Drug: Attenuvax

ATTENUVAX* (Measles Virus Vaccine Live) is a live virus vaccine for vaccination against measles (rubeola). ATTENUVAX (measles virus vaccine live) is a sterile lyophilized preparation of a more attenuated line of measles virus derived from Enders' attenuated Edmonston strain and propagated in chick embryo cell culture. The growth medium for measles is Medium 199 (a buffered salt solution containing vitamins and amino acids and supplemented with fetal bovine serum) containing SPGA (sucrose, phosphate, glutamate, and human albumin) as stabilizer and neomycin. The cells, virus pools, fetal bovine serum, and human albumin are all screened for the absence of adventitious agents. Human albumin is processed using the Cohn cold ethanol fractionation procedure. The reconstituted vaccine is for subcutaneous administration. Each 0.5 mL dose contains not less than 1,000 TCID50 (tissue culture infectious doses) of measles virus. Each dose of the vaccine is calculated to contain sorbitol (14.5 mg), sodium phosphate, sucrose (1.9 mg), sodium chloride, hydrolyzed gelatin (14.5 mg), human albumin (0.3 mg), fetal bovine serum ( < 1 ppm), other buffer and media ingredients and approximately 25 mcg of neomycin. The product contains no preservative. Before reconstitution, the lyophilized vaccine is a light yellow compact crystalline plug. ATTENUVAX (measles virus vaccine live) , when reconstituted as directed, is clear yellow.

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The following adverse reactions are listed in decreasing order of severity, without regard to causality, within each body system category and have been reported during clinical trials, with use of the marketed vaccine, or with use of polyvalent vaccine containing measles: Body as a Whole Panniculitis; atypical measles; fever; syncope; headache; dizziness; malaise; irritability. Cardiovascular System Vasculitis. Digestive System Diarrhea, vomiting, nausea. Hemic and Lymphatic System Thrombocytopenia (see WARNINGS, Thrombocytopenia); purpura; lymphadenopathy; leukocytosis. Immune System Anaphylaxis and anaphylactoid reactions have been reported as well as related phenomena such as angioneurotic edema (including peripheral or facial edema) and bronchial spasm in individuals with or without an allergic history. Musculoskeletal Arthralgia, myalgia. Nervous System Encephalitis; encephalopathy; measles inclusion body encephalitis (MIBE) (see CONTRAINDICATIONS); subacute sclerosing panencephalitis (SSPE); Guillain-Barré syndrome (GBS); febrile convulsions; afebrile convulsions or seizures; ataxia; ocular palsies. Experience from more than 80 million doses of all live measles vaccines given in the U.S. through 1975 indicates that significant central nervous system reactions such as encephalitis and encephalopathy, occurring within 30 days after vaccination, have been temporally associated with measles vaccine very rarely.28 In no case has it been shown that reactions were actually caused by vaccine. The Centers for Disease Control and Prevention has pointed out that “a certain number of cases of encephalitis may be expected to occur in a large childhood population in a defined period of time even when no vaccines are administered”.29 However, the data suggest the possibility that some of these cases may have been caused by measles vaccines. The risk of such serious neurological disorders following live measles virus vaccine administration remains far less than that for encephalitis and encephalopathy with natural measles (one per two thousand reported cases).30 Post-marketing surveillance of the more than 200 million doses of M-M-R and M-M-R II that have been distributed worldwide over 25 years (1971-1996) indicates that serious adverse events such as encephalitis and encephalopathy continue to be rarely reported.10 There have been reports of subacute sclerosing panencephalitis (SSPE) in children who did not have a history of natural measles but did receive measles vaccine. Some of these cases may have resulted from unrecognized measles in the first year of life or possibly from the measles vaccination. Based on estimated nationwide measles vaccine distribution, the association of SSPE cases to measles vaccination is about one case per million vaccine doses distributed. This is far less than the association with natural measles, 6-22 cases of SSPE per million cases of measles. The results of a retrospective case-controlled study conducted by the Centers for Disease Control and Prevention suggest that the overall effect of measles vaccine has been to protect against SSPE by preventing measles with its inherent higher risk of SSPE.31 Respiratory System Pneumonitis (see CONTRAINDICATIONS); cough; rhinitis. Skin Stevens-Johnson syndrome; erythema multiforme; urticaria; rash. Local reactions including burning/stinging at injection site; wheal and flare; redness (erythema); swelling; vesiculation at injection site. Special Senses — Ear Nerve deafness; otitis media. Special Senses — Eye Retinitis; optic neuritis; papillitis; retrobulbar neuritis; conjunctivitis. Other Death from various, and in some cases unknown, causes has been reported rarely following vaccination with measles, mumps, and rubella vaccines; however, a causal relationship has not been established. No deaths or permanent sequelae were reported in a published post-marketing surveillance study in Finland involving 1.5 million children and adults who were vaccinated with M-M-R II during 1982-1993.32 Under the National Childhood Vaccine Injury Act of 1986, health care providers and manufacturers are required to record and report certain suspected adverse events occurring within specific time periods after vaccination. However, the U.S. Department of Health and Human Services (DHHS) has established a Vaccine Adverse Event Reporting System (VAERS) which will accept all reports of suspected events.28 A VAERS report form as well as information regarding reporting requirements can be obtained by calling VAERS 1-800-822-7967. Read the Attenuvax (measles virus vaccine live) Side Effects Center for a complete guide to possible side effectsLearn More »

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FOR SUBCUTANEOUS ADMINISTRATION Do not inject intravenously The dose for any age is 0.5 mL administered subcutaneously, preferably into the outer aspect of the upper arm. The recommended age for primary vaccination is 12 to 15 months. Revaccination with M-M-R II is recommended prior to elementary school entry. See also INDICATIONS AND USAGE, Recommended Vaccination Schedule. Children first vaccinated when younger than 12 months of age should receive another dose between 12 to 15 months of age followed by revaccination prior to elementary school entry.35 See also INDICATIONS AND USAGE, Measles Outbreak Schedule. Immune Globulin (IG) is not to be given concurrently with ATTENUVAX (measles virus vaccine live) . CAUTION: A sterile syringe free of preservatives, antiseptics, and detergents should be used for each injection and/or reconstitution of the vaccine because these substances may inactivate the live virus vaccine. A 25 gauge, 5/8“ needle is recommended. To reconstitute, use only the diluent supplied, since it is free of preservatives or other antiviral substances which might inactivate the vaccine. Single Dose Vial - First withdraw the entire volume of diluent into the syringe to be used for reconstitution. Inject all the diluent in the syringe into the vial of lyophilized vaccine, and agitate to mix thoroughly. If the lyophilized vaccine cannot be dissolved, discard. Withdraw the entire contents into a syringe and inject the total volume of restored vaccine subcutaneously. It is important to use a separate sterile syringe and needle for each individual patient to prevent transmission of hepatitis B and other infectious agents from one person to another. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. ATTENUVAX (measles virus vaccine live) , when reconstituted, is clear yellow. Use With Other Vaccines ATTENUVAX (measles virus vaccine live) should not be given less than one month before or after administration of other live viral vaccines. M-M-R II has been administered concurrently with VARIVAX* [Varicella Virus Vaccine Live (Oka/Merck)], and PedvaxHIB* [Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate)] using separate sites and syringes. No impairment of immune response to individually tested vaccine antigens was demonstrated. The type, frequency, and severity of adverse experiences observed with M-M-R II were similar to those seen when each vaccine was given alone. Routine administration of DTP (diphtheria, tetanus, pertussis) and/or OPV (oral poliovirus vaccine) concurrently with measles, mumps, and rubella vaccines is not recommended because there are limited data relating to the simultaneous administration of these antigens. However, other schedules have been used. The ACIP has stated ”Although data are limited concerning the simultaneous administration of the entire recommended vaccine series (i.e., DTP, OPV, MMR, and Hib vaccines, with or without hepatitis B vaccine), data from numerous studies have indicated no interference between routinely recommended childhood vaccines (either live, attenuated, or killed). These findings support the simultaneous use of all vaccines as recommended.“14

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See DOSAGE AND ADMINISTRATION, Use With Other Vaccines. Immunosuppressive Therapy The immune status of patients about to undergo immunosuppressive therapy should be evaluated so that the physician can consider whether vaccination prior to the initiation of treatment is indicated (see CONTRAINDICATIONS and PRECAUTIONS). The ACIP has stated that “patients with leukemia in remission who have not received chemotherapy for at least 3 months may receive live-virus vaccines. Short-term ( < 2 weeks), low- to moderate-dose systemic corticosteroid therapy, topical steroid therapy (e.g., nasal, skin), long-term alternate-day treatment with low to moderate doses of short-acting systemic steroid, and intra-articular, bursal, or tendon injection of corticosteroids are not immunosuppressive in their usual doses and do not contraindicate the administration of measles vaccine.”15 Immune Globulin Administration of immune globulins concurrently with ATTENUVAX (measles virus vaccine live) may interfere with the expected immune response.15,24 See also PRECAUTIONS, General. REFERENCES 10. Months of Age, Pediatrics 77(4): 471-476, April 1986. 10. Unpublished data: Files of Merck Research Laboratories. 15. Measles Prevention: Recommendations of the Immunization Practices Advisory Committee (ACIP), MMWR 38(S-9): 5-22, December 29, 1989. 24. Peter, G.; et al (eds): Report of the Committee on Infectious Diseases, Twenty-fourth Edition, American Academy of Pediatrics, 344-357, 1997. 28. CDC, Important Information about Measles, Mumps, and Rubella, and Measles, Mumps, and Rubella Vaccines. 1980. 1983. 29. CDC, Measles Surveillance, Report No. 8, p. 23, December 1971. 30. CDC, Encephalitis Surveillance, p. 16, May 1981. 31. CDC, Measles Surveillance, Report No. 11, p. 14, September 1982. 32. Peltola, H.; et al: The elimination of indigenous measles, mumps, and rubella from Finland by a 12-year, two dose vaccination program. N. Engl. J. Med. 331: 1397-1402, 1994. Last reviewed on RxList: 12/2/2008
This monograph has been modified to include the generic and brand name in many instances.

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Recommended Vaccination Schedule ATTENUVAX (measles virus vaccine live) is indicated for vaccination against measles in persons 12 months of age or older. Individuals first vaccinated with ATTENUVAX (measles virus vaccine live) at 12 months of age or older should be revaccinated with M-M-R* II (Measles, Mumps, and Rubella Virus Vaccine Live) prior to elementary school entry. Revaccination is intended to seroconvert those who do not respond to the first dose. The Advisory Committee on Immunization Practices (ACIP) recommends administration of the first dose of M-M-R II at 12-15 months of age and administration of the second dose of M-M-R II at 4-6 years of age.35 In addition, some public health jurisdictions mandate the age for revaccination. Consult the complete text of applicable guidelines regarding routine revaccination including that of high-risk adult populations. Measles Outbreak Schedule Infants Between 6-12 Months of Age Local health authorities may recommend measles vaccination of infants between 6-12 months of age in outbreak situations. This population may fail to respond to the measles component of the vaccine. The younger the infant, the lower the likelihood of seroconversion (see CLINICAL PHARMACOLOGY). Such infants should receive a second dose of M-M-R II between 12 to 15 months of age followed by revaccination prior to elementary school entry.35 Unnecessary doses of a vaccine are best avoided by ensuring that written documentation of vaccination is preserved and a copy given to each vaccinee's parent or guardian. Other Vaccination Considerations Other Populations Individuals planning travel outside the United States, if not immune, can acquire measles, mumps, or rubella and import these diseases into the United States. Therefore, prior to international travel, individuals known to be susceptible to one or more of these diseases can receive either a monovalent vaccine (measles, mumps or rubella), or a combination vaccine as appropriate. However, M-M-R II is preferred for persons likely to be susceptible to mumps and rubella; and if monovalent measles vaccine is not readily available, travelers should receive M-M-R II regardless of their immune status to mumps or rubella.15-17 Vaccination is recommended for susceptible individuals in high-risk groups such as college students, health care workers, and military personnel.15 According to ACIP recommendations, most persons born in 1956 or earlier are likely to have been infected with measles naturally and generally need not be considered susceptible. All children, adolescents, and adults born after 1956 are considered susceptible and should be vaccinated, if there are no contraindications. This includes persons who may be immune to measles but who lack adequate documentation of immunity such as: (1) physician-diagnosed measles, (2) laboratory evidence of measles immunity, or (3) adequate immunization with live measles vaccine on or after the first birthday.15 The ACIP recommends that “Persons vaccinated with inactivated vaccine followed within 3 months by live vaccine should be revaccinated with two doses of live vaccine. Revaccination is particularly important when the risk of exposure to natural measles virus is increased, as may occur during international travel.”15 Post-Exposure Vaccination ATTENUVAX (measles virus vaccine live) given immediately after exposure to natural measles may provide some protection if the vaccine can be administered within 72 hours of exposure. If, however, the vaccine is given a few days before exposure, substantial protection may be provided.15,18,19 Use With Other Vaccines See DOSAGE AND ADMINISTRATION, Use With Other Vaccines.

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Hypersensitivity to any component of the vaccine, including gelatin.20 Do not give ATTENUVAX (measles virus vaccine live) to pregnant females; the possible effects of the vaccine on fetal development are unknown at this time. If vaccination of postpubertal females is undertaken, pregnancy should be avoided for 3 months following vaccination (see PRECAUTIONS, Pregnancy). Anaphylactic or anaphylactoid reactions to neomycin (each dose of reconstituted vaccine contains approximately 25 mcg of neomycin). Febrile respiratory illness or other active febrile infection. However, the ACIP has recommended that all vaccines can be administered to persons with minor illnesses such as diarrhea, mild upper respiratory infection with or without low-grade fever, or other low-grade febrile illness.21 Patients receiving immunosuppressive therapy. This contraindication does not apply to patients who are receiving corticosteroids as replacement therapy, e.g., for Addison's disease. Individuals with blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems. Primary and acquired immunodeficiency states, including patients who are immunosuppressed in association with AIDS or other clinical manifestations of infection with human immunodeficiency viruses;21-23 cellular immune deficiencies; and hypogammaglobulinemic and dysgammaglobulinemic states. Measles inclusion body encephalitis36 (MIBE), pneumonitis37 and death as a direct consequence of disseminated measles vaccine virus infection has been reported in immunocompromised individuals inadvertently vaccinated with measles-containing vaccine. Individuals with a family history of congenital or hereditary immunodeficiency, until the immune competence of the potential vaccine recipient is demonstrated. REFERENCES 20. Kelso, J.M.; Jones, R.T.; Yunginger, J.W.: Anaphylaxis to measles, mumps, and rubella vaccine mediated by IgE to gelatin, J. Allergy Clin. Immunol. 91: 867-872, 1993. 21. General Recommendations on Immunization, Recommendations of the Advisory Committee on Immunization Practices, MMWR 43(RR-1): 1-38, January 28, 1994. 22. 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. 23. Krasinski, K.; Borkowski, 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. 36. Bitnum, A.; et al: Measles Inclusion Body Encephalitis Caused by the Vaccine Strain of Measles Virus. Clin. Infect. Dis. 29: 855-861, 1999. 37. Angel, J.B.; et al: Vaccine Associated Measles Pneumonitis in an Adult with AIDS. Annals of Internal Medicine, 129: 104-106, 1998. Last reviewed on RxList: 12/2/2008
This monograph has been modified to include the generic and brand name in many instances.

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No information provided.

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No. 4589X/4309 ATTENUVAX (measles virus vaccine live) is supplied as follows: (1) a box of 10 single-dose vials of lyophilized vaccine (package A), NDC 0006-4589-00; and (2) a box of 10 vials of diluent (package B). To conserve refrigerator space, the diluent may be stored separately at room temperature. Storage During shipment, to ensure that there is no loss of potency, the vaccine must be maintained at a temperature of 10°C (50°F) or colder. Freezing during shipment will not affect potency. Protect the vaccine from light at all times, since such exposure may inactivate the virus. Before reconstitution, store the vial of lyophilized vaccine at 2-8°C (36-46°F) or colder. The diluent may be stored in the refrigerator with the lyophilized vaccine or separately at room temperature. It is recommended that the vaccine be used as soon as possible after reconstitution. Store reconstituted vaccine in the vaccine vial in a dark place at 2-8°C (36-46°F) and discard if not used within 8 hours. REFERENCES 14. Centers for Disease Control and Prevention. Recommended childhood immunization schedule — United States, January-June 1996, MMWR 44(51 & 52): 940-943, January 5, 1996. 15. Measles Prevention: Recommendations of the Immunization Practices Advisory Committee (ACIP), MMWR 38(S-9): 5-22, December 29, 1989. 16. Jong, E.C.: The Travel and Tropical Medicine Manual, W.B. Saunders Company, p. 12-16, 1987. 17. Committee on Immunization Council of Medical Societies, American College of Physicians, Phila. PA, Guide for Adult Immunization, First Edition, 1985. 18. King, G.E.; Markowitz, L.E.; Patriarca, P.A.; et al: Clinical Efficacy of Measles Vaccine During the 1990 Measles Epidemic, Pediatr. Infect. Dis. J. 10(12): 883-888, December 1991. 19. Krasinski, K.; Borkowski, W.: Measles and Measles Immunity in Children Infected With Human Immunodeficiency Virus, JAMA 261(17): 2512-2516, 1989. 35. Measles, Mumps, and Rubella — Vaccine Use and Strategies for Elimination of Measles, Rubella, and Congenital Rubella Syndrome and Control of Mumps: Recommendations of the Advisory Committee on Immunization Practices (ACIP), MMWR 47(RR-8): May 22, 1998. Manuf. and Dist. by: Merck & Co. Inc., Whitehouse Station, New Jersey, NJ 08889, USA. Issued February 2006. FDA revision date: n/a Last reviewed on RxList: 12/2/2008
This monograph has been modified to include the generic and brand name in many instances.

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General 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).22,23 Vaccination should be deferred for 3 months or longer following blood or plasma transfusions, or administration of immune globulin (human).24 There are no reports of transmission of live attenuated measles virus from vaccinees to susceptible contacts. It has been reported that attenuated measles virus vaccine live may result in a temporary depression of tuberculin skin sensitivity.24 Therefore, if a tuberculin test is to be done, it should be administered either before or simultaneously with ATTENUVAX (measles virus vaccine live) . Children under treatment for tuberculosis have not experienced exacerbation of the disease when immunized with live measles virus vaccine;26 no studies have been reported to date of the effect of measles virus vaccines on untreated tuberculous children. However, individuals with active untreated tuberculosis should not be vaccinated. As for any vaccine, vaccination with ATTENUVAX (measles 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 ATTENUVAX (measles virus vaccine live) or other measles-containing vaccines. Carcinogenesis, Mutagenesis, Impairment of Fertility ATTENUVAX (measles virus vaccine live) has not been evaluated for carcinogenic or mutagenic potential, or potential to impair fertility. Pregnancy Pregnancy Category C Animal reproduction studies have not been conducted with ATTENUVAX (measles virus vaccine live) . It is also not known whether ATTENUVAX (measles virus vaccine live) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Therefore, the vaccine should not be administered to pregnant females; 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 reports have indicated that contracting natural measles during pregnancy enhances fetal risk. Increased rates of spontaneous abortion, stillbirth, congenital defects and prematurity have been observed subsequent to natural measles during pregnancy.33,34 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. Nursing Mothers It is not known whether measles vaccine virus is secreted in human milk. Therefore, because many drugs are excreted in human milk, caution should be exercised when ATTENUVAX (measles virus vaccine live) is administered to a nursing woman. Pediatric Use Safety and effectiveness in infants below the age of 6 months have not been established (see also CLINICAL PHARMACOLOGY). Geriatric Use Clinical studies of ATTENUVAX (measles 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. REFERENCES 22. 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. 23. Krasinski, K.; Borkowski, 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. 24. Peter, G.; et al (eds): Report of the Committee on Infectious Diseases, Twenty-fourth Edition, American Academy of Pediatrics, 344-357, 1997. 25. Isaacs, D.; Menser, M.: Modern Vaccines, Measles, Mumps, Rubella, and Varicella, Lancet335: 1384-1387, June 9, 1990. 26. Starr, S.; Berkovich, S.: The effect of measles, gammaglobulin modified measles, and attenuated measles vaccine on the course of treated tuberculosis in children, Pediatrics 35: 97-102, Jan. 1965. 27. Vaccine Adverse Event Reporting System — United States, MMWR 39(41): 730-733, October 19, 1990. Last reviewed on RxList: 12/2/2008
This monograph has been modified to include the generic and brand name in many instances.

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