SOLIRIS® (Eculizumab)

SOLIRIS®

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Important Safety Information

SOLIRIS® (eculizumab) is an infusion prescription medication used to treat adults with neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin-4 (AQP4) antibody-positive. Adults may also have paroxysmal nocturnal hemoglobinuria (PNH), hemolytic uremic syndrome (aHUS), and myasthenia gravis.

While it is an effective form of treatment, it also affects the immune system’s ability to fight infections. Specifically, SOLIRIS® may increase your risk of contracting life-threatening meningococcal infections. For this reason, you must receive meningococcal vaccines at least two weeks prior to your first SOLIRIS® dose. Your medical provider will continue to monitor you throughout treatment to determine whether you need additional vaccinations.

Keep in mind that while meningococcal vaccines reduce the risk of meningococcal infections, they do not completely eliminate it. Seek emergency medical care immediately if you experience any of the following symptoms:

  • Headache with a fever
  • Headache with nausea and vomiting
  • Fever and a rash
  • Stiff neck
  • Rash
  • Stiff back
  • Confusion
  • Muscle aches and flu-like symptoms
  • Sensitivity to light

Before you start treatment, your doctor will provide you with a patient safety card with all relevant information relating to meningococcal infections. Keep it with you at all times for the duration of the treatment — and for three months once treatment has ended. In the event you receive medical treatment from another medical provider, show them the card.

It is unknown whether SOLIRIS® could harm an unborn baby or pass to a child through breast milk. Therefore, talk to your doctor if you’re pregnant, planning on becoming pregnant, or are breastfeeding, so that you can discuss your options.

What is the most important information I should know about SOLIRIS®?

Prior to starting treatment, your doctor will enroll you in a program called the SOLIRIS® REMS. This is required for all patients who undergo infusion therapy with SOLIRIS®. Your doctor will also provide you with all information relating to the program, as well as discuss all symptoms relating to a meningococcal infection — so that you can recognize them immediately.

Do not seek treatment with SOLIRIS® if you have a history of meningococcal infections or if you have not been vaccinated for meningitis. In addition, talk to your doctor about your entire medical history, including if you’ve experienced recurring infections or fever.

SOLIRIS® may not interact well with other medications. Tell your doctor about all drugs you’re currently taking — regardless of whether they’re prescription, over-the-counter, vitamins, or herbal supplements.

Side Effects of SOLIRIS®

As with any prescription medication, SOLIRIS® carries the risk of side effects. The most common ones include:

  • Fever
  • Joint pain
  • Throat irritation
  • Bruising
  • Flu-like symptoms
  • Coughing
  • Back pain
  • Diarrhea
  • Common colds
  • Pain or swelling of the nose and/or throat

In rare cases, patients may experience more serious, life-threatening side effects. Seek emergency medical care immediately if you experience:

  • Chest pain
  • Breathing difficulties
  • Swelling of the face, throat, lips, and/or tongue
  • Feeling faint
  • Fainting

Tell your doctor if you experience any negative side effects. You are also encouraged to report such side effects to the Food and Drug Administration (FDA) by visiting www.fda.gov/medwatch, or by calling 1-800-FDA-1088.

Indications

SOLIRIS® is used to treat adults with neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin-4 (AQP4) antibody-positive, as well as have paroxysmal nocturnal hemoglobinuria (PNH), hemolytic uremic syndrome (aHUS), and myasthenia gravis. The recommended dosage may vary depending on the condition being treated.

Please refer to the full prescribing information.