Labeling updates and warnings through October 2008 for adalimumab (Humira), certolizumab pegol (Cimzia), etanercept (Enbrel), infliximab (Remicade), and rituximab (Rituxan)
Labeling updates and warnings through October 2008 for adalimumab (Humira), certolizumab pegol (Cimzia), etanercept (Enbrel), infliximab (Remicade), and rituximab (Rituxan).
FDA has notified the manufacturers of adalimumab (Humira, Abbott), certolizumab pegol (Cimzia, UCB), etanercept (Enbrel, Amgen/Wyeth), and infliximab (Remicade, Centocor) that the labeling for these drugs must be changed to strengthen warnings regarding the risk of development of opportunistic fungal infections. Although the prescribing information for these drugs already contains information about this risk, reports received by FDA have suggested that healthcare professionals are not consistently recognizing cases of histoplasmosis and other invasive fungal infections in patients treated with these agents, which could lead to delays in treatment. These treatment delays could result in death.
Genentech and Biogen Idec have notified healthcare professionals that a case of progressive multifocal leukoencephalopathy (PML) leading to death has been reported in a patient with rheumatoid arthritis who was treated with rituximab (Rituxan) in a long-term safety extension clinical trial. The prescribing information for rituximab has been updated to reflect this new information.
Navitus to Offer Unbranded Stelara Biosimilar, Remove Stelara from Formulary
March 13th 2025Lumicera Health Services, Navitus’ specialty pharmacy, has made a deal with Teva to offer an unbranded biosimilar that they estimate will save $112,000 and $336,000 per patient per year. Navitus will remove Stelara from formulary on July 1, 2025.
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FDA Approves Neffy 1 mg Nasal Spray for Pediatric Patients
March 6th 2025Neffy 1 mg is now approved by the FDA to treat pediatric patients who weigh 33 to 65 lbs. Neffy was first FDA-approved as a 2 mg dose in August 2024 for the emergency treatment of anaphylaxis in children and adults weighing at least 66 lbs.
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