Taltz (ixekizumab) is an injectable medicine used to treat plaque psoriasis, psoriatic arthritis, ankylosing spondylitis and non-radiographic axial spondyloarthritis, which are all autoimmune disorders. Taltz works by reducing inflammation which helps improve the symptoms of these conditions.   

Taltz is a monoclonal antibody that acts by binding and neutralizing a naturally occurring protein called interleukin 17A (IL-17A).  This protein is involved in inflammation and how the immune system responds. When Taltz binds to the protein, inflammation is reduced, and this improves symptoms of plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, and non-radiographic axial spondyloarthritis.

Who can use Taltz?

Taltz is FDA approved to treat:

• Plaque Psoriasis for patients 6 years of age and older  who have moderate-to-severe plaque psoriasis, and are candidates for systemic therapy or phototherapy.
• Psoriatic Arthritis for adult patients with active psoriatic arthritis.
• Ankylosing Spondylitis for adult patients with active ankylosing spondylitis.
• Non-radiographic Axial Spondyloarthritis for adult patients who have active non-radiographic axial spondyloarthritis (nr-axSpA) that has objective signs of inflammation.

Infections. This medicine affects your immune system. You may get infections more easily, even serious or fatal infections. Call your doctor if you have a fever, chills, sweating, muscle pain, weight loss, skin sores, shortness of breath, cough with red or pink mucus, increased urination, or painful urination.

Tuberculosis. Your doctor may perform tests to make sure you do not have tuberculosis or other infections

Hypersensitivity. Serious hypersensitivity reactions can occur with this medicine. If an allergic reaction occurs discontinue treatment immediately and initiate appropriate therapy. Taltz is contraindicated in patients who have had previous serious hypersensitivity reaction to this medicine.

Immunization. You should not have live vaccines while being treated with this medicine.

Inflammatory bowel disease. Crohn's disease and ulcerative colitis, including exacerbations have occurred during treatment with this medicine. Patients should be monitored closely when this medicine is prescribed to patients with inflammatory bowel disease (IBD). If IBD develops and appropriate medical management should be started.

Take this medicine exactly as prescribed. Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Taltz is a solution (liquid) injected under the skin (subcutaneously) using a in a prefilled syringe or a prefilled autoinjector. You may be shown how to use injections at home. Do not give yourself this medicine if you do not understand how to use the injection.

Taltz instructions

• Remove the prefilled syringe or autoinjector from the refrigerator. 
• Place it on a flat surface without removing the needle cap and allow it warm to room temperature for 30 minutes before you are ready to inject the medication. Do not use the medicine if it has become frozen.
• Do not try to warm the medication by heating it in a microwave, placing it in hot water, leaving it in sunlight, or through any other method.
• Do not shake a syringe or autoinjector.
• Always look at the solution before injecting it. Check that the expiration date has not passed and that the liquid is clear or slightly yellow. The liquid should not contain visible particles. Do not use a syringe or autoinjector if it is cracked or broken, if it is expired or frozen, or if the liquid is cloudy or contains small particles.
• Use each syringe or autoinjector only once and inject all the solution in the syringe or autoinjector.
• You can inject anywhere on the front of your thighs (upper leg) or abdomen (stomach) except your navel and the area 1 inch (2.5 centimeters) around it. If you have a caregiver to inject the medication, the back of the upper arm may also be used. Use a different place each time you give an injection. 
• Do not inject into the same place two times in a row. Do not inject into an area where the skin is tender, bruised, red, or hard or where you have psoriasis, scars or stretch marks.
• Each single-use injection pen or prefilled syringe is for one use only. Throw away after one use, even if there is still some medicine left after injecting your dose. Dispose of used syringes and autoinjector in a puncture-resistant container. Talk to your doctor or pharmacist about how to dispose of the puncture-resistant container.
• Taltz is not used daily. Your first dose may be given as 2 injections at the same time. Later doses are then given once every 2 to 4 weeks.
• The timing of your injections will depend on the condition being treated. Follow your doctor's dosing instructions very carefully.

For more detailed instructions, including diagrams for all device types, click on this link: Taltz Instructions For Use.

Usual Adult Dose for Plaque Psoriasis

• 160 mg (two 80 mg injections) subcutaneously at Week 0, followed by 80 mg at Weeks 2, 4, 6, 8, 10, and 12, then 80 mg every 4 weeks.
• Use: For the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

Usual Pediatric Dose for Plaque Psoriasis

• Weight less than 25 kg. Dose 40 mg subcutaneously at Week 0, followed by 20mg every 4 weeks thereafter.
• Weight 25 to 50 kg. Dose 80 mg subcutaneously at Week 0, followed by 40mg every 4 weeks thereafter.
• Weight greater than 50 kg. Dose 160 mg (two 80 mg injections) subcutaneously at Week 0, followed by 80mg every 4 weeks thereafter.
• Use: For the treatment of pediatric patients from 6 years of age to less than 18 years of age with moderate-to-severe plaque psoriasis

Usual Adult Dose for Psoriatic Arthritis

• 160 mg (two 80 mg injections) subcutaneously 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 plaque psoriasis.
• This drug may be administered alone or in combination with a conventional disease-modifying antirheumatic drug (cDMARD) (e.g., methotrexate).
• Use: For the treatment of adult patients with active psoriatic arthritis

Usual Adult Dose for Ankylosing Spondylitis

• 160 mg (two 80 mg injections) subcutaneously at Week 0, followed by 80 mg every 4 weeks.

Usual Adult Dose for Non-radiographic Axial Spondyloarthritis

• 160 mg (two 80 mg injections) subcutaneously at Week 0, followed by 80 mg every 4 weeks.

Taltz is available as: 

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

Prefilled Syringe: 80 mg/mL solution in a single-dose prefilled syringe.

You should not use this medicine if you are allergic to the active ingredient ixekizumab, or any of the inactive ingredients contained in this medicine. To check for a complete list of ingredients click here: Taltz ingredients.

To make sure Taltz is safe for you, tell your doctor if you have:

• an active or recent infection;
• Crohn's disease, ulcerative colitis;
• tuberculosis (or if you have close contact with someone who has tuberculosis): or.
• if you have recently received or are scheduled to receive a vaccine.

Your doctor may perform tests to make sure you do not have tuberculosis or other infections.

Make sure you are up to date with all age-appropriate vaccinations before you start treatment with this medicine.

Pregnancy

Tell your doctor if you are pregnant or plan to become pregnant . It is not known if Taltz can harm your unborn baby. If you are pregnant or you become pregnant, your name may be listed on a pregnancy registry to track the effects of ixekizumab on the baby. The purpose of this registry is to collect information about the health of you and your baby. 

Breastfeeding

Tell your doctor if you are breastfeeding or planning to breastfeed. It is not known whether this medicine passes into breast milk or if it could harm a nursing baby.

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Do not share this medicine with another person, even if they have the same symptoms you have.

Do not receive a "live" vaccine while using this injection. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

Allergic reaction: Immediately get emergency medical help if you have signs of an allergic reaction such as rash, chest tightness, difficult breathing. feeling like you might pass out, swelling of your face, eyelids, lips, mouth, tongue, or throat.

Taltz may cause other serious side effects:

Call your doctor at once if you have:

• fever, chills, sweating, muscle pain, weight loss;
• diarrhea (may be bloody), stomach cramps;
• painful skin sores;
• cough, shortness of breath, cough with red or pink mucus;
• sores or white patches in your mouth or throat (yeast infection or "thrush");
• increased urination, pain or burning when you urinate;
• eye swelling, redness, crusting or drainage (may be signs of infection); or
• signs of a fungal infection (rash or red patches, itching, burning, cracked skin, hair loss).

Common Taltz side effects may include:

• pain or redness where the medicine was injected;
• nausea;
• ear infection; or
• cold symptoms such as stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other drugs may interact with this medicine including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

It is important to tell your doctor if you take any of these medicines:

• carbamazepine (Carbatrol, Epitol, Equetro, Tegretol, Teril)
• cyclosporine (Gengraf, Neoral, Sandimmune)
• quinidine (in Nuedexta)
• sirolimus (Rapamune)
• tacrolimus (Astagraf, Envarsus, Prograf)
• warfarin (Coumadin, Jantoven) 

Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with Taltz so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list. To check for interactions with Taltz click on the link below.