rubella virus vaccine, live
Meruvax II

Pharmacologic classification: vaccine
Therapeutic classification: viral vaccine
Pregnancy risk category C


Available forms
Available by prescription only
Injection: Single-dose vial containing not less than 1,000 TCID50 (tissue culture infective doses) of the Wistar RA 27/3 strain of rubella virus propagated in human diploid cell culture

Indications and dosages
 Rubella (German measles) immunization. Adults and children older than age 1: 1 vial (0.5 ml) S.C.

Pharmacodynamics
Rubella prophylaxis: Vaccine promotes active immunity to rubella by inducing production of antibodies.

Pharmacokinetics
Absorption: Antibodies are usually detectable 2 to 6 weeks after injection; duration of vaccine-induced immunity is expected to be lifelong.
Distribution: No information available.
Metabolism: No information available.
Excretion: No information available.

Route Onset Peak Duration
S.C. 2-6 wk Unknown > 10 yr


Contraindications and precautions
Contraindicated in pregnant women, immunosuppressed patients, patients receiving corticosteroids (except as replacement therapy) or radiation therapy, and patients with cancer, blood dyscrasias, gamma globulin disorders, fever, active untreated tuberculosis, or history of hypersensitivity to neomycin.

Interactions
Drug-drug. Immune serum globulin or transfusions of blood and blood products: May impair immune response to vaccine. If possible, defer vaccination for 3 months.
Immunosuppressants: May reduce response to vaccine. Monitor patient closely. Defer vaccination until immunosuppressant is discontinued, if possible.

Adverse reactions
CNS: polyneuritis, malaise, headache, fever.
EENT: sore throat.
Hematologic: thrombocytopenic purpura.
Musculoskeletal: arthralgia, arthritis.
Skin: rash, urticaria; pain, erythema, and induration at injection site.
Other: anaphylaxis, lymphadenopathy.

Effects on lab test results
None reported.

Overdose and treatment
No information available.

Special considerations
• Obtain a thorough history of allergies, especially to antibiotics, and of reactions to immunizations.
• Keep epinephrine solution (1:1,000) available to treat allergic reactions.
• Don’t give rubella vaccine less than 1 month before or after immunization with other live virus vaccines, except for monovalent or trivalent live poliovirus vaccine; live, attenuated measles virus vaccine; or live mumps virus vaccine, which may be administered simultaneously.
• Don’t inject I.M. Inject S.C. into the outer aspect of the upper arm.
• Use only diluent supplied. Discard 8 hours after reconstituting.
• Store vaccine at 36° to 46° F (2° to 8° C), and protect from light. Solution may be used if red, pink, or yellow, but it must be clear.
• c Vaccine won’t offer protection when given after exposure to natural rubella, although there’s no evcVaccine won’t offer protection when given after exposure to natural rubella, although there’s no evidence that it would be harmful.
• Although rubella vaccine administration should be deferred in patients with febrile illness, it may be administered to susceptible children with mild illnesses such as upper respiratory tract infection.
• Rubella vaccine may temporarily decrease response to tuberculin skin testing. If a tuberculin test is needed, administer it either before, simultaneously with, or at least 8 weeks after rubella vaccine.
• Women who have rubella antibody titers of 1:8 or greater (by hemagglutination inhibition) need not be vaccinated with rubella virus vaccine.
• Revaccination or booster dose is required if patient was previously vaccinated younger than age 1. The Advisory Committee on Immunization Practices and the American Academy of Pediatrics currently recommend that a second dose be routinely given at ages 4 to 6 or 11 to 12. It may be given at any other time provided at least 1 month has elapsed since the first dose. There’s no conclusive evidence of an increased risk of adverse reactions for persons who are already immune when revaccinated.
Pregnant patients
• Women who aren’t immune to rubella are at risk for congenital rubella injury to the fetus if exposed to rubella during pregnancy. Tell women of childbearing age to avoid pregnancy for 3 months after rubella immunization. Provide contraceptive information if needed.
Breast-feeding patients
• Rubella virus or virus antigen appears in breast milk in about 68% of patients. Few adverse effects have been linked to breast-feeding after immunization with rubella-containing vaccines. Risk-benefit ratio suggests that breast-feeding women may be immunized, if needed.
Pediatric patients
• Live, attenuated rubella virus vaccine isn’t recommended for children younger than age 1 because retained maternal antibodies may impair immune response.

Patient education
• Tell patient that tingling sensations in limbs or arthritis-like aches and pains in joints may occur starting several days to several weeks after vaccination. These symptoms usually resolve within 1 week. Pain and inflammation at injection site and low-grade fever, rash, or breathing difficulties may also occur. Encourage patient to report distressing adverse reactions.
• Recommend acetaminophen to relieve fever or other minor discomfort after vaccination.

Reactions may be common, uncommon, life-threatening, or COMMON AND LIFE THREATENING.
◆ Canada only
◇ Unlabeled clinical use