Ebanga (Intravenous)

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

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

It is very important that your doctor closely monitors your progress while you are receiving this medicine to ensure that it is working properly. Blood tests may be needed to check for side 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 experience 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 receive any immunizations (vaccines) without your doctor's approval. Ansuvimab-zykl may lower your body's resistance, and you could get the infection that the vaccine is intended to prevent. Additionally, you should avoid being around people in your household who receive live virus vaccines, as 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.

In deciding to use a medicine, you and your doctor need to consider the risks and benefits. For this medicine, think about the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, tell your healthcare professional if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies have not shown any specific problems that would limit the use of ansuvimab-zykl injection in children. Its safety and effectiveness have been confirmed.

Geriatric

While studies on how age affects the effects of ansuvimab-zykl injection in older adults have not been done, no specific problems related to older adults have been reported so far.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medicine while breastfeeding. Consider the potential benefits and risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others can be used together even if an interaction might occur. In these cases, your doctor may adjust the dose or take other precautions. When receiving this medicine, it is especially important for your healthcare professional 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 all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be needed in some situations. 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, 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

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around the time of eating food or certain types of food, as interactions may happen. Using alcohol or tobacco with certain medicines may also lead to interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

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 you experience any of the following side effects:

More common

• Back pain
• blurred vision
• chest tightness
• chills
• confusion
• dizziness, faintness, or lightheadedness when suddenly getting up from a lying or sitting position
• 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. Your health care professional may also be able to suggest ways to prevent or lessen 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

• 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 happen 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.

• Ebanga

Pharmacologic Class: Ansuvimab

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.