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

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

TALTZ is a medicine that affects your immune system. TALTZ may lower the ability of your immune system to fight infections and may increase your risk of infections. Some people have had serious infections while taking TALTZ, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have been hospitalized from these infections.

Your healthcare provider should check you for TB before you start treatment with TALTZ.
Your healthcare provider may treat you with medicine for TB before you begin treatment with TALTZ if you have a past history of TB or have TB.
Your healthcare provider should watch you closely for signs and symptoms of TB during and after treatment with TALTZ.

Before starting TALTZ, tell your healthcare provider if you:

are being treated for an infection
have an infection that does not go away or that keeps coming back
have TB or have been in close contact with someone with TB
think you have an infection or have symptoms of an infection such as:

fever, sweats, or chills
muscle aches
cough
shortness of breath
blood in your phlegm (mucus)

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

After starting TALTZ, call your healthcare provider right away if you have any of the symptoms of infection listed above.

Do not use TALTZ if you have any symptoms of infection unless you are instructed to by your healthcare provider.

See “What are the possible side effects of TALTZ?” for more information about side effects.

What is TALTZ?

TALTZ is a prescription medicine used to treat:

people 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 or UV light).
adults with active psoriatic arthritis. TALTZ can be used alone or with the medicine methotrexate.
adults with active ankylosing spondylitis.
adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation.

It is not known if TALTZ is safe and effective in children for conditions other than plaque psoriasis or in children under 6 years of age.

Do not use TALTZ if you have had a severe allergic reaction to ixekizumab or any of the other ingredients in TALTZ.

See the end of this Medication Guide for a complete list of ingredients in TALTZ.

Before using TALTZ, 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 TALTZ?”
have Crohn's disease or ulcerative colitis
have recently received or are scheduled to receive an immunization (vaccine). You should avoid receiving live vaccines during treatment with TALTZ.
are pregnant or plan to become pregnant. It is not known if TALTZ can harm your unborn baby.
Pregnancy Exposure Registry: There is a pregnancy registry to collect information about women who are exposed to TALTZ during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. If you become pregnant while taking TALTZ, you are encouraged to enroll in the pregnancy registry by calling 1-800-284-1695 or by visiting online at www.pregnancyregistry.lilly.com.
are breastfeeding or plan to breastfeed. It is not known if TALTZ passes into your breast milk.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How should I use TALTZ?

See the detailed “Instructions for Use” that comes with your TALTZ for information on how to prepare and inject a dose of TALTZ, and how to properly throw away (dispose of) used TALTZ autoinjectors and prefilled syringes.

Use TALTZ exactly as prescribed by your or your child's healthcare provider.
For children 6 to 17 years of age:
- Your child's healthcare provider will decide which dose of TALTZ is right for your child and if you can give TALTZ to your child at home.
- If your child's healthcare provider decides that you may give TALTZ injections at home, you should receive training on the right way to prepare and inject TALTZ. Do not try to give TALTZ to your child until you have been shown how to inject TALTZ.
- Children should not inject themselves with TALTZ. You or an adult caregiver should prepare and give TALTZ injections to your child.
- Children will be given a TALTZ injection every 4 weeks.
For adults, if your healthcare provider decides that you or a caregiver may give your TALTZ injections at home, you should receive training on the right way to prepare and inject TALTZ. Do not try to inject TALTZ yourself, until you or your caregiver have been shown how to inject TALTZ.
TALTZ comes in a single-dose autoinjector and single-dose prefilled syringes that you or your caregiver may use at home to give injections. Your or your child's healthcare provider will decide which type of TALTZ is best to use at home.
TALTZ is given as an injection under the skin (subcutaneous injection), in the thighs or stomach area (abdomen) by you or a caregiver. A caregiver may also give the injection of TALTZ in the back of the arm.
Do not give an injection in an area of the skin that is tender, bruised, red or hard, or in an area of skin that is affected by psoriasis.
Each TALTZ injection should be given at a different site. Do not use the 1 inch area around your navel (belly button).

If you or your child forget to take a dose of TALTZ:

Do not miss any doses of TALTZ unless your or your child's healthcare provider says it is okay. If you forget to take or give the TALTZ dose, inject a dose as soon as you remember. Then, take or give the next dose at the regular scheduled time.
If you inject more TALTZ than prescribed, call your or your child's healthcare provider or go to the nearest emergency room right away.

What are the possible side effects of TALTZ?

TALTZ may cause serious side effects, including:

See “What is the most important information I should know about TALTZ?”
Serious allergic reactions. If you have a severe allergic reaction, do not give another injection of TALTZ. Get emergency medical help right away if you get any of the following symptoms of a serious allergic reaction:

feel faint
swelling of your face, eyelids, lips, mouth, tongue, or throat

trouble breathing or throat tightness
chest tightness
skin rash

Severe skin reactions that look like eczema can happen during treatment with TALTZ from days to months after your first dose and can sometimes lead to hospitalization. Your healthcare provider may temporarily stop treatment with TALTZ if you develop severe skin reactions. Tell your healthcare provider if you have any of the following signs or symptoms:

redness or rash
itching
patches

your skin is dry or feels like leather
blisters or erosions that ooze or become crusty
small bumps or plaques with scale or crusting

Crohn's disease or ulcerative colitis (inflammatory bowel disease) can happen during treatment with TALTZ, including worsening symptoms. Tell your healthcare provider if you have new or worsening symptoms of inflammatory bowel disease during treatment with TALTZ, including:
- stomach (abdomen) pain
- diarrhea with or without blood
- weight loss

The most common side effects of TALTZ in adults and children include:

injection site reactions
upper respiratory infections

nausea
fungal infections

These are not all of the possible side effects of TALTZ. Tell your healthcare provider about any side effect that bothers you or that does not go away. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store TALTZ?

Protect TALTZ from light.
Store TALTZ in the refrigerator between 36°F to 46°F (2°C to 8°C).
- If needed, you or a caregiver may store TALTZ at room temperature up to 86°F (30°C) for up to 5 days in the original carton to protect from light. Once TALTZ has been stored at room temperature, do not return to the refrigerator. Throw away TALTZ if it is not used within 5 days at room temperature.
- Record the date when TALTZ is first removed from the refrigerator in the spaces provided on the carton.
- For the 2 or 3 autoinjector pack, remove a single autoinjector at a time leaving the remaining autoinjector(s) in the original carton in the refrigerator. Make sure the unrefrigerated TALTZ is protected from light.
Do not freeze TALTZ. Do not use if TALTZ has been frozen.
Do not shake TALTZ.

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

General information about the safe and effective use of TALTZ.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use TALTZ for a condition for which it was not prescribed. Do not give TALTZ to other people, even if they have the same symptoms you have. It may harm them. You can ask your healthcare provider or pharmacist for information about TALTZ that is written for health professionals.

What are the ingredients in TALTZ?

Active ingredient: ixekizumab

Inactive ingredients: Polysorbate 80, Sucrose, and Water for Injection. Sodium Hydroxide may have been added to adjust pH.

Not made with natural rubber latex.

For more information about TALTZ, call 1-800-545-5979 (1-800-LillyRx) or go to the following website: www.taltz.com.

TALTZ^®(ixekizumab) injection is a registered trademark of Eli Lilly and Company.

Eli Lilly and Company Indianapolis, IN 46285, USA, US License Number 1891

TAL-0011-MG-20240820

TALTZ 80 mg Autoinjector

INSTRUCTIONS FOR USE

TALTZ^®[tol-t-s]

(ixekizumab)

injection, for subcutaneous use

Autoinjector

This Instructions for Use contains information on how to inject TALTZ.

Important Information You Need to Know Before Injecting TALTZ

Your healthcare provider or nurse should show you how to prepare and inject TALTZ using the autoinjector. Do not inject yourself or someone else until you have been shown how to inject TALTZ.

You and your caregiver should read this Instructions for Use before you start using TALTZ and each time you get a refill. Keep the Instructions for Use and refer to them as needed.

Each TALTZ autoinjector contains 1 dose of TALTZ. The autoinjector is for one-time use only.

The autoinjector contains glass parts. Handle autoinjector carefully. If you drop it on a hard surface, do not use it. Use a new TALTZ autoinjector for your injection.

Your healthcare provider may help you decide where on your body to inject your dose. Do not give an injection in an area of the skin that is tender, bruised, red or hard, or in an area of skin that is affected by psoriasis. Read the “Choose your injection site” section of these instructions to help you choose which area can work best for you.

If you have vision or hearing problems, do not use TALTZ autoinjector without help from a caregiver.

INSTRUCTIONS FOR USE Before you use the TALTZ autoinjector, read and carefully follow all the step-by-step instructions.

Parts of the TALTZ autoinjector


Step 1	Preparing to Inject TALTZ

Step 1a	Take the TALTZ autoinjector from the refrigerator. Remove the autoinjector from the package. Put the original package with any unused autoinjectors back in the refrigerator. Leave the base cap on until you are ready to inject. Wait 30 minutes to let the autoinjector warm to room temperature before you use it. Do not microwave the autoinjector, run hot water over it, or leave it in direct sunlight. Do not shake the autoinjector.

Step 1b	Gather the supplies needed for your injection: 1 alcohol wipe 1 cotton ball or piece of gauze 1 sharps disposal container. See “Disposing of TALTZ.”

Step 1c	Figure A	Inspect the autoinjector. Make sure the name TALTZ appears on the label. The medicine inside should be clear. Its color may be colorless to slightly yellow. Do not use the autoinjector, and dispose of as directed by your healthcare provider or pharmacist if: the expiration date printed on the label has passed (see Figure A). it looks damaged. the medicine is frozen. the medicine is cloudy, discolored, or has small particles. The medicine should look clear and colorless to slightly yellow.

Step 1d	Wash your hands with soap and water before you inject TALTZ.

Step 1e	Figure B	Choose your injection site. You may inject in your stomach area (abdomen) or in your thigh, or in the back of your arm (see Figure B). To inject in your arm, you will need someone to help you. Do not give an injection into areas where the skin is tender, bruised, red or hard, or in an area of skin that is affected by psoriasis. Do not inject within 1 inch of the navel (belly button). Alternate your injection sites. Do not inject in the exact same spot every time. For example, if your last injection was in your left thigh, your next injection should be in your right thigh, your abdomen, or the back of either arm. Talk with your healthcare provider about where on your body to best inject TALTZ.

Step 1f	Prepare your skin. Clean your injection site with an alcohol wipe. Let the injection site dry before you inject TALTZ.

Step 2	Injecting TALTZ

Step 2a	Figure C	Make sure the lock ring is in the lock position. Leave the base cap on until you are ready to inject. Do not touch the needle. Twist off the base cap in the direction of the arrows (see Figure C). Throw the base cap in the trash. You will not need to put the base cap back on. If you do, you could damage the needle or stick yourself by accident.

Step 2b	Figure D	Place the clear base flat and firmly against your skin at the injection site (see Figure D).


Step 2c	Figure E	While holding the clear base against your skin, turn the lock ring to the unlock position (see Figure E). You are now ready to inject.

Step 2d	Figure F	Press the green injection button. There will be a loud click (see Figure F). Keep holding the clear base firmly against your skin. You will hear a second click in about 10 seconds after the first one. The second click tells you that your injection is complete. You will see the gray plunger at the top of the clear base. Remove the autoinjector from your skin. Press a cotton ball or gauze over the injection site. Do not rub the injection site, as this may cause bruising. You may have slight bleeding. This is normal. Do not put the base cap back on the autoinjector.

Step 3	Disposing of TALTZ

Step 3a	Figure G
Put the used TALTZ autoinjector in an FDA-cleared sharps disposal container right away after use (see Figure G). Do not throw away (dispose of) the TALTZ autoinjector 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 your sharps disposal container. There may be state or local laws about how you should throw away needles and syringes. For more information about safe sharps disposal, and for specific information about sharps disposal in the state you live in, go to the FDA's website at: http://www.fda.gov/safesharpsdisposal
Do not recycle your used sharps disposal container.

Commonly asked questions and answers.

Q. What if I see bubbles in the TALTZ autoinjector?

A.

It is normal to have air bubbles in the autoinjector.

Q. What if there is a drop of liquid on the tip of the needle when I remove the base cap?

A.

It is okay to see a drop of liquid on the tip of the needle.

Q. What if I unlocked the autoinjector and pressed the green injection button before I twisted off the base cap?

A.

Do not remove the base cap. Dispose of the autoinjector and get a new one.

Q. Do I need to hold the injection button down until the injection is complete?

A.

You do not need to hold the injection button down, but it may help you keep the autoinjector steady and firm against your skin.

Q. What if the needle did not retract after my injection or I am not sure that the autoinjector worked in the right way?

A.

Do not touch the needle or replace the base cap. Store the autoinjector in a safe place (e.g., a household container as described in “Disposing of TALTZ”) to avoid an accidental needlestick and contact Lilly (1-800-545-5979) for instructions on how to return the autoinjector.

Q. What if I hear more than 2 clicks during my injection?

Did I get my complete dose?

A.

You may hear a soft click right before the second loud click. This is the normal operation of the autoinjector. Do not remove the autoinjector from your skin until you hear the second loud click.

Q. How can I tell if my injection is complete?

A.

After you press the green injection button, you will hear 2 loud clicks. The second click tells you that your injection is complete. You will also see the gray plunger at the top of the clear base.

Q. What if the autoinjector is left at room temperature for longer than 30 minutes?

A.

If needed, the autoinjector may be left out of the refrigerator at room temperature up to 86°F (30°C) for up to 5 days if protected from light. Throw away TALTZ if not used within the 5-day period at room temperature. See "Storing TALTZ" for more detail.

If you have more questions about how to use the TALTZ autoinjector:

Call your healthcare provider
Call Lilly at 1-800-545-5979 (1-800-Lilly-Rx)
Visit www.taltz.com

Storing TALTZ

Protect TALTZ from light.

Store TALTZ in the refrigerator between 36°F to 46°F (2°C to 8°C).
- If needed, you or a caregiver may store TALTZ at room temperature up to 86°F (30°C) for up to 5 days in the original carton to protect from light. Once TALTZ has been stored at room temperature, do not return to the refrigerator. Throw away TALTZ if it is not used within 5 days at room temperature.
- Record the date when TALTZ is first removed from the refrigerator in the spaces provided on the carton.
- For the 2 or 3 autoinjector pack, remove a single autoinjector at a time leaving the remaining autoinjector(s) in the original carton in the refrigerator. Ensure the unrefrigerated TALTZ is protected from light.

Do not freeze TALTZ. Do not use if TALTZ has been frozen.

Do not shake TALTZ.

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

Read the full Prescribing Information and Medication Guide for TALTZ inside this box to learn more about your medicine.

Eli Lilly and Company

Indianapolis, IN 46285, USA

US License Number 1891

TALTZ is a trademark of Eli Lilly and Company.

The TALTZ autoinjector meets the current dose accuracy and functional requirements of ISO 11608-1 and 11608-5.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Revised: December 2023

TALAI-0008-IFU-20231218

TALTZ 80 mg Prefilled Syringe

INSTRUCTIONS FOR USE

TALTZ^®(tol(t)s)

(ixekizumab)

injection, for subcutaneous use

Prefilled Syringe

Before you use the TALTZ prefilled syringe, read and carefully follow all the step-by-step instructions.

Important information:

Your healthcare provider or nurse should show you how to prepare and inject TALTZ using the prefilled syringe. Do not inject yourself or someone else until you have been shown how to inject TALTZ.

You and your caregiver should read this Instructions for Use before you start using TALTZ and each time you get a refill. Keep the Instructions for Use and refer to them as needed.

Each TALTZ prefilled syringe contains 1 dose of TALTZ. The syringe is for one-time use only. Do not share or reuse your TALTZ prefilled syringe. You may give or get an infection.

Your healthcare provider may help you decide where on your body to inject your dose. Do not give an injection in an area of the skin that is tender, bruised, red or hard, or in an area of skin that is affected by psoriasis. Read the “Choose your injection site” section of these instructions to help you choose which area can work best for you.

If you have vision problems, do not use TALTZ prefilled syringe without help from a caregiver.

INSTRUCTIONS FOR USE

Before you use the TALTZ prefilled syringe, read and carefully follow all the step-by-step instructions.

Parts of the TALTZ prefilled syringe

1 Get Ready

1a

Take the TALTZ prefilled syringe from the refrigerator.
Remove the prefilled syringe from the package. Put the original package with any unused syringes back in the refrigerator.
Leave the needle cap on the syringe until you are ready to inject.
Wait 30 minutes to let the prefilled syringe warm to room temperature before you use it.
Do not microwave the syringe, run hot water over it, or leave it in direct sunlight.
Do not shake the prefilled syringe.

1b

Gather the supplies needed for your injection:

1 alcohol wipe
1 cotton ball or piece of gauze
1 sharps disposal container. See “Dispose of the used prefilled syringe.”

1c

Inspect the syringe. Leave the needle cap on the syringe until you are ready to inject.

Make sure the name TALTZ appears on the label.
The medicine inside should be clear. Its color may be colorless to slightly yellow.

Do not use the prefilled syringe, and dispose of as directed by your healthcare provider or pharmacist if:

the expiration date printed on the label has passed.
it looks damaged.
the medicine is frozen.
the medicine is cloudy, discolored, or has small particles. The medicine should look clear and colorless to slightly yellow.

1d

Wash your hands with soap and water before you inject TALTZ.

1e

Choose your injection site.

You may inject in your stomach area (abdomen) or in your thigh, or in the back of your arm. To inject in your arm, you will need someone to help you.

Do not give an injection into areas where the skin is tender, bruised, red or hard, or in an area of skin that is affected by psoriasis.

Do not inject within 1 inch of the navel (belly button).

Alternate your injection sites.

Do not inject in the exact same spot every time. For example, if your last injection was in your left thigh, your next injection should be in your right thigh, your abdomen, or the back of either arm.
Talk with your healthcare provider about where on your body to best inject TALTZ.

1f

Prepare your skin. Clean your injection site with an alcohol wipe. Let the injection site dry before you inject TALTZ.

2 Inject TALTZ

2a

Pull the needle cap off and throw it away.

Do not put the needle cap back on. You could damage the needle or stick yourself by accident.
Do not touch the needle.

2b

Gently pinch and hold a fold of skin where you will inject.

2c

Insert the needle at a 45-degree angle. Then gently let go of your skin. Make sure to keep the needle in place.

Let go of your skin before you push the plunger in.

2d

Push in the plunger.

Slowly push on the thumb pad to push the plunger all the way in until all the medicine is injected.
The gray syringe plunger should be pushed all the way to the needle end of the syringe.
You should see the green plunger rod show through the syringe body when the injection is complete.
Gently remove the needle from your skin.
Press a cotton ball or gauze over the injection site. Do not rub the injection site, as this may cause bruising. You may have slight bleeding. This is normal.

Do not put the needle cap back on the prefilled syringe.

3

Dispose of (throw away) the used prefilled syringe.