Taltz 80 mg

/ Eli Lilly

Plaque psoriasis
The recommended dose is 160 mg by subcutaneous injection (two 80 mg injections) at week 0, followed by 80 mg (one injection) at weeks 2, 4, 6, 8, 10, and 12, then maintenance dosing of 80 mg (one injection) every 4 weeks.
Psoriatic arthritis
The recommended dose is 160 mg by subcutaneous injection (two 80 mg injections) at week 0, followed by 80 mg (one injection) every 4 weeks thereafter. For psoriatic arthritis patients with concomitant moderate to severe plaque psoriasis, the recommended dosing regimen is the same as for plaque psoriasis.
Axial spondyloarthritis (radiographic and non-radiographic)
The recommended dose is 160 mg (two 80 mg injections) by subcutaneous injection at week 0, followed by 80 mg every 4 weeks (see section 5.1 for further information).
For all indications (plaque psoriasis, psoriatic arthritis, axial spondyloarthritis) consideration should be given to discontinuing treatment in patients who have shown no response after 16 to 20 weeks of treatment. Some patients with initially partial response may subsequently improve with continued treatment beyond 20 weeks.
See prescribing information for full details.

Plaque psoriasis
Treatment of moderate to severe plaque psoriasis in adults who are candidates for
systemic therapy.
Psoriatic arthritis
Taltz, alone or in combination with methotrexate, is indicated for the treatment of active psoriatic arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease modifying anti-rheumatic drug (DMARD) therapies.
Axial spondyloarthritis
Ankylosing spondylitis (radiographic axial spondyloarthritis)
Treatment of adult patients with active ankylosing spondylitis who have
responded inadequately to conventional therapy.
Non-radiographic axial spondyloarthritis
Treatment of adult patients with active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and magnetic resonance imaging (MRI) who have responded inadequately to nonsteroidal anti-inflammatory drugs (NSAIDs).

* Serious hypersensitivity to the active substance or to any of the excipients
* Clinically important active infections (e.g. active tuberculosis)

Infections: Treatment with Ixekizumab  is associated with an increased rate of infections such as upper respiratory tract infection, oral candidiasis, conjunctivitis, and tinea infections. Ixekizumab  should be used with caution in patients with clinically important chronic infection. If such an infection develops, monitor carefully and discontinue Ixekizumab  if the patient is not responding to standard therapy or the infection becomes serious. Ixekizumab  should not be resumed until the infection resolves. Ixekizumab  must not be given to patients with active tuberculosis (TB). Consider anti-TB therapy prior to initiation of Ixekizumab  in patients with latent TB.
Hypersensitivity: Serious hypersensitivity reactions, including some cases of angioedema, urticaria and, rarely, late (10-14 days following injection) serious hypersensitivity reactions including widespread urticaria, dyspnea and high antibody titres have been reported. If a serious hypersensitivity reaction occurs, administration of Ixekizumab  should be discontinued immediately and appropriate therapy initiated.
Inflammatory Bowel Disease: Cases of new or exacerbations of Crohn’s disease and ulcerative colitis have been reported. Caution should be exercised when prescribing Ixekizumab  to patients with inflammatory bowel disease, including Crohn’s disease and ulcerative colitis, and patients should be monitored closely.
Immunisations: Ixekizumab  should not be used with live vaccines. No data are available on the response to live vaccines; there are insufficient data on response to inactive vaccines.
Excipients: This medicinal product contains less than 1 mmol sodium (23 mg) per 80 mg dose, i.e., essentially “sodium-free”.

Very common: Upper respiratory tract infection, Injection site reactions.
Common: Tinea infection, Herpes simplex (mucocutaneous), Oropharyngeal pain, Nausea.
See prescribing information for full details.

In plaque psoriasis studies, the safety of Taltz in combination with other immunomodulatory agents or phototherapy has not been evaluated.
In population pharmacokinetic analyses, clearance of ixekizumab was not affected by concomitant administration of oral corticosteroids, NSAIDs, sulfasalazine, or methotrexate.
Cytochrome P450 substrates
Results from an interaction study in patients with moderate-to-severe psoriasis determined that 12 weeks of administration of ixekizumab with substances metabolised by CYP3A4 (i.e., midazolam), CYP2C9 (i.e., warfarin), CYP2C19 (i.e., omeprazole), CYP1A2 (i.e., caffeine) or CYP2D6 (i.e., dextromethorphan) does not have a clinically significant impact on the pharmacokinetics of these substances.

Women of childbearing potential: Women of childbearing potential should use an effective method of contraception during treatment and for at least 10 weeks after treatment.
Pregnancy: There is a limited amount of data from the use of ixekizumab in pregnant women.
Lactation: It is not known whether ixekizumab is excreted in human milk or absorbed systemically after ingestion.
See prescribing information for full details.

Doses up to 180 mg have been administered subcutaneously in clinical trials without dose-limiting toxicity. Overdoses up to 240 mg, subcutaneously, as a single administration in clinical trials, have been reported without any serious adverse events. In the event of overdose, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions and appropriate symptomatic treatment be instituted immediately.

Storage: Store in a refrigerator (2 ºC – 8 ºC). Do not freeze or shake. Store in the original package in order to protect from light.