Pronunciation:

rax-i-BAK-ue-mab

Brand Names:

• Raxibacumab

Warnings:

Hypersensitivity reactions, including anaphylaxis, have been reported during or after the administration of raxibacumab by intravenous infusion. Administer raxibacumab by intravenous infusion in monitored settings where appropriate equipment, medication (including epinephrine) and personnel trained in the management of hypersensitivity, anaphylaxis, and shock are available .

Classifications:

Pharmacologic—

Monoclonal Antibody

Uses of This Medicine:

Raxibacumab injection is given with antibiotic medicines to treat inhalational anthrax. It is also used to prevent inhalational anthrax when there are no other available treatments. It works by preventing the anthrax bacteria from entering the body's cells, which prevents an infection.

Anthrax is a serious disease that may cause death. It is spread by touching or eating something that is infected with the anthrax germ, such as animals, or by breathing in the anthrax germ.

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 have not been performed on the relationship of age to the effects of raxibacumab injection in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of raxibacumab 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 in a medical facility. It is given through a needle placed in a vein. It must be given slowly, so the needle will have to remain in place for at least 2 hours and 15 minutes.

Your doctor will give you other medicine (eg, diphenhydramine) 1 hour before you receive this medicine to help prevent allergic reactions.

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 to make sure it is working properly and to decide if you should continue to receive it. Blood tests may be needed to check for unwanted effects.

This medicine may cause serious allergic reactions including anaphylaxis, which can be life-threatening and require immediate medical attention. Check with your doctor right away if you have chest tightness, cough, difficulty swallowing, dizziness, fast heartbeat, hives, itching, puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue, skin rash, trouble breathing, or unusual tiredness or weakness.

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

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 site

Less common

Black, tarry stools

blurred vision

chest pain or tightness

chills

confusion

cough

dizziness

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

fainting

fast, irregular, pounding, or racing heartbeat or pulse

feeling of warmth

fever

headache

itching, skin rash

lip and throat swelling

painful or difficult urination

pale skin

pounding in the ears

redness of the face, neck, arms, and occasionally, upper chest

redness of the skin

sore throat

sores, ulcers, or white spots on the lips or in the mouth

sweating

swollen, painful, or tender lymph glands in the neck, armpit, or groin

swollen glands

trouble breathing

unusual bleeding or bruising

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:

Less common

Back pain

feeling of constant movement of self or surroundings

muscle spasms

pain in the arms or legs

sensation of spinning

sleepiness or unusual drowsiness

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.