Soliris rems program

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Prescribing Information. Medication Guide. Increased risk of meningococcal infections with Soliris Early signs of invasive meningococcal infections, and Need for immediate medical evaluation of signs and symptoms consistent with possible meningococcal infections.

Alexion reserves the right to rescind, revoke, or amend this program without notice. Life-threatening and fatal meningococcal infections have occurred in patients treated with Soliris and may become rapidly life-threatening or fatal if not recognized and treated early.

Vaccinate or revaccinate for meningococcal disease according to the most current ACIP recommendations for patients with complement deficiencies. Immunize patients without a history of meningococcal vaccination at least 2 weeks prior to receiving the first dose of Soliris. If Soliris must be initiated immediately in an unvaccinated patient, administer meningococcal vaccine s as soon as possible and provide 2 weeks of antibacterial drug prophylaxis.

Discontinue Soliris in patients who are undergoing treatment for serious meningococcal infections. Prescribers must counsel patients about the risk of meningococcal infection, provide the patients with the REMS educational materials, and ensure patients are vaccinated with meningococcal vaccine s. Serious infections with Neisseria species other than N. Patients may have increased susceptibility to infections, especially with encapsulated bacteria.

Additionally, Aspergillus infections have occurred in immunocompromised and neutropenic patients. Use caution when administering Soliris to patients with any systemic infection. Administration of Soliris may result in infusion reactions, including anaphylaxis or other hypersensitivity reactions.

Interrupt Soliris infusion and institute appropriate supportive measures if signs of cardiovascular instability or respiratory compromise occur.