Indication & Important Safety Information for Soliris® (eculizumab)INDICATION
What is SOLIRIS?
SOLIRIS is a prescription medicine called a monoclonal antibody. SOLIRIS is used to treat:
- adults and children with a disease called atypical Hemolytic Uremic Syndrome (aHUS)
- SOLIRIS is not for use in treating people with Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS)
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about SOLIRIS?
SOLIRIS is a medicine that affects your immune system. SOLIRIS can lower the ability of your immune system to fight infections.
- SOLIRIS increases your chance of getting serious and life-threatening meningococcal infections. Meningococcal infections may quickly become life-threatening and cause death if not recognized and treated early.
- You must receive meningococcal vaccines at least 2 weeks before your first dose of SOLIRIS if you have not already had this vaccine.
- If your doctor decided that urgent treatment with SOLIRIS is needed, you should receive meningococcal vaccination as soon as possible.
- If you have not been vaccinated and SOLIRIS therapy must be initiated immediately, you should also receive 2 weeks of antibiotics with your vaccinations.
- If you had a meningococcal vaccine in the past, you might need additional vaccination before starting SOLIRIS. Your doctor will decide if you need additional meningococcal vaccinations.
- Meningococcal vaccines reduce the risk of meningococcal infection but do not prevent all meningococcal infections. Call your doctor or get emergency medical care right away if you get any of these signs and symptoms of a meningococcal infection:
- headache with nausea or vomiting
- headache and a fever
- headache with a stiff neck or stiff back
- fever and rash
- muscle aches with flu-like symptoms
- eyes sensitive to light
Your doctor will give you a Patient Safety Card about the risk of meningococcal infection. Carry it with you at all times during treatment and for 3 months after your last SOLIRIS dose. Your risk of meningococcal infection may continue for several weeks after your last dose of SOLIRIS. It is important to show this card to any doctor or nurse who treats you. This will help them diagnose and treat you quickly.
SOLIRIS is only available through a program called the SOLIRIS REMS. Before you can receive SOLIRIS, your doctor must:
- enroll in the SOLIRIS REMS program
- counsel you about the risk of meningococcal infection
- give you information about the symptoms of meningococcal infection
- give you a Patient Safety Card about your risk of meningococcal infection, as discussed above
- make sure that you are vaccinated with a meningococcal vaccine
SOLIRIS may also increase the risk of other types of serious infections. If your child is treated with SOLIRIS, make sure that your child receives vaccinations against Streptococcus pneumoniae and Haemophilus influenzae type b (Hib). Certain people may be at risk of serious infections with gonorrhea. Talk to your doctor about whether you are at risk for gonorrhea infection, about gonorrhea prevention, and regular testing. Certain fungal infections (Aspergillus) may also happen if you take SOLIRIS and have a weak immune system or a low white blood cell count.
Who should not receive SOLIRIS?
Do not receive SOLIRIS if you:
- have a meningococcal infection.
- have not been vaccinated against meningitis infection unless your doctor decides that urgent treatment with SOLIRIS is needed. See “What is the most important information I should know about SOLIRIS?”
Before you receive SOLIRIS, tell your doctor about all of your medical conditions, including if you:
- have an infection or fever.
- are pregnant or plan to become pregnant. It is not known if SOLIRIS will harm your unborn baby.
- are breastfeeding or plan to breastfeed. It is not known if SOLIRIS passes into your breast milk.
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. SOLIRIS and other medicines can affect each other causing side effects.
It is important that you:
- have all recommended vaccinations before you start SOLIRIS
- receive 2 weeks of antibiotics if you immediately start SOLIRIS
- stay up-to-date with all recommended vaccinations during treatment with SOLIRIS
Know the medications you take and the vaccines you receive. Keep a list of them to show your doctor and pharmacist when you get a new medicine.
Monitoring Disease After Stopping SOLIRIS
- If you have aHUS, your doctor will need to monitor you closely during and for at least 12 weeks after stopping treatment for signs of worsening aHUS symptoms or problems related to abnormal clotting (thrombotic microangiopathy). Symptoms or problems that can happen with abnormal clotting may include:
- chest pain (angina)
- difficulty breathing
- kidney problems
- swellings in arms or legs
- a drop in your platelet count
What are the possible side effects of SOLIRIS?
SOLIRIS can cause serious side effects including:
- See “What is the most important information I should know about SOLIRIS?”
- Serious allergic reactions. Serious allergic reactions can happen during your SOLIRIS infusion. Tell your doctor or nurse right away if you get any of these symptoms during your SOLIRIS infusion:
- chest pain
- trouble breathing or shortness of breath
- swelling of your face, tongue, or throat
- feel faint or pass out
If you have an allergic reaction to SOLIRIS, your doctor may need to infuse SOLIRIS more slowly, or stop SOLIRIS. See “How will I receive SOLIRIS?” in the Medication Guide.
The most common side effects in people with aHUS treated with SOLIRIS include:
- high blood pressure (hypertension)
- common cold (upper respiratory infection)
- stomach-area (abdominal pain)
- pain or swelling of your nose or throat (nasopharyngitis)
- low red blood cell count (anemia)
- swelling of legs or feet (peripheral edema)
- urinary tract infections
Tell your doctor about any side effect that bothers you or that does not go away. These are not all the possible side effects of SOLIRIS. For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.