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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.

The U.S. FDA has approved Imcivree® (setmelanotide) for treatment of obesity and control of hunger in patients who are at least six years old and have Bardet-Biedl syndrome or Alström syndrome.

• Imcivree first received FDA approval in 2020. It is also indicated for chronic weight management in patients at least six years old who have obesity due to proopiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency confirmed by genetic testing demonstrating variants in POMC, PCSK1, or LEPR genes that are interpreted as pathogenic, likely pathogenic, or of uncertain significance.
• Bardet-Biedl syndrome and Alström syndrome are rare, complex genetic disorders that can have a wide range of symptoms. These symptoms can include hyperphagia, an abnormally strong feeling of hunger or desire to eat, which can lead to obesity and may be present as early as the patient’s first year of life.
• Recommended dosing under the new indication is based on the patient’s age, renal health, and clinical response to treatment. Daily dosing can range from 0.25mg to 3mg administered via subcutaneous injection. Imcivree can be self-administered or administered by a caregiver once the individual has been trained in proper technique.

Amneal has received FDA approval for Alymsys® (bevacizumab-maly) intravenous injection, a biosimilar to Genentech’s Avastin® (bevacizumab).

• Alymsys is approved to treat certain patients who have colorectal cancer, non-squamous non- small cell lung cancer, glioblastoma, renal cell carcinoma, and epithelial ovarian, fallopian tube, or primary peritoneal cancer.
• Unlike Avastin, Alymsys is not indicated to treat hepatocellular carcinoma. It is also more limited in its approved use for treating epithelial ovarian, fallopian tube, or primary peritoneal cancer.
• Recommended dosing is based on the indication. Alymsys is not approved to be automatically interchangeable with Avastin.
• Launch and pricing information have not been Alymsys is the third Avastin biosimilar to receive FDA approval, with Amgen’s Mvasi® (bevacizumab-awwb) approved in 2017 and Pfizer’s Zirabev® (bevacizumab-bvzr) approved in 2019.

Xigduo® XR (dapagliflozin/metformin) has received a new indication for one of its active pharmaceutical ingredients (APIs), dapagliflozin, to reduce the risk of sustained estimated glomerular filtration rate (EGFR) decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in adults who have chronic kidney disease at risk of progression.

• Xigduo XR’s other API, metformin, is indicated as an adjunct to diet and exercise to improve glycemic control in adults who have type 2 diabetes mellitus. Dapagliflozin holds two additional indications to reduce the risk of:
  • Hospitalization for heart failure in adults who have type 2 diabetes and established cardiovascular disease or multiple cardiovascular risk factors.
  • Cardiovascular death and hospitalization for heart failure in adults who have heart failure (NYHA class II-IV) with reduced ejection fraction.
• Due to the metformin component, Xigduo XR should only be used in the treatment of adults who have type 2 diabetes. The FDA first approved Xigduo XR in 2014.
• Recommended dosing is based on a variety of factors, such as the patient’s current treatment regimen and treatment effectiveness and tolerability. Xigduo XR is taken by mouth once daily in the morning with food.

ArmonAir® Digihaler® (fluticasone propionate) has received an expanded indication to provide maintenance treatment (as prophylactic therapy) for asthma in patients who are at least four years old.

• First approved in 2020, ArmonAir Digihaler was initially indicated for patients at least 12 years The active pharmaceutical ingredient, fluticasone propionate, has been FDA approved since 1994.
• The FDA also approved a new ArmonAir Digihaler 30mcg dosage strength for the younger pediatric Recommended dosing under the expanded indication is determined by the patient’s age and severity of disease:
  • Patients 12 years and older: One 55mcg, 113mcg, or 232mcg dose taken twice daily by oral inhalation.
  • Patients 4-11 years old: One 30mcg or 55mcg dose taken twice daily by oral inhalation.

Novartis has obtained FDA approval for Vijoice® (alpelisib) to treat severe manifestations of PIK3CA-related overgrowth spectrum (PROS) in patients at least two years of age who require systemic therapy. Vijoice is the first FDA-approved treatment for PROS.

• PROS describes a range of rare disorders caused by mutations of the PIK3CA The mutations lead to overgrowth in various parts of the body and can cause severe complications.
• Vijoice addresses the root cause of PROS by inhibiting the PIK3 pathway. The recommended dosing is 50mg once daily for pediatric patients and 250mg once daily for adults. Vijoice is taken by mouth with food.
• Novartis also markets alpelisib, the active pharmaceutical ingredient of Vijoice, under the brand name Piqray®. Piqray has been FDA approved since 2019 for use in combination with fulvestrant to treat males and postmenopausal females who have HR-positive, HER2-negative, PIK3CA- mutated advanced or metastatic breast cancer that has progressed on or after an endocrine- based regimen.
• The wholesale acquisition cost (WAC) for Vijoice is $32,500 per Each carton provides a 28- day supply of medication.

Igalmi™ (dexmedetomidine) sublingual film, made by BioXcel Therapeutics, has received FDA approval to treat agitation associated with schizophrenia or bipolar I or II disorder in adults.

• According to the manufacturer, “Igalmi is the first new acute treatment for schizophrenia or bipolar disorder-associated agitation in nearly a ” The active pharmaceutical ingredient is the same as in Hospira’s Precedex®, an FDA-approved intravenous medication used to provide sedation in clinical settings.
• Under the prescribing information, Igalmi can be given in three doses, each spaced two hours apart, in one 24-hour The number of doses and total daily dose are determined by factors that include:
  • The severity of agitation;
  • Whether the patient has hepatic impairment;
  • Whether the patient is over or under 65 years of age;
  • The patient’s blood pressure and heartrate; and
  • The patient’s treatment
• Igalmi should be used under the supervision of a healthcare provider, and patient vital signs and alertness should be monitored by a healthcare provider following administration. It is given by buccal (placed against the inside of the cheek and allowed to dissolve) or sublingual (placed under the tongue and allowed to dissolve) administration.
• BioXcel plans to launch the product during the second quarter of 2022.