Ontruzant (Intravenous)

Trastuzumab-dttb injection is used to treat breast cancer that overproduces the HER2 protein, whether the cancer is node positive or node negative (ER/PR negative or with one high-risk feature). It can be used on its own after receiving treatment with an anthracycline medicine or alongside other cancer medicines (for example, carboplatin, cyclophosphamide, docetaxel, doxorubicin, paclitaxel).

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

Trastuzumab-dttb injection can be combined with cisplatin and capecitabine or 5-fluorouracil to treat HER2-overexpressing metastatic stomach and gastroesophageal cancer.

Trastuzumab-dttb stops the growth of some tumors that produce high levels of the HER2 protein. It should only be used in patients whose tumors have been confirmed to produce excess amounts of this protein (HER2 overexpression). Your doctor will test for this protein.

Trastuzumab-dttb is a monoclonal antibody. It disrupts the growth of cancer cells, which are then eventually destroyed by the body. Since trastuzumab-dttb may also affect the growth of normal body cells, there may be other effects. Some of these effects can be serious and should 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 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 your last dose. If you think you may be pregnant while receiving the medicine, tell your doctor right away.

Your doctor may test your heart before you begin receiving trastuzumab-dttb 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 abnormal swelling in your ankles or legs. These could be signs of a serious heart problem.

This medicine may cause infusion-related reactions, which can be life-threatening and need immediate medical attention. Tell your doctor right away if you develop 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 immediately if you notice changes in your breathing, chest tightness, or any type of breathing issue.

This medicine can temporarily lower the number of white blood cells in your blood, increasing the risk of getting an infection. It can also lower the number of platelets, which are important 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 possible, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you develop 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 doctor, dentist, or nurse may suggest other ways to clean your teeth and gums. Check with your 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 cautious when using sharp objects, like a safety razor or fingernail or toenail clippers, to avoid cuts.
• Avoid contact sports or other situations where bruising or injury might happen.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the benefits it will provide. This is a decision you and your doctor will make together. 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 health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on how age affects the effects of trastuzumab-dttb injection in children. Safety and effectiveness have not been established.

Geriatric

Appropriate studies performed to date have not shown any geriatric-specific problems that would limit the usefulness of trastuzumab-dttb injection in older adults. However, older patients are more likely to have age-related heart issues, 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 medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Certain medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction could occur. In these cases, your doctor may want to adjust the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional knows if you are taking any of the medicines listed below. The following interactions have been selected based on 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 situations. If both medicines are prescribed together, your doctor may adjust the dose or how often you use 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 drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may adjust the dose or how often you use one or both of the medicines.

• Warfarin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or certain types of food since 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

Having other medical problems may affect the use of this medicine. Make sure to tell your doctor if you have any other medical issues, 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. May worsen these conditions.

• Infection—May reduce your body's ability to fight infection.

Along with its needed effects, a medicine may cause some unwanted effects. Not all of these side effects may occur, 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 or 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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