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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

Oxbryta Withdrawn from the Market

Pfizer announced on Sept. 25, 2024, that it is voluntarily withdrawing all lots of Oxbryta® (voxelotor) from the worldwide market. Oxbryta received accelerated approval in November 2019 to treat sickle cell disease (SCD) in adults and children 12 years and older. It received an expanded accelerated approval in December 2021 to treat children between the ages of four years and 12 years of age. Oxbryta is an oral sickle hemoglobin polymerization inhibitor that is taken once daily. Accelerated approval was based on studies that showed it increased hemoglobin; confirmatory clinical trials were ongoing. Pfizer decided to withdraw Oxbryta from the market because clinical data indicate that the risks of vaso-occlusive crises (painful complications of SCD) and death outweigh its potential benefits. Pfizer is also discontinuing all Oxbryta clinical trials and expanded access programs. Pfizer recommends that all patients taking Oxbryta contact their physicians to discuss alternative treatment options. Anyone with questions regarding this withdrawal is directed to Pfizer Medical Information at 800.438.1985.

Dupixent approved for COPD

Sanofi/Regeneron’s Dupixent® (dupilumab) gained a new indication on Sept. 27, 2024, for use as an add-on maintenance treatment of adults who have inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype. According to Regeneron, an estimated 300,000 people in the U.S. have the specific type of COPD that would make them eligible for treatment with Dupixent. In clinical trials, patients treated with Dupixent experienced lower rates of moderate to severe acute exacerbations by up to 34% compared to placebo, and improved lung function at 52 weeks. The recommended dose for treating COPD is 300mg, administered as a subcutaneous (SC) injection every other week. Dupixent also has indications for treating atopic dermatitis, eosinophilic esophagitis (EoE), certain types of asthma and chronic rhinosinusitis with nasal polyposis, and prurigo nodularis. Revised prescribing information is here.

Self-Administered Flu Vaccine Approved for Fall 2025 Season

The U.S. Food and Drug Administration (FDA) approved MedImmune and AstraZeneca’s FluMist® (influenza virus vaccine) for self-administration on Sept. 20, 2024.  As the only flu vaccine administered intranasally for individuals between two years and 49 years of age, this approval also makes it the only flu vaccine that may be administered at home by the individual or a caregiver. It was initially approved in 2003 for the prevention of influenza disease caused by influenza subtypes A and B. MedImmune plans to make FluMist available through a third-party online pharmacy for Fall 2025 that will write the prescription and ship the vaccine once the individual’s online questionnaire is reviewed and approved by a pharmacist. The prescribed individual can then self-administer the vaccine; a caregiver should administer the vaccine to children two years to 17 years of age. For more information on influenza and available vaccines, please see the 2024/2025 Influenza Season Issues Document. Updated prescribing information can be found here.

Sarclisa’s Indication Expanded

On Sept. 20, 2024, Sarclisa® (isatuximab-irfc – Sanofi) gained another indication for adults with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplant (ASCT). For this indication, it should be combined with bortezomib, lenalidomide, and dexamethasone. A CD38-directed cytolytic antibody, Sarclisa was initially approved in 2020 to be used along with Pomalyst® (pomalidomide) and dexamethasone for the treatment of adults who have multiple myeloma that already has been treated two or more times with Revlimid® (lenalidomide) and a proteasome inhibitor, such as bortezomib. The Phase III trial studied individuals with newly diagnosed multiple myeloma who are not eligible for ASCT and showed a 40% reduction in risk of disease progression or death in the Sarclisa with bortezomib, lenalidomide, and dexamethasone treated group compared to the bortezomib, lenalidomide, and dexamethasone only group. The recommended dose is 10mg/kg administered by intravenous (IV) infusion once weekly for five doses, then once every other week for 33 doses, followed by once every four weeks thereafter. Here is Sarclisa’s updated prescribing information.

Bimzelx Gets Three New Indications

UCB announced on Sept. 23, 2024, that the FDA approved Bimzelx® (bimekizumab-bkzx) for the treatment of adults with active psoriatic arthritis (PsA), adults with active non-radiographic axial spondylarthritis (nr-axSpA) with objective signs of inflammation and adults with active ankylosing spondylitis (AS). Bimzelx blocked the activity of interleukins (IL) 17A and 17F and was initially approved in 2023 for treating adults who have moderate to severe plaque psoriasis that will respond to systemic therapy or phototherapy. These three approvals mark the first IL 17A/17F inhibitor for these indications; it now treats four chronic immune-mediated inflammatory diseases. When compared to placebo, Bimzelx showed a statistically significant improvement in joint and skin symptoms in PsA at week 16 that was sustained until week 52. For nr-axSpA and AS, Bimzelx was also compared to placebo and showed a statistically significant clinical response at week 16, which was sustained until week 52. Results in PsA, nr-asXpA, and AS were consistent in both biologic naïve and those treated with a tumor necrosis factor (TNF) inhibitor but considered inadequate responders. Recommended dosing for PsA, AS, and nr-axSpA is 160mg subcutaneous (SC) injections every four weeks. The recommended dose for plaque psoriasis is 320mg (two SC injections at the same time) spaced four weeks apart for the first five treatments. Then, the schedule for most patients shifts to once every eight weeks. For patients that have both PsA and plaque psoriasis, psoriasis dosing is recommended. Safety warnings for Bimzelx include a possible increase in the risk of suicidal ideation and behavior, infections, inflammatory bowel disease, and liver abnormalities. Updated prescribing information can be found here.  

Tagrisso Label Expanded in Lung Cancer

Under its Priority Review program, the FDA expanded the non-small cell lung cancer (NSCLC) indication for AstraZeneca’s Tagrisso® (osimertinib) tablets on Sept. 25, 2024. It is now indicated to treat adults with unresectable, Stage III epidermal growth factor receptor-mutated (EGFRm) NSCLC whose disease has not progressed during or following concurrent or sequential platinum-based chemoradiation therapy (CRT). It is approved to treat patients whose tumors have EGFR exon 19 deletions or exon 21 (L858R) mutations, as detected by an FDA-approved test. Tagrisso is a third-generation, irreversible EGFR-tyrosine kinase inhibitor (TKI) that was initially approved in 2015; it now has several indications for the treatment of adults with EGFRm NSCLC. Approximately 180,000 new cases of NSCLC are diagnosed each year in the U.S. and about 15% of these patients have EGFR mutations. Recommended dosing is 80mg once daily until the cancer worsens or the drug’s side effects are no longer bearable. In the LAURA clinical study, progression-free survival (PFS) for patients treated with Tagrisso averaged 39.1 months versus 5.6 months for patients who took the placebo. Updated prescribing information is here.

Recall

Atovaquone Recalled

On Sept. 17, 2024, Bionpharma Inc. recalled one lot of Atovaquone Oral Suspension because it was found to be contaminated with the bacteria Cohnella. In immunocompromised individuals, this could pose a risk for serious or deadly infections in areas of the heart or soft tissue. Atovaquone is an antimicrobial drug used for the prevention or treatment of infections, including lung infections caused by pneumocystis jirovecii pneumonia in adults and adolescents aged 13 years and older. For more information, see here.

Veklury Recalled

On Sept. 20, 2024, Gilead Sciences recalled one lot of Veklury® (remdesivir) for injection 100mg/vial. A glass particle was found inside one of the vials which may cause local irritation or swelling upon injection. There is a risk that the glass particle could travel through the blood vessels, potentially leading to a stroke or death. Veklury is indicated for the treatment of COVID-19 in adult and pediatric patients weighing at least 1.5kg who are hospitalized or non-hospitalized patients who have mild to moderate COVID-19 and are at high risk for progression to severe COVID-19, which includes hospitalization or death. To read more about the recall, see here.