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.
