INDICATION
What is SOLIRIS?
SOLIRIS is a prescription medicine used to treat people with paroxysmal nocturnal
hemoglobinuria (PNH). It is not known if SOLIRIS is safe and effective in children
with PNH.
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about SOLIRIS?
SOLIRIS is a medicine that affects your immune system and may lower the ability of
your immune system to fight infections.
- SOLIRIS increases your chance of getting serious meningococcal
infections that may quickly become life-threatening or cause death if not
recognized and treated early.
- You must complete or update your meningococcal vaccine(s) at least 2 weeks
before your first dose of SOLIRIS.
- If you have not been vaccinated and SOLIRIS must be started right away, you
should receive the required vaccine(s) as soon as possible.
- If you have not been vaccinated and SOLIRIS must be started right away, you
should also receive antibiotics 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 SOLIRIS. 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 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 SOLIRIS. 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 healthcare provider who treats
you. This will help them diagnose and treat you quickly.
SOLIRIS is only available through a program called the ULTOMIRIS and
SOLIRIS
Risk
Evaluation and Mitigation Strategy (REMS). Before you can receive
SOLIRIS, your
healthcare provider must: enroll in the 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 SOLIRIS right away and you are not up to date
on
your vaccines; give you a Patient Safety Card about your risk
of
meningococcal
infection.
SOLIRIS may also increase the risk of other types of serious
infections, including
Streptococcus pneumoniae, Haemophilus influenzae, and Neisseria gonorrhoeae.
Certain
people may be at risk of serious infections with gonorrhea. Certain fungal
infections (Aspergillus) may occur 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 serious meningococcal infection when you
are
starting SOLIRIS.
Before you receive SOLIRIS, 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, and are breastfeeding or plan to breastfeed. It is not known if
SOLIRIS will harm your unborn baby or if it passes into your breast milk.
Tell your healthcare provider about all the vaccines you receive and
medicines you
take, including prescription and over-the-counter medicines,
vitamins,
and herbal
supplements which could affect your treatment.
If you have PNH, your healthcare provider will need to monitor you
closely
for at
least 8 weeks after stopping SOLIRIS. Stopping treatment with SOLIRIS 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 count, confusion, kidney problems, blood clots,
difficulty breathing, and chest pain.
What are the possible side effects of SOLIRIS?
SOLIRIS can cause serious side effects including serious infusion-related
reactions. Tell your healthcare provider 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, and feel faint or
pass out. If you have an infusion-related reaction to SOLIRIS, your healthcare
provider may need to infuse SOLIRIS more slowly, or stop SOLIRIS.
The most common side effects in people with PNH treated with SOLIRIS
include:
headache, pain or swelling of your nose or throat (nasopharyngitis), back pain,
and
nausea.
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 SOLIRIS. For more
information, ask your healthcare provider or pharmacist. Call your healthcare
provider for medical advice about side effects. You may report side effects to
FDA
at 1-800-FDA-1088.
Please see the full Prescribing
Information and Medication
Guide for SOLIRIS,
including Boxed WARNING regarding serious meningococcal infections.
