TALTZ AUTOINJECTOR (ixekizumab)

There are 1 contraindications. Absolute contraindication.

Contraindication List
Active tuberculosis

There are 4 severe contraindications. Adequate patient monitoring is recommended for safer drug use.

Severe List
Crohn's disease
Inactive tuberculosis
Infection
Ulcerative colitis

There are 0 moderate contraindications.

There are 11 severe adverse reactions.

More Frequent	Less Frequent
Infection	Colitis Influenza Neutropenic disorder

Rare/Very Rare
Anaphylaxis Angioedema Crohn's disease Hypersensitivity drug reaction Inflammatory bowel disease Thrombocytopenic disorder Ulcerative colitis

There are 14 less severe adverse reactions.

More Frequent	Less Frequent
Dermatophytosis Injection site sequelae Nausea Upper respiratory infection	Atopic dermatitis Bacterial infection Conjunctivitis Eczema Exfoliative dermatitis Opportunistic fungal infection Oral candidiasis Rhinitis Viral infection

Rare/Very Rare
Urticaria

There are insufficient data from the published literature and the pharmacovigilance database toevaluate therisks of ixekizumab in pregnant women. Human immunoglobulin G (IgG) is known to cross the placenta, and ixekizumab crossed the placenta in monkeys. Thus, the potential exists for fetal exposure to the drug.

An embryofetal development study in cynomolgus monkeys revealed no evidence of adverse developmental effects; however, when ixekizumab administration was continued until parturition, an increase in neonatal deaths was observed. No ixekizumab-related effects on functional or immunologic development were observed in the offspring from birth through 6 months of age. Pregnant women exposed to ixekizumab areencouraged to enroll in the TALTZ Pregnancy Registry by calling 1-800-284-1695 or accessing the website athttps://www.taltz.com.

Drug/Drug Class	Severity	Precaution Description	Pregnancy Category Description
Ixekizumab	2	Insuff human data avail; consider maternal benefit vs neonatal risk	No fda rating but may have precautions or warnings; may have animal and/or human studies or pre or post marketing information.

It is not known whether ixekizumab is distributed into human milk, affects milk production, or affects the breast-fed infant. Ixekizumab is distributed into milk in cynomolgus monkeys; when a drug is present in animal milk, it is likely to also be present in human milk. Consider the benefits of breast-feeding and the importance of ixekizumab to the woman along with potential adverse effects on the breast-fed infant from the drug or from the underlying maternal condition.

Precaution Exists
Precaution exists. (No data or inconclusive human data.) Use of this drug by breast feeding mothers should be evaluated carefully.

Drug Name	Excretion Potential	Effect on Infant	Notes
Ixekizumab	Unknown. It is unknown whether the drug is excreted in human breast milk.	It is not known whether this drug has an adverse effect on the nursing infant. (No data or inconclusive human data)	Insufficient human data available; excretion unlikely due to large mw

Of the 4204 adult patients with psoriasis who received ixekizumab in clinical trials, 7% were >=65 years of age, while <1% were >=75 years of age. Although no overall differences in efficacy or safety between geriatric patients and younger adults were observed, the clinical trials did not include sufficient numbers of patients >=65 years of age to determine whether geriatric patients respond differently than younger adults. In a population pharmacokinetic analysis, clearance of ixekizumab was similar in patients >=65 years of age and younger adults.