TALTZ ixekizumab 80 mg/mL Injection, Solution, 1 syringe — NDC 0002-1445-61 (Billing 00002-1445-61)
This is a package of 1 syringe of TALTZ ixekizumab 80 mg/mL Injection, Solution from Eli Lilly and Company, marketed since Mar 2016 and currently FDA-listed.
NDC database record
One package, one record: these facts belong to NDC 0002-1445-61 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 0002 labeler · 1445 product · 61 package
- Package marketed since
- Apr 19, 2016
- Sample package
- Yes — professional sample, not for sale
- Listing certified through
- Dec 31, 2027
- Barcode (UPC-A, from the NDC)
- 3 0002144561 4
- FDA record last changed
- Jul 24, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 075731
- GCN: 40848
- GPI-14 (Medi-Span): 9025055400D520
- HICL (First Databank): 043193
- AHFS class code: 90:24.20.92
- RxCUI (RxNorm): 1745103
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 5, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Interleukin-17A Antagonist class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
- Taltz is approved to treat moderate-to-severe plaque psoriasis in people 6 years and older, and for adults it also treats psoriatic arthritis, ankylosing spondylitis, and a conditi...
- Take Taltz out of the fridge 30 minutes before your injection and let it warm up with the needle cap still on — injecting a cold solution can sting more. Choose a spot on your thig...
- How do I give myself the injection, and does it hurt?
- Don't just skip a dose without calling your doctor or pharmacist first. Taltz does lower your immune defenses, so your doctor will want to know about any infection — even what feel...
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Ixekizumab — tap one for details:
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 5, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $7,535.52 | $7,535.52 / 1 ml |
Where does this data come from?
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 5, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Marketing end | Status |
|---|---|---|---|---|---|---|
| 00002-1445-09 0002-1445-09 | 3 SYRINGE in 1 CARTON / 1 mL in 1 SYRINGE | $7,388.22 / mL | $22,164.66 | 2016-03-22 | — | Active |
| 00002-1445-11 0002-1445-11 Main listing | 1 SYRINGE in 1 CARTON / 1 mL in 1 SYRINGE | $7,370.72 / mL | $7,370.72 | 2016-03-22 | — | Active |
| 00002-1445-27 0002-1445-27 | 2 SYRINGE in 1 CARTON / 1 mL in 1 SYRINGE | $7,435.87 / mL | $14,871.74 | 2016-03-22 | — | Active |
| 00002-1445-61 You're viewing this | 1 SYRINGE in 1 CARTON / 1 mL in 1 SYRINGE Sample | — | — | 2016-04-19 | — | Active |
This pack shows little to no recent Medicaid volume — a different pack size carries most fills. See all packs ↓
Pack size FAQ
What quantity is in this package?
How does this package differ from NDC 00002-1445-11?
What NDC number is used to bill for this package of TALTZ ixekizumab 80 mg/mL Injection, Solution?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Taltz 80 mg/mL 00002-7724-11 | Eli | 1 syringe | $7,402.070 | — | FDA listed | — |
| Taltz 80 mg/mLthis 00002-1445-61 | Eli | 1 syringe | — | — | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Purple Book · refreshed Oct 5, 2026
- CMS NADAC weekly file
Availability & biosimilar status
Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.
Why the date isn’t exact: Biosimilar timing can change because patents may be challenged, settled, licensed, added or removed, and litigation can move the real date earlier or later.
🛈 What do these terms mean?
- Biologic patent
- A patent the reference product’s maker has publicly listed. A biosimilar generally can’t launch until these expire — unless they’re invalidated or resolved in a settlement.
- Reference-product exclusivity
- A flat 12 years of FDA market protection from the biologic’s first licensure (the BPCIA). No biosimilar can be licensed before it ends, regardless of patents.
- Interchangeable exclusivity
- The first interchangeable biosimilar can earn a period as the only interchangeable version (pharmacists can substitute it without the prescriber).
- Earliest biosimilar (LOE)
- The latest of all the dates above — the soonest a biosimilar can realistically reach the market. Litigation and settlements can move it earlier.
Biologics have no small-molecule “generics” — competition comes from FDA-licensed biosimilars, tracked in the FDA Purple Book.
| Code | What it grants | Expires |
|---|---|---|
| RefProduct | Reference-product exclusivity (12-year, BPCIA) — no biosimilar can be licensed before this date | Mar 22, 2028 |
Is there a biosimilar for TALTZ 80 MG/ML AUTOINJ (2-PK)?
Why do different websites show different biosimilar dates?
Can a biosimilar launch before the last patent expires?
What does “current Purple Book estimate” mean?
What does “FDA listed” mean?
What does a patent or protection date mean here?
Where does this data come from?
- FDA Purple Book · refreshed Oct 5, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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0.30 mg / 1 mL
UNII 6OZP39ZG8H
Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
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UNII 55X04QC32I
A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
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80 mg / 1 mL
UNII C151H8M554
A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
4 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.- FDA label on DailyMed · label index refreshed Oct 5, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
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Manufacturer & labeler
More NDCs from Eli Lilly and Company labeler code 00002
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- Insulin glargine 100 [iU]/mL Injection, Solution NDC 0002-1437-00
- Omvoh mirikizumab-mrkz 100 mg/mL Injection, Solution NDC 0002-1442-11
- Insulin lispro 100 [iU]/mL Injection, Solution NDC 0002-1455-00
- Mounjaro tirzepatide 15 mg/.5mL Injection, Solution NDC 0002-1457-80
- Mounjaro tirzepatide 12.5 mg/.5mL Injection, Solution NDC 0002-1460-80
- Mounjaro tirzepatide 10 mg/.5mL Injection, Solution NDC 0002-1471-80
- Mounjaro tirzepatide 7.5 mg/.5mL Injection, Solution NDC 0002-1484-80
- Mounjaro tirzepatide 5 mg/.5mL Injection, Solution NDC 0002-1495-80
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE TALTZ ® is a humanized interleukin-17A antagonist indicated for the treatment of: patients aged 6 years or older with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. ( 1.1 ) adults with active psoriatic arthritis. ( 1.2 ) adults with active ankylosing spondylitis. ( 1.3 ) adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation. ( 1.4 )
1.1Plaque Psoriasis TALTZ ® is indicated for the treatment of patients 6 years of age and older with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
1.2Psoriatic Arthritis TALTZ is indicated for the treatment of adult patients with active psoriatic arthritis.
1.3Ankylosing Spondylitis TALTZ is indicated for the treatment of adult patients with active ankylosing spondylitis.
1.4Non-radiographic Axial Spondyloarthritis TALTZ is indicated for the treatment of adult patients with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation.
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Administer by subcutaneous injection. Adult Plaque Psoriasis ( 2.2 ) Recommended dosage 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 ( 2.3 ) For patients weighing greater than 50 kg, recommended dosage is 160 mg (two 80 mg injections) at Week 0, followed by 80 mg every 4 weeks.
For patients weighing 25-50 kg, recommended dosage is 80 mg at Week 0, followed by 40 mg every 4 weeks. For patients weighing less than 25 kg, recommended dosage is 40 mg at Week 0, followed by 20 mg every 4 weeks. Psoriatic Arthritis ( 2.4 ) Recommended dosage 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. ( 2.2 ) TALTZ may be administered alone or in combination with a conventional DMARD (e.g., methotrexate). Ankylosing Spondylitis ( 2.5 ) Recommended dosage is 160 mg by subcutaneous injection (two 80 mg injections) at Week 0, followed by 80 mg every 4 weeks.
Non-radiographic Axial Spondyloarthritis ( 2.6 ) Recommended dosage is 80 mg by subcutaneous injection every 4 weeks.
2.1Testing and Procedures Prior to Treatment Initiation Perform the following evaluations prior to TALTZ initiation: Evaluate patients for tuberculosis (TB) infection. TALTZ initiation is not recommended in patients with active TB infection. Initiate treatment of latent TB prior to initiation of TALTZ [see Warnings and Precautions ( 5.2 )] .
Complete all age-appropriate vaccinations as recommended by current immunization guidelines prior to initiating treatment with TALTZ [see Warnings and Precautions ( 5.6 )] .
2.2Recommended Dosage in Adult Plaque Psoriasis TALTZ is administered by subcutaneous injection. The recommended dosage in adults with moderate-to-severe plaque psoriasis 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.
2.3Recommended Dosage in Pediatric Plaque Psoriasis TALTZ is administered by subcutaneous injection every 4 weeks (Q4W). The recommended dosage in pediatric patients from 6 to less than 18 years of age with moderate-to-severe plaque psoriasis is based on the following weight categories. Table 1: Recommended Dosage for Pediatric Patients 6 Years of Age and Older with Plaque Psoriasis Pediatric Patient's Weight Starting Dose (Week 0) Dose every 4 weeks (Q4W) Thereafter Greater than 50 kg 160 mg (two 80 mg injections) 80 mg 25 to 50 kg 80 mg 40 mg Less than 25 kg 40 mg 20 mg
2.4Recommended Dosage in Psoriatic Arthritis The recommended dosage 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 [see Dosage and Administration ( 2.2 )] . TALTZ may be administered alone or in combination with a conventional disease-modifying antirheumatic drug (cDMARD) (e.g., methotrexate).
2.5Recommended Dosage in Ankylosing Spondylitis The recommended dosage is 160 mg by subcutaneous injection (two 80 mg injections) at Week 0, followed by 80 mg every 4 weeks.
2.6Recommended Dosage in Non-radiographic Axial Spondyloarthritis The recommended dosage is 80 mg by subcutaneous injection every 4 weeks.
2.7Preparation and Administration Instructions TALTZ is intended for use under the guidance and supervision of a healthcare provider. Adult patients may self-inject or caregivers may give injections of TALTZ after training in subcutaneous injection technique using the autoinjector or prefilled syringe. Safety and effectiveness of pediatric self-administration has not been established.
Therefore, TALTZ should be administered to pediatric patients by a healthcare provider or by a caregiver who has received train… [Excerpted — this section continues on DailyMed.]
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS TALTZ is a clear and colorless to slightly yellow solution available as: Injection: 80 mg/mL solution of TALTZ in a single-dose prefilled autoinjector Injection: 80 mg/mL solution of TALTZ in a single-dose prefilled syringe Injection: 40 mg/0.5 mL solution of TALTZ in a single-dose prefilled syringe Injection: 20 mg/0.25 mL solution of TALTZ in a single-dose prefilled syringe Injection: ( 3 ) 80 mg/mL solution in a single-dose prefilled autoinjector 80 mg/mL solution in a single-dose prefilled syringe 40 mg/0.5 mL solution in a single-dose prefilled syringe 20 mg/0.25 mL solution in a single-dose prefilled syringe
⛔ Contraindications ▾
4 CONTRAINDICATIONS TALTZ is contraindicated in patients with a previous serious hypersensitivity reaction, such as anaphylaxis, to ixekizumab or to any of the excipients [see Warnings and Precautions ( 5.3 )] . Serious hypersensitivity reaction to ixekizumab or to any of the excipients. ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Infections : 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.
( 5.1 ) Tuberculosis (TB) : Evaluate for TB prior to initiating treatment. ( 5.2 ) Hypersensitivity : If a serious allergic reaction occurs, discontinue TALTZ immediately and initiate appropriate therapy. ( 5.3 ) Eczematous Eruptions: In the postmarketing setting, cases of severe eczematous eruptions were reported in patients receiving TALTZ.
Treatment may need to be discontinued to resolve the eczematous eruption. ( 5.4 ) 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. ( 5.5 ) Immunizations : Avoid use of live vaccines. ( 5.6 )
5.1Infections TALTZ may increase the risk of infection. In clinical trials in adult patients with plaque psoriasis, the TALTZ group had a higher rate of infections than the placebo group (27% vs. 23%).
Upper respiratory tract infections, oral candidiasis, conjunctivitis and tinea infections occurred more frequently in the TALTZ group than in the placebo group. A similar increase in risk of infection was seen in placebo-controlled trials in patients with pediatric psoriasis, psoriatic arthritis, ankylosing spondylitis, and non-radiographic axial spondyloarthritis [see Adverse Reactions ( 6.1 )] . In the postmarketing setting, serious bacterial, viral, and fungal opportunistic infections have been reported in patients receiving IL-17 inhibitors including TALTZ.
Instruct patients treated with TALTZ to seek medical advice if signs or symptoms of clinically important chronic or acute infection occur. If a patient develops a serious infection or is not responding to standard therapy, monitor the patient closely and discontinue TALTZ until the infection resolves.
5.2Pre-treatment Evaluation for Tuberculosis 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.
Consider anti-TB therapy prior to initiating TALTZ in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Patients receiving TALTZ should be monitored closely for signs and symptoms of active TB during and after treatment.
5.3Hypersensitivity Serious hypersensitivity reactions, including angioedema and urticaria (each ≤0.1%), occurred in the TALTZ group in clinical trials. Anaphylaxis, including cases leading to hospitalization, has been reported in post marketing use with TALTZ [see Adverse Reactions ( 6.1 , 6.3 )] . If a serious hypersensitivity reaction occurs, discontinue TALTZ immediately and initiate appropriate therapy.
5.4Eczematous Eruptions In the postmarketing setting, cases of severe eczematous eruptions, including atopic dermatitis-like eruptions, dyshidrotic eczema, and erythroderma were reported in patients receiving TALTZ; some cases resulted in hospitalization. The onset of eczematous eruptions was variable, ranging from days to months after the first dose of TALTZ. Treatment may need to be discontinued to resolve the eczematous eruption.
Some patients with limited psoriasis treatment options were successfully treated for eczema while continuing TALTZ.
5.5Inflammatory Bowel Disease Patients treated with TALTZ may be at increased risk of inflammatory bowel disease. In clinical trials, Crohn's disease and ulcerative colitis, including exacerbations, occurred at a greater frequency in the TALTZ group than the placebo control group [see Adverse Reactions ( 6.1 )] . During TALTZ treatment, monitor for onset or… [Excerpted — this section continues on DailyMed.]
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following adverse drug reactions are discussed in greater detail in other sections of the label: Infections [see Warnings and Precautions ( 5.1 )] Hypersensitivity Reactions [see Contraindications ( 4 ) and Warnings and Precautions ( 5.3 )] Eczematous Eruptions [see Warnings and Precautions ( 5.4 )] Inflammatory Bowel Disease [see Warnings and Precautions ( 5.5 )] Most common (≥1%) adverse reactions associated with TALTZ treatment are injection site reactions, upper respiratory tract infections, nausea, and tinea infections.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and Company at 1-800-545-5979 (1-800-LillyRx) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying and controlled conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adult Plaque Psoriasis Weeks 0 to 12 : Three placebo-controlled trials in subjects with plaque psoriasis were integrated to evaluate the safety of TALTZ compared to placebo for up to 12 weeks. A total of 1167 subjects (mean age 45 years; 66% men; 94% White) with plaque psoriasis received TALTZ (160 mg at Week 0, 80 mg every 2 weeks [Q2W] for 12 weeks) subcutaneously.
In two of the trials, the safety of TALTZ (use up to 12 weeks) was also compared with an active comparator, U.S. approved etanercept [see Clinical Studies ( 14 )] . In the 12-week, placebo-controlled period, adverse events occurred in 58% of the TALTZ Q2W group (2.5 per subject-year of follow-up) compared with 47% of the placebo group (2.1 per subject-year of follow-up). Serious adverse events occurred in 2% of the TALTZ group (0.07 per subject-year of follow-up), and in 2% of the placebo group (0.07 per subject-year of follow-up).
Table 2 summarizes the adverse reactions that occurred at a rate of at least 1% and at a higher rate in the TALTZ group than in the placebo group during the 12-week placebo-controlled period of the pooled clinical trials. Table 2: Adverse Reactions Occurring in ≥1% of the TALTZ Group and More Frequently than in the Placebo Group in the Plaque Psoriasis Clinical Trials through Week 12 a Upper respiratory tract infections cluster includes nasopharyngitis and rhinovirus infection. b U.S. approved etanercept. Adverse Reactions TALTZ 80 mg Q2W (N=1167) n (%) Etanercept b (N=287) n (%) Placebo (N=791) n (%) Injection site reactions 196 (17) 32 (11) 26 (3) Upper respiratory tract infections a 163 (14) 23 (8) 101 (13) Nausea 23 (2) 1 (<1) 5 (1) Tinea infections 17 (2) 0 1 (<1) Adverse reactions that occurred at rates less than 1% in the TALTZ group and more frequently than in the placebo group during the 12-week induction period included rhinitis, oral candidiasis, urticaria, influenza, conjunctivitis, inflammatory bowel disease, and angioedema.
Weeks 13 to 60 : A total of 332 subjects received the recommended maintenance regimen of TALTZ 80 mg dosed every 4 weeks. During the maintenance period (Weeks 13 to 60), adverse events occurred in 80% of subjects treated with TALTZ (1.0 per subject-year of follow-up) compared to 58% of subjects treated with placebo (1.1 per subject-year of follow-up). Serious adverse events were reported in 4% of subjects treated with TALTZ (0.05 per subject-year of follow-up) and none in the subjects treated with placebo.
Weeks 0 to 60 : Over the entire treatment period (Weeks 0 to 60), adverse events were reported in 67% of subjects treated with TALTZ (1.4 per subject-year of follow-up) compared to 48% of subjects treated with placebo (2.0 per subject-year of follow-up). Serious adverse events were reported in 3% of subjects treated with TALTZ (0.06 per subject-year of follow-up), and in 2% of subjects treated with placebo (0.06 per subject-year of follow-up). Specific Adverse Drug Reactions Injection Site React… [Excerpted — this section continues on DailyMed.]
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to TALTZ during pregnancy. Pregnant women exposed to TALTZ are encouraged to enroll in the TALTZ Pregnancy Registry by calling 1-800-284-1695. Contact information for the registry is also available on http://www.pregnancyregistry.lilly.com.
Risk Summary Available data from the published literature and the pharmacovigilance database with TALTZ use in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. Human IgG is known to cross the placental barrier; therefore, TALTZ may be transmitted from the mother to the developing fetus. An embryofetal development study conducted in pregnant monkeys during organogenesis at doses up to 19 times the maximum recommended human dose (MRHD) revealed no evidence of harm to the developing fetus.
When dosing was continued until parturition, neonatal deaths were observed at 1.9 times the MRHD [see Data] . The clinical significance of these nonclinical findings is unknown. The background risk of major birth defects and miscarriage for the indicated population is unknown.
All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data An embryofetal development study was conducted in cynomolgus monkeys administered ixekizumab.
No malformations or embryofetal toxicity were observed in fetuses from pregnant monkeys administered ixekizumab weekly by subcutaneous injection during organogenesis to near parturition at doses up to 19 times the MRHD (on a mg/kg basis of 50 mg/kg/week). Ixekizumab crossed the placenta in monkeys. In a pre- and post-natal development toxicity study, pregnant cynomolgus monkeys were administered weekly subcutaneous doses of ixekizumab up to 19 times the MRHD from the beginning of organogenesis to parturition.
Neonatal deaths occurred in the offspring of two monkeys administered ixekizumab at 1.9 times the MRHD (on a mg/kg basis of 5 mg/kg/week) and two monkeys administered ixekizumab at 19 times the MRHD (on a mg/kg basis of 50 mg/kg/week). These neonatal deaths were attributed to early delivery, trauma, or congenital defect. The clinical significance of these findings is unknown.
No ixekizumab-related effects on functional or immunological development were observed in the surviving infants from birth through 6 months of age.
8.2Lactation Risk Summary There are no available data on the presence of ixekizumab in human milk, the effects on the breastfed infant, or the effects on milk production. Ixekizumab was detected in the milk of lactating cynomolgus monkeys. When a drug is present in animal milk, it is likely that the drug will be present in human milk.
The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for TALTZ and any potential adverse effects on the breastfed infant from TALTZ or from the underlying maternal condition.
8.4Pediatric Use 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.
8.5Geriatric Use Of the 4204 adult psoriasis subjects exposed to TALTZ, a total of 301 were 65 years or older, and 36 subjects were 75 years or older. Although no differences in safety or efficacy were observed between older and younger subjects, the number of subjects aged 65 and over is not sufficient to determine whether they respond differently from younger subjects [see Clinical Pharmacology ( 12.… [Excerpted — this section continues on DailyMed.]
🤰 Pregnancy ▾
8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to TALTZ during pregnancy. Pregnant women exposed to TALTZ are encouraged to enroll in the TALTZ Pregnancy Registry by calling 1-800-284-1695. Contact information for the registry is also available on http://www.pregnancyregistry.lilly.com.
Risk Summary Available data from the published literature and the pharmacovigilance database with TALTZ use in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. Human IgG is known to cross the placental barrier; therefore, TALTZ may be transmitted from the mother to the developing fetus. An embryofetal development study conducted in pregnant monkeys during organogenesis at doses up to 19 times the maximum recommended human dose (MRHD) revealed no evidence of harm to the developing fetus.
When dosing was continued until parturition, neonatal deaths were observed at 1.9 times the MRHD [see Data] . The clinical significance of these nonclinical findings is unknown. The background risk of major birth defects and miscarriage for the indicated population is unknown.
All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data An embryofetal development study was conducted in cynomolgus monkeys administered ixekizumab.
No malformations or embryofetal toxicity were observed in fetuses from pregnant monkeys administered ixekizumab weekly by subcutaneous injection during organogenesis to near parturition at doses up to 19 times the MRHD (on a mg/kg basis of 50 mg/kg/week). Ixekizumab crossed the placenta in monkeys. In a pre- and post-natal development toxicity study, pregnant cynomolgus monkeys were administered weekly subcutaneous doses of ixekizumab up to 19 times the MRHD from the beginning of organogenesis to parturition.
Neonatal deaths occurred in the offspring of two monkeys administered ixekizumab at 1.9 times the MRHD (on a mg/kg basis of 5 mg/kg/week) and two monkeys administered ixekizumab at 19 times the MRHD (on a mg/kg basis of 50 mg/kg/week). These neonatal deaths were attributed to early delivery, trauma, or congenital defect. The clinical significance of these findings is unknown.
No ixekizumab-related effects on functional or immunological development were observed in the surviving infants from birth through 6 months of age.
🧒 Pediatric Use ▾
8.4Pediatric Use 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.
🧓 Geriatric Use ▾
8.5Geriatric Use Of the 4204 adult psoriasis subjects exposed to TALTZ, a total of 301 were 65 years or older, and 36 subjects were 75 years or older. Although no differences in safety or efficacy were observed between older and younger subjects, the number of subjects aged 65 and over is not sufficient to determine whether they respond differently from younger subjects [see Clinical Pharmacology ( 12.3 )] .
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Ixekizumab is a humanized IgG4 monoclonal antibody that selectively binds with the interleukin 17A (IL-17A) cytokine and inhibits its interaction with the IL-17 receptor. IL-17A is a naturally occurring cytokine that is involved in normal inflammatory and immune responses. Ixekizumab inhibits the release of proinflammatory cytokines and chemokines.
12.2Pharmacodynamics No formal pharmacodynamic studies have been conducted with TALTZ.
12.3Pharmacokinetics The pharmacokinetic (PK) properties of ixekizumab were similar across the adult plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, and non-radiographic axial spondyloarthritis indications. Absorption Following a single subcutaneous dose of 160 mg in subjects with plaque psoriasis, ixekizumab reached peak mean (±SD) serum concentrations (C max ) of 16.2 ±6.6 mcg/mL by approximately 4 days post dose. Steady-state concentrations were achieved by Week 8 following the 160 mg starting dose and 80 mg every 2 weeks dosing regimen; the mean ±SD steady-state trough concentration was 9.3 ±5.3 mcg/mL.
Steady-state concentrations were achieved approximately 10 weeks after switching from the 80 mg every 2 weeks dosing regimen to the 80 mg every 4 weeks dosing regimen at Week 12. The mean ±SD steady-state trough concentration was 3.5 ±2.5 mcg/mL. In studies of subjects with plaque psoriasis, ixekizumab bioavailability ranged from 60% to 81% following subcutaneous injection.
Administration of ixekizumab via injection in the thigh achieved a higher bioavailability relative to that achieved using other injection sites including the arm and abdomen. Distribution The mean (geometric CV%) volume of distribution at steady-state was
7.11L (29%) in subjects with plaque psoriasis. Elimination The metabolic pathway of ixekizumab has not been characterized. As a humanized IgG4 monoclonal antibody ixekizumab is expected to be degraded into small peptides and amino acids via catabolic pathways in the same manner as endogenous IgG. The mean systemic clearance was
0.39L/day (37%) and the mean (geometric CV%) half-life was 13 days (40%) in subjects with plaque psoriasis. Weight Ixekizumab clearance and volume of distribution increase as body weight increases. Dose Linearity Ixekizumab exhibited dose-proportional pharmacokinetics in subjects with plaque psoriasis over a dose range from 5 mg (not the recommended dose) to 160 mg following subcutaneous administration.
Specific Populations Age: Geriatric Population Population pharmacokinetic analysis indicated that age did not significantly influence the clearance of ixekizumab in adult subjects with plaque psoriasis. Subjects who are 65 years or older had a similar ixekizumab clearance as compared to subjects less than 65 years old. Pediatric Population Pediatric psoriasis subjects (6 to less than 18 years of age) were administered ixekizumab at the recommended pediatric dosing regimen for 12 weeks.
Subjects weighing >50 kg and 25 to 50 kg had a mean ±SD steady-state trough concentration of 3.8 ±2.2 mcg/mL and 3.9 ±2.4 mcg/mL at Week 12, respectively. There were limited PK data (n=2) in subjects weighing <25 kg at Week 12. Drug Interaction Studies Population PK data analyses indicated that the clearance of ixekizumab was not impacted by concomitant administration of methotrexate, or by prior exposure to methotrexate or adalimumab in patients with psoriatic arthritis.
Population PK data analyses indicated that the clearance of ixekizumab was not impacted by concomitant administration of oral corticosteroids, NSAIDs, or cDMARDs (sulfasalazine and methotrexate) in patients with ankylosing spondylitis and non-radiographic axial spondyloarthritis. Cytochrome P450 Substrates No clinically significant changes in exposure of caffeine (CYP1A2 substrate), warfarin (CYP2C9 substrate), omeprazole (CYP2C19 substrate) or midazolam (CYP3A substrate) were observed in subjects with plaque psoriasis when used conco… [Excerpted — this section continues on DailyMed.]
🧬 Mechanism of Action ▾
12.1Mechanism of Action Ixekizumab is a humanized IgG4 monoclonal antibody that selectively binds with the interleukin 17A (IL-17A) cytokine and inhibits its interaction with the IL-17 receptor. IL-17A is a naturally occurring cytokine that is involved in normal inflammatory and immune responses. Ixekizumab inhibits the release of proinflammatory cytokines and chemokines.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied TALTZ injection is a sterile, preservative free, clear and colorless to slightly yellow solution available in: a single-dose prefilled autoinjector or a single-dose prefilled syringe to deliver 80 mg ixekizumab. a single-dose prefilled syringe to deliver 40 mg ixekizumab. a single-dose prefilled syringe to deliver 20 mg ixekizumab. TALTZ is supplied as: Pack Size NDC Code Autoinjector Carton of 1 0002-1445-11 80 mg single-dose Carton of 2 0002-1445-27 Carton of 3 0002-1445-09 Prefilled syringe 80 mg single-dose Carton of 1 0002-7724-11 40 mg single-dose Carton of 1 0002-8905-11 20 mg single-dose Carton of 1 0002-8900-11 Storage and Handling 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.
How Supplied TALTZ injection is a sterile, preservative free, clear and colorless to slightly yellow solution available in: a single-dose prefilled autoinjector or a single-dose prefilled syringe to deliver 80 mg ixekizumab. a single-dose prefilled syringe to deliver 40 mg ixekizumab. a single-dose prefilled syringe to deliver 20 mg ixekizumab. TALTZ is supplied as: Pack Size NDC Code Autoinjector Carton of 1 0002-1445-11 80 mg single-dose Carton of 2 0002-1445-27 Carton of 3 0002-1445-09 Prefilled syringe 80 mg single-dose Carton of 1 0002-7724-11 40 mg single-dose Carton of 1 0002-8905-11 20 mg single-dose Carton of 1 0002-8900-11
📦 Storage and Handling ▾
Storage and Handling 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.
📋 Description ▾
11 DESCRIPTION Ixekizumab is a humanized immunoglobulin G subclass 4 (IgG4) monoclonal antibody (mAb) with neutralizing activity against IL-17A. Ixekizumab is produced by recombinant DNA technology in a recombinant mammalian cell line and purified using standard technology for bioprocessing. Ixekizumab is comprised of two identical light chain polypeptides of 219 amino acids each and two identical heavy chain polypeptides of 445 amino acids each and has a molecular weight of 146,158 Daltons for the protein backbone of the molecule.
TALTZ injection is a sterile, preservative free, clear and colorless to slightly yellow solution, for subcutaneous use available as 80 mg of ixekizumab in a 1 mL single-dose prefilled autoinjector or a single-dose prefilled syringe, 40 mg of ixekizumab in a 0.5 mL single-dose prefilled syringe, or 20 mg of ixekizumab in a 0.25 mL single-dose prefilled syringe. The prefilled autoinjector and prefilled syringe each contain a 1 mL glass syringe with a fixed 27 gauge ½ inch needle. The TALTZ 80 mg prefilled autoinjector and prefilled syringe are manufactured to deliver 80 mg of ixekizumab.
The TALTZ 40 mg prefilled syringe is manufactured to deliver 40 mg of ixekizumab. The TALTZ 20 mg prefilled syringe is manufactured to deliver 20 mg of ixekizumab. Each TALTZ 80 mg/mL single-dose autoinjector or TALTZ 80 mg/mL single-dose prefilled syringe is composed of ixekizumab (80 mg); Polysorbate 80, USP (0.3 mg); Sucrose, USP (80 mg); and Water for Injection, USP.
Sodium Hydroxide, USP-NF, may have been added to adjust pH. The TALTZ solution has a pH of 5.2 – 6.2. Each TALTZ 40 mg/0.5 mL single-dose prefilled syringe is composed of ixekizumab (40 mg); Polysorbate 80, USP (0.15 mg); Sucrose, USP (40 mg); and Water for Injection, USP.
Sodium Hydroxide, USP-NF, may have been added to adjust pH. The TALTZ solution has a pH of 5.2 – 6.2. Each TALTZ 20 mg/0.25 mL single-dose prefilled syringe is composed of ixekizumab (20 mg); Polysorbate 80, USP (0.08 mg); Sucrose, USP (20 mg); and Water for Injection, USP.
Sodium Hydroxide, USP-NF, may have been added to adjust pH. The TALTZ solution has a pH of 5.2 – 6.2.
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient and/or caregiver to read the FDA-approved patient labeling (Medication Guide and Instructions for Use) before the patient starts using TALTZ, and each time the prescription is renewed, as there may be new information they need to know. Instructions on Self-Administration : Provide guidance to patients and caregivers on proper subcutaneous injection technique, including aseptic technique, and how to use the autoinjector or prefilled syringe correctly [see Instructions for Use] .
Infection : Inform patients that TALTZ may lower the ability of their immune system to fight infections, and that serious infections, including opportunistic infections, may occur with the use of TALTZ. Instruct patients of the importance of communicating any history of infections to the healthcare provider, and contacting their healthcare provider if they develop any symptoms of infection [see Warnings and Precautions ( 5.1 )] . Allergic Reactions : Advise patients to seek immediate medical attention if they experience any symptoms of serious hypersensitivity reactions [see Warnings and Precautions ( 5.3 )] .
Eczematous Eruptions: Inform patients that skin reactions resembling eczema may occur with the use of TALTZ. Instruct patients to seek medical advice if they develop signs or symptoms of eczema [see Warnings and Precautions ( 5.4 )] . Pregnancy : Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to TALTZ during pregnancy.
Advise patients to contact the registry at 1-800-284-1695 to enroll [see Use in Specific Populations ( 8.1 )] . Eli Lilly and Company, Indianapolis, IN 46285, USA US License Number 1891 Copyright © 2016, 2025, Eli Lilly and Company. All rights reserved.
Pat.: www.lilly.com/patents TAL-0017-USPI-20250819
💬 Medication Guide ▾
This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 08/2024 Medication Guide TALTZ ® (tolts) (ixekizumab) injection, for subcutaneous use What is the most important information I should know about TALTZ?
TALTZ is a medicine that affects your immune system. TALTZ may lower the ability of your immune system to fight infections and may increase your risk of infections. Some people have had serious infections while taking TALTZ, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses that can spread throughout the body.
Some people have been hospitalized from these infections. Your healthcare provider should check you for TB before you start treatment with TALTZ. Your healthcare provider may treat you with medicine for TB before you begin treatment with TALTZ if you have a past history of TB or have TB.
Your healthcare provider should watch you closely for signs and symptoms of TB during and after treatment with TALTZ. Before starting TALTZ, tell your healthcare provider if you: are being treated for an infection have an infection that does not go away or that keeps coming back have TB or have been in close contact with someone with TB think you have an infection or have symptoms of an infection such as: 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 After starting TALTZ, call your healthcare provider right away if you have any of the symptoms of infection listed above.
Do not use TALTZ if you have any symptoms of infection unless you are instructed to by your healthcare provider. See “ What are the possible side effects of TALTZ? ” for more information about side effects. What is TALTZ?
TALTZ is a prescription medicine 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. It is not known if TALTZ is safe and effective in children for conditions other than plaque psoriasis or in children under 6 years of age.
Do not use TALTZ if you have had a severe allergic reaction to ixekizumab or any of the other ingredients in TALTZ. See the end of this Medication Guide for a complete list of ingredients in TALTZ. Before using TALTZ, tell your healthcare provider about all of your medical conditions, including if you: have any of the conditions or symptoms listed in the section “ What is the most important information I should know about TALTZ? ” have Crohn's disease or ulcerative colitis have recently received or are scheduled to receive an immunization (vaccine).
You should avoid receiving live vaccines during treatment with TALTZ. are pregnant or plan to become pregnant. It is not known if TALTZ can harm your unborn baby. Pregnancy Exposure Registry: There is a pregnancy registry to collect information about women who are exposed to TALTZ during pregnancy.
The purpose of this registry is to collect information about the health of you and your baby. If you become pregnant while taking TALTZ, you are encouraged to enroll in the pregnancy registry by calling 1-800-284-1695 or by visiting online at www.pregnancyregistry.lilly.com. are breastfeeding or plan to breastfeed. It is not known if TALTZ passes into your breast milk.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. How should I use TALTZ? See the detailed “Instructions for Use” that comes with your TALTZ for information on how to prepare a… [Excerpted — this section continues on DailyMed.]
🧬 Pharmacokinetics ▾
12.3Pharmacokinetics The pharmacokinetic (PK) properties of ixekizumab were similar across the adult plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, and non-radiographic axial spondyloarthritis indications. Absorption Following a single subcutaneous dose of 160 mg in subjects with plaque psoriasis, ixekizumab reached peak mean (±SD) serum concentrations (C max ) of 16.2 ±6.6 mcg/mL by approximately 4 days post dose. Steady-state concentrations were achieved by Week 8 following the 160 mg starting dose and 80 mg every 2 weeks dosing regimen; the mean ±SD steady-state trough concentration was 9.3 ±5.3 mcg/mL.
Steady-state concentrations were achieved approximately 10 weeks after switching from the 80 mg every 2 weeks dosing regimen to the 80 mg every 4 weeks dosing regimen at Week 12. The mean ±SD steady-state trough concentration was 3.5 ±2.5 mcg/mL. In studies of subjects with plaque psoriasis, ixekizumab bioavailability ranged from 60% to 81% following subcutaneous injection.
Administration of ixekizumab via injection in the thigh achieved a higher bioavailability relative to that achieved using other injection sites including the arm and abdomen. Distribution The mean (geometric CV%) volume of distribution at steady-state was
7.11L (29%) in subjects with plaque psoriasis. Elimination The metabolic pathway of ixekizumab has not been characterized. As a humanized IgG4 monoclonal antibody ixekizumab is expected to be degraded into small peptides and amino acids via catabolic pathways in the same manner as endogenous IgG. The mean systemic clearance was
0.39L/day (37%) and the mean (geometric CV%) half-life was 13 days (40%) in subjects with plaque psoriasis. Weight Ixekizumab clearance and volume of distribution increase as body weight increases. Dose Linearity Ixekizumab exhibited dose-proportional pharmacokinetics in subjects with plaque psoriasis over a dose range from 5 mg (not the recommended dose) to 160 mg following subcutaneous administration.
Specific Populations Age: Geriatric Population Population pharmacokinetic analysis indicated that age did not significantly influence the clearance of ixekizumab in adult subjects with plaque psoriasis. Subjects who are 65 years or older had a similar ixekizumab clearance as compared to subjects less than 65 years old. Pediatric Population Pediatric psoriasis subjects (6 to less than 18 years of age) were administered ixekizumab at the recommended pediatric dosing regimen for 12 weeks.
Subjects weighing >50 kg and 25 to 50 kg had a mean ±SD steady-state trough concentration of 3.8 ±2.2 mcg/mL and 3.9 ±2.4 mcg/mL at Week 12, respectively. There were limited PK data (n=2) in subjects weighing <25 kg at Week 12. Drug Interaction Studies Population PK data analyses indicated that the clearance of ixekizumab was not impacted by concomitant administration of methotrexate, or by prior exposure to methotrexate or adalimumab in patients with psoriatic arthritis.
Population PK data analyses indicated that the clearance of ixekizumab was not impacted by concomitant administration of oral corticosteroids, NSAIDs, or cDMARDs (sulfasalazine and methotrexate) in patients with ankylosing spondylitis and non-radiographic axial spondyloarthritis. Cytochrome P450 Substrates No clinically significant changes in exposure of caffeine (CYP1A2 substrate), warfarin (CYP2C9 substrate), omeprazole (CYP2C19 substrate) or midazolam (CYP3A substrate) were observed in subjects with plaque psoriasis when used concomitantly with a single 160 mg dose of ixekizumab, or multiple doses of 80 mg every 2 weeks.
The potential effect of ixekizumab on the CYP2D6 activity cannot be ruled out due to high variability in exposure (approximately ±2-fold) of dextromethorphan and its CYP2D6 metabolite dextrorphan in psoriasis subjects.
🧬 Pharmacodynamics ▾
12.2Pharmacodynamics No formal pharmacodynamic studies have been conducted with TALTZ.
🔬 Clinical Studies ▾
14 CLINICAL STUDIES
14.1Adult Plaque Psoriasis Three multicenter, randomized, double-blind, placebo-controlled trials, Trials 1, 2, and 3 (NCT 01474512, NCT 01597245, NCT 01646177), enrolled a total of 3866 subjects 18 years of age and older with plaque psoriasis who had a minimum body surface area involvement of 10%, a static Physician Global Assessment (sPGA) score of ≥3 in the overall assessment (plaque thickness/induration, erythema, and scaling) of psoriasis on a severity scale of 0 to 5, a Psoriasis Area and Severity Index (PASI) score ≥12, and who were candidates for phototherapy or systemic therapy.
In all three trials, subjects were randomized to either placebo or TALTZ (80 mg every 2 weeks [Q2W]) for 12 weeks, following a 160 mg starting dose. In the two active comparator trials (Trials 2 and 3), subjects were also randomized to receive U.S. approved etanercept 50 mg twice weekly for 12 weeks. All three trials assessed the changes from baseline to Week 12 in the two co-primary endpoints: 1) PASI 75, the proportion of subjects who achieved at least a 75% reduction in the PASI composite score that takes into consideration both the percentage of body surface area affected and the nature and severity of psoriatic changes (induration, erythema and scaling) within the affected regions, and 2) sPGA of “0” (clear) or “1” (minimal), the proportion of subjects with an sPGA 0 or 1 and at least a 2-point improvement.
Other evaluated outcomes included the proportion of subjects with an sPGA score of 0 (clear), a reduction of at least 90% in PASI (PASI 90), a reduction of 100% in PASI (PASI 100), and an improvement of itch severity as measured by a reduction of at least 4 points on an 11-point itch Numeric Rating Scale. Subjects in all treatment groups had a median baseline PASI score ranging from approximately 17 to 18. Baseline sPGA score was severe or very severe in 51% of subjects in Trial 1, 50% in Trial 2, and 48% in Trial 3.
Of all subjects, 44% had received prior phototherapy, 49% had received prior conventional systemic therapy, and 26% had received prior biologic therapy for the treatment of psoriasis. Of the subjects who had received prior biologic therapy, 15% had received at least one anti-TNF alpha agent, and 9% had received an anti-IL 12/IL23. A total of 23% of study subjects had a history of psoriatic arthritis.
Clinical Response at Week 12 The results of Trials 1, 2, and 3 are presented in Table 3 . Table 3: Efficacy Results at Week 12 in Adults with Plaque Psoriasis in Trials 1, 2, and 3; NRI a a Abbreviations: N = number of patients in the intent-to-treat population; NRI = Non-Responder Imputation. b At Week 0, subjects received 160 mg of TALTZ. c Co-primary endpoints. d Itch NRS (≥4 improvement) in subjects with baseline Itch NRS ≥4. The number of ITT subjects with baseline Itch NRS Score ≥4 are as follows: Trial 1, TALTZ n=391, PBO n=374; Trial 2, TALTZ n=303, PBO n=135; Trial 3, TALTZ n=320, PBO n=158.
Trial 1 Trial 2 Trial 3 TALTZ 80 mg b Q2W (N=433) n (%) Placebo (N=431) n (%) TALTZ 80 mg b Q2W (N=351) n (%) Placebo (N=168) n (%) TALTZ 80 mg b Q2W (N=385) n (%) Placebo (N=193) n (%) sPGA of “0” (clear) or “1” (minimal) c 354 (82) 14 (3) 292 (83) 4 (2) 310 (81) 13 (7) sPGA of “0” (clear) 160 (37) 0 147 (42) 1 (1) 155 (40) 0 PASI 75 c 386 (89) 17 (4) 315 (90) 4 (2) 336 (87) 14 (7) PASI 90 307 (71) 2 (1) 248 (71) 1 (1) 262 (68) 6 (3) PASI 100 153 (35) 0 142 (40) 1 (1) 145 (38) 0 Itch NRS (≥4 point improvement) d 336 (86) 58 (16) 258 (85) 19 (14) 264 (83) 33 (21) Examination of age, gender, race, body weight, and previous treatment with a biologic did not identify differences in response to TALTZ among these subgroups at Week 12.
An integrated analysis of the U.S. sites in the two active comparator studies using U.S. approved etanercept, TALTZ demonstrated superiority to U.S. approved etanercept (50 mg twice weekly) on sPGA and PASI scores during the 12-week treatment period. The respective response rates for… [Excerpted — this section continues on DailyMed.]
🧪 Nonclinical Toxicology ▾
13 NONCLINICAL TOXICOLOGY
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Animal studies have not been conducted to evaluate the carcinogenic or mutagenic potential of TALTZ. Moreover published literature is mixed on potential effects on malignancy risk due to the inhibition of IL-17A activity, the pharmacological action of TALTZ. Some published literature suggests that IL-17A directly promotes cancer cell invasion, suggesting a potential beneficial effect by TALTZ, whereas other reports indicate IL-17A promotes T-cell mediated tumor rejection, suggesting a potential adverse effect by TALTZ.
However, neutralization of IL-17A with TALTZ has not been studied in these models. Depletion of IL-17A with a neutralizing antibody inhibited tumor development in mice, suggesting a potential beneficial effect by TALTZ. The relevance of experimental findings in mouse models for malignancy risk in humans is unknown.
No effects on fertility parameters such as reproductive organs, menstrual cycle length, or sperm analysis were observed in sexually mature cynomolgus monkeys that were administered ixekizumab for 13 weeks at a subcutaneous dose of 50 mg/kg/week (19 times the MRHD on a mg/kg basis). The monkeys were not mated to evaluate fertility.
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Animal studies have not been conducted to evaluate the carcinogenic or mutagenic potential of TALTZ. Moreover published literature is mixed on potential effects on malignancy risk due to the inhibition of IL-17A activity, the pharmacological action of TALTZ. Some published literature suggests that IL-17A directly promotes cancer cell invasion, suggesting a potential beneficial effect by TALTZ, whereas other reports indicate IL-17A promotes T-cell mediated tumor rejection, suggesting a potential adverse effect by TALTZ.
However, neutralization of IL-17A with TALTZ has not been studied in these models. Depletion of IL-17A with a neutralizing antibody inhibited tumor development in mice, suggesting a potential beneficial effect by TALTZ. The relevance of experimental findings in mouse models for malignancy risk in humans is unknown.
No effects on fertility parameters such as reproductive organs, menstrual cycle length, or sperm analysis were observed in sexually mature cynomolgus monkeys that were administered ixekizumab for 13 weeks at a subcutaneous dose of 50 mg/kg/week (19 times the MRHD on a mg/kg basis). The monkeys were not mated to evaluate fertility.
📖 Instructions for Use ▾
TALTZ 80 mg Autoinjector INSTRUCTIONS FOR USE TALTZ ® [tol-t-s] (ixekizumab) injection, for subcutaneous use Autoinjector This Instructions for Use contains information on how to inject TALTZ. Important Information You Need to Know Before Injecting TALTZ Your healthcare provider or nurse should show you how to prepare and inject TALTZ using the autoinjector. Do not inject yourself or someone else until you have been shown how to inject TALTZ.
You and your caregiver should read this Instructions for Use before you start using TALTZ and each time you get a refill. Keep the Instructions for Use and refer to them as needed. Each TALTZ autoinjector contains 1 dose of TALTZ.
The autoinjector is for one-time use only. The autoinjector contains glass parts. Handle autoinjector carefully.
If you drop it on a hard surface, do not use it. Use a new TALTZ autoinjector for your injection. Your healthcare provider may help you decide where on your body to inject your dose.
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. Read the “ Choose your injection site ” section of these instructions to help you choose which area can work best for you. If you have vision or hearing problems, do not use TALTZ autoinjector without help from a caregiver.
INSTRUCTIONS FOR USE Before you use the TALTZ autoinjector, read and carefully follow all the step-by-step instructions. Parts of the TALTZ autoinjector Step 1 Preparing to Inject TALTZ Step 1a Take the TALTZ autoinjector from the refrigerator. Remove the autoinjector from the package.
Put the original package with any unused autoinjectors back in the refrigerator. Leave the base cap on until you are ready to inject. Wait 30 minutes to let the autoinjector warm to room temperature before you use it.
Do not microwave the autoinjector, run hot water over it, or leave it in direct sunlight. Do not shake the autoinjector. Step 1b Gather the supplies needed for your injection: 1 alcohol wipe 1 cotton ball or piece of gauze 1 sharps disposal container.
See “ Disposing of TALTZ. ” Step 1c Figure A Inspect the autoinjector. Make sure the name TALTZ appears on the label. The medicine inside should be clear.
Its color may be colorless to slightly yellow. Do not use the autoinjector, and dispose of as directed by your healthcare provider or pharmacist if: the expiration date printed on the label has passed (see Figure A ). it looks damaged. the medicine is frozen. the medicine is cloudy, discolored, or has small particles. The medicine should look clear and colorless to slightly yellow.
Step 1d Wash your hands with soap and water before you inject TALTZ. Step 1e Figure B Choose your injection site. You may inject in your stomach area (abdomen) or in your thigh, or in the back of your arm (see Figure B ).
To inject in your arm, you will need someone to help you. Do not give an injection into areas where the skin is tender, bruised, red or hard, or in an area of skin that is affected by psoriasis. Do not inject within 1 inch 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 provider about where on your body to best inject TALTZ. Step 1f Prepare your skin. Clean your injection site with an alcohol wipe.
Let the injection site dry before you inject TALTZ. Step 2 Injecting TALTZ Step 2a Figure C 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 in the direction of the arrows (see Figure C ). Throw the base cap in the trash.
You will not need to put the base cap back on. If you do, you could damage the needle or stick yourself by accident. Step 2b Figure D Place the clear base flat and firmly against… [Excerpted — this section continues on DailyMed.]
📄 Recent Major Changes ▾
Warnings and Precautions ( 5.1 , 5.4 ) 08/2024
📄 Package Label / Principal Display Panel ▾
PACKAGE CARTON – Taltz Autoinjector 80 mg taltz ® (ixekizumab) injection 80 mg/mL For Subcutaneous Use Only 1 Single-Dose prefilled autoinjector Discard any unused product. NDC 0002-1445-11 1 x 1 mL Single-Dose prefilled autoinjector Rx Only Dispense enclosed Medication Guide to each patient. Lilly PACKAGE CARTON – Taltz Autoinjector 80 mg
PACKAGE CARTON – Taltz Prefilled Syringe 80 mg taltz ® (ixekizumab) injection 80 mg/mL For Subcutaneous Use Only 1 Single-Dose prefilled syringe Discard any unused product. NDC 0002-7724-11 1 x 1 mL Single-Dose prefilled syringe Rx Only Dispense enclosed Medication Guide to each patient. Lilly PACKAGE CARTON – Taltz Prefilled Syringe 80 mg
PACKAGE CARTON – Taltz Prefilled Syringe 40 mg taltz ® (ixekizumab) injection 40 mg/0.5 mL For Subcutaneous Use Only 1 Single-Dose prefilled syringe Discard any unused product. NDC 0002-8905-11 1 x 0.5 mL Single-Dose prefilled syringe Rx Only Dispense enclosed Medication Guide to each patient. Lilly PACKAGE CARTON – Taltz Prefilled Syringe 40 mg
PACKAGE CARTON – Taltz Prefilled Syringe 20 mg taltz ® (ixekizumab) injection 20 mg/0.25 mL For Subcutaneous Use Only 1 Single-Dose prefilled syringe Discard any unused product. NDC 0002-8900-11 1 x 0.25 mL Single-Dose prefilled syringe Rx Only Dispense enclosed Medication Guide to each patient. Lilly PACKAGE CARTON – Taltz Prefilled Syringe 20 mg
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| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |