PRIORIX

Priorix Generic Name & Formulations

Legal Class

General Description

Measles, mumps and rubella viruses live, attenuated; lyophilized susp for SC inj after reconstitution; contains neomycin, ovalbumin, bovine serum albumin; preservative-free.

Pharmacological Class

MMR.

How Supplied

Single-dose vials—10 (w. prefilled syringes of diluent)

Storage

Refrigerate vials of lyophilized antigen component between 36 and 46°F (2 and 8°C); protect from light.

Store prefilled ungraduated syringes of sterile water diluent between 36 and 46°F (2 and 8°C) or at controlled room temperature up to 77°F (25°C).

After reconstitution:

Administer immediately.
If not used immediately, refrigerate between 36 and 46°F (2 and 8°C) and administer within 8 hours.
Discard reconstituted vaccine if not used within 8 hours.

Manufacturer

GlaxoSmithKline

Generic Availability

Mechanism of Action

Priorix vaccination induces antibodies to measles, mumps, and rubella associated with protection, which can be measured by enzyme-linked immunosorbent assays (ELISAs).

Priorix Indications

Indications

Active immunization for the prevention of measles, mumps, and rubella.

Priorix Dosage and Administration

Adults and Children

<12 months: not established. Each dose is 0.5mL. Give by SC inj. First dose at 12–15 months of age, second dose at 4–6yrs of age. If Priorix is not given according to this schedule and 2 doses are recommended: separate the first and second dose by a minimum of 4 weeks. Priorix may be given as a second dose to individuals who received a first dose of another measles, mumps and rubella-containing vaccine.

Administration

Administer immediately after reconstitution. Reconstitute with the accompanying prefilled syringe of sterile water diluent. A single dose after reconstitution is ~0.5mL.

If not used immediately, store refrigerated between 36° and 46° F (2° and 8°C) and administer within 8 hours. If not used within 8 hours, discard reconstituted vaccine.

The reconstituted vaccine should be a clear peach to fuchsia pink-colored suspension.

For subcutaneous injection only.

Priorix Contraindications

Contraindications

History of severe allergic reactions after a previous dose of any measles, mumps, and rubella virus-containing vaccine. Severe humoral or cellular (primary or acquired) immunodeficiency. Pregnancy (during and for 1 month after vaccination).

Priorix Boxed Warnings

Not Applicable

Priorix Warnings/Precautions

Warnings/Precautions

Have epinephrine inj available. Risk of febrile seizures or vaccine virus transmission. Latex allergy. Vaccination may not protect all susceptible individuals. Nursing mothers.

Pregnancy Considerations

Contraindicated for use in pregnant women. Contains live attenuated measles, mumps and rubella viruses. Infection with the wild-type viruses has been associated with maternal and fetal adverse outcomes. Avoid pregnancy for 1 month after vaccination.

Nursing Mother Considerations

No data available on the effects of Priorix on the breastfed infant or on milk production. Studies have shown that lactating postpartum women vaccinated with live attenuated rubella vaccine may secrete virus in breast milk and transmit it to a breastfed infant. Consider the health benefits of breastfeeding, along with the mother’s clinical need for Priorix and any potential adverse effects on the breastfed child.

Pediatric Considerations

Safety and effectiveness of Priorix in infants younger than 12 months have not been established.

Geriatric Considerations

Clinical studies did not include participants 65 years of age and older to determine whether they respond differently from younger participants.

Priorix Pharmacokinetics

See Literature

Priorix Interactions

Interactions

Concomitant immune globulins, other blood products may interfere with the expected immune response to the vaccine. May cause a temporary suppression of tuberculin reactivity. Avoid false (–) results by administering tuberculin test any time before, simultaneously with, or at least 4 weeks after vaccination.

Priorix Adverse Reactions

Adverse Reactions

Local reactions (eg, pain, redness, swelling), irritability, loss of appetite, drowsiness, fever; thrombocytopenia, thrombocytopenic purpura, syncope.

Priorix Clinical Trials

Clinical Trials

The approval of Priorix was based on safety data from 6 clinical studies that assessed Priorix in a total of 12,151 participants, of which 8780 were between 12 to 15 months of age, 2917 were between 4 to 6 years of age, and 454 were 7 years of age and older.

In the clinical studies, participants received at least 1 dose of either Priorix or a US-licensed MMR virus vaccine, live (M-M-R® II). Efficacy was demonstrated based on comparative immunogenicity data with M-M-R II.

Concomitant Administration With Havrix, Varivax, and Prevnar 13

Concomitant administration of Priorix or M-M-R II with Havrix and Varivax was evaluated in children 12 through 15 months of age.
Children enrolled in the US also received Prevnar 13.
Results showed no evidence that Priorix interfered with the antibody responses to these vaccines relative to the antibody responses when M-M-R II was concomitantly administered.

Concomitant Administration With Kinrix and Varivax

Concomitant administration of Priorix or M-M-R II with Kinrix and Varivax was evaluated in children 4 through 6 years of age.
Results showed no evidence that Priorix interfered with the antibody responses to these vaccines relative to the antibody responses when M-M-R II was concomitantly administered.

Priorix Note