Liletta Gets New Indication

The U.S. Food and Drug Administration (FDA) approved Liletta^® (levonorgestrel-releasing intrauterine system – Medicines360) 52mg for a new indication on June 29, 2023. Available in the U.S. since 2015 to provide birth control, it now can be used for as long as five years to reduce heavy menstrual periods for women who use intrauterine contraception. After insertion by a trained healthcare provider, Liletta releases the progestin, levonorgestrel, in gradually decreasing, but continually effective, doses. While Liletta can be removed by a healthcare professional at any time, it must be removed by the end of the eighth year when used for contraception or the fifth year when used to manage heavy bleeding. A new device can be inserted immediately, however. Using Liletta is not recommended for women who already are pregnant or who are prone to pelvic or genital infections. Those who have endometriosis, uterine abnormalities, acute liver disease, or cancers that could be worsened by progestin also should not use Liletta. It is not appropriate for emergency contraception and it does not prevent sexually transmitted diseases (STDs). For revised prescribing information, look here.

Expanded Indication for Leqvio

Novartis got an extended approval on July 7, 2023, for its small interfering RNA (siRNA) drug, Leqvio^® (inclisiran) injection. Originally FDA-approved in December 2021, its first indication is as an addition to dietary modifications and the highest bearable doses of an HMG-CoA reductase inhibitor (statin) for treating adults who have heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease (ASCVD), but whose current treatment has not reduced low-density lipoprotein cholesterol (LDL-C) levels adequately. Now, Leqvio also can be used, along with diet and statins, to treat primary hyperlipidemia by lowering LDL-C for adult patients who are at high risk of having heart disease, but who have not yet had a cardiovascular (CV) event, such as a heart attack. Leqvio increases LDL-C uptake and lowers blood levels of LDL-C by blocking proprotein convertase subtilisin/kexin type 9 (PCSK9), an enzyme that affects lipid metabolism. It is administered subcutaneously (SC) by a healthcare provider using a prefilled syringe that contains the recommended dose of 284mg. The second dose is given three months after the first, and then doses are spaced at once every six months. Here is the updated prescribing information.

Veklury Approved for Patients Who Have Kidney Disease

The indication for Veklury^® (remdesivir) injection, Gilead’s intravenous (IV) antiviral for treating COVID-19, was extended by the FDA on July 13, 2023. It is a nucleotide analog that slows or prevents viral reproduction by interfering with the RNA of SARS-CoV-2 virus. Already approved for treating patients as young as 28 days old who weighs 3kg (about 7 pounds) or more, it now is approved for patients who have kidney diseases, including patients who need dialysis. Previously, it had dosing limitations for patients who had estimated glomerular filtration rates (eGFR) below 30mL/min, and regular monitoring of kidney function was recommended. Both those provisions have been eliminated. Patients may be in the hospital or they may be outpatients who have mild or moderate COVID-19, but who are at increased risk for progressing to severe infection. Recommended doses of Veklury for patients who weigh at least 40kg (88 pounds) are 100mg per day after a 200mg dose on the first day of treatment. Depending on whether or not the patient is hospitalized, treatment lasts between three days and 10 days. It should be given in facilities that are equipped and staffed to provide emergency treatment for severe infusion reactions that may be associated with administering Veklury. Check here for its current prescribing information

Recalls
Cipla Albuterol

On July 6, 2023, Cipla raised a previous recall of albuterol inhalers to the consumer level because at least one inhaler was found empty due to leaks around the valve. As a rescue medicine, albuterol inhalers typically are used to treat acute symptoms of asthma attacks. Although the possibility is small, missing a dose due to leaks could result in life-threatening situations. For additional information, an FDA notice is here.

B. Braun Sodium Chloride

Also on July 6, 2023, B. Braun recalled two lots of sodium chloride injection 0.9% in 1,000mL bags. The lots were shipped to wholesalers before the required inspections were completed, so sterility could be assured. Look here for details about the recall.