Pronunciation:

oh-bil-tox-AX-i-mab

Brand Names:

• Anthim

Classifications:

Pharmacologic—

Monoclonal Antibody

Uses of This Medicine:

Obiltoxaximab injection is used together with antibiotics to treat inhalational anthrax. It is also used to prevent inhalational anthrax after a person is exposed. Obiltoxaximab works by preventing the anthrax bacteria from entering the body's cells, which prevents an infection.

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

Before Using This Medicine:

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.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of obiltoxaximab injection in children.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of obiltoxaximab injection in the elderly.

Breast-feeding—

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.

Other medicines—

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.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine. The medicine is given through a needle placed in a vein.

You may also receive medicines (eg, diphenhydramine, Benadryl®) before you receive obiltoxaximab to help prevent allergic reactions to the injection.

This medicine comes with a patient information leaflet. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Precautions While Using This Medicine:

Your doctor will 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 check for unwanted effects.

This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Talk to your nurse or doctor right away if you have very fast or irregular breathing, a very fast or irregular heartbeat, a rash, fainting, hive-like swellings on the skin, or swelling of the eyelids or around the eyes, face, lips, or tongue.

Side Effects of This Medicine:

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

Chest discomfort

cough

difficulty swallowing

dizziness

fainting or loss of consciousness

fast heartbeat

fast or irregular breathing

hives, itching, or skin rash

swelling of the eyelids or around the eyes, face, lips, or tongue

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

Headache

Less common

Body aches or pain

chills

ear congestion

fever

loss of voice

nasal congestion

pain, bruise, or swelling at the injection site

pain in the arms or legs

runny nose

sneezing

sore throat

Less common or rare

Bone pain

difficulty with moving

dry mouth

muscle aching or cramping

muscle pains or stiffness

swollen joints

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.