Indication Extension for Krystexxa

The U.S. Food and Drug Administration (FDA) granted an indication extension on July 7, 2022, for Horizon Therapeutics’ Krystexxa® (pegloticase) injection. Already approved as monotherapy to treat gout for adults who do not respond to or cannot tolerate typical first-line treatment, it now can be used in combination with methotrexate to treat the same group of patients who have gout.

In the decisive clinical trial, 60% of patients using the combination of drugs reached a complete response (CR) to therapy as compared with 31% of patients using Krystexxa with a placebo for 12 months. Additionally, only 4% of the participants on Krystexxa and methotrexate had infusion reactions, but 31% of those using only Krystexxa did. The labeling for Krystexxa has boxed warnings that it may cause infusion reactions or anaphylaxis, so it has to be administered in a healthcare facility that is equipped and staffed to manage any serious adverse reactions that occur.

Patients must receive an antihistamine and a corticosteroid prior to each infusion, and they also must be observed for any potential problems after each treatment. Dosing begins with a lead-in of methotrexate 15mg taken orally once a week for at least four weeks. Then, Krystexxa is added as 8mg intravenous (IV) infusions over at least two hours once every two weeks. Patients should take a folic acid supplement, usually once a day, as well. Patients who have a deficiency of the enzyme glucose-6-phosphate dehydrogenase (G6PD) should not use Krystexxa because it may damage or destroy their red blood cells.

Change to Paxlovid Dispensing

In an amendment to the emergency use authorization (EUA) for Pfizer’s COVID-19 treatment, Paxlovid™ (nirmatrelvir tablets and ritonavir tablets), the FDA is allowing pharmacists to prescribe and dispense the drug under some conditions.

In states that permit pharmacist dispensing, pharmacists now can opt-in to evaluate patients aged 12 years old and older and weighing at least 40kg (88 pounds) who test positive for mild-to-moderate COVID-19 infection, who have an elevated chance of developing a serious case and who can provide medical records no more than one-year old that show normal kidney and liver function.

Patients also will need a complete list of all the medications, including non-prescription products, that they take.

Dispensed in dose packs containing a five-day supply, Paxlovid is taken twice a day for five days beginning as soon as possible after a positive diagnosis – no more than five days after symptoms start. It is not indicated for treating patients who are in the hospital or for preventing COVID-19.

Zelnorm Removed from Sale

Due to what it described as a business decision, Alfasigma Pharmaceuticals stopped marketing Zelnorm® (tegaserod) tablets in the United States on June 30, 2022. A serotonin-4 (5-HT4) receptor agonist, it was indicated to treat irritable bowel syndrome with constipation (IBS-C) for young and middle-aged women. No drug safety or effectiveness issues influenced the decision.

Patients who have been using Zelnorm are advised to consult with their healthcare providers to find alternate treatments before the remaining supplies of Zelnorm run out.

Lutathera and Pluvicto Returning to Stock

In mid-May 2022, Novartis stopped production for two radioactive therapies after possible quality-control problems were discovered in some of its manufacturing plants. The issues were corrected ahead of schedule, however; and the drugs, Lutathera® (lutetium Lu 177 dotatate) injection and Pluvicto™ (lutetium Lu 177 vipivotide tetraxetan) are available again in the U.S. Lutathera is indicated to treat adults who have gastroenteropancreatic neuroendocrine tumors (GEP-NETs) and Pluvicto treats some prostate cancers. Each includes a targeting agent specific to the type of cancer cells and a radioactive isotope that damages the cancer’s DNA.

Although full production may take slightly longer to resume, adequate supplies of each product should be available for patients to restart therapy. To help prevent future shortages, Novartis hopes to open a new U.S. production facility next year.

Recall: Insulin Glargine-yfgn

On July 5, 2022, the Mylan division of Viatris recalled one lot (BF21002895) of Insulin Glargine-yfgn U-100, in 3mL pen devices that are packaged in boxes of five pens (NDC # 49502-0394-75). Although the box labels are correct, some pens may not be labeled, which could lead to incorrect doses and possible hyperglycemic or hypoglycemic episodes.

FDA Action Date: REGEN-COV® (casirivimab and imdevimab – Regeneron) injection

Virus-neutralizing human monoclonal antibodies for treating COVID-19 in non-hospitalized patients and preventing symptomatic infection in asymptomatic household contacts of individuals who have SARS-CoV-2 infections: IV and SC

Patent Expiration: Iressa® (gefitinib – AstraZeneca) tablets

Iressa is no longer covered by any patents and its FDA-granted Orphan Drug Exclusivity (ODE) is set to expire, allowing the FDA to approve any eligible generic applications.