Session FR5-162 Kimberly Cauthon, PharmD, CGP Anita Mosley, PhD, PharmD Feik School of Pharmacy University of the Incarnate Word

Immunization Updates and

Treatment of Latent Tuberculosis

Infections for Young Adults

Session FR5-162

Kimberly Cauthon, PharmD, CGPAnita Mosley, PhD, PharmD

Feik School of PharmacyUniversity of the Incarnate Word

2

Objective 1: Objective 2:

List the CDC recommended immunizations for young adults

Discuss when and how students should be treated for latent tuberculosis infection

Learning Objectives

We have no actual or potential conflicts of interest in relation to this activity.

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A 19 year-old female student is matriculating into

the sophomore class of your university. She is moving into the dorms. She brings her immunization records signed by her

physician. She requests a tuberculosis (TB) test today. She moved to the United States from India 4 years

ago. She has no major health conditions and no drug

allergies. Her medications are YAZ birth control pills.

Student Case Study

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Immunization

Date Received

Varicella 1/15/2000, 6/16/2000MMR 1/15/2000, 3/15/2000 Hepatitis A 1/15/1996, 1/14/1997Hepatitis B 1/2/1995, 2/1/1995,

1/15/1996Influenza 10/2/12IPV 3/3/1995, 5/1/1995,

1/15/1996, 1/16/1999DTaP 3/3/1995, 5/1/1995,

7/1/1995, 1/15/1996, 1/16/1999

Student Immunization Record

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What immunizations is our student missing

per the recommended adult immunization schedule - 2014?

Immunization Schedules updated annually No major changes from the 2013 schedule

CDC Recommended Adult Immunization

Schedule

http://www.cdc.gov/vaccines/schedules/index.htmlhttp://www.acha.org/topics/vaccine.cfm

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Adult Immunization Schedule 2014

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Adult Immunization Schedule 2014

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Based on the immunizations our student needs, which of the following screening questions must be asked?

Yes or No

Are you sick today?

What are your allergies? Do you have allergies to medications, food, a vaccine component, or latex?

Have you ever had a serious reaction after receiving a vaccination?

What are your medical conditions?

Have you received any vaccinations within the past 4 weeks?

Screening for Vaccine Contraindications

http://www.immunize.org/clinic/screening-contraindications.asphttp://www.cdc.gov/vaccines/schedules/index.html

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Based on the immunizations our student needs, which of the following screening questions must be asked?

Yes or No

In the past 3 months, have you taken medications that weaken your immune system or have you had radiation treatments?

During the past year, have you received a transfusion of blood or blood products or been given immune (gamma) globulin or an antiviral drug?

Are you pregnant or is there a chance you could become pregnant during the next month?

Have you had a seizure, brain, or other nervous system disorder?

Screening for Vaccine Contraindications

10

True/False – The student can receive all the

needed vaccinations at the same time.

Immunization Administration

http://www.cdc.gov/vaccines/recs/vac-admin/default.htm

11

What percentage of all influenza related

hospitalizations were within the age range of 18 – 64 years of age for the 2013-14 season?

A. 20%B. 40%C. 60%D. 80%

Influenza Vaccination

Morb Mortality Wkly Rep. 2014; 63(7): 137-142.

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Abbreviation

Explanation

IIV Inactivated influenza vaccine

RIV Recombinant hemagglutinin influenza vaccine

LAIV Live, attenuated influenza vaccine

ccIIV Cell culture-based inactivated influenza vaccine

3 or 4 Addition of 3 or a 4 at the end of an abbreviation indicates if the vaccine is trivalent or quadrivalent

New Influenza Vaccine

Abbreviations

Morb Mortality Wkly Rep. 2013; 62(RR07): 1-43.

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True/False – The influenza vaccine is 100%

effective.

True/False – The intranasal flu vaccine is a safe choice for patients allergic to eggs.

Influenza Vaccines

Morb Mortality Wkly Rep. 2013; 62(23): 473-479.Morb Mortality Wkly Rep. 2013; 62(RR07):1-43.

http://www.immunize.org/catg.d/p4072.pdf

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Trade Name Dose Route Information

FluMist (LAIV4)

0.2 mL Nasal Quadrivalent replaces trivalent

Fluarix (IIV3&4)Fluzone (IIV3&4)FluLaval (IIV3&4)Afluria (IIV3)Fluvirin (IIV3)

0.5 mL Intramuscular (IM)

Quadrivalent options available in addition to trivalent options

Fluzone (IIV3) 0.1 mL Intradermal Continues to be the only intradermal option

Associated with equal rates of erythema, induration, swelling, and pruritus compared to intramuscular

Influenza Vaccines

http://www.immunize.org/influenza/

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Trade Name

Dose

Route Information

Flucelvax (ccIIV3)

0.5 mL

IM Manufactured in mammalian animal cells instead of eggs

Seed virus was initially cultured in chicken eggs

Flublok (RIV3)

0.5 mL

IM Egg free Recombinant hemagglutinin Produced in an insect cell

line No neuraminidase present Has shorter expiration date

- 16 weeks from production date; other vaccines expire June 30, 2014

Influenza Vaccines

http://www.immunize.org/influenza/

16

True/False - MCV4 is the preferred vaccine

formulation for the college age group.

True/False – The meningococcal vaccine is 60% effective for serogroups A, B, and C.

Meningococcal Vaccination

Morb Mortality Wkly Rep 62(2): 2013.http://www.immunize.org/meningococcal/

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Brand Name

Vaccine Type

Dose & Route

Description

Menactra MCV4 0.5 mL IM Meningococcal polysaccharide diphtheria toxoid conjugate vaccine

Menveo MCV4 0.5 mL IM Meningococcal oligosaccharide diphtheria CRM197 conjugate vaccine

Menomune

MPSV4 0.5 mL subcutaneous

Meningococcal polysaccharide vaccine

Meningococcal Vaccines

Abbreviation

Explanation

MCV4 Meningococcal conjugate vaccine• Quadrivalent • Serogroups A, C, Y, W-135

MPSV4 Meningococcal polysaccharide vaccine• Same serogroups as MCV4

Morb Mortality Wkly Rep 62(2): 2013.http://www.immunize.org/meningococcal/

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First year college students up through the age

of 21 years who are living in residence halls

Meningococcal Recommendations

No History of Vaccination

Previous Vaccination

One dose of MCV 4

One dose of MCV4 if the previous dose was given when the student was < 16 years

http://www.cdc.gov/vaccines/schedules/index.html

19

True/False – Gardasil is the preferred HPV

vaccine for college age students.

True/False – HPV vaccines are almost 100% effective in prevention of cervical cancer if the patient is vaccinated prior to sex.

Human Papillomavirus (HPV)

http://www.cdc.gov/vaccines/schedules/index.html

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HPV Vaccination

CDC recommendation is up to 26 years of age Off-label if given

above 26 years of age No safety issues

documented Preferred to be given

before sexually active Do not withhold if

sexually active

Vaccination endorsements American College Health

Association American Academy of

Pediatrics American Academy of

Family Physicians American College of

Obstetricians and Gynecologists

http://www.cdc.gov/vaccines/schedules/index.html http://www.immunize.org/press/recommend_hpv_vaccination.asp

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No recommendation on the interchangeability

of the HPV vaccines No HPV or Pap test screening is required to

receive the HPV vaccine

HPV Vaccine Formulations

Brand Name

HPV Types Dose & Route

Dosing Series

Gender

Gardasil Quadrivalent – 6 , 11, 16, 18

0.5 mL IM 0, 2, 6 months

Females & Males

Cervarix Bivalent – 16 and 18

0.5 mL IM 0, 1, 6 months

Females Only

https://www.merck.com/product/usa/pi_circulars/g/gardasil/gardasil_pi.pdfhttps://www.gsksource.com/gskprm/htdocs/documents/CERVARIX-PI-PIL.PDF

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True/False – An adult Tdap booster has been

recommended since 2005 due to waning protection and increased incidence of acellular pertussis.

Tetanus, Diphtheria, and Acellular Pertussis (Tdap)

Vaccines

New Engl J Med. 2012; 367(11): 1012-9. http://www.cdc.gov/vaccines/pubs/pinkbook/index.html

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If there is no record of a Tdap dose

Give a single dose of Tdap followed by one dose of Td every 10 years

Tdap can be administered regardless of the interval since the last tetanus and diphtheria toxoid-containing vaccine

Vaccine formulations include Boostrix and Adacel Dose is 0.5 mL IM

Tdap Vaccines

http://www.cdc.gov/vaccines/schedules/index.htmlhttp://www.immunize.org/packageinserts/

pi_tdap.asp

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The student had positive TST, normal chest x-

ray and a negative sputum test (she reports having never received the BCG vaccine)

She is diagnosed with latent TB infection Should she be treated?

What is appropriate treatment?

Student Case Continued

25

True/False – The student’s use of oral

contraceptives increases her likelihood of having LTBI.

Risk Factors

http://www.cdc.gov/TB/education/corecurr/index.htm

N Engl J Med 2004;350(20):2060-2067

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Over 11 million people in the U.S. estimated to

have LTBI (4% of population) 5%-10% will develop TB disease if untreated

Treatment of LTBI essential to controlling and eliminating TB disease Reduces risk of progression of LTBI to active TB

disease

Latent Tuberculosis Infection (LTBI)

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Infants, children and adolescents who have close contact with high-risk adults

Employees of long-term care facilities, hospitals, clinics and medical laboratories

Foreign-born persons from countries with high prevalence of TB, especially within 5 years of arrival in the US

High-risk racial and ethnic minorities, as defined locally

Individuals who have close contact with someone known or suspected to have active TB

Residents and employees of congregates living facilities, including prisons and jails, nursing homes, hospitals, and homeless shelters

Some medically underserved, low-income populations

Groups at Increased Risk of LTBI

Am Fam Physician. 2009;79(10)879-886

N Engl J Med. 2011;364:1441-1448

19931994199519961997199819992000200120022003200420052006200720082009201020112012

0

5,000

10,000

15,000

20,000

U.S.-born Foreign-born

Number of TB Cases inU.S.-born vs. Foreign-born

Persons, United States, 1993–2012*

* Updated as of June 10, 2013

No. of

Case

s

28http://www.cdc.gov/tb

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True/False – Individuals with a history of

untreated TB have an increased risk of progression from LTBI to active TB disease.

Risk Factors


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Children younger than 4 years old

Individuals with advanced, untreated HIV infection

Individuals infected within the past two years

Individuals who inject illicit drugs or use other locally identified high-risk substances

Individuals with a history of untreated TB

Individuals with the following clinical conditions or other immunocompromising conditions:• Disorders that require long-term use of immunosuppressant

medications including corticosteroids or TNF- inhibitors• Body weight 10% or more below ideal• Chronic renal failure• Poorly controlled diabetes

Groups at Increased Risk of Progression from LTBI to

Active TB

Am Fam Physician 2009;79(10)879-886

N Engl J Med 2011;364:1441-1447

31

True/False – If active TB disease is suspected

but not confirmed, an appropriate course of action would be to proceed with treatment for LTBI.

Treatment


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Initiate of treatment of LTBI only after the possibility of active TB disease has been excluded Medical History Chest Radiograph Bacteriologic Examination of Specimens

When to Treat LTBI


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9-month daily regimen is preferred - 270 doses

Effective for HIV-infected individuals taking antiretroviral therapy (ART)

Can be given twice weekly via DOT - 76 doses Preferred for children 2–11 years of age

6-month regimen also generally acceptable - 180 doses Can be given twice weekly via DOT - 52 doses Shorter regimen not recommended for children,

immunosuppressed individuals, individuals whose x-rays suggest previous TB

Dosing: 5 mg/kg (maximum: 300 mg/dose) once daily or 15 mg/kg (maximum: 900 mg/dose) twice weekly

Isoniazid (INH)Treatment Regimens


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INH and RPT given in 12 once-weekly doses under

DOT Offers equal option to 9 months daily INH, but does

not replace other treatment options for LTBI Recommended for treating LTBI in otherwise healthy

people ≥12 years of age who had recent contact with infectious TB, or who had a tuberculin skin test conversion or a positive blood test for TB infection

12-dose regimen is not recommended for children <2 years, HIV-infected persons on ART drugs, patients with presumed INH or RIF resistance, women who are or might become pregnant during treatment

Isoniazid-Rifapentine (RPT) LTBI Treatment

Regimen


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Isoniazid: 15 mg/kg rounded up to the nearest

50 or 100 mg, with a 900 mg maximum Rifapentine:

10.0-14.0 kg: 300 mg 14.1-25.0 kg: 450 mg 25.1-32.0 kg: 600 mg 32.1-49.9 kg: 750 mg > 50.0 kg: 900 mg maximum

Dosing for INH-RPT LTBI Treatment

Regimen


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Alternative to INH 4 months daily - 120 doses Should not be used in HIV-infected persons

being treated with some antiretroviral therapy (ART)

Dosing: 10 mg/kg/day (maximum: 600 mg/day)

Rifampin (RIF)


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Medication Duration Dosing

FrequencyMinimum

Doses

Isoniazid 9 months Daily 270

Twice weekly* 76

Isoniazid 6 months Daily 180

Twice weekly* 52

Isoniazid & Rifapentine

3 months Once weekly* 12

Rifampin 4 months Daily 120

*Directly Observed Therapy

LTBI Treatment Options

http://www.cdc.gov/tb

38

Which LTBI treatment regimen would you

recommend for this student?

LTBI

39

Peripheral neuropathy – INH Fatal hepatitis Elevated liver enzymes GI distress – nausea, vomiting Discolored fluids or stools – RIF Rash or pruritus

Adverse Reactions to LTBI Medications


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RIF and RPT are strong inducers of

cytochrome P-450 enzymes and P-glycoprotein transport systems resulting in interactions with a large number of medications including oral contraceptives and HIV-1 protease inhibitors

INH might affect the serum concentrations of some anti-seizure medications including carbemazepine and phenytoin

Drug-Drug Interactions

N Engl J Med 2011;365(23):2155-2166

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Are there any changes to her current

medications that you would recommend?

Drug-Drug Interactions

42

Baseline laboratory monitoring of ALT, AST, andbilirubin during treatment of LTBI is indicated only for students with a history of liver disorder with a risk of chronic liver disease who regularly use alcohol with HIV infection who are pregnant or up to three months

postpartum

Monitoring

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At least monthly, evaluate for Adherence to prescribed regimen Signs and symptoms of TB disease Signs and symptoms of adverse

effects, especially hepatitis Jaundice, loss of appetite, fatigue,

and/or muscle and joint aches

Monitoring (continued)

44

Recommend Immunizations

for Young Adults

LTBI Initiation and Treatment

• Download the CDC Recommended Adult Immunization Schedule every year

• Screen, educate, and immunize students

• Rule out active TB infection before starting LTBI treatment

• Discuss the pros and cons of the LTBI treatment options with each patient

Summary/Recommendations

Thank you for attending the presentation!

46

ACHA Guidelines. Recommendations for institutional prematriculation immunizations.

March 2013. Available at: http://www.acha.org/topics/vaccine.cfm. Accessed April 25, 2014.

ACHA Guidelines. Tuberculosis screening and targeted testing of college and university students. April 2014. Available at: http://www.acha.org/Topics/tb.cfm. Accessed April 25, 2014.

Baxter R, Bartlett J, Rowhani-Rahbar, et al. Effectiveness of pertussis vaccines for adolescents and adults: case-control study. BMJ. 2013; 347: f4249.

Brokhof MM, Foster SL, Hayney MS. New options for influenza vaccines: quadrivalent, recombinant, and cell culture – vaccine update. J Am Pharm Assoc. 2013; 53(5): 545-549.

Capua T, Katz JA, Bocchini JA. Update on adolescent immunizations: selected review of US recommendations and literature. Curr Opin Pediatr. 2013; 25: 397-405.

Centers for Disease Control and Prevention; Advisory Committee on Immunization Practices. Influenza activity – United States, 2012-13 season and composition of the 2013-14 influenza vaccine. Morb Mortality Wkly Rep. 2013; 62(23): 473-479.

Centers for Disease Control and Prevention; Advisory Committee on Immunization Practices. Prevention and control of influenza with vaccines – United States, 2013 -2014. Morb Mortality Wkly Rep. 2013; 62(RR07):1-43.

Centers for Disease Control and Prevention. Core Curriculum on Tuberculosis. Available at: http://www.cdc.gov/TB/education/corecurr/index.htm. Accessed April 25, 2014.

References

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Centers for Disease Control and Prevention. Epidemiology and prevention of vaccine-

preventable diseases. The Pink Book: Course Textbook. 12th ed. 2012 May. Available at: http://www.cdc.gov/vaccines/pubs/pinkbook/index.html. Accessed April 25, 2014.

Centers for Disease Control and Prevention. Prevention and control of meningococcal disease – recommendations of the Advisory Committee on Immunization Practices. Morb Mortality Wkly Rep 62(2): 2013.

Centers for Disease Control and Prevention. Recommended adult immunization schedule. Available at: http://www.cdc.gov/vaccines/schedules/hcp/adult.html. Accessed March 6, 2014.

FDA licensure of quadrivalent (HPV4, Gardasil) for use in males and guidance from the Advisory Committee on Immunization Practices. Morb Mortality Wkly Report. 2010; 59 (20): 630-632.

Froeschle J. Meningococcal disease in college students. Clin Infect Dis. 1999; 29:215-16. Hauck FR, Neese BH, Panchal AS, El-Amin W. Identification and management of latent

tuberculosis infectin. Am Fam Physician. 2009;79(10)879-886. Healthy People 2020 Topics and Objectives. Available at:

http://www.healthypeople.gov/2020/topicsobjectives2020/ Accessed April 25, 2014. Heartland National Tuberculosis Center. Model Tuberculosis Prevention Program for College

Campuses. 2nd ed. 2011. http://www.heartlandntbc.org/products/model_tb_prevention_program_college_campuses.pdf. Accessed April 25, 2014.

Horsburgh CR. Priorities for the treatment of latent tuberculosis in the United States. 2004; 350: 2060-7.

References

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Horsburgh CR, Rubin EJ. Latent tuberculosis infection in the United States. N

Engl J Med. 2011; 364: 1441-1448. Klein NP, Bartlett J, Rowhani-Rhabar A, et al. Waning protection after fifth

dose of acellular pertussis vaccine in children. N Engl J Med. 2012; 367: 1012-9

Malik H, Khan FH, Ahsan H. Human papillomavirus: current status and issues of vaccination. Arch Virol. 2014; 159: 199-205.

Meningococcal: Questions and Answers. Immunization Action Coalition. Available at: http://www.immunize.org. Accessed March 6, 2014.

Panatto D, Amicizia D, Lai PL, Gasparini R. Neisseria meningitidis B vaccines. Expert Rev Vaccines. 2011; 10(9): 1337-1351.

State Information. Meningococcal Prevention Mandates for Colleges and Universities. Available at: http://www.immunize.org/laws/menin.asp. Accessed March 6, 2014.

Sterling TR, Villarino ME, Borisov AS, et al. Three months of rifapentine and isoniazid for latent tuberculosis infection. N Engl J Med. 2011; 365: 2155-66.

References

Documents

Session FR5-162 Kimberly Cauthon, PharmD, CGP Anita Mosley, PhD, PharmD Feik School of Pharmacy University of the Incarnate Word