What is the most important information I should know about EPYSQLI?
EPYSQLI is a medicine that affects your immune system. EPYSQLI may lower the ability of your immune system to fight infections.
- EPYSQLI increases your chance of getting serious meningococcal infections caused by Neisseria meningitidis bacteria. Meningococcal infections may quickly become life-threatening or cause death if not recognized and treated early.
- You must complete or update your meningococcal vaccines at least 2 weeks before your first dose of EPYSQLI.
- If you have not completed your meningococcal vaccines and EPYSQLI must be started right away, you should receive the required vaccine(s) as soon as possible.
- If you have not been vaccinated and EPYSQLI must be started right away, you should also receive antibiotics to take for as long as your healthcare provider tells you.
- If you had a meningococcal vaccine in the past, you might need additional vaccines before starting EPYSQLI. Your healthcare provider will decide if you need additional meningococcal vaccines.
- Meningococcal vaccines do not prevent all meningococcal infections. Call your healthcare provider or get emergency medical care right away if you get any of these signs and symptoms of a serious meningococcal infection. Fever, fever with high heart rate, headache and fever, confusion, muscle aches with flu-like symptoms, fever and a rash, headache with nausea or vomiting, headache with a stiff neck or stiff back or eyes sensitive to light.
Your healthcare provider will give you a Patient Safety Card about the risk of serious meningococcal infection. Carry it with you at all times during treatment and for 3 months after your last dose of EPYSQLI. Your risk of meningococcal infection may continue for several weeks after your last dose of EPYSQLI. It is important to show this card to any healthcare provider who treats you. This will help them diagnose and treat you quickly.
EPYSQLI is only available through a program called the EPYSQLI Risk Evaluation and Mitigation Strategy (REMS). Before you can receive EPYSQLI, your healthcare provider must:
- enroll in the EPYSQLI REMS program
- counsel you about the risk of serious meningococcal infections
- give you information about the signs and symptoms of serious meningococcal infection
- make sure that you are vaccinated against serious infections caused by meningococcal bacteria and that you receive antibiotics if you need to start EPYSQLI right away and you are not up to date on your vaccines
- give you a Patient Safety Card about your risk of meningococcal infection, as discussed above
EPYSQLI may also increase the risk of other types of serious infections caused by encapsulated bacteria, including Streptococcus pneumoniae, Haemophilus influenzae, and Neisseria gonorrhoeae.
- If your child is treated with EPYSQLI, your child should receive vaccines against Streptococcus pneumoniae and Haemophilus influenzae type b (Hib).
- Certain people may be at risk of serious infections with gonorrhea. Talk to your healthcare provider 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 EPYSQLI and have a weak immune system or a low white blood cell count.
For more information about side effects, see “What are the possible side effects of EPYSQLI?”
Who should not receive EPYSQLI?
Do not receive EPYSQLI if you have a serious meningococcal infection when you are starting EPYSQLI treatment.
Before you receive EPYSQLI, tell your healthcare provider 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 EPYSQLI will harm your unborn baby or are breastfeeding or plan to breastfeed. It is not known if EPYSQLI passes into your breast milk.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. EPYSQLI and other medicines can affect each other causing side effects.
Know the medications you take and the vaccines you receive. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
If you miss an EPYSQLI infusion, call your healthcare provider right away.
If you have PNH, your healthcare provider will need to monitor you closely for at least 8 weeks after stopping EPYSQLI. Stopping treatment with EPYSQLI may cause breakdown of your red blood cells due to PNH. Symptoms or problems that can happen due to red blood cell breakdown include:
- drop in the number of your red blood cell count
- drop in your platelet counts
- confusion
- difficulty breathing
- blood clots
- chest pain
- kidney problems
If you have aHUS, your healthcare provider will need to monitor you closely for at least 12 weeks after stopping EPYSQLI 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:
- stroke
- confusion
- kidney problems
- seizure
- difficulty breathing
- swelling in arms or legs
- chest pain (angina)
- a drop in your platelet count
What are the possible side effects of EPYSQLI?
EPYSQLI can cause serious side effects including:
See “What is the most important information I should know about EPYSQLI?”
Serious infusion-related reactions can happen during your EPYSQLI infusion. Tell your healthcare provider or nurse right away if you experience chest pain, trouble breathing or shortness of breath, swelling of your face, tongue, or throat or feel faint or pass out during your EPYSQLI infusion.
If you have an infusion-related reaction to EPYSQLI, your healthcare provider may need to infuse EPYSQLI more slowly, or stop EPYSQLI.
The most common side effects in people with PNH treated with EPYSQLI include:
headache, pain or swelling of your nose or throat (nasopharyngitis), back pain and nausea.
The most common side effects in people with aHUS treated with EPYSQLI include:
Headache, diarrhea, high blood pressure (hypertension), common cold (upper respiratory infection), stomach-area (abdominal) pain, vomiting, pain or swelling of your nose or throat (nasopharyngitis), low red blood cell (anemia), cough, swelling of legs or feet (peripheral edema), nausea, urinary tract infections and fever.
The most common side effects in people with gMG treated with EPYSQLI include: muscle and joint (musculoskeletal) pain
Tell your healthcare provider about any side effect that bothers you or that does not go away. These are not all the possible side effects of EPYSQLI.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Please read the Medication Guide in the full Prescribing Information, including Boxed Warning.
