PYZCHIVA® is a human interleukin-12 (IL-12) and -23 (IL-23) antagonist indicated for the treatment of:
Adult patients with:
-
moderate to severe plaque psoriasis (PsO) who are candidates for
phototherapy or systemic therapy
- active psoriatic arthritis (PsA)
- moderately to severely active Crohn’s disease (CD)
- moderately to severely active ulcerative colitis
Pediatric patients 6 years of age and older with:
-
moderate to severe plaque psoriasis, who are candidates for
phototherapy or systemic therapy
- active psoriatic arthritis
PYZCHIVA® is a prescription medicine that affects your immune
system. PYZCHIVA® can increase your risk of having serious
side effects, including:
Serious infections: PYZCHIVA® may lower your ability
to fight infections. Some people have serious infections while taking PYZCHIVA®, including tuberculosis (TB), and infections caused by bacteria,
fungi, or viruses. Some people have to be hospitalized for treatment of
their infection. Therefore, your doctor should check you for TB before
starting PYZCHIVA®
and watch you closely for signs and symptoms of TB during treatment with
PYZCHIVA®. If your doctor feels that you are at risk for
TB, you may be treated for TB before and during treatment with PYZCHIVA®. You should not start taking PYZCHIVA® if you have any kind
of infection unless your doctor says it is okay.
Before starting PYZCHIVA®, tell your doctor if you:
-
think you have an infection or have symptoms of an infection such
as:
- fever, sweat, or chills
- muscle aches
- cough
- shortness of breath
- blood in phlegm
- weight loss
- warm, red, or painful skin or sores on your body
- diarrhea or stomach pain
-
burning when you urinate or urinate more often than normal
- feel very tired
- are being treated for an infection or have any open cuts
-
get a lot of infections or have infections that keep coming back
- have TB or have been in close contact with someone with TB
After starting PYZCHIVA®, call your doctor right
away if you have any symptoms of an infection (see above). These may be signs
of infections such as chest infections, or skin infections or shingles that
could have serious complications. PYZCHIVA®
can make you more likely to get infections or make an infection that you
have worse. People who have a genetic problem where the body does not make
any of the proteins IL-12 and IL-23 are at a higher risk for certain serious infections. These infections can
spread throughout the body and cause death. People who take PYZCHIVA® may also be more likely to get these infections.
Cancers: PYZCHIVA® is an immunosuppressant and may
increase your risk of certain types of cancers. Tell your doctor if you have
ever had any type of cancer. Some people who are receiving PYZCHIVA® and have risk factors for skin cancer have developed certain types of skin
cancers. During your treatment with PYZCHIVA®, tell your
doctor if you develop any new skin growths.
Posterior Reversible Encephalopathy Syndrome (PRES): PRES is a rare
condition that affects the brain and can cause death. The cause of PRES is
not known. If PRES is found early and treated, most people recover. Tell
your doctor right away if you have any new or worsening medical problems
including:
- headache
- seizures
- confusion
- vision problems
Serious Allergic Reactions: Serious allergic reactions can occur with
PYZCHIVA®. Stop using PYZCHIVA® and get medical
help right away if you have any of the following symptoms of a serious allergic
reaction:
- feeling faint
- chest tightness
- swelling of your face, eyelids, tongue, or throat
- skin rash
Lung Inflammation: Cases of lung inflammation have happened in some
people who receive PYZCHIVA®, and may be serious. These
lung problems may need to be treated in a hospital. Tell your doctor
right away if you develop shortness of breath or a cough that
doesn’t go away during treatment with PYZCHIVA®.
Before you receive PYZCHIVA®, tell your doctor about
all of your medical conditions, including if you:
-
have any of the conditions or symptoms listed above for serious
infections, cancers, or PRES
-
ever had an allergic reaction to PYZCHIVA® or other ustekinumab
products. Ask your doctor if you are not sure
-
have recently received or are scheduled to receive an immunization
(vaccine). People who take PYZCHIVA®
should not receive live vaccines. Tell your doctor if anyone in your
house needs a live vaccine. The viruses used in some types of live vaccines
can spread to people with a weakened immune system and can cause serious
problems.
You should not receive the BCG vaccine during the one year
before receiving PYZCHIVA® or one year after you stop
receiving PYZCHIVA®
-
have any new or changing lesions within psoriasis areas or on normal
skin
-
are receiving or have received allergy shots, especially for serious
allergic reactions. Allergy shots may not work as well for you
during treatment with PYZCHIVA®. PYZCHIVA® may also increase your risk of having an allergic reaction to an allergy
shot.
- receive or have received phototherapy for your psoriasis
-
are pregnant or plan to become pregnant. It is not known if PYZCHIVA® can harm your unborn baby. You and your doctor should decide if you
will receive PYZCHIVA®
-
received PYZCHIVA® while you were pregnant. It is important
that you tell your baby’s doctor before any vaccinations are given
to your baby
-
are breastfeeding or plan to breastfeed. PYZCHIVA® can
pass into your breast milk
-
Talk to your doctor about the best way to feed your baby if you
receive PYZCHIVA®
Tell your doctor 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 doctor and
pharmacist when you get a new medicine.
When prescribed PYZCHIVA®:
-
use PYZCHIVA® exactly as your doctor tells you to
-
PYZCHIVA® is intended for use under the guidance and supervision
of your doctor. In children 6 years and older, it is recommended that
PYZCHIVA®
be administered by a healthcare provider. If your doctor decides that
you or a caregiver may give your injections of PYZCHIVA® at home, you should receive training on the right way to prepare and
inject PYZCHIVA®. Your doctor will determine the
right dose of PYZCHIVA®
for you, the amount for each injection, and how often you should receive
it. Do not try to inject PYZCHIVA® yourself until you
or your caregiver have been shown how to inject PYZCHIVA® by your doctor or nurse
Keep PYZCHIVA® and all medicines out of the reach of
children.
Common side effects for PYZCHIVA® include nasal congestion,
sore throat, and runny nose; upper respiratory infections; fever; headache;
tiredness; itching; nausea and vomiting; redness at the injection site; vaginal
yeast infections; urinary tract infections; sinus infection; bronchitis;
diarrhea; and stomach pain. These are not all of the possible side effects
with PYZCHIVA®. Tell your doctor about any side effect
that you experience. Ask your doctor or pharmacist for more information.
Please see your doctor to discuss any questions you may have.
Please see full Prescribing Information, including Medication Guide, for PYZCHIVA®.
You are encouraged to report negative side effects of prescription
drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
