"The U.S. Food and Drug Administration today approved Siliq (brodalumab) to treat adults with moderate-to-severe plaque psoriasis. Siliq is administered as an injection.
Siliq is intended for patients who are candidates for systemic therapy "...
(stel ar' a)
(ustekinumab) Injection, for Subcutaneous or Intravenous Use
What is the most important information I should know about STELARA?
STELARA is a medicine that affects your immune system. STELARA can increase your risk of having serious side effects, including:
Serious infections: STELARA may lower the ability of your immune system to fight infections and may increase your risk of infections. Some people have serious infections while taking STELARA, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses. Some people have to be hospitalized for treatment of their infection.
- Your doctor should check you for TB before starting STELARA.
- If your doctor feels that you are at risk for TB, you may be treated with medicine for TB before you begin treatment with STELARA and during treatment with STELARA.
- Your doctor should watch you closely for signs and symptoms of TB during treatment with STELARA.
You should not start taking STELARA if you have any kind of infection unless your doctor says it is okay.
Before starting STELARA, tell your doctor if you:
- think you have an infection or have symptoms of an
infection such as:
- fever, sweat, or chills
- weight loss
- muscle aches
- warm, red, or painful skin or sores on your body
- diarrhea or stomach pain
- shortness of breath
- burning when you urinate or urinate more often than normal
- blood in phlegm ¢ feel very tired
- are being treated for an infection.
- 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 STELARA, call your doctor right away if you have any symptoms of an infection (see above). STELARA 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 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 STELARA may also be more likely to get these infections.
STELARA may decrease the activity of your immune system and increase your risk for certain types of cancers. Tell your doctor if you have ever had any type of cancer. Some people who are receiving STELARA and have risk factors for skin cancer have developed certain types of skin cancers. During your treatment with STELARA, tell your doctor if you develop any new skin growths.
Reversible Posterior Leukoencephalopathy Syndrome (RPLS)
RPLS is a rare condition that affects the brain and can cause death. The cause of RPLS is not known. If RPLS is found early and treated, most people recover. Tell your doctor right away if you have any new or worsening medical problems including:
- vision problems
What is STELARA?
STELARA is a prescription medicine used to treat adults 18 years and older with:
- moderate or severe psoriasis that involves large areas or many areas of their body, who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet light alone or with pills).
- active psoriatic arthritis. STELARA can be used alone or with methotrexate.
- moderately to severely active Crohn's disease in people who have already taken other medicine that did not work well enough or they could not tolerate it.
STELARA may improve your psoriasis, psoriatic arthritis or Crohn's disease, but may also lower the ability of your immune system to fight infections. Taking STELARA may also increase your risk for certain types of cancer.
It is not known if STELARA is safe and effective in children.
Do not take STELARA if you are allergic to ustekinumab or any of the ingredients in STELARA. See the end of this Medication Guide for a complete list of ingredients in STELARA.
Before you receive STELARA, tell your doctor if you:
- have any of the conditions or symptoms listed in the section “What is the most important information I should know about STELARA?”
- ever had an allergic reaction to STELARA. Ask your doctor if you are not sure.
- are allergic to latex. The needle cover on the prefilled syringe contains latex.
- have recently received or are scheduled to receive an immunization (vaccine). People who take STELARA should not receive live vaccines. Tell your doctor if anyone in your house needs a vaccine. The viruses used in some types of 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 taking STELARA or one year after you stop taking STELARA.
- 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 STELARA. STELARA may also increase your risk of having an allergic reaction to an allergy shot.
- receive or have received phototherapy for your psoriasis.
- have any other medical conditions.
- are pregnant or planning to become pregnant. It is not known if STELARA can harm your unborn baby. You and your doctor should decide if you will take STELARA. There is a pregnancy registry for women who take STELARA during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. If you are pregnant or become pregnant while taking STELARA, talk to your doctor about how you can join this pregnancy registry or you may contact the registry at 1-877-311-8972 to enroll.
- are breastfeeding or plan to breastfeed. It is thought that STELARA passes into your breast milk in small amounts.
- Talk to your doctor about the best way to feed your baby if you take STELARA.
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.
How should I use STELARA?
- Use STELARA exactly as prescribed by your doctor.
- The needle cover on the STELARA prefilled syringe contains latex. Do not handle the needle cover if you are sensitive to latex.
- Adults with Crohn's disease will receive the first dose of STELARA 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. You will then receive STELARA as an injection under the skin (subcutaneous injection) 8 weeks after the first dose of STELARA, as described below.
- Adults with psoriasis or psoriatic arthritis will receive STELARA as an injection under the skin (subcutaneous injection) as described below.
- Injecting STELARA under your skin
- If your doctor decides that you or a caregiver may give your injections of STELARA at home, you should receive training on the right way to prepare and inject STELARA. Do not try to inject STELARA yourself until you or your caregiver have been shown how to inject STELARA by your doctor or nurse.
- Inject STELARA under the skin (subcutaneous injection) in your 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 STELARA.
- If you inject more STELARA than prescribed, call your doctor right away.
- Be sure to keep all of your scheduled follow-up appointments.
- Read the detailed Instructions for Use at the end of this Medication Guide for instructions about how to prepare and inject a dose of STELARA, and how to properly throw away (dispose of) used needles and syringes.
What should I avoid while using STELARA?
You should not receive a live vaccine while taking STELARA. See “What should I tell my doctor before receiving STELARA?”
What are the possible side effects of STELARA?
STELARA may cause serious side effects, including:
- See “What is the most important information I should know about STELARA?”
- Serious allergic reactions. Serious allergic
reactions can occur with STELARA. Stop using STELARA 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
Common side effects of STELARA include:
- upper respiratory infections
- vaginal yeast infections
- urinary tract infections
- redness at the injection site
These are not all of the possible side effects of STELARA. 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 Janssen Biotech, Inc. at 1-800 JANSSEN (1-800-526-7736).
How should I store STELARA?
- Store STELARA prefilled syringes in a refrigerator between 36°F to 46°F (2°C to 8°C).
- Store STELARA in the original carton to protect it from light until time to use it.
- Do not freeze STELARA.
- Do not shake STELARA.
Keep STELARA and all medicines out of the reach of children.
General information about the safe and effective use of STELARA.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use STELARA for a condition for which it was not prescribed. Do not give STELARA to other people, even if they have the same symptoms that you have. It may harm them.
You can ask your doctor or pharmacist for information about STELARA that was written for health professionals.
What are the ingredients in STELARA?
Active ingredient: ustekinumab
Inactive ingredients: single-dose prefilled syringe contains L-histidine, L-histidine monohydrochloride monohydrate, polysorbate 80, and sucrose. Single-dose vial contains L-histidine, L-histidine hydrochloride monohydrate, polysorbate 80 and sucrose.
INSTRUCTIONS FOR USE
(stel ar' a)
(ustekinumab) injection, for subcutaneous use
Instructions for injecting STELARA using a prefilled syringe.
Read this Instructions for Use before you start using STELARA. Your doctor or nurse should show you how to prepare and give your injection of STELARA the right way.
If you cannot give yourself the injection:
- ask your doctor or nurse to help you, or
- ask someone who has been trained by a doctor or nurse to give your injections.
Do not try to inject STELARA yourself until you have been shown how to inject STELARA by your doctor, nurse or health professional.
- Before you start, check the carton to make sure that it
is the right dose. You will have either 45 mg or 90 mg as prescribed by your
- If your dose is 45 mg, you will receive one 45 mg prefilled syringe.
- If your dose is 90 mg, you will receive either one 90 mg prefilled syringe or two 45 mg prefilled syringes. If you receive two 45 mg prefilled syringes for a 90 mg dose, you will need to give yourself two injections, one right after the other.
- Check the expiration date on the pre-filled syringe and carton. If the expiration date has passed, do not use it. If the expiration date has passed call your doctor or pharmacist, or call 1-800-JANSSEN (1-800-526-7736) for help.
- Make sure the syringe is not damaged.
- The needle cover on the prefilled syringe contains latex. Do not handle the needle cover on the STELARA prefilled syringe if you are sensitive to latex.
- Check your prefilled syringe for any particles or discoloration. Your prefilled syringe should look clear and colorless to light yellow with few white particles.
- Do not use if it is frozen, discolored, cloudy or has large particles. Get a new prefilled syringe.
- Do not shake the prefilled syringe at any time. Shaking your prefilled syringe may damage your STELARA medicine. If your prefilled syringe has been shaken, do not use it. Get a new prefilled syringe.
- To reduce the risk of accidental needle sticks, each prefilled syringe has a needle guard that is automatically activated to cover the needle after you have given your injection. Do not pull back on the plunger at any time.
Gather the supplies you will need to prepare and to give your injection. (See Figure A)
You will need:
- antiseptic wipes
- cotton balls or gauze pads
- adhesive bandage
- your prescribed dose of STELARA (See Figure B)
FDA-cleared sharps disposal container. See “Step 4: Dispose of the syringe.”
Step 1: Prepare the injection.
- Choose a well lit, clean, flat work surface.
- Wash your hands well with soap and warm water.
- Hold the prefilled syringe with the covered needle pointing upward.
Step 2: Prepare your injection site
- Choose an injection site around your stomach area (abdomen), buttocks, upper legs (thighs). If a caregiver is giving you the injection, the outer area of the upper arms may also be used. (See Figure C)
- Use a different injection site for each injection. Do not give an injection in an area of the skin that is tender, bruised, red or hard.
- Clean the skin with an antiseptic wipe where you plan to give your injection.
- Do not touch this area again before giving the injection. Let your skin dry before injecting.
- Do not fan or blow on the clean area.
*Areas in gray are recommended injection sites.
Step 3: Inject STELARA
- Remove the needle cover when you are ready to inject your STELARA.
- Do not touch the plunger while removing the needle cover.
- Hold the body of the prefilled syringe with one hand, and pull the needle cover straight off. (see Figure D)
- Put the needle cover in the trash.
- You may also see a drop of liquid at the end of the needle. This is normal.
- Do not touch the needle or let it touch anything.
- Do not use the prefilled syringe if it is dropped without the needle cover in place. Call your doctor, nurse or health professional for instructions.
- Hold the body of the prefilled syringe in one hand between the thumb and index fingers. (See Figure E)
- Do not pull back on the plunger at any time.
- Use the other hand to gently pinch the cleaned area of skin. Hold firmly.
- Use a quick, dart-like motion to insert the needle into the pinched skin at about a 45-degree angle. (See Figure F)
- Inject all of the liquid by using your thumb to push in the plunger until the plunger head is completely between the needle guard wings. (See Figure G)
- When the plunger is pushed as far as it will go, keep pressure on the plunger head. Take the needle out of the skin and let go of the skin.
- Slowly take your thumb off the plunger head. This will let the empty syringe move up until the entire needle is covered by the needle guard. (See Figure H)
- When the needle is pulled out of your skin, there may be a little bleeding at the injection site. This is normal. You can press a cotton ball or gauze pad to the injection site if needed. Do not rub the injection site. You may cover the injection site with a small adhesive bandage, if necessary.
Step 4: Dispose of the syringe.
- Put the syringe in a FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) loose syringes in your household trash.
- If you do not have a FDA-cleared sharps disposal
container, you may use a household container that is:
- made of heavy-duty plastic.
- can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out.
- upright and stable during use,
- and properly labeled to warn of hazardous waste inside the container.
- When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be local or state laws about how to throw away syringes and needles. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA's website at: http://www.fda.gov/safesharpsdisposal.
- Do not dispose of your sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your sharps disposal container.
- If you have any questions, talk to your doctor or pharmacist.
Keep STELARA and all medicines out of the reach of children.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 10/24/2016
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