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Comirnaty® (COVID-19 vaccine, mRNA – Pfizer and BioNTech) is now FDA approved for use in adolescents who are 12-15 years old. This age group was previously eligible to receive Comirnaty under emergency use authorization (EUA).

• Under its newly expanded indication, the vaccine is approved to prevent COVID-19 caused by the SARS-CoV-2 virus in individuals 12 years of age and older.
• Recommended dosing for ages 12-15 is a two-dose primary vaccination series, with a third dose recommended for individuals with certain types of immunocompromise. The age group is also eligible under EUA to receive a booster dose at least five months after completing a primary vaccination series. If a patient has certain types of immunocompromise, a second booster dose may also be appropriate.
• Comirnaty has been in use in the United States under EUA since December 2020, and first received FDA approval in August 2021.

Mylan Pharmaceuticals has recalled one batch of Insulin Glargine (insulin glargine-yfgn) Injection, 100 units/mL (U-100), 3mL prefilled pens. The product is packaged in cartons of five pens and is being recalled due to the potential for missing labels on some pens.

• There is no impact to members through Benecard Central Fill.
• Insulin glargine is indicated to improve glycemic control in adults who have type 1 or type 2 diabetes and pediatric patients who have type 1 A missing label on insulin glargine pens could lead to a mix-up of products/strengths if a patient uses more than one type of insulin. This could cause potentially dangerous high or low blood sugar. As of the recall date, Mylan had received no reports of related adverse events.
• Mylan advises patients to contact Sedgwick at 1-877-643-8438 for the documentation packet to return the product if they have unlabeled insulin glargine Questions regarding this recall can be directed to Viatris Customer Relations at 1-800-796-9526 or customer.service@viatris.com. Mylan recommends patients contact a healthcare provider if they have experienced any problems that may be related to using the recalled product.
• Full recall details are available on the S. FDA’s website.

The U.S. FDA has revised emergency use authorization (EAU) for Pfizer’s Paxlovid™ (nirmatrelvir and ritonavir) to allow state-licensed pharmacists to prescribe the drug to eligible patients, within certain limitations.

• The FDA recommends that patients first consider obtaining care from their regular healthcare provider or a Test-to-Treat site in their area.
• If a patient has tested positive for COVID-19 and wishes to obtain a Paxlovid prescription from a pharmacist, the FDA advises them to bring the following information to determine their eligibility to receive the medication:
  • Electronic or printed health records less than 12 months old. These should include the most recent reports of laboratory blood work for the pharmacist to review for kidney or liver problems. A pharmacist can also obtain this information through consultation with the patient’s healthcare provider.
  • A list of all medications the patient is taking, including over the counter (OTC) products, so the pharmacist can screen for potentially serious drug-to-drug interactions.

• The pharmacist should refer patients for clinical evaluation with a physician, advanced practice registered nurse, or physician assistant licensed or authorized under state law to prescribe drugs, if any of the following apply:
  • Sufficient information is not available to assess renal and hepatic function or to assess for a potential drug interaction.
  • Modification of other medications is needed due to a potential drug interaction.
  • Paxlovid is not an appropriate therapeutic option based on the current Fact Sheet for Healthcare Providers or due to potential drug interactions for which recommended monitoring would not be feasible.
• Paxlovid is authorized to treat mild-to-moderate COVID-19 in adults and pediatric patients (at least 12 years old and weighing at least 40kg, or 88 pounds) who are at high risk for progression to severe COVID-19 and have positive results of direct SARS-CoV-2 viral testing (including OTC at- home tests).

• Evamist (estradiol) – for menopause
• Iressa (gefitinib) – for cancer

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://www.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/formsreporting–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.

The U.S. FDA has issued a safety warning for Secura Bio’s Copiktra® (duvelisib), a treatment for chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL).

• Data from a recent clinical trial shows a possible increased risk of death and serious side effects with Copiktra compared to another medicine used to treat leukemia and lymphoma.
• The FDA advises patients and their healthcare providers to discuss the risks and benefits of Copiktra in the context of other possible treatment alternatives.
• First FDA approved in 2018, Copiktra is indicated to treat adults who have relapsed or refractory CLL and SLL after at least two prior therapies.

Drug manufacturer Alfasigma has withdrawn Zelnorm® (tegaserod) from the U.S. market. According to the company, the withdrawal is the result of a business decision and not based on the safety or efficacy of the drug.

• Zelnorm received FDA approval in 2002 to treat irritable bowel syndrome with constipation (IBS- C) in female patients. It was withdrawn from the market in 2007 due to concerns over increased risk of heart attack, stroke, and unstable angina.
• In 2019, Zelnorm was reintroduced to the U.S. marketing as a treatment for IBS-C in female patients under 65 years age.
• Zelnorm will remain available to patients until the current supply is exhausted. Several potential treatment alternatives are currently available in the U.S.

Based on recent data, the U.S. FDA has revised emergency use authorization (EUA) for

AstraZeneca’s Evuseld™ (tixagevimab co-packaged with cilgavimab).

• According to the FDA, data suggests that Evusheld retains activity for six months, when given at a dose of 300mg tixagevimab and 300mg cilgavimab, against the current prevalent Omicron subvariants of SARS-CoV-2, the virus that causes COVID-19. Therefore, the FDA now recommends repeating this dose once every six months in eligible individuals.
• Evusheld is authorized to prevent COVID-19 in adults and pediatric individuals (at least 12 years old and weighing at least 40kg, or 88 pounds) who are not currently infected with SARS-CoV-2, who have not had a known recent exposure to an individual infected with SARSCoV-2, and:
  • Who have moderate to severe immune compromise due to a medical condition or receipt of immunosuppressive medications or treatments and may not mount an adequate immune response to COVID-19 vaccination, or
  • For whom vaccination with any available COVID-19 vaccine, according to the approved or authorized schedule, is not recommended due to a history of severe adverse reaction to a COVID-19 vaccine(s) and/or COVID-19 vaccine component(s).
• Evusheld first received EUA to prevent COVID-19 in 2021.

The U.S. FDA has approved two new indications for Breyanzi® (lisocabtagene maraleucel), in the treatment of large B-cell lymphoma (LBCL).

• Breyanzi is now approved to treat LBCL in adults who:
  • Have disease refractory to first-line chemoimmunotherapy or that has relapsed within 12 months of first-line chemoimmunotherapy; or
  • Are not eligible for hematopoietic stem cell transplant due to comorbidities or age and have disease refractory to first-line chemoimmunotherapy or that has relapsed after firstline chemoimmunotherapy.
• First FDA approved in 2021, Breyanzi is also indicated to treat relapsed or refractory LBCL in adults who have received two or more lines of systemic therapy.
• Recommended dosing is individualized, as Breyanzi is a CAR-T therapy made using the patient’s own immune cells.

Tafinlar® (dabrafenib) and Mekinist® (trametinib), both made by Novartis, are now approved for combination use to treat unresectable or metastatic solid tumors with BRAF V600E mutation in patients who are at least six years old and have disease progression following prior treatment, with no satisfactory alternative treatment options.

• Both medications have held FDA approval since 2013. They are indicated to treat multiple forms of cancer in patients who have a BRAF mutation.
• The recommended dosage of Tafinlar is 150mg twice daily for adults and based on body weight in children. Recommended dosing for Mekinist is 2mg once daily for adults and based on body weight in children. Both medications are taken by mouth at least one hour before or two hours after a meal.

The U.S. FDA has approved an expanded indication for Vaxneuvance™ (pneumococcal 15valent conjugate vaccine) to include pediatric patients.

• First FDA approved in 2021 to vaccinate adults, Vaxneuvance is now indicated to provide active immunization in patients at least six weeks of age to prevent invasive disease caused by fifteen specific variants of Streptococcus pneumoniae.
• Vaxneuvance is administered via intramuscular injection. The recommended dosing is:
  • Ages six weeks through 17 years: A series of four 0.5mL doses given at 2, 4, 6, and 12 through 15 months of age.
  • Ages 18 and up: A single 0.5mL dose.