Antivenin (Crotalidae) polyvalent

Because you will receive Crotalidae antivenin in a clinical setting, you are not likely to miss a dose.

Since this medicine is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

Get emergency medical help if you have signs of an allergic reaction: hives, itching, redness; wheezing, trouble breathing; feeling light-headed; swelling of your face, lips, tongue, or throat.

Some side effects may occur during the injection. Tell your caregiver right away if you feel feverish or nauseated, or if you have low back pain or trouble breathing.

Call your doctor at once if you have:

• easy bruising, unusual bleeding (nosebleeds, bleeding gums, bleeding from an injury);

• purple or red pinpoint spots under your skin;

• fever, swollen glands, rash or itching, joint pain, or general ill feeling;

• heavy menstrual bleeding; or

• itching, rash, or skin redness several days after you were treated with Crotalidae antivenin.

Common side effects may include:

• itching;

• rash;

• nausea; or

• back pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Applies to antivenin (crotalidae) polyvalent: intravenous powder for solution

Along with its needed effects, antivenin (crotalidae) polyvalent 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 while taking antivenin (crotalidae) polyvalent:

• 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

• 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

Some side effects of antivenin (crotalidae) polyvalent 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:

• Headache
• pain in the arms or legs

• Fear or nervousness
• trouble sleeping

Immediate systemic reactions (allergic reactions or anaphylaxis) can occur whenever a horse-serum-containing product is administered. An immediate reaction (e.g. shock, anaphylaxis) usually occurs within 30 minutes. Symptoms and signs may develop before the needle is withdrawn and may include apprehension, flushing, itching, urticaria; edema of the face, tongue, and throat; cough, dyspnea, cyanosis, vomiting, and collapse. There have been isolated reports of cardiac arrest and death associated with Antivenin (Crotalidae) Polyvalent (equine origin) use. However, serious immediate reactions to Antivenin are rare. In skin-test-negative patients, Antivenin caused a true immediate sensitivity reaction in less than 1 percent of patients. 10

Serum sickness usually occurs 5 to 24 days after administration and its frequency may be related to the number of Antivenin vials administered. 30 The incubation period may be less than 5 days, especially in those who have received horse-serum-containing preparations in the past. The usual symptoms and signs are malaise, fever, urticaria, lymphadenopathy, edema, arthralgia, nausea, and vomiting. Occasionally, neurological manifestations develop, such as meningismus or peripheral neuritis. Peripheral neuritis usually involves the shoulders and arms. Pain and muscle weakness are frequently present, and permanent atrophy may develop.

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