Taltz Injection

Ixekizumab

80mg

ELI LILLY AND COMPANY

Pack size	1 Pre-Filled Glass Syringe Autoinjector (1 ml)
Dispensing mode	POM
Source	USA
Agent	PHARMATRADE
Retail Price	7431.50 AED

Indications

Taltz Injection is used for: Moderate to severe plaque psoriasis, in adults who are candidates for systemic therapy.

Adult Dose

Psoriasis Indicated for adults with moderate-to-severe plaque psoriasis Week 0: 160 mg SC (two 80-mg injections), THEN 80 mg SC q2wks at weeks 2, 4, 6, 8, 10, and 12, THEN 80 mg SC q4wks Psoriatic Arthritis Indicated for adults with active psoriatic arthritis May be administered alone or in combination with a conventional DMARD (eg, methotrexate) 160 mg SC (ie, as two 80-mg injections) once, THEN 80 mg SC q4wk For patients with coexisting moderate-to-severe plaque psoriasis, use the dosing regimen for plaque psoriasis

Child Dose

Renal Dose

No dosage adjustment required

Administration

SC Preparation Before injection, remove autoinjector or prefilled syringe from the refrigerator and allow to reach room temperature (30 minutes) without removing the needle cap Inspect visually for particulate matter and discoloration prior to administration Should appear as a clear and colorless to slightly yellow solution Do not use if the liquid contains visible particles or is discolored or cloudy (other than clear and colorless to slightly yellow) Does not contain preservatives; therefore, discard any unused product remaining in the autoinjector or prefilled syringe SC Administration Intended for use under the guidance and supervision of a physician Patients may self-inject after training in SC injection technique using the autoinjector or prefilled syringe Instruct patients using the autoinjector or prefilled syringe to inject the full amount (1 mL), which provides 80 mg, according to the directions provided in the Instructions for Use provided in the Medication Guide supplied with the drug Administer each injection at a different anatomic location (eg, upper arms, thighs, or any quadrant of abdomen) than the previous injection, and not into areas where the skin is tender, bruised, erythematous, indurated, or affected by psoriasis Administration in the upper, outer arm may be performed by a caregiver or healthcare provider

Contra Indications

Previous serious hypersensitivity reaction (eg, anaphylaxis) to drug or excipients

Precautions

Increased rate of infections eg, upper resp tract infection, oral candidiasis, conjunctivitis & tinea infections. Patients w/ clinically important chronic infection. Monitor & discontinue if the patient is not responding to standard therapy or infection becomes serious. Do not resume treatment until infection resolves. Do not administer in patients w/ active TB. Consider anti-TB therapy prior to initiation in patients w/ latent TB. Discontinue immediately if serious hypersensitivity reaction occurs. Closely monitor patients w/ inflammatory bowel disease including Crohn's disease & ulcerative colitis. Do not use w/ live vaccines. Women of childbearing potential should use an effective method of contraception during treatment & for at least 10 wk after treatment. Renal or hepatic impairment. Pregnancy (avoid use) & lactation. Childn & adolescents 6-18 yr; childn <6 yr (treatment of moderate to severe plaque psoriasis).

Pregnancy-Lactation

Pregnancy There are no available data regarding use in pregnant women to inform 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 Animal studies Unknown if distributed in human breast milk Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug, and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition Lactation Unknown if distributed in human breast milk Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug, and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition

Interactions

Adverse Effects

Side effects of Ixekizumab : >10% Injection site reactions (17%) Upper respiratory tract infections (14%) 1-10% Thrombocytopenia, Grade 1 (3%) Nausea (2%) Tinea infections (2%) <1% Serious hypersensitivity reactions Serious infections Neutropenia

Mechanism of Action

Humanized monoclonal IgG4 antibody that targets interleukin-17A (IL-17A) and neutralizes the proinflammatory effects of IL-17A IL-17A is a naturally occurring cytokine that is involved in normal inflammatory and immune responses and plays a key role in the pathogenesis of plaque psoriasis

Note

Taltz 80mg Injection manufactured by ELI LILLY AND COMPANY. Its generic name is Ixekizumab. Taltz is availble in United Arab Emirates. Farmaco UAE drug index information on Taltz Injection is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.