Etelcalcetide Hydrochloride and Pretomanid

• Generic Name: etelcalcetide
• Dosage Forms: n.a.
• Other Brand Names: Parsabiv

Treatment of secondary hyperparathyroidism associated with chronic renal disease in patients undergoing hemodialysis.

Additional studies needed to determine effects on clinical outcomes, including cardiovascular morbidity and mortality.

Safety and efficacy not established in patients with chronic renal disease who are not undergoing hemodialysis; use not recommended in these patients.

Safety and efficacy not established in patients with parathyroid carcinoma or primary hyperparathyroidism; use not recommended in these patients.

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

Limited Population: Pretomanid is an antimycobacterial indicated as part of a combination regimen with bedaquiline and linezolid for the treatment of adults with pulmonary extensively drug resistant (XDR), treatment-intolerant or nonresponsive multidrug-resistant (MDR) tuberculosis (TB). Approval of this indication is based on limited clinical safety and efficacy data. This drug is indicated for use in a limited and specific population of patients.

Pretomanid is not indicated for patients with: drug-sensitive (DS) tuberculosis, latent infection due to Mycobacterium tuberculosis, extrapulmonary infection due to M. tuberculosis, or MDR-TB that is not treatment-intolerant or nonresponsive to standard therapy.

Safety and effectiveness of pretomanid have not been established for its use in combination with drugs other than bedaquiline and linezolid as part of the recommended dosing regimen.