Leiters Health is voluntarily recalling 33 lots of products listed below to the user level. The recalled batches of vancomycin IV bags, phenylephrine IV bags, and fentanyl IV bags are being recalled due to the potential for superpotency because they may contain twice the labeled amount of drug.

The semi-automated IV bag filling equipment used to fill the recalled batches may not eject the IV bags properly when compressed air tanks become low or a leak was detected, causing the recalled IV bags to be dosed twice.

To date, Leiters Health has not received any reports of adverse events related to this recall.

Fentanyl is an analgesic packaged in an IV bag under codes F3355 and F3342. Phenylephrine is used for perioperative hypotension, hypotension during anesthesia, and shock and is packaged in an IV bag under codes F3360 and F3352.

Vancomycin is used for endocarditis and staphylococcal infections and is packaged in an IV bag under codes F3206 and F3208.

The products were distributed nationwide to hospitals for administration in the hospital. Leiters Health has notified its customers by a letter; sent via mail, requiring signature upon receipt, and an email to all affected customers. Leiters Health is arranging for a credit for all recalled products. Customers that have a product which is being recalled should cease using it and return it to Leiters Health.

Consumers with questions regarding this recall can contact Leiters Health by phone at 1-800-292-6772 or email at recall@leiters.com Monday through Friday between 8:00 AM MST and 5:30 PM MST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these drug products. Customers will receive return shipping labels for phenylephrine and vancomycin returns via email from Leiters Health, to return their products to Leiters Health at 13796 Compark Blvd., Englewood, CO 80112. Customers will receive return shipping labels, along with a DEA Form 222, for fentanyl returns via mail from Leiters Health, to return their products to Leiters Health at 13796 Compark Blvd., Englewood, CO 80112.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report Online

• Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then
complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

FDA Approves Zelsuvmi (berdazimer topical gel) for the Treatment of Molluscum Contagiosum

Ligand Pharmaceuticals Incorporated has announced that the U.S. Food and Drug Administration (FDA) has approved Zelsuvmi™ (berdazimer topical gel, 10.3%) for the treatment of molluscum contagiosum (MC) in adults and pediatric patients one year of age and older. The FDA approved Zelsuvmi as the first novel drug for the treatment of molluscum infections.

Zelsuvmi is the first and only topical prescription medication that can be applied by patients, parents, or caregivers at home, outside of a physician’s office, or other medical setting to treat this highly contagious viral skin infection.

Molluscum is a highly contagious viral skin infection characterized by skin-colored to red lesions with a central, umbilicated viral core. Approximately 6 million Americans, primarily children, are infected each year. However, up to 73% of children go untreated. Treating the lesions is critical to preventing the viral infection from spreading to other people or to other areas of the body.

Zelsuvmi is expected to be available in the United States in the second half of 2024.

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Author: Melody L. Berg, PharmD, BCPS, MPH/ Medically reviewed by Carmen Pope, BPharm.

Biologic or biosimilar drug, what is the difference?

Much like a generic is similar to the brand-name drug, each biosimilar drug is similar to an already- approved biologic drug. Biologic drugs are developed through a complex process that utilizes sugars, proteins, cells, or tissues from humans, animals, or microorganisms. There are many biologics on the market, and they are used to treat several medical conditions.

Examples of commonly used biologics are adalimumab (Humira®) to treat rheumatoid arthritis and psoriasis, epoetin (Epogen® or Procrit®) to increase red blood cell production in the body, and trastuzumab (Herceptin®) to treat breast cancer. Making medications from living cells is a very complicated process and requires a large investment of time and money. That’s why biologics can be expensive. The average daily cost for a biologic is more expensive vs. a non-biologic medication.

Biosimilar drugs are very similar to, but are not exact copies of, the original biologic drug in the way the product is made. However, biosimilars produce equivalent clinical outcomes to that of the original biologic, and they cost less.

Biosimilars have been compared to generic drugs. However, there are several important differences between these types of medications. Generic medications are exact copies of the original drug product with the exact same active ingredient and name. Biosimilars, on the other hand, work the same way as the original biologic medications but are not exact copies of the original medication.

The FDA requires all biosimilar medications to be approved for safety and effectiveness. Current state laws require biosimilars to be specifically prescribed for you by a doctor or other healthcare prescriber. Someday, pharmacists may be allowed to switch prescriptions from a biologic to a biosimilar if it is cost-effective for the patient.

Although biosimilars are new to the United States, they have been offered to patients in Europe for almost a decade. Biosimilars have the potential to drive down drug costs, saving the healthcare system billions of dollars and providing lower-cost treatment options for patients. Be on the lookout for new biosimilars in the near future.

Learn more about biosimilar medications.

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.

Nilotinib is used to treat a type of blood cancer called Philadelphia chromosome positive chronic myeloid leukemia (CML) in adults and children who are at least 1 year old. Nilotinib is usually taken every 12 hours on an empty stomach.

Nilotinib can cause a serious heart problem, especially if you use certain other medicines at the same time. Nilotinib is usually given after other treatments have failed.

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FDA Approves Wainua (eplontersen) for the Treatment of Adults with Polyneuropathy of Hereditary Transthyretin-Mediated Amyloidosis

Ionis Pharmaceuticals, Inc. has announced that the U.S. Food and Drug Administration (FDA) has approved Ionis and AstraZeneca’s Wainua™ (eplontersen) for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults, commonly referred to as hATTR-PN or ATTRv-PN. Wainua is the only approved medicine for the treatment of ATTRv-PN that can be self-administered via an auto-injector.

U.S. FDA approval based on Phase 3 NEURO-TTRansform results showing Wainua demonstrated consistent and sustained benefit halting neuropathy disease progression and improving neuropathy impairment and quality of life.

ATTRv-PN is a debilitating disease that leads to peripheral nerve damage with motor disability within five years of diagnosis and, without treatment, is generally fatal within a decade. Wainua is a ligand-conjugated antisense oligonucleotide (LICA) medicine designed to reduce the production of TTR protein at its source. Wainua will be available in the U.S. in January 2024. Additional regulatory reviews for Wainua are underway in the rest of world.

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FDA Approves Filsuvez (birch triterpenes) Topical Gel for the Treatment of Epidermolysis Bullosa

Chiesi Global Rare Diseases, a business unit of the Chiesi Group has announced that the U.S. Food and Drug Administration (FDA) approved Filsuvez® (birch triterpenes) topical gel for the treatment of partial thickness wounds in patients 6 months and older with Junctional Epidermolysis Bullosa (JEB) and Dystrophic Epidermolysis Bullosa (DEB).

Filsuvez is the first approved treatment for wounds associated with JEB, a rare, moderate-to-severe form of epidermolysis bullosa (EB) with blisters beginning in infancy. Filsuvez joined the Chiesi portfolio as part of the agreement reached during the acquisition of Amryt Pharma in January of this year.

EB is a debilitating inherited skin disease that causes a person’s skin to be so fragile it can be injured just from touch. This rare, chronic, and distressing disorder affects infants, children and adults and is intensely painful; recurrent blistering and chronic wounds can result in intolerable pain with limited mobility. Living with EB entails daily challenges to navigate, including slow healing wounds at risk of infection and painful dressing changes.

Filsuvez is administered at home, allowing for integration into existing treatment routines. Filsuvez is applied topically to the wound at each dressing change.

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FDA Approves Alyglo (Immune Globulin Intravenous, Human-stwk) 10% Liquid for Adults with Primary Humoral Immunodeficiency (PI)

GC Biopharma Corp has announced that the U.S. Food and Drug Administration (FDA) has approved Alyglo (immune globulin intravenous, human-stwk) 10% Liquid, formerly referred to as “GC5107,” for the treatment of adult patients aged 17 years and older with primary humoral immunodeficiency (PI).

Primary Humoral Immunodeficiency (PI) refers to a group of disorders where the body’s ability to produce antibodies is impaired, affecting the immune system’s ability to fight infections. In PI, there’s a deficiency or absence of B cells or plasma cells, which are key in producing antibodies, particularly immunoglobulin G, leading to increased susceptibility to infection, especially bacterial infections affecting the respiratory and gastrointestinal tracts. People with PI might experience frequent infections, some of which can be severe or chronic. Treatment often involves immunoglobulin replacement therapy to boost the immune system.

Vaccinations and antibiotics may also be used to prevent and treat infections. The exact type and severity of PI can vary widely among individuals.

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FDA Approves iDose TR (travoprost intracameral implant) for the Treatment of Glaucoma

Glaukos Corporation, announced that the U.S. Food and Drug Administration (FDA) approved its New Drug Application (NDA) for a single administration per eye of iDose® TR (travoprost intracameral implant) 75 mcg, a prostaglandin analog indicated for the reduction of intraocular pressure (IOP) in patients with ocular hypertension (OHT) or open-angle glaucoma (OAG).

iDose TR is a first-of-its-kind, long-duration, intracameral procedural pharmaceutical therapy designed to continuously deliver 24/7 therapeutic levels of a proprietary formulation of travoprost inside the eye for extended periods of time. iDose TR is intended to improve the standard of care by addressing the ubiquitous patient non-compliance issues and chronic side effects associated with topical glaucoma medications.

Glaukos intends to commence initial commercial launch activities for iDose TR in the latter part of the first
quarter of 2024.

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FDA Approves Iwilfin (eflornithine) as Maintenance Therapy for High-Risk
Neuroblastoma

USWM, LLC (US WorldMeds) has announced that the U.S. Food and Drug Administration (FDA) has approved Iwilfin ™ (eflornithine) 192 mg tablets, a groundbreaking oral maintenance therapy for high-risk neuroblastoma. Iwilfin is indicated to reduce the risk of relapse in adult and pediatric patients with high-risk neuroblastoma who have demonstrated at least a partial response to prior multiagent, multimodality therapy, including anti-GD2 immunotherapy.

According to the American Cancer Society, 700-800 cases of neuroblastoma are diagnosed in the U.S. each year, with 90% of diagnoses coming before age 5. Over 50% of these cases are classified as high-risk. High-risk neuroblastoma is a challenging disease, with a high mortality rate driven primarily by the risk of relapse after achieving remission. Approximately half of children with high-risk neuroblastoma do not survive beyond five years from diagnosis. Although existing treatments are effective in helping patients achieve remission, patients lack options to sustain it. Avoiding relapse is crucial to improving survival rates.

Iwilfin is taken orally, with or without food, twice daily for two years. Iwilfin is generally well-tolerated, with side effects typically manageable through dose modifications. The most common side effects are hearing loss, otitis media, pyrexia, pneumonia, and diarrhea.

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Study By Ernie Mundell HealthDay Reporter

Folks who take the blockbuster weight-loss med tirzepatide (Zepbound) may regain much of the weight they lost soon after discontinuing it, new research shows.

A trial funded by Eli Lilly, the injected drug’s maker, found that “in patients with obesity or overweight, withdrawing tirzepatide led to substantial regain of weight.”

On the other hand, continuing with tirzepatide kept the weight off, over the full two years of the trial.

Of course, sticking with the drug could mean big bills for users.

Medicare and Medicaid do not cover the drug, and if your private insurance doesn’t cover Zepbound, it can cost over $1,000 per month. Lilly says certain commercial card savings programs it offers can reduce the monthly cost to about $550, or even lower.

Zepbound was approved for weight loss by the U.S. Food and Drug Administration on Nov. 8, and Lilly announced its availability to consumers on Dec. 6.

To trigger weight loss, tirzepatide mimics two hormones, GLP-1 and GIP, which stimulate the release of insulin in the body. It quells appetite and slows the rate at which food moves through the stomach, helping patients feel full.

It’s the first drug in its class to compete with another weight-loss blockbuster, Wegovy.

Wegovy, made by Novo Nordisk, uses a similar active ingredient, semaglutide, which only focuses on GLP-1.

That difference appears to translate to greater weight loss with Zepbound than Wegovy, a recent study found. Zepbound has been found to prompt up to a 20.9% drop in weight at higher doses, while Wegovy patients typically see a 15% reduction in weight.

But if patients quit Zepbound, does the weight come back?

Yes, according to the new study, which was led by Dr. Louis Aronne, a professor of clinical medicine at Cornell University. He also directs the Comprehensive Weight Control Center at Weill-Cornell Medical Center, in New York City.

The research involved 670 overweight or obese people without diabetes who averaged 48 years of age. About 70% were women.

All participants first took tirzepatide for nine months. Then some were randomized to either another year taking the drug, or to a year taking a “dummy” placebo. Neither the participants nor researchers knew whether a participant was taking the active drug or the placebo.

By the end of trial, nearly all (89.9%) of the those who got tirzepatide for all 22 months maintained at least 80% of the weight loss they’d already experienced by the nine-month mark, Aronne’s group reported. However, that was only true for about 17% of participants who’d been switched over to the placebo shot at the nine-month mark. By the study’s end, folks who’d stuck with tirzepatide lost a quarter (25.3%) of their baseline weight, compared to about 10% weight loss for those who’d stopped taking the drug at nine months.

The study was published Dec. 11 in the Journal of the American Medical Association.

Side effects could occur — people were more likely to experience “mild to moderate gastrointestinal events” while on tirzepatide long-term versus placebo, the team noted.

Aronne’s team also noted that the weight regain observed after stopping tirzepatide isn’t unique to the drug. At least four other trials focused on weight-loss drugs have found the same rebound effect after quitting, including one trial focused on semaglutide (Wegovy).

Together, the data suggests that “obesity is a chronic metabolic condition similar to type 2 diabetes and hypertension requiring long-term therapy in most patients,” Aronne’s team said.