New drug
LETIBOTULINUMTOXINA-wLBG
(Letybo—Hugel Inc.)
Drug class: Letybo is a cetylcholine release inhibitor.
Indication: Letybo is indicated for the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients.
Recommended dosage: The recommended dose is 0.1 mL (4 units) by I.M. injection into each of five sites, for a total dose of 20 units. The dosage form and strength are 50 units or 100 units of freeze-dried powder in a single-dose vial.
Contraindications: Contraindications include known hypersensitivity to any botulinum toxin preparation or to any of the components in the Letybo formulation and infection at the injection site.
Common adverse effects: The most common adverse reaction is headache.
Warnings and precautions: Seek immediate medical attention if respiratory, speech, or swallowing difficulties occur. Potency units of Letybo are not interchangeable with other preparations of botulinum toxin products. If a hypersensitivity reaction occurs, discontinue Letybo and immediately initiate appropriate therapy.
Adverse events have been reported involving the CV system, some with fatal outcomes. Use caution when administering to patients with pre-existing CVD. Concomitant neuromuscular disorder may exacerbate clinical effects of treatment. Use with caution in patients with compromised respiratory function or dysphagia. Coadminister aminoglycoside antibiotics, anticholinergic agents, or any other agents that interfere with neuromuscular transmission with caution, as these may augment the effect of Letybo.
CEFEPIME; ENMETAZOBACTAM
(Exblifep—Allecra Therapeutics)
Drug class: Exblifep is a cephalosporin antibacterial and b-lactamase inhibitor.
Indication: Exblifep is indicated for the treatment of patients 18 years and older with complicated UTIs, including pyelonephritis caused by designated susceptible microorganisms. Exblifep should only be used to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria to reduce the development of drug-resistant bacteria.
Recommended dosage: Exblifep is supplied as a sterile powder for reconstitution in single-dose vials containing 2 grams cefepime and 0.5 grams enmetazobactam. Administer Exblifep 2.5 grams (2 grams cefepime and 0.5 grams enmetazobactam) every 8 hours by I.V. infusion over 2 hours for 7 days to 14 days, in patients 18 years and older with an eGFR between 60 to 129 mL/min. Dosage adjustment is recommended in patients with renal impairment who have an eGFR <60 mL/min or >130 mL/min. See label for a table of recommended dosages based on renal function.
Contraindications: Exblifep is contraindicated in patients with a history of serious hypersensitivity reactions to the components of Exblifep (cefepime and enmetazobactam), or other b-lactam antibacterial drugs.
Common adverse effects: The most frequently reported adverse reactions occurring in ≥5% of patients treated with Exblifep were increased transaminases, increased bilirubin, headache, and phlebitis/infusion site reactions.
Warnings and precautions: Hypersensitivity reactions have been reported in patients treated with Exblifep. Serious and occasionally fatal hypersensitivity reactions, including anaphylaxis, have been reported with b-lactam antibacterial drugs. If an allergic reaction to Exblifep occurs, discontinue the drug and institute appropriate therapy. Neurotoxicity has been reported during treatment with cefepime. Most cases occurred in patients with renal impairment who did not receive appropriate dosage adjustment of cefepime. If neurotoxicity occurs, discontinue Exblifep and institute appropriate supportive measures. Clostridioides difficile–associated diarrhea has been reported with nearly all systemic antibacterial agents, including Exblifep. Evaluate if diarrhea occurs.
New indication
AMIVANTAMAB-VMJW
(Rybrevant —Janssen Biotech)
Drug class: Rybrevant is a bispecific epidermal growth factor receptor (EGF)–directed and MET receptor–directed antibody.
Indication: Rybrevant is indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer with EGF receptor exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.
Recommended dosage: The recommended dosage of Rybrevant is based on baseline body weight and administered as an I.V. infusion after dilution. Administer 350 mg/7 mL (50 mg/mL) in a single-dose vial intravenously per infusion rates listed in the label.
Administer premedications as recommended. Administer Rybrevant via a peripheral line weekly for 4 weeks, with the initial dose as a split infusion in Week 1 on Day 1 and Day 2, then administer every 2 weeks thereafter.
Contraindications: None.
Common adverse effects: The most common adverse reactions (≥20%) were rash, infusion-related reactions, paronychia, musculoskeletal pain, dyspnea, nausea, fatigue, edema, stomatitis, cough, constipation, and vomiting. The most common Grade 3 or 4 laboratory abnormalities (≥2%) were decreased lymphocytes, decreased albumin, decreased phosphate, decreased potassium, increased alkaline phosphatase, increased glucose, increased gamma-glutamyl transferase, and decreased sodium.
Warnings and precautions: Interrupt infusion at the first sign of infusion-related reactions. Reduce infusion rate or permanently discontinue Rybrevant based on severity. Monitor for new or worsening symptoms indicative of interstitial lung disease and immediately withhold Rybrevant in patients with suspected interstitial lung disease/pneumonitis and permanently discontinue if interstitial lung disease/pneumonitis is confirmed. Rybrevant may cause rash, including acneiform dermatitis and toxic epidermal necrolysis. Withhold, reduce dose, or permanently discontinue Rybrevant based on severity. Promptly refer patients with worsening eye symptoms to an ophthalmologist. Withhold, reduce dose, or permanently discontinue Rybrevant based on severity. Rybrevant can cause fetal harm. Advise patients of the potential risk to the fetus and to use effective contraception.
New formulation
CLOBETASOL PROPRIONATE
(Clobetasol propionate—Formosa Pharmaceuticals)
Drug class: Clobetasol is a corticosteroid.
Indication: Clobetasol propionate is indicated for the treatment of postoperative inflammation and pain following ocular surgery.
Recommended dosage: Instill one drop of clobetasol propionate ophthalmic suspension 0.05% into the affected eye twice daily beginning the day after surgery and continuing throughout the first 2 weeks of the postoperative period. Wash hands well before each use.
Contraindications: Most active viral diseases of the cornea and conjunctiva, including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also mycobacterial infection of the eye and fungal diseases of ocular structures are included in contraindications.
Common adverse effects: Ocular adverse reactions occurring in ≥1% of subjects in clinical studies who received clobetasol propionate ophthalmic suspension 0.05% included eye inflammation (2%), corneal edema (2%), anterior chamber inflammation (2%), cystoid macular edema (2%), intraocular pressure elevation (1%), photophobia (1%), and vitreous detachment (1%). Many of these reactions may have been the consequence of the surgical procedure.
Warnings and precautions: Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve and defects in visual acuity and fields of vision. Steroids should be used with caution in the presence of glaucoma. If this product is used for 10 days or longer, intraocular pressure should be monitored. Prolonged use of corticosteroids may result in posterior subcapsular cataract formation. The use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation. In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical steroids. The initial prescription and renewal of the medication order should be made by a physician only after examination of the patient with the aid of magnification, such as slit lamp biomicroscopy, and when appropriate, fluorescein staining. Prolonged use of corticosteroids may suppress the host response and thus increase the hazard of secondary ocular infections. In acute purulent conditions, steroids may mask infection or enhance existing infection. If signs and symptoms fail to improve after 2 days, the patient should be re-evaluated. Employment of a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution. Use of ocular steroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex). Fungal infections of the cornea are particularly prone to develop coincidentally with long-term local steroid application. Fungus invasion must be considered in any persistent corneal ulceration where a steroid has been used or is in use. Fungal cultures should be taken when appropriate. ■
FDA approves first OTC glucose monitor
On March 5, 2024, FDA cleared the first OTC continuous glucose monitor (CGM) for marketing, allowing adults to purchase the CGM without a prescription. The Dexcom Stelo Glucose Biosensor System is an integrated CGM (iCGM) intended for patients 18 years and older who do not use insulin, such as individuals with diabetes treating their condition with oral medications, or those without diabetes who want to better understand how diet and exercise may impact blood glucose levels. Importantly, this system is not for individuals with problematic hypoglycemia, as the system is not designed to alert the user to this potentially dangerous condition.
The Stelo Glucose Biosensor System pairs a wearable sensor with an application installed on a user’s smartphone or other smart device to continuously measure, record, analyze, and display glucose values. Users can wear each sensor for up to 15 days before replacing with a new sensor. The device presents blood glucose measurements and trends every 15 minutes in the accompanying app. Users should not make medical decisions based on the device’s output without first consulting their health care provider.
Adverse events included local infection, skin irritation, and pain or discomfort. ■