Kanjinti (Intravenous)

Trastuzumab-anns injection is used along with other cancer medicines (like doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel, or docetaxel and carboplatin) or on its own after 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 had treatment before.

Trastuzumab-anns 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 make extra amounts of this protein (HER2 overexpression).

Trastuzumab-anns is a monoclonal antibody. It affects 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 occur. Some of these may be serious and need to 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 that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood and urine 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 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-anns 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 symptoms 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 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.

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 think about the risks and benefits. Consider the following for this medicine:

Allergies

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

Pediatric

There have not been appropriate studies on how trastuzumab-anns injection affects children. Safety and effectiveness have not been established.

Geriatric

Studies to date have not shown specific problems in older adults that would limit the usefulness of trastuzumab-anns injection. However, older patients are more likely to have heart problems related to age, 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 medicine during breastfeeding. Consider the potential benefits and risks before taking this medicine while breastfeeding.

Interactions with Medicines

Some medicines should not be used together, while others may be used together even if an interaction could happen. In these cases, your doctor may adjust the dose, or other precautions may be necessary. 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 have been chosen based on their potential importance and do not include all possible interactions.

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some situations. If both medicines are prescribed together, your doctor may adjust the dose or frequency of use 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 it may be necessary to use both drugs for the best treatment. If both medicines are prescribed together, your doctor may adjust the dose or frequency of use for one or both medicines.

• Warfarin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used around the time of eating or with certain types of food due to potential interactions. Using alcohol or 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

Other medical conditions may affect how you can use this medicine. Be sure to tell 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 necessary effects, a medicine can 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

• 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 adjusts to the medicine. Also, your health care professional may be able to tell you how 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

• 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 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.

• 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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