Tildrakizumab
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From MedlinePlus, U.S. National Library of Medicine
Specialty pharmacy: therapy management checklist, storage and cold chain, dosing calendar, Medicare Part D coverage.
Interleukin-23 Antagonist
Dosing in kidney impairment
This label has no separate kidney-impairment dosing section. Check warnings and clinical pharmacology in the full label.
Preparation and administration
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Important Administration Instructions ILUMYA should only be administered by a healthcare provider. Administer ILUMYA subcutaneously. Each prefilled syringe is for single-dose only. Inject the full amount (1 mL), which provides 100 mg of tildrakizumab per syringe. If a dose is missed, administer the dose as soon as possible.
Thereafter, resume dosing at the regularly scheduled interval.
Preparation and Administration of ILUMYA Before injection, remove ILUMYA carton from the refrigerator, and let the prefilled syringe (in the ILUMYA carton with the lid closed) sit at room temperature for 30 minutes. Follow the instructions on the ILUMYA carton to remove the prefilled syringe correctly, and remove only when ready to inject.
Do not pull off the needle cover until you are ready to inject. Inspect ILUMYA visually for particulate matter and discoloration prior to administration. ILUMYA is a 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.
Choose an injection site with clear skin and easy access (such as abdomen, thighs, or upper arm). Do not administer 2 inches around the navel or where the skin is tender, bruised, erythematous, indurated, or affected by psoriasis. Also, do not inject into scars, stretch marks, or blood vessels. While holding the body of the syringe, pull the needle cover straight off (do not twist) and discard.
Inject ILUMYA subcutaneously as recommended [see Dosage and Administration ] . Press down the blue plunger until it can go no further. This activates the safety mechanism that will ensure full retraction of the needle after the injection is given. Remove the needle from the skin entirely before letting go of the blue plunger.
After the blue plunger is released, the safety lock will draw the needle inside the needle guard. Discard any unused portion. Dispose of used syringe. image-1 image-2 image-3
Drug interactions
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- Tildrakizumab
Contraindications
4 CONTRAINDICATIONS ILUMYA is contraindicated in patients with a previous serious hypersensitivity reaction to tildrakizumab or to any of the excipients [see Warnings and Precautions (5.1) ]. Serious hypersensitivity reaction to tildrakizumab or to any of the excipients. ( 4 )
Safety data
Reported adverse events (FAERS)
Liver injury (LiverTox)
E*Likelihood score E*: Unlikely cause of clinically apparent liver injury but experience with its use has been limited.
Tildrakizumab is humanized monoclonal antibody to interleukin-23 that is used to treat moderate-to-severe plaque psoriasis. Tildrakizumab is associated with a low rate of transient and asymptomatic serum enzyme elevations during therapy, but has not been linked to cases of idiosyncratic, clinically apparent liver injury.
ABCDEA: well known cause; E: unlikely cause. [HD]: high doses only.
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors outcomes in women with plaque psoriasis who become pregnant while being treated with ILUMYA during pregnancy. These patients can enroll in this registry by calling MotherToBaby a service of the Organization of Teratology Information Specialists (OTIS) at 1-866-626-6847 or by visiting the website https://mothertobaby.org/ongoing-study/ilumya-tildrakizumab-asmn.
Risk Summary Available data from clinical trials, published literature, and pharmacovigilance with ILUMYA use in pregnant women are insufficient to inform a drug associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. Monoclonal antibodies are actively transported across the placenta (see Clinical Considerations). An embryofetal developmental study conducted with tildrakizumab in pregnant monkeys revealed no treatment-related effects to the developing fetus when tildrakizumab was administered subcutaneously during organogenesis to near parturition at doses up to 159 times the maximum recommended human dose (MRHD).
When dosing was continued until parturition, an increase in neonatal death was observed at 59 times the MRHD (see Data). The clinical significance of this nonclinical finding is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
Clinical Considerations Fetal/Neonatal Adverse Reactions Transport of endogenous IgG antibodies across the placenta increases as pregnancy progresses, and peaks during the third trimester. Therefore, ILUMYA may be present in infants exposed in utero . The potential clinical impact of tildrakizumab exposure in infants exposed in utero should be considered. Data Animal Data In an embryofetal developmental study, subcutaneous doses up to 300 mg/kg tildrakizumab were administered to pregnant cynomolgus monkeys once every two weeks during organogenesis to gestation day 118 (22 days from parturition).
No maternal or embryofetal toxicities were observed at doses up to 300 mg/kg (159 times the MRHD of 100 mg, based on AUC comparison). Tildrakizumab crossed the placenta in monkeys. In a pre- and postnatal developmental study, subcutaneous doses up to 100 mg/kg tildrakizumab were administered to pregnant cynomolgus monkeys…
Breastfeeding (LactMed)
No information is available on the clinical use of tildrakizumab during breastfeeding. Because tildrakizumab is a large protein molecule with a molecular weight of 147,000 Da, the amount in milk is likely to be very low. It is also likely to be partially destroyed in the infant's gastrointestinal tract and absorption by the infant is probably minimal. Some professional guidelines state that the drug is acceptable to use during breastfeeding. Until more data become available, tildrakizumab should be used with caution during breastfeeding, especially while nursing a newborn or preterm infant. Waiting for at least 2 weeks postpartum to resume therapy may minimize transfer to the infant.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
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