Trastuzumab-dttb (Intravenous)

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

Trastuzumab-dttb injection is also used alone to treat HER2-overexpressing metastatic (cancer that has spread) breast cancer in patients who have already received one or more cancer treatments or as the first treatment together with paclitaxel for HER2-overexpressing metastatic breast cancer.

Trastuzumab-dttb injection is also used in combination with cisplatin and capecitabine or 5-fluorouracil to treat HER2-overexpressing metastatic (cancer that has spread) stomach and gastroesophageal (stomach and esophagus) cancer.

Trastuzumab-dttb prevents the growth of some tumors that produce too much of a substance called the HER2 protein. It should only be used in patients whose tumors have been confirmed to produce extra amounts of this protein (HER2 overexpression). Your doctor will test to see if this protein is present.

Trastuzumab-dttb is a monoclonal antibody. It affects the growth of cancer cells, which are eventually destroyed by the body. Since it may also affect the growth of normal body cells, there may be other effects. Some of these could 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 that your doctor checks your progress at regular visits to ensure this medicine is working properly. You may need blood and urine tests 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 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-dttb (Intravenous) injection and during your treatment 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 may be signs of a serious heart problem.

This medicine may cause infusion-related 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, 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 notice changes in your breathing, chest tightness, or any type of breathing problem.

This medicine can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this happens, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you have a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
• Check with your doctor immediately if you notice any unusual bleeding or bruising, black, tarry stools, blood in urine or stools, or pinpoint red spots on your skin.
• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may suggest other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
• Be careful not to cut yourself when using sharp objects, such as a safety razor or fingernail or toenail clippers.
• Avoid contact sports or other situations where bruising or injury could occur.

In deciding to use a medicine, you and your doctor need to consider the risks and benefits. For this medicine, keep the following points in mind:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare provider know if you have other allergies, 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 trastuzumab-dttb injection affects children. Its safety and effectiveness in this age group have not been established.

Geriatric

So far, studies have not shown any specific problems in older adults that would limit the use of trastuzumab-dttb 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 sufficient studies in women to determine the risk to infants when this medication is used during breastfeeding. Consider the potential benefits and 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 situations, your doctor may adjust the dose or take other precautions. When receiving this medicine, it is very important for your healthcare provider to know if you are taking any of the medicines listed below. The following interactions have been chosen based on their potential importance and are not necessarily 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, your doctor may adjust the dose or frequency of one or both of the 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 you. If both medicines are prescribed together, your doctor may change the dose or frequency of one or both of the medicines.

• Warfarin

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around mealtime or with certain foods due to possible 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 issues may affect how this medicine works. Be sure to inform your doctor if you have any other medical problems, especially:

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

• Infection—This medicine may reduce your body's ability to fight infections.

Along with its needed 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 immediately if any of the following side effects occur:

More common

• Black, tarry stools
• bleeding gums
• bloating or swelling of the face, arms, hands, lower legs, or feet
• bloody urine
• body aches or pain
• chest pain
• chills
• cough
• decreased frequency or amount of urine
• diarrhea
• difficulty in breathing
• dilated neck veins
• dry mouth
• dryness or soreness of the throat
• ear congestion
• extreme tiredness or weakness
• fever
• general feeling of discomfort or illness
• headache
• hoarseness
• increased blood pressure
• increased cough
• increased thirst
• irregular breathing
• irregular heartbeat
• joint pain
• loss of appetite
• loss of voice
• lower back or side pain
• mood changes
• muscle pain or cramps
• nausea
• numbness or tingling in the hands, feet, or lips
• pain or tenderness around the eyes and cheekbones
• painful or difficult urination
• pale skin
• pinpoint red spots on the skin
• rapid weight gain
• seizures
• shivering
• sneezing
• sore throat
• stuffy or runny nose
• sweating
• tender, swollen glands in the neck
• tightness in the chest
• trouble in swallowing
• trouble sleeping
• troubled breathing with exertion
• ulcers, sores, or white spots in the mouth
• unusual bleeding or bruising
• unusual tiredness or weakness
• unusual weight gain or loss
• voice changes
• vomiting

Less common

• Bladder pain
• blindness or vision changes
• blurred vision
• burning of the face or mouth
• burning, crawling, itching, numbness, painful, prickling, "pins and needles", or tingling feelings
• cloudy urine
• clumsiness or unsteadiness
• dizziness
• fast, pounding, or irregular heartbeat or pulse
• frequent urge to urinate
• nervousness
• nosebleed
• painful cold sores or blisters on the lips, nose, eyes, or genitals
• pounding in the ears
• slow heartbeat
• weakness in the hands or feet

Rare

• Decreased ability to exercise
• fainting
• hives, itching, skin rash
• irritation
• joint stiffness or swelling
• neck tenderness or swelling
• redness of the skin

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 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

• Back pain
• bone pain
• change in or loss of taste
• cracked lips
• depression
• difficulty in moving
• lack or loss of strength
• stomach pain
• swelling or inflammation of the mouth
• trouble sleeping
• weight decreased

Less common

• Belching
• heartburn
• indigestion
• muscle spasm
• stabbing pain
• stomach discomfort or upset
• upper stomach pain

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.

• Ontruzant

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. 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.

Avoid using other cancer medicines (eg, anthracyclines) for up to 7 months after stopping treatment with trastuzumab-dttb injection. If you are receiving an anthracycline medicine, your doctor may need to check for heart problems regularly.

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