PRIORIX-TETRA®

05/22/2024
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Product Information

  • Name: PRIORIX-TETRA®
  • Type: Combined measles, mumps, rubella, and varicella vaccine, live, attenuated
  • Form: Lyophilized powder for injection
  • Manufacturer: GlaxoSmithKline Inc.

Indications and Clinical Use

  • Indication: Active immunization against measles, mumps, rubella, and varicella in individuals from 9 months to 6 years of age. May be used in individuals up to 12 years of age based on previous experience with the component vaccines (PRIORIX and VARILRIX).

Contraindications

  • Known hypersensitivity to neomycin or any other component of the vaccine.
  • Severe humoral or cellular immunodeficiency.
  • Pregnant women (pregnancy should be avoided for one month after vaccination).

Warnings and Precautions

  • General: Do not administer intravascularly or intradermally. Postpone vaccination in cases of acute severe febrile illness.
  • Anaphylaxis: Appropriate medical treatment should be available in case of anaphylactic reactions.
  • Syncope: Procedures should be in place to prevent injury from fainting.
  • Immune Response: Limited protection may be obtained if vaccinated up to 72 hours post-exposure to natural measles.
  • Transmission Risk: Pharyngeal excretion of the rubella virus can occur; transmission of the Oka vaccine virus may occur, particularly in vaccinees who develop a rash.

Adverse Reactions

  • Very Common (≥1/10): Pain and redness at the injection site, fever (rectal ≥38°C and ≤39.5°C; axillary/oral: ≥37.5°C and ≤39°C).
  • Common (≥1/100 to <1/10): Swelling at the injection site, fever (rectal >39.5°C; axillary/oral >39°C), irritability, rash (measles-like, rubella-like, varicella-like).
  • Uncommon (≥1/1,000 to <1/100): Lymphadenopathy, diarrhea, vomiting, lethargy, fatigue, upper respiratory tract infection, anorexia, insomnia, nervousness, rhinitis.
  • Rare (≥1/10,000 to <1/1,000): Injection site bruising, otitis media, febrile convulsions, cough, bronchitis.

Drug Interactions

  • Can be co-administered with vaccines like hexavalent vaccines (DTaP-HBV-IPV-Hib), diphtheria-tetanus-acellular pertussis vaccine (DTaP), Hib, IPV, HBV, BEXSERO, MenC, MenACWY, and PCV.
  • Avoid salicylates for 6 weeks post-vaccination due to the risk of Reye’s Syndrome.

Dosage and Administration

  • Primary Immunization: Two doses, with an interval of at least 6 weeks between doses (not less than 4 weeks).
  • Route: Subcutaneous (SC) or intramuscular (IM) injection.
  • Reconstitution: Reconstitute with the provided diluent, inspect for particulates, and administer promptly or within 8 hours if refrigerated.

Storage and Stability

  • Store at 2°C to 8°C. Do not freeze. Protect from light. Use reconstituted vaccine within 8 hours if stored in a refrigerator.
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Written By Paul Kim

Medical Director - APN, NSWOC, RNP

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