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Navigating Toward TB Free Pacific IslandsDecember 11‐12, 2019Majuro, Marshall Islands
Monitoring for Side Effects and Toxicity
Barbara Seaworth, MDDecember 12, 2019
• No conflict of interests
• No relevant financial relationships with any commercial companies pertaining to this educational activity
Barbara Seaworth, MDhas the following disclosures to make:
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EXCELLENCE EXPERTISE INNOVATION
MonitoringforSideEffectsandToxicity
BarbaraJSeaworth,MDMedicalDirector,HeartlandNationalTBCenter
Professor,InternalMedicineandInfectiousDiseaseTheUniversityofTexasHealthScienceCenter,Tyler
Navigating Toward TB Free Pacific Islands December 10, 2019
Majuro, Republic of the Marshall Islands
LTBI Can Progress to Active TB Disease Chance is Increased By
• HIV infection• Underweight by >10%• Intravenous drug use• Diabetes• Chronic kidney disease• Silicosis• Smoking – active and passive • Pregnancy• Weak Immune system
• Be watching to be sure the patient receiving LTBI treatment does not develop symptoms of TB disease
• If your patient is sick let someone know
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Images from Flipchart Panel Introducing Side Effects, Toxicity and Risks
Makes hormonal BC methods less effective/use barrier methods
Stop or limit alcohol consumption to less than 1 drink per day
Stop or cut back on smoking
Orange discoloration of body fluids RISK
Side Effects
Side Effect Drug Interactions
• Careful assessment before treatment – Know what problems patient has before treatment.
Numbness? Arthritis? Itchy skin?
• Reassure your patient. Let them know.– Most side effects are manageable and do not require
stopping the medication
– Nearly all TB patients complete their treatment without any long term harm from the medicines.
• Side effects must be differentiated from toxicity
Side Effects?
Toxicity often requires adjustment of medical regimen
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• “Face‐to‐face clinical assessments are the cornerstone of clinical monitoring for treatment adherence and adverse events.”
• Identifying Toxicity Depends on the Risk
• Patients should be told to immediately stop medications for nausea, vomiting, severe abdominal discomfort, or unexplained fatigue and to contact the clinic for further evaluation– Know what you should tell patient
– Know how to get the message to the doctor that same day
• Write down what the patient tells you; keep it for future reference.
Toxicity Monitoring
MostCommonSideEffects
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Images from Flipchart Panel on Minor Side Effects
Numbness or tingling in fingers or toes
Aching joints
Less appetite or no appetite
Combined image
These usually cause discomfort to patient but are not harmful unless
severe
INH
• G.I. upset• Rash• Hepatotoxicity• Peripheral
neuropathy
Rifampin• G.I. upset• Rash• Hepatotoxicity• Thrombocytopenia, hemolytic
anemia• Renal toxicity• Flu-like syndrome• Orange staining of body fluids
Rifabutin
• Rash/Skin discoloration• Hepatotoxicity• Leukopenia• Thrombocytopenia• Uveitis• Arthralgias
PZA
• G.I. upset• Rash• Hepatotoxicity• Arthralgias• Gout (rare
Ethambutol
• Optic Neuritis• Rash
Fluoroquinolones
• GI upset• Dizziness,• hypersensitivity
photosensitivity• Headaches, tendonitis
tendon rupture• Insomnia.
Gastro Intestinal Upset
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Gastrointestinal Upset
• Decreased appetite,
• Nausea/vomiting/diarrhea (NVD)
• Common in the first few weeks of therapy
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Helpful to ask the patient which medication they think is causing the
problem
Common causes of GI symptoms
• Gastritis
• Hepatitis/ hepatotoxicity
• Biliary disease/pancreatitis
• Other infections ‐ UTI
• Peptic ulcer disease
• Clostridium difficile colitis
• Inflammatory bowel disease
• Lactose intolerance
• Acute renal failure or nephrotoxicity
• GI TB especially if early in treatment
Unrecognized TB meningitis
• Diabetic gastroparesis
• Pregnancy
• Other medications/ETOH
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•Exclude drug induced hepatitis
Responding to GI Upset
INH• G.I. upset• Rash• Hepatotoxicity• Peripheral
neuropathy• Mild CNS Toxicity
Rifampin • G.I. upset• Rash• Hepatotoxicity• Thrombocytopenia, hemolytic
anemia• Renal toxicity• Flu-like syndrome• Orange staining of body fluids
Rifabutin• Rash/Skin discoloration• Hepatotoxicity• Leukopenia• Thrombocytopenia• Uveitis• Arthralgias
PZA• G.I. upset• Rash• Hepatotoxicity• Arthralgias• Gout (rare
Ethambutol• Optic Neuritis• Rash
Fluoroquinolones
• GI upset• Dizziness,• hypersensitivity
photosensitivity• Headaches, tendonitis
tendon rupture• Insomnia.
Hepatotoxicity with First Line Drugs
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• Underlying liver disease
– Hepatitis B and C
• Alcoholism
• Pregnancy
• Immediate (4 months) post-partum period
• Hepatotoxic medications
Risk Factors for Hepatotoxicity
Hepatotoxicity
Early Signs
• Fatigue• Poor appetite• Taste alteration• Nausea• Abdominal
discomfort• Bloating• Minimal rash
Later Signs
• Vomiting
• Abdominal pain
• Jaundice
• Change in color of urine and stool
• Changes in behavior, memory loss
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Images from Flipchart Panel on Major Side Effects
• Bad rash or itching
• Fever or chills
• Fainting
• Nausea or stomach cramps with vomiting
• Yellow skin or eyes
Possible serious toxicityStop TB medications
Sometimes our interventions can be dangerous…
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INH
• G.I. upset• Rash• Hepatotoxicity• Peripheral
neuropathy
Rifampin• G.I. upset• Rash• Hepatotoxicity• Thrombocytopenia, hemolytic
anemia• Renal toxicity• Flu-like syndrome• Orange staining of body fluids
Rifabutin
• Rash/Skin discoloration• Hepatotoxicity• Leukopenia• Thrombocytopenia• Uveitis• Arthralgias
PZA
• G.I. upset• Rash• Hepatotoxicity• Arthralgias• Gout (rare)
Ethambutol
• Optic Neuritis• Rash
Fluoroquinolones
• GI upset• Dizziness,• hypersensitivity
photosensitivity• Headaches, tendonitis
tendon rupture• Insomnia.
Side Effects of First Line Drugs
• Tingling, prickling & burning balls of feet or tips of toes– More likely: Diabetic, alcoholic, HIV infection, pregnancy,
poor nutrition, hypothyroidism
– Loss of feeling or an unsteady painful walk can occur
– Can progress to the fingers and hands
– Usually symmetrical
Peripheral Neuropathy
Administer Vitamin B6 (pyridoxine) 50mg daily‐ increase to 100 mg if no response
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• Sensory peripheral neuropathy
• loss of ability to feel touch
• Difficulty with vision
• Central Nervous System
• Behavior change
Neurotoxicity
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VisionChanges
Ethambutol
• Nausea
• Vomiting
• Loss of appetite
• Fever
• Headaches
• Dizziness
• Rash
• Changes in visual acuity
• Changes in red/green color discrimination
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Managing & Monitoring Visual Toxicities
• Baseline & monthly screen by TB clinic
• You can ask?– How clearly does patient see?– Do they have trouble with color vision– blurred vision
• Children to look for eye rubbing, excessive blinking, sitting close TV, difficulty with accurate grasping
• Let TB Clinic know if you find these problems– Hold EMB – if drug not stopped patient at risk of complete loss
of vision
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• INH may be associated with a variety of effects
– Drowsiness,
– headaches,
– poor concentration,
– irritability,
– mild mood changes,
– insomnia,
– Caution patients to expect these effects and understand that they typically improve .
Central Nervous System Toxicity
Side effectsTry to ContinueDon’t Stop treatment
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• Psychiatric effects– Depression – may lead to suicidal ideation if medication continues
• INH
• Medication must be stopped and patient watched closely until no longer a threat to self if suicidal
– Must stop INH
Central Nervous System Toxicity
1. Unwanted side effect of a certain medicine
2. Caused by an allergic reaction to the medicine: Most rashes
Side Effect or Allergic Reaction?
What we really need to know is if medications should be stoppedIf suspect allergic reaction – Stop all medications – rechallenge one at a time
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Evaluate the Rash
• Where is it?
• What does it look like?
• Does it itch?
• When did it start?
• Has it spread?
• What makes it better or worse?
• Have you had an insect bite?
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• Insect bites
• Scabies
• Contact dermatitis
– Question patient about new soaps, lotions, perfumes,
laundry detergents, etc
• Sunburn
• Dry skin
• Other drugs, especially new agents
• Viral or fungal infections
Other Possible Causes
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• Common
• Often resolve after first several weeks of treatment
• Usually do not require stopping medication
• Treated symptomatically with Benadryl, other antihistamines, low-dose prednisone
Mild Rash
1. Caused by an allergic reaction to the medicine: Most rashes
Allergic Reaction?
What we really need to know is if medications should be stoppedIf suspect allergic reaction – Stop all medications – rechallenge one at a time
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Nursing Guide
The guide is designed to
1) Identify symptoms that may indicate a side effect related to DR-TB treatment or antiretroviral medication
2) Assess for severity as well as other potential contributors
3) Intervene appropriately to minimize patient discomfort, reduce side effect progression, and ultimately support successful treatment completion
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