Patient information: uses, side effects, how to take - Steqeyma

What is the most important information I should know about STEQEYMA?

STEQEYMA is a medicine that affects your immune system. STEQEYMA can increase your risk of having serious side effects, including:

Serious infections.STEQEYMA 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 STEQEYMA.
- 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 STEQEYMA and during treatment with STEQEYMA.
- Your healthcare provider should watch you closely for signs and symptoms of TB while you are being treated with STEQEYMA.

You should not start STEQEYMA if you have any kind of infection unless your healthcare provider says it is okay.

Before starting STEQEYMA, tell your healthcare provider 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 STEQEYMA, 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. STEQEYMA 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 STEQEYMA may also be more likely to get these infections.
Cancers. STEQEYMA 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 STEQEYMA, tell your healthcare provider if you develop any new skin growths.

What is STEQEYMA?

STEQEYMA 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 STEQEYMA 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.

Who should not use STEQEYMA?

Do not use STEQEYMA if you are allergic to ustekinumab products or any of the ingredients in STEQEYMA. See the end of this Medication Guide for a complete list of ingredients in STEQEYMA.

Before you use or receive STEQEYMA, 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 STEQEYMA?"
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 STEQEYMA 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 STEQEYMA or one year after you stop receiving STEQEYMA.
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 STEQEYMA. STEQEYMA 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 STEQEYMA can harm your unborn baby. You and your healthcare provider should decide if you will receive STEQEYMA.
are breastfeeding or plan to breastfeed. STEQEYMA can pass into your breast milk.
Talk to your healthcare provider about the best way to feed your baby if you receive STEQEYMA.

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 STEQEYMA?

Use STEQEYMA exactly as the healthcare provider tells you to. The healthcare provider will determine the right dose of STEQEYMA, 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 STEQEYMA 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. STEQEYMA will then be received as an injection under the skin (subcutaneous injection) 8 weeks after the first dose of STEQEYMA, as described below.
Adults and children 6 years of age and older with plaque psoriasis or psoriatic arthritis will receive STEQEYMA as an injection under the skin as described below.
Injecting STEQEYMA under the skin
- STEQEYMA is intended for use under the guidance and supervision of a healthcare provider.
- In children, it is recommended that STEQEYMA be administered by a healthcare provider. If a healthcare provider decides that you or a caregiver may give the injections of STEQEYMA at home, you or a caregiver should receive training on the right way to prepare and inject STEQEYMA.
- Do not try to inject STEQEYMA until you have been shown how to inject STEQEYMA by a healthcare provider.
- STEQEYMA 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 STEQEYMA.
If you inject too much STEQEYMA, 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 STEQEYMA, and how to properly throw away (dispose of) used needles, syringes and vials. The syringe, needle and vial must never be re-used. After the rubber stopper is punctured, STEQEYMA can become contaminated by harmful bacteria which could cause an infection if re-used. Therefore, throw away any unused portion of STEQEYMA.

What should I avoid while using STEQEYMA?

You should avoid receiving a live vaccine during treatment with STEQEYMA. See "Before you use or receive STEQEYMA, tell your healthcare provider about all of your medical conditions, including if you:"

What are the possible side effects of STEQEYMA?

STEQEYMA may cause serious side effects, including:

See " What is the most important information I should know about STEQEYMA? "
Serious allergic reactions. Serious allergic reactions including death can occur with STEQEYMA. Stop using STEQEYMA and get medical help right away if you get any of the following symptoms of a serious allergic reaction:

feeling faint
swelling of your face, eyelids, tongue, or throat
chest discomfort

trouble breathing
skin rash

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 STEQEYMA, including:

headache
seizures

confusion
vision problems

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 STEQEYMA.

The most common side effects of STEQEYMA include:

nasal congestion, sore throat, and runny nose
upper respiratory infections
fever
headache
tiredness
itching
nausea and vomiting
influenza

redness at the injection site
vaginal yeast infections
urinary tract infections
sinus infection
bronchitis
diarrhea
stomach pain
joint pain

These are not all of the possible side effects of STEQEYMA. 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 CELLTRION USA, Inc. at 1-800-560-9414.

How should I store STEQEYMA?

Store STEQEYMA vials and prefilled syringes in a refrigerator between 36°F to 46°F (2°C to 8°C).
Store STEQEYMA vials standing up straight (upright).
Store STEQEYMA in the original carton to protect it from light until time to use it.
Do not freeze STEQEYMA.
Do not shake STEQEYMA.
If needed, individual STEQEYMA prefilled syringes may also be stored at room temperature up to 77ºF (25°C) for a maximum single period of up to 31 days in the original carton to protect from light.
Record the date when the prefilled syringe is first removed from the refrigerator on the carton in the space provided.
You may return the prefilled syringe to the refrigerator 1 time only during the 31-day period at room temperature or at the end of the 31-day period at room temperature.
Throw away (discard) the prefilled syringe if not used within 31 days at room temperature storage and you did not return it to the refrigerator.
If needed, individual STEQEYMA vials may also be stored at room temperature up to 86ºF (30°C) for a maximum single period of up to 15 days in the original carton to protect from light.
Record the date when the vial is first removed from the refrigerator on the carton in the space provided.
After a vial has been stored at room temperature, do not return it to the refrigerator.
Throw away (discard) the vial if not used within 15 days at room temperature storage.
Do not use STEQEYMA after the expiration date on the carton or on the vial or the prefilled syringe.

Keep STEQEYMA and all medicines out of the reach of children.

General information about the safe and effective use of STEQEYMA.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use STEQEYMA for a condition for which it was not prescribed. Do not give STEQEYMA 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 STEQEYMA that was written for health professionals.

What are the ingredients in STEQEYMA?

Active ingredient: ustekinumab-stba

Inactive ingredients: Single-dose prefilled syringe for subcutaneous use contains histidine, L-histidine monohydrochloride monohydrate, polysorbate 80, sucrose, and Water for Injection. Single-dose vial for subcutaneous use contains histidine, L-histidine monohydrochloride monohydrate, polysorbate 80, sucrose, and Water for Injection. Single-dose vial for intravenous infusion contains edetate disodium, histidine, L-histidine monohydrochloride monohydrate, methionine, polysorbate 80, sucrose, and Water for Injection.

Manufactured by: CELLTRION, Inc. 23, Academy-ro, Yeonsu-gu, Incheon, 22014, Republic of Korea, US License No. 1996

Distributed by: CELLTRION USA, Inc. One Evertrust Plaza Suite 1207, Jersey City, New Jersey, 07302, USA

For more information go to www.steqeyma.com or call 1-888-804-3433.

INSTRUCTIONS FOR USE

STEQEYMA (ste-qey-ma)

(ustekinumab-stba)

injection, for subcutaneous use

This Instructions for Use contains information on how to inject STEQEYMA using a vial.

Read this Instructions for Use before you start using STEQEYMA. A healthcare provider should show you how to prepare, measure the dose, and give an injection of STEQEYMA the right way.

If you cannot give the injection:

ask your healthcare provider to help you, or
ask someone who has been trained by a healthcare provider to give the injections.

Do not try to inject STEQEYMA until you have been shown how to inject STEQEYMA by a healthcare provider.

The STEQEYMA vial is for single-use only (see Figure A ). It contains 45 mg of STEQEYMA for injection under the skin (subcutaneous injection).

Figure A

Important Information You Need to Know Before Injecting STEQEYMA:

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 the healthcare provider.
- If the dose is 45 mg or less you will receive one 45 mg vial.
- If the dose is 90 mg, you will receive two 45 mg vials, and you will need to give two injections, one right after the other.
Check the expiration date on the vial and carton. If the expiration date has passed, do not use it. If the expiration date has passed, call the healthcare provider or pharmacist, or call 1-888-804-3433 for help.
Check the vial for any particles or discoloration. The liquid in the vial should look clear to very slightly opalescent and colorless to pale yellow.
Do not use STEQEYMA if it is frozen, discolored, cloudy or has particles. Get a new vial.
Do not shake the vial at any time. Shaking the vial may damage the STEQEYMA medicine. If your vial has been shaken, do not use it. Get a new vial.
Do not use a STEQEYMA vial more than one time, even if there is medicine left in the vial. After the rubber stopper is punctured, STEQEYMA can become contaminated by harmful bacteria which could cause an infection if re-used.
Therefore, throw away any unused STEQEYMA after you give the injection.
Safely throw away (dispose of) STEQEYMA vials, needles, and syringes after use. See " Step 20: Throw away (dispose of) STEQEYMA ."
Do not re-use syringes or needles.
To avoid needle-stick injuries, do not recap needles.

Storing STEQEYMA vials

Store STEQEYMA vials in a refrigerator between 36°F to 46°F (2°C to 8°C).
Store STEQEYMA vials standing up straight (upright).
Store STEQEYMA vials in the original carton to protect from light until the time of use.
Do not freeze STEQEYMA vial.
Do not shake STEQEYMA.
If needed, individual vials may be stored at room temperature up to 86°F (30°C) for a maximum single period of up to 15 days in the original carton to protect from light.
Record the date when the vial is first removed from the refrigerator on the carton in the space provided.
After a vial has been stored at room temperature, it should not be returned to the refrigerator.
Throw away (discard) the vial if not used within 15 days at room temperature storage.
Do not use STEQEYMA after the expiration date on the carton or on the vial.

Keep STEQEYMA vial and all medicines out of the reach of children.

Preparing to inject STEQEYMA

Step 1. Gather the supplies for the injection.

Prepare a clean, flat surface, such as a table or countertop, in a well-lit area.
Take the carton containing the STEQEYMA vial needed to administer your prescribed dose out of the refrigerator.
Make sure you have the following supplies (see Figure B ):
- Carton containing the STEQEYMA vial
Not included in the carton:
- Syringe with needle
- 2 Alcohol wipes
- Cotton ball or gauze
- Adhesive bandage
- FDA-cleared sharps disposal container

Note: You will need a prescription from a healthcare provider to get syringes with the needles attached from a pharmacy.

Figure B

Step 2. Check the expiration date on the carton (see Figure C ).

Do not use the medicine if the expiration date has passed. If the expiration date has passed, safely throw away (dispose of) the carton in an FDA-cleared sharps disposal container (see Step 20. Throw away (dispose of) STEQEYMA ).

Figure C

Step 3. Wait 30 minutes.

Leave the carton containing the STEQEYMA vial at room temperature 68°F to 77°F (20°C to 25°C) for 30 minutes to allow it to warm up (see Figure D ).
Do not warm the vial using heat sources such as hot water or a microwave.
If the vial does not reach room temperature, this could cause the injection to feel uncomfortable and make it hard to inject.

Figure D

Step 4. Wash your hands.

Wash your hands with soap and water and dry them thoroughly (see Figure E ).

Figure E

Step 5. Inspect the STEQEYMA vial.

Look at the vial and make sure you have the correct medicine (STEQEYMA) and dosage.
Look at the vial and make sure it is not cracked or damaged.
Do not use STEQEYMA if the vial has been dropped or damaged.
Check the expiration date on the label of the vial (see Figure F ).
Do not use STEQEYMA if the expiration date has passed.

Figure F

Step 6. Inspect the medicine.

Look at the medicine in the vial to make sure that the liquid is clear to very slightly opalescent and colorless to pale yellow (see Figure G ).
Do not use STEQEYMA if the liquid is discolored or cloudy, or if it contains visible flakes or particles.

Figure G

Step 7. Choose an injection site (see Figure H).

Choose an injection site around the stomach area (abdomen), buttocks, and upper legs (thighs). If a caregiver is giving the injection, the outer area of the upper arms may also be used.
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. If possible, do not use areas of skin that show signs of psoriasis.

Figure H

Step 8. Clean the injection site.

Clean the skin with an alcohol wipe where you plan to give the injection (see Figure I ).
Do not touch this area again before giving the injection. Let the skin dry before injecting.
Do not fan or blow on the clean area.

Figure I

Step 9. Remove the protective cap from the vial.

Remove the protective cap from the STEQEYMA vial. Throw away the cap (see Figure J ).
Do not remove the rubber stopper.

Figure J

Step 10. Clean the rubber stopper.

Wipe the rubber stopper of the vial with an alcohol wipe and allow it to dry (see Figure K ).
Do not touch the rubber stopper after you clean it.
Put the vial on a flat surface.

Figure K

Step 11. Remove the needle cap from the syringe.

Hold the syringe at the middle of the syringe body with the needle pointing away from yourself, and pull the needle cap straight off the syringe (see Figure L ).
Throw away (dispose of) the needle cap right away in an FDA-cleared sharps disposal container (see Step 20. Throw away (dispose of) STEQEYMA ).
Do not re-cap the syringe.
Do not touch the needle or let the needle touch anything. Doing so may result in a needle stick injury.
Do not use the syringe if it has been dropped without the needle cap in place. Call your healthcare provider for further instructions.

Figure L

Step 12. Draw air into the syringe.

Pull back on the plunger rod to draw air into the syringe equal to your STEQEYMA dose volume.
Hold the vial between your thumb and index (pointer) finger.
Push the needle through the rubber stopper of the vial, and push the plunger rod to inject the air into the vial (see Figure M).

Figure M

Step 13. Withdraw the correct dose.

Leave the needle in the vial and turn both the syringe and vial upside down (vial on top).
Hold the syringe and vial firmly in one hand. Make sure the tip of the needle is in the STEQEYMA medicine.
It is important that the needle tip is always in the medicine. This stops air bubbles from forming in the syringe.
With your other hand, pull on the plunger rod to fill the syringe with the amount of medicine prescribed by the healthcare provider (see Figure N ).
Fill the syringe until the black tip of the plunger lines up with the mark that matches your prescribed dose.

Figure N

Step 14. Check for air bubbles.

Do not remove the needle from the vial. Hold the syringe with the needle pointing up to see if it has any air bubbles inside.
If there are air bubbles, gently tap the side of the syringe until the air bubbles go to the top of the syringe (see Figure O ).
Slowly press the plunger rod until all of the air bubbles (but none of the medicine) have been removed.
Remove the syringe from the vial. Do not lay the syringe down or allow the needle to touch anything.

Figure O

Injecting STEQEYMA

Step 15. Insert the needle into the injection site.

Hold the body of the syringe in one hand between the thumb and index fingers (see Figure P ).
Do not pull back on the plunger rod at any time.
Use the other hand to gently pinch the cleaned area of skin. Hold firmly.
Note: Pinching the skin is important to make sure that you inject under the skin (into the fatty area) but not any deeper (into muscle).
Use a quick and dart-like motion to insert the needle into the pinched skin at about a 45-degree angle (see Figure P ).

Figure P

Step 16. Give the injection.

After the needle is inserted use your thumb to slowly and evenly push the plunger rod all the way to the bottom of the syringe body. Keep the skin gently pinched.
Make sure you have injected all of the STEQEYMA medicine (see Figure Q ).

Figure Q

Step 17. Remove the syringe from the injection site.

After the syringe is empty, release the pinched skin and slowly pull the needle out of the injection site. (see Figure R ).
Do not re-cap the used needle. Recapping the used needle can lead to a needle-stick injury.
Do not rub the injection site.
There may be some bleeding at the injection site. This is normal (see Step 18. Care for the injection site ).

Figure R

After the Injection

Step 18. Care for the injection site.

Do not rub the injection site.
There may be a small amount of blood or liquid at the injection site. This is normal.

If some bleeding occurs, you can press a cotton ball or gauze over the injection site and hold for 10 seconds. You may cover the injection site with a small adhesive bandage, if necessary.

Step 19. If your dose requires 2 injections, give the second injection right after the first.

If your dose is 90 mg, you will have two 45 mg vials. You will need to give a second injection right after the other.
Repeat Steps 5 to 18 for the second injection using a new vial and syringe with needle.
Choose a different site for the second injection.

Step 20. Throw away (dispose of) STEQEYMA.

Put the used needle, syringe and vial in an FDA-cleared sharps disposal container right away after use (see Figure S ).
Do not throw away (dispose of) the syringe in your household trash.
Never re-use needles and syringes, for your safety and health, and for the safety of others.
Alcohol wipes, and other supplies can be disposed of in your household trash.
If you do not have an FDA-cleared sharps disposal container, you may use a household container that is:
- made of a 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,
- leak-resistant, 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 it. There may be state or local laws about how you should throw away used needles and syringes. 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 used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container.