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Olumiant® (baricitinib – Eli Lilly and Incyte) is now approved to treat COVID-19 in hospitalized adults who require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).

• In 2020, the U.S. FDA granted emergency use authorization (EAU) for Olumiant to be used alongside Veklury® (remdesivir – Gilead) to treat COVID-19 in certain patients. An EUA is still in effect for Olumiant’s use in the treatment of hospitalized pediatric patients at least two years of age who require oxygen support.
• Recommended dosing under the new FDA approval for adults is 4mg once daily for 14 days or until hospital discharge, whichever comes first.

Due to potential for rare but serious blood clots, the FDA has limited emergency use authorization (EAU) for Janssen’s COVID-19 vaccine.

• The vaccine initially received an EUA in February 2021 to prevent COVID-19 in individuals at least 18 years of age. It is now only authorized to prevent COVID-19 in:
  • Individuals at least 18 years old for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate.
  • Individuals at least 18 years old who elect to receive the Janssen COVID-19 vaccine because they would otherwise not receive a COVID-19 vaccine.
• The FDA has determined that the risk of thrombosis with thrombocytopenia syndrome (TTS), a rare but life-threatening condition observed in some recipients of the vaccine, warrants limiting the product’s authorized use.

The U.S. FDA has granted regular approval to Enhertu® (fam-trastuzumab deruxtecan-nxki) as a treatment for unresectable or metastatic HER2-positive breast cancer in adults who have received a prior anti-HER2-based regimen (in the metastatic setting or in the neoadjuvant or adjuvant setting) and have developed disease recurrence during or within six months of completing therapy.

• Enhertu initially received accelerated approval for this indication in Continued approval was contingent upon the results of confirmatory trials. Enhertu won regular approval based on data from the DESTINY-Breast03 randomized trial.
• The drug is also approved to treat locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma in adults.
• Recommended dosing for breast cancer is 5.4mg/kg administered via intravenous infusion once every three weeks (21-day cycle) until disease progression or unacceptable toxicity occur.

Phathom Pharmaceuticals’ Voquezna™ Triple Pack (vonoprazan/amoxicillin/clarithromycin) and Voquezna™ Double Pack (vonoprazan/amoxicillin) have been approved to treat Helicobacter pylori infection in adults.

• H. pylori bacteria cause infections in the stomach and duodenum (first part of the small intestine) and are the main cause of peptic ulcers. Voquezna Triple Pack and Double Pack co-package antibiotics with a novel acid-blocking medication, vonoprazan, to treat such infections.
• The recommended dosing is as follows:
  • Voquezna Triple Pack: Vonoprazan 20mg, amoxicillin 1,000mg, and clarithromycin 500mg each taken twice daily (12 hours apart) for 14 days.
  • Voquezna Double Pack: Vonoprazan 20mg taken twice daily plus amoxicillin 1,000mg taken three times daily (morning, mid-day, and evening) for 14 days.
• Both Voquezna Triple Pack and Voquezna Double Pack have a wholesale acquisition cost of $812 per treatment course.

Supernus Pharmaceuticals’ Qelbree® (viloxazine extended-release capsules) has received an expanded indication to treat attention deficit hyperactivity disorder (ADHD) in adults as well as in pediatric patients six years old and up.

• The S. FDA originally approved Qelbree in 2021 to treat ADHD in patients 6-17 years of age. The drug is the first new nonstimulant ADHD treatment to receive FDA approval for adults since 2002.
• Recommended dosing is:
  • Patients 6-11 years old: 100mg once daily to start, with the option to titrate in increments of 100 g weekly to a maximum recommended dose of 400mg once daily.
  • Patients 12-17 years old: 200mg once daily, with the option to increase the dosage by 200mg after one week to the maximum recommended dose of 400mg once daily.
  • Patients 18 years old and up: 200mg once daily, with the option to titrate in increments of 200mg weekly to a maximum recommended dose of 600mg once daily.

The U.S. FDA has approved Cuvrior™ (trientine tetrahydrochloride) to treat stable Wilson’s disease in adults who are de-coppered and tolerant to penicillamine, an FDA-approved first-line treatment for the disease.

• Wilson’s disease is a rare, genetic disorder in which the body cannot properly filter out copper. The excess copper that remains is stored in various bodily tissues, including the eyes, liver, and brain. De-coppering is the process of using chelating agents to help remove copper from the body.
• Cuvrior is taken by mouth on an empty stomach twice per day. The total daily dose can range from 300mg to 3,000mg, with dosing adjusted according to clinical assessment and laboratory monitoring of copper.
• Orphalan, the manufacturer, plans to launch Cuvrior in early 2023.

The U.S. FDA has approved the first therapeutically equivalent generics for Takeda’s Velcade® (bortezomib). Although Fresenius and Dr. Reddy’s have marketed generic bortezomib for several years, the U.S. FDA does not consider their products therapeutically equivalent because of differences in formulation.

• There are now eight approved bortezomib generics considered therapeutically equivalent by the FDA. They are available in the form of single-use vials containing 3.5mg bortezomib as a lyophilized cake or powder for reconstitution.
• Recommended dosing for bortezomib is 1.3mg/m² of the patient’s body surface area, given as either a 3-5 second bolus intravenous injection or a subcutaneous The dosing schedule and treatment duration depend on the indication and other patient-specific factors.
• The following manufacturers have launched their newly approved bortezomib generics: Apotex, Aurobindo, Baxter, Fresenius Kabi, Ingenus, Sagent, and Zydus.

• Alimta (pemetrexed) – for cancer
• Banzel 100mg tablets (rufinamide) – for seizures
• Velcade (bortezomib) – for cancer

Adverse reactions or quality problems experienced with the use of a recalled product can be reported to the FDA’s MedWatch Adverse Event Reporting Program online, by mail, or by fax.

• Submit a Report Online: https://www.accessdata.fda.gov/scripts/medwatch/index.cfm
• Send a Report Via U.S. Mail or Fax: Download a form from https://www.fda.gov/safety/reporting-serious-problems-fda/forms- reporting-fda or call 1-800-332-1088 to request a reporting form. Then complete and return to the address on the form or submit by fax to 1-800-FDA-0178.

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.

The U.S FDA has approved Rinvoq® (upadacitinib – AbbVie) to treat active ankylosing spondylitis (AS) in adults who have an inadequate response or intolerance to one or more tumor necrosis factor blockers.

• AS is a chronic inflammatory disease that can cause bones in the spine to fuse together. Rinvoq, which first received FDA approval in 2019, is also indicated to treat rheumatoid arthritis, active psoriatic arthritis, and moderate to severe ulcerative colitis.
• The recommended dose to treat AS is 15mg of Rinvoq taken by mouth once daily.

AstraZeneca’s Ultomiris® (ravulizumab-cwvz) is now approved to treat generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor antibody positive.

• Myasthenia gravis is a rare neuromuscular condition that causes severe weakness and loss of muscle function. Ultomiris is the first drug in its class approved to treat gMG.
• The FDA first approved Ultomiris in The drug is also indicated to treat paroxysmal nocturnal hemoglobinuria or atypical hemolytic uremic syndrome in patients at least one month of age.
• Recommended dosing is based on the patient’s diagnosis and body. To treat gMG, Ultomiris is administered via intravenous infusion once every eight weeks.