HyperRAB S / D

Name: HyperRAB S / D

Commonly used brand name(s)

In the U.S.

  • Bayrab
  • HyperRAB S/D
  • Imogam Rabies-HT

Available Dosage Forms:

  • Solution

Therapeutic Class: Immune Serum

Precautions While Using HyperRAB S/D

It is very important that your doctor check you closely to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

This medicine is made from donated human blood. Some human blood products have transmitted 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 are being treated with rabies immune globulin, do not have any immunizations (vaccinations) without your doctor's approval. Live virus vaccines (e.g., measles, mumps, polio, rubella) should not be given within 3 months after receiving rabies immune globulin.

HyperRAB S/D Side Effects

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 immediately if any of the following side effects occur:

Rare
  • 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 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:

Less common
  • Fever
  • pain, soreness, tenderness, or stiffness at the injection site
Rare
  • Skin rash

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.

Uses of HyperRAB S/D

  • It is used to treat rabies infection.

What do I need to tell my doctor BEFORE I take HyperRAB S/D?

  • If you have an allergy to rabies immune globulin, thimerosal, or any other part of HyperRAB S/D (rabies immune globulin (human)).
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of certain infections (parvovirus B19, hepatitis A) like fever or chills, feeling very sleepy, runny nose, rash, joint pain, tiredness, poor appetite, upset stomach or throwing up, belly pain, or yellow skin or eyes.
  • Feeling very tired or weak.
  • Dark urine.
  • Loose stools (diarrhea).
  • The chance of blood clots may be raised with HyperRAB S/D. The chance may be higher in older people, if you have to be in a bed or chair for a long time, if you take estrogen products, or if you have certain catheters. Some health problems like thick blood, heart problems, or a history of blood clots raise the chance of having blood clots. Blood clots can happen if you do not have any of these health problems. Call your doctor right away if you have numbness or weakness on 1 side of your body; pain, redness, tenderness, warmth, or swelling in the arms or legs; change in color of an arm or leg; chest pain or pressure; shortness of breath; fast heartbeat; or coughing up blood. Talk with your doctor.

Contraindications

None known.

Warnings

Rabies Immune Globulin (Human) HyperRABTMS/D is made from human plasma. Products made from human plasma may contain infectious agents, such as viruses, and, theoretically, the Creutzfeldt-Jakob Disease (CJD) agent that can cause disease. The risk that such products will transmit an infectious agent has been reduced by screening plasma donors for prior exposure to certain viruses, by testing for the presence of certain current virus infections, and by inactivating and/or removing certain viruses. Despite these measures, such products can still potentially transmit disease. There is also the possibility that unknown infectious agents may be present in such products. Individuals who receive infusions of blood or plasma products may develop signs and/or symptoms of some viral infections, particularly hepatitis C. ALL infections thought by a physician possibly to have been transmitted by this product should be reported by the physician or other healthcare provider to Talecris Biotherapeutics, Inc. [1-800-520-2807].

The physician should discuss the risks and benefits of this product with the patient, before prescribing or administering it to the patient.

HyperRAB S/D should be given with caution to patients with a history of prior systemic allergic reactions following the administration of human immunoglobulin preparations.

The attending physician who wishes to administer HyperRAB S/D to persons with isolated immunoglobulin A (IgA) deficiency must weigh the benefits of immunization against the potential risks of hypersensitivity reactions. Such persons have increased potential for developing antibodies to IgA and could have anaphylactic reactions to subsequent administration of blood products that contain IgA.(25)

As with all preparations administered by the intramuscular route, bleeding complications may be encountered in patients with thrombocytopenia or other bleeding disorders.

Adverse Reactions

Soreness at the site of injection and mild temperature elevations may be observed at times. Sensitization to repeated injections has occurred occasionally in immunoglobulin-deficient patients. Angioneurotic edema, skin rash, nephrotic syndrome, and anaphylactic shock have rarely been reported after intramuscular injection, so that a causal relationship between immunoglobulin and these reactions is not clear.

Package label

Rabies
Immune
Globulin
(Human)

HyperRAB™ S/D

Solvent/Detergent
Treated

Preservative-free,
latex-free

150 IU/mL
Suitable for use with
Rabies Vaccine

10 mL

NDC 13533-618-10

Talecris
BIOTHERAPEUTICS

The patient and physician
should discuss the risks and
benefits of this product.

One Single Dose Vial

FOR INTRAMUSCULAR
INJECTION ONLY. DO NOT
GIVE INTRAVENOUSLY.

For complete dosage and
administration information,
read enclosed package insert.

Store at 2-8°C (36-46°F).
Do not freeze.

If the shrink band is absent or
shows any sign of tampering,
do not use the product and
notify Talecris Biotherapeutics, Inc.
immediately.

Not returnable for credit or
exchange.

Rx only

CAUTION:  U.S. federal law
prohibits dispensing without
prescription.

Rabies Immune Globulin
(Human) is a sterile solution
of immunoglobulin containing
15%-18% protein stabilized
with 0.21-0.32 M glycine.  The
pH is adjusted with sodium
carbonate.

The potency of each vial is
150 IU/mL based on the U.S.
Standard Rabies Immune
Globulin.

08940040

Talecris Biotherapeutics, Inc.
Research Triangle Park,
NC 27709 USA
U.S. License No. 1716

LOT

EXP.

NDC 13533-618-10
Rabies Immune Globulin
(Human)

HyperRAB™ S/D 10 mL

Solvent/Detergent Treated                  
Talecris                                                The Patient and
Biotherapeutics, Inc.                           physician should
RTP, NC 27709                              discuss the risks and
U.S. License No. 1716                 benefits of this product.

08907466

Lot

Exp.

One Single Dose Vial

150 IU/mL

Do not give intravenously.

Dosage: 20 IU/kg in con-
junction with Rabies
Vaccine.

See directions before using.

Rx only

HyperRAB S/D  
human rabies virus immune globulin injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:13533-618
Route of Administration INTRAMUSCULAR DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Human Rabies Virus Immune Globulin (Human Rabies Virus Immune Globulin) Human Rabies Virus Immune Globulin 150 [iU]  in 1 mL
Inactive Ingredients
Ingredient Name Strength
Glycine  
Product Characteristics
Color YELLOW (Clear liquid, colorless to pale yellow) Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description
1 NDC:13533-618-02 2 mL in 1 VIAL, GLASS
2 NDC:13533-618-10 10 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA101144 08/14/1996
Labeler - TALECRIS BIOTHERAPEUTICS, INC. (839731507)
Establishment
Name Address ID/FEI Operations
TALECRIS BIOTHERAPEUTICS HOLDINGS CORP 611019113 MANUFACTURE
Revised: 10/2010   TALECRIS BIOTHERAPEUTICS, INC.
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