"The cystic fibrosis (CF) drug Orkambi (Vertex Pharmaceuticals) has received a green light from the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP).
Orkambi is a fixed-dose oral combination "...
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-Jacob disease (CJD), no cases of transmission of CJD or viral disease have ever been identified that were associated with the use of albumin.
Hypersensitivity to Eggs
Live mumps vaccine is produced in chick embryo cell culture. Persons with a history of anaphylactic, anaphylactoid, or other immediate 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. The potential risk to benefit ratio should be carefully evaluated before considering vaccination in such cases. Such individuals may be vaccinated with extreme caution, having adequate treatment on hand should a reaction occur (see PRECAUTIONS).30
However, the American Academy of Pediatrics (AAP) has stated, "Most children with a history of anaphylactic reactions to eggs have no untoward reactions to measles or MMR vaccine. Persons are not at increased risk if they have egg allergies that are not anaphylactic, and they should be vaccinated in the usual manner. In addition, skin testing of egg-allergic children with vaccine has not been predictive of which children will have an immediate hypersensitivity reaction. Persons with allergies to chickens or chicken feathers are not at increased risk of reaction to the vaccine."29
Hypersensitivity to Neomycin
The AAP states, "Persons who have experienced anaphylactic reactions to topically or systemically administered neomycin should not receive measles vaccine. Most often, however, neomycin allergy manifests as a contact dermatitis, which is a delayed-type (cell-mediated) immune response rather than anaphylaxis. In such persons, an adverse reaction to neomycin in the vaccine would be an erythematous, pruritic nodule or papule, 48 to 96 hours after vaccination. A history of contact dermatitis to neomycin is not a contraindication to receiving measles vaccine."29
Individuals with current thrombocytopenia may develop more severe thrombocytopenia following vaccination. In addition, individuals who experienced thrombocytopenia with the first dose of M-M-R II (or its component vaccines) may develop thrombocytopenia with repeat doses. Serologic status may be evaluated to determine whether or not additional doses of vaccine are needed. The potential risk to benefit ratio should be carefully evaluated before considering vaccination in such cases.
Adequate treatment provisions including epinephrine injection (1:1000), should be available for immediate use should an anaphylactic or anaphylactoid reaction occur.
Special care should be taken to ensure that the injection does not enter a blood vessel.
Children and young adults who are known to be infected with human immunodeficiency viruses and are not immunosuppressed may be vaccinated. However, vaccinees who are infected with HIV should be monitored closely for vaccine-preventable diseases because immunization may be less effective than for uninfected persons (see CONTRAINDICATIONS).27,28
There are no reports of transmission of live mumps virus from vaccinees to susceptible contacts.
It has been reported that mumps virus vaccine live may result in a temporary depression of tuberculin skin sensitivity. Therefore, if a tuberculin test is to be done, it should be administered either before or simultaneously with MUMPSVAX (mumps virus vaccine live) .7,31
Individuals with active untreated tuberculosis should not be vaccinated.
As for any vaccine, vaccination with MUMPSVAX (mumps virus vaccine live) may not result in protection in 100% of vaccinees.
The health-care provider should determine the current health status and previous vaccination history of the vaccinee.
The health-care provider should question the patient, parent or guardian about reactions to a previous dose of MUMPSVAX (mumps virus vaccine live) or other mumps-containing vaccines.
Carcinogenesis, Mutagenesis, Impairment of Fertility
MUMPSVAX (mumps virus vaccine live) has not been evaluated for carcinogenic or mutagenic potential, or potential to impair fertility.
Pregnancy Category C
Animal reproduction studies have not been conducted with MUMPSVAX (mumps virus vaccine live) . It is also not known whether MUMPSVAX (mumps virus vaccine live) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Therefore, mumps virus vaccine should not be given to persons known to be pregnant; furthermore, pregnancy should be avoided for 3 months following vaccination (see CONTRAINDICATIONS).
In counseling women who are inadvertently vaccinated when pregnant or who become pregnant within 3 months of vaccination, the physician should be aware that 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 humans.16
It is not known whether mumps vaccine virus is secreted in human milk. Therefore, because many drugs are excreted in human milk, caution should be exercised when MUMPSVAX (mumps virus vaccine live) is administered to a nursing woman.
Safety and effectiveness in infants below the age of 12 months have not been established (see INDICATIONS, Recommended Vaccination Schedule).
Clinical studies of MUMPSVAX (mumps virus vaccine live) did not include sufficient numbers of seronegative subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger subjects.
7. Horowitz, S.D.; Nagatani, M.S.; Bowen, G.S.; Holloway, A.W.; St. Geme, J.W., Jr.: The acquisition of delayed hypersensitivity following attenuated mumps virus infection, Pediatrics 45(1): 77-82, Jan. 1970.
27. Center for Disease Control: Immunization of Children Infected with Human T-Lymphotropic Virus Type III/Lymphadenopathy-Associated Virus, Annals of Internal Medicine, 106: 75-78, 1987.
28. Krasinski, K.; Borkowsky, W.; Krugman, S.: Antibody following measles immunization in children infected with human T-cell lymphotropic virus-type III/lymphadenopathy associated virus (HTLV-III/LAV) [Abstract]. In: Program and abstracts of the International Conference on Acquired Immunodeficiency Syndrome, Paris, France, June 23-25, 1986.
29. Peter, G.; et al (eds): Report of the Committee on Infectious Diseases, Twenty-fourth Edition, American Academy of Pediatrics, 344-357, 1997.
30. Isaacs, D.; Menser, M.: Modern Vaccines, Measles, Mumps, Rubella, and Varicella, Lancet 335: 1384-1387, June 9, 1990.
31. Kupers, T.A.; Petrich, J.M.; Holloway, A.W.; St. Geme, J.W., Jr.: Depression of tuberculin delayed hypersensitivity by live attenuated mumps virus, J. Pediatr. 76: 716-721, May 1970.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 12/29/2008
Additional Mumpsvax Information
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