Delamanid, a nitroimidazole drug was approved for use in combination with bedaquiline for treating multidrug-resistant or extensively drug-resistant tuberculosis.
Delamanid is an anti-tubercular drug prescribed in combination with bedaquiline for treating active multidrug-resistant tuberculosis in adults when other treatments fail or show no response.
Delamanid works by interfering with the synthesis of bacterial cell wall components leading to loss of rigidity and resulting in cell death.
Delamanid should not be used in patients with-
• Allergy to delamanid
• Pregnancy and breastfeeding
• Low levels of albumin (less than 2.8g/dl)
Patients taking medicines that are strong inducers of CYP3A4
Children below 18 years of age as the safety and efficacy of delamanid are not established.
• The dose of delamanid for adults is 100 mg which should be taken two times daily for 24 weeks.
• Delamanid must be given as part of the combination regimen and should be followed with the appropriate treatment schedule according to WHO guidelines.
• Delamanid is recommended to be given by directly observed therapy (DOT).
• Delamanid is available as a tablet which should be taken by mouth with food to avoid gastric comfort.
• Patients should be monitored for cardiac function as delamanid can result in alterations in the cardiac rhythm.
• It is advised to obtain an ECG before starting treatment with delamanid and every following month until the full course of treatment is completed.
• Levels of albumin should be monitored during treatment with delamanid as cases of hypoalbuminemia have been reported.
• Blood parameters should be monitored for detecting abnormalities of potassium, calcium, and magnesium electrolyte levels.
• Women of childbearing age should use effective contraceptive measures before starting treatment with delamanid.
• Common: A headache, dizziness, nausea, vomiting, muscle pain, asthenia or weakness
• Gastrointestinal: Pain in the stomach, gastritis, constipation, indigestion
• Cardiovascular: Abnormal heart rhythm, increased or decreased blood pressure, hematoma
• Blood: Reticulocytosis, anemia, eosinophilia
• Nervous system: Anxiety, depression, restlessness, agitation, drowsiness
• Respiratory: Difficulty in breathing, cough, pain and irritation of the throat, runny nose
• Skin: Dermatitis, hyperhidrosis, pruritus, rashes, urticaria, acne
• Others: Blood in urine, fever, chest pain, dry eyes, earache
• Follow the treatment schedule strictly to gain more benefit.
• Liver function should be evaluated before, during, and after the treatment.
• Treatment of overdose should be treated by removing delamanid from the gastrointestinal tract, and by providing supportive care.
Avoid using delamanid with the following drugs that increase the cardiac rhythm.
• Anti-arrhythmic drugs (e.g., amiodarone, quinidine, sotalol)
• Antipsychotics (e.g., chlorpromazine, haloperidol, fluphenazine)
• Anti-retrovirals (e.g., lopinavir, ritonavir, efavirenz)
• Anti-fungals (e.g., itraconazole, fluconazole, voriconazole)
• Antidepressants (e.g., amitriptyline, imipramine)
• Store in the original container at room temperature below 25° C.
• Protect from excess heat and moisture.
• Keep the tablets out of reach of children.
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