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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.

Bavarian Nordic’s Jynneos® has been approved as a vaccine for individuals 18 years of age and older who are determined to be at high risk for monkeypox infection.

• Recommended dosing is two doses (0.5 mL each) 4 weeks apart, both taken subcutaneously.
• The FDA issued an emergency use authorization (EUA) for Jynneos.

Enhertu® (fam-trastuzumab deruxtecan-nxki) has won FDA approval to treat unresectable or metastatic HER2-low breast cancer in adults who have received prior chemotherapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy.

• This is the first FDA approved targeted therapy for HER2-low metastatic breast cancer.
• First FDA approved in 2019, Enhertu is also indicated to treat certain adults who have HER2- positive breast cancer or HER2-positive gastric or gastroesophageal junction adenocarcinoma.
• Recommended dosing for breast cancer is 5.4mg/kg of the patient’s body weight given as an intravenous infusion once every three weeks until disease progression or unacceptable toxicity occur.

The U.S. FDA has approved Nubeqa® (darolutamide – Bayer) for use in combination with docetaxel to treat metastatic hormone-sensitive prostate cancer in males.

• Nubeqa first received FDA approval in 2019 and is also indicated to treat non-metastatic castration-resistant prostate cancer.
• Recommended dosing is 600mg (two 300mg tablets) taken by mouth twice daily with food.

Calquence® tablet (acalabrutinib), manufactured by AstraZeneca Pharmaceuticals, are a new formulation with the same indications as their previously approved capsules, including adult patients with chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL) and for those with relapsed or refractory mantle cell lymphoma (MCL).

• Calquence capsules were originally approved in 2017.
• Recommended dosing for Calquence tablets for patients with MCL, CLL, or SLL is 100 mg, taken orally approximately every 12 hours until disease progression or unacceptable The WAC for Calquence oral capsule 100 mg is $14485.92 for a 30-day supply.