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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.

Xelstrym™ (dextroamphetamine – Noven Pharmaceuticals) is now the first FDA- approved dextroamphetamine transdermal patch for attention deficit hyperactivity disorder (ADHD). It is indicated to treat ADHD in patients who are at least six years of age.

• The active pharmaceutical ingredient of Xelstrym, dextroamphetamine, has held FDA approval since 2001 to treat ADHD. It is considered a Class II Controlled Substance.
• Recommended dosing is as follows:
  • Pediatric patients (6-17 years old): Recommended starting dose of 4.5mg/9 hours, titrated in weekly implements of 4.5mg based on tolerability and clinical effect, up to a maximum recommended dose of 18mg/9 hours.
  • Adults (18 years and up): Recommended starting dose of 9mg/9 hours, with possible dosage adjustment up to a maximum recommended dose of 18mg/9 hours based on tolerability and clinical effect.
• Per the prescribing information, Xelstrym patches should be applied two hours before an effect is needed and removed within nine hours of application. The product will be available in four dosage strengths: 5mg/9 hours, 9mg/9 hours, 13.5mg/9 hours, and 18mg/9 hours. It cannot be substituted for other amphetamine products on a milligram per milligram basis because of differences in amphetamine base compositions and pharmacokinetic profiles.
• Launch and pricing information are not yet available.

March 21, 2022 – The U.S. FDA has approved Keytruda® (pembrolizumab) to treat advanced endometrial carcinoma that is microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) in patients who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation. An FDA-approved test must confirm MSI-H or dMMR status.

• This is Keytruda’s fourth indication to treat gynecological Originally FDA approved in 2014, Keytruda holds more than 30 indications to treat various types of cancer.
• Recommended dosing for endometrial carcinoma is 200mg administered by intravenous infusion once every three weeks or 400mg once every six weeks, for up to 24 months or until disease progression or unacceptable toxicity occur.

Perrigo has received FDA approval to market Nasonex® 24Hr Allergy (mometasone furoate monohydrate) 50mcg nasal spray as an over the counter (OTC) drug. Previously, mometasone nasal spray required a prescription.

• Nasonex was formerly a brand name prescription drug made by Merck Pharmaceuticals. After Merck discontinued the product, mometasone nasal spray was only available from generic manufacturers. The prescription version of the drug is indicated to treat allergies and nasal
• Perrigo’s OTC product is indicated for the temporary relief of symptoms of hay fever or other upper respiratory allergies. The company plans to launch Nasonex 24Hr Allergy later this year.

Ztalmy® (ganaxolone) oral suspension, made by Marinus Pharmaceuticals, has become the first FDA-approved treatment for cyclin-dependent kinase-like 5 deficiency disorder (CDD). It is indicated to treat seizures associated with CDD in patients who are at least two years old.

• CDD is a rare, difficult-to-treat form of epilepsy caused by a genetic mutation. Although other anti-seizure drugs are used off-label for CDD, there has been little clinical evidence to guide treatment decisions.
• Recommended dosing for Ztalmy is based on the patient’s weight:
  • 28kg (62 pounds) or less: Starting dosage is 6mg/kg of the patient’s weight three times daily (18mg/kg/day), which can be titrated up to a maximum dosage of 21mg/kg three times daily (63mg/kg/daily).

• Greater than 28kg: Starting dosage is 150mg three times daily (450mg daily), which can be titrated up to a maximum dosage of 600mg three times daily (1,800mg daily).

• Ztalmy is expected to launch in July 2022 with a wholesale acquisition cost of $2,425 per 110mL bottle containing 50mg of ganaxolone per milliliter. It is currently awaiting controlled substance scheduling by the U.S. Drug Enforcement Administration (DEA).

Bristol Myers Squibb’s (BMS) Opdualag™ (nivolumab and relatlimab-rmbw) has received FDA approval to treat unresectable or metastatic melanoma in patients who are at least 12 years old.

• Opdualag combines nivolumab, the active pharmaceutical ingredient (API) in BMS’s Opdivo®, with a first-in-class LAG-3-blocking antibody, Both APIs help to increase the body’s immune activity to fight cancer cells.
• In adults and pediatric patients who are at least 12 years old and weigh at least 40kg (88 pounds), the recommended dosing is 480mg nivolumab and 160mg relatlimab administered by intravenous infusion once every four weeks until disease progression or unacceptable toxicity occur. The recommended dosing has not been established for pediatric patients at least 12 years of age who weigh less than 40kg.
• Although launch plans are not yet available, Opdualag is anticipated to have a wholesale acquisition cost (WAC) of $27,389 per infusion.

March 16, 2022 – Rinvoq® (upadacitinib), made by AbbVie, has a new indication to treatment moderately to severely active ulcerative colitis in adults who have had an inadequate response or intolerance to at least one tumor necrosis factor blocker.

• Recommended dosing under the new indication is 45mg once daily for eight weeks, followed by maintenance dosing of 15mg once daily. For patients who have refractory, severe, or extensive disease, a dose of 30mg once daily can be considered. Rinvoq should be used at the lowest effective dose to maintain response and should be discontinued if an adequate therapeutic response is not achieved at the 30mg dosage.
• First FDA approved in 2019, Rinvoq is also indicated to treat rheumatoid arthritis, psoriatic arthritis, and atopic dermatitis.

The U.S. FDA has approved Mylan’s Breyna®, a generic for AstraZeneca’s Symbicort® (budesonide/formoterol fumarate dihydrate) inhalation aerosol. Brand name Symbicort first received FDA approval in 2006, and an authorized generic from Prasco launched in 2020.

• The first AB-rated generic for Symbicort, Breyna is indicated to provide:
  • Asthma treatment for patients at least six years of
  • Maintenance treatment for airflow obstruction and to reduce exacerbations for patients who have chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.
• Recommended dosing is as follows:
  • Asthma (patients at least 12 years old): Two inhalations twice daily of either 80mcg budesonide/4.5mcg formoterol or 160mcg budesonide/4.5mcg formoterol. The starting dosage strength is based on asthma severity.
  • Asthma (patients six to less than 12 years old): Two 80mcg/4.5mcg inhalations twice
  • COPD: Two 160mcg/4.5mcg inhalations twice
• Mylan hopes to launch Breyna in 2022, depending on the outcome of patent litigation. Pricing information is not yet available.