Description
Zanidatamab-hrii injection is used to treat HER2-positive (IHC 3+) biliary tract cancer (BTC) that has spread (metastatic) or cannot be removed by surgery (unresectable) in patients who have previously received treatment. Your doctor will perform a test before you receive this medicine.
This medicine is to be given only by or under the supervision of your doctor.
This product is available in the following dosage forms:
- Powder for Solution
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. 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 tell 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 the relationship of age to the effects of zanidatamab-hrii injection in the pediatric population. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of zanidatamab-hrii injection in the elderly.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Heart disease—Use with caution. May make this condition worse.
Proper Use
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 nurse or other trained health professional will give you this medicine in a medical facility. It is given through an IV catheter that is placed into one of your veins. It must be given slowly, so the IV will have to remain in place for at least 120 to 150 minutes. The infusion is given every 2 weeks.
This medicine comes with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor if you have any questions.
Your doctor will give you other medicines (eg, allergy medicine, fever medicine, steroid) 30 to 60 minutes before you receive this medicine to help prevent unwanted effects.
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.
Precautions
It is very important that your doctor check your progress closely while you are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it. Blood tests may be needed to check for unwanted effects.
Receiving this medicine while you are pregnant can harm your unborn baby. If you can get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment. Use an effective form of birth control to keep from getting pregnant during treatment and for at least 4 months after the last dose. If you think you have become pregnant while receiving this medicine, tell your doctor right away.
Check with your doctor right away if you have dizziness, feeling tired, irregular heartbeat, loss of consciousness, sudden weight gain, swelling of your ankles or feet, or trouble breathing. These may 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.
This medicine can cause severe diarrhea. Tell your doctor right away if you have any concerns about this.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur:
More common
- Back pain
- chest pain or tightness
- chills
- confusion
- cough
- diarrhea
- dizziness
- fainting
- fast heartbeat
- fever
- flushing
- headache
- lightheadedness
- nausea
- sneezing
- sore throat
- stomach pain or cramps
- trouble breathing
- vomiting
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. Also, 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
- Decreased appetite
- lack or loss of strength
- redness, swelling, or pain of the skin
- scaling of the skin on the hands or feet
- skin rash
- tingling of the hands and feet
- ulceration of the skin
- unusual tiredness or weakness
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.
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