Ixekizumab

Ixekizumab is used to treat moderate-to-severe plaque psoriasis, active psoriatic arthritis, and active ankylosing spondylitis.

Ixekizumab is available under the following different brand names: Taltz.

Dosages of Ixekizumab:

Dosage Forms and Strengths

Auto-Injector

• 80mg/mL

Prefilled Syringe

• 80mg/mL

Dosage Considerations – Should be Given as Follows:

Psoriasis

• Indicated for moderate-to-severe plaque psoriasis
• Week 0: 160 mg subcutaneous (SC) (two 80-mg injections), THEN
• 80 mg SC every 2 weeks at weeks 2, 4, 6, 8, 10, and 12, THEN
• 80 mg SC every 4 weeks

Psoriatic Arthritis

• Indicated for active psoriatic arthritis
• May be administered alone or in combination with a conventional DMARD (e.g., methotrexate)
• 160 mg SC (i.e., as two 80-mg injections) once, then 80 mg SC every 4 weeks
• For patients with coexisting moderate-to-severe plaque psoriasis, use the dosing regimen for plaque psoriasis

Ankylosing Spondylitis

• Indicated for active ankylosing spondylitis
• 160 mg SC (i.e., as two 80-mg injections) once, then 80 mg SC every 4 weeks
• May be administered with conventional (nonbiologic) DMARDs (e.g., sulfasalazine), corticosteroids, NSAIDs, and/or analgesics

Dosage Modifications

Hepatic or renal impairment

• No dosage adjustment required

Common side effects of ixekizumab include:

• Injection site reactions
• Upper respiratory tract infections
• Low blood platelets (thrombocytopenia)
• Nausea
• Tinea infections

Less common side effects of ixekizumab include:

• Serious hypersensitivity reactions
• Serious infections
• Low white blood cell count (neutropenia)
• Rhinitis
• Oral thrush
• Hives
• Influenza
• Conjunctivitis
• Inflammatory bowel disease
• Angioedema

Postmarketing side effects of ixekizumab reported include:

• Immune system disorders: Anaphylaxis

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first.

• Severe interactions of ixekizumab include:
  • adenovirus types 4 and 7 live, oral
  • BCG vaccine live
  • influenza virus vaccine quadrivalent, intranasal
  • measles mumps and rubella vaccine, live
  • measles, mumps, rubella and varicella vaccine, live
  • rotavirus oral vaccine, live
  • smallpox (vaccinia) vaccine, live
  • typhoid polysaccharide vaccine
  • typhoid vaccine live
  • varicella virus vaccine live
  • yellow fever vaccine
  • zoster vaccine live
• Serious interactions of ixekizumab include:
  • anthrax vaccine adsorbed
  • diphtheria & tetanus toxoids/ acellular pertussis vaccine
  • diphtheria & tetanus toxoids/acellular pertussis/poliovirus, inactivated vaccine
  • influenza virus vaccine quadrivalent, recombinant
  • influenza virus vaccine trivalent, recombinant
  • meningococcal A C Y and W-135 diphtheria conjugate vaccine
  • meningococcal A C Y and W-135 polysaccharide vaccine combined
  • meningococcal C and Y/haemophilus influenza type B vaccine
  • meningococcal group B vaccine
  • modified ragweed tyrosine adsorbate
  • pneumococcal vaccine 13-valent
  • pneumococcal vaccine heptavalent
  • pneumococcal vaccine polyvalent
  • tetanus and reduced diphtheria toxoids/ acellular pertussis vaccine
  • tetanus toxoid adsorbed or fluid
• Moderate interactions of ixekizumab include:
  • carbamazepine
  • clonidine
  • cyclosporine
  • dengue vaccine
  • disopyramide
  • ethosuximide
  • fosphenytoin
  • haemophilus influenzae type b vaccine
  • ifosfamide
  • lomustine
  • mechlorethamine
  • phenobarbital
  • phenytoin
  • primidone
  • quinidine
  • quinine
  • sirolimus
  • tacrolimus
  • theophylline
  • trastuzumab
  • valproic acid
  • warfarin
  • zoster vaccine recombinant
• Ixekizumab has no listed mild interactions with other drugs.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with your physician if you have health questions or concerns.

Warnings

• This medication contains ixekizumab. Do not take Taltz if you are allergic to ixekizumab or any ingredients contained in this drug.

Contraindications

• Hypersensitivity reaction (e.g., anaphylaxis) to drug or excipients

Effects of Drug Abuse

• No information available

Short-Term Effects

• See "What Are Side Effects Associated with Using Ixekizumab?"

Long-Term Effects

• See "What Are Side Effects Associated with Using Ixekizumab?"

Cautions

• Serious hypersensitivity reactions were reported, including angioedema and urticaria; anaphylaxis reported, some requiring hospitalization; if a serious hypersensitivity reaction occurs, discontinue the drug immediately and initiate appropriate therapy
• Monitor for onset or exacerbation of Crohn’s disease and ulcerative colitis

Risk of infections

• May increase risk of infection; upper respiratory tract infections, oral candidiasis, conjunctivitis, and tinea infections reported
• Instruct patients to seek medical advice if signs or symptoms of infection occur
• If a serious infection develops or infection is not responding to standard therapy, monitor the patient closely and discontinue therapy until the infection resolves

Tuberculosis evaluation

• Evaluate patients for TB before initiating treatment
• Do not administer to patients with active TB
• Initiate treatment of latent TB before administering therapy
• Consider anti-TB therapy before initiating in patients with a history of latent or active TB in whom an adequate course of treatment cannot be confirmed
• Monitor closely for signs and symptoms of active TB during and after treatment

Drug interaction overview

• Before initiating drug, consider completion of all age-appropriate immunizations; avoid the use of live vaccines; no data are available on the response to live vaccines while taking ixekizumab
• Altering CYP450 enzymes
  • The formation of CYP450 enzymes can be altered by increased levels of certain cytokines (e.g., IL-1, IL-6, IL-10, TNF-alpha, IFN) during chronic inflammation; thus, ixekizumab, an IL-17A antagonist, could normalize the formation of CYP450 enzymes
  • Upon initiating or discontinuing ixekizumab in patients receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for effect (e.g., warfarin) or drug concentration (e.g., cyclosporine) and consider dosage modification of the CYP450 substrate

Pregnancy and Lactation

• There are no available data regarding the use of ixekizumab in pregnant women to inform of any drug-associated risks. Human IgG is known to cross the placental barrier; therefore, ixekizumab may be transmitted from the mother to the developing fetus.
• It is unknown if ixekizumab is distributed in human breast milk. Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for ixekizumab, and any potential adverse effects on the breastfed infant from ixekizumab or the underlying maternal condition.