Ogivri (Intravenous)

Trastuzumab-dkst injection is used by itself or along with other cancer medicines (for example, carboplatin, cyclophosphamide, docetaxel, doxorubicin, paclitaxel) to treat HER2-overexpressing new or metastatic (cancer that has spread) breast cancer.

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

Trastuzumab-dkst stops the growth of some tumors that make extra amounts of a specific 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-dkst is a monoclonal antibody. It interferes with the growth of cancer cells, which are eventually eliminated by the body. Since normal body cells may also be affected by trastuzumab-dkst, other effects may occur. Some of these effects may be serious and should be reported to your doctor. Other effects, like a skin rash, may not be serious but could cause concern. Some effects may not appear until months or years after the medicine is used.

This medicine is to be given only by or under the immediate supervision of your doctor.

It is very important that your doctor checks your progress at regular visits to ensure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Using 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 using this medicine, tell your doctor right away.

Your doctor may test your heart before you start receiving trastuzumab-dkst injection 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 abnormal swelling in your ankles or legs. These could be symptoms 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, 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-dkst 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 use 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 will need to consider the risks versus the benefits. For this medicine, please keep the following in mind:

Allergies

Inform your doctor if you have ever experienced any unusual or allergic reactions to this medicine or any other medications. Also, let your healthcare professional know about any other allergies you may 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 age affects the use of trastuzumab-dkst injection in children. Safety and effectiveness have not been proven.

Geriatric

Current studies have not shown any specific problems in older adults that would limit the use of trastuzumab-dkst injection in this age group. 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 adequate studies in women to determine the risk to infants when using this medication while breastfeeding. Consider the potential benefits and risks before taking this medication during breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction might happen. In these situations, your doctor may adjust the dose or take other precautions. It is very important for your healthcare professional to know if you are taking any of the medicines listed below while receiving this medicine. The following interactions are significant but may not include all possible interactions.

Using this medicine with any of the following medications is usually not recommended, but may be necessary in some cases. If both are prescribed together, your doctor may change the dose or how often you take one or both of them.

• Daunorubicin
• Daunorubicin Citrate Liposome
• Daunorubicin Liposome
• Doxorubicin
• Doxorubicin Hydrochloride Liposome
• Epirubicin
• Idarubicin
• Pirarubicin
• Pixantrone
• Valrubicin

Using this medicine with any of the following medications may increase the risk of certain side effects, but using both may be the best option for you. If both are prescribed together, your doctor may adjust the dose or how often you take one or both of them.

• 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 lead to interactions. Talk to your healthcare professional about how to use your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical conditions may impact the use of this medicine. Make sure to tell your doctor about any other medical issues you have, 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)—Use with caution. This medicine may worsen these conditions.

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they may require medical attention.

Check with your doctor or nurse right away if any of the following side effects occur:

More common

• Black, tarry stools
• Bleeding gums
• Blood in the urine or stools
• Chest pain
• Chills
• Cough
• Cracked lips
• Decreased frequency or amount of urine
• Diarrhea
• Difficult or labored breathing
• Difficulty in swallowing
• Dry mouth
• Fever
• Headache
• Hoarseness
• Increased blood pressure
• Increased thirst
• Irregular heartbeat
• Loss of appetite
• Lower back or side pain
• Mood changes
• Muscle aches, pain, or cramps
• Nausea
• Numbness or tingling in the hands, feet, or lips
• Painful or difficult urination
• Pale skin
• Peeling of the skin
• Pinpoint red spots on the skin
• Seizures
• Sore throat
• Sores, ulcers, or white spots on the lips, tongue, or inside the mouth
• Stuffy or runny nose
• Swelling of the face, fingers, or lower legs
• Swollen glands
• Tightness in the chest
• Troubled breathing
• Troubled breathing with exertion
• Unusual bleeding or bruising
• Unusual tiredness or weakness
• Vomiting
• Weight gain

Less common

• Bladder pain
• Bloody nose
• Blurred vision
• Body aches or pain
• Burning or stinging of the skin
• Cloudy urine
• Dilated neck veins
• Dizziness
• Ear congestion
• Extreme tiredness or weakness
• Fainting
• Fast, irregular, pounding, or racing heartbeat or pulse
• Frequent urge to urinate
• General feeling of discomfort or illness
• Irregular breathing
• Joint pain
• Loss of voice
• Nasal congestion
• Nervousness
• Pain or tenderness around the eyes and cheekbones
• Painful cold sores or blisters on the lips, nose, eyes, or genitals
• Pounding in the ears
• Shivering
• Sneezing
• Sweating
• Trouble sleeping

Rare

• Chest discomfort
• Hives, itching, skin rash
• Joint stiffness or swelling
• Neck tenderness or swelling
• Redness of the skin
• Tightness in the chest

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. Your health care professional may also 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, are bothersome, or if you have any questions about them:

More common

• Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• Difficulty in moving
• Feeling of warmth
• Muscle stiffness
• Redness of the face, neck, arms, and occasionally, upper chest
• Sudden sweating

Less common

• Acne
• Back pain
• Belching
• Bone pain
• Constipation
• Discoloration of the fingernails or toenails
• Heartburn
• Indigestion
• Lack or loss of strength
• Muscle spasm
• Stomach upset or pain
• Upper stomach pain

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your health care 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.

• Ogivri

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.

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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