Anti-Tuberculosis Drugs

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1 Tuberculosis in Nursing: Prevention, Treatment, and nfection Control Curry nternational Tuberculosis Center Anti-Tuberculosis Drugs What Nurses Need to Know Objectives Describe the anti-tb medications used to treat drugsusceptible TB infection and disease and their role in the treatment of each Describe how acquired drug-resistance develops and principles of TB treatment to prevent acquired resistance dentify resources available to guide nursing management of common side-effects of anti-tb medications 1

2 Tuberculosis in Nursing: Prevention, Treatment, and nfection Control Curry nternational Tuberculosis Center The Drugs for TB TB Chemotherapy Fun Fact Match What is the origin of the discovery of rifamycins? What is the origin of the discovery of streptomycin? What is the origin of the discovery of isoniazid? A. A soil sample from a pine forest in the French Riviera B. Chemical variation of PAS and thioacetazone s molecular structure C. A soil actinomycete isolated from the throat of a sick chicken in New Jersey 2

3 Tuberculosis in Nursing: Prevention, Treatment, and nfection Control Curry nternational Tuberculosis Center ntroduction of Anti-TB Drugs Second-line First-line 1952 soniazid and Pyrazinamide 1962 Ethambutol 1967 Rifampin 1957 Kanamycin/Amikacin 1970 Pyrazinamide 1998 Rifapentine Streptomycin ~ Linezolid Cycloserine ~1998: Capreomycin Thioacetazone Levofloxacin ~ : 1966 Para-aminosalicylic FQs: Moxifloxacin Ethionamide acid (PAS) Ofloxacin Bedaquiline Delamanid References: Drug-Resistant Tuberculosis: A Survival Guide for Clinicians, 3 rd ed.; WHO, Anti-TB Drug Resistance in the World, (1997) The First-line Anti-TB Drugs Rifamycins Rifampin (RF, R ) Rifabutin (RFB) Rifapentine (RPT, P ) soniazid (NH, H or ) Pyrazinamide (PZA, Z ) Ethambutol (EMB, E ) 3

4 Tuberculosis in Nursing: Prevention, Treatment, and nfection Control Curry nternational Tuberculosis Center Rifamycins ncludes: rifampin (150mg, 300mg caps), rifabutin (150mg caps), and rifapentine (150mg tab) Bactericidal; inhibits protein synthesis Rifampin is a powerful inducer of hepatic cytochrome P450 enzymes increases metabolism of MANY drugs Examples: hormonal contraception, methadone, antiseizure medications, anti-coagulants, anti-retrovirals Complete medication review is needed and any new additions should be noted during treatment Drug-Drug nteractions - Rifampin Rifampin Hypoglycemic (sulfonylureas) efficacy of antidiabetics, RF also intestinal glucose absorption ~ monitor glucose Anticoagulants anticoagulant effect Diltiazem Diltiazem effect Antidepressants antidepressants Fluconazole fluconazole effect effect Beta-Blockers beta blockade traconazole itraconazole effect Contraceptives OCP effect Haloperidol haloperidol effect Corticosteroids steroid effect Methadone methadone effect Cyclosporine CsA effect, RF Phenytoin phenytoin effect Protease nhibitors P effect, RF Verapamil verapamil effect Delavirdine effect DLV Tetracyclines TCNs effect Efavirenz Slightly effect EFV, TMP-SMX Possible RF toxicity RF Digoxin DG levels Chloramphenicol chloramphenicol effect Reference: 4

5 Tuberculosis in Nursing: Prevention, Treatment, and nfection Control Curry nternational Tuberculosis Center RF Side Effects and Monitoring Side Effects Pruritus +/- rash ~ 6% Hepatotoxicity ~ <1%-2.7% ( w/nh, PZA) Orange discoloration of body fluids (expected) Less common: Hyperbilirubinemia ~ 0.6% G upset, flu-like syndrome (more common with intermittent dosing) Hypersensitivity ~ 0.3% Hemolytic anemia, acute renal failure, and TTP ~ <0.1% Monitoring Baseline LFTs, bilirubin, alkaline phosphatase, and platelet count (CBC) No routine monitoring Therapeutic drug monitoring (TDM) when indicated: Situations of slow response to therapy Those at risk for malabsorption When concern of drug-drug interactions soniazid (NH) Discovered anti-tb properties ~ 1945 Causes the greatest early reduction in colony forming units found in the sputum Mechanism of Action: NH is a prodrug activated by mycobacterial KatG catalaseperoxidase NH also blocks nha, a key enzyme involved in fatty and mycolic acid synthesis (cell wall) Used in treatment of TB infection and active disease 5

6 Tuberculosis in Nursing: Prevention, Treatment, and nfection Control Curry nternational Tuberculosis Center Drug-Drug nteractions - NH NH Hypoglycemics APAP Anticoagulants Benzodiazepines Anti-epileptics Disulfiram (Antabuse) Haloperidol Ketoconazole Dilantin Theophylline Valproate Monitor glucose, may BG hepatotoxicity anticoagulant effect toxicity toxicity of carbamazepine and phenytoin Psychotic episodes toxicity antipsychotics efficacy of ketoconazole toxicity antiepileptic toxicity theophylline; monitor levels hepatic and CNS toxicity NH Side Effects and Monitoring Side Effects Asymptomatic ALT ~12-15% Rash ~ 2% Fever ~ 1.2% Overt hepatotoxicity ~ 1% - 2.7% ( w/rf, PZA) Neuropathy ~ <0.2% (B 6 supplement 25-50mg/day) CNS ~ restlessness, insomnia, Dysarthria, seizures Lupus-like syndrome Monitoring LFTs ~ baseline and monthly if symptoms of hepatotoxicity Discontinue if transaminases > 3 X ULN with symptoms OR > 5 X ULN 6

7 Tuberculosis in Nursing: Prevention, Treatment, and nfection Control Curry nternational Tuberculosis Center Pyrazinamide (PZA) Generally used during intensive phase of treatment for active TB disease (first 2 months) One of the required drugs for shortening duration of active treatment to 6 months Mechanism of Action: Synthetic prodrug; converts to form pyrazinoic acid (POA) Bactericidal; accumulates in bacteria, causing lethal membrane damage Active against dormant / semidormant bacteria within macrophage/acidic environment of caseous granulomas PZA Side Effects and Monitoring Side Effects Hepatotoxicity G: anorexia and nausea Nongouty polyarthralgia ~ 40% receiving daily doses Asymptomatic hyperuricemia Rash, photosensitive dermatitis Monitoring Baseline LFTs, serum creatinine and uric acid Follow-up LFTs in patients with underlying liver disease Follow-up renal function in renal impairment 7

8 Tuberculosis in Nursing: Prevention, Treatment, and nfection Control Curry nternational Tuberculosis Center Ethambutol (EMB) Discovered ~ 1961 Bacteriostatic at typical doses (bactericidal at higher end of dose range) Least potent first-line drug ncluded in regimen primarily to prevent emergence of RF resistance, when primary NH resistance is suspected Discontinue once drug susceptibility test results confirm fully drug-susceptible Mechanism of Action: nhibits cell wall synthesis EMB Side Effects and Monitoring Side Effects Retrobulbar neuritis ~ 1%-5%, dose-dependent and increased with renal impairment Blurred vision Red-green color blindness Monitoring Baseline serum creatinine Follow-up renal function in impairment Baseline visual acuity test and color discrimination Question patients at monthly visit about visual changes 8

9 Tuberculosis in Nursing: Prevention, Treatment, and nfection Control Curry nternational Tuberculosis Center Rifabutin (RFB) Alternative for drug-drug interaction (has lesser degree of induction) or intolerance to rifampin Sometimes used in place of RF HV co-infected patients on Ps, some NNRTs (etravirine, rilpivirine), solid organ transplant recipients, patients on methadone maintenance therapy Mechanism of action ~ same as RF Concentration dependent, bactericidal activity Supplied: Capsules (150mg) Rifabutin (RFB) (2) Doses must be adjusted when administered with antiretroviral therapy (ARVs) Dose adjustment recommendations available at: Renal dose adjustment NOT required, but some sources recommend renal dose adjustment T ½ ~ 45 hours (much longer than RF) Penetrates CNS Cross-resistance often seen when resistant to RF 9

10 Tuberculosis in Nursing: Prevention, Treatment, and nfection Control Curry nternational Tuberculosis Center RFB Side Effects and Monitoring Side Effects Leukopenia (dose dependent); thrombocytopenia Rash and skin discoloration (bronzing or pseudojaundice) Anterior uveitis Hepatotoxicity ~ <1% Arthralgias ~ 1-2% Monitoring Baseline CBC Baseline LFTs and followup as indicated Question patients at monthly visit about visual changes (vision screening) Drug-drug interactions similar to RF, but lesser degree (~ 40% that of RF) Adherence to treatment Rifapentine (RPT) Bactericidal activity Concentration dependent killing Mechanism of action ~ same as RF nduces CYP enzymes ~ 85% of RF Drug-drug interactions similar to RF Absorption: Food AUC 40-50% (but NH C max ) 10

11 Tuberculosis in Nursing: Prevention, Treatment, and nfection Control Curry nternational Tuberculosis Center Rifapentine (RPT) (2) Approved for LTB when dosed once weekly with NH for 3 months Prolonged t ½ (~ hours) permits weekly dosing 25-O-desacetyl metabolite is active t ½ (~ hours) Highly protein bound ~ 98% RPT Side Effects and Monitoring Side Effects Rash and pruritus Hypersensitivity Hepatotoxicity Hematologic abnormalities Red-orange discoloration of body fluids (expected) Monitoring LFT monitoring as appropriate Baseline CBC When indicated, monitor drug concentrations of interacting medications 11

12 Tuberculosis in Nursing: Prevention, Treatment, and nfection Control Curry nternational Tuberculosis Center Rationale for Multiple Drugs for Treating Active Tuberculosis Rationale for Multiple Drugs Past observation of treatment failure with individual drugs Mutation conferring resistance to any one first-line drug occurs at a predictable rate Likelihood of bacilli developing resistance to 2 or more anti-tb drugs is the product of the individual mutation rates ~10 9 EMB SM NH RF Combinations 1 x X X X 10 9 ~ 1 X (HR) ~ 1 X (HRE) Gillespie et al. Antimicrob. Agents Chemother. 2002, 46(2):267. Zumla et al. N Engl J Med Feb 21;368(8):

13 Tuberculosis in Nursing: Prevention, Treatment, and nfection Control Curry nternational Tuberculosis Center Selection for Drug Resistance 1 2 NH RF PZA R P NH 3 = NH resistant, R = RF resistant, P = PZA resistant Selection for Drug Resistance (2) NH R P NH RF R R R R R R R R RP R R R R R = NH resistant, R = RF resistant, P = PZA resistant 13

14 Tuberculosis in Nursing: Prevention, Treatment, and nfection Control Curry nternational Tuberculosis Center Four Drug Combination Rifampin (RF, R) or Rifabutin soniazid (NH, H ) Pyrazinamide (PZA, Z) Ethambutol (EMB, E) (Referred to as RPE or HRZE outside the U.S.) Designed to prevent secondary development of resistance to RF in populations with a high rate of primary resistance to NH ( 4%) Blumberg et al. Am J Respir Crit Care Med 2003; 167:603. WHO. Treatment of tuberculosis guidelines (4th edition). TB Treatment Side Effects Resources for Nursing Care 14

15 Tuberculosis in Nursing: Prevention, Treatment, and nfection Control Curry nternational Tuberculosis Center Nursing Guide for Managing SE s Designed as a reference guide so nurses can quickly: dentify symptoms that may indicate a drug-related side effect Assess for severity as well as potential contributors ntervene appropriately in order to: minimize patient discomfort, reduce side effect progression, and ultimately support successful treatment completion Structure: Presenting Symptoms Presents symptoms that a patient may express during treatment ndicates the potential toxicity: diagnosis associated with these presenting symptoms Lists possible TB and/or antiretroviral (ARV) drugs associated with the symptom(s)/toxicity 15

16 Tuberculosis in Nursing: Prevention, Treatment, and nfection Control Curry nternational Tuberculosis Center Structure: Nursing Assessment What to observe for? What questions to ask the patient? What tests or evaluations should the nurse check for? Structure: Nursing nterventions Urgent action to take when indicated (criteria provided) nformation to cover in counseling the patient When to bring to the doctor s attention and what questions to raise with the doctor regarding potential medical interventions 16

17 Tuberculosis in Nursing: Prevention, Treatment, and nfection Control Curry nternational Tuberculosis Center Structure: Comments Provides additional information on potential causes of the symptom(s) May provide location for additional resources May provide information on related considerations for management TB Drug-related Resources 17

18 Tuberculosis in Nursing: Prevention, Treatment, and nfection Control Curry nternational Tuberculosis Center 18

19 Tuberculosis in Nursing: Prevention, Treatment, and nfection Control Curry nternational Tuberculosis Center Summary Anti-TB drugs have associated adverse effects that require monitoring and management A combination of drugs active against M. tuberculosis is required for patients with active TB disease Synergistic effect when used in combination Target different aspects of the TB organism EMB is on board until TB organism is known to be fully drug sensitive (Pan Sensitive) Drug interactions are numerous for RF and many for NH; careful medication history is important prior to TB treatment start TB Consultation Warmline = (877) Acknowledgements Rupali Jain, PharmD, BCPS University of Washington Medical Center Chis Keh, MD San Francisco DPH, TB Control Lisa Chen, MD Curry nternational Tuberculosis Center 19

20 Tuberculosis in Nursing: Prevention, Treatment, and nfection Control Curry nternational Tuberculosis Center References 1. Nahid P, Dorman SE, Alipanah N, et al. Official American Thoracic Society/Centers for Disease Control and Prevention/nfectious Diseases Society of America Clinical Practice Guidelines. Treatment of drug-susceptible tuberculosis. Clin nfect Dis. 2016;63(7):e Curry nternational Tuberculosis Center and California Department of Public Health, 2016: Drug-resistant tuberculosis: a survival guide for clinicians, 3 rd ed. [pages ]. 3. Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HV-1-infected adults and adolescents. Department of Health and Human Services Peloquin CA, Namdar R. Chapter 121. Tuberculosis. n: Talbert RL, DiPiro JT, Matzke GR, Posey LM, Wells BG, Yee GC, eds. Pharmacotherapy: A Pathophysiologic Approach. 8th ed. New York: McGraw-Hill;

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