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Pharmacy Bulletin

Pharmacy Bulletin

We share important prescription drug information to help you stay informed about updates concerning particular prescription medicines.

VativoRx Bottle update

FDA Approves Ycanth to Treat Molluscum Contagiosum

Verrica Pharmaceuticals received approval from the U.S. Food and Drug Administration on July 21, 2023, for Ycanth™ (cantharidin) topical solution, 0.7%. It treats patients who are two years old and older for molluscum contagiosum, a viral skin disease that is estimated to affect about six million Americans, mostly children. The condition produces small, inflamed, and/or itchy bumps similar to chicken pox, and it spreads easily to other parts of the patient’s body and to other people. The virus also can survive on objects, such as toys, and on surfaces that are wet. Without treatment, molluscum contagiosum bumps can last for years. Currently, they are treated with oral cimetidine, topical products that include podophyllotoxin or salicylic acid, or physical removal of bumps with a scalpel, a laser, or liquid nitrogen. Ycanth is the first prescription drug for treating them. A healthcare provider will apply Ycanth to each bump once every three weeks as long as needed. The solution is dispensed in single-use applicators and it contains purple coloring to make it visible on the skin. Patients should not apply any topical products, such as lotion or sunscreen, to treated areas before they wash off Ycanth 24 hours after it is applied. Possible side effects include blistering, itching, pain, and redness at the application sites. Ycanth is toxic if swallowed, so it should not be used close to the mouth. Treated areas should not be covered with bandages or wrappings. Because the liquid is flammable, even after drying on the skin, patients should avoid close contact with open flames and burning cigarettes. The launch is planned before the end of August 2023, but its price has not yet been disclosed. For full prescribing information, look here.

Xdemvy Receives FDA Approval

The FDA approved Xdemvy (lotilaner ophthalmic solution – Tarsus Pharmaceuticals) 0.25% on July 24, 2023. It is the first prescription drug approved to treat Demodex blepharitis, chronic inflammation around the eyelashes, caused by over-infection with Demodex mites. Normal inhabitants of hair follicles, Demodex mites are thought to help protect the eyes from bacteria and other types of mites. When they become too prolific, collarettes (white, waxy mite fragments) can accumulate on the edges of the eyelids. Patients may experience irritated, itchy, red eyes. Often misidentified as allergies, Demodex blepharitis is more likely to affect the eyelids than the eyes, themselves. The mites are resistant to most antiseptics, including alcohol. Presently, treatment centers on the topical application of tea tree oil, an over-the-counter product. A typical regimen includes tea-tree-oil doses as strong as 50% applied by a healthcare provider once a week combined with doses as little as 5% applied twice a day at home. Some patients have had irritation in their eyes or on the skin around the eyes from tea tree oil. Xdemvy will be supplied in 10mL dropper bottles with instructions to use one drop in each eye twice a day for six weeks. In the two clinical trials that lead to its approval, 44% and 56% of patients using Xdemvy for six weeks had a decrease in collarettes to two or less per eye as compared to 7% and 13% of patients who used the base solution that did not contain lotilaner. Tarsus expects to release Xdemvy to the U.S. market in August 2023, at a wholesale acquisition cost (WAC) of $1,850 for the six-week supply. Here is its prescribing information.

Balfaxar Approved to Reverse Anticoagulation

On July 21, 2023, the FDA approved a new blood coagulation factor replacement product, Balfaxar® (prothrombin complex concentrate, human-lans) made by Octapharma. It is indicated for adults who must have an emergency, invasive medical procedure, but who have a significant risk of excess bleeding because they take warfarin or another vitamin K antagonist to prevent blood clotting. With doses based on both the patient’s weight and their international normalized ratio (INR), Balfaxar will be administered as one intravenous (IV) infusion. Vitamin K will be given at the same time. In the phase III clinical study, Balfaxar produced results that were comparable to CSL Behring’s Kcentra® (prothrombin complex concentrate [human]), a current standard of care. Both Balfaxar and Kcentra contain four non-activated vitamin K-dependent clotting factors: II, VII, IX, and X, along with antithrombotic proteins C and S. A boxed warning on the labeling of both drugs outlines the chances for fatal and non-fatal arterial and venous thromboembolic complications. The risks and benefits of their use should be carefully weighed by healthcare providers. Because they are derived from human blood plasma, each has a slight risk of containing viruses or other infectious agents. No information is available on a launch date or cost for Balfaxar. Prescribing information for Balfaxar is here.

New Maintenance Dose Option for Wegovy

A new, lower dose for maintenance therapy with Wegovy® (semaglutide – Novo Nordisk) injection was approved by the FDA on July 21, 2023. Wegovy promotes weight loss and management in adults who are obese (who have a body mass index [BMI] of at least 30 kg/m²), adults who are overweight (a BMI of 27 kg/m² or higher) and who have weight-related medical conditions, and patients at least 12 years old who have BMIs in the 95th percentile for their peers of the same age and gender. Administered subcutaneously (SC) once per week, it is used along with a reduced-calorie meal plan and increased physical activity. Previously, the maintenance dose for patients of any age was 2.4mg once a week. Adults now have the option of a 1.7mg weekly Wegovy dose, which was effective as 2.4mg doses for some patients in a clinical trial. Look here for its revised prescribing information.

Generic Approved for Mozobil Several generic companies were FDA approved for plerixafor injection, the first generic for Genzyme’s Mozobil®, on July 24 and July 26, 2023. Eugia Pharma Specialties, a division of Aurobindo, intends to introduce its version to the U.S. market within a week. None of the other companies have released launch plans, yet; and whether any has exclusivity is unclear. Plerixafor has injected SC once a day for up to four days to move hematopoietic stem cells (HSCs) from the bone marrow into the peripheral circulation. About 11 hours later, HSCs can be harvested through apheresis to provide autologous transplants for patients who have non-Hodgkin’s lymphoma (NHL) or multiple myeloma. For most patients, the recommended dose is 20mg, but patients who weigh more than 83kg (about 183 pounds) are given 0.24mg/kg and those who have kidney conditions that lower creatinine clearances receive 0.16mg/kg. It is available in single-dose vials that contain 24mg in 1.2mL of solution. A granulocyte-colony stimulating factor (G-CSF), such as pegfilgrastim, should be given to the patient for each of the four days immediately before starting plerixafor. According to IQVIA, U.S. sales for Mozobil totaled about $210 million for the 12 months that ended on May 31, 2023.