Ansuvimab-zykl (intravenous route)


    Brand Name

    US Brand Name

    Ebanga


    Description

    Ansuvimab-zykl injection is used to treat infection caused by Zaire ebolavirus.

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


    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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of ansuvimab-zykl injection in the pediatric population. Safety and efficacy have been established.

    Geriatric

    Although appropriate studies on the relationship of age to the effects of ansuvimab-zykl injection have not been performed in the geriatric population, no geriatric-specific problems have been documented to date.

    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. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of 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 required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

    • Adenovirus Vaccine Type 4, Live
    • Adenovirus Vaccine Type 7, Live
    • Bacillus of Calmette and Guerin Vaccine, Live
    • Dengue Tetravalent Vaccine, Live
    • Influenza Virus Vaccine, Live
    • Measles Virus Vaccine, Live
    • Mumps Virus Vaccine, Live
    • Poliovirus Vaccine, Live
    • Rotavirus Vaccine, Live
    • Rubella Virus Vaccine, Live
    • Smallpox Vaccine
    • Typhoid Vaccine, Live
    • Varicella Virus Vaccine, Live
    • Yellow Fever Vaccine
    • Zoster Vaccine, Live

    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.


    Proper Use

    A nurse or other trained health professional will give you this medicine in a medical facility. This medicine is given through a needle placed in one of your veins. The medicine must be injected slowly, so your IV tube will need to stay in place for at least 1 hour.


    Precautions

    It is very important that your doctor check your progress closely while you are receiving this medicine to make sure that it is working properly. Blood tests may be needed to check for unwanted effects.

    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, headache, trouble breathing, itching or skin rash, lightheadedness, fainting, or fast, pounding, or uneven heartbeat after receiving this medicine.

    While you are being treated with ansuvimab-zykl, do not have any immunizations (vaccines) without your doctor's approval. Ansuvimab-zykl may lower your body's resistance and there is a chance you might get the infection the vaccine is meant to prevent. In addition, you should not be around other persons living in your household who receive live virus vaccines because there is a chance they could pass the virus on to you. Some examples of live vaccines include measles, mumps, influenza (nasal flu vaccine), poliovirus (oral form), rotavirus, and rubella. Do not get close to them and do not stay in the same room with them for very long. If you have questions about this, talk to your doctor.


    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
    • blurred vision
    • chest tightness
    • chills
    • confusion
    • dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
    • fast, pounding, or irregular heartbeat or pulse
    • fever
    • flushing
    • headache
    • nausea and vomiting
    • rapid shallow breathing
    • sweating
    • trouble breathing
    • unusual tiredness or weakness

    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

    • Bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
    • diarrhea

    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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