Delamanid

Dosing

100 mg PO twice daily x24w

  • In combination with multidrug-resistant TB regimen

Safety and effectiveness in pediatric patients <18y of age have not been established

Mild hepatic impairment No dose adjustment

Severe hepatic impairment Not recommended

Mild or moderate renal impairment No dose adjustment

Severe renal impairment Not recommended

General Information

Multidrug resistant respiratory tuberculosis, use only in combination with other agents.

Directly observed therapy (DOT) is recommended.

Obtain serum electrolytes at baseline.

Obtain ECG prior to treatment and monthly; monitoring if QTc interval exceeds 500 msec before or during treatment.

Common

  • Palpitations

  • Hyperuricemia

  • Hypokalemia

  • Decrease in appetite

  • Diarrhea

  • Nausea

  • Upper abdominal pain

  • Vomiting

  • Reticulocytosis

  • Arthralgia

  • Myalgia

  • Asthenia

  • Dizziness

  • Headache

  • Insomnia

  • Paresthesia

  • Tremor

  • Tinnitus

  • Hemoptysis

Serious

  • Prolonged QT interval

  • Drug resistance

Contraindications:

  • QT interval prolonging drugs

  • CYP3A4 inducers

Antimicrobial class: Antimycobacterial, Nitroimidazole

Pregnancy category: Not recommended

Average serum half life: 30-38 hours

Precautions: QT prolongation slowly increases during the first 6-10 weeks of treatment; monitoring recommended; discontinue use if QTcF >500 msec occurs.

Avoid use in patients with electrolyte disturbances, especially hypokalemia, hypocalcemia or hypomagnesemia; monitor frequently if use is unavoidable.

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