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Pulse Newsletter

Your source for the latest industry trends and drug information news.

Volume 4 | Issue 21
November 1, 2022

Chief Authors: Rebecca Waite, PharmD, Bonnie Broczkowski, PharmD & Colleen Peehler, PharmD
Contributing Authors: Yi (Eve) Zheng, PharmD/MBA Candidate, Gabrielle Graca, PharmD/MBA Candidate

Clinical Pharmacy Update

FDA Approves Sotyktu™ for Plaque Psoriasis

Psoriasis is a chronic, inflammatory disease caused by an overactive immune system, affecting around 7.5 million people in the United States. Ninety percent of affected patients have plaque psoriasis, characterized by round plaques covered by silvery white scales on the skin, and 25% of patients with the disease are classified as having moderate-to-severe cases. On September 9, 2022, the U.S. Food & Drug Administration (FDA) approved Bristol Myers Squibb’s Sotyktu™ (deucravacitinib), an oral treatment for adults with moderate-to-severe plaque psoriasis, based on positive results from two clinical trials. In these trials, once-daily Sotyktu™ provided greater plaque psoriasis improvement than both twice-daily Otezla® (apremilast) and placebo. Sotyktu™ blocks the enzyme tyrosine kinase 2 (TYK 2) which is involved in inflammation. Side effects seen in the clinical trials included upper respiratory tract infection, herpes simplex infection, mouth ulcers, infected skin follicles and acne. Participants receiving Sotyktu™ were less likely to discontinue therapy due to side effects compared to those receiving Otezla® or placebo. Sotyktu™ can increase the risk of infections, so it may not be appropriate for individuals who have conditions or are receiving treatments that predispose them to infection or for those with active infection such as tuberculosis or hepatitis B or C.  

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Drug Safety

Recall of Sodium Bicarbonate Injection due to Vial Breakage

On October 12, 2022, Exela Pharma Sciences, LLC (Exela) issued a voluntary recall on 49 lots of Sodium Bicarbonate Injection, USP, 8.4%, 50 mEq/50mL vials, packaged in 20-count cartons. The recall is in response to the potential safety risk of the product breaking and glass flying when withdrawing the contents into a syringe due to a change in pressure within the vial. Sodium bicarbonate injection is used for various reasons in a clinical setting. The vials affected by the recall are labeled with Exela brand (Carton NDC: 51754-5001-05; Vial NDC: 51754-5001-01) and Civica brand (Carton NDC: 72572-0740-20; Vial NDC: 72572-0740-01).. As of now, there have been five reports of flying glass-related injuries. Adverse events from the affected lots should be reported to the FDA’s MedWatch Adverse Event Reporting Program.

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From the Pharmaceutical Industry

Boostrix Approved During Third Trimester of Pregnancy to Prevent Whooping Cough in Infants

On October 7, 2022 the FDA released a statement in regards to the recent approval of Boostrix (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed [Tdap]) for immunization during the third trimester of pregnancy to prevent pertussis infections in infants younger than two months. Pertussis is a respiratory disease that is also known as whooping cough because of the “whooping” sound people make when gasping for air after coughing fits. Although any age group can be infected by pertussis, infants are more likely to have severe complications that could result in hospitalizations or death. Infants rely on their mothers' antibodies that are passed down during pregnancy to provide immunity against infection for about six months after birth. The Boostrix immunization works by boosting the antibodies in the mother which are then transferred to the developing baby. Boostrix was initially approved by the FDA in 2005 and has been used in pregnancy since 2012, when the CDC recommended the use of the vaccine during the third trimester of each pregnancy. While Boostrix has always been approved for use during pregnancy, this latest approval focuses on the vaccine’s preventive effects against pertussis in infants younger than two months. Studies have not identified any serious vaccine-related side effects in pregnant mothers or their fetuses/newborns. The most commonly reported side effects following Boostrix vaccination are soreness and injection site reactions. 

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FDA Approvals

New FDA Approvals

Novel Drug Approval: Furoscix® (furosemide)

Injectable solution that is pre-loaded into a single-use infusion device which has been approved for the treatment of congestion resulting from fluid overload in adult patients with Class II/III chronic heart failure. [10/07/22 – SCPHARMACEUTICALS, INC.]

New Indication: Iheezo™ (chloroprocaine hydrochloride 3%)  

Ophthalmic gel approved to be used as a numbing agent for the surface of the eye for patients undergoing an eye procedure. [09/27/22 – SINTETICA SA]

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New Generics

New Generics Entering the Marketplace

Divigel® (estradiol) gel
Indication: Moderate-to-severe vasomotor symptoms, such as hot flashes and night sweats, due to menopause
Dosage Form/Strength: 0.25 mg/gm, 0.5 mg/gm, 0.75mg/gm, 1.0 mg/gm, 1.25 mg/gm topical gel
Average Wholesale Price (AWP): Generic = $190 | Brand = $202