Taltz: Uses, Dosage & Side Effects

What Is Taltz and What Is It Used For?

Taltz contains the active substance ixekizumab, a humanized immunoglobulin G4 (IgG4) monoclonal antibody produced using recombinant DNA technology. As a biologic medicine, Taltz is a highly specialized protein engineered to target and neutralize one specific molecular target in the body: interleukin-17A (IL-17A). IL-17A belongs to a group of signaling proteins called cytokines, which act as messengers between immune cells and play critical roles in coordinating the body's inflammatory responses.

In healthy individuals, IL-17A plays a beneficial role in defending against certain bacterial and fungal infections. However, in people with psoriasis and spondyloarthritis, the immune system produces excessive amounts of IL-17A, leading to chronic, destructive inflammation. In psoriasis, overproduction of IL-17A stimulates rapid keratinocyte (skin cell) proliferation, recruits neutrophils and other inflammatory cells to the skin, and promotes the release of additional pro-inflammatory mediators. This cascade results in the characteristic thick, red, scaly plaques that define plaque psoriasis. In the joints and spine, excessive IL-17A drives chronic synovitis (joint inflammation), enthesitis (inflammation where tendons and ligaments attach to bone), and progressive structural damage.

By selectively binding to IL-17A with high affinity and preventing it from interacting with its receptor (IL-17RA), ixekizumab effectively blocks this inflammatory cascade. This leads to reduced keratinocyte proliferation, decreased neutrophil infiltration, and suppression of downstream inflammatory pathways. The clinical result is significant improvement in skin lesions, reduced joint pain and swelling, decreased spinal inflammation, and improved physical function.

Approved Indications

Taltz is approved for the treatment of the following conditions:

• Plaque Psoriasis in Adults: Treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy. In the landmark UNCOVER-1, UNCOVER-2, and UNCOVER-3 clinical trials, ixekizumab demonstrated superior efficacy compared with both placebo and the TNF inhibitor etanercept. At week 12, approximately 89% of patients achieved PASI 75 (75% or greater improvement from baseline Psoriasis Area and Severity Index), 71% achieved PASI 90, and 35–40% achieved complete skin clearance (PASI 100). These results were rapid, with significant improvements visible as early as week 2.
• Plaque Psoriasis in Children and Adolescents: Treatment of moderate-to-severe plaque psoriasis in patients aged 6 years and older weighing at least 25 kg who are candidates for systemic therapy. The IXORA-PEDS trial demonstrated that ixekizumab was well-tolerated and effective in this population, with efficacy results comparable to those seen in adults.
• Psoriatic Arthritis: Treatment of active psoriatic arthritis in adult patients who have had an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs (DMARDs). Taltz can be used alone or in combination with methotrexate. In the SPIRIT-P1 and SPIRIT-P2 trials, ixekizumab significantly improved joint symptoms, physical function, skin manifestations, enthesitis, and dactylitis (swelling of entire fingers or toes), and inhibited radiographic progression of structural joint damage.
• Radiographic Axial Spondyloarthritis (including Ankylosing Spondylitis): Treatment of active radiographic axial spondyloarthritis in adults who have had an inadequate response to conventional therapy. The COAST-V and COAST-W trials demonstrated significant improvement in spinal inflammation, pain, stiffness, and physical function with ixekizumab treatment.
• Non-Radiographic Axial Spondyloarthritis: Treatment of active non-radiographic axial spondyloarthritis with objective signs of inflammation (elevated CRP and/or MRI evidence) in adults who have had an inadequate response to NSAIDs. The COAST-X trial confirmed the efficacy and safety of ixekizumab in this patient population.
• Juvenile Idiopathic Arthritis: Treatment of enthesitis-related arthritis and juvenile psoriatic arthritis in patients aged 6 years and older weighing at least 25 kg.

Taltz was first approved by the U.S. Food and Drug Administration (FDA) in March 2016 for plaque psoriasis and subsequently received approval from the European Medicines Agency (EMA) in April 2016. It has since gained additional approvals for psoriatic arthritis, axial spondyloarthritis, and juvenile indications, and is now available in more than 60 countries worldwide. Taltz represents an important advancement in biologic therapy for IL-17-mediated inflammatory diseases, offering rapid onset of action and high rates of skin clearance that were not consistently achievable with earlier biologic therapies.

What Should You Know Before Taking Taltz?

Contraindications

Taltz must not be used in the following situations:

• Hypersensitivity: If you are allergic to ixekizumab or any of the other ingredients in Taltz (sucrose, polysorbate 80, water for injections). If you suspect you may be allergic, consult your doctor before using Taltz. Serious allergic reactions, including anaphylaxis, have been reported rarely.
• Active infection: If you have an active infection that your doctor considers to be clinically significant, such as active tuberculosis (TB). Your doctor should evaluate you for tuberculosis before initiating treatment.

Warnings and Precautions

Talk to your doctor before using Taltz if any of the following apply to you:

• Infections: Taltz may increase the risk of infections by suppressing part of the immune response. Patients with a history of chronic, recurring, or serious infections should be closely monitored. If you develop signs of a serious infection (fever, flu-like symptoms, persistent cough, warm/red/painful skin), stop using Taltz and contact your doctor immediately.
• Inflammatory Bowel Disease (IBD): Cases of new onset or exacerbation of Crohn's disease and ulcerative colitis have been reported in patients receiving IL-17 inhibitors, including Taltz. If you have a history of IBD, your doctor will monitor you closely. Stop using Taltz and seek medical attention immediately if you develop abdominal cramps, diarrhea, weight loss, or blood in your stool.
• Concurrent immunosuppressive therapy: If you are receiving other treatments for psoriasis (such as other immunosuppressants or UV light therapy), combining these with Taltz has not been extensively studied and may increase the risk of infection.
• Vaccinations: You should not receive live vaccines while being treated with Taltz. Inactivated vaccines (such as influenza and COVID-19 vaccines) can be given during treatment. Ideally, all recommended vaccinations should be completed before starting Taltz.

Pregnancy and Breastfeeding

If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using Taltz. It is best to avoid using Taltz during pregnancy as the effects on the unborn baby are not fully known. If you are a woman of childbearing potential, you are advised to avoid becoming pregnant and must use effective contraception during treatment and for at least 10 weeks after the last dose of Taltz.

If you are breastfeeding or planning to breastfeed, talk to your doctor before using Taltz. You and your doctor should decide whether you will breastfeed or use Taltz. You should not do both, as it is not known whether ixekizumab passes into human breast milk. IgG antibodies are known to be excreted in breast milk, so a risk to the nursing infant cannot be excluded.

Driving and Operating Machinery

Taltz is unlikely to affect your ability to drive or use machines. No studies on the effects on the ability to drive and use machines have been performed, and the mechanism of action of ixekizumab suggests no such effect would be expected.

Important Information About Excipients

Taltz contains less than 1 mmol sodium (23 mg) per 80 mg dose, meaning it is essentially sodium-free. It also contains 0.30 mg polysorbate 80 per dose, which may cause allergic reactions in individuals with known polysorbate sensitivity. Inform your doctor if you have any known allergies to these substances.

How Does Taltz Interact with Other Drugs?

Because ixekizumab is a monoclonal antibody, it is catabolized (broken down) by general protein degradation pathways rather than by the cytochrome P450 (CYP) enzyme system that metabolizes most conventional drugs. This means that traditional drug-drug interactions are not expected with Taltz, and no formal clinical drug interaction studies have been deemed necessary by regulatory authorities.

However, there are important considerations regarding drug interactions with Taltz. In chronic inflammatory conditions such as psoriasis, elevated levels of certain cytokines (including IL-17A) can alter the expression and activity of CYP enzymes. Specifically, chronic inflammation can suppress CYP enzyme activity, leading to higher-than-expected blood levels of drugs metabolized by these enzymes. When Taltz effectively reduces IL-17A levels and resolves the inflammatory state, CYP enzyme activity may return to normal. This normalization could potentially reduce the blood levels of co-administered CYP450 substrates, particularly those with a narrow therapeutic index.

Always tell your doctor, pharmacist, or nurse about all medications you are currently taking, have recently taken, or might take, including over-the-counter drugs, herbal supplements, and vitamins. Your healthcare team can assess whether any adjustments are necessary.

What Is the Correct Dosage of Taltz?

Always use Taltz exactly as your doctor or nurse has told you. The dosing regimen varies depending on the condition being treated, the patient's age, and body weight. Taltz is intended for long-term treatment, and your doctor will regularly evaluate whether the treatment is producing the desired effect.

Adults – Plaque Psoriasis

Adults – Psoriatic Arthritis

The dosing for psoriatic arthritis depends on whether the patient also has moderate-to-severe plaque psoriasis:

Adults – Axial Spondyloarthritis

Children and Adolescents (6 Years and Older)

Dosing in children is based on body weight. Taltz is not recommended for children under 6 years of age or weighing less than 25 kg, as it has not been studied in this population.

Missed Dose

If you forget to inject a dose of Taltz, contact your doctor as soon as possible. Do not take a double dose to make up for a forgotten injection. Your doctor will advise you on when to take the next dose and help you establish a new dosing schedule if needed. It is helpful to use a reminder system, such as a calendar or diary, to keep track of your injection dates and avoid missing doses.

Overdose

If you have received more Taltz than prescribed or if you received a dose earlier than scheduled, tell your doctor. In clinical trials, doses up to 180 mg have been administered subcutaneously without dose-limiting toxicities. There is no specific antidote for ixekizumab overdose. In the event of an overdose, the patient should be monitored for signs of adverse reactions and appropriate symptomatic treatment should be initiated.

What Are the Side Effects of Taltz?

Like all medicines, Taltz can cause side effects, although not everybody gets them. It is important to be aware of the potential side effects and to know when to seek medical attention. The following section describes the reported side effects organized by frequency, based on data from clinical trials and post-marketing surveillance.

Additional Side Effects in Children and Adolescents

In clinical trials involving children and adolescents, the following side effects were observed more frequently than in adults:

• Common: Influenza, runny nose, hives (urticaria), eye discharge with itching, redness and swelling (conjunctivitis)

The overall safety profile in children was consistent with that observed in adults, with no new safety signals identified.

How Should You Store Taltz?

Proper storage of Taltz is essential to maintain the medication's effectiveness and safety. The pre-filled autoinjector pens are biological products that are sensitive to temperature extremes and light exposure.

• Refrigeration: Store in a refrigerator at 2°C to 8°C (36°F to 46°F). Do not store against the back wall of the refrigerator where freezing may occur.
• Do not freeze: If the medication has been frozen, do not use it. Freezing can damage the protein structure of the antibody and render it ineffective.
• Light protection: Keep in the original packaging to protect from light. Ixekizumab is a protein that can be degraded by prolonged light exposure.
• Room temperature option: If needed, Taltz can be stored at room temperature (up to 30°C / 86°F) for a maximum of 5 days, protected from direct sunlight. This is useful when traveling or when refrigeration is temporarily unavailable. Discard if not used within the 5-day period.
• Before use: Allow the pen to reach room temperature (approximately 30 minutes) before injecting. Do not use external heat sources such as microwaves, hot water, or direct sunlight to warm the pen.
• Inspection: Before each injection, visually inspect the solution. The liquid should be clear. The color may vary from colorless to slightly yellow. Do not use if the solution is cloudy, distinctly brown, or contains visible particles, or if the pen appears damaged.
• Expiry date: Do not use after the expiry date printed on the pen label and outer carton.
• Disposal: Each pen is for single use only. Dispose of used pens in a sharps container. Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer needed.

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

What Does Taltz Contain?

Understanding the composition of your medication helps ensure safe use, particularly if you have known allergies to any ingredients.

The solution is enclosed in a clear glass syringe within a single-use disposable autoinjector pen. The solution should appear clear, colorless to slightly yellow. Pack sizes are available in 1, 2, or 3 pre-filled pens, although not all pack sizes may be available in every country.

The marketing authorization holder is Eli Lilly and Company (Ireland) Limited, Dunderrow, Kinsale, Co. Cork, Ireland. The manufacturing facility is Eli Lilly Italia S.p.A., Via Gramsci 731/733, 50019 Sesto Fiorentino, Italy.