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

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

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

Serious infections. OTULFI 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 OTULFI.
- 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 OTULFI and during treatment with OTULFI.
- Your healthcare provider should watch you closely for signs and symptoms of TB while you are being treated with OTULFI.
You should not start OTULFI if you have any kind of infection unless your healthcare provider says it is okay.

Before starting OTULFI, 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 OTULFI, 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, skin infections, or shingles that could have serious complications. OTULFI 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 OTULFI may also be more likely to get these infections.
• Cancers. OTULFI 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 OTULFI, tell your healthcare provider if you develop any new skin growths.

What is OTULFI?

OTULFI 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 OTULFI 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 OTULFI?

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

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

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 OTULFI?

Use OTULFI exactly as the healthcare provider tells you to. The healthcare provider will determine the right dose of OTULFI, 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 OTULFI 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. OTULFI will then be received as an injection under the skin (subcutaneous injection) 8 weeks after the first dose of OTULFI, as described below.
Adults and children 6 years of age and older with plaque psoriasis or psoriatic arthritis will receive OTULFI as an injection under the skin as described below.
Injecting OTULFI under the skin
- OTULFI is intended for use under the guidance and supervision of a healthcare provider.
- In children, it is recommended that OTULFI be administered by a healthcare provider. If a healthcare provider decides that you or a caregiver may give the injections of OTULFI at home, you or a caregiver should receive training on the right way to prepare and inject OTULFI.
- Do not try to inject OTULFI until you have been shown how to inject OTULFI by a healthcare provider.
- OTULFI 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 OTULFI.
If you inject too much OTULFI, 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 OTULFI, 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,

OTULFI can become contaminated by harmful bacteria which could cause an infection if re-used. Therefore, throw away any unused portion of OTULFI.

What should I avoid while using OTULFI?

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

What are the possible side effects of OTULFI?

OTULFI may cause serious side effects, including:

See “What is the most important information I should know about OTULFI?”
Serious allergic reactions. Serious allergic reactions including death can occur with OTULFI. Stop using OTULFI 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
trouble breathing

chest discomfort
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 OTULFI, 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 OTULFI.

The most common side effects of OTULFI 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 OTULFI. 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 Fresenius Kabi USA, LLC at 1-800-551-7176.

How should I store OTULFI?

Store OTULFI vials and prefilled syringes in a refrigerator between 36°F to 46°F (2°C to 8°C).
Store OTULFI vials standing up straight (upright).
Store OTULFI in the original carton to protect it from light until time to use it.
Do not freeze OTULFI.
Do not shake OTULFI.
If needed, individual OTULFI prefilled syringes may also be stored at room temperature up to 86°F (30°C) for a maximum single period of up to 30 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.
After a prefilled syringe has been stored at room temperature, you may return the prefilled syringe to the refrigerator 1 time during the 30-day room temperature storage period, including the last day (day 30), and keep it in the refrigerator until you use it or the expiration date on the carton or prefilled syringe.
Throw away (discard) the prefilled syringe if it is not used within 30 days at room temperature storage and you did not return it to the refrigerator.
Do not use OTULFI after the expiration date on the carton or on the prefilled syringe.

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

General information about the safe and effective use of OTULFI.

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

What are the ingredients in OTULFI?

Active ingredient: ustekinumab-aauz

Inactive ingredients: Single-dose prefilled syringe and single-dose vial for subcutaneous use contain histidine, Polysorbate 80, sucrose and hydrochloric acid (to adjust pH). Single-dose vial for intravenous infusion contains edetate disodium, histidine, L-histidine hydrochloride monohydrate, methionine, Polysorbate 80, and sucrose.

Manufactured by: Fresenius Kabi USA, LLC, Lake Zurich, IL 60047, U.S.A, US License Number 2146

For more information, call 1-833-522-4227 or visit the patient support program website: www.kabicare.us

INSTRUCTIONS FOR USE

OTULFI (oh tool fee)

(ustekinumab-aauz)

injection, for subcutaneous use

This Instructions for Use contains information on how to inject OTULFI using a prefilled syringe.

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

If you cannot give the injection:

ask a 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 OTULFI until you have been shown how to inject OTULFI by a healthcare provider.

Important Information You Need to Know Before Injecting OTULFI:

For subcutaneous use only (inject directly under the skin).
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, you will receive one 45 mg prefilled syringe.
- If the 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 two injections, one right after the other.
Check the expiration date on the prefilled syringe and carton. Do not use OTULFI after the expiration date has passed or if the prefilled syringe has been kept at room temperature up to 86ºF (30ºC) for longer than a maximum single period of 30 days, or if the prefilled syringe has been stored above 86ºF (30ºC). Call your healthcare provider or pharmacist, or call Fresenius Kabi USA, LLC at 1-800-551-7176 for help.
Make sure the syringe is not damaged.
Check the prefilled syringe for any particles or discoloration. The liquid in the prefilled syringe should look clear and colorless to slightly brown-yellow.
Do not use if it is frozen, discolored, cloudy or has particles. Get a new prefilled syringe.
Do not shake the prefilled syringe at any time. Shaking the prefilled syringe may damage the OTULFI medicine. If the 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 the injection. Do not pull back on the plunger at any time.

Storing OTULFI prefilled syringes

Store OTULFI prefilled syringes in the refrigerator between 36°F to 46°F (2°C to 8°C).
Store OTULFI prefilled syringes in the original carton to protect from light.
Do not freeze OTULFI prefilled syringes.
If needed, individual OTULFI prefilled syringes may be stored at room temperature up to 86ºF (30°C) for a maximum single period of up to 30 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.
After a prefilled syringe has been stored at room temperature, you may return the prefilled syringe to the refrigerator 1 time during the 30-day room temperature storage, including the last day (day 30), and keep it in the refrigerator until you use it or until the expiration date on the carton or prefilled syringe.
Throw away (discard) the prefilled syringe if it is not used within 30 days at room temperature storage and you did not return it to the refrigerator.

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

Gather the supplies you will need to prepare and to give the injection. (See Figure A)

You will need:

antiseptic wipes
cotton balls or gauze pads
adhesive bandage
the prescribed dose of OTULFI (See Figure B)
FDA-cleared sharps disposal container. See "Step 4: Disposing of the syringes."

Figure A

Figure B

To prevent early activation of the needle safety guard, do not touch the NEEDLE GUARD ACTIVATION CLIPS at any time during use.

Step 1: Preparing 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: Preparing the injection site

Choose an injection site around the stomach area (abdomen), buttocks, upper legs (thighs). If a caregiver is giving 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 the injection.
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 C

*Areas in gray are recommended injection sites

Step 3: Injecting OTULFI

Remove the needle cover when you are ready to inject OTULFI.
Do not touch the plunger or plunger head 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.
Figure D

Hold the body of the prefilled syringe in one hand between the thumb and index fingers. (See Figure E)

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)

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)

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 then 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)

Figure H

When the needle is pulled out of the 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.

If the 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 a second injection right after the first. Repeat Steps 1 to 3 for the second injection using a new syringe. Choose a different site for the second injection.