Dapagliflozin Propanediol and Pretomanid

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

Used as monotherapy as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus.

Used in combination with other antidiabetic agents (e.g., metformin and/or a sulfonylurea, a peroxisome proliferator-activated receptorγ [PPARγ] agonist [thiazolidinedione], a dipeptidyl peptidase-4 [DPP-4] inhibitor) and/or insulin or a glucagon-like peptide 1 (GLP-1) receptor agonist (e.g., exenatide) as an adjunct to diet and exercise in patients with type 2 diabetes mellitus who have not achieved adequate glycemic control.

Used in fixed combination with extended-release metformin hydrochloride as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus when treatment with both drugs is appropriate.

Used in fixed combination with saxagliptin as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus.

Current guidelines for the treatment of type 2 diabetes mellitus generally recommend metformin as first-line therapy in addition to lifestyle modifications due to its well-established safety and efficacy (e.g., beneficial effects on glycosylated hemoglobin [hemoglobin A1c; HbA1c], weight, and cardiovascular mortality). Consider patient's comorbidities when selecting additional antidiabetic agents.

Patients with type 2 diabetes mellitus who have established atherosclerotic cardiovascular disease (ASCVD) should receive a drug with demonstrated cardiovascular disease benefit (e.g., GLP-1 receptor agonist [e.g., liraglutide], SGLT2 inhibitor [e.g., empagliflozin]). In patients with ASCVD and heart failure or at an increased risk of heart failure, an SGLT2 inhibitor with demonstrated cardiovascular benefit may be preferred.

Evidence of macrovascular risk reduction with dapagliflozin, the fixed combination of dapagliflozin and extended-release metformin hydrochloride, or the fixed combination of dapagliflozin and saxagliptin has not been conclusively demonstrated in clinical trials.

In patients with type 2 diabetes mellitus and CKD, an SGLT2 inhibitor or GLP-1 receptor agonist with demonstrated ability to reduce the risk of CKD progression, cardiovascular events, or both should be considered.

In patients without ASCVD, heart failure, or CKD, the decision regarding the addition of other antidiabetic agents (e.g., sulfonylurea, thiazolidinedione, DPP-4 inhibitor, SGLT2 inhibitor, GLP-1 receptor agonist, basal insulin) should be based on drug-specific effects and individual patient factors.

Some data indicate that in addition to its beneficial glycemic effects, dapagliflozin therapy is associated with a reduction of heart failure-related hospitalizations and reduction in CKD progression.

Not indicated for type 1 diabetes mellitus or treatment of diabetic ketoacidosis.

• 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.