The June update to the AHFS Drug Information/Essentials database has been published. Highlights from this month’s update include:
New AHFS/Essentials Monographs
- New Full-Length Monographs
- Elotuzumab (Empliciti®) – 10:00 (Antineoplastic Agents)
- Indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received one to three prior therapies.
- Metreleptin (Myalept®) – 68:40 (Leptins)
- Treatment of leptin deficiency in congenital or acquired generalized lipodystrophy.
- Tenofovir Alafenamide Fumarate (Vemlidy®) – 8:18.32 (Nucleosides and Nucleotides)
- Indicated for the treatment of chronic hepatitis B virus (HBV) infection in adults with compensated liver disease.
- Elotuzumab (Empliciti®) – 10:00 (Antineoplastic Agents)
- New First-Release Monographs
- Niraparib Tosylate (Zejula®) – 10:00 (Antineoplastic Agents)
- Maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.
- Valbenazine Tosylate (Ingrezza®) – 28:92 (Central Nervous System Agents, Miscellaneous)
- Treatment of tardive dyskinesia in adults.
- Durvalumab (Imfinzi®) – 10:00 (Antineoplastic Agents)
- Treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
- Brigatinib (Alunbrig®) – 10:00 (Antineoplastic Agents)
- Treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib.
- Midostaurin (Rydapt®) – 10:00 (Antineoplastic Agents)
- Acute Myeloid Leukemia
- In combination with standard cytarabine and daunorubicin induction and cytarabine consolidation chemotherapy, for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) who are FLT3 mutation-positive, as detected by a FDA approved test (not indicated as a single-agent induction therapy).
- Systemic Mastocytosis
- Indicated for the treatment of adult patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated hematological neoplasm (SM-AHN), or mast cell leukemia (MCL).
- Acute Myeloid Leukemia
- Cerliponase Alfa (Brineura®) – 44:00 (Enzymes)
- To slow the loss of ambulation in symptomatic pediatric patients 3 years of age and older with late infantile neuronal ceroid lipofuscinosis type 2 (CLN2), also known as tripeptidyl peptidase 1 (TPP1) deficiency.
- Abaloparatide (Tymlos®) – 68:24 (Parathyroid)
- Human parathyroid hormone related peptide [PTHrP(1-34)] analog indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture.
- Safinamide Mesylate (Xadago®) – 28:36.32 (Monoamine Oxidase B Inhibitors)
- Adjunctive treatment to levodopa/carbidopa in patients with Parkinson’s disease experiencing “off” episodes.
- Edaravone (Radicava®) – 28:92 (Central Nervous System Agents, Miscellaneous)
- Treatment of amyotrophic lateral sclerosis (ALS).
- Niraparib Tosylate (Zejula®) – 10:00 (Antineoplastic Agents)
FDA MedWatch Alerts
- The FDA has approved previously announced label changes regarding the use of general anesthetic and sedation medicines in children younger than 3 years.
- Affected Monographs:
- 302025,”Propofol”,”28:04.92″
- 302038,”Etomidate”,”28:04.92″
- 382053,”LORazepam”,”28:24.08″
- 382416,”PENTobarbital”,”28:24.04″
- 387008,”Midazolam”,”28:24.08″
- Affected Monographs:
- The FDA has concluded that the type 2 diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR) causes an increased risk of leg and foot amputations.
- Affected Monographs:
- 313046,”Canagliflozin”,”68:20.18″
- Affected Monographs:
