Taltz (ixekizumab)

What are the Indications for Taltz?

Taltz is indicated for the following inflammatory conditions:

• Moderate to severe plaque psoriasis in patients 6 years of age or older
• Psoriatic Arthritis in patients 18 years of age or older
• Ankylosing spondylitis in patients 18 years of age or older
• Non-radiographic axial spondyloarthritis with signs of inflammation

Taltz is not recommended if you have an infection or are allergic to Taltz or any ingredients in Taltz.

How is Taltz used?

Storage

Taltz should be stored in a refrigerator between 2°C and 8°C (36°F and 46°F) in its original carton to protect it from light. If needed, Taltz can be stored at room temperature for up to 14 days in the original carton, as long as it is not exposed to light. Do not freeze Taltz or shake the medication vigorously.

Keep out of reach of children and pets.

Instruction

Before injecting Taltz, take it out of the refrigerator for at least 30 minutes to allow it to reach room temperature. Inspect the injection pen to ensure the medication is clear to yellow. Do not use the injection pen if it has expired or is damaged, or if the medication is frozen or cloudy with small particles.

Inject Taltz under your skin, usually every 2 to 4 weeks, as directed by your healthcare provider following the medication pamphlet. Taltz can also be injected by your provider in a clinic.

Dosage

Taltz Is available in the following forms and strengths:

• Prefilled syringes: 80 mg/mL and 160 mg/mL
• Autoinjectors: 80 mg/mL and 160 mg/mL

The recommended dosage is dependent on your diagnosis. If you are taking Taltz for:

Plaque Psoriasis

18+ years of age: The recommended dose is 160 mg the first week. Then inject 80 mg once every two weeks for the first 3 months (12 weeks). Once completed, the regular dose will be 80 mg injected once every 4 weeks

12 – 17 years of age: The recommended dose is dependent on the child’s weight.

• Less than 25 kg: The recommended dose is 40 mg the first week followed by 20 mg injected once every 4 weeks
• 25 – 50 kg: The recommended starting dose is 80 mg followed by 40 mg injected once every 4 weeks
• Greater than 50 kg: The recommended starting dose is 160 mg injected once followed by 80 mg every 4 weeks

Psoriatic Arthritis and Ankylosing Spondylitis

The recommended starting dose is a one time injection of 160 mg the first week. Then inject a dose of 80 mg injected once every 4 weeks.

Non-radiographic Axial Spondyloarthritis

The recommended injection dose is 80 mg injected once every 4 weeks.

Do not change your dosage and take more than what is prescribed without consulting with your doctor. If you inject more than prescribed, contact your doctor or seek emergency medical care right away.

Side Effects

It’s important to understand that although Taltz is FDA-approved, it comes with side effects that may or may not affect you.

Before starting Taltz, you should discuss possible side effects with your doctor or pharmacist.

Common Side Effects

Not all side effects require medical attention. As your body adjusts to Taltz, side effects may go away.

Tell your doctor if you experience the following symptoms, and they become severe or do not go away on their own:\

• Nausea
• Flu
• Diarrhea
• Pain, swelling, or irritation around the injection site
• Upper respiratory infections, such as a cold
• Fungal skin infections

Serious Side Effects

Severe adverse reactions while taking Taltz can occur. Seek emergency medical care or call 911 if you experience any of the following symptoms:

• Severe allergic reaction: severe rash or itching, swelling in the face, lips, tongue, or throat, rapid heartbeat, fainting or dizziness, or problems breathing or swallowing.
• Serious infections, such as pneumonia or cellulitis
• Inflammatory bowel disease
• Depression or suicidal thoughts

The information above does not list all possible side effects. Contact your doctor or pharmacist if you experience any side effects not listed. You or your doctor may report side effects to the FDA by calling 1-800-FDA-1088.

Warnings & Precautions

Before taking Taltz, tell your doctor or pharmacist:

• If you are allergic to any medications such as Taltz
• If you have an infection or signs of an infection
• If you have tuberculosis (TB)
• If you have an inflammatory bowel disease such as Crohn’s disease or ulcerative colitis
• If you are pregnant or expect to become pregnant or conceive
• If you are breastfeeding or plan to breastfeed

Infections

Using Taltz can increase your risk of infections, including serious infections, such as pneumonia or cellulitis. This is because Taltz works by suppressing the immune system, which can make it harder for your body to fight off infections. Signs of infections include fever, chills, cough, or urinary tract symptoms. If you get an infection or have signs of an infection, contact your doctor right away.

Tuberculosis

Before starting Taltz, your doctor will screen you for TB and other infections. If you have a history of TB or have been in close contact with someone who has TB, your healthcare provider may recommend treatment for TB before starting Taltz.

Using Taltz can increase your risk of developing tuberculosis (TB), an infectious disease caused by the bacteria Mycobacterium tuberculosis. Taltz suppresses the immune system, which can make it harder for your body to fight off TB infection. Symptoms of TB include cough, fever, weight loss, and night sweats. If you experience any of these symptoms, contact your doctor right away.

Inflammatory Bowel Disease

Using Taltz can increase your risk of developing inflammatory bowel disease (IBD), which is a group of chronic inflammatory conditions that affect the digestive tract. In rare cases, Taltz has been associated with the development of IBD, including Crohn’s disease and ulcerative colitis. If you experience any symptoms of IBD, such as diarrhea, abdominal pain, or rectal bleeding, contact your doctor right away.

Vaccines

Since Taltz suppresses the immune system, this makes it harder for your body to fight off infections caused by live vaccines. Vaccines should be avoided while taking Taltz; however if you need a vaccine, consult with your doctor to determine if change or temporary stop of Taltz is needed.

Pregnant or Planning to Become Pregnant

There is not enough data to determine if using Taltz while pregnant can harm a developing fetus. Taltz should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Use effective contraception during Taltz treatment to avoid pregnancy.

If you become pregnant during Taltz treatment, contact your doctor right away to determine treatment plans and options.

Interactions & Contraindications

Before taking Taltz, tell your doctor or pharmacist if you take any medications, herbal supplements, or vitamins.

Biologic Medications

Using Taltz with other biologic medications that affect the immune system may increase your risk of infections. Avoid use of other biologic medications unless otherwise directed by your doctor.