Inmazeb (Intravenous)

Atoltivimab, maftivimab, and odesivimab-ebgn combination injection is used to treat infections caused by Zaire ebolavirus.

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

It is very important that your doctor check your progress closely while you are receiving this medicine to ensure 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 atoltivimab, maftivimab, and odesivimab-ebgn, and after you stop treatment with it, do not have any immunizations (vaccines) without your doctor's approval. Atoltivimab, maftivimab, and odesivimab-ebgn 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.

In deciding to use a medicine, you and your doctor will weigh the risks against the benefits. Consider the following for this medicine:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know about any other allergies you have, 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 in children that would limit the use of atoltivimab, maftivimab, and odesivimab-ebgn combination injection in the pediatric population. Safety and effectiveness have been established.

Geriatric

Studies have not shown any specific problems in older adults that would limit the use of atoltivimab, maftivimab, and odesivimab-ebgn combination injection in the elderly. Safety and effectiveness have been established.

Breast Feeding

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

Interactions with Medicines

Some medicines should not be used together, while others may be used together even if an interaction could occur. In such cases, your doctor may adjust the dose, or other precautions may be needed. When receiving this medicine, it is important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions are significant but not necessarily complete.

Using this medicine with any of the following is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may alter the dose or frequency of one or both 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
• Varicella Virus Vaccine, Live
• Yellow Fever Vaccine
• Zoster Vaccine, Live

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken with food or certain types of food because interactions may occur. Using alcohol or tobacco with some medicines may also lead to interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

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 suddenly 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. 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.

In the U.S.

• Inmazeb

Pharmacologic Class: Monoclonal Antibody

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 2 to 4 hours.