"The U.S. Food and Drug Administration today expanded the approved use of Xgeva (denosumab) to treat adults and some adolescents with giant cell tumor of the bone (GCTB), a rare and usually non-cancerous tumor.
GCTB generally occurs in a"...
Fever And Febrile Seizures
Administration of ProQuad (dose 1) to children 12 to 23 months old who have not been previously vaccinated against measles, mumps, rubella, or varicella, nor had a history of the wild-type infections, is associated with higher rates of fever and febrile seizures at 5 to 12 days after vaccination when compared to children vaccinated with dose 1 of both M-M-R II and VARIVAX administered separately [see ADVERSE REACTIONS].
History Of Cerebral Injury Or Seizures
Exercise caution when administering ProQuad to persons with a history of cerebral injury, individual or family history of convulsions, or any other condition in which stress due to fever should be avoided. Healthcare providers should be alert to the temperature elevations that may occur following vaccination.
Hypersensitivity To Eggs
Live measles vaccine and live mumps vaccine are produced in chick embryo cell culture. Persons with a history of anaphylactic or other immediate hypersensitivity reactions (e.g., hives, swelling of the mouth and throat, difficulty breathing, hypotension, or shock) subsequent to egg ingestion may be at an enhanced risk of immediate-type hypersensitivity reactions after receiving vaccines containing traces of chick embryo antigen. Carefully evaluate the potential risk-to-benefit ratio before considering vaccination in such cases. Such individuals may be vaccinated with extreme caution; adequate treatment should be readily available should a reaction occur [see CONTRAINDICATIONS]2.
Children with egg allergy are at low risk for anaphylactic reactions to measles-containing vaccines (including M-M-R II), and skin testing of children allergic to eggs is not predictive of reactions to M-M-R II vaccine. Persons with allergies to chickens or feathers are not at increased risk of reaction to the vaccine2.
Contact Hypersensitivity To Neomycin
Carefully evaluate the potential risk-to-benefit ratio before considering vaccination with ProQuad in children with thrombocytopenia or in those who experienced thrombocytopenia after vaccination with a previous dose of measles, mumps, rubella, and/or varicella vaccine. No clinical data are available regarding the development or worsening of thrombocytopenia in individuals vaccinated with ProQuad. Cases of thrombocytopenia have been reported after primary vaccination with measles vaccine; measles, mumps, and rubella vaccine; after varicella vaccination, and following re-vaccination with measles vaccine or M-M-R II [see ADVERSE REACTIONS].
Use For Post-Exposure Prophylaxis
The safety and efficacy of ProQuad for use after exposure to measles, mumps, rubella, or varicella have not been established.
Use In HIV-Infected Children
Risk Of Vaccine Virus Transmission
Post-licensing experience with VARIVAX suggests that transmission of varicella vaccine virus may occur between healthy vaccine recipients (who develop or do not develop a varicella-like rash) and contacts susceptible to varicella, as well as high-risk individuals susceptible to varicella.
High-risk individuals susceptible to varicella include:
- Immunocompromised individuals;
- Pregnant women without documented positive history of varicella (chickenpox) or laboratory evidence of prior infection;
- Newborn infants of mothers without documented positive history of varicella or laboratory evidence of prior infection and all newborn infants born at < 28 weeks gestation regardless of maternal varicella immunity.
Vaccine recipients should attempt to avoid, to the extent possible, close association with high-risk individuals susceptible to varicella for up to 6 weeks following vaccination. In circumstances where contact with high-risk individuals susceptible to varicella is unavoidable, the potential risk of transmission of the varicella vaccine virus should be weighed against the risk of acquiring and transmitting wild-type varicella virus.
Excretion of small amounts of the live, attenuated rubella virus from the nose or throat has occurred in the majority of susceptible individuals 7 to 28 days after vaccination. There is no confirmed evidence to indicate that such virus is transmitted to susceptible persons who are in contact with the vaccinated individuals. Consequently, transmission through close personal contact, while accepted as a theoretical possibility, is not regarded as a significant risk. However, transmission of the rubella vaccine virus to infants via breast milk has been documented [see Use in Specific Populations].
There are no reports of transmission of the more attenuated Enders' Edmonston strain of measles virus or the Jeryl Lynn™ strain of mumps virus from vaccine recipients to susceptible contacts.
Immune Globulins And Transfusions
Immune globulins (IG) administered concomitantly with ProQuad contain antibodies that may interfere with vaccine virus replication and decrease the expected immune response. Vaccination should be deferred for at least 3 months following blood or plasma transfusions, or administration of IG.
The appropriate suggested interval between transfusion or IG administration and vaccination will vary with the type of transfusion or indication for, and dose of, IG (e.g., 5 months for Varicella Zoster Immune Globulin [VZIG])2. Following administration of ProQuad, any IG including VZIG should not be given for 1 month thereafter unless its use outweighs the benefits of vaccination2. [See DRUG INTERACTIONS]
Risk Of Transmission Of Creutzfeldt-Jakob Disease And Other Adventitious Agents
This product contains albumin, a derivative of human blood. Based on effective donor screening and product manufacturing processes, it carries an extremely remote risk for transmission of viral diseases. Although there is a theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD), no cases of transmission of CJD or viral disease have ever been identified that were associated with the use of albumin. The cells, virus pools, bovine serum, and human albumin used in manufacturing are all evaluated and tested to provide assurance that the final product is free of potential adventitious agents [see DESCRIPTION].
Carcinogenesis, Mutagenesis, Impairment Of Fertility
Use In Specific Populations
Contraindication [see CONTRAINDICATIONS].
Do not administer ProQuad to pregnant females. It is also not known whether ProQuad can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. If vaccination of postpubertal females is undertaken, pregnancy should be avoided for 3 months following vaccination. [See CONTRAINDICATIONS and PATIENT INFORMATION]
In counseling women who are inadvertently vaccinated when pregnant or who become pregnant within 3 months of vaccination, the healthcare provider should be aware of the following: (1) Reports have indicated that contracting wild-type measles during pregnancy enhances fetal risk. Increased rates of spontaneous abortion, stillbirth, congenital defects, and prematurity have been observed subsequent to wild-type measles during pregnancy. There are no adequate studies of the attenuated (vaccine) strain of measles virus in pregnancy. However, it would be prudent to assume that the vaccine strain of virus is also capable of inducing adverse fetal effects; (2) Mumps infection during the first trimester of pregnancy may increase the rate of spontaneous abortion. Although mumps vaccine virus has been shown to infect the placenta and fetus, there is no evidence that it causes congenital malformations in humans5; (3) In a 10-year survey involving over 700 pregnant women who received rubella vaccine within 3 months before or after conception (of whom 189 received the Wistar RA 27/3 strain), none of the newborns had abnormalities compatible with congenital rubella syndrome6; and (4) Wild-type varicella can sometimes cause congenital varicella infection.
From 1995 to 2013, Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., maintained a Pregnancy Registry to monitor fetal outcomes following inadvertent administration of VARIVAX during pregnancy or within three months prior to conception. In 2006, reports of exposure to two other varicella (Oka/Merck)-containing vaccines, ProQuad and ZOSTAVAX® (Zoster Vaccine Live), were added to the Registry. The Pregnancy Registry has been discontinued. As of March 2011, 811 women with pregnancy outcome information available for analysis were prospectively enrolled following vaccination with VARIVAX, within three months prior to conception or any time during pregnancy. Of these women, 170 were seronegative at the time of exposure and 627 women had an unknown serostatus. The remaining women were seropositive. Nine exposures to either ProQuad or ZOSTAVAX have been reported that met criteria for inclusion into the Registry.
None of the 820 women who received a varicella-containing vaccine delivered infants with abnormalities consistent with congenital varicella syndrome.
All exposures to VARIVAX, ProQuad, or ZOSTAVAX during pregnancy or within three months prior to conception should be reported as suspected adverse reactions by contacting Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., at 1-877-888-4231 or VAERS at 1-800-822-7967 or www.vaers.hhs.gov.
Do not administer ProQuad to nursing women. It is not known whether ProQuad is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when ProQuad is administered to a nursing woman. The secretion of measles and mumps viruses in human milk has not been studied; however, studies have shown that lactating postpartum women vaccinated with live rubella vaccine may secrete the virus in breast milk and transmit it to breast-fed infants. Limited evidence in the literature suggests that virus, viral DNA, or viral antigen could not be detected in the breast milk of women who were vaccinated postpartum with the vaccine strain of varicella virus7,8. [See WARNINGS AND PRECAUTIONS]
Do not administer ProQuad to infants younger than 12 months of age or to children 13 years and older. Safety and effectiveness of ProQuad in infants younger than 12 months of age and in children 13 years and older have not been studied. ProQuad is not approved for use in persons in these age groups. [See ADVERSE REACTIONS and Clinical Studies]
ProQuad is not indicated for use in the geriatric population ( ≥ age 65).
2. Committee on Infectious Diseases, American Academy of Pediatrics. In: Pickering LK, Baker CJ, Overturf GD, et al., eds. Red Book: 2003 Report of the Committee on Infectious Diseases. 26th ed. Elk Grove Village, IL: American Academy of Pediatrics. 419-29, 2003.
5. Recommendations of the Immunization Practices Advisory Committee (ACIP), Mumps Prevention. MMWR. 38(22):388-392, 397-400, 1989.
6. Rubella vaccination during pregnancy--United States, 1971-1986. MMWR Morb Mortal Wkly Rep. 36(28):457-61, 1987.
7. Bohlke K, Galil K, Jackson LA, et al. Postpartum varicella vaccination: Is the vaccine virus excreted in breast milk? Obstetrics and Gynecology. 102(5):970-977, 2003.
8. Dolbear GL, Moffat J, Falkner C and Wojtowycz M. A Pilot Study: Is attenuated varicella virus present in breast milk after postpartum immunization? Obstetrics and Gynecology. 101(4 Suppl.):47S-47S, 2003.
Last reviewed on RxList: 9/12/2014
This monograph has been modified to include the generic and brand name in many instances.
Additional Proquad Information
Report Problems to the Food and Drug Administration
Find out what women really need.