Class: Skin and Mucous Membrane Agents, Miscellaneous
Chemical Name: Immunoglobulin G1, anti-(human interleukin 23) (human-Mus musculus monoclonal heavy chain), disulfide with human-Mus musculus monoclonal light chain, dimer
Molecular Formula: C6426H9918N1698O2000S46
CAS Number: 1326244-10-3
Tildrakizumab-asmn, an interleukin-23 (IL-23) antagonist, is a skin or mucous membrane agent.
Uses for Tildrakizumab-asmn
Tildrakizumab-asmn has the following uses:
Tildrakizumab-asmn is an interleukin-23 antagonist indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
Tildrakizumab-asmn Dosage and Administration
Tildrakizumab-asmn is available in the following dosage form(s) and strength(s):
Injection: 100 mg/mL solution in a single-dose prefilled syringe.
It is essential that the manufacturer's labeling be consulted for more detailed information on dosage and administration of this drug. Dosage summary:
Dosage & Administration
Administer by subcutaneous injection.
Recommended dose is 100 mg at Weeks 0, 4, and every twelve weeks thereafter.
Cautions for Tildrakizumab-asmn
Serious hypersensitivity reaction to tildrakizumab or to any of the excipients.
Cases of angioedema and urticaria occurred in tildrakizumab-asmn treated subjects in clinical trials. If a serious hypersensitivity reaction occurs, discontinue tildrakizumab-asmn immediately and initiate appropriate therapy.
Tildrakizumab-asmn may increase the risk of infection. Although infections were slightly more common in the tildrakizumab-asmn group (23%), the difference in frequency of infections between the tildrakizumab-asmn group and the placebo group was less than 1% during the placebo-controlled period. However, subjects with active infections or a history of recurrent infections were not included in clinical trials. Upper respiratory infections occurred more frequently in the tildrakizumab-asmn group than in the placebo group.
The rates of serious infections for the tildrakizumab-asmn group and the placebo group were ≤0.3%. Treatment with tildrakizumab-asmn should not be initiated in patients with any clinically important active infection until the infection resolves or is adequately treated.
In patients with a chronic infection or a history of recurrent infection, consider the risks and benefits prior to prescribing tildrakizumab-asmn. 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 the patient closely and consider discontinuation of tildrakizumab-asmn until the infection resolves.
Pretreatment Evaluation for Tuberculosis
Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with tildrakizumab-asmn. Initiate treatment of latent TB prior to administering tildrakizumab-asmn. In clinical trials, of 55 subjects with latent TB who were concurrently treated with tildrakizumab-asmn and appropriate TB prophylaxis, no subjects developed active TB (during the mean follow-up of 56.5 weeks). One other subject developed TB while receiving tildrakizumab-asmn. Monitor patients for signs and symptoms of active TB during and after tildrakizumab-asmn treatment. Consider anti-TB therapy prior to initiation of tildrakizumab-asmn in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Do not administer tildrakizumab-asmn to patients with active TB infection.
Prior to initiating therapy with tildrakizumab-asmn, consider completion of all age appropriate immunizations according to current immunization guidelines. Avoid the use of live vaccines in patients treated with tildrakizumab-asmn. No data are available on the response to live or inactive vaccines.
Risk Summary: Limited available data with tildrakizumab-asmn use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes. Human IgG is known to cross the placental barrier; therefore, tildrakizumab-asmn may be transferred from the mother to the fetus. 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, a small increase in neonatal death was observed at 59 times the MRHD. 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.
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 once every two weeks from gestation day 50 to parturition. Neonatal deaths occurred in the offspring of one control monkey, two monkeys at 10 mg/kg dose (6 times the MRHD based on AUC comparison), and four monkeys at 100 mg/kg dose (59 times the MRHD based on AUC comparison). The clinical significance of these nonclinical findings is unknown. No tildrakizumab-related adverse effects were noted in the remaining infants from birth through 6 months of age.
Risk Summary: There are no data 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.
The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for tildrakizumab-asmn and any potential adverse effects on the breastfed child from tildrakizumab-asmn or from the underlying maternal condition.
Animal Data: Very low levels of tildrakizumab were detected in breast milk of monkeys in a pre- and postnatal developmental study. The mean tildrakizumab concentrations in milk were approximately 0.09 – 0.2% of that in serum on postpartum days 28 and 91.
Safety and effectiveness of tildrakizumab-asmn in pediatric patients (<18 years of age) have not been established.
A total of 1083 subjects were exposed to tildrakizumab-asmn 100 mg during Phase 2 and 3 trials. A total of 92 subjects were 65 years or older, and 17 subjects were 75 years or older. Although no differences in safety or efficacy were observed between older and younger subjects, the number of subjects aged 65 and over is not sufficient to determine whether they respond differently from younger subjects.
Common Adverse Effects
Most common (≥1%) adverse reactions associated with tildrakizumab-asmn treatment are upper respiratory infections, injection site reactions, and diarrhea.
It is essential that the manufacturer's labeling be consulted for more detailed information on interactions with this drug, including possible dosage adjustments. Interaction highlights:
Live Vaccines: Avoid use of live vaccines in patients treated with tildrakizumab-asmn.
Mechanism of Action
Tildrakizumab is a humanized IgG1/k monoclonal antibody that selectively binds to the p19 subunit of 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.
Advice to Patients
Patient Counseling Information
Advise the patient and/or caregiver to read the FDA-approved patient labeling (Medication Guide).
Instruct patients and/or caregivers to read the Medication Guide before starting tildrakizumab-asmn therapy and to reread the Medication Guide each time the prescription is renewed. Advise patients of the potential benefits and risks of tildrakizumab-asmn.
Advise patients to seek immediate medical attention if they experience any symptoms of serious hypersensitivity reactions.
Instruct patients of the importance of communicating any history of infections to the doctor and contacting their doctor if they develop any symptoms of infection.
AHFSfirstRelease™. For additional information until a more detailed monograph is developed and published, the manufacturer's labeling should be consulted. It is essential that the manufacturer's labeling be consulted for more detailed information on usual uses, dosage and administration, cautions, precautions, contraindications, potential drug interactions, laboratory test interferences, and acute toxicity.
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.
100 mg/1 mL
Sun Pharma Global FZE
AHFS Drug Information. © Copyright 2021, Selected Revisions August 27, 2018. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.
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