HyperRAB S / D

This section provides information on the proper use of a number of products that contain rabies immune globulin. It may not be specific to HyperRAB S/D. Please read with care.

You will receive this medicine while you are in a hospital or clinic. A doctor, nurse, or other trained health professional will give you this medicine. It is given as a shot in the upper arm (deltoid) or thigh muscle. It may also be injected into the wound that caused your exposure to rabies (e.g., animal bite or scratch).

This medicine is given preferably at the time of your first rabies vaccine dose. It may also be given through the seventh day after the first dose of rabies vaccine is given.

• Tell all of your health care providers that you take HyperRAB S/D. This includes your doctors, nurses, pharmacists, and dentists.
• Talk with your doctor before getting any vaccines while you take this medicine and after you stop taking it. Vaccine use with HyperRAB S/D may either raise the chance of an infection or make the vaccine not work as well. Talk with your doctor.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take this medicine.
• This medicine is made from human plasma (part of the blood) and may have viruses that may cause disease. This medicine is screened, tested, and treated to lower the chance that it carries an infection. Talk with the doctor.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using HyperRAB S/D while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as a shot into a muscle.
• It is given as a shot into the skin.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about HyperRAB S/D, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about HyperRAB S/D. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using HyperRAB S/D (rabies immune globulin (human)).

Review Date: October 4, 2017

The usefulness of prophylactic rabies antibody in preventing rabies in humans when administered immediately after exposure was dramatically demonstrated in a group of persons bitten by a rabid wolf in Iran.(1,2) Similarly, beneficial results were later reported from the U.S.S.R.(3) Studies coordinated by WHO (World Health Organization) helped determine the optimal conditions under which antirabies serum of equine origin and rabies vaccine can be used in man.(4-7) These studies showed that serum can interfere to a variable extent with the active immunity induced by the vaccine, but could be minimized by booster doses of vaccine after the end of the usual dosage series.

Preparation of rabies immune globulin of human origin with adequate potency was reported by Cabasso et al.(8) In carefully controlled clinical studies, this globulin was used in conjunction with rabies vaccine of duck-embryo origin (DEV).(8,9) These studies determined that a human globulin dose of 20 IU/kg of rabies antibody, given simultaneously with the first DEV dose, resulted in amply detectable levels of passive rabies antibody 24 hours after injection in all recipients. The injections produced minimal, if any, interference with the subject's endogenous antibody response to DEV.

More recently, human diploid cell rabies vaccines (HDCV) prepared from tissue culture fluids containing rabies virus have received substantial clinical evaluation in Europe and the United States.(10-16) In a study in adult volunteers, the administration of Rabies Immune Globulin (Human) did not interfere with antibody formation induced by HDCV when given in a dose of 20 IU per kilogram body weight simultaneously with the first dose of vaccine.(15)

In a clinical study in eight healthy human adults receiving a 20 IU/kg intramuscular dose of Rabies Immune Globulin (Human) treated with solvent/detergent, HyperRAB S/D, detectable passive rabies antibody titers were observed in the serum of all subjects by 24 hours post injection and persisted through the 21 day study period. These results are consistent with prior studies(17,18) with non-solvent/detergent treated product.

General

HyperRAB S/D should not be administered intravenously because of the potential for serious reactions. Although systemic reactions to immunoglobulin preparations are rare, epinephrine should be available for treatment of acute anaphylactoid symptoms.

Drug Interactions

Repeated doses of HyperRAB S/D should not be administered once vaccine treatment has been initiated as this could prevent the full expression of active immunity expected from the rabies vaccine.

Other antibodies in the HyperRAB S/D preparation may interfere with the response to live vaccines such as measles, mumps, polio or rubella. Therefore, immunization with live vaccines should not be given within 3 months after HyperRAB S/D administration.

Pregnancy Category C

Animal reproduction studies have not been conducted with HyperRAB S/D. It is also not known whether HyperRAB S/D can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. HyperRAB S/D should be given to a pregnant woman only if clearly needed.

Pediatric Use

Safety and effectiveness in the pediatric population have not been established.

A number of factors could reduce the efficacy of this product or even result in an ill effect following its use. These include improper storage and handling of the product after it leaves our hands, diagnosis, dosage, method of administration, and biological differences in individual patients. Because of these factors, it is important that this product be stored properly and that the directions be followed carefully during use.

No warranty, express or implied, including any warranty of merchantability or fitness is made. Representatives of the Company are not authorized to vary the terms or the contents of the printed labeling, including the package insert for this product, except by printed notice from the Company's headquarters. The prescriber and user of this product must accept the terms hereof.

Applies to rabies immune globulin, human: intramuscular solution

Along with its needed effects, rabies immune globulin, human (the active ingredient contained in HyperRAB S / D) 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 immediately if any of the following side effects occur while taking rabies immune globulin, human:

• Cloudy or bloody urine
• high blood pressure
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• swelling of the face, feet, or lower legs

Some side effects of rabies immune globulin, human 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:

• Fever
• pain, soreness, tenderness, or stiffness at the injection site

• Skin rash

Applies to rabies immune globulin, human: intramuscular solution

General

The most common adverse events were injection site and skin reactions.[Ref]

Local

Rare (less than 0.1%): Injection site: swelling, pain, erythema, induration, warmth, pruritus, rash
Frequency not reported: Discomfort at injection site, soreness at injection site[Ref]

Dermatologic

Rare (less than 0.1%): Skin reaction, erythema, pruritus, skin rash
Frequency not reported: Angioneurotic edema, bruising[Ref]

Hypersensitivity

Rare (less than 0.1%): Hypersensitivity, anaphylactic shock, allergic type reactions[Ref]

Other

Rare (less than 0.1%): Fever, malaise, chill, fatigue, influenza like illness
Frequency not reported: Mild temperature elevations, disabling pain that limited motion[Ref]

Renal

Rare (less than 0.1%): Nephrotic syndrome[Ref]

Cardiovascular

Rare (less than 0.1%): Tachycardia, hypotension[Ref]

Musculoskeletal

Rare (less than 0.1%): Arthralgia
Frequency not reported: Compartment syndrome, infiltration of wounds[Ref]

Gastrointestinal

Rare (less than 0.1%): Nausea, vomiting[Ref]

Nervous system

Rare (less than 0.1%): Headache[Ref]

Immunologic

Frequency not reported: Sensitization to repeated injections[Ref]

Some side effects of HyperRAB S / D may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.