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Imogam Rabies

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Imogam Rabies

Imogam Rabies Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Imogam Rabies - HT Rabies Immune Globulin (human) is an immunization used to prevent rabies in people who have been bitten by an animal or otherwise exposed to the rabies virus. Common side effects include headaches, or tenderness, pain, soreness or stiffness of the muscles at the injection site that may persist for several hours after injection.

The recommended dose of Imogam Rabies - HT is 20 IU/kg (0. 133 mL/kg) or 9 IU/lb (0. 06 mL/lb) of body weight administered at time of the first vaccine dose. It should be used in conjunction with a rabies vaccine such as Imovax Rabies Vaccine. Imogam may interact with steroids, chemotherapy or radiation cancer treatments, x-rays, cyclosporine, azathioprine, basiliximab, etanercept, leflunomide, muromonab-CD3, mycophenolate mofetil, sirolimus, tacrolimus, or "live" vaccines. Tell your doctor all medications and supplements you use, and all vaccines you recently received. During pregnancy, Imogam should be used only if prescribed. Tell your doctor if you are pregnant or breastfeeding before receiving Imogam vaccine.

Our Imogam Rabies - HT Rabies Immune Globulin (human) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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.

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Imogam Rabies FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

In a recent clinical trial involving 16 volunteers in 4 treatment groups, two subjects reported severe headaches, one in the Imogam® Rabies - HT + placebo group and one in the Imogam® Rabies + Imovax® Rabies group, and one third of the volunteers reported moderate systemic (headache and malaise) reactions. These were equally distributed among the 4 treatment groups with no significant differences between the groups. 28

Local adverse reactions such as tenderness, pain, soreness or stiffness of the muscles may occur at the injection site and may persist for several hours after injection. These may be treated symptomatically. Mild systemic adverse reactions to the globulin after intramuscular injection are uncommon. 28, 38, 39 Although not reported specifically for HRIG, angioneurotic edema, nephrotic syndrome, and anaphylaxis have been reported after injection of immune globulin (IG), a product similar in biochemical composition but without antirabies activity. These reactions occur so rarely that a causal relationship between IG and these reactions has not been established. 1

Reporting of Adverse Events

The National Vaccine Injury Compensation Program, established by the National Childhood Vaccine Injury Act of 1986, requires physicians and other health-care providers who administer vaccines to maintain permanent vaccination records and to report occurrences of certain adverse events to the US Department of Health and Human Services. Reportable events include those listed in the Act for each vaccine and events specified in the package insert as contraindications to further doses of that vaccine. 40, 41, 42

Reporting by patients, parents or guardians of all adverse events occurring after HRIG administration should be encouraged. Adverse events following treatment with HRIG should be reported by the health-care provider to the US Department of Health and Human Services (DHHS) Vaccine Adverse Event Reporting Systems (VAERS). Reporting forms and information about reporting requirements or completion of the form can be obtained from VAERS through a toll-free number 1-800-822-7967. 40, 41, 42

The health-care provider also should report these events to the Director of Scientific and Medical Affairs, Aventis Pasteur Inc., Discovery Drive, Swiftwater, PA 18370 or call 1-800-822-2463.

Read the entire FDA prescribing information for Imogam Rabies (Rabies Immune Globulin (Human)) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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