Your source for the latest industry trends and drug information news.
Volume 6 | Issue 3
February 1, 2024
Contributors:
Chief Authors: Rebecca Waite, PharmD
Contributing Authors: Gabrielle Graca, PharmD/MBA Candidate and Salome Mawi, PharmD/MBA Candidate
On January 16, 2024, Takeda announced the U.S. Food and Drug Administration (FDA) approval of HyQvia (human immune globulin infusion 10% with recombinant human hyaluronidase) as maintenance therapy for chronic inflammatory demyelinating polyneuropathy (CIDP). CIDP is a rare, progressive neuromuscular disorder often associated with weakness or loss of feeling in the arms and legs on both sides of the body. HyQvia is a subcutaneous infusion administered to patients by their health care provider or self-administered after appropriate training and was first approved by the FDA in 2014 for the treatment of primary immunodeficiency. For patients with CIDP, it is typically administered every 2-4 weeks. In clinical trials, HyQvia had lower relapse rates of CIDP (14%) compared to placebo (32.3%) after 6 months. The most common adverse effects were injection site reactions, headache, fever, nausea, fatigue, redness, itching, increased lipase levels, abdominal pain, back pain and pain in the extremities. HyQvia is currently available in the U.S. for maintenance treatment of CIDP.
On January 5, 2024, Leiters Health announced a voluntary recall of 33 lots of IV bags containing vancomycin, phenylephrine or fentanyl. The recalled IV bags may contain twice the amount of drug, increasing the risk of life-threatening adverse events such as cardiac arrest, respiratory depression, low or high blood pressure or acute kidney injury. The manufacturer’s semi-automated IV bag filling equipment may have failed to eject the bags after filling them, allowing a second dose to be added to the bags. Affected fentanyl IV bags are labeled with codes F3355 and F3342. Phenylephrine is packaged with codes F3360 and F3352. Vancomycin is packaged under codes F3206 and F3208. The products were distributed to hospitals nationwide. Leiters Health notified all its customers of the safety recall via mail and email. Customers with the affected lot are encouraged to immediately stop using the product and return it. Leiters Health is arranging for the return and credit for all recalled bags. There have been no adverse events related to this recall to date, but patients should contact their health care provider if any problems arise from use of this product. Adverse effects should also be reported to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.
On January 15, 2024, the FDA announced their approval of the AutoGenomics, Inc. AvertD test. This tool is a genetic test designed to assess an adult’s risk of developing opioid use disorder (OUD). The prescription-only test requires collection of the patient’s DNA via cheek swab by a healthcare professional who has received training from AutoGenomics on the appropriate use of the test. It is intended for use in consenting individuals who are considering a short-term course of prescription opioid medication to manage pain following a scheduled surgical procedure. The results of this test could provide more personalized insight into the patient’s risk of potential dependence. While these results should not be the only information considered, they could be used as part of a more comprehensive risk assessment, allowing prescribers and patients to make an informed decision when considering treatment options for short-term pain management.
New Dosage Form: Abacavir and Lamivudine
Tablets able to be dispersed in water and used as an oral liquid suspension, swallowed whole or broken in half. This combination therapy is indicated to be used with other antiretroviral agents for the treatment of HIV-1 in patients 3 months of age and older, weighing at least 11 lbs. [12/22/2023 – Mylan]
Prolensa® (bromfenac sodium)
Indication: Eye drops approved for the treatment of eye pain and postoperative inflammation in patients who have undergone cataract surgery
Dosage Form/Strength: 0.07% ophthalmic solution
Average Wholesale Price (AWP): Generic = $384 | Brand = $429
