Trastuzumab-anns (Intravenous)

Trastuzumab-anns injection is used with other cancer medicines (for example, doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel, or docetaxel and carboplatin) or alone after a previous treatment with an anthracycline medicine to treat HER2-overexpressing node positive or node negative (ER/PR negative or with one high risk feature) breast cancer.

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

Trastuzumab-anns 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 been treated before.

Trastuzumab-anns prevents the growth of some tumors that produce extra amounts of a certain 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-anns 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-anns, other effects may 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 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 monitor 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 might be pregnant while receiving the medicine, tell your doctor right away.

Your doctor may test your heart before you start receiving trastuzumab-anns (Intravenous) and while you are getting treatments with this medicine. Contact your doctor right away 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 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.

Trastuzumab-anns 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 around 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.

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 must consider the risks and benefits. For this medicine, keep the following in mind:

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 provider about any other allergies you may have, such as to foods, dyes, preservatives, or animals. For over-the-counter products, read the label or package ingredients carefully.

Pediatric

There have not been appropriate studies on how age affects the use of trastuzumab-anns injection in children. Safety and effectiveness have not been proven.

Geriatric

So far, studies have not shown specific problems for older adults that would limit the use of trastuzumab-anns injection in this age group. However, older patients are more likely to have heart issues related to aging, which may require caution when using this medicine.

Breast Feeding

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

Interactions with Medicines

Some medicines should not be used together at all, while others can be used together even if interactions might occur. In these cases, your doctor may adjust the dose or take other precautions. It is especially important for your healthcare provider to know if you are taking any of the following medicines while receiving this medicine. The following interactions are based on their significance and are not an exhaustive list.

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

• Warfarin

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken close to mealtime or with certain foods because of potential interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Talk to your healthcare provider about how to use your 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
• Heart disease (e.g., cardiomyopathy)
• Heart rhythm problems (e.g., arrhythmia)
• Hypertension (high blood pressure)
• Lung disease (e.g., interstitial pneumonitis, pulmonary fibrosis, tumor)—Use with caution. This 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 happen:

More common

• Bloating or swelling of the face, arms, hands, lower legs, or feet
• Tingling of the hands or feet
• Unusual weight gain or loss

Less common

• Black, tarry stools
• Bloody urine
• Blurred vision
• Bone pain
• Burning or stinging of the skin
• Chest pain, discomfort, or tightness
• Cough or hoarseness
• Difficult, burning, or painful urination
• Dilated neck veins
• Dizziness
• Fainting
• Fast, slow, or irregular heartbeat or pulse
• Fever or chills
• Headache
• Increased thirst
• Irregular breathing
• Loss of appetite
• Lower back or side pain
• Nausea
• Nervousness
• Painful cold sores or blisters on the lips, nose, eyes, or genitals
• Pale skin
• Pounding in the ears
• Sore throat
• Sores, ulcers, or white spots on the lips or in the mouth
• Swelling of the face, fingers, feet, or lower legs
• Swollen glands
• Troubled breathing
• Unusual bleeding or bruising
• Unusual tiredness or weakness
• Vomiting

Rare

• Hives, itching, rash
• Irritation
• Joint pain, stiffness, or swelling
• Neck tenderness or swelling
• Redness of the skin
• Troubled swallowing

Some side effects may happen that usually do not need medical attention. These side effects may go away during treatment as your body gets used to the medicine. Your healthcare professional may also know ways to prevent or lessen some of these side effects. Check with your healthcare professional if any of the following side effects continue, are bothersome, or if you have any questions about them:

More common

• Back pain
• Change in taste
• Cracked lips
• Diarrhea
• Difficulty in moving
• Muscle aching or cramping
• Muscle pain or stiffness

Less common

• Belching
• Bladder pain
• Blemishes on the skin
• Bloody or cloudy urine
• Body aches or pain
• Burning, crawling, itching, numbness, prickling, "pins and needles," or tingling feelings
• Clumsiness or unsteadiness
• Constipation
• Discoloration of the fingernails or toenails
• Ear congestion
• Feeling of warmth
• General feeling of discomfort or illness
• Heartburn
• Indigestion
• Lack or loss of strength
• Loss of voice
• Muscle spasm
• Pain or tenderness around the eyes and cheekbones
• Peeling of the skin
• Pimples
• Redness of the face, neck, arms, and occasionally, upper chest
• Runny or stuffy nose
• Shivering
• Sneezing
• Stomach discomfort, upset, or pain
• Sweating
• Swelling or inflammation of the mouth
• Trouble sleeping
• Weakness in the hands or feet

Other side effects not listed may also happen 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.

• Kanjinti

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.

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.

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