Focalin XR and Meningococcal Groups A, C, Y, and W-135 Vaccine

• Generic Name: dexmethylphenidate
• Dosage Forms: capsule, extended release
• Other Brand Names: Focalin, Focalin XR

Focalin XR is a mild stimulant to the central nervous system. It affects chemicals in the brain that contribute to hyperactivity and impulse control.

Focalin XR is used to treat attention deficit hyperactivity disorder (ADHD).

Focalin XR may also be used for purposes not listed in this medication guide.

• Generic Name: meningococcal polysaccharide vaccine
• Dosage Forms: n.a.
• Other Brand Names: Menactra, Menveo

Prevention of meningococcal infection caused by N. meningitidis serogroups A, C, Y, and W-135 in adults, adolescents, children, and infants ≥2 months of age.

N. meningitidis can cause invasive meningococcal disease that usually presents as severe and potentially life-threatening meningitis and/or meningococcemia with abrupt onset; transmitted person to person by the respiratory route. In the US, N. meningitidis serogroups B, C, and Y cause most cases of meningococcal disease and serogroup W-135 causes a small percentage of cases; approximately 67% of cases in adults and adolescents ≥11 years are caused by serogroups C, Y, or W-135. Although overall incidence of meningococcal disease in the US has been historically low during the last 10–15 years (about 370 cases reported to CDC during 2016), overall case fatality rate has remained 10–15% (even with appropriate anti-infective treatment) and fatality rate may be as high as 40% in those with meningococcemia. In addition, long-term sequelae (e.g., hearing loss, neurologic disability, digit or limb amputations) reported in 11–20% of patients. While 98% of US cases of meningococcal disease are sporadic, localized outbreaks do occur and most outbreaks have been caused by serogroups B and C.

USPHS Advisory Committee on Immunization Practices (ACIP), AAP, and others recommend routine vaccination against meningococcal serogroups A, C, Y, and W-135 infection in all adolescents, preferably at 11 through 12 years of age, followed by a booster dose at 16 years of age. Catch-up vaccination recommended at 13 through 18 years of age for those not previously vaccinated; catch-up vaccination also recommended for all first-year college students through 21 years of age living in residence halls who did not receive a dose of meningococcal vaccine on or after their 16th birthday.

ACIP, AAP, and others also recommend routine primary and booster vaccination against meningococcal serogroups A, C, Y, and W-135 infection in selected infants, children, adolescents, and adults at increased risk because of certain chronic medical conditions (e.g., persistent complement component deficiencies, anatomic or functional asplenia, HIV infection) or because they will be traveling to or residing in areas with hyperendemic or epidemic meningococcal disease caused by serogroups represented in the vaccine. Also recommended in some other individuals at increased risk (e.g., certain health-care and laboratory personnel, military recruits).

MenACWY vaccine may be used as an adjunct to anti-infective prophylaxis in household and other close contacts of individuals with invasive meningococcal disease when clusters or outbreaks are occurring and are caused by meningococcal serogroups represented in the vaccine (i.e., A, C, Y, W-135).

MenACWY vaccine provides protection only against N. meningitidis serogroups represented in the vaccine (i.e., serogroups A, C, Y, W-135); will not prevent meningococcal infection caused by other serogroups (e.g., serogroup B) and will not prevent infections caused by other pathogens.

ACIP and AAP do not state a preference for MenACWY-D or MenACWY-CRM; either age-appropriate vaccine can be used for primary immunization and/or revaccination or booster doses. Consider that dosage schedules (i.e., number and timing of doses for primary immunization) differ depending on which vaccine used.

Preexposure Vaccination Against Meningococcal Infection in High-risk Groups

Infants 2 through 23 months of age with certain chronic medical conditions (e.g., persistent complement component deficiencies, anatomic or functional asplenia, HIV infection) and those who will be traveling to or residing in areas where meningococcal infection is hyperendemic or epidemic are at increased risk for meningococcal infection and should receive routine primary and booster immunization against meningococcal serogroups A, C, Y, and W-135 infection using age-appropriate MenACWY vaccine (MenACWY-D or MenACWY-CRM). Routine vaccination against meningococcal serogroups A, C, Y, and W-135 infection not recommended in infants not at increased risk.

Children 2 through 10 years of age with certain chronic medical conditions (e.g., persistent complement component deficiencies, anatomic or functional asplenia, HIV infection) and those who will be traveling to or residing in areas where meningococcal infection is hyperendemic or epidemic are at increased risk for meningococcal infection and should receive routine primary and booster immunization against meningococcal serogroups A, C, Y, and W-135 infection using MenACWY vaccine (MenACWY-D or MenACWY-CRM). Routine vaccination against meningococcal serogroups A, C, Y, and W-135 infection not recommended in children 2 through 10 years of age not at increased risk.

Adolescents 11 through 18 years of age are at increased risk for meningococcal infection and should receive routine primary immunization against meningococcal serogroups A, C, Y, and W-135 disease using MenACWY vaccine (MenACWY-D or MenACWY-CRM). ACIP, AAP, and others recommend a dose of MenACWY vaccine in all young adolescents at 11 through 12 years of age, followed by a booster dose at 16 years of age. Catch-up vaccination recommended at first opportunity for all older adolescents 13 through 18 years of age not vaccinated at 11 through 12 years of age. If first dose of MenACWY vaccine given at 13 through 15 years of age, a booster dose is recommended at 16 through 18 years of age; booster dose not needed if first dose given at ≥16 years of age.

College freshmen through 21 years of age living in dormitories are at increased risk for meningococcal infection and should receive primary immunization against meningococcal serogroups A, C, Y, and W-135 infection using MenACWY vaccine (MenACWY-D or MenACWY-CRM) if they did not receive a dose at ≥16 years of age.

Individuals with persistent complement component deficiencies (e.g., inherited or chronic deficiencies in C3, C5–C9, properdin, factor D, factor H) or anatomic or functional asplenia (e.g., sickle cell disease) and those receiving eculizumab are at increased risk for invasive meningococcal disease, and ACIP, AAP, and others recommend routine age-appropriate primary and booster immunization against meningococcal serogroups A, C, Y, and W-135 infection using MenACWY vaccine (MenACWY-D or MenACWY-CRM). If not previously vaccinated, individuals undergoing elective splenectomy should receive MenACWY vaccine ≥14 days before surgery whenever possible.

HIV-infected individuals are at increased risk for invasive meningococcal disease, and ACIP, AAP, CDC, NIH, HIV Medicine Association of IDSA, and others recommend routine age-appropriate primary and booster immunization against meningococcal serogroups A, C, Y, and W-135 infection in all HIV-infected adults, adolescents, children, and infants ≥2 months of age using MenACWY vaccine (MenACWY-D or MenACWY-CRM). Because HIV-infected individuals may not respond optimally to a single dose, use 2-dose primary series of MenACWY vaccine in all previously unvaccinated HIV-infected individuals ≥2 years of age. HIV-infected individuals ≥2 years of age who previously received only a single dose for primary immunization should receive a booster dose of MenACWY vaccine at the earliest opportunity (provided it has been ≥8 weeks after previous dose). HIV-infected infants 2 months to <2 years of age should receive age-appropriate multiple-dose primary series of MenACWY vaccine. Consider that vaccines may be less immunogenic in immunocompromised individuals.

Health-care and laboratory personnel with certain chronic medical conditions known to increase risk for meningococcal disease (e.g., persistent complement component deficiencies, anatomic or functional asplenia, HIV infection) and those who are routinely exposed to isolates of N. meningitidis or will be traveling to areas where meningococcal disease is hyperendemic or epidemic should be vaccinated against meningococcal serogroups A, C, Y, and W-135 disease. ACIP and Healthcare Infection Control Practices Advisory Committee (HICPAC) state that routine immunization against meningococcal serogroups A, C, Y, and W-135 disease is not recommended in other health-care personnel. However, in the setting of a community or institutional outbreak of meningococcal disease, vaccination of health-care personnel may be indicated if the outbreak is caused by a meningococcal serogroup represented in the vaccine. Regardless of vaccination status, postexposure anti-infective prophylaxis against meningococcal infection (i.e., 2-day regimen of oral rifampin or single dose of IM ceftriaxone, oral ciprofloxacin, or oral azithromycin) is recommended for all health-care personnel who have had unprotected (i.e., without wearing a mask) intensive contact (i.e., mouth-to-mouth resuscitation, endotracheal intubation or endotracheal tube management) with an infected patient.

Military recruits are at increased risk for meningococcal disease and should receive MenACWY vaccine.

Travelers to and residents of areas where N. meningitidis is hyperendemic or epidemic are at risk for exposure to meningococcal disease and should be vaccinated against meningococcal serogroups A, C, Y, and W-135 infection. Although reported worldwide, highest incidence of meningococcal disease occurs in sub-Saharan Africa in area known as the “meningitis belt” extending from Senegal and Guinea eastward to Ethiopia; meningococcal disease is hyperendemic in this region with epidemics occurring periodically during dry season (December through June). Historically, meningococcal disease outbreaks in the meningitis belt were caused by serogroup A; recent outbreaks have primarily been caused by serogroups C and W, although serogroup X outbreaks also reported. ACIP, AAP, CDC, and others recommend age-appropriate primary immunization against meningococcal serogroups A, C, Y, and W-135 disease for individuals ≥2 months of age who will be traveling to or residing in hyperendemic or epidemic areas, including the meningitis belt during dry season, especially if prolonged contact with local populations is expected. In those previously vaccinated, booster dose of MenACWY vaccine recommended if it has been ≥5 years since last dose of meningococcal vaccine. Officials in Saudi Arabia require that individuals traveling to their country for annual Hajj and Umrah pilgrimages or for seasonal work in Hajj ad Umrah zones must have a valid vaccination certificate indicating vaccination against meningococcal serogroups A, C, Y, and W-135 administered ≥10 days and ≤3 years (unconjugated polysaccharide vaccine) or ≤5 years (conjugated polysaccharide vaccine) prior to arrival in Saudi Arabia. Consult international health clinics for travelers, state health departments, CDC at 877-394-8747, or CDC Travelers’ Health website for most recent information concerning geographic areas for which vaccination against meningococcal disease is recommended.

Household and other close contacts of individuals with invasive meningococcal disease are at increased risk for meningococcal infection. Whenever a case of invasive meningococcal disease occurs, anti-infective prophylaxis (i.e., 2-day regimen of oral rifampin or single dose of IM ceftriaxone, oral ciprofloxacin, or oral azithromycin) is indicated for close contacts of index case (e.g., household contacts, day-care center contacts, individuals exposed to index case’s oropharyngeal secretions) and is principal means of preventing secondary cases. In some situations, MenACWY vaccine may be recommended as an adjunct to anti-infective prophylaxis.

Outbreak Control

Whenever sporadic or cluster cases or outbreaks of meningococcal disease occur in US, anti-infective prophylaxis (i.e., 2-day regimen of oral rifampin or single dose of IM ceftriaxone, oral ciprofloxacin, or oral azithromycin) is the principal means of preventing secondary cases in household and other close contacts.

Mass vaccination programs may be indicated in some meningococcal outbreaks if the outbreak is caused by a vaccine-preventable serogroup of N. meningitidis. Decision to implement such vaccination campaigns depends on whether the occurrence of >1 case represents an outbreak or an unusual clustering of endemic disease. If an outbreak occurs in the US, public health authorities will determine whether mass vaccinations (with or without mass anti-infective prophylaxis) are indicated.

MenACWY vaccine (MenACWY-D or MenACWY-CRM) does not stimulate immunity to meningococcal infection caused by serogroup B and is not indicated for meningococcal serogroup B outbreaks.