Monthly Archives: March 2022

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.

UCB’s Fintepla® (fenfluramine) has obtained an expanded indication to treat seizures associated with Dravet syndrome and Lennox-Gastaut syndrome in patients at least two years of age.

• When first FDA approved in 2020, Fintepla was indicated only to treat seizures associated with Dravet Both Dravet syndrome and Lennox-Gastaut syndrome are rare conditions that cause severe, drug-resistant epilepsy.
• Recommended Fintepla dosing is based on the patient’s diagnosis, weight, and renal health; treatment efficacy and tolerability; and whether the patient is taking stiripentol and clobazam.

The U.S. FDA has approved Pluvicto™ (lutetium Lu 177 vipivotide tetraxetan), a new radioactive therapeutic agent from Novartis, to treat prostate cancer. It has also approved an accompanying new indication for Locametz® (kit for the preparation of gallium Ga 68 gozetotide injection), an imaging agent also made by Novartis and first FDA approved in 2020.

• Pluvicto is indicated to treat adults who have prostate-specific membrane antigen (PSMA) positive metastatic castration-resistant prostate cancer. Patients must have undergone treatment with androgen receptor pathway inhibition and taxane-based chemotherapy.
• Locametz received a new indication for positron emission tomography (PET) of PSMA-positive lesions for selection of male patients who have metastatic prostate cancer and for whom Pluvicto PSMA-directed therapy is indicated.
• Both Pluvicto and Locametz should be used by or under the control of healthcare providers qualified in proper handling of radiopharmaceuticals. Recommended dosing is as follows:
  • Pluvicto: 7.4 GBq (200 mCi) once every six weeks, administered via intravenous injection or infusion, for up to six doses or until disease progression or unacceptable toxicity occur.
  • Locametz: 111 MBq to 259 MBq (3 mCi to 7 mCi) radioactivity, administered as a slow intravenous injection.
• Novartis has launched Pluvicto at a wholesale acquisition cost (WAC) of $42,500 per vial.

Drug manufacturers Pfizer and Sandoz have recalled multiple lots of medication due to the presence of nitrosamine impurities. Pfizer’s recall affects select lots of Accuretic® (quinapril HCl/ hydrochlorothiazide) and two authorized generics (quinapril and hydrochlorothiazide, and quinapril HCl/ hydrochlorothiazide tablets) from Greenstone. Sandoz is recalling 13 lots of orphenadrine citrate 100mg extended release (ER) tablets.

• There is minimal impact to members through Benecard Central
• Nitrosamines are probable human carcinogens with the potential to cause cancer if an individual is exposed to them above acceptable levels over a long period of Pfizer and Sandoz identified nitrosamines above the FDA-established Acceptable Daily Intake level in the recalled medications.
• Pfizer: Accuretic and the authorized generics included in the recall are used to treat hypertension (high blood pressure). Pfizer had received no reports of adverse events related to the affected products as of the recall The company has stated there is no immediate risk to patients using the affected medications, and that the benefit/risk profile of the products remains positive.
• Sandoz: Orphenadrine citrate ER tablets are indicated as an adjunct to rest, physical therapy, and other measures to relieve discomfort associated with acute painful musculoskeletal conditions. Sandoz had received no reports of adverse events related to the affected lots as of the recall
• The FDA has made details of both recalls available on its website, including instructions on identifying the affected lots and next steps for The Pfizer announcement can be found here, and the Sandoz recall notice is located here.

Adamis Pharmaceuticals has recalled Symjepi® (epinephrine) injection 0.15mg (0.15mg/ 0.3mL) and 0.3mg (0.3mg/0.3mL) pre-filled single-dose syringes. The syringe needles of the affected lots may become clogged, which can prevent the proper dispensing of epinephrine.

• There is no impact to members through Benecard Central
• Symjepi is indicated for emergency treatment of allergic reactions including anaphylaxis, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis.
• If a syringe malfunctions, patients may not receive the correct dose of medication, putting them at risk of life-threatening consequences. Adamis has received two customer complaints about difficulty dispensing medication from three syringes. However, the company states these complaints have not been confirmed as being related to the recall. Adamis had received no reports of adverse events connected to the recall as of March 22, 2022.
• According to Adamis, consumers and institutions that have Symjepi subject to the recall should stop using it immediately and either return or discard Questions regarding the recall should be directed to US WorldMeds at 1-888-900-8796 or medinfo@usworldmeds.com.
• A full copy of the recall notice, including affected lot numbers, is available on the FDA website.

SMOFlipid® (lipid emulsion – Fresenius Kabi) has received an expanded indication as a source of calories and essential fatty acids in patients of all ages receiving parenteral nutrition when oral or enteral nutrition is insufficient, not possible, or contraindicated. Previously, the product was approved only for adults.

• Parenteral nutrition describes intravenous administration of nutritional products, while enteral nutrition is the delivery of nutritional products through the gastrointestinal (GI) tract, such as via a gastrointestinal (GI) tube.
• Recommended SMOFlipid dosing is based on the patient’s age, energy expenditure, clinical status, body weight, tolerance, ability to metabolize and eliminate lipids, and consideration of additional energy given to the patient. Infusion times can range from 12-24 hours.
• SMOFlipid first received FDA approval in 2016.