temporarily reduce 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 activities where you could get bruised, cut, or injured. Brush and floss your teeth gently. Be careful 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, you and your doctor need to consider the risks of the medicine compared to the benefits it may provide. Here are some important points to think about for this medicine:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also let your healthcare professional know 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

There have not been appropriate studies on how trastuzumab-pkrb injection affects children. Its safety and effectiveness have not been established for this age group.

Geriatric

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

Breast Feeding

There are no sufficient studies to determine the risk to infants when this medication is used during breastfeeding. Consider the potential benefits and risks before using this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together even if an interaction might happen. In such cases, your doctor may adjust the dose or take other precautions. When receiving this medicine, it is very important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions are important to consider but may not include all possibilities.

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

• Warfarin

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around meal times or with certain types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Talk to your healthcare professional about using this medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical conditions may affect the use of this medicine. Be sure to inform your doctor if you have any other medical issues, 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 intended effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they might 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 in 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.

• Biosimilars vs Biologics: What are they and how do they compare?
• What are the biosimilars of Herceptin?
• What biosimilars have been approved in the United States?
• What is the difference between Herzuma and Herceptin?
• 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?

View more FAQ