Nalmefene HCl injection available for reversal of opioid drug effects
Nalmefene HCl injection is now available for the complete or partial reversal of opioid drug effects, including respiratory depression, induced by natural or synthetic opioids, and in the management of known or suspected opioid overdose. The medication was approved by the FDA in February 2022 and was developed as an alternative to naloxone to reverse the effects of opioids, including respiratory depression, sedation, and hypotension. Studies have shown that nalmefene has a longer duration of action than naloxone.
Nalmefene can be administered via I.V., I.M., or subcutaneous routes. It is supplied as a single-dose vial containing 2 mg/2 mL (1 mg/mL) of nalmefene base in a carton of 10 vials.
Nalmefene HCl injection is a product of Purdue Pharma L.P., which is distributing the product for no profit.
FDA approves Skyrizi for Crohn disease
The FDA approved Skyrizi (risankizumab-rzaa) for the treatment of moderately to severely active Crohn disease in adults. The approval was based on data from phase 3 studies that showed a greater proportion of patients treated with the Skyrizi 600 mg induction regimen met the efficacy end points versus placebo at week 12: clinical remission, endoscopic response, clinical response, and endoscopic remission. The onset of clinical response and clinical remission occurred as early as week 4 in a greater proportion of patients in the Skyrizi arm of the studies.
The most commonly reported adverse reactions with Skyrizi during maintenance treatment were arthralgia, injection site reactions, abdominal pain, anemia, pyrexia, back pain, arthropathy, and urinary tract infections.
Skyrizi was previously approved for the treatment of plaque psoriasis and psoriatic arthritis and is a product of AbbVie Inc.
Pneumococcal 15-valent Conjugate Vaccine approved for pediatric use
Merck's Vaxneuvance (Pneumococcal 15-valent Conjugate Vaccine) was granted an expanded approval to include the prevention of invasive pneumococcal disease in pediatric patients 6 weeks through 17 years of age. The serotypes covered include serotypes 22F and 33F, which are associated with invasive pneumococcal disease. Vaxneuvance is administered to children as a 4-dose series at 2, 4, 6, and 12 to 15 months of age (and at least 2 months after the third dose).
Vaxneuvance is now indicated for active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F in individuals 6 weeks of age and older.
Vaxneuvance is supplied in 0.5 mL single-dose prefilled syringes for I.M. injection.
Zulresso now indicated for younger patients with postpartum depression
Zulresso (brexanolone) is now approved for use in patients 15 years of age and older with postpartum depression. Zulresso was previously approved only for adults 18 years of age and older and is a Schedule IV controlled substance.
The most common adverse reactions associated with treatment include sedation/somnolence, dry mouth, loss of consciousness, and flushing/hot flush.
Zulresso is administered via continuous I.V. infusion over a total of 60 hours following a titration schedule. It must be administered by a healthcare provider in a certified healthcare facility under close monitoring and should not be given to patients with end-stage renal disease. Zulresso's prescribing information carries a boxed warning associated with the risk of excessive sedation or sudden loss of consciousness during administration. Zulresso is a product of Sage Therapeutics and is only available through the restricted Zulresso REMS Program.