Vaccine Information: IMOVAX RABIES (Page 3 of 4)

Data from post-marketing experience

The following additional adverse events have been identified during postapproval use of Imovax Rabies vaccine. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to Imovax Rabies vaccine exposure.

Blood and Lymphatic System Disorders

Lymphadenopathy

Immune System Disorders

Anaphylactic reaction, serum sickness type reaction, dermatitis allergic, pruritus (itching), edema

Nervous System Disorders

Paresthesia, neuropathy, convulsion, encephalitis

Gastrointestinal Disorders

Vomiting, diarrhea

Musculoskeletal and Connective Tissue Disorders

Arthralgia

General Disorders and Administration Site Conditions

Asthenia, malaise, fever and chills (shivering), injection site hematoma

Respiratory, Thoracic, and Mediastinal Disorders

Wheezing, dyspnea

DOSAGE AND ADMINISTRATION

The package contains a vial of freeze-dried vaccine, a Luer-Lok™ syringe containing 1.0 mL of diluent with a plunger rod either inserted into the syringe or provided separately, and a sterile reconstitution needle. The syringe and its package should be inspected prior to use for evidence of leakage, premature activation of the plunger rod, or a faulty tip seal. If evidence of such defects is observed, the product should not be used.

Instructions for vaccine reconstitution

Figure
(click image for full-size original)

Luer-Lok™ syringe components (with plunger rod inserted)

Step 1: Remove plastic cover from the vial. Cleanse the vial stopper with a suitable germicide. Do not remove the stopper or the metal seal holding it in place.

Step 2: Screw the plunger rod into the syringe, if it is provided separately.

Step 3: Hold the syringe cap in one hand (avoid holding the plunger rod or syringe barrel), and unscrew the tip cap by twisting it counterclockwise.
Figure
(click image for full-size original)
Step 4: Attach the reconstitution needle to the syringe, by gently twisting the needle clockwise into the syringe until slight resistance is felt.
Figure
(click image for full-size original)

Step 5: Reconstitute the freeze-dried vaccine by injecting the diluent from the syringe into the vial. While the syringe and reconstitution needle are still attached, gently swirl the contents of the vial until completely dissolved and proceed to Step 6.

Step 6: Prior to withdrawing vial contents and without removing the reconstitution needle from the vial, unscrew the syringe to eliminate negative pressure (as the vial is sealed under vacuum). Reattach the syringe to the reconstitution needle which has remained in the vial.

Step 7: Withdraw the total contents of the vial into the syringe. Remove the reconstitution needle and discard it.

Step 8: Attach a new sterile needle (as per step 4) of a proper length and gauge suitable for intramuscular injection.

The supplied syringe is intended for single use only, must not be reused, and must be disposed of properly and promptly following its use.

To help avoid transmission of infectious diseases due to accidental needle sticks, needles should not be recapped but disposed of according to recommended guidelines.

The reconstituted vaccine should not be mixed with any other vaccine and should be used immediately.

Vaccine administration

Parenteral drug products should be inspected for particulate matter and discoloration prior to administration, whenever solution and container permit. If evidence of such defects is observed, the product should not be used.

After preparation of the injection site with an appropriate germicide, immediately inject the vaccine intramuscularly. For adults and older children, the vaccine should be injected into the deltoid muscle. (10) (18) (19) In infants and small children, the anterolateral aspect of the thigh may be preferable, depending on age and body mass. Care should be taken to avoid injection into or near blood vessels and nerves. If blood or any suspicious discoloration appears in the syringe, do not inject but discard contents and repeat procedure using a new dose of vaccine at a different site.

The gluteal area should not be used for administration of the vaccine as administration in this area may result in lower neutralizing antibody titers. (11)

NOTE: The freeze-dried vaccine is creamy white to orange. After reconstitution, it is pink to red.

Dosage schedules

A. Pre-exposure dosage

1. Primary vaccination

In the United States, the Advisory Committee on Immunization Practices (ACIP) recommends three injections of 1.0 mL each, one injection on Day 0, one on Day 7, and one either on Day 21 or 28. (11)

2. Booster dose

A booster dose consists of one injection of 1.0 mL of Imovax Rabies vaccine. To ensure the presence of a primed immune response over time among persons at higher than normal risk for exposure, titers should be checked periodically, with booster doses administered only as needed. Persons working with live rabies virus in research laboratories and in vaccine production facilities (continuous risk category) should have rabies antibody titers checked every six months and boosters given as needed to maintain an adequate titer defined as virus neutralization at a 1:5 dilution by a RFFIT. Other laboratory workers (eg, those performing rabies diagnostic testing), cavers, veterinarians and staff, animal-control and wildlife officers in areas where rabies is enzootic, and bat handlers regardless of location, (frequent risk category), should have their serum tested for rabies antibody every 2 years. If their titer is inadequate, they should receive a single booster dose of vaccine. Veterinarians, veterinary students, and terrestrial animal-control and wildlife officers, working in areas of low rabies endemicity (infrequent risk category) and certain at-risk international travelers who have completed a full pre-exposure vaccination series with licensed vaccines and according to schedule do not require routine booster serologic verification of detectable antibody titers or routine pre-exposure booster doses of vaccine (see Table 1). (11)

Persons who have experienced “immune complex-like” hypersensitivity reactions should receive no further doses of Imovax Rabies vaccine unless they are exposed to rabies or they are truly likely to be inapparently and/or unavoidably exposed to rabies virus and have unsatisfactory antibody titers.

B. Post-exposure dosage

1. Post-exposure dosage for previously unimmunized persons
Dose

Previously unvaccinated persons should receive 5 intramuscular doses (1 mL each) of Imovax Rabies vaccine, one dose immediately after exposure (Day 0) and one dose 3, 7, 14, and 28 days later.

RIG

Rabies immune globulin (RIG) 20 IU/kg on Day 0 in conjunction with the first vaccine dose. If possible, the full calculated dose of RIG should be used to infiltrate the wound(s). If it is not possible to do so, any remaining portion of the dose should be administered intramuscularly at a site different from the site used to administer the vaccine.

Because the antibody response following the recommended vaccination regimen with HDCV has been satisfactory, routine post-vaccination serologic testing is not recommended. Serologic testing is indicated in unusual circumstances, as when the patient is known to be immunosuppressed. Contact local or state health department or CDC for recommendations. (11)

2. Post-exposure dosage for previously immunized persons

When an immunized person who was vaccinated using the recommended pre-exposure regimen or a prior post-exposure regimen with a cell culture vaccine or who had previously demonstrated rabies antibody is exposed to rabies, that person should receive two intramuscular doses (1.0 mL each) of Imovax Rabies vaccine, one dose immediately after the exposure and one dose 3 days later. RIG should not be given in these cases.

If the immune status of a previously vaccinated person who did not receive the recommended HDCV regimen is not known, full primary post-exposure antirabies treatment (RIG plus 5 doses of HDCV) may be necessary. In such cases, if antibody levels of greater than 1:5 dilution by a RFFIT can be demonstrated in a serum sample collected before vaccine is given, treatment can be discontinued after at least two doses of HDCV. (20)

HOW SUPPLIED

Imovax Rabies vaccine is supplied in a tamper evident unit dose box with:

-
One vial of freeze-dried vaccine containing a single dose (NDC 49281-248-58 or 49281-246-58).
-
One sterile syringe containing diluent (NDC 49281-249-01 or 49281-263-58). If not already inserted into the syringe, a separate plunger rod is provided.
-
One sterile disposable needle for reconstitution.

Packaged as NDC 49281-250-51 or 49281-252-51.

STORAGE

The freeze-dried vaccine is stable if stored in the refrigerator between 2°C and 8°C (35°F to 46°F). Do not freeze.

REFERENCES

1
Aoki FY, Tyrell DAJ, Hill LE. Immunogenicity and acceptability of a human diploid cell culture rabies vaccine in volunteers. The Lancet. 1975 Mar 22;1(7908):660-2.
2
Cox JH, Schneider LG. Prophylactic immunization of humans against rabies by intradermal inoculation of human diploid cell culture vaccine. J Clin Microbiol. 1976 Feb;3(2):96-101.
3
Kuwert EK, Marcus I, Werner J, Iwand A, Thraenhart O. Some experiences with human diploid cell strain—(HDCS) rabies vaccine in pre- and postexposure vaccinated humans. Dev Biol Stand. 1978;40:79-88.
4
Ajjan N, Soulebot J-P, Stellmann C, Biron G, Charbonnier C, Triau R, Mérieux C. Résultats de la vaccination antirabique préventive par le vaccin inactivé concentré souche rabies PM/W138-1503-3M cultivés sur cellules diploïdes humaines. Dev Biol Stand. 1978;40:89-100.
5
Costy-Berger F. Vaccination antirabique préventive par du vaccin préparé sur cellules diploïdes humaines. Dev Biol Stand. 1978;40:101-4.
6
Bernard KW, Roberts MA, Sumner J, Winkler WG, Mallonee J, Baer GM, Chaney R. Human diploid cell rabies vaccine. JAMA. 1982 Feb 26;247(8):1138-42.
7
Bahmanyar M, Fayaz A, Nour-Salehi S, Mohammadi M, Koprowski H. Successful protection of humans exposed to rabies infection. JAMA. 1976 Dec 13;236(24):2751-4.
8
CDC. Recommendations of the Advisory Committee on Immunization Practices (ACIP). Rabies Prevention–United States, 1984. MMWR. 1984 Jul 20;33(28):393-402, 407-8.
9
Shill M, Baynes RD, Miller SD. Fatal rabies encephalitis despite appropriate postexposure prophylaxis. N Engl J Med. 1987 May 14;316(20):1257-58.
10
CDC. Human rabies despite treatment with rabies immune globulin and human diploid cell rabies vaccine — Thailand. MMWR. 1987 Nov 27;36(46):759-60, 765.
11
Manning SE, Rupprecht CE, Fishbein D, Hanlon CA, Lumlertdacha B, Guerra M, et al. Human rabies prevention — United States 2008: recommendations of the Advisory Committee on Immunization Practices. MMWR. 2008 May 23;57(RR-3):1-28.
12
Rabies vaccines: WHO position paper. Weekly epidemiological record. 2010 Aug 6;85(32):309-320. Available from: http://www.who.int/wer.
13
CDC. Systemic allergic reactions following immunization with human diploid cell rabies vaccine. MMWR. 1984 Apr 13;33(14):185-7.
14
Boe E, Nyland H. Guillain-Barré syndrome after vaccination with human diploid cell rabies vaccine. Scand J Infect Dis. 1980;12(3):231-2.
15
CDC. Adverse reactions to human diploid cell rabies vaccine. MMWR. 1980;29:609-10.
16
Bernard KW, Smith PW, Kader FJ, Moran MJ. Neuroparalytic illness and human diploid cell rabies vaccine. JAMA. 1982 Dec 17;248(23):3136-8.
17
Varner MW, McGuinness GA, Galask RP. Rabies vaccination in pregnancy. Am J of Obstet Gynecol. 1982 Jul 15;143(6):717-8.
18
Cockshott WP, Thompson GT, Howlett LJ, Seely ET. Intramuscular or intralipomatous injections? N Eng J Med. 1982 Aug 5;307(6):356-8.
19
Baer GM, Fishbein DB. Rabies postexposure prophylaxis. N Engl J Med. 1987;316:1270-72.
20
CDC. Recommendations of the Advisory Committee on Immunization Practices. Human rabies prevention-United States, 1999. MMWR. 1999;48(RR-1):1-21.

Product information as of December 2019.

US Govt License #1724

Manufactured by:
Sanofi Pasteur SA
Lyon France

Distributed by:
Sanofi Pasteur Inc.
Swiftwater PA 18370 USA
1-800-VACCINE (1-800-822-2463)

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