Clinical Information
Gen. Code and Des.
83448 measles,mumps,rubella vacc/PF SUBCUT VIAL 3.4-4.2
GCN and Des.
52407 measles,mumps,rubella vacc/PF SUBCUT VIAL 3.4-4.2
Strength
Dose Form
VIAL (EA)
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family
AHFS Class
80120000 VACCINES
Active Ingredients
3116 measles, mumps, and rubella vaccine live
9870 preservative free
Inactive Ingredients
2272 mannitol 69658
2432 lactose 64044515
2599 sorbitol 50704
9283 beef derived (bovine)
These highlights do not include all the information needed to use PRIORIX safely and effectively. See full prescribing information for PRIORIX.
PRIORIX (Measles, Mumps, and Rubella Vaccine, Live), suspension for subcutaneous injection
Initial U.S. Approval: 2022
INDICATIONS AND USAGE
PRIORIX is a vaccine indicated for active immunization for the prevention of measles, mumps, and rubella in individuals 12 months of age and older. (1)
DOSAGE AND ADMINISTRATION
For subcutaneous injection only.
Each dose is approximately 0.5 mL.
•
The first dose is administered at 12 through 15 months of age. (2.1)
•
The second dose is administered at 4 through 6 years of age. (2.1)
DOSAGE FORMS AND STRENGTHS
PRIORIX is a suspension for injection supplied as a single-dose vial of lyophilized antigen component to be reconstituted with the accompanying prefilled syringe of sterile water diluent component. A single dose after reconstitution is approximately 0.5 mL. (3)
CONTRAINDICATIONS
•
Severe allergic reaction (e.g., anaphylaxis) to any component of PRIORIX, or after a previous dose of any measles, mumps, and rubella virus-containing vaccine. (4.1)
•
Severe immunodeficiency. (4.2)
•
Pregnancy. (4.3, 8.1)
WARNINGS AND PRECAUTIONS
•
There is a risk of febrile seizure following administration of PRIORIX. (5.2)
•
Thrombocytopenia and thrombocytopenic purpura have been reported following vaccination with PRIORIX. (5.3)
•
Syncope (fainting) can occur in association with administration of injectable vaccines, including PRIORIX. Procedures should be in place to avoid injury from fainting. (5.4)
•
The tip caps of the prefilled syringes contain natural rubber latex, which may cause allergic reactions. (5.5)
ADVERSE REACTIONS
Most common solicited adverse reactions in clinical trials participants:
•
12 through 15 months of age: local reactions were pain (26%) and redness (25%); systemic reactions were irritability (63%), loss of appetite (45%), drowsiness (45%), and fever (35%). (6.1)
•
4 through 6 years of age: local reactions were pain (41%), redness (22%), and swelling (11%); systemic reactions were loss of appetite (21%), drowsiness (27%), and fever (24%). (6.1)
•
7 years of age and older: local reactions were pain (12%) and redness (12%). (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or VAERS at 1-800-822-7967 or www.vaers.hhs.gov.
DRUG INTERACTIONS
•
Administration of immune globulins and other blood products concurrently with PRIORIX may interfere with the expected immune response to the vaccine. (7.1)
•
PRIORIX may result in a temporary suppression of tuberculin reactivity. (7.2)
USE IN SPECIFIC POPULATIONS
•
Do not use during pregnancy. (8.1)
•
Avoid pregnancy for 1 month following vaccination with PRIORIX. (8.1)
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 6/2022
