ixekizumab

REMS

Moderate to severe plaque psoriasis in patients who are candidates for systemic therapy or phototherapy.
Active psoriatic arthritis (as monotherapy or in combination with a nonbiologic DMARD).
Active ankylosing spondylitis.
Active nonradiographic axial spondyloarthritis in patients with objective signs of inflammation.

Contraind./Precautions ⬆ ⬇

Contraindicated in:

Hypersensitivity;
Active tuberculosis.

Use Cautiously in:

Inflammatory bowel disease (may lead to exacerbations);
OB: Safety not established in pregnancy;
Lactation: Use while breastfeeding only if potential maternal benefit justifies potential risk to infant;
Pedi: Children <6 yr (safety and effectiveness not established).

Adv. Reactions/Side Effects ⬆ ⬇

Derm: eczematous eruptions

GI: inflammatory bowel disease, nausea

Hemat: neutropenia, thrombocytopenia

Local: injection site reactions

Misc: infection (including reactivation tuberculosis [TB]), HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS, ANGIOEDEMA, AND URTICARIA)

Interactions ⬆ ⬇

Drug-drug:

May ↓ antibody response to live-virus vaccine and ↑ risk of adverse reactions; do not administer concurrently.

Availability ⬆ ⬇

Solution for injection (prefilled autoinjectors): 80 mg/mL
Solution for injection (prefilled syringes): 20 mg/0.25 mL; 40 mg/0.5 mL; 80 mg/mL

Route/Dosage ⬆ ⬇

Plaque Psoriasis

SC (Adults ): 160 mg (as two 80-mg injections) at Wk 0; then 80 mg at Wk 2, 4, 6, 8, 10, and 12; then 80 mg every 4 wk.
SC (Children ≥6 yr and >50 kg): 160 mg (as two 80-mg injections) at Wk 0; then 80 mg every 4 wk.
SC (Children ≥6 yr and 25–50 kg): 80 mg at Wk 0; then 40 mg every 4 wk.
SC (Children ≥6 yr and <25 kg): 40 mg at Wk 0; then 20 mg every 4 wk.

Psoriatic Arthritis and Ankylosing Spondylitis

SC (Adults ): 160 mg (as two 80-mg injections) initially; then 80 mg every 4 wk.

Nonradiographic Axial Spondyloarthritis

SC (Adults ): 80 mg every 4 wk.

US Brand Names ⬆ ⬇

Action ⬆ ⬇

A monoclonal antibody that acts as an antagonist of interleukin (IL)-17A by selectively binding to it and preventing its interaction with the IL-17 receptor. Antagonism prevents the production of inflammatory cytokines and chemokines.

Therapeutic effects:

Decreased plaque formation and spread in plaque psoriasis.
Decreased pain and swelling with decreased joint destruction in psoriatic arthritis.
Decreased disease activity in ankylosing spondylitis and nonradiographic axial spondyloarthritis.

Classifications ⬆ ⬇

Therapeutic Classification: antipsoriatics

Pharmacologic Classification: interleukin antagonists

Pharmacokinetics ⬆ ⬇

Absorption: Well absorbed (60–81%) following SUBQ administration.

Distribution: Minimally distributed to tissues.

Metabolism/Excretion: Catabolized into small peptides and amino acids.

Half-Life: 13 days.

Time/Action Profile ⬆ ⬇

(plasma concentrations)

ROUTE	ONSET	PEAK	DURATION
SUBQ	unknown	4 days	unknown

Patient/Family Teaching ⬆ ⬇

Explain the purpose and side effects of ixekizumab to patient. Instruct patient and caregiver in proper technique for self-injection and care and disposal of equipment. Administer missed doses as soon as possible and resume regular dosing schedule. Advise patient to read Medication Guide and Instructions for Use prior to starting therapy and with each Rx refill in case of changes.
Advise patient to notify health care professional if signs and symptoms of allergic reaction, infection, or inflammatory bowel disease occur.
Advise patient to avoid use of live vaccines during therapy.
Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and consult health care professional before taking any new medications. May be used with conventional disease-modifying antirheumatic drugs, corticosteroids, NSAIDs, and/or analgesics.
Rep: Advise female patients of reproductive potential to notify health care professional if pregnancy is planned or suspected, or if breastfeeding. There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ixekizumab during pregnancy. Pregnant women exposed to ixekizumab are encouraged to enroll in the pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ixekizumab, by calling the Taltz Pregnancy Registry at 1-800-284-1695 or contacting the registry at https://www.taltz.com.

Pronunciation ⬆ ⬇

Code ⬆

NDC Code

0002- Eli Lilly and Company
- 0002-1445- TALTZ
  - 0002-1445-09- 3 SYRINGE in 1 CARTON (0002-1445-09) > 1 mL in 1 SYRINGE (0002-1445-01)

0002- Eli Lilly and Company
- 0002-1445- TALTZ
  - 0002-1445-11- 1 SYRINGE in 1 CARTON (0002-1445-11) > 1 mL in 1 SYRINGE (0002-1445-01)

0002- Eli Lilly and Company
- 0002-1445- TALTZ
  - 0002-1445-27- 2 SYRINGE in 1 CARTON (0002-1445-27) > 1 mL in 1 SYRINGE (0002-1445-01)

0002- Eli Lilly and Company
- 0002-1445- TALTZ
  - 0002-1445-61- 1 SYRINGE in 1 CARTON (0002-1445-61) > 1 mL in 1 SYRINGE

0002- Eli Lilly and Company
- 0002-7724- TALTZ
  - 0002-7724-11- 1 SYRINGE in 1 CARTON (0002-7724-11) > 1 mL in 1 SYRINGE (0002-7724-01)

0002- Eli Lilly and Company
- 0002-7724- TALTZ
  - 0002-7724-99- 1 SYRINGE in 1 CARTON (0002-7724-99) > 1 mL in 1 SYRINGE

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Indications ⬇