"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 "...
Persons previously diagnosed with Guillain-Barre syndrome (kGBS) may be at increased risk of GBS following receipt of Menactra vaccine. The decision to give Menactra vaccine should take into account the potential benefits and risks.
GBS has been reported in temporal relationship following administration of Menactra vaccine.1,2 The risk of GBS following Menactra vaccination was evaluated in a post-marketing retrospective cohort study [Post-Marketing Experience].
Preventing And Managing Allergic Vaccine Reactions
Prior to administration, the healthcare provider should review the immunization history for possible vaccine sensitivity and previous vaccination-related adverse reactions to allow an assessment of benefits and risks. Epinephrine and other appropriate agents used for the control of immediate allergic reactions must be immediately available should an acute anaphylactic reaction occur.
Limitations Of Vaccine Effectiveness
Menactra vaccine may not protect all recipients.
Use In Specific Populations
Animal reproduction studies have not been conducted with Menactra vaccine. It is also not known whether Menactra vaccine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. There are no adequate and well controlled studies in pregnant women. Menactra vaccine should only be given to a pregnant woman if clearly needed. Assessment of the effects on animal reproduction has not been fully conducted with Menactra vaccine as effects on male fertility in animals has not been evaluated. The effect of Menactra vaccine on embryo-fetal and pre-weaning development was evaluated in one developmental toxicity study in mice. Animals were administered Menactra vaccine on Day 14 prior to gestation and during the period of organogenesis (gestation Day 6). The total dose given per time point was 0.1 mL/mouse via intramuscular injection (900 times the human dose, adjusted by body weight). There were no adverse effects on pregnancy, parturition, lactation or pre-weaning development noted in this study. Skeletal examinations revealed one fetus (1 of 234 examined) in the vaccine group with a cleft palate. None were observed in the concurrent control group (0 of 174 examined). There are no data that suggest that this isolated finding is vaccine related, and there were no vaccine related fetal malformations or other evidence of teratogenesis observed in this study.
Healthcare providers are encouraged to register women who receive Menactra vaccine during pregnancy in Sanofi Pasteur Inc.'s vaccination pregnancy registry by calling 1-800-822-2463.
It is not known whether Menactra vaccine is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Menactra vaccine is administered to a nursing woman.
Menactra vaccine is not approved for use in infants under 9 months of age. Available data show that infants administered three doses of Menactra vaccine (at 2, 4, and 6 months of age) had diminished responses to each meningococcal vaccine serogroup compared to older children given two doses at 9 and 12 months of age.
Safety and effectiveness of Menactra vaccine in adults older than 55 years of age have not been established.
1 CDC. Guillain-Barre Syndrome Among Recipients of Menactra® Meningococcal Conjugate Vaccine - United States, June 2005 - September 2006. MMWR 2006;55(41);1120-1124.
2 Harvard Medical School/Harvard Pilgrim Health Care Institute. Risk of Guillain-Barre Syndrome Following Meningococcal Conjugate (MCV4) Vaccination. Final Study Report, Revised March 11, 2010.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 9/12/2014
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