Posts in category: Uncategorized

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.

The FDA has approved Juvéderm® Volux™ XC (hyaluronic acid) to improve moderate to severe loss of jawline definition in adults older than 21 years.

• The product is the newest addition to the Juvéderm line of injectable gels for cosmetic use made by Allergan Juvéderm injectable gels treat wrinkles and lines in cheeks, chin, lips, and undereye hollows.
• Juvéderm Volux XC is administered via deep injection by a trained healthcare professional. The manufacturer plans to launch healthcare provider training in the fall of 2022, with wider product distribution expected in 2023.

Cimerli™ (ranibizumab-eqrn) from Coherus BioSciences has been approved as the first interchangeable biosimilar to Lucentis (ranibizumab injection). Cimerli is used to treat neovascular (wet) age-related macular degeneration (AMD)

• Cimerli is used to treat macular edema (swelling) caused by diabetes or by a blockage in the blood vessels. it is also used to treat diabetic retinopathy, the most common cause of vision loss in people with diabetes.
• Usual Adult Dose for Macular Degeneration:
  • 5 mg via intravitreal injection once a month (approximately 28 days)
  • Although not as effective, patients may be treated with 3 monthly doses followed by less frequent dosing with regular assessment. Patients may also be treated with one dose every 3 months after 4 monthly doses. Patients should be assessed regularly.
  • Use: Neovascular (wet) age-related macular degeneration (AMD)
• Usual Adult Dose for Macular Edema Following Retinal Vein Occlusion (RVO):
  • 5 mg via intravitreal injection once a month (approximately 28 days)
  • Use: Macular edema following retinal vein occlusion (RVO)
• Usual Adult Dose for Diabetic Macular Edema (DME):
  • 3 mg via intravitreal injection once a month (approximately 28 days)
  • Use: Diabetic macular edema (DME)
• Usual Adult Dose for Diabetic Retinopathy:
  • 3 mg via intravitreal injection once a month (approximately 28 days)
  • Use: Diabetic retinopathy
• Usual Adult Dose for Myopic Choroidal Neovascularization (mCNV):
  • 5 mg via intravitreal injection once a month (approximately 28 days) for up to three months. Patients may be retreated if needed
  • Use: Myopic choroidal neovascularization (mCNV)
• No pricing information has been made available, but an October launch is anticipated.