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Nursing Guidefor Second-LineTuberculosis MedicationsTuberculosis and Hansen’s Disease UnitDrug Resistant TB Monitoring ProgramDecember 2021

Table of ContentsIntroduction . 3Overview of Second-Line TB Medications . 4Aminoglycosides/Injectable Agents . 4Side Effects and Symptoms of Medication Toxicity . 4Recommended Assessments and Monitoring . 4Bedaquiline (BDQ) . 5Side Effects and Symptoms of Medication Toxicity . 5Recommended Assessments and Monitoring . 5Clofazimine (CFZ) . 6Side Effects and Symptoms of Medication Toxicity . 6Recommended Assessments and Monitoring . 6Cycloserine (CS) . 7Side Effects and Symptoms of Medication Toxicity . 7Recommended Assessments and Monitoring . 7Ethionamide (ETA) . 8Side Effects and Symptoms of Medication Toxicity . 8Recommended Assessments and Monitoring . 8Fluoroquinolones (FQN) — Levofloxacin and Moxifloxacin . 9Side Effects and Symptoms of Medication Toxicity . 10Recommended Assessments and Monitoring . 10High Dose Isoniazid (INH). 11Side Effects and Symptoms of Medication Toxicity . 11Recommended Assessments and Monitoring . 11Linezolid (LZD) . 12Side Effects and Symptoms of Medication Toxicity . 12Recommended Assessments and Monitoring . 13Para-Aminosalicylic Acid (PAS) . 14Side Effects and Symptoms of Medication Toxicity . 14Recommended Assessments and Monitoring . 14Pretomanid (Pa) . 15Side Effects and Symptoms of Medication Toxicity . 15Recommended Assessments and Monitoring . 15Fact Sheets and Medication Resources . 16Nursing Cheat Sheets. 19References . 20

IntroductionThe purpose of this guide is to provide TB nurse case managers with: An overview of second-line TB medications;Fact sheets and resources to support patient education;Nursing cheat sheets on medication-related recommendations;andRecommended references.Clinicians prescribe second-line medications to treat certain types oftuberculosis (TB), including drug-resistant TB (DR-TB). Clinicians mayrecommend second-line TB medications for patients with drugsusceptible TB disease who are intolerant to first-line medications.Although these medications have known side effects, they arenecessary and at times the only option to treat TB.Nurses should understand each drug and the associated monitoring,which can minimize potential adverse reactions. In addition, anelement of patient-centered care is educating patients and families ontheir treatment plans to promote medication adherence. The guide isdesigned to supplement the nurses’ knowledge of second-linemedications and should be used along with orders by the treatingphysician.Page 3 of 20Nursing Guide for Second-Line Tuberculosis Medications, December 2021

Overview of Second-Line TB MedicationsThis section outlines potential side effects and toxicities associated with eachdrug and summarizes recommended assessments.Aminoglycosides/Injectable Agents Amikacin (AK), 1g/4mL vial:Side Effects and Symptoms of Medication Toxicity General — Rash or swelling of the face, shortness of breath (SOB),decreased urination, renal toxicity, electrolyte imbalance, muscletwitching or weakness, pain at injection siteOtotoxicity — Hearing loss, tinnitusVestibular Disturbance — Dizziness, loss of balanceRecommended Assessments and Monitoring Baseline, Monthly:o Medication Assessments Toxicity Assessment Audiometry Testing Vestibular Testingo Laboratory Complete Blood Count (CBC), Comprehensive MetabolicPanel (CMP), and magnesiumOther:o Adjust dose, interval for renal insufficiency, or both.o Rule out pregnancy prior to administering drug.o Aminoglycosides can cause permanent hearing loss. Earlyintervention is crucial.Page 4 of 20Nursing Guide for Second-Line Tuberculosis Medications, December 2021

Bedaquiline (BDQ) 100mg tablet:Side Effects and Symptoms of Medication Toxicity General — Hepatotoxicity, headaches, arthralgias, rashCardiac — Corrected QT interval (QTc) prolongation; chest pain, SOB,fainting or near fainting, sudden fatigue, change in heart rhythm,tachycardia, syncopeRecommended Assessments and Monitoring Baseline:o Medication Assessments Toxicity Assessment Cardiac monitoring or Electrocardiogram (ECG)o Laboratory CBC, CMP, Thyroid-Stimulating Hormone (TSH) andMagnesiumAt two weeks:o ECGMonthly:o Toxicity Assessmento Cardiac Monitoring or ECGo CBC, CMP and MagnesiumEvery three months:o TSHOther:o Monitor for signs and symptoms of prolonged QTc interval.o Swallow tablet whole and take with food.o Avoid alcohol.Page 5 of 20Nursing Guide for Second-Line Tuberculosis Medications, December 2021

Clofazimine (CFZ) 100mg tablet:Side Effects and Symptoms of Medication Toxicity General — Bloody or black stools or diarrhea, jaundice, retinopathy,photosensitivity, acne, rare instance-depression or thoughts of hurtingselfSkin Discoloration — Clofazimine is a dye and may cause skindiscoloration and ichthyosis, xerosis. Hyperpigmentation resolves 1–2years after discontinuation.GI Intolerance — Severe abdominal symptoms, bleeding and bowelobstructionCardiac — Can cause prolongation of QTcRecommended Assessments and Monitoring Baseline, monthly:o Medication Assessments Toxicity Assessment Mental Health Assessmento Laboratory CBC, CMPEvery three months:o Follow-up Assessment (with prescribing physician)o Clofazimine Monitoring FormOther:o Prescriber must enroll in the Institutional Review Board (IRB)program to prescribe CFZ.o Recommend sunscreen.o Rule out pregnancy prior to administering drug.Page 6 of 20Nursing Guide for Second-Line Tuberculosis Medications, December 2021

Cycloserine (CS) 250mg capsule:Side Effects and Symptoms of Medication Toxicity General — Rash, hives, headaches, seizures, insomniaDepression and Suicidal Ideation — Mental status or moodchanges, aggression, depression, disorientation, hallucinations,inability to concentrate, lethargy, nightmares, slurred speech, suicidalthoughts, psychosisRecommended Assessments and Monitoring Baseline, monthly:o Medication Assessments Toxicity Assessment Mental Health Assessmento Laboratory CBC, CMPOther:o Adjust with renal failure.o Use Vitamin B6 when giving Cycloserine.o Avoid alcohol.Page 7 of 20Nursing Guide for Second-Line Tuberculosis Medications, December 2021

Ethionamide (ETA) 250mg tablet:Side Effects and Symptoms of Medication Toxicity General — Change in vision, headaches, photosensitivity, neuropathy,gastrointestinal (GI) upset, hepatotoxicity, dizziness, hypoglycemia,peripheral neuropathy, hypersensitivity, hypotension, mentaldisturbanceHypothyroidism — Unusual bruising or bleeding, increased tiredness,hair loss, skin changes, trouble concentrating, irritable, depression,irregular menses, metallic taste, salivation, gynecomastia, impotenceRecommended Assessments and Monitoring Baseline, Monthly:o Toxicity Assessment Assess for changes in visiono Laboratory CBC, CMP and TSHEvery three months:o TSHPage 8 of 20Nursing Guide for Second-Line Tuberculosis Medications, December 2021

Fluoroquinolones (FQN) — Levofloxacin andMoxifloxacinLevofloxacin (LFX) 250mg tablets (varies depending on manufacturer): 500mg tablet: 750mg tablet: 25mg/mL oral solution:Moxifloxacin (MFX) 400mg tablet:Page 9 of 20Nursing Guide for Second-Line Tuberculosis Medications, December 2021

Side Effects and Symptoms of Medication Toxicity General — GI upset, hepatotoxicity, hypersensitivity, dizziness,headaches, changes in heart rhythm, hypo- and hyper-glycemia,photosensitivity, arthralgias, insomnia, agitation, psychosis, paranoia,depression, peripheral neuropathy, thrush, seizuresTendonitis — Monitor for pain or rupture to tendons.Cardiac — Can cause prolongation of QTcRecommended Assessments and Monitoring Baseline, Monthly:o Toxicity Assessment Ask about tendon pain.o Laboratory CBC, CMPOther:o Do not take with milk-based products, antacids, mineralsupplements (iron or magnesium) within two hours ofmedication.o Avoid caffeinated foods and beverages.o Recommend sunscreen.Page 10 of 20Nursing Guide for Second-Line Tuberculosis Medications, December 2021

High Dose Isoniazid (INH)(Adults 15mg/kg) 100mg tablet: 300mg tablet:Side Effects and Symptoms of Medication Toxicity General — Anemia, agranulocytosis, vasculitis, decreased platelets,fever, chills, rashHepatotoxicity — GI upset, nausea or vomiting (N/V), clay colorstools, dark urine, yellow eyes, jaundicePeripheral Neuropathy — May cause numbness or tingling inextremitiesOptic Neuropathy — Pain, blurred vision, trouble seeing to the side,loss of color vision, flashing lightsRecommended Assessments and Monitoring Baseline, monthly:o Medication Assessments Toxicity Assessment Peripheral Neuropathy Monitoringo Laboratory Liver Function Tests (LFTs)Other:o Add Vitamin B6 to regimen.o Take one hour before or two hours after antacids.o May interact with other drugs and foods. Avoid foods and drinksthat contain tyramine. Monitor for serotonin syndrome.Page 11 of 20Nursing Guide for Second-Line Tuberculosis Medications, December 2021

Linezolid (LZD) 600mg tablet: 100mg/5mL oral suspension:Side Effects and Symptoms of Medication Toxicity General — Neuropathy, GI upset, change in vision, headaches, severediarrhea, rashHematological — Lactic acidosis, bone marrow suppression, anemia,thrombocytopenia, pancytopenia (confusion, SOB, rapid pulse, fever,chills, dizziness, unusual bleeding or bruising, petechiae, purpura,bruising, change in urinary frequency, black or tarry stools, unusualtiredness or weakness, signs and symptoms of infection, such as paleskin, lips, or nail beds)Peripheral Neuropathy — Numbness or tingling in extremities; maybe permanent; usually occurs after 12–20 weeks of treatmentOptic Neuropathy — Pain, blurred vision, trouble seeing to the side,loss of color vision, flashing lights; may be irreversible; usually occursafter 12—20 weeks of treatmentPage 12 of 20Nursing Guide for Second-Line Tuberculosis Medications, December 2021

Recommended Assessments and Monitoring Baseline, monthly:o Medication Assessments Toxicity Assessment Peripheral Neuropathy Monitoring Visual Acuity Ishihara Plateso Laboratory CBC, CMPSome guidelines recommend weekly measurements of CBCduring the initial phase. DSHS recommends consultation with aDSHS-recognized TB medical consultant. Other:o Add Vitamin B6 to regimen.o Monitor blood pressure.o May interact with other drugs and foods. Avoid foods and drinksthat contain tyramine. Monitor for serotonin syndrome.Page 13 of 20Nursing Guide for Second-Line Tuberculosis Medications, December 2021

Para-Aminosalicylic Acid (PAS) 4g packet:Side Effects and Symptoms of Medication Toxicity General — GI upset, diarrhea, hepatotoxicity, rash, severe itching orhives, hypokalemiaHypothyroidism — Unusual bruising or bleeding, increased tiredness,hair loss, skin changes, trouble concentrating, irritable, depression,irregular menses, metallic taste, salivation, gynecomastia, impotenceRecommended Assessments and Monitoring Baseline:o Monthly Toxicity Assessmento Laboratory CBC, CMP and TSHMonthly:o Toxicity Assessmento CBC and CMPEvery three months:o TSHOther:o Sprinkle over applesauce or yogurt or mix with acidic juice.o Do not chew granules.o Refrigerate.o Avoid alcohol.Page 14 of 20Nursing Guide for Second-Line Tuberculosis Medications, December 2021