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The U.S. FDA has approved Tyvaso DPI™ (treprostinil) inhalation powder to treat pulmonary arterial hypertension (PAH; WHO Group 1) and pulmonary hypertension associated with interstitial lung disease (PH-ILD; WHO Group 3) to improve exercise ability.

• Tyvaso DPI is the only FDA-approved dry powder inhaler for PAH and PH-ILD. It is a new formulation of treprostinil, the active pharmaceutical ingredient of Tyvaso® inhaled solution. Both products are made by United Therapeutics.
• Recommended dosing for Tyvaso DPI is one 16mcg cartridge per treatment session to start, titrated up to a target maintenance dose of 48mcg to 64mcg per session. The recommended dosing frequency is four separate treatment sessions each day, set approximately four hours apart, during waking hours.
• The medication has launched with a wholesale acquisition cost (WAC) of $20,906.09 for a 28-day supply of the maintenance dose.

Vtama® (tapinarof) 1% cream has been approved to treat plaque psoriasis in adults.

• Vtama is the first novel topical treatment for plaque psoriasis to receive FDA approval in 25 It is also the first steroid-free topical medication in its class.
• Recommended dosing is a thin layer of cream applied to the affected area once daily.
• Manufacturer Dermavant Sciences has launched the product at a wholesale acquisition cost (WAC) of $1,325 per 60g tube.

Teva Pharmaceuticals has recalled one lot of Anagrelide Capsules, USP 0.5mg, due to dissolution failure during routine stability testing. The affected capsules belong to Lot #GD01090.

• There is no impact to members through Benecard Central
• Anagrelide capsules are indicated to treat thrombocythemia (secondary to myeloproliferative neoplasms) to reduce the elevated platelet count and risk of thrombosis as well as ameliorate associated symptoms, including thrombo-hemorrhagic events.
• If anagrelide capsules fail to properly dissolve, this may decrease the drug’s effectiveness. This could have lift-threatening consequences for seriously ill As of the recall date, Teva had received no quality complaints or reports of adverse events of this nature for the affected lot.
• Teva advises patients who have questions or concerns to first consult with their healthcare provider. For medical-related questions or to report an adverse event, Teva Medical Information can be reached at 1-888-838-2872 (option 3, then option 4) or druginfo@tevapharm.com. For product quality complaint-related questions, Teva Quality Assurance Services can be reached at 1-888-838-2872 (option 4).
• The S. FDA has published the full recall notice on its website.

Vidaza® (azacytidine) is now approved to treat newly diagnosed juvenile myelomonocytic leukemia (JMML), a rare form of blood cancer, in pediatric patients who are at least one month old.

• Manufactured by Celgene, Vidaza first received FDA approval in 2004. In addition to treating JMML, it is also indicated to treat certain subtypes of myelodysplastic syndrome (MDS) in Both MDS and JMML occur when normal blood cell production is disrupted.
• Vidaza for JMML is administered via intravenous infusion once daily for seven days in a 28-day cycle, with patients receiving a minimum of three cycles and a maximum of The recommended dosing for JMML is:
  • 5mg/kg of the patient’s body weight for patients one month to less than one year old or weighing less than 10kg (22 pounds).
• 75mg/m² of the patient’s body surface area for patients at least one year of age who weigh 10kg or more.

Tpoxx® (tecovirimat – SIGA Technologies) has received an expanded smallpox treatment indication, as well as FDA approval of a new dosage formulation. Tpoxx is now approved for pediatric patients who weigh as little as 3kg (6.6 pounds) and comes in oral capsule and intravenous formulations.

• The U.S. FDA approved Tpoxx oral capsules in 2018 to treat human smallpox disease caused by variola virus in adults and pediatric patients weighing at least 13kg (28.7 pounds). The new intravenous solution allows Tpoxx to be used in patients who are unable to swallow capsules.
• Recommended dosing is based on the patient’s age, weight, and ability to swallow capsules.
• Although naturally occurring smallpox has been eradicated since 1980, the disease remains of concern to the U.S. FDA as a potential bioweapon.

May 17, 2022 – The U.S. FDA has expanded emergency use authorization (EUA) for Comirnaty® (COVID- 19 vaccine, mRNA), made by Pfizer and BioNTech. The product is now authorized for use as a single booster dose for individuals 5-11 years old.

• The booster dose is authorized in children who have completed a primary vaccination series with Comirnaty at least five months prior.
• Comirnaty has been authorized since January 3, 2022, for use as a booster dose in individuals who are at least 12 years old.

Dupixent® (tirzepatide) has become the first drug to win FDA approval specifically for treating eosinophilic esophagitis (EoE). It is indicated to treat EoE in adults and in pediatric patients who are at least 12 years old and weigh at least 40kg (88 pounds).

• EoE is a chronic autoimmune disease that causes an inflammatory response in the esophagus, a muscular tube that carries food and drink from the throat to the It can lead to difficulty swallowing and eating, and can cause food to become trapped in the esophagus.
• Dupixent first received FDA approval in 2017 to treat atopic dermatitis, a chronic inflammatory skin disease. It has since gained indications for asthma and for chronic rhinosinusitis.
• Recommended dosing for EoE is 300mg via subcutaneous injection once Dupixent can be self-administered or administered by a caregiver or healthcare provider.

Eli Lilly’s Mounjaro™ (tirzepatide) has received FDA approval for use alongside diet and exercise to improve blood sugar control in adults who have type 2 diabetes.

• A first-in-class treatment, Mounjaro activates the GLP-1 and GIP receptors in the body to improve blood sugar control.
• The recommended starting dose is 2.5mg administered via subcutaneous injection once weekly, with the dose increased to 5mg once weekly after four weeks. If additional glycemic control is required after another four weeks, the dosage can be increased in increments of 2.5mg, up to a maximum of 15mg once weekly.
• Mounjaro has launched at a wholesale acquisition cost (WAC) of $974.33 per month.

Sandoz has launched the first fully substitutable generic for Genentech’s Esbriet® (pirfenidone) tablets. Esbriet is also available in capsule form, for which there is currently no generic.

• Esbriet and its generic are indicated to treat idiopathic pulmonary fibrosis, a rare disease that causes scarring of the lungs, making breathing difficult.
• The recommended starting dose is 267mg three times daily for Days 1-7. This is then titrated to 534mg three times daily on Days 8-14, before being increased to a maintenance dose of 801mg three times daily from Day 15 onward. Pirfenidone should be taken with food.
• Sandoz’s generic is available at a wholesale acquisition cost (WAC) of $9,130.57 per 30-day supply, while the WAC for a 30-day supply of brand name Esbriet tablets is $10,449.43.

Radicava ORS® (edaravone – Mitsubishi Tanabe Pharma America), has received FDA approval to treat amyotrophic lateral sclerosis (ALS) in adults.

• The product is a new oral suspension version of Radicava, a drug that first received FDA approval to treat ALS in 2017. Radicava is approved only for intravenous use.
• Recommended dosing for Radicava ORS is 105mg (5mL) administered by mouth or via feeding tube. The medication is taken in the morning after overnight fasting. For one hour following administration, patients should consume no food and should only drink water.
• Administration of both Radicava and Radicava ORS follows the following schedule:
  • Initial treatment cycle: Daily dosing for 14 days followed by a 14-day drug-free period.
  • Subsequent treatment cycles: Daily dosing for 10 days out of each 14-day period, followed by 14-day drug-free periods.
• The wholesale acquisition cost of Radicava ORS is $12,719.30 per 28-day supply.