MEDICATION GUIDE
PYZCHIVA® (Piz-chi-va)
(ustekinumab-ttwe)
injection, for subcutaneous or intravenous use |
What is the most important information I should know about PYZCHIVA?
PYZCHIVA is a medicine that affects your immune system. PYZCHIVA can increase your risk of having serious side effects, including:
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Serious infections: PYZCHIVA may lower the ability of your immune system to fight infections and may increase your risk of infections. Some people have serious infections during treatment with ustekinumab products, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses. Some people have to be hospitalized for treatment of their infection.
- Your healthcare provider should check you for TB before starting PYZCHIVA.
- If your healthcare provider feels that you are at risk for TB, you may be treated with medicine for TB before you begin treatment with PYZCHIVA and during treatment with PYZCHIVA.
- Your healthcare provider should watch you closely for signs and symptoms of TB while you are being treated with PYZCHIVA.
You should not start PYZCHIVA if you have any kind of infection unless your healthcare provider says it is okay.
Before starting PYZCHIVA, tell your healthcare provider if you:
- think you have an infection or have symptoms of an infection such as:
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| ◦ 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 healthcare provider 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.
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People who have a genetic problem where the body does not make any of the proteins interleukin 12 (IL-12) and interleukin 23 (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.
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Cancers. PYZCHIVA may decrease the activity of your immune system and increase your risk for certain types of cancers. Tell your healthcare provider if you have ever had any type of cancer. Some people who are receiving ustekinumab products and have risk factors for skin cancer have developed certain types of skin cancers. During your treatment with PYZCHIVA, tell your healthcare provider if you develop any new skin growths.
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What is PYZCHIVA?
PYZCHIVA is a prescription medicine used to treat:
- adults and children 6 years of age and older with moderate to severe plaque psoriasis who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet light alone or with pills).
- adults and children 6 years of age and older with active psoriatic arthritis.
- adults with moderately to severely active Crohn's disease.
- adults with moderately to severely active ulcerative colitis.
It is not known if PYZCHIVA is safe and effective in children with Crohn's disease or ulcerative colitis or in children less than 6 years of age with plaque psoriasis or psoriatic arthritis.
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Who should not use PYZCHIVA?
Do not use PYZCHIVA if you are allergic to ustekinumab products or any of the ingredients in PYZCHIVA. See the end of this Medication Guide for a complete list of ingredients in PYZCHIVA. |
Before you use or receive PYZCHIVA, tell your healthcare provider about all of your medical conditions, including if you:
- have any of the conditions or symptoms listed in the section "What is the most important information I should know about PYZCHIVA?"
- ever had an allergic reaction to ustekinumab products. Ask your healthcare provider if you are not sure.
- have recently received or are scheduled to receive an immunization (vaccine). People who are being treated with PYZCHIVA should avoid receiving live vaccines. Tell your healthcare provider 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 avoid receiving 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 healthcare provider should decide if you will receive PYZCHIVA.
- are breastfeeding or plan to breastfeed. PYZCHIVA can pass into your breast milk.
- Talk to your healthcare provider about the best way to feed your baby if you receive PYZCHIVA.
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. |
How should I use PYZCHIVA?
- Use PYZCHIVA exactly as your healthcare provider tells you to. The healthcare provider will determine the right dose of PYZCHIVA, the amount for each injection, and how often it should be given. Be sure to keep all scheduled follow-up appointments.
- Adults with Crohn's disease and ulcerative colitis will receive the first dose of PYZCHIVA through a vein in the arm (intravenous infusion) in a healthcare facility by a healthcare provider. It takes at least 1 hour to receive the full dose of medicine. PYZCHIVA will then be received as an injection under the skin (subcutaneous injection) 8 weeks after the first dose of PYZCHIVA, as described below.
- Adults and children 6 years of age and older with plaque psoriasis or psoriatic arthritis will receive PYZCHIVA as an injection under the skin as described below.
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Injecting PYZCHIVA under the skin
- PYZCHIVA is intended for use under the guidance and supervision of a healthcare provider.
- In children, it is recommended that PYZCHIVA be administered by a healthcare provider. If a healthcare provider decides that you or a caregiver may give the injections of PYZCHIVA at home, you or a caregiver should receive training on the right way to prepare and give the injections.
- Do not try to inject PYZCHIVA until you have been shown how to give the injections by a healthcare provider.
- PYZCHIVA can be injected under the skin in the upper arms, buttocks, upper legs (thighs) or stomach area (abdomen).
- Do not give an injection in an area of the skin that is tender, bruised, red or hard.
- Use a different injection site each time you use PYZCHIVA.
- If you inject too much PYZCHIVA, call the healthcare provider or Poison Help line at 1-800-222-1222, or go to the nearest emergency room right away.
Read the detailed Instructions for Use at the end of this Medication Guide for instructions about how to prepare and inject a dose of PYZCHIVA, and how to properly throw away (dispose of) used needles, syringes, vials, and PYZCHIVA AUTOINJECTORs. The syringe, needle, vial, and PYZCHIVA AUTOINJECTOR must never be re-used. After the rubber stopper is punctured, PYZCHIVA can become contaminated by harmful bacteria which could cause an infection if re-used. Therefore, throw away any unused portion of PYZCHIVA. |
What should I avoid while using PYZCHIVA?
You should avoid receiving a live vaccine during treatment with PYZCHIVA. See "Before you use or receive PYZCHIVA, tell your healthcare provider about all of your medical conditions, including if you:" |
What are the possible side effects of PYZCHIVA?
PYZCHIVA may cause serious side effects, including:
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- feeling faint
- swelling of your face, eyelids, tongue, or throat
- chest discomfort
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- trouble breathing
- skin rash
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Posterior Reversible Encephalopathy Syndrome (PRES). PRES is a rare condition that affects the brain and can cause death. Tell your healthcare provider right away if you get any symptoms of PRES during treatment with PYZCHIVA, including:
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- confusion
- vision problems
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Lung inflammation. Cases of lung inflammation have happened in some people who receive ustekinumab products, and may be serious. These lung problems may need to be treated in a hospital. Tell your healthcare provider right away if you develop shortness of breath or a cough that doesn't go away during treatment with PYZCHIVA.
The most common side effects of PYZCHIVA include: |
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- nasal congestion, sore throat, and runny nose
- upper respiratory infections
- fever
- headache
- tiredness
- itching
- nausea and vomiting
- influenza
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- redness at the injection site
- vaginal yeast infections
- urinary tract infections
- sinus infection
- bronchitis
- diarrhea
- stomach pain
- joint pain
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These are not all of the possible side effects of PYZCHIVA. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
You may also report side effects to Cordavis Limited at 1-833-267-3114. |
How should I store PYZCHIVA?
- Store PYZCHIVA vials, prefilled syringes, and prefilled PYZCHIVA AUTOINJECTORs in a refrigerator between 36°F to 46°F (2°C to 8°C).
- Store PYZCHIVA vials standing up straight (upright).
- Store PYZCHIVA in the original carton to protect it from light until time to use it.
- Do not freeze PYZCHIVA.
- Do not shake PYZCHIVA.
- If needed, individual PYZCHIVA prefilled syringes, and prefilled PYZCHIVA AUTOINJECTORs may be stored at room temperature up to 86°F (30°C) for a maximum single period of up to 35 days in the original carton to protect from light.
- Record the date when the prefilled syringe and prefilled PYZCHIVA AUTOINJECTOR are first removed from the refrigerator on the carton in the space provided.
- You may return the prefilled syringe and prefilled PYZCHIVA AUTOINJECTOR to the refrigerator 1 time only for a maximum of 60 days, either during the 35-day period or at the end of the 35-day period.
- Record the date when the prefilled syringe and prefilled PYZCHIVA AUTOINJECTOR are returned to the refrigerator on the carton.
- Throw away (discard) the prefilled syringe and prefilled PYZCHIVA AUTOINJECTOR if not used within 35 days of room temperature storage and you did not return it to the refrigerator, or if it has been returned to the refrigerator and is not used within 60 days.
- Do not use PYZCHIVA after the expiration date on the carton or on the prefilled syringe and prefilled PYZCHIVA AUTOINJECTOR.
Keep PYZCHIVA and all medicines out of the reach of children. |
General information about the safe and effective use of PYZCHIVA.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use PYZCHIVA for a condition for which it was not prescribed. Do not give PYZCHIVA to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about PYZCHIVA that was written for health professionals. |
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What are the ingredients in PYZCHIVA?
Active ingredient: ustekinumab-ttwe
Inactive ingredients: Single-dose prefilled syringe, single-dose vial, and single-dose prefilled PYZCHIVA AUTOINJECTOR for subcutaneous use contain histidine, histidine hydrochloride monohydrate, polysorbate 80, and sucrose. Single-dose vial for intravenous infusion contains edetate disodium, histidine, histidine hydrochloride monohydrate, methionine, polysorbate 80, and sucrose.
Manufactured by: Samsung Bioepis Co., Ltd.,
76, Songdogyoyuk-ro, Yeonsu-gu, Incheon, 21987, Republic of Korea
U.S. License No. 2046
Manufactured for: Cordavis Limited
Dublin, Ireland
For more information, call 1-833-267-3114.
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