Pronunciation:

kroe-TAL-i-dee i-MUNE fab 2 (EE-kwyne)

Brand Names:

• Anavip

Dosage Forms:

• Powder for Solution

Classifications:

Therapeutic—

Antivenom

Uses of This Medicine:

Crotalidae immune F(ab)2 (equine) injection is used to treat poisoning caused by the bite of a North American Pit Viper. This medicine belongs to the group of medicines known as immunizing agents.

This medicine is to be given only by or under the immediate 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 Anavip® in children.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of Anavip® 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.

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 cresol or
• Allergy to horses or horse blood products—May increase risk for more serious side effects.

Proper Use of This Medicine:

A nurse or other trained health professional will give you or your child this medicine in a hospital. 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 60 minutes.

Precautions While Using This Medicine:

Your doctor will check your or your child's progress closely while you are receiving this medicine. This will allow your doctor to see if the medicine is working properly and does not cause any unwanted effect. 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. Tell your doctor right away if you or your child has a rash, itching, lightheadedness, dizziness, or fainting, joint or muscle pain, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after you get the injection.

Check with your doctor right away if you or your child has muscle or joint pain, fever, itching, or rash after receiving this medicine. These can be signs and symptoms of a delayed allergic reaction called serum sickness.

This medicine is made from horse plasma. Some horse blood products have transmitted viruses to people who have received them, although the risk is low. Talk to your doctor if you have any symptoms that concern you.

Tell your doctor right away if you or your child has unusual bleeding or bruising, blood in the urine or stool, heavy menstrual bleeding, or nosebleeds after receiving this medicine.

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

Bloating or swelling of the face, arms, hands, lower legs, or feet

difficulty with moving

flushing or redness of the skin

itching skin or rash

muscle pain or stiffness

nausea

pain in the joints

tingling of the hands or feet

unusual weight gain or loss

unusually warm skin

vomiting

Less common

Black, tarry stools

bleeding gums

blood in the urine or stools

chills

confusion

decreased urination

dizziness

dry mouth

fainting

fever

increase in heart rate

lightheadedness

pinpoint red spots on the skin

rapid breathing

sunken eyes

thirst

unusual bleeding or bruising

unusual tiredness or weakness

wrinkled skin

Incidence not known

Break in the skin, especially associated with blue-black discoloration, swelling, or drainage of fluid

chest pain, discomfort, or tightness

fast, pounding, or irregular heartbeat or pulse

hives or welts

hoarseness

irritation

joint stiffness or swelling

trouble breathing or swallowing

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

pain in the arms or legs

Less common

Fear or nervousness

trouble sleeping

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.