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Igalmi™ (dexmedetomidine) sublingual film, made by BioXcel Therapeutics, has received FDA approval to treat agitation associated with schizophrenia or bipolar I or II disorder in adults.

• According to the manufacturer, “Igalmi is the first new acute treatment for schizophrenia or bipolar disorder-associated agitation in nearly a ” The active pharmaceutical ingredient is the same as in Hospira’s Precedex®, an FDA-approved intravenous medication used to provide sedation in clinical settings.
• Under the prescribing information, Igalmi can be given in three doses, each spaced two hours apart, in one 24-hour The number of doses and total daily dose are determined by factors that include:
  • The severity of agitation;
  • Whether the patient has hepatic impairment;
  • Whether the patient is over or under 65 years of age;
  • The patient’s blood pressure and heartrate; and
  • The patient’s treatment
• Igalmi should be used under the supervision of a healthcare provider, and patient vital signs and alertness should be monitored by a healthcare provider following administration. It is given by buccal (placed against the inside of the cheek and allowed to dissolve) or sublingual (placed under the tongue and allowed to dissolve) administration.
• BioXcel plans to launch the product during the second quarter of 2022.

Several years following FDA approval, Ibsrela® (tenapanor) oral tablets are now available to treat irritable bowel syndrome with constipation (IBS-C) in adults.

• Ibsrela is a first-in-class treatment for IBS-C that received FDA approval on September 12, 2019. However, manufacturer Ardelyx has only recently launched the product.
• Recommended dosing is 50mg taken twice daily by mouth: once immediately prior to breakfast or the first meal of the day, and once immediately prior to dinner.
• The wholesale acquisition cost (WAC) is $1,500 per 60 tablets.

• Zoladex (goserelin implant) – for prostate cancer, breast cancer, and endometriosis

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.

Gilead’s Yescarta® (axicabtagene ciloleucel) has been approved to treat adults diagnosed with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy.

• Originally FDA approved in 2017, Yescarta is a chimeric antigen receptor T-cell (CAR-T) therapy. CAR-T treatments are created by modifying a donation of the patient’s own T-cells, a type of immune cell, to target cancer. Dosing varies per patient.
• Yescarta is also indicated to treat relapsed or refractory large B-cell lymphoma or follicular lymphoma in adults who have had two or more lines of systemic therapy.

ViiV Healthcare’s Triumeq PD® (abacavir/dolutegravir/lamivudine) has been approved to treat HIV-1 infection in children who weigh 10kg (22 pounds) to less than 25kg (55 pounds).

• Triumeq PD is a new oral tablet for suspension that contains the same active pharmaceutical ingredients as ViiV Healthcare’s Triumeq® oral tablets.
  • Triumeq first received FDA approval in
  • Previously approved only for patients weighing at least 40kg (88 pounds), Triumeq is now indicated for patients who weigh at least 25kg.
  • Triumeq and Triumeq PD cannot be interchanged on a milligram per milligram basis due to differences in how the products move through the body.
• Recommended dosing is as follows:
  • Triumeq PD: Four to six tablets taken once daily, based on the patient’s weight. The oral tablets for suspension must be fully dispersed in 20mL of drinking water in a cup supplied with the medication. Triumeq PD is not recommended for adults or for children who weigh at least 25kg.
  • Triumeq: One tablet taken by mouth once Triumeq is recommended for adults and for children who weigh at least 25kg.
• Triumeq PD has launched at a wholesale acquisition cost (WAC) of $1,001.72 for 90 tablets.

Janssen’s Edurant® (rilpivirine) and ViiV Healthcare’s Vocabria® (cabotegravir) have received expanded indications for the short-term treatment of HIV-1 infection.

• Previously approved for short-term treatment of HIV in adults only, the drugs are now indicated for short-term treatment of HIV in patients who are at least 12 years old and weigh at least 35kg (77 pounds). Under this indication, Edurant and Vocabria must be used together.
• Before switching to Edurant and Vocabria, patients must already be virologically suppressed on a stable antiretroviral regimen with no history of treatment failure and no suspected resistance to either drug.
• Recommended dosing for short-term treatment is one 30mg tablet of Vocabria and one 25mg tablet of Edurant taken once daily by mouth with a meal. Recommended treatment duration is based on whether the medications are being used as an oral lead-in therapy or as a missed dose replacement for a long-acting injectable HIV treatment.
• Vocabria, which received initial FDA approval in 2021, is also indicated in at-risk adults and adolescents (weighing at least 35kg) for short-term pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection.
• First FDA approved in 2011, Edurant is also approved for use in combination with other antiretroviral agents to treat HIV in treatment-naïve patients at least 12 years old (weighing at least 35kg) with HIV-1 RNA less than or equal to 100,000 copies/mL.

The FDA has approved updated prescribing information for Cabenuva® (cabotegravir and rilpivirine), ViiV Healthcare’s long-lasting injectable HIV treatment. Cabenuva replaces the current antiretroviral regimen in individuals who are virologically suppressed on a stable antiretroviral regimen with no history of treatment failure and no known or suspected resistance to either of its active pharmaceutical ingredients (APIs).

• First approved in 2021, Cabenuva formerly required one month of oral lead-in dosing to assess the tolerability of its APIs before a patient switched to extended-release injections. Oral lead-in dosing is now optional.
• Cabenuva is also now indicated as a complete regimen to treat HIV-1 infection in pediatric patients who are at least 12 years old and weigh at least 35kg (77 pounds). It was previously approved only in adults.
• A healthcare provider must administer Cabenuva through gluteal intramuscular injection. The recommended dosing is:
  • Monthly Dosing: Initiate Cabenuva injections of 600mg cabotegravir/900mg rilpivirine on the last day of current antiretroviral therapy or oral lead-in and continue with Cabenuva injections of 400mg cabotegravir/600mg rilpivirine monthly thereafter.
  • Every Two-Months Dosing: Initiate Cabenuva injections of 600mg cabotegravir/900mg rilpivirine on the last day of current antiretroviral therapy or oral lead-in for two consecutive months and continue with Cabenuva injections at the same dosing strength once every two months thereafter.

Teva Pharmaceuticals has recalled lot 31329657B of IDArubicin Hydrochloride Injection USP 5mg/5mL vials. An internal inspection found one vial contained silica and iron oxide particulate matter. According to Teva, this defect has not been observed in other vials as of the recall date.

• There is no member impact through Benecard Central.
• IDArubicin Hydrochloride Injection USP is used in combination with other FDA-approved anti- leukemic drugs to treat acute myeloid leukemia in adults. Administering an injectable that contains particulate matter can have consequences ranging from local irritation to fatal blood vessel However, Teva has determined the chance of harm to patients from the recalled lot is remote or unlikely.
• Teva advises consumers who have questions or concerns about the recalled medication to first consult with their healthcare provider. To contact Teva with medical-related questions or to report an adverse event, consumers can call Teva Medical Information at 1-888-838-2872 (option 3, then option 4) or email druginfo@tevapharm.com. For questions related to product quality complaints, consumers can call Teva Quality Assurance Services at 1-888-838-2872 (option 4).
• The FDA has published a copy of the complete recall notice on its website.

The U.S. FDA has approved higher Ozempic® (semaglutide) dosing to improve glycemic control in adults who have type 2 diabetes. Ozempic, which previously had a recommended maintenance dose of 0.5mg or 1mg per week, is now approved for a dose of 2mg per week.

• Initially approved in 2017, Ozempic is indicated:
  • As an adjunct to diet and exercise to improve glycemic control in adults who have type 2 diabetes mellitus.
  • To reduce the risk of major adverse cardiovascular events in adults who have type 2 diabetes mellitus and established cardiovascular disease.
• Ozempic is administered by subcutaneous injection. Patients and caregivers can inject Ozempic at home once trained in proper technique. Recommended dosing is as follows:
  • Initiate at 25mg once weekly for four weeks, and then increase to 0.5mg once weekly.
  • If the patient requires additional glycemic control after at least four weeks on 5mg, the dosage can be increased to 1mg once weekly.
  • If, after at least four weeks on 1mg, the patient requires further glycemic control, the dosage can be increased to 2mg once weekly.
• Manufacturer Novo Nordisk will make a new single-patient-use pen available that delivers 2mg per injection. Ozempic is also available in a pen that delivers 0.25mg and 5mg doses, and a pen that delivers 1mg doses.

Both Pfizer and Moderna have received emergency use authorization (EUA) for a second booster dose of their COVID-19 vaccines in certain populations. For both products, the second booster dose is given at least four months following administration of a first booster dose of any authorized or approved COVID-19 vaccine.

• Pfizer’s Comirnaty® (COVID-19 vaccine, mRNA), developed in collaboration with BioNTech, is now authorized as a second booster dose in adults at least 50 years of age, as well as individuals who are at least 12 years old and have certain kinds of immunocompromise.
• Moderna’s Spikevax® (COVID-19 vaccine, mRNA) is authorized as a second booster dose for adults who are at least 50 years old, as well as for adults at least 18 years of age who have certain kinds of immunocompromise.