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 meningitidis, 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
decrease in blood pressure
chest discomfort
rapid heartbeat
nausea
injection site reaction
flushing
headache
dizziness
rash
itchy skin
shortness of breath
decrease in blood pressure
chest discomfort
rapid heartbeat
nausea
injection site reaction
flushing
headache
dizziness
rash
itchy skin
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 the return of your symptoms after you stop ENJAYMO. Stopping ENJAYMO may cause the breakdown of your red blood cells due to CAD 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
tiredness
shortness of breath
rapid heart rate
blood in your urine or
dark urine
The most common side effects of ENJAYMO include:
increase in blood pressure
urinary tract infection
respiratory tract infection
bacterial infection
swelling in lower
legs or hands
joint pain
headache
nausea
runny nose
bluish color to
the lips and skin
dizziness
feeling tired or weak
cough
changes in color or sensation
in the fingers and toes
(Raynaud's phenomenon)
increase in blood
pressure
urinary tract infection
respiratory tract
infection
bacterial infection
swelling in lower legs
or hands
joint pain
headache
nausea
runny nose
bluish color to
the lips and skin
dizziness
feeling tired or weak
cough
changes in color or
sensation in the fingers
and toes (Raynaud's
phenomenon)
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.
Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
