Dosing & Uses
Dosage Forms & Strengths
injection, solution
- 100mg/mL (single-dose prefilled syringe)
Plaque Psoriasis
Indicated for moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy
100 mg SC at Weeks 0, 4, and q12Weeks thereafter
Dosage Modifications
Hepatic and renal impairment
- Not studied
Dosing Considerations
Evaluate patients for tuberculosis (TB) infection prior to initiating treatment
<18 years: Safety and efficacy not established
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (0)
Serious - Use Alternative (13)
- adenovirus types 4 and 7 live, oral
tildrakizumab decreases effects of adenovirus types 4 and 7 live, oral by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Before initiating tildrakizumab therapy, consider completion of all age appropriate immunizations according to current immunization guidelines. Avoid use of live vaccines in patients treated with tildrakizumab. No data are available on the response to live or inactive vaccines.
- BCG vaccine live
tildrakizumab decreases effects of BCG vaccine live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Before initiating tildrakizumab therapy, consider completion of all age appropriate immunizations according to current immunization guidelines. Avoid use of live vaccines in patients treated with tildrakizumab. No data are available on the response to live or inactive vaccines.
- cholera vaccine
tildrakizumab decreases effects of cholera vaccine by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Before initiating tildrakizumab therapy, consider completion of all age appropriate immunizations according to current immunization guidelines. Avoid use of live vaccines in patients treated with tildrakizumab. No data are available on the response to live or inactive vaccines.
- influenza virus vaccine quadrivalent, intranasal
tildrakizumab decreases effects of influenza virus vaccine quadrivalent, intranasal by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Before initiating tildrakizumab therapy, consider completion of all age appropriate immunizations according to current immunization guidelines. Avoid use of live vaccines in patients treated with tildrakizumab. No data are available on the response to live or inactive vaccines.
- measles mumps and rubella vaccine, live
tildrakizumab decreases effects of measles mumps and rubella vaccine, live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Before initiating tildrakizumab therapy, consider completion of all age appropriate immunizations according to current immunization guidelines. Avoid use of live vaccines in patients treated with tildrakizumab. No data are available on the response to live or inactive vaccines.
- measles, mumps, rubella and varicella vaccine, live
tildrakizumab decreases effects of measles, mumps, rubella and varicella vaccine, live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Before initiating tildrakizumab therapy, consider completion of all age appropriate immunizations according to current immunization guidelines. Avoid use of live vaccines in patients treated with tildrakizumab. No data are available on the response to live or inactive vaccines.
- rotavirus oral vaccine, live
tildrakizumab decreases effects of rotavirus oral vaccine, live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Before initiating tildrakizumab therapy, consider completion of all age appropriate immunizations according to current immunization guidelines. Avoid use of live vaccines in patients treated with tildrakizumab. No data are available on the response to live or inactive vaccines.
- smallpox (vaccinia) vaccine, live
tildrakizumab decreases effects of smallpox (vaccinia) vaccine, live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Before initiating tildrakizumab therapy, consider completion of all age appropriate immunizations according to current immunization guidelines. Avoid use of live vaccines in patients treated with tildrakizumab. No data are available on the response to live or inactive vaccines.
- typhoid polysaccharide vaccine
tildrakizumab decreases effects of typhoid polysaccharide vaccine by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Before initiating tildrakizumab therapy, consider completion of all age appropriate immunizations according to current immunization guidelines. Avoid use of live vaccines in patients treated with tildrakizumab. No data are available on the response to live or inactive vaccines.
- typhoid vaccine live
tildrakizumab decreases effects of typhoid vaccine live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Before initiating tildrakizumab therapy, consider completion of all age appropriate immunizations according to current immunization guidelines. Avoid use of live vaccines in patients treated with tildrakizumab. No data are available on the response to live or inactive vaccines.
- varicella virus vaccine live
tildrakizumab decreases effects of varicella virus vaccine live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Before initiating tildrakizumab therapy, consider completion of all age appropriate immunizations according to current immunization guidelines. Avoid use of live vaccines in patients treated with tildrakizumab. No data are available on the response to live or inactive vaccines.
- yellow fever vaccine
tildrakizumab decreases effects of yellow fever vaccine by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Before initiating tildrakizumab therapy, consider completion of all age appropriate immunizations according to current immunization guidelines. Avoid use of live vaccines in patients treated with tildrakizumab. No data are available on the response to live or inactive vaccines.
- zoster vaccine live
tildrakizumab decreases effects of zoster vaccine live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Before initiating tildrakizumab therapy, consider completion of all age appropriate immunizations according to current immunization guidelines. Avoid use of live vaccines in patients treated with tildrakizumab. No data are available on the response to live or inactive vaccines.
Monitor Closely (1)
- dengue vaccine
tildrakizumab decreases effects of dengue vaccine by immunosuppressive effects; risk of infection. Use Caution/Monitor. Immunosuppressive therapies (eg, irradiation, antimetabolites, alkylating agents, cytotoxic drugs, corticosteroids [greater than physiologic doses]) may reduce immune response to dengue vaccine.
Minor (0)
Adverse Effects
>10%
Upper respiratory infections (14%)
1-10%
Injection site reactions (3%)
Diarrhea (2%)
Warnings
Contraindications
Hypersensitivity reaction to tildrakizumab or to any of the excipients
Cautions
In clinical trials, cases of angioedema and urticaria occurred; if serious hypersensitivity reaction occurs, discontinue treatment immediately and initiate appropriate therapy (see Contraindications)
There is a slight increased risk of infection with patients treated with tildrakizumab in clinical trials; patients with active infections or history of recurrent infections were not included in clinical trials; consider the risks and benefits before prescribing
Infections
- There is a slight increased risk of infection with patients treated with tildrakizumab in clinical trials; patients with active infections or history of recurrent infections were not included in clinical trials
- Instruct patients to seek medical help if signs or symptoms of clinically important chronic or acute infection occur; if a patient develops a clinically important or serious infection or is not responding to standard therapy, monitor patient closely and consider discontinuation of therapy until infection resolves
- Consider risks and benefits before prescribing
Immunizations
- Before initiating therapy, consider completion of all age appropriate immunizations according to current immunization guidelines
- No data are available on the response to live or inactive vaccines
- Avoid use of live vaccines
Pretreatment evaluation for tuberculosis
- Evaluate patients for TB infection before initiating treatment
- Initiate treatment of latent TB before administering tildrakizumab; monitor for signs and symptoms of active TB during and after tildrakizumab
- Consider anti-TB therapy before initiating treatment in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed; do not administer to patients with active TB infection
Pregnancy
Pregnancy
Data are limited regarding use in pregnant women and are insufficient to inform a drug associated risk of adverse developmental outcomes
Human IgG is known to cross the placental barrier; therefore, tildrakizumab may be transferred from the mother to the fetus
Lactation
No data are available on the presence of tildrakizumab in human milk, the effects on the breastfed infant, or the effects on milk production
Human IgG is known to be present in human milk
Tildrakizumab was detected in the milk of monkeys
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Humanized IgG1/k monoclonal antibody that selectively binds to the p19 subunit of interleukin-23 (IL-23) and inhibits its interaction with the IL-23 receptor
IL-23 is a naturally occurring cytokine that is involved in inflammatory and immune responses
Tildrakizumab inhibits the release of proinflammatory cytokines and chemokines
Absorption
Bioavailability: 73-80%
Peak plasma time: ~6 days
Steady peak plasma concentration: 8.1 mcg/mL
Distribution
Vd: 10.8 L
Metabolism
Metabolic pathway has not been characterized
Tildrakizumab is expected to degrade into small peptides and amino acids via catabolic pathways similarly to endogenous IgG
Elimination
Half-life: ~23 days
Clearance: 0.32 L/day
Administration
SC Preparation
Remove carton from refrigerator, and leave prefilled syringe (in the carton) at room temperature for 30 min
Do not pull off needle cover until you are ready to inject
Visually inspect syringe for particulate matter and discoloration prior to administration; drug should appear clear to slightly opalescent, colorless to slightly yellow solution
Do not use if the liquid contains visible particles or the syringe is damaged; air bubbles may be present; there is no need to remove them
SC Administration
SC administration only
Inject full amount (1 mL), which provides 100 mg of tildrakizumab per syringe
Inject a site with clear skin and easy access (eg, abdomen, thighs, or upper arm); do not administer 2 inches around navel or where skin is tender, bruised, erythematous, indurated, or affected by psoriasis; do not inject into scars, stretch marks, or blood vessels
Discard of any unused portion; dispose of used syringe
Missed dose
- If a dose is missed, administer the dose as soon as possible
- Thereafter, resume dosing at regularly scheduled interval
Storage
Unused syringes
- Refrigerate at 2-8°C (36-46°F) in the original carton; do not freeze; do not shake
- May store at room temperature at 25°C (77°F) for up to 30 days
- Protect from light until the time of use
- Once stored at room temperature, do not place back in the refrigerator
- If not used within 30 days, discard syringe
- Do not store at >25°C (77°F)
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Ilumya subcutaneous - | 100 mg/mL solution |  |
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Formulary
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