Ixekizumab

What is Ixekizumab?

• Ixekizumab (TALTZ) is a humanized interleukin-17A antagonist used for the treatment of autoimmune diseases.

What are the uses of this medicine?

This medicine is 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.

How does this medicine work?

• Ixekizumab (ix" ee kiz' ue mab) is a recombinant, humanized IgG4 monoclonal antibody to interleukin (IL)-17A, an important cytokine responsible for local release of proinflammatory mediators.
• The binding of the monoclonal antibody to the cytokine blocks its interaction with the receptor and thus decreases inflammatory pathways that are involved in immune mediated cell injury.
• Ixekizumab is considered an immunomodulatory and anti inflammatory agent and has been evaluated in several immune mediated diseases including rheumatoid arthritis, Crohn disease and psoriasis.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• a previous serious hypersensitivity reaction, such as anaphylaxis, to ixekizumab or to any of the excipients.

What drug interactions can this medicine cause?

• No clinically important drug interactions have been observed with TALTZ.

Is this medicine FDA approved?

• It was approved for use in the United States in 2016.

How should this medicine be used?

Recommended Dosage: Adult Plaque Psoriasis

• Recommended dose is 160 mg (two 80 mg injections) at Week 0, followed by 80 mg at Weeks 2, 4, 6, 8, 10, and 12, then 80 mg every 4 weeks.

Pediatric Plaque Psoriasis

• For patients weighing greater than 50 kg, recommended dose is 160 mg (two 80 mg injections) at Week 0, followed by 80 mg every 4 weeks.
• For patients weighing 25-50 kg, recommended dose is 80 mg at Week 0, followed by 40 mg every 4 weeks.
• For patients weighing less than 25 kg, recommended dose is 40 mg at Week 0, followed by 20 mg every 4 weeks.

Psoriatic Arthritis

• Recommended dose is 160 mg by subcutaneous injection (two 80 mg injections) at Week 0, followed by 80 mg every 4 weeks.
• For psoriatic arthritis patients with coexistent moderate-to-severe plaque psoriasis, use the dosing regimen for adult plaque psoriasis.
• TALTZ may be administered alone or in combination with a conventional DMARD (e.g., methotrexate).

Ankylosing Spondylitis

• Recommended dose is 160 mg by subcutaneous injection (two 80 mg injections) at Week 0, followed by 80 mg every 4 weeks.

Non-radiographic Axial Spondyloarthritis

• Recommended dose is 80 mg by subcutaneous injection every 4 weeks.

Administration

• Use TALTZ exactly as prescribed by your healthcare provider.
• For children weighing 110 pounds (50 kg) or less, TALTZ must be given by a healthcare provider. TALTZ will be given every 4 weeks.
• For children weighing more than 110 pounds (50 kg), if your healthcare provider decides that your caregiver may give your injections of TALTZ at home, your caregiver should ask and receive training from the healthcare provider on the right way to prepare and inject TALTZ. TALTZ will be given every 4 weeks.
• For adults, if your healthcare provider decides that you or a caregiver may give your injections of TALTZ 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 an autoinjector and a prefilled syringe that you or your caregiver may use at home to give injections. Your healthcare provider will decide which type of TALTZ is best for you to use at home.
• TALTZ is given as an injection under your skin (subcutaneous injection), in your thighs or stomach area (abdomen) by you or a caregiver. A caregiver may also give you an injection of TALTZ in the back of your 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).

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form: As Autoinjector

• Injection: 80 mg/mL solution in a single-dose prefilled autoinjector.

AsPrefilled Syringe

• Injection: 80 mg/mL solution in a single-dose prefilled syringe.

This medicine is available in fallowing brand namesː

• TALTZ

What side effects can this medication cause?

The most common side effects of this medicine include:

• injection site reactions
• upper respiratory infections
• nausea
• fungal infections

TALTZ may cause serious side effects, including:

• Serious allergic reactions
• Crohn's disease or ulcerative colitis (inflammatory bowel disease) can happen during treatment with TALTZ, including worsening symptoms

What special precautions should I follow?

• TALTZ may increase the risk of infection. Serious infections have occurred. Instruct patients to seek medical advice if signs or symptoms of clinically important chronic or acute infection occur. If a serious infection develops, discontinue TALTZ until the infection resolves.
• Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with TALTZ. Do not administer to patients with active TB infection. Initiate treatment of latent TB prior to administering TALTZ.
• Serious hypersensitivity reactions, including angioedema and urticaria have occurred with TALTZ.
• Patients treated with TALTZ may be at increased risk of inflammatory bowel disease. Crohn's disease and ulcerative colitis, including exacerbations, occurred during clinical trials. Monitor closely when prescribing TALTZ to patients with inflammatory bowel disease (IBD). Discontinue TALTZ and initiate appropriate medical management if IBD develops.
• Prior to initiating therapy with TALTZ, consider completion of all age appropriate immunizations according to current immunization guidelines. Avoid use of live vaccines in patients treated with TALTZ. No data are available on the response to live vaccines.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• There are no available data on TALTZ use in pregnant women to inform any drug associated risks.

Can this medicine be used in children?

• The safety and effectiveness of TALTZ have been established in pediatric subjects aged 6 years to less than 18 years with moderate-to-severe plaque psoriasis.
• The safety and effectiveness of TALTZ in other pediatric indications and for pediatric subjects less than 6 years of age have not been established.

What are the active and inactive ingredients in this medicine?

• Active ingredient: ixekizumab
• Inactive ingredients: Citric Acid Anhydrous, Polysorbate 80, Sodium Chloride, Sodium Citrate Dihydrate, and Water for Injection

Who manufactures and distributes this medicine?

• Packager: Eli Lilly and Company

What should I know about storage and disposal of this medication?

• TALTZ is sterile and preservative-free.
• Discard any unused portion.
• TALTZ must be protected from light until use.
• Store refrigerated at 2°C to 8°C (36°F to 46°F).
• If needed, patients/caregivers may store TALTZ at room temperature up to 30°C (86°F) 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 and discard, if unused, within 5 days.
• 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.
• Do not use TALTZ if it has been frozen.
• Do not shake.
• Discard the TALTZ single-dose autoinjector or syringe after use in a puncture-resistant container.
• Not made with natural rubber latex.

• Dailymed label info on Ixekizumab
• FDA Ixekizumab

Ixekizumab Resources
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