New Cotellic Indication
As a Breakthrough Therapy, Cotellic® (cobimetinib – Genentech) tablets received approval from the U.S. Food and Drug Administration (FDA) on Oct. 28, 2022, for a second indication. An inhibitor of mitogen-activated protein kinase kinase(MEK or MAPKK), it initially was FDA approved in 2018 to be used along with Zelboraf® (vemurafenib – Genentech) for treating adults who have metastatic melanoma that has a BRAF V600E or V600K mutation. Now, it also is indicated for the treatment of histiocytic neoplasms in adult patients. A group of rare diseases that together affect fewer than 3,500 people in the U.S., histiocytic neoplasms are caused by accumulations of a white blood cell type that ordinarily is found in connective tissues. Although bones and skin are most commonly affected, histiocyte deposits can occur in any part of the body, including the brain, eyes, heart, and kidneys. To treat the conditions, the recommended daily dose of Cotellic is 60mg (three tablets) taken together at the same time each day for 21 consecutive days, followed by seven days without treatment. As monotherapy, Zelboraf is approved for treating one of the main histiocytic neoplasms, Erdheim-Chester disease (ECD), which has BRAF V600E mutations in about 50% of cases. Cotellic is the first specifically indicated drug that can be used for patients who have any type of histiocytic neoplasm, including those that do not have BRAF V600E mutations. Check here for its complete prescribing information.
Pediatric Indication Approved for Vemlidy
Vemlidy® (tenofovir alafenamide – Gilead Sciences) tablets were FDA approved on Oct 17, 2022, to treat patients as young as 12 years old who have chronic hepatitis B (HBV) with liver disease that is compensated (not yet progressed to cirrhosis). Originally approved for patients aged 18 years and older, Vemlidy is a nucleoside analog reverse transcriptase inhibitor that is effective at lower doses than its predecessor, Viread® (tenofovir disoproxil fumarate). In a clinical trial of 70 patients between the ages of 12 years and 18 years, 21% of those taking Vemlidy met the goal of less than 20IU/mL of HBV DNA after 24 weeks, as opposed to none of the participants who took a placebo tablet. Recommended dosing is 25mg once a day along with a meal or snack. Its labeling includes a boxed warning that hepatitis B may reactivate after treatment with Vemlidy ends, so the liver function should continue to be checked after patients stop treatment with it. Additionally, taking it rarely may cause two potentially serious conditions — lactic acidosis (excessive lactate accumulation) and hepatomegaly with steatosis (enlargement of the liver with fat deposits). For revised prescribing information, go here.
Dupixent Pen Receives Extended Pediatric Indication
Previously limited to use for patients aged 12 years and older, prefilled Dupixent® (dupilumab) pen devices now can be used for children at least two years old. In addition to the treatment of adults who have prurigo nodularis or chronic rhinosinusitis with nasal polyposis, Dupixent is approved by the FDA to treat patients aged 12 years and older for eosinophilic esophagitis, patients aged six years and older for asthma with an eosinophilic phenotype and patients aged six months and older for atopic dermatitis. Most doses for children, which are based on both age and weight, are given once every two weeks. Dupixent is available in 200mg and 300mg pens as well as in 100mg, 200mg, and 300mg prefilled syringes – all for single-dose subcutaneous (SC) injection. Regeneron and Sanofi, the manufacturers of Dupixent, recommend that a parent or other caregiver give doses to children under the age of 12 years. Older children may be able to self-administer their injections after being trained. Here is the updated prescribing information for Dupixent.
New Guidelines for Prescribing Opioids
On Nov. 4, 2022, the Centers for Disease Control and Prevention (CDC) issued new guidelines for prescribing opioids to treat nonhospitalized adults for pain that is not associated with cancer, sickle cell disease, or palliative care. Relaxing some of the recommendations in the previous version from six years ago, the new voluntary guidance provides advice that can be adapted to individual situations more easily. Emphasizing the need for patient-prescriber collaboration, they cover appropriate dosing for chronic pain as well as for more acute conditions. Included are suggestions about whether to start opioids, which ones to choose, what doses to use, how long to continue them, and how to minimize the risk of misuse and dependence. Evernorth’s Office of Clinical Evaluation and Policy (OCEP) is assessing the clinical impact of the CDC’s update across all programs. We will work with product teams to coordinate any program revisions that may be needed. Look here for the full guideline document.