Serious Infections: ENJAYMO is a prescription
medicine that affects your immune system. ENJAYMO can lower the ability of your immune
system to fight infections. People who take ENJAYMO may have an increased risk of getting
infections caused by certain kinds of bacteria such as
Neisseria
meningitides, Streptococcus pneumoniae
, and
Haemophilus
influenzae
. These infections may be serious or life-threatening. Some infections
may quickly become life-threatening or cause death if not recognized and treated early.
You need to receive vaccinations against infections caused by certain kinds of bacteria at least
2 weeks before your first dose of ENJAYMO. You may need to have additional vaccinations during
treatment
If your healthcare provider decides that urgent treatment with ENJAYMO is needed, you should
receive vaccinations as soon as possible.
Vaccinations may reduce the risk of these infections, but do not prevent all infections. Call
your healthcare provider or get medical help right away if you get any new signs and symptoms of
an infection, including:
fever
severe headache with stiff neck or back
pain during urination or urinating more often than usual
cough or difficulty breathing
flu-like symptoms
pain, redness or swelling of the skin
Infusion-related reactions: Treatment with ENJAYMO may
cause infusion-related reactions, including allergic reactions that may be serious or
life-threatening. Your healthcare provider may slow down or stop your ENJAYMO infusion if
you have an infusion-related reaction, and will treat your symptoms if needed. Tell your
healthcare provider right away if you develop symptoms during your ENJAYMO infusion that may
mean you are having an infusion-related reaction, including:
shortness of breath
rapid heartbeat
nausea
Risk of autoimmune disease: ENJAYMO may increase your risk
for developing an autoimmune disease such as systemic lupus erythematosus (SLE). Tell your
healthcare provider and get medical help if you develop any symptoms of SLE, including:
joint pain or swelling
rash on the cheeks and nose
unexplained fever
If you have CAD and you stop receiving ENJAYMO, your healthcare provider should monitor you
closely for return of your symptoms after you stop ENJAYMO. Stopping ENJAYMO may cause the
breakdown of your red blood cells due to CAD to return. Symptoms or problems that can happen due
to red blood cell breakdown include:
tiredness
shortness of breath
rapid heart rate
blood in your urine or dark urine
The most common side effects of ENJAYMO include:
respiratory tract infection
viral infection
diarrhea
indigestion
cough
joint pain
joint inflammation (arthritis)
swelling of the lower legs, ankles, and feet
These are not all the possible side effects of ENJAYMO. Call your doctor for medical advice about
side effects.
Before receiving ENJAYMO, tell your healthcare provider about all of your medical conditions, including if you:
have a fever or infection, including a history of human immunodeficiency virus (HIV), hepatitis
B, or hepatitis C.
have an autoimmune disease such as systemic lupus erythematosus (SLE), also known as lupus.
are pregnant or plan to become pregnant. It is not known if ENJAYMO will harm your unborn baby.
are breastfeeding or plan to breastfeed. It is not known if ENJAYMO 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.
