RX Product News: April 2022

Pharmacy TimesApril 2022
Volume 88
Issue 4

This month's Rx product new features Cabotegravir and Rilpivirine, Fleqsuvy, and Enjaymo.

Sutimlimab-Jome (Enjaymo)

Manufactured by Sanofi

The FDA has approved sutimlimab-jome (Enjaymo; Sanofi) to decrease the need for red blood cell transfusion because of hemolysis in adults with cold agglutinin disease (CAD). Enjaymo is the first and only approved treatment for individuals with CAD and works by inhibiting the destruction of red blood cells. CAD is a rare autoimmune hemoltic anemia caused by antibodies binding to the surface of red blood cells. Enjaymo is a humanized monoclonal antibody designed to selectively target and inhibit C1s in the classical complement pathway but it does not inhibit the lectin and alternative pathway. The most common adverse events were arthralgia, arthritis, cough, diarrhea, and respiratory tract or viral infection.



Baclofen Oral Suspension (Fleqsuvy)

Manufactured by Azurity Pharmaceuticals

The FDA has approved baclofen oral suspension (Fleqsuvy; Azurity Pharmaceuticals) at the 25 mg/5 mL strength for the treatment of individuals with spasticity from multiple sclerosis (MS) or individuals with other spinal cord diseases or injuries. Dysphagia is commonly experienced with MS so the oral liquid provides a solution for those who have trouble swallowing pills or prefer a liquid formula. Fleqsuvy is a grape-flavored oral suspension formulation, particularly for the relief of clonus, flexor spasms and concomitant pain, and muscular rigidity. It is available in 120- and 300-mL bottles. There
is no indication for the treatment of skeletal muscle spasms resulting from rheumatic disorder.



Cabotegravir and Rilpivirine (Cabenuva)

Manufactured by ViiV Healthcare

The FDA has approved cabotegravir and rilpivirine (Cabenuva; ViiV Healthcare) for every-2-month dosing treatment of HIV-1 in virologically suppressed adults on a stable regimen with no history of prior treatments not working and with no known or suspected resistance to either drug. The drug comprises ViiV Healthcare’s cabotegravir extended-release (ER) injectable suspension in a single-dose vial and rilpivirine ER injectable suspension in a single-dose vial, a product of Janssen Sciences Ireland Unlimited Company, one of the Janssen Pharmaceutical Companies of Johnson & Johnson. Cabenuva is the first and only long-acting HIV treatment regimen. The FDA approved the drug in January 2021 as a once-monthly treatment.



Atogepant Oral Tablets (Qulipta)

Manufactured by AbbVie

The FDA has approved atogepant oral tablets (Qulipta; AbbVie) for the preventive treatment of episodic migraines for adults. Qulipta, a calcitonin gene–related peptide receptor antagonist, is the only oral medication specifically developed for the prevention of migraines. The recommended dosage is 10, 30, or 60 mg per day, orally, with dose modification depending on the concurrent use of specific drugs and renal functions. The medication can be taken with or without food. The most common adverse events are constipation, fatigue, and nausea. Investigators have not established an efficacy and safety profile for Qulipta in children.



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