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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

Vyvgart Hytrulo Receives New Indication 

On June 21, 2024, the U.S. Food and Drug Administration (FDA) gave argenx’s Vyvgart® Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) an additional indication for the treatment of adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP). The recommended dose is 1,008mg efgartigimod alfa and 11,200 units of hyaluronidase, given as once-weekly subcutaneous (SC) injections. It should be administered only by a healthcare professional over 30 to 90 seconds. Vyvgart Hytrulo is a neonatal Fc receptor (FcRn) blocker. It also contains hyaluronidase to increase the incorporation and distribution of the SC injection. By sticking to FcRn, it decreases the amount of immunoglobulin G (IgG) in the blood. CIDP is a progressive autoimmune disorder that causes weakness, numbness, and tingling of the arms and legs due to damaged myelin sheath (protective covering) of the peripheral nerves. It is believed that by reducing levels of IgG in the blood, there are fewer antibodies to attack myelin sheaths. Approximately 40,000 patients in the U.S. have CIDP. In the ADHERE trial, 69% of patients treated with Vyvgart Hytrulo showed a clinical improvement in mobility, function, and strength. Patients also saw a 61% reduction in the risk of relapse vs. placebo. Vyvgart Hytrulo is also approved to treat adults who have generalized myasthenia gravis (gMG) that have antibodies against acetylcholine receptors (AChR). For the complete prescribing information, see here.

Krazati Approved for Colorectal Cancer

A combination of Krazati® (adagrasib) and Erbitux® (cetuximab) was granted accelerated approval by the FDA for the treatment of adult patients with KRASG12C-mutated locally advanced or metastatic colorectal cancer (CRC), as determined by an FDA-approved test, who have received prior treatment with fluoropyrimidine, oxaliplatin, and irinotecan-based chemotherapy. Accelerated approval means that more positive results from continuing clinical studies will be needed before full FDA approval is granted. The recommended dose of Krazati is 600mg orally twice daily, along with biweekly or weekly intravenous doses of Erbitux. Krazati is a potent inhibitor of KRASG12C, a protein that plays a role in cell growth. Mutations in this protein can cause overproduction of KRAS, which increases cancer growth. There are an estimated 106,590 new cases of CRC in the U.S. each year. Approximately three to four percent of CRC patients will have these mutations, making them eligible for the new combination. Results from a clinical study showed an objective response rate (ORR) of 34% in pretreated patients with a median duration of response (DOR) of 5.8 months. All patients had partial responses, with 31% having responses lasting six months or longer. The most frequent adverse effects (AEs), which occurred in 20% of patients, were rash, nausea, diarrhea, vomiting, fatigue, musculoskeletal pain, hepatotoxicity, headache, dry skin, abdominal pain, decreased appetite, edema, anemia, cough, dizziness, constipation, and peripheral neuropathy. Krazati is also approved for the treatment of adults with KRASG12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC) who have received at least one prior systemic treatment. Updated prescribing information is found here.

Wakix Approved for Children with Narcolepsy

On June 21, 2024, Harmony Biosciences’ Wakix® (pitolisant) received an expanded approval from the FDA. It is now approved for the treatment of excessive daytime sleepiness (EDS) in pediatric patients six years of age and older with narcolepsy. Wakix is a selective histamine 3 (H₃) receptor antagonist/inverse agonist that was originally approved in August 2019 to treat adults with EDS caused by narcolepsy. In October 2020, the label was updated to treat cataplexy in adults with narcolepsy. Harmony received a complete response letter regarding its application to seek expanded approval to treat cataplexy in children six years of age and older. Wakix is supplied as 4.45mg and 17.8mg tablets. Pediatric patients should start with 4.45mg once daily for the first week of treatment. The dose should be increased to 8.9mg once daily in Week 2 and titrated up to 17.8mg once daily in Week 3. This is the maximum dose for patients weighing less than 40kg (88 pounds). Patients weighing 40kg or more can increase their dosage to a maximum of 35.6mg once daily beginning Week 4. Wakix should be taken each morning upon waking. Here is its updated prescribing information.

Epkinly Receives an Expanded Indication for Follicular Lymphoma

AbbVie’s Epkinly® (epcoritamab-bysp) was approved by the FDA on June 26, 2024, for the treatment of adults with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy. Epkinly is a bispecific CD20-directed CD3 T-cell engager that is administered as a SC injection by a healthcare professional. It was first approved in May 2023 for treating adults with R/R diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. To treat FL, three small doses are spaced one week apart during the first 28-day cycle. The recommended dose increases to 48mg each at the start of the first cycle’s fourth week (day 22). The same 48mg dose is given on the first, eighth, 15th and 22nd days of cycles two and three; on the first and 15th days of the next six cycles; and finally, on only the first day of every cycle beginning with the 10th one. The labeling has a boxed warning due to potentially deadly adverse effects that include cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS). AbbVie has received accelerated approval for both of the DLBCL and FL indications and additional studies that demonstrate a clinical benefit are required before FDA will consider granting full approval. The updated prescribing information can be found here.

Sirturo Granted Traditional FDA Approval

On June 21, 2024, Janssen’s Sirturo® (bedaquiline) received traditional FDA approval; it was originally approved in December 2012 under the FDA’s accelerated approval pathway. Sirturo is a diarylquinoline antimycobacterial drug that is indicated for use in combination with other therapies to treat adults and children five years of age and older and weighing at least 15kg (33 pounds) with pulmonary tuberculosis due to Mycobacterium tuberculosis resistant to at least rifampin and isoniazid. Sirturo is supplied as 20mg and 100mg tablets. The recommended dose for adults and children weighing at least 30kg (66 pounds) is 400mg once daily for two weeks, followed by 200mg three times per week for 22 weeks. The recommended dose in children weighing 15kg to less than 30kg is 200mg once daily for two weeks, followed by 100mg three times per week for 22 weeks. The labeling for Sirturo contains a boxed warning concerning the risk for QTc prolongation, a potentially fatal heart rhythm. The FDA converted the approval of Sirturo from accelerated to traditional based on results from a phase III confirmatory study demonstrating efficacy. Here is its updated prescribing information.

Authorized Generic to Victoza Launched

Teva Pharmaceuticals announced the launch of its authorized generic (AG) to Victoza® (liraglutide – Novo Nordisk) on June 24, 2024. Liraglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated along with diet and exercise to improve glucose levels in patients at least ten years of age with type 2 diabetes. It is also approved to reduce the risk of a cardiovascular (CV) event in adults who have both type 2 diabetes and CV disease. While one manufacturer, Hikma, received ‘tentative approval’ for its generic, the availability of true A-rated generics is still pending final FDA approval, and the timing remains unclear. Victoza had annual sales of about $1.7 billion in a 12-month period ending April 2024. A link to the prescribing information of Teva’s AG to Victoza can be found here.

New Dosage Form of Thiotepa Approved

Shorla Oncology received FDA approval for Tepylute (thiotepa) injection on June 25, 2024. It is a ready-to-dilute formulation of the alkylating drug, which is used to treat adenocarcinoma of the breast or ovary. It is supplied as 15mg/1.5mL (10mg/mL) of thiotepa solution in single-dose vials. The recommended dose is 0.3mg/kg to 0.4mg/kg administered intravenously (IV) at one to four-week intervals. Tepylute requires dilution in 0.9% Sodium Chloride Injection prior to infusion. Currently, available forms of thiotepa are supplied as lyophilized powder formulations that need to be reconstituted with sterile water prior to dilution with sodium chloride. Tepylute comes with a boxed warning that it can cause a decrease in bone marrow activity resulting in decreased red blood cells, white blood cells, and platelets. It also carries a boxed warning indicating an elevated risk of developing secondary cancers. Launch date and pricing information are not available at this time. Prescribing information for Tepylute can be found here.


Potassium Chloride Extended-Release Capsules Recalled

On June 25, 2024, Glenmark Pharmaceuticals, Inc. recalled numerous lots of potassium chloride extended-release 750mg capsules from the consumer level. Additionally, on June 26, 2024, American Health Packaging issued a recall for the same medication. The recalls were initiated due to concerns that the capsules might not dissolve properly, leading to higher potassium blood levels. This can result in irregular heartbeat or cardiac arrest. Potassium chloride is an essential mineral supplement used to treat individuals with low blood levels of potassium. For the FDA notices, see here and here.