Taltz: Uses, Side Effects and Dosage

What is TALTZ used for?

Plaque Psoriasis

TALTZ is a prescription medicine used to treat adults and children 6 years or older with a skin condition called “plaque psoriasis”. Plaque psoriasis causes inflammation of the skin, appearing as raised, thick, red and scaly patches (“psoriatic lesions”) that can appear anywhere on your body. TALTZ reduces the inflammation and other symptoms of the disease.

Psoriatic Arthritis

TALTZ is used to treat adults with active psoriatic arthritis and can be used alone or with another medicine called a conventional disease modifying anti-rheumatic drug (cDMARD), for example methotrexate. You may first be given other medicines for this disease. If you do not respond well enough to these medicines, you will be given TALTZ. Psoriatic arthritis is an inflammatory disease of the joints, usually accompanied by psoriasis. TALTZ reduces signs and symptoms of your arthritis and improves your psoriasis.

Ankylosing Spondylitis

TALTZ is used to treat a condition called ankylosing spondylitis. The condition is an inflammatory disease primarily affecting the spine, which causes inflammation of the spinal joints. TALTZ is used in adults with active ankylosing spondylitis. You may first be given other medicines for this disease. If you do not respond well enough to these medicines, you will be given TALTZ.

Non-Radiographic Axial Spondyloarthritis

TALTZ is used to treat adults with a type of arthritis of the back (spine) called non-radiographic axial spondyloarthritis. “Non-radiographic” means that you have symptoms of the disease but the damage cannot be seen on X-ray. You may first be given other medicines for this disease. If you do not respond well enough to these medicines, you will be given TALTZ to reduce the symptoms of your disease.

How does TALTZ work?

TALTZ contains the active substance ixekizumab. Ixekizumab is a monoclonal antibody. Monoclonal antibodies are proteins that recognize and bind specifically to certain proteins in the body.

TALTZ belongs to a group of medicines called interleukin (IL) inhibitors. This medicine works by neutralizing the activity of a protein called IL-17A, which is present at increased levels in diseases such as plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, and non-radiographic axial spondyloarthritis. By blocking IL-17A, TALTZ helps reduce the signs and symptoms of psoriasis such as itching, pain, and scaling; psoriatic arthritis such as painful and swollen joints; ankylosing spondylitis, and non-radiographic axial spondyloarthritis such as back pain and morning stiffness.

Using TALTZ will benefit you by leading to fast and sustained improvements of skin clearance and reducing your symptoms such as scaling, itching and pain. If you have any questions about how TALTZ works or why this medicine has been prescribed for you, ask your healthcare professional.

What are the ingredients in TALTZ?

Medicinal ingredients: ixekizumab

Non-medicinal ingredients: polysorbate 80, sucrose, and water for injection. Sodium hydroxide may have been added to adjust pH.

TALTZ comes in the following dosage forms:

• 80 mg solution for injection in prefilled autoinjector*
• 80 mg solution for injection in prefilled syringe*

*not all presentations may be marketed.

Do not use TALTZ if:

• you are allergic to ixekizumab or any of the other ingredients in TALTZ. See What are the ingredients in TALTZ.

If you think you may be allergic, ask your healthcare professional for advice before using TALTZ.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take TALTZ. Talk about any health conditions or problems you may have, including if you:

• currently have an infection or if you have long-term or repeated infections
• have tuberculosis or have been in close contact with someone with tuberculosis
• have inflammatory bowel disease (Crohn’s disease or ulcerative colitis)
• have recently had a vaccination or if you are due to have a vaccination during treatment with TALTZ
• are receiving any other treatment for psoriasis, such as another immunosuppressant or phototherapy with ultraviolet (UV) light

• are pregnant, think that you may be pregnant or are planning to have a baby

• are breast-feeding or plan to breast-feed

Other warnings you should know about:

TALTZ may increase the risk of serious side effects, such as infections, allergic reactions, and development of new or worsening symptoms of inflammatory bowel disease. You must look out for signs of these conditions while you are taking TALTZ.

Stop using TALTZ and tell your healthcare professional or seek medical help immediately if you notice any signs indicating a possible serious infection, a serious allergic reaction, or new or worsening of inflammatory bowel disease.

Signs or symptoms of a potentially serious infection may include:

• 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

Signs or symptoms of a serious allergic reaction may include:

• feeling faint
• swelling of your face, eyelids, lips, mouth, tongue, or throat
• trouble breathing or throat tightness
• chest tightness
• skin rash

Signs or symptoms of inflammatory bowel disease may include:

• stomach pain
• diarrhea with or without blood
• weight loss

Tell your doctor or pharmacist immediately if you (or your child) get any of these symptoms during treatment with TALTZ:

• If you develop itchy rash, dry skin, dry patches, inflamed skin, coin-shaped spots on the skin [dermatitis (including eczema)].
• If you develop severe inflammation of the entire skin surface (dermatitis exfoliative).

Children and adolescents

TALTZ is not recommended for children under 6 years of age with plaque psoriasis.

TALTZ is not recommended for children and adolescents (under 18 years of age) with the primary diagnosis of psoriatic arthritis, ankylosing spondylitis, or non-radiographic axial spondyloarthritis.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

Tell your doctor or pharmacist:

• If you (or your child) are taking, have recently taken or might take any other medicines.
• If you (or your child) have recently had or are going to have a vaccination. You should not receive certain types of vaccines (live vaccines) while using TALTZ.

How to take TALTZ:

Always use this medicine exactly as your healthcare professional has told you. Check with your healthcare professional if you are not sure.

Each prefilled autoinjector and each prefilled syringe contains one dose of TALTZ (80 mg). Each prefilled autoinjector and each prefilled syringe delivers only one dose.

TALTZ is given via injection under your skin (known as a subcutaneous injection). You and your healthcare professional should decide if you should inject TALTZ yourself.

It is important not to try to inject yourself until you have been trained by your healthcare professional. A caregiver may also give you your TALTZ injection after proper training.

See the detailed Instructions for Use provided for information on how to prepare and inject a dose of TALTZ, and how to properly throw away used TALTZ prefilled autoinjectors and prefilled syringes.

Usual dose:

Your doctor will decide how much TALTZ you need and for how long.

Adult Plaque Psoriasis

• The initial dose is 160 mg (two injections) by subcutaneous injection.
• After the first dose you will receive further injections at Weeks 2, 4, 6, 8, 10, and 12. From Week 12, you will receive injections every 4 weeks. At each time point, after the initial dose, you will receive an 80 mg dose (one injection).

Pediatric Plaque Psoriasis

The usual dose given by subcutaneous injection for children 6 to less than 18 years of age is based on body weight.

If you weigh 50 kilograms (i.e., 110 pounds) or less, TALTZ doses of 20 mg and 40 mg must be prepared and given by a healthcare provider.

If you weigh more than 50 kilograms and if your doctor determines that it is appropriate, you or a responsible caregiver may be able to administer TALTZ at home after proper training in injection technique.

Psoriatic Arthritis

• The initial dose is 160 mg (two injections) by subcutaneous injection.
• After the first dose, you will receive 80 mg (one injection) every 4 weeks.
• For patients with psoriatic arthritis and with moderate-to-severe plaque psoriasis, use the dosing and administration recommendations for plaque psoriasis.
• For patients with psoriatic arthritis and with mild plaque psoriasis, use the dosing and administration recommendations for psoriatic arthritis.

Ankylosing Spondylitis

• You will receive 80 mg (one injection) by subcutaneous injection every 4 weeks.

Non-Radiographic Axial Spondyloarthritis

• You will receive 80 mg (one injection) by subcutaneous injection every 4 weeks.

TALTZ is for long-term treatment. Your healthcare professional will regularly monitor your condition to check that the treatment is having the desired effect.

Overdose:

If you accidentally inject more TALTZ than you should or the dose has been administered sooner than according to your doctor’s prescription, inform your healthcare professional.

Missed Dose:

If you have forgotten to inject a dose of TALTZ, inject the next dose as soon as you remember. Then talk to your healthcare professional to discuss when you should inject the next dose.

What are possible side effects from using TALTZ?

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Most of the following side effects are mild to moderate. If any of these side effects becomes severe, tell your healthcare professional.

Some side effects are very common (may affect more than 1 in 10 people):

• upper respiratory tract infections with symptoms such as sore throat and stuffy nose (nasopharyngitis)
• injections site reactions (e.g. rash, pain, itch or swelling)

Some side effects are common (may affect up to 1 in 10 people):

• feeling sick to your stomach (nausea)
• athlete’s foot (tinea pedis)
• sore throat
• diarrhea
• headache
• inflammation of the eye with redness, pain, and blurred vision (iridocyclitis)

Some side effects are uncommon (may affect up to 1 in 100 people):

• oral thrush (oral candidiasis)
• esophageal candidiasis
• fever, flu-like symptoms
• runny nose
• hives
• signs of low levels of white blood cells, such as fever, sore throat or mouth ulcers due to infections (neutropenia)
• discharge from the eye with itching, redness and swelling (conjunctivitis)
• stomach pain, diarrhea with or without blood, weight loss (inflammatory bowel disease)
• eczema
• itching

These are not all the possible side effects you may have when taking TALTZ. If you experience any side effects not listed here, tell your healthcare professional.

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting Side Effects

Storage:

Store in a refrigerator (2°C - 8°C). Do not freeze or shake. Do not use if TALTZ has been frozen. If needed, TALTZ may be left out of the refrigerator at a temperature up to 30°C (86°F) for up to 5 days. TALTZ should be discarded if not used within this 5-day period.

Store in the original packaging in order to protect from light.

Do not use TALTZ prefilled syringe or prefilled autoinjector:

• if you notice that it is damaged, or the medicine is cloudy, distinctly brown or yellow or has particles in it, or
• after the expiry date which is stated on the label and on the outer carton after “EXP”.

This medicine is for single use only. Ask your healthcare professional how to throw away medicines no longer required.

Keep out of reach and sight of children.

If you want more information about TALTZ:

• Talk to your healthcare professional.
• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website www.lilly.ca, or by calling 1-888-545-5972.
• The information in this document is current as of the last revision date shown below. For the most current information please visit our website or contact us directly.
• You may need to read this package insert again. Please do not throw it away until you have finished your medicine.

TALTZ is a registered trademark owned by or licensed to Eli Lilly and Company, its subsidiaries, or affiliates.

Last Revised: March 14, 2025

A3.0-TAL-PM-0009-YYYYMMDD

INSTRUCTIONS FOR USE How to use the TALTZ prefilled autoinjector
PrTALTZ® (ixekizumab) injection 80 mg/mL
www.lilly.ca
PLEASE READ THESE INSTRUCTIONS BEFORE USE
Before you use the TALTZ prefilled autoinjector, read and carefully follow all the step-by-step instructions.
BEFORE USING YOUR PREFILLED AUTOINJECTOR: IMPORTANT POINTS TO KNOW
Read and carefully follow all the instructions. Keep the Instructions for Use and refer to them as needed.
The prefilled autoinjector contains 1 dose of TALTZ. The prefilled autoinjector is for ONE-TIME USE ONLY.
The prefilled autoinjector contains glass parts. Handle it carefully. If you drop it on a hard surface, do not use it. Use a new prefilled autoinjector for your injection.
Your healthcare professional may help you decide where on your body to inject your dose. You can also read the GET READY section of these instructions to help you choose which area can work best for you.
Read the TALTZ Patient Medication Information inside this box to learn more about your medicine.

IMPORTANT SAFETY INFORMATION If you have questions or need help with your prefilled autoinjector, call your healthcare professional or visit the manufacturer’s website at www.lilly.ca or call 1-888-545-5972. If you have vision problems, DO NOT use the prefilled autoinjector, without help from a person trained to use it. Keep the prefilled autoinjector out of the reach and sight of children. If you do not have a sharps container, ask your healthcare professional where you can get one.
INSTRUCTIONS FOR USE Before you use the TALTZ prefilled autoinjector, read and carefully follow all the step-by-step instructions.
Guide to the parts Top
Injection button Lock ring Lock/unlock symbols Medicine Clear base Twist-off base cap Bottom/Needle End

1	GET READY
1a	Take the prefilled autoinjector from the refrigerator. Leave the base cap on until you are ready to inject. Wait 30 minutes to let the prefilled autoinjector warm to room temperature before you use it. This will make the medicine easier to inject. DO NOT microwave the prefilled autoinjector, run hot water over it, or leave it in direct sunlight.		minutes 30
1b	Gather the supplies for your injection: 1 alcohol wipe 1 cotton ball or piece of gauze 1 sharps container for disposal of prefilled autoinjector
1c	Expiration date	Inspect the prefilled autoinjector. Check the label. Make sure the name TALTZ appears on the label. Also make sure the medicine has not expired. The medicine inside should be clear. Its color may vary from colorless to slightly yellow. If you see any of the following, DO NOT USE the prefilled autoinjector, and dispose of it as directed: It is past the expiration date It looks damaged The medicine is cloudy, is distinctly brown, or has small specks
1d	Wash your hands before you inject your medicine.

1e		Back of arm Abdomen Thigh	Choose your injection site. You may inject in your abdomen (stomach area), in your thigh, or in the back of your arm. To inject in your arm, you will need someone to help you. DO NOT inject into areas where the skin is tender, bruised, red, scaly, or hard or where you have scars or stretch marks. DO NOT inject within 1 inch (2.5 centimeters) around 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 professional about where on your body may be best to inject your dose.
1f		Prepare your skin. Clean your skin with an alcohol wipe. Let the injection site dry before you inject your medicine.
2	INJECT
2a				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. Throw the base cap in the garbage. You will not need to put the base cap back on—doing so could damage the needle or cause you to stick yourself by accident.

2b		Place the clear base flat and firmly against your skin.
2c		Keep the base on your skin, and then turn the lock ring to the unlock position. You are now ready to inject.
2d	5-10 seconds Click Gray plunger	Press the green injection button. There will be a loud click. Keep holding the clear base firmly against your skin. You will hear a second click in about 5 to 10 seconds after the first one. The second click tells you that your injection is complete. You will also see the gray plunger at the top of the clear base. Remove the prefilled 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.

3	FINISH
3a			Dispose of the prefilled autoinjector. DO NOT put the base cap back on. Dispose of the used prefilled autoinjector in a sharps container such as a closeable, puncture-resistant container.
When you dispose of the prefilled autoinjector and the sharps container:
Put the prefilled autoinjector in a sharps container (like a biohazard container) or a hard plastic container with a secure lid. Do not throw the prefilled autoinjector directly into your household garbage.
Do not recycle the filled container. The full container must be disposed of according to your provincial and local laws.
For information on how to dispose of the container properly, ask your healthcare professional about options available in your area.
Commonly asked questions
Q.	What if I see bubbles in the prefilled autoinjector?
A.	It is normal to have air bubbles in the prefilled autoinjector. TALTZ is injected under the skin (subcutaneous injection). Air bubbles are not a problem in this type of injection. They will not harm you or affect your dose.
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. This will not harm you or affect your dose.
Q.	What if I unlocked the prefilled autoinjector and pressed the green injection button before I twisted off the base cap?
A.	Do not remove the base cap. Contact 1-888-545-5972.
Q.	Do I need to hold the injection button down until the injection is complete?
A.	This is not necessary, but it may help you keep the prefilled autoinjector steady and firm against your skin.

How to store your TALTZ prefilled autoinjector

DO
				DO store the prefilled autoinjector in the refrigerator between 2°C to 8°C (36°F to 46°F) until you are ready to use it. If needed, the prefilled autoinjector may be left out of the refrigerator at a temperature up to 30°C (86°F) for up to 5 days. TALTZ should be discarded if not used within this 5-day period.
		30 minutes		DO wait 30 minutes to let the prefilled autoinjector warm to room temperature before you use it.
DO NOT
				DO NOT freeze the prefilled autoinjector. If the prefilled autoinjector has been frozen, do not use it.
				DO NOT microwave the prefilled autoinjector, run hot water over it, or leave it in direct sunlight.
				DO NOT shake the prefilled autoinjector.
Read the Patient Medication Information for TALTZ inside this box to learn more about your medicine.
TALTZ is a registered trademark owned or licensed to Eli Lilly and Company, its subsidiaries or affiliates. Copyright © 2016, 2021, Eli Lilly and Company. All rights reserved. Document Revision Date: July 23, 2021 The TALTZ prefilled autoinjector meets the current dose accuracy and functional requirements of ISO 11608-1:2012 and 11608-5:2012 TAL-AI-0006-CA-IFU-20210723

INSTRUCTIONS FOR USE How to use the TALTZ prefilled syringe
PrTALTZ® (ixekizumab) injection 80 mg/mL
www.lilly.ca
PLEASE READ THESE INSTRUCTIONS BEFORE USE Before you use the TALTZ prefilled syringe, read and carefully follow all the step-by-step instructions.
BEFORE USING YOUR PREFILLED SYRINGE: IMPORTANT POINTS TO KNOW
Read and carefully follow all the instructions. Keep the Instructions for Use and refer to them as needed.
The prefilled syringe contains 1 dose of TALTZ. The syringe is for ONE-TIME USE ONLY.
Your healthcare professional may help you decide where on your body to inject your dose. You can also read the GET READY section of these instructions to help you choose which area can work best for you.
Read the TALTZ Patient Medication Information inside this box to learn more about your medicine.
IMPORTANT SAFETY INFORMATION If you have questions or need help with your prefilled syringe, call your healthcare professional or visit the manufacturer’s website at www.lilly.ca or call 1-888-545-5972. If you have vision problems, DO NOT use the prefilled syringe, without help from a person trained to use it. DO NOT share or reuse your TALTZ prefilled syringe. You may give or get an infection. Keep the syringe out of the reach and sight of children.

Guide to the parts Thumb pad
Green plunger rod Finger grips Gray syringe plunger Needle cap Syringe body with medicine Needle

1	GET READY
1a	Take the syringe from the refrigerator. Leave the needle cap on the syringe until you are ready to inject. Wait 30 minutes to let the syringe warm to room temperature before you use it. This will make the medicine easier to inject. DO NOT microwave the syringe, run hot water over it, or leave it in direct sunlight.		30 minutes
1b	Gather the supplies for your injection: 1 alcohol wipe 1 cotton ball or piece of gauze 1 sharps container for disposal of syringe
1c	Expiration date	Inspect the syringe for damage to the outside. Leave the needle cap on the syringe until you are ready to inject. Check the label. Make sure the name TALTZ appears on the label. Also make sure the medicine has not expired. The medicine inside should be clear. Its color may vary from colorless to slightly yellow. If you see any of the following, DO NOT USE the syringe, and dispose of it as directed: It is past the expiration date It looks damaged The medicine is cloudy, is distinctly brown, or has small specks
1d	Wash your hands before you inject your medicine.

1e		Back of arm Abdomen Thigh	Choose your injection site. You may inject in your abdomen (stomach area), in your thigh, or in the back of your arm. To inject in your arm, you will need someone to help you. DO NOT inject into areas where the skin is tender, bruised, red, scaly, or hard or where you have scars or stretch marks. DO NOT inject within 1 inch (2.5 centimeters) 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 professional about where on your body may be best to inject your dose.
1f	Prepare your skin. Clean your skin with an alcohol wipe. Let the injection site dry before you inject your medicine.

2	INJECT
2a			Pull the needle cap off and throw it away. DO NOT put the 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		Green plunger rod Gray syringe plunger	Push in the plunger. Slowly 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. 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. You should see the green plunger rod show through the syringe body when the injection is complete.
3	FINISH
3a			Dispose of the syringe. DO NOT put the needle cap back on. Dispose of the used syringe in a sharps container such as a closeable, puncture-resistant container.
When you dispose of syringes and the sharps container:
Put the syringe in a sharps container (like a biohazard container) or a hard plastic container with a secure lid. Do not throw the syringe directly into your household garbage.
Do not recycle the filled container. The full container must be disposed of according to your provincial and local laws.
For information on how to dispose of the container properly, ask your healthcare professional about options available in your area.

How to store your TALTZ prefilled syringe

DO
				DO store the syringe in the refrigerator between 2°C to 8°C (36°F to 46°F) until you are ready to use it. If needed, the prefilled syringe may be left out of the refrigerator at a temperature up to 30°C (86°F) for up to 5 days. TALTZ should be discarded if not used within this 5-day period.
		30 minutes		DO wait 30 minutes to let the syringe warm to room temperature before you use it.
DO NOT
				DO NOT freeze the syringe. If the syringe has been frozen, do not use it.
				DO NOT microwave the syringe, run hot water over it, or leave it in direct sunlight.
				DO NOT shake the syringe.
Read the Patient Medication Information for TALTZ inside this box to learn more about your medicine.
TALTZ is a registered trademark owned or licensed to Eli Lilly and Company, its subsidiaries or affiliates. Copyright © 2016, 2021, Eli Lilly and Company. All rights reserved. Document Revision Date: July 23, 2021 TAL-PFS-0004-CA-IFU-20210723