"The U.S. Food and Drug Administration yesterday approved Rixubis [Coagulation Factor IX (Recombinant)] for use in people with hemophilia B who are 16 years of age and older. Rixubis is indicated for the control and prevention of bleeding episodes"...
Soliris Patient Information Including Side Effects
Brand Names: Soliris
Generic Name: eculizumab (Pronunciation: E kue LIZ oo mab)
- What is eculizumab (Soliris)?
- What are the possible side effects of eculizumab (Soliris)?
- What is the most important information I should know about eculizumab (Soliris)?
- What should I discuss with my health care provider before taking eculizumab (Soliris)?
- How is eculizumab given (Soliris)?
- What happens if I miss a dose (Soliris)?
- What happens if I overdose (Soliris)?
- What should I avoid while taking eculizumab (Soliris)?
- What other drugs will affect eculizumab (Soliris)?
- Where can I get more information?
What is eculizumab (Soliris)?
Eculizumab is a monoclonal antibody that binds to proteins in the blood that can destroy red blood cells in people with a genetic condition that affects the natural defenses of red blood cells.
Eculizumab is used to prevent the breakdown of red blood cells in people with paroxysmal nocturnal hemoglobinemia (PNH).
Eculizumab is also used to treat a rare chronic blood disease called atypical hemolytic (HEEM-oh-LIT-ik yoo-REEM-ik) uremic syndrome.
Eculizumab may also be used for purposes not listed in this medication guide.
What are the possible side effects of eculizumab (Soliris)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have a serious side effect such as:
- severe headache with fever, confusion, purple spots on the skin, nausea or vomiting, and/or seizure (convulsions);
- stiffness in your neck or back;
- sensitivity to bright light;
- high fever (103 degrees or higher), chills, body aches, flu symptoms;
- pain or burning when you urinate;
- any signs of a new illness or infection; or
- signs that the medication is not working (pale skin, easy bruising, weakness, dark urine, feeling short of breath, or sudden numbness, severe headache, deep leg pain, or problems with vision, speech, or balance).
Less serious side effects may include:
- mild headache;
- runny nose, sore throat; or
- back pain.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Read the Soliris (eculizumab) Side Effects Center for a complete guide to possible side effects
What is the most important information I should know about eculizumab (Soliris)?
Eculizumab affects your immune system, and using this medication may increase your risk of serious infection such as meningitis. You must be vaccinated against meningococcal infection at least 2 weeks before you start treatment with eculizumab. If you have been vaccinated in the past, you may need a booster dose. Call your doctor at once if you have a serious side effect such as severe headache, high fever, chills, stiffness in your neck or back, confusion, sensitivity to bright light, purple spots on the skin, nausea or vomiting, and/or seizure (convulsions). With your medication you will receive a Patient Safety Card listing the symptoms of meningococcal infection. Carry this card with you at all times. Seek emergency medical attention or call your doctor right away if you notice any of these symptoms.
You should not use this medication if you are allergic to eculizumab, if you have bacterial meningitis, or if you have not been vaccinated against meningitis.
Before using eculizumab, tell your doctor if you have a fever or any type of infection.
Do not stop using eculizumab without first talking to your doctor. Stopping or interrupting your treatment could cause sudden and serious effects on your red blood cells. This may result in symptoms such as pale skin, easy bruising, confusion, chest pain, blood clots, or kidney problems.
Eculizumab is available only under a special program called Soliris REMS. You must be registered in the program and sign documents stating that you understand the risks and benefits of taking this medication.
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