Pronunciation:

AN-thrax i-MUNE GLOB-ue-lin

Brand Names:

• Anthrasil

Warnings:

Falsely elevated blood glucose measurements may occur during therapy in diabetic patients because of the maltose ingredient; this increases the risk of masked hypoglycemic episodes and over administration of insulin, potentially causing life-threatening hypoglycemia. To avoid maltose interference, monitor blood glucose during therapy with glucose-specific methods (ie, monitor and test strips) in diabetic patients. Thrombosis may occur with or without known risk factors. Risk of thrombosis is increased with advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, estrogen use, indwelling central vascular catheters, hyperviscosity, and cardiovascular risk factors . For patients at risk of thrombosis, administer IVIG at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity .

Uses of This Medicine:

Anthrax immune globulin belongs to a group of medicines known as immunizing agents. It is used to prevent or treat diseases that occur when your body has a weak immune system. Immune globulin contains antibodies that make your immune system stronger. It is used in combination with other medicines to treat inhalational anthrax in adults and children.

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 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 on the relationship of age to the effects of anthrax immune globulin injection have not been performed in the pediatric population. Safety and efficacy have not been established in children 16 years of age and younger.

Older adults—

Appropriate studies have not been performed on the relationship of age to the effects of anthrax immune globulin injection in the geriatric population. Safety and efficacy have not been established.

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.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Allergy to IgA (immunoglobulin A), history of or
• IgA (immunoglobulin A) deficiency with antibodies against IgA—Should not be given to patients with these conditions.

• Blood clotting problems or
• Diabetes or
• Heart attack or stroke, recent or
• Heart or blood vessel disease or
• Hyperviscosity (thick blood), known or suspected or
• Kidney disease or
• Paraproteinemia (paraproteins in the blood) or
• Sepsis (serious infection in the body)—Use with caution. May cause side effects to become worse.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine in a hospital. This medicine is given through a needle placed in one of your veins.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits for any problems that may be caused by this medicine. Blood and urine tests may be needed to check for unwanted effects.

This medicine may cause a serious type of allergic reaction, including anaphylaxis, which can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a rash, itching, hives, chest pain, dizziness or lightheadedness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after receiving this medicine. Certain people, including those with IgA (an immunoglobulin) deficiency and antibodies against IgA and a history of hypersensitivity to human immunoglobulin products should not use this medicine.

This medicine contains maltose and may cause changes in your blood sugar levels. Check with your doctor if you notice a change in the results of your blood or urine sugar tests.

This medicine may cause blood clots. This is more likely to occur if you have a history of blood clotting problems, heart disease, or if you are obese, take medicines containing estrogen, or must stay in bed for a long time because of surgery or illness. Check with your doctor right away if you suddenly have chest pain, trouble breathing, a severe headache, leg pain, or problems with vision, speech, or walking.

Tell your doctor right away if you start having red or dark brown urine, lower back or side pain, a sudden weight gain, a swollen face, arms, or legs, decreased urine output, or any problems with urination after you receive this medicine. These may be symptoms of a serious kidney problem.

This medicine may cause fever, chills, flushing, headaches, nausea, and vomiting after receiving this medicine. Tell your doctor or nurse right away if you have any of these symptoms.

This medicine may cause bleeding (hemolysis) or hemolytic anemia. Tell your doctor right away if you have stomach or back pain, dark urine, decreased urination, difficulty with breathing, an increased heart rate, tiredness, or yellow eyes or skin after you receive the medicine.

Tell your doctor right away if you start to have a stiff neck, drowsiness, fever, severe headache, nausea or vomiting, painful eye movements, or eye sensitivity to light. These could be symptoms of a serious condition called aseptic meningitis syndrome (AMS).

Call your doctor right away if you start having chest pain, difficult, fast, or noisy breathing, blue lips and fingernails, fever, pale skin, increased sweating, coughing that sometimes produces a pink frothy sputum, shortness of breath, or swelling of the legs and ankles after receiving this medicine. These may be symptoms of a serious lung problem.

Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests.

This medicine is made from donated human blood. Some human blood products have transmitted certain viruses to people who have received them, although the risk is low. Human donors and donated blood are both tested for viruses to keep the transmission risk low. Talk with your doctor about this risk if you are concerned.

While you or your child are being treated with immune globulin injection, do not have any immunizations (vaccines) without your doctor's approval. Live virus vaccines should not be given for 3 months after receiving immune globulin.

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:

Incidence not known

Agitation

back, leg, or stomach pains

bleeding gums

blurred vision

chills

coma

confusion

cough

dark urine

decreased urine output

depression

difficulty breathing

difficulty with swallowing

dizziness

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

fast, pounding, or irregular heartbeat or pulse

fever

flushing or redness of the skin

general body swelling

headache

hives or welts, itching, or skin rash

hoarseness

hostility

irritability

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

lethargy

loss of appetite

muscle twitching

nausea or vomiting

noisy breathing

nosebleeds

pains in the chest, groin, or legs, especially calves of the legs

pale skin

rapid weight gain

redness of the skin

seizures

severe headaches of sudden onset

slow or irregular breathing

sore throat

stiff neck or back

stupor

sudden loss of coordination

sudden onset of shortness of breath for no apparent reason

sudden onset of slurred speech

sudden vision changes

sweating

swelling of the face, ankles, or hands

tightness in the chest

unusual tiredness or weakness

unusually warm skin

yellowing of the eyes or skin

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

Pain or swelling at the injection site

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.