ix-ee-KIZ-ue-mab

Therapeutic Classification: antipsoriatics

Pharmacologic Classification: interleukin antagonists

• 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.

• 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.

• 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.

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.

(plasma concentrations)

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).

GI: inflammatory bowel disease, nausea.

Hemat: neutropenia, thrombocytopenia.

Local: injection site reactions.

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

Drug-Drug:

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

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.

• Solution for injection (prefilled autoinjectors and prefilled syringes): 80 mg/mL;

• Assess for tuberculosis infection before starting therapy; do not administer to patient with active TB infection. Initiate treatment of latent TB before administering ixekizumab. In patient with previous history of TB in whom an adequate course cannot be confirmed, consider anti-TB therapy before starting ixekizumab.
• Monitor for signs and symptoms of infection (fever, sweats, chills, muscle aches, cough, dyspnea, blood in mucus, weight loss, warm, red, or painful skin or sores, diarrhea or stomach pain, burning or frequency of urination) before and periodically during therapy.
• Monitor for signs and symptoms of hypersensitivity (urticaria, feeling faint, swelling of face, eyelids, lips, mouth, tongue, or throat, dyspnea, throat tightness, chest tightness, rash) during therapy. If hypersensitivity reaction occurs, discontinue ixekizumab immediately and begin supportive therapy.
• Monitor for onset or exacerbation of inflammatory bowel disease (abdominal pain, diarrhea with or without blood, weight loss) during therapy.

• May cause neutropenia and thrombocytopenia.

• Complete all age-appropriate vaccinations as recommended by current immunization guidelines before starting therapy.
• SC: Allow to reach room temperature (30 min) before injection; do not microwave, run under hot water, or leave in sunlight to warm. Solution is clear and colorless to slightly yellow; do not administer solutions that are cloudy, discolored, or contain a precipitate. For prefilled syringe, pinch skin and inject into upper arm, thigh, or abdomen at a 45° angle; let go of skin pinch before injecting. Place autoinjector flat against skin at injection site before injecting. Avoid areas where skin is bruised, tender, erythematous, indurated, or affected by psoriasis. Rotate injection sites. Store in refrigerator in original box to protect from light; may be stored at room temperature for up to 5 days. Do not return to refrigerator once stored at room temperature.
  • For children ≤50 kg, after withdrawing dose from vial, change to a 27–gauge needle for administration.

• 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.
• 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 Taltzduring pregnancy. Pregnant women exposed to ixekizumab are encouraged to enroll in the pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ixekizumab during pregnancy, by calling the Taltz Pregnancy Registry at 1-800-284-1695 or contacting the registry at www.taltz.com.

• Decreased plaque formation and spread in patients with plaque psoriasis.
• Decreased pain and swelling with decreased joint destruction in psoriatic arthritis.
• Decreased disease activity in ankylosing spondylitis and non-radiographic axial spondyloarthritis.

Taltz

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