Department: Medication Update
New drug for nausea and vomiting of pregnancy
Doxylamine succinate and pyridoxine hydrochloride (Bonjesta) extended-release tablets are now available for the treatment of nausea and vomiting in pregnant women who do not respond to conservative treatments, such as change in diet or other nonmedical treatments. The medication was approved in November 2016, and the drug launched in the United States in April 2018.
Doxylamine succinate and pyridoxine HCl has not been studied in women with hyperemesis gravidarum, and the safety of the drug has not been established in these women. The drug is contraindicated in women with known hypersensitivity to any of the drug components and those taking monoamine oxidase inhibitors. The most common adverse reaction is somnolence. Doxylamine succinate and pyridoxine HCl is available as 20 mg/20 mg strength tablets and should be taken on an empty stomach with a glass of water. It is a product of Duchesnay USA.
FDA approves new drug for plaque psoriasis
The FDA approved tildrakizumab-asmn (Ilumya) for adults with moderate-to-severe plaque psoriasis who are eligible for systemic therapy or phototherapy. The drug is a selective interleukin (IL)-23p19 inhibitor that is administered via subcutaneous injection by a healthcare provider. Patients must be evaluated for tuberculosis infection before starting the drug.
The efficacy of tildrakizumab-asmn was shown in the phase III REsurface 1 and 2 clinical development program involving 926 adults. Both studies met primary efficacy end points, demonstrating significant clinical improvement with the drug as compared with placebo when measured by at least a 75% reduction in the Psoriasis Area and Severity Index score and Physician Global Assessment score of clear or minimal at week 12 after 2 doses.
The most common adverse reactions include upper respiratory infections, injection site reactions, and diarrhea, and the drug may increase the risk of infections. The risks and benefits of treatment should be considered in patients with chronic infection or a history of recurrent infection.
Tildrakizumab-asmn is a product of Sun Pharmaceuticals.
Highest capacity long-acting insulin pen approved
Sanofi's insulin glargine 300 units/mL (Toujeo Max SoloStar) was approved by the FDA for adults with diabetes mellitus. It will be the highest-capacity long-acting insulin pen on the market. The new pen holds 900 units of insulin glargine and provides up to 160 units of insulin glargine in a single subcutaneous injection.
Its higher capacity may mean a reduced number of pens prescribed, allowing for fewer refills and related copays. Additionally, it may also help reduce the number of injections needed to deliver the required dosage for some adults with diabetes.
The insulin glargine pen will be available in retail pharmacies in the United States in the third quarter of 2018. Sanofi is offering a savings program for the pen.
For more information, visit www.toujeo.com.
FDA approves new nebulizer
The FDA approved the Flyp handheld nebulizer for use at home or in healthcare facilities for patients age 13 years and older with asthma, chronic obstructive pulmonary disease, and other lung-related diseases to prevent and manage flare-ups.
According to manufacturer Convexity Scientific, Flyp is smaller and lighter than a smartphone and is virtually silent. There are no tubes or control units; users simply fill, click, and breathe. Flyp uses HypersoniQ technology, with an internal disk that vibrates at ultrasonic speed. When the medication passes through the holes of the disk, it produces an inhalable aerosol mist, delivering the medication into the lungs. Because the disk vibrates 110,000 times per second, the time it takes to dispense the medication is significantly shortened to about 7 minutes for most medications.
Flyp is powered by a USB rechargeable lithium-ion battery that lasts 10 treatments between recharging.
Flyp is available at www.flypnebulizer.com.