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

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

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

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

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

Before starting IMULDOSA, 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 IMULDOSA, 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. IMULDOSA can make you more likely to get infections or make an infection that you have worse.

People who havea 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 IMULDOSA may also be more likely to get these infections.
Cancers. IMULDOSA 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 ustekinumab products and have risk factors for skin cancer have developed certain types of skin cancers. During your treatment with IMULDOSA, tell your doctor if you develop any new skin growths.

What is IMULDOSA?

IMULDOSA is a prescription medicine used to treat:

adults and children 6 years and older with moderate to severe 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 and older with active psoriatic arthritis.
adults 18 years and older with moderately to severely active Crohn’s disease.
adults 18 years and older with moderately to severely active ulcerative colitis.

It is not known if IMULDOSA is safe and effective in children less than 18 years of age with ulcerative colitis or in children less than 6 years of age with plaque psoriasis or psoriatic arthritis.

Who should not use IMULDOSA?

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

Before you use or receive IMULDOSA, tell your doctor 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 IMULDOSA?”
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 IMULDOSA 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 1 year before receiving IMULDOSA or 1 year after you stop receiving IMULDOSA.
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 IMULDOSA. IMULDOSA 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 IMULDOSA can harm your unborn baby. You and your healthcare provider should decide if you will receive IMULDOSA.
are breastfeeding or plan to breastfeed. IMULDOSA can pass into your breast milk.
Talk to your healthcare provider about the best way to feed your baby if you receive IMULDOSA.

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 IMULDOSA?

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

What should I avoid while using IMULDOSA?

You should not receive a live vaccine while taking IMULDOSA. See “Before you receive IMULDOSA, tell your healthcare provider about all of your medical conditions, including if you:”

What are the possible side effects of IMULDOSA?

IMULDOSA may cause serious side effects, including:

See “ What is the most important information I should know about IMULDOSA?”
Serious allergic reactions. Serious allergic reactions can occur with IMULDOSA. Stop using IMULDOSA and get medical help right away if you have 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 IMULDOSA, 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 doctor right away if you develop shortness of breath or a cough that doesn’t go away during treatment with IMULDOSA.

The most common side effects of IMULDOSA 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 IMULDOSA. 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 Accord BioPharma, Inc. at 1-866-941-7875.

How should I store IMULDOSA?

Store IMULDOSA vials and prefilled syringes in a refrigerator between 36°F to 46°F (2°C to 8°C).
Store IMULDOSA vials standing up straight.
Store IMULDOSA in the original carton to protect it from light until time to use it.
Do not freeze IMULDOSA.
Do not shake IMULDOSA.
If needed, individual IMULDOSA prefilled syringes may also 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, do not return it to the refrigerator.
Throw away (discard) the prefilled syringe if it is not used within 30 days at room temperature storage.
Do not use IMULDOSA after the expiration date on the carton or on the prefilled syringe.

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

General information about the safe and effective use of IMULDOSA.

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

What are the ingredients in IMULDOSA?

Active ingredient: ustekinumab-srlf

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

Manufactured by: Accord BioPharma Inc. 8041 Arco Corporate Drive, Suite 200, Raleigh, North Carolina (NC), 27617 USA.

US License No. 2105

For more information go to www.imuldosa.com or call 1-866-941-7875.

INSTRUCTIONS FOR USE

IMULDOSA (im ul doe' sah)

(ustekinumab-srlf)

injection, for subcutaneous use

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

Read this Instructions for Use before you start using IMULDOSA. A healthcare provider should show you how to prepare and give the injection of IMULDOSA 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 your injections.

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

Important information You Need to Know Before Injecting IMULDOSA:

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. If the expiration date has passed or if the prefilled syringe has been kept at room temperature up to 86°F (30°C) for longer than a maximum single period of 30 days or if the prefilled syringe has been stored above 86°F (30°C), do not use it. If the expiration date has passed or if the prefilled syringe has been stored above 86°F (30°C) or at room temperature for longer than 30 days, call the healthcare provider or pharmacist, or call 1-866-941-7875 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 to slightly opalescent and colorless to slightly yellow solution.
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 IMULDOSA 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 IMULDOSA prefilled syringes

Store IMULDOSA prefilled syringes in the refrigerator between 36ºF to 46ºF (2ºC to 8ºC).
Store IMULDOSA prefilled syringes in the original carton to protect from light .
Do not freeze IMULODSA prefilled syringes.
If needed, IMULDOSA prefilled syringe may 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 removed from the refrigerator on the carton in the space provided.
After a prefilled syringe has been stored at room temperature, do not return it to the refrigerator.
Throw away (discard) the prefilled syringe if it is not used within 30 days at room temperature storage.

Keep IMULDOSA 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
your prescribed dose of IMULDOSA ( 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 IMULDOSA

Remove the needle cover when you are ready to inject IMULDOSA.
Do not the plunger or the 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 1 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.

Step 4: Disposing of the syringes.

Put the syringe in a FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) 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,
- 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 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 healthcare provider or pharmacist.

Manufactured by:

Accord BioPharma Inc. 8041 Arco Corporate Drive, Suite 200, Raleigh, North Carolina (NC), 27617 USA