Monthly Archives: August 2022

Xenpozyme™ (olipudase alfa-rpcp) has been approved for the treatment of non-central nervous system (non-CNS) manifestations of acid sphingomyelinase deficiency (ASMD) in pediatric and adult patients.

• Xenpozyme, manufactured by Sanofi, is the first therapy indicated specifically for the treatment of ASMD, and is currently the only approved treatment for this disease.
• ASMD represents a spectrum of disease, with two types that may represent opposite ends of a continuum referred to as ASMD type A and ASMD type ASMD type A/B is an intermediate form that includes varying degrees of central nervous system (CNS) involvement.
• Xenpozyme is administered intravenously every two weeks, and its administration requires a dose escalation phase followed by a maintenance phase.
• It is expected that Xenpozyme will be available in the S. in the coming weeks. The U.S. list price, or wholesale acquisition cost, of Xenpozyme is $7,142.00 per vial.

Konvomep™ (omeprazole and sodium bicarbonate for oral suspension) has been approved for gastric ulcer and reduction of risk of upper gastrointestinal (GI) bleeding in critically ill patients.

• Azurity Pharmaceuticals, Inc. has received FDA approval for the use of Konvomep, an oral liquid formulation of the FDA-approved proton pump inhibitor omeprazole and sodium bicarbonate combination
• It is expected that Konvomep™ will become commercially available in pharmacies nationwide in Q1 2023.

For full prescribing and additional information, please go to www.konvomep.com

The Food and Drug Administration approved pemigatinib (Pemazyre, Incyte Corporation) for adults with relapsed or refractory myeloid/lymphoid neoplasms (MLNs) with fibroblast growth factor receptor 1 (FGFR1) rearrangement.

• Efficacy was established based on complete response (CR) rates per the response criteria relevant to the morphologic disease type.
• The recommended pemigatinib dose is 13.5 mg orally once daily on a continuous basis until disease progression or unacceptable toxicity.

The FDA approved ibrutinib (Imbruvica, Pharmacyclics LLC) for pediatric patients ≥ 1 year of age with chronic graft versus host disease (cGVHD) after failure of 1 or more lines of systemic therapy. Formulations include capsules, tablets, and oral suspension.

• The recommended dosage of Imbruvica for patients 12 years of age and older with cGVHD is 420 mg orally once daily, and for patients 1 to less than 12 years of age with cGVHD is 240 mg/m2 orally once daily (up to a dose of 420 mg), until cGVHD progression, recurrence of an underlying malignancy, or unacceptable toxicity.

Hospira, a Pfizer Company, has voluntarily recalled one lot Propofol Injectable Emulsion (containing benzyl alcohol), 100mL Single Patient Use Glass Fliptop Vial; lot EA7470, to the user level due to visible particulates observed in two vials during annual examination of retention samples.

• There is no impact to members through Benecard Central Fill.
• Patients receiving the impacted product have a remote probability of experiencing potential adverse events, such as blockage of blood vessels, including decreased blood flow to the brain, heart attack, pulmonary embolus, and tissue necrosis. Hypersensitivity reactions and transmission of infectious disease can also occur.
• Full recall details are available on the S. FDA website.

The FDA has approved Akorn’s generic version of Merck’s Cetrotide® (cetrorelix acetate for injection) 0.25mg to prevent premature ovulation during controlled ovarian stimulation.

• Cetrotide first received FDA approval in Akorn’s 0.25mg strength generic is the first generic version of the drug.
• Recommended dosing is 25mg once daily during the early- to mid-follicular phase.
• Launch and pricing information are not yet available.

Auvelity® (bupropion and dextromethorphan), made by Axsome, has been approved for the treatment of major depressive disorder (MDD) in adults.

• Auvelity is used to treat Major Depressive Disorder (MDD), in adults.
• Recommended dosing is one tablet once daily in the morning for three days, then an increase to the maximum recommended dosage of one tablet twice daily, separated by at least 8 hours.
  • Each extended-release tablet contains dextromethorphan hydrobromide 45 mg and bupropion hydrochloride 105 mg.
• Axsome Therapeutics has not yet set a price for Auvelity, but costs are expected to exceed $1,000 per year.

August 17, 2022 – Bayer’s Mirena® (levonorgestrel-releasing intrauterine system) has been approved for prevention of pregnancy for up to 8 years; Mirena may be replaced after the end of the eighth year.

• Mirena also treats heavy periods for up to 5 years in women who choose intrauterine contraception.
• For recommended dosing, there are two options:
  • For contraception, it is recommended to remove Mirena by the end of the eighth year and replace at the time of removal with a new Mirena if continued use is desired.
  • For treatment of heavy menstrual bleeding, it is recommended to replace Mirena by the end of the fifth year if continued use is needed because data on use in this indication beyond 5 years are limited.
• Mirena first received FDA approval in 2000.
• The cost for Mirena is roughly $1,050.

Zynteglo® (betibeglogene autotemcel), made by bluebird bio, Inc., now has the first cell-based gene therapy for the treatment of beta-thalassemia in patients who require regular red blood cell transfusions.

• Beta-thalassemia is an inherited blood disorder that affects hemoglobin and red blood cells causing issues such as insufficient delivery of oxygen in the body.
• Under the recommended dosing, Zynteglo is given as a one-time gene therapy customized to the patient.
• Zynteglo will be available on the S. market at a wholesale acquisition cost (WAC) of $2.8 million per treatment.

Genetech’s Xofluza® (baloxavir marboxil) has been approved for the treatment of acute uncomplicated influenza in otherwise healthy children aged five to less than 12 years of age who have been symptomatic for no more than 48 hours.

• The cost for Xofluza oral tablet 40 mg is around $ 50 for a supply of 1 tablet.
• Recommended dosing is based on weight and taken as a single dose. 2 mg/kg taken as a single dose 40 mg (20 mL) taken as a single dose 80 mg (40 mL) taken as a single dose.
• Xofluza first received FDA approval in 2018.