Monthly Archives: April 2022

The U.S FDA has approved Rinvoq® (upadacitinib – AbbVie) to treat active ankylosing spondylitis (AS) in adults who have an inadequate response or intolerance to one or more tumor necrosis factor blockers.

• AS is a chronic inflammatory disease that can cause bones in the spine to fuse together. Rinvoq, which first received FDA approval in 2019, is also indicated to treat rheumatoid arthritis, active psoriatic arthritis, and moderate to severe ulcerative colitis.
• The recommended dose to treat AS is 15mg of Rinvoq taken by mouth once daily.

AstraZeneca’s Ultomiris® (ravulizumab-cwvz) is now approved to treat generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor antibody positive.

• Myasthenia gravis is a rare neuromuscular condition that causes severe weakness and loss of muscle function. Ultomiris is the first drug in its class approved to treat gMG.
• The FDA first approved Ultomiris in The drug is also indicated to treat paroxysmal nocturnal hemoglobinuria or atypical hemolytic uremic syndrome in patients at least one month of age.
• Recommended dosing is based on the patient’s diagnosis and body. To treat gMG, Ultomiris is administered via intravenous infusion once every eight weeks.

Vivjoa™ (oteseconazole capsules – Mycovia Pharmaceuticals) has received FDA approval to reduce the incidence of recurrent vulvovaginal candidiasis (RVVC) in females who have a history of RVVC and are not of reproductive potential.

• RVVC is also known as chronic yeast infection and defined by the S. Centers for Disease Control as three or more symptomatic acute episodes of yeast infection within 12 months. Vivjoa is the first medication FDA approved specifically for treatment of RVVC.
• Vivjoa is taken by mouth with Recommended dosing is as follows:
  • Treatment with Vivjoa ONLY: Administer 600mg on Day 1 and 450mg on Day Beginning on Day 14, administer 150mg once every seven days for 11 weeks.
  • Treatment with Vivjoa and fluconazole: Administer fluconazole 150mg by mouth on Days 1, 4, and On Days 14 through 20, administer Vivjoa 150mg once daily. Beginning on Day 28, administer Vivjoa 150mg once every seven days for 11 weeks.
• Launch and pricing information are not available.

Bristol Myers Squibb’s Camzyos™ (mavacamten) has been approved to improve functional capacity and symptoms as a treatment for symptomatic New York Heart Association (NYHA) class II-III obstructive hypertrophic cardiomyopathy (HCM) in adults. Camzyos is the first drug in its class to receive FDA approval for this indication.

• Obstructive HCM occurs when a wall of muscle in the heart becomes thicker than normal and interferes with blood flow. Usually, the condition is caused by genetic mutations.
• Due to a risk of heart failure, Camzyos dosing must be individualized based on the patient’s clinical status and echocardiographic assessments of treatment response. The medication is taken once daily by mouth.
• Camzyos has launched at an annual wholesale acquisition cost (WAC) of $89,500.

Caplyta® (lumateperone) has received FDA approval for two new dosages strengths: 10.5mg capsules and 21mg capsules.

• First FDA approved in 2019, Caplyta is indicated to treat schizophrenia, as well as depressive episodes associated with bipolar I or II disorder.
• Typical recommended dosing is 42mg taken once daily, currently available in capsule form. However, patients may require dose reduction if they are also taking moderate or strong CYP3A4 inhibitors, or if they have moderate (Child-Pugh class B) or severe (Child-Pugh class C) hepatic impairment. Recommended dosing for these patient populations is:
  • 5mg once daily for patients on moderate CYP3A4 inhibitors.
  • 21mg once daily for patients on strong CYP3A4 inhibitors or with moderate or severe hepatic impairment.
• Intra-Cellular Therapies, the manufacturer, plans to launch the new dosage strengths mid-2022.

The U.S. FDA has approved Epsolay® (benzoyl peroxide, cream, 5%), from Sol-Gel Technologies, to treat inflammatory lesions of rosacea in adults.

• Epsolay uses a proprietary microencapsulation technology that slowly release benzoyl peroxide over time. It is the first benzoyl peroxide formulation FDA approved to treat rosacea.
• Under the recommended dosing, a pea-sized amount of Epsolay is applied once daily in a thin layer to each area of the face (forehead, chin, nose, and each cheek). Any unused Epsolay must be discarded 30 days after opening.
• Epsolay has launched at a wholesale acquisition cost (WAC) of $475 per 30g pump.

Veklury® (remdesivir) is now indicated to treat patients as young as 28 days and weighing at least 3kg (7 pounds) who have positive results of direct SARS-CoV-2 viral testing.

• Veklury was previously approved for adults and for pediatric patients at least 12 years of age and weighing at least 40kg (88 pounds). It is now the first COVID-19 treatment FDA approved for children under 12 years of age. It formerly held emergency use authorization for this younger patient population.
• Per the prescribing information, Veklury should only be used to treat patients who are hospitalized with COVID-19, or who are not hospitalized but have mild-to-moderate COVID-19 at high risk for progression to severe COVID-19. It is given via intravenous infusion over the course of 30 minutes to two hours.
• Recommended dosing is:
  • Adults and pediatric patients weighing at least 40kg: A single 200mg loading dose on Day 1 followed by once daily 100mg maintenance doses from Day 2.
  • Pediatric patients at least 28 days old weighing 3kg to less than 40kg: A single loading dose of 5mg/kg of the patient’s body weight on Day 1 followed by once-daily maintenance doses of 2.5mg/kg from Day 2.
• The recommended total duration of treatment is:
  • Non-hospitalized patients: 3
  • Hospitalized patients not requiring invasive mechanical ventilation and/or extracorporeal membrane oxygenation (ECMO): 5 days, with potential to extend treatment duration to 10 days if the patient does not demonstrate clinical improvement.
  • Hospitalized patients requiring invasive mechanical ventilation and/or ECMO: 10 days.

Pfizer has recalled five lots of Accupril® (quinapril HCl) tablets due to the presence of a nitrosamine identified as above the established acceptable daily intake (ADI) level in recent testing.

• Nitrosamines are potential carcinogens (substances that may cause cancer) found in water and foods. Sustained exposure to them above the ADI may increase an individual’s risk of cancer.
• Accupril is indicated to treat hypertension and as an adjunctive therapy for management of heart failure when added to conventional therapy. As of the recall date, Pfizer has received no reports of adverse events related to the affected product and states that there is no immediate risk to patients taking the medication.
• Pfizer recommends patients reach out to their healthcare provider or pharmacy for help in determining whether the Accupril they are taking is part of the recall. Patients in possession of the affected product should contact Sedgwick at 1-888-345-0481 for return instructions and reimbursement. For help with alternative treatment options, Pfizer has asked patients to contact their healthcare provider.
• A full copy of the recall notice can be found on the FDA’s website.

Zerbaxa® (ceftolozane/tazobactam) has received an expanded indication to treat complicated intra-abdominal infections and complicated urinary tract infections, including pyelonephritis, in patients of all ages. It was previously approved for this use only in adults.

• First FDA approved in 2014, Zerbaxa is also indicated to treat adults who have hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia.
• Recommended dosing and the duration of treatment are based on factors such as the patient’s age, weight, renal health, and diagnosis.

Due to the potential for missing labels, Mylan has recalled batch BF21002800 of its Insulin Glargine (Insulin glargine-yfgn) Injection, 100 units/mL (U-100), packaged in a 10 mL vial inside a carton.

• There is no impact to members through Benecard Central
• Insulin glargine-yfgn is indicated to improve glycemic control in adults who have type 1 or type 2 diabetes mellitus and in pediatric patients who have type 1 diabetes A missing label could cause a mix-up in which insulin is being used, which could cause high or low blood sugar and potentially serious complications. As of the recall date, Mylan has received no reports of related adverse events.
• Mylan asks consumers to contact their healthcare provider if they have experienced any problems that may be due to using the affected product. For returns of unlabeled insulin glargine-yfgn, consumers should contact Stericycle at 1-888-912-7084. Questions about the recall can be directed to Viatris Customer Relations at 1-800-796-9526 or service@viatris.com.
• The recall does not apply to Semglee® (insulin glargine-yfgn) injection, the branded interchangeable biosimilar for Sanofi’s Lantus® (insulin glargine) injection. It applies only to the unbranded interchangeable biosimilar insulin glargine-yfgn.
• A full copy of the recall notice is available on the FDA’s website.