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Pharmacy Bulletin

Pharmacy Bulletin

We share important prescription drug information to help you stay informed about updates concerning particular prescription medicines.

VativoRx Bottle update

Arexvy’s Use Expanded to Prevent RSV in Certain Adults 50 to 59 Years of Age

On July 7, 2024, the indication for GSK’s Arexvy (respiratory syncytial virus vaccine) was expanded to include use in adults 50 to 59 years of age who are at increased risk for lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) infection. This includes patients with underlying medical conditions, such as chronic obstructive pulmonary disease (COPD), chronic cardiovascular disease, diabetes, and chronic kidney or liver disease. It was originally approved in May 2023 to prevent LRTD in patients at least 60 years of age. Arexvy is administered as a single dose (0.5 mL) intramuscular injection. The Centers for Disease Control and Prevention (CDC) reports that as many as 160,000 U.S. patients aged 65 years or older are hospitalized for RSV each year, and up to 10,000 die. Two other RSV vaccines are approved for use on the U.S. market, including Pfizer’s Abrysvo® and Moderna’s mRESVIA®. Both are indicated for use in patients 60 years of age and older. Abrysvo is also approved for vaccinating women who are in late pregnancy to help protect newborns from LRTD caused by RSV during the first six months of life. Look here for prescribing information.

Generic to Emflaza Oral Solution Available

Cranbury Pharmaceuticals, a subsidiary of Tris Pharma, received FDA approval for its generic version of Emflaza® oral suspension (deflazacort – PTC therapeutics) on June 12, 2024. Deflazacort is an oral corticosteroid that decreases immune and inflammatory activity to treat Duchenne muscular dystrophy (DMD). It is dosed by weight at 0.9mg/kg/day as either tablets (which can be crushed and mixed with applesauce for administration) or oral suspension. DMD is a rare genetic condition that affects around 10,000 patients, almost exclusively boys and young men, in the United States. It is caused by mutations in the gene for dystrophin, a muscle protein, and leads to progressive muscle weakening, usually resulting in paralysis during the teen years and premature death in early adulthood. Cranbury Pharmaceuticals has announced that the deflazacort oral suspension is now available. Generic versions of the tablet formulation of Emflaza have been available since February 2024.

Klisyri Approval Expanded

Initially approved in December 2020, Klisyri® (tirbanibulin) 1% ointment is a microtubule inhibitor used as a topical treatment of actinic keratosis (AK) of the face or scalp. Originally, an area of up to 25 cm2 was allowed per daily treatment for five consecutive days. On June 7, 2024, the FDA approved applications for a larger surface area, now allowing up to 100 cm2 per application. A larger 350mg single-dose package size is also now available, which should be enough to cover the larger approved surface area. Both 250mg and 350mg sizes are available in packages that contain five single-dose packets, enough to finish the treatment course. AK is a common skin disease caused by long-term exposure to the sun and/or indoor tanning and is characterized as a dry, scaly patch or skin lesion. If left untreated, it may progress to skin cancer. With a prevalence of up to 25% of people over 30, AK is the second most common diagnosis by dermatologists in the United States. Look here for current prescribing information.

Additional Indication for Kevzara

Regeneron Pharmaceuticals and Sanofi were granted a third indication from the FDA for their interleukin-6 (IL-6) receptor blocker, Kevzara® (sarilumab) injection. On June 11, 2024, it was approved to treat active polyarticular juvenile idiopathic arthritis (pJIA) for patients who weigh 63kg or more. A chronic autoimmune disease that affects five or more joints at a time, pJIA causes symptoms of pain, swelling, discoloration, and stiffness. Other symptoms include fatigue, decreased appetite, uveitis, delayed growth, and intermittent fevers. Typically, pJIA occurs in patients who are under the age of 16 years old and can be managed with other drug therapies such as nonsteroidal anti-inflammatory drugs (NSAIDs), methotrexate, adalimumab, and Xeljanz® (tofacitinib). The recommended dose for patients with pJIA is 200mg given subcutaneously once every two weeks for patients weighing 63kg or greater using the 200mg/1.14mL prefilled syringe. Kevzara was originally approved in 2017 to treat adults who have rheumatoid arthritis (RA) that is resistant or refractory to disease-modifying antirheumatic drugs (DMARDs). It also has an indication for treating adult patients with polymyalgia rheumatica (PMR). A boxed warning alerts patients and prescribers that serious infections, including tuberculosis (TB), may be associated with using it. Here is the updated prescribing information. 

Full Approval for Retevmo

On June 12, 2024, the FDA granted full approval to Eli Lilly and Company’s Retevmo (selpercatinib) for the treatment of adult and pediatric patients at least two years of age with advanced or metastatic rearranged during transfection (RET) fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine (RAI) refractory, if RAI is appropriate. Originally, Retevmo was granted Accelerated Approval in May 2020 for the same indication in patients 12 years of age and older. Approval was based on study results that showed overall response rates (ORR) of 85% in previously treated adults and 96% in adults who had no prior therapy. In the pediatric study, ten patients were treated with Retevmo, which resulted in an ORR of 60%. The recommended dose for adults 12 years of age and older is based on body weight and for pediatric patients at least 2 years of age and less than 12 years of age it is based on body surface area. The most common adverse events (AEs) were swelling, diarrhea, fatigue, dry mouth, abdominal pain, constipation, rash, nausea, and headache. Grade 3 or higher blood abnormalities included decreased lymphocytes, increased liver enzymes, decreased sodium, and decreased calcium. Retevmo has full FDA approval for adults who have locally advanced or metastatic RET-positive non-small lung cancer (NSCLC), as detected by an FDA-approved test. For full prescribing information, see here.

Augtyro Granted Accelerated Approval

Bristol Myers Squibb was granted Accelerated Approval for its tyrosine kinase inhibitor (TKI), Augtyro (repotrectinib) capsules. The indication is for adult and pediatric patients aged 12 years and older with solid tumors harboring a neurotrophic receptor tyrosine kinase (NTRK) gene fusion that is locally advanced or metastatic or where surgical resection is likely to result in severe morbidity and that has progressed after treatment or have no satisfactory alternative therapy. Although rare, NTRK fusions are found in many malignancies, including some cancers of the appendix, breast, colon, lungs, pancreas, or thyroid. Study endpoints that led to Accelerated Approval were based on a confirmed overall response rate (cORR) of 58% with a duration of response (DOR) of about 18 months who were TKI naïve. For those who were previously treated, the cORR was 50% with a median DOR of under just less than ten months. The recommended dose is 160mg orally once daily for 14 days, then increased to 160mg twice daily. The most common adverse events (AEs) were dizziness, dysgeusia, peripheral neuropathy, constipation, dyspnea, fatigue, ataxia, cognitive impairment, muscular weakness, and nausea. It will compete with Rozlytrek® (entrecitinib – Genentech) and Vitrakvi® (larotrectinib – Bayer) since they have similar indications for treating cancers that have NTRK gene fusions. The approval came under the FDA’s Assessment Aid with Priority Review, Fast Track Designation, Breakthrough Therapy, and Orphan Drug Designation. The FDA granted Augtyro Accelerated Approval, which means that further results confirming its effectiveness and safety will be required before the FDA gives it full approval. See here for full prescribing information.

New Dosage Form for Adbry

Adbry® (tralokinumab-ldrm – LEO Pharma) singe-dose autoinjectors were FDA-approved on June 12, 2024. A monoclonal antibody that inhibits the action of interleukin-13 (IL-13), Adbry is indicated for treating patients as young as 12 years old with moderate-to-severe atopic dermatitis (AD) that has not been relieved by topical therapies. All doses are given by subcutaneous (SC) injections. The Adbry 300mg single-use autoinjectors will be available for adult use in the coming months. Pediatric patients should be treated or supervised by an adult caregiver. The prefilled syringes will continue to be available. Using Adbry may increase the risk of eye and upper respiratory infections. All patients should be current on all the recommended vaccinations for their age groups before beginning treatment. Updated prescribing information for Adbry is here.

Pediatric Indication for Farxiga

The FDA broadened an indication for Farxiga® (dapagliflozin – AstraZeneca) on June 12, 2024. The sodium-glucose cotransporter 2 (SGLT2) inhibitor is now approved for use in children as young as ten years as an add-on treatment with diet changes and exercise to improve glycemic control in patients with type 2 diabetes (T2D) mellitus. In a clinical study, patients aged 10 to 17 years of age with uncontrolled T2D treated with Farxiga showed an average reduction in hemoglobin A1c (HbA1c), a marker of long-term glucose control, of -0.62% after 26 weeks compared to a +0.41% increase in those taking a placebo, resulting in a difference of -1.03%. This change demonstrated that Farxiga can significantly improve blood glucose control in children and adolescents with T2D. The recommended dose for treating T2D is 5mg orally once daily. Jardiance® (empagliflozin – Boehringer Ingelheim and Eli Lilly), another SGLT2 inhibitor, is also indicated for use in the same age group. According to the company, around 30,000 T2D patients under 20 years of age are living in the United States, and approximately 5,300 new cases are diagnosed each year. In addition to T2D, Farxiga is also indicated for treating chronic kidney disease and heart failure. Its updated prescribing information can be found here.