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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

Elevidys Indication Expanded

The U.S. Food and Drug Administration (FDA) gave Sarepta Therapeutics formal approval for Elevidys® (delandistrogene moxeparvovec-rokl) suspension on June 20, 2024, for use in ambulatory patients at least four years of age with Duchenne muscular dystrophy (DMD). Elevidys was also granted accelerated approval to treat non-ambulatory patients who are at least four years old. Continued approval for this use may be contingent upon verification of clinical benefit in confirmatory trials. All eligible patients must have a confirmed mutation in the DMD gene. The viral-based micro-dystrophin gene therapy is given as one intravenous (IV) infusion containing 1.33 x 1014 vector genomes (vg)/kg for patients weighing 10kg (22 pounds) to 70kg (154 pounds). Those weighing 70kg or more receive a fixed dose of 9.31 × 1015 vg in total. All patients should be treated with a corticosteroid beginning one day before the infusion and lasting for at least 60 days after it. DMD is a rare genetic condition that affects around 10,000 patients, almost exclusively boys and young men, in the United States. In DMD, a mutation in the gene for dystrophin, a muscle protein, causes progressive muscle wasting — typically beginning with muscles in the shoulders and thighs, then spreading gradually to other muscles, including the heart. Eventually, DMD patients need to use wheelchairs and ventilators. Currently, few patients live beyond 30 years of age. Here is the complete prescribing information.

Yimmugo Approved for Primary Immunodeficiencies

On June 17, 2024, the FDA approved Grifols’ Yimmugo® (immune globulin (Ig) intravenous, human – dira), 10% (100mg/mL) liquid. It is indicated for the treatment of primary humoral immunodeficiency (PI) in patients two years of age or older. Patients who have a PI are at risk for repeated, serious infections. Given intravenously, the recommended dose is 300 to 800 mg/kg every three to four weeks. The most commonly reported adverse events (AEs) were headaches, upper respiratory tract infections, fatigue, nausea, and increased blood pressure. There is also a boxed warning for increased risk of blood clots, renal dysfunction, and renal failure. In a clinical study that led to its approval, individuals with PI who had previously been on intravenous Ig therapy (IVIG) for at least three months showed that individuals treated with Yimmugo resulted in less than one serious bacterial infection (SBI) per year with a total of only five SBIs among study participants. The launch is expected in the second half of 2024. For full prescribing information, see here.

Sofdra Approved for Excessive Underarm Sweating

On June 18, 2024, Botanix Pharmaceuticals received FDA approval for Sofdra (sofpironium) gel, 12.45%, a prescription medication to treat patients nine years of age and older who have primary axillary hyperhidrosis (excessive underarm sweating). This condition affects approximately 10 million people in the United States. Sofdra is an anticholinergic medication. One pump of the gel is rubbed into each armpit once daily at bedtime. Patients should be instructed not to shave their armpits for at least eight hours before, and not to shower for at least 30 minutes before applying the gel. Patients are advised to wash their hands immediately after the application and not to shower or wash their armpits for at least eight hours. Sofdra should not be used in patients with medical conditions that could be worsened by the anticholinergic effect of the medication (e.g., glaucoma, severe ulcerative colitis, myasthenia gravis). Common side effects may include dry mouth, blurry vision, dilated pupils, and application site pain. Botanix plans to launch Sofdra in the third quarter. Here is its prescribing information.

Capvaxive Approved for Pneumonia Prevention

Merck’s Capvaxive (pneumococcal 21-valent conjugate vaccine) injection was given the FDA’s Accelerated Approval on June 17, 2024. Given in one intramuscular (IM) injection one time for patients at least 18 years old, it is an immunization that protects against 21 subtypes of Streptococcus pneumoniae bacteria, which are major causes of pneumonia and several other infections. Each year, approximately 150,000 adults in the U.S. are hospitalized with pneumococcal disease. Merck has indicated that it will cost $287 for the one-time shot, which does not include administration fees. In the STRIDE-3 study, Capvaxive showed it was non-inferior to Prevnar® 20 (pneumococcal 20-valent conjugate vaccine – Pfizer) for the ten serotypes common to both vaccines and superior for ten of the 11 serotypes included. According to data from the Centers for Disease Control and Prevention (CDC), the vaccine is effective in preventing around 84% of serotypes responsible for pneumococcal infections in adults aged 50 years and above, and around 85% in adults aged 65 years and above. In comparison, Prevnar 20 is effective in preventing around 52% and 51% of these serotypes in the respective age groups. The injection will also cover eight serotypes that are not targeted by any other available vaccine. The FDA’s Advisory Committee on Immunization Practices (ACIP) will meet on June 27, 2024, to determine who will be eligible for Capvaxive. Depending on the recommendation, Merck said it would make the vaccine available in late July 2024. It was approved with a Priority Review voucher, and since it was given accelerated approval, continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. See here for prescribing information.

Keytruda Gets Another Approval

On June 17, 2024, Merck’s Keytruda® (pembrolizumab) injection was granted a new FDA indication for the treatment of adult patients with primary advanced or recurrent endometrial carcinoma in combination with carboplatin and paclitaxel, followed by treatment with Keytruda single agent therapy. Endometrial cancer affects about 67,000 U.S. women each year and about 13,000 will die. The recommended dose is a 200mg IV infusion once every three weeks or 400mg once every six weeks in combination with carboplatin and paclitaxel regardless of mismatch repair (MMR) or microsatellite instability (MSI) status. Approval was based on a phase III study, in which individuals treated with the approved combination vs. a placebo plus chemotherapy group had a decreased risk for progression or death by 40% in patients who were mismatch repair proficient (pMMR) and a decrease of 70% for those who were mismatch repair deficient (dMMR). Keytruda has two additional indications for endometrial cancer in addition to numerous other FDA approvals with and without other cancer drugs for treating various types of non-small cell lung cancer (NSCLC), some kidney cancers, some esophageal, stomach and head and neck cancers, as well as Merkel cell carcinoma, multiple myeloma, and non-Hodgkin lymphoma. It also has indications for pediatric and adult patients whose cancers have specific genetic characteristics (biomarkers) rather than developing from a particular body tissue. Approved under the FDA’s Project Orbis, this also marked the 40th indication for Keytruda. The updated prescribing information can be found here.

New Indication for Imfinzi

In combination with chemo that includes carboplatin and paclitaxel, AstraZeneca’s programmed death ligand 1 (PD-L1) inhibitor, Imfinzi® (durvalumab) was approved on June 14, 2024, to treat adults with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR). It is used once per 21-day cycle before the chemo drugs are given, for a total of six cycles. For patients weighing less than 30kg (66 pounds), doses are 15mg/kg. Heavier patients receive 1,500mg/dose. When the chemo cycles are finished, treatment with Imfinzi switches to once every four weeks and continues until its side effects are intolerable or the cancer returns. In a clinical study, this treatment regimen led to a 58% reduction in disease progression or death compared to chemotherapy alone. Imfinizi is also FDA-approved to treat some types of extensive-stage small cell lung cancers (ES-SCLC), non-small cell lung cancers (NSCLC), biliary tract cancer (BTC), and unresectable hepatocellular carcinoma (uHCC). Complete prescribing information is here.

Skyrizi Approved for Ulcerative Colitis

Skyrizi® (risankizumab-rzaa – AbbVie) injection was approved by the FDA on June 18, 2024, to treat adults who have moderately to severely active ulcerative colitis (UC). UC, which involves progressing chronic inflammation of the large intestines, is believed to affect more than 1 million Americans. Skyrizi is an interleukin-23 (IL-23) inhibitor that blocks inflammatory processes. It was originally approved in April 2019 to treat adults with moderate-to-severe psoriasis. It is also approved to treat adults with active psoriatic arthritis or moderately to severely active Crohn’s disease. For treating UC, the first three doses of Skyrizi are 1,200mg, each given as one-hour or longer intravenous (IV) infusions at four-week intervals. For the fourth dose, which is four weeks after the third IV dose, the route of administration switches to a subcutaneous (SC) injection and the strength lowers to 180mg or 360mg. Beginning with the fifth dose, scheduling extends to once every eight weeks. SC doses are delivered through prefilled cartridges that fit into a one-use auto-injector temporarily attached to the skin of the abdomen or thigh. Auto-injectors should be kept at least one foot away from cell phones and other electronic devices. Because using Skyrizi may increase the risk of having infections, patients should be tested for tuberculosis (TB) before beginning treatment. In addition, liver enzyme levels and bilirubin should be checked prior to starting treatment. Tremfya® (guselkumab – Janssen), another IL-23 inhibitor, is expected to receive an expanded approval for UC by Sept. 11, 2024. Here is the updated prescribing information for Skyrizi.

Vigafyde Solution Approved

On June 17, 2024, the FDA approved a new formulation of vigabatrin from Pyros Pharmaceuticals called Vigafyde. It is approved as monotherapy for the treatment of infantile spasms in pediatric patients aged one month to two years of age when the benefits outweigh the risk for potential vision loss. Vigafyde is the first ready-to-use oral solution, it is also available in the generic formulations of oral tablets and powder for oral solution. Available as 100mg/mL solution, the initial dose is 25mg/kg twice daily and titrated based on weight every three days to a maximum of 75mg/kg twice daily. Infantile spasms are a severe type of epilepsy that can cause slight repetitive movements in children less than one-year-old. If untreated, these repetitive seizures can lead to developmental issues, including autism spectrum disorder, additional forms of epilepsy, and continued seizures. There are approximately 2,000 to 2,500 new cases of infantile spasms diagnosed in the U.S. annually. Vigafyde is expected to be launched in the second half of 2024 with a cost that is yet to be determined. The label has a boxed warning indicating that Vigafyde can potentially cause permanent vision loss. As with all vigabatrin formulations, it will also be available through a limited program under a risk evaluation and mitigation strategy (REMS). Prescribers must enroll in the program and patients are required to receive a Medication Guide that describes the risks associated with the use of Vigafyde. Here is the prescribing information.

Blincyto Labeling Expanded for ALL Amgen announced that the FDA approved Blincyto® (blinatumomab), a bispecific T-cell engager (BiTE) therapy, to treat CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia (ALL) during the consolidation phase of multiphase chemotherapy. The consolidation phase aims to eliminate any remaining cancer cells after the initial treatment because even tiny levels of cancer cells significantly increase the risk of relapse. In a trial, the three-year overall survival (OS) for patients who received Blincyto during their consolidation phase was 84.8%, compared to 69% for patients who received chemotherapy alone. The labeling for Blincyto contains a boxed warning that using it may cause potentially life-threatening cytokine release syndrome (CRS) and neurologic toxicities. CRS is a systemic inflammatory response that may cause low blood pressure and difficulty breathing. Neurologic problems could include confusion, convulsions, and encephalopathy. Look here for updated prescribing information.