Soliris REMS Enrollment

(Instructions to the HCP - "Please read the following information about Soliris REMS Program

and complete the REMS Enrollment form at the bottom of this information page".)


Dear Soliris® (eculizumab) Prescriber,

 

Alexion, the maker of Soliris, would like to notify you of a Risk Evaluation and Mitigation Strategy (REMS) called the OneSource Safety Support Program to provide important safety information about Soliris.

 

To get started in the Program, please complete this Prescriber Enrollment Form. The completed Prescriber Enrollment Form can be faxed to the Soliris OneSource Safety Support Program (OSSP) at 1.877.580.2596 (ALXN); scanned and e-mailed to OSSP@alxn.com; or mailed to Alexion Pharmaceuticals, Inc., Attn: OneSource Safety Support Program; 352 Knotter Drive, Cheshire, CT 06410. Enrollment can also be completed online at SolirisREMS.com.

 

I have received the Soliris educational materials provided through the Soliris OneSource Safety Support Program and I have reviewed information about:

 

  The need for the patient to receive meningococcal vaccination at least 2 weeks prior to beginning Soliris (eculizumab), unless the risk of delaying Soliris therapy outweighs the risk of developing meningococcal infection
  The risks of developing meningococcal infection while receiving Soliris (eculizumab)

 

I agree to:

 

  Review the product labeling and educational materials, and comply with the safety instructions for use, including ensuring meningococcal vaccination status
  Counsel patients (or caregivers, or legal guardians) and provide educational materials to the patient (or caregivers, or legal guardians), including the Soliris Patient Safety Information Card, and the Soliris Medication Guide
  Intend to promptly report cases of meningococcal infection, including the patient's clinical outcomes, by contacting the OneSource Safety Support Program (Alexion Pharmaceuticals, Inc.) at l.888.SOLIRIS (1.888.765.4747); or reporting the information to the FDA MedWatch Reporting System by phone at l.800.FDA.l088 (1.800.332.1088) or by mail using Form 3500 at www.fda.gov/medwatch
  Revaccinate patients in accordance with the Advisory Committee on Immunization Practices (ACIP) recommendations for the duration of Soliris therapy

 

WARNING: SERIOUS MENINGOCOCCAL INFECTIONS

 

Life-threatening and fatal meningococcal infections have occurred in patients treated with Soliris. Meningococcal infection may become rapidly life-threatening or fatal if not recognized and treated early.

      Comply with the most current Advisory Committee on Immunization Practices (ACIP) recommendations for meningococcal vaccination in patients with complement deficiencies.
      Immunize patients with a meningococcal vaccine at least 2 weeks prior to administering the first dose of Soliris, unless the risks of delaying Soliris therapy outweigh the risks of developing a meningococcal infection. (See Serious Meningococcal Infections (5.1) for additional guidance on the management of the risk of meningococcal infection.)
      Monitor patients for early signs of meningococcal infections, and evaluate immediately if infection is suspected.

 

Soliris is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). Under the Soliris REMS prescribers must enroll in the program. Enrollment in the Soliris REMS program and additional information are available by telephone:
l-888-SOLIRIS (l-888-765-4747).

 

INDICATIONS AND USAGE

Soliris is a complement inhibitor indicated for:

          The treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis.
          The treatment of patients with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy.

 

Limitation of Use

Soliris is not indicated for the treatment of patients with Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS).

 

CONTRAINDICATIONS

Soliris is contraindicated in:

          Patients with unresolved Neisseria meningitidis infection.
          Patients who are not currently vaccinated against Neisseria meningitidis, unless the risks of delaying Soliris treatment outweigh the risks of developing a meningococcal infection.

 

WARNINGS AND PRECAUTIONS

          Discontinue Soliris in patients who are being treated for serious meningococcal infections.
          Use caution when administering Soliris to patients with any other systemic infection.

 

ADVERSE REACTIONS

          The most frequently reported adverse reactions in the PNH randomized trials (≥10% overall and greater than placebo) are: headache, nasopharyngitis, back pain, and nausea.
          The most frequently reported adverse reactions in aHUS single arm prospective trials (≥20% combined per patient incidence) are: headache, diarrhea, hypertension, upper respiratory infection, abdominal pain, vomiting, nasopharyngitis, anemia, cough, peripheral edema, nausea, urinary tract infections, and pyrexia.
        Please see full prescribing information for Soliris (eculizumab), including boxed WARNING regarding serious meningococcal infection.

 

Enrollment Form (Fields with asterisk * are compulsory) 

 
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