Tildrakizumab dosing, indications, interactions, adverse effects, and more

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Sections tildrakizumab
Dosing & Uses
Interactions
Adverse Effects
Warnings
Pregnancy
Pharmacology
Administration
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Patient Handout
Formulary

Dosing & Uses

AdultPediatric

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

Interaction Checker

Enter a drug name and tildrakizumab

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Interactions Found

Contraindicated

Serious - Use Alternative

Significant - Monitor Closely

Minor

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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)

adenovirus types 4 and 7 live, oral
Serious - Use Alternative (1)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
Serious - Use Alternative (1)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
Serious - Use Alternative (1)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.
dengue vaccine
Monitor Closely (1)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.
influenza virus vaccine quadrivalent, intranasal
Serious - Use Alternative (1)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
Serious - Use Alternative (1)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
Serious - Use Alternative (1)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
Serious - Use Alternative (1)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
Serious - Use Alternative (1)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
Serious - Use Alternative (1)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
Serious - Use Alternative (1)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
Serious - Use Alternative (1)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
Serious - Use Alternative (1)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
Serious - Use Alternative (1)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.

>10%

Upper respiratory infections (14%)

1-10%

Injection site reactions (3%)

Diarrhea (2%)

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

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

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.

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

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)

BRAND	FORM.	UNIT PRICE	PILL IMAGE
Ilumya subcutaneous -	100 mg/mL solution

Patient Handout

A Patient Handout is not currently available for this monograph.

Formulary

FormularyPatient Discounts

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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

View explanations for tiers and restrictions

Tier	Description
1	This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2	This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3	This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4	This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5	This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6	This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC	NOT COVERED – Drugs that are not covered by the plan.

Code	Definition
PA	Prior Authorization Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL	Quantity Limits Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST	Step Therapy Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR	Other Restrictions Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.

Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.

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