• Pulmonary extensively drug resistant or treatment-intolerant or nonresponsive multidrug-resistant tuberculosis (in combination with bedaquiline and linezolid).

Contraindicated in:

• None.

Use Cautiously in:

• History of torsade de pointes, congenital long QT syndrome, hypothyroidism, bradycardia, decompensated HF, hypocalcemia, hypomagnesemia, or hypokalemia (↑ risk of QT interval prolongation)
• OB: Use during pregnancy only if potential maternal benefit justifies potential fetal risk
• Lactation: Use while breastfeeding only if potential maternal benefit justifies potential risk to infant
• Rep: Men of reproductive potential
• Pedi: Safety and effectiveness not established in children.

Reflect side effects experienced with combination regimen of pretomanid, bedaquiline, and linezolid.

CV: hypertension, QT interval prolongation.

Derm: acne, pruritus, rash, dry skin.

EENT: optic neuropathy, visual impairment.

Endo: hypoglycemia, hyperglycemia.

F and E: LACTIC ACIDOSIS, hyperkalemia, hypokalemia, hypomagnesemia, hyponatremia.

GI: HEPATOTOXICITY, PANCREATITIS, abdominal pain, dyspepsia, ↑amylase, diarrhea, nausea, vomiting, constipation, gastritis, ↑ lipase.

GU: ↓fertility (males), ↑ serum creatinine, testicular abnormalities.

Hemat: anemia, NEUTROPENIA, leukopenia, thrombocytopenia.

Metab: ↓appetite, ↓weight.

MS: ↑creatine kinase, pain.

Neuro: peripheral neuropathy , SEIZURES, headache, dizziness, dysgeusia, insomnia.

Resp: cough, hemoptysis, lower respiratory tract infection, pleuritic pain.

Drug-Drug:

• Hepatotoxic drugs, including alcohol may ↑ risk of hepatotoxicity; avoid concurrent use.
• QT interval prolonging drugs may ↑ risk of QT interval prolongation or torsade de pointes; avoid concurrent use.
• Strong CYP3A4 inducers or moderate CYP3A4 inducers, including rifampin or efavirenz may ↓ levels and effectiveness; avoid concurrent use.
• May ↑ levels and toxicity of methotrexate.

Drug-Natural Products:

• St. John's wort may ↓ levels and effectiveness; avoid concurrent use.

• Tablets: 200 mg;

• PO (Adults): 200 mg once daily for 26 wk (in combination with bedaquiline and linezolid).

• Kills actively replicating Mycobacterium tuberculosisby inhibiting mycolic acid biosynthesis which subsequently blocks cell wall production. Acts as a respiratory poison following nitric oxide release against nonreplicating Mycobacterium tuberculosisunder anaerobic conditions.

• Bacteriostatic action against susceptible Mycobacterium tuberculosis.

Therapeutic Classification: antituberculars

Pharmacologic Classification:

Absorption: High-fat, high-calorie food ↑ drug exposure.

Distribution: Extensively distributed to extravascular tissues.

Metabolism/Excretion: Metabolized by several pathways with some metabolism via CYP3A4. Primarily excreted as metabolites in urine (53%) and feces (38%).

Half-life: 16–17 hr.

(plasma concentrations)

• Instruct patient to take pretomanid as directed for full course of therapy, even if feeling better. Missing doses may decrease effectiveness of therapy and increase chance that TB will not be treatable by the combination regimen of pretomanid, bedaquiline, and linezolid or other medicines. Advise patient to read Medication Guide before starting therapy and with each Rx refill in case of changes.
• Advise patient to notify health care professional promptly if signs and symptoms of hepatitis (yellow eyes and skin, nausea, vomiting, anorexia, unusual tiredness, weakness, dark urine, tenderness in right upper abdomen), thrombocytopenia (unusual bleeding or bruising), or prolonged QT interval (fast or irregular heartbeat, feeling dizzy or faint) occur.
• Caution patient to avoid the use of alcohol during this therapy, because this may increase the risk of hepatotoxicity.
• Caution patient to avoid crowds and persons with known infections. Instruct patient to use soft toothbrush and electric razor and to avoid falls.
• Advise patient to notify health care professional if signs and symptoms of peripheral neuropathy (numbness, burning, a feeling of “pins and needles”, tremors, problems with balance, weakness) or visual changes occur.
• Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications, especially St. John's Wort.
• Rep: Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding. May impair fertility in males.
• Emphasize the importance of regular follow-up exams to monitor progress and to check for side effects.

pre-TOE-ma-nid

NDC Code^*

• 49502- Mylan Specialty L.P.
  • 49502-476- Pretomanid
    • 49502-476-26- 26 TABLET in 1 BOTTLE (49502-476-26)