Monthly Archives: July 2022

Krystexxa® (pegloticase – Horizon Therapeutics) has received an expanded indication for co-administration with methotrexate to treat chronic gout in adults whose disease is refractory to conventional therapy.

• First FDA approved in 2010, Krystexxa was originally as a single therapy to treat gout. Gout is an inflammatory condition that causes uric acid to crystallize and form deposits in the joints.
• Recommended dosing under the expanded indication is 8mg of Krystexxa given as an intravenous infusion once every two weeks, co-administered with weekly oral methotrexate (15mg once a week week) and folic acid or folinic acid supplementation.
  • Methotrexate and folic acid or folinic acid supplementation should be started at least four weeks prior to initiating Krystexxa.
  • Krystexxa can be used alone in patients for whom methotrexate is contraindicated or not clinically appropriate.

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.