Monthly Archives: August 2022

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.

• Oravig (miconazole) – for oropharyngeal candidiasis

Adverse reactions or quality problems experienced with the use of a recalled product can be reported to the FDA’s MedWatch Adverse Event Reporting Program online, by mail, or by fax.

• Submit a Report Online: https://accessdata.fda.gov/scripts/medwatch/index.cfm
• Send a Report Via U.S. Mail or Fax: Download a form from https://www.fda.gov/safety/reporting-serious-problems-fda/forms- reporting-fda or call 1-800-332-1088 to request a reporting form. Then complete and return to the address on the form or submit by fax to 1-800-FDA-0178.

Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.

*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.

Janssen’s Stelara® (ustekinumab) has received expanded approval to treat patients who are at least six years old and have active psoriatic arthritis.

• Stelara first received FDA approval in 2009, and is also indicated to treat psoriasis, Crohn’s disease, and ulcerative Prior to the expanded indication, it was only approved for psoriatic arthritis in adult patients.
• Recommended dosing for pediatric patients for the treatment of active psoriatic arthritis is based on the patient’s weight. The recommended route of administration is subcutaneous injection.

AstraZeneca and Daiichi Sankyo’s joint product Enhertu® (fam-trastuzumab deruxtecan- nxki) has been approved for the treatment of adult patients with unresectable or metastatic NSCLC whose tumors have activating HER2 (ERBB2) mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy based on the results from the DESTINY-Lung02 trial.

• The FDA also approved two companion diagnostics for Enhertu: Life Technologies’ Oncomine Dx Target Test (for tissue) and Guardant Health’s Guardant360 CDx (for plasma).
• Enhertu has been evaluated at two recommended doses: 4 mg/kg and 6.4 mg/kg given intravenously every 3 weeks.
• Enhertu is priced at $2,613.56 per 100mg.
• Emhertu first received FDA approval on 12/20/2019, under the provisions of accelerated approval regulations (21 CFR 314.500).