Bedaquiline Fumarate and Deferoxamine Mesylate

• Generic Name: bedaquiline
• Dosage Forms: n.a.
• Other Brand Names: Sirturo

Treatment of pulmonary multidrug-resistant tuberculosis (i.e., caused by Mycobacterium tuberculosis resistant to isoniazid and rifampin) in conjunction with other antituberculosis agents.

Designated an orphan drug by FDA for use in treatment of active tuberculosis.

Use only when an effective treatment regimen for multidrug-resistant tuberculosis cannot otherwise be provided.

Safety and efficacy for treatment of drug-susceptible tuberculosis, extrapulmonary (e.g., CNS) tuberculosis, or latent tuberculosis infection not established; use not recommended.

Safety and efficacy for treatment of infections caused by nontuberculous mycobacteria (NTM) not established; use not recommended.

Patients with multidrug-resistant tuberculosis are at high risk for treatment failure and acquisition of further drug resistance. ATS, CDC, and IDSA recommend that such patients be referred to or that consultation be obtained from a specialized treatment center as identified by local or state health departments or the CDC.

• Generic Name: deferoxamine
• Dosage Forms: n.a.
• Other Brand Names: Desferal

Adjunctive therapy for acute iron intoxication.

Not a substitute for standard measures generally used, including GI decontamination (e.g., induction of emesis, gastric lavage, whole-bowel irrigation), suction and maintenance of airway, correction of acidosis, and control of shock with IV fluids, blood, oxygen, and vasopressors.

Recommended for patients with severe manifestations of iron intoxication (e.g., metabolic acidosis, repetitive vomiting, lethargy, coma, seizures, hypotension, GI bleeding, signs of shock) or serum iron concentration >500 mcg/dL; less serious ingestions may be treated with supportive care alone.

Treatment of chronic iron overload resulting from multiple transfusions in patients with thalassemia or other chronic anemias.

Long-term therapy may have beneficial effects on the liver (i.e., slow accumulation of hepatic iron, retard or eliminate progression of hepatic fibrosis).

In patients with thalassemia, long-term therapymay have beneficial effects on the heart (e.g., delay and/or prevent development of iron-associated cardiac disease, improve left ventricular function in patients with subclinical cardiac dysfunction, improve cardiac function in at least some patients with symptomatic cardiac disease ) and improve survival.

Initiate therapy early in the course of thalassemia (i.e., some clinicians recommend initiation of chelation therapy when serum ferritin concentrations reach 1000 ng/mL or child reaches the age of 3 years [see Pediatric Use under Cautions]) and monitor compliance closely; noncompliance with chelation regimen and failure to initiate therapy prior to development of irreversible tissue damage are associated with cardiac disease.

Diagnosis or treatment of aluminum-associated neurotoxicity and/or bone abnormalities in patients with chronic renal failure undergoing dialysis.

Has been used with some success for treatment of iron overload secondary to primary hemochromatosis. Phlebotomy is the method of choice for removal of excess iron; however, deferoxamine may be beneficial when phlebotomy is contraindicated.

Has been studied as a chelating agent for aluminum and its potential beneficial effects in patients with Alzheimer’s disease; not currently recommended for this use since existing evidence to support such use is weak and long-term chelation therapy may be associated with potentially serious adverse effects.