6/18. Tildrakizumab -(IIUMYA)- (Apr 2018)- to treat adult patients with moderate to severe plaque psoriasis
Drug Name:6/18. Tildrakizumab -(IIUMYA)- (Apr 2018)- to treat adult patients with moderate to severe plaque psoriasis
List Of Brands:
Indication Type Description:
Drug Interaction
Indication
Adverse Reaction
Contra-Indications
Dosages/ Overdosage Etc
Patient Information
Pharmacology/ Pharmacokinetics
Pregnancy and lactation
Drug Interaction:
DRUG INTERACTIONS
Live Vaccines:
Avoid use of live vaccines in patients treated with ILUMYA.
Indication:
BRIEF SUMMARY
TILDRAKIZUMAB-(April 2018)
Indn- To treat adult patients with moderate to severe plaque psoriasis who are candidates for systemic therapy or thrombocytopenia (ITP)
Comp- Injection: 100 mg/mL solution in a single-dose prefilled syringe. Recommended dose is 100 mg at Weeks 0, 4, and every twelve weeks thereafter.
Indn- Most common (=1%) adverse reactions associated with ILUMYA treatment are upper respiratory infections, injection site reactions, and diarrhea. Serious hypersensitivity reaction to tildrakizumab or to any of the excipients.
ADR- Most common (=1%) adverse reactions associated with ILUMYA treatment are upper respiratory infections, injection site reactions, and diarrhea.
CI- Serious hypersensitivity reaction to tildrakizumab or to any of the excipients.
WARNINGS AND PRECAUTIONS
Hypersensitivity:
If a serious allergic reaction occurs, discontinue ILUMYA immediately and initiate appropriate therapy.
Pat Inform-
Instruct patients and/or caregivers to read the Medication Guide before starting A therapy and to reread the Medication Guide each time the prescription is renewed.
Advise patients of the potential benefits and risks
Hypersensitivity
Advise patients to seek immediate medical attention if they experience any symptoms of serious hypersensitivity reactions
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U.S. FDA APPROVED DRUGS DURING 2018
Sr.No- 6
Name of the Drug- IIumya
Active Ingredient - Tildrakizumab
Pharmacological Classification-
To treat adult patients with moderate to severe plaque psoriasis who are candidates for systemic therapy or thrombocytopenia (ITP)
Date of Approval- April 2018
(Ref- FDA approved List 2018)
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
ILUMYA safely and effectively. See full prescribing information for ILUMYA. ILUMYA™ (tildrakizumab-asmn) injection, for subcutaneous use
Initial U.S. Approval: 2018
INDICATIONS AND USAGE
ILUMYA 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.
DOSAGE AND ADMINISTRATION
Administer by subcutaneous injection.
Recommended dose is 100 mg at Weeks 0, 4, and every twelve weeks thereafter.
DOSAGE FORMS AND STRENGTHS
Injection: 100 mg/mL solution in a single-dose prefilled syringe.
CONTRAINDICATIONS
Serious hypersensitivity reaction to tildrakizumab or to any of the excipients.
WARNINGS AND PRECAUTIONS
Hypersensitivity:
If a serious allergic reaction occurs, discontinue ILUMYA immediately and initiate appropriate therapy.
Adverse Reaction:
ADVERSE REACTIONS
Most common (=1%) adverse reactions associated with ILUMYA treatment are upper respiratory infections, injection site reactions, and diarrhea.
Contra-Indications:
CONTRAINDICATIONS
Serious hypersensitivity reaction to tildrakizumab or to any of the excipients.
WARNINGS AND PRECAUTIONS
Hypersensitivity:
If a serious allergic reaction occurs, discontinue ILUMYA immediately and initiate appropriate therapy.
Infections:
ILUMYA may increase the risk of infection. Instruct patients to seek medical advice if signs or symptoms of clinically important chronic or acute infection occur. If a serious infection develops, consider discontinuing ILUMYA until the infection resolves.
Tuberculosis (TB):
Evaluate for TB prior to initiating treatment.
See
Dosages/ Overdosage Etc:
INDICATIONS AND USAGE
ILUMYA 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.
DOSAGE AND ADMINISTRATION
Administer by subcutaneous injection.
Recommended dose is 100 mg at Weeks 0, 4, and every twelve weeks thereafter.
DOSAGE FORMS AND STRENGTHS
Injection: 100 mg/mL solution in a single-dose prefilled syringe.
Patient Information:
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 ILUMYA therapy and to reread the Medication Guide each time the prescription is renewed.
Advise patients of the potential benefits and risks of ILUMYA.
Hypersensitivity
Advise patients to seek immediate medical attention if they experience any symptoms of serious hypersensitivity reactions
Infections
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
Manufactured by
Merck Sharp and Dhome
U.S. License No. 0002
At: MSD Ireland (Carlow)
County Carlow, Ireland
For patent information: www.merck.com/product/patent/home.html
Copyright © 2018 Merck Sharp & Dohme Corp.,
Pharmacology/ Pharmacokinetics:
CLINICAL PHARMACOLOGY
1 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.
2. Pharmacodynamics- No formal pharmacodynamics studies have been conducted with ILUMYA.
3.Pharmacokinetics-
Tildrakizumab pharmacokinetics increases proportionally over a dose range from 50 mg to 200 mg (0.5 to 2 times the approved recommended dosage) following subcutaneous administration in subjects with plaque psoriasis.
Steady-state concentrations were achieved by Week 16 following subcutaneous administration of tildrakizumab at Weeks 0, 4, and every 12 weeks thereafter.
At the 100 mg dose at Week 16, the mean (± SD) steady-state trough concentrations ranged from 1.22 ± 0.94 mcg/mL to 1.47 ± 1.12 mcg/mL. The geometric mean (CV%) steady-state Cmax was 8.1 mcg/mL (34%).
Absorption
The absolute bioavailability of tildrakizumab was estimated to be 73-80% following subcutaneous injection. The peak concentration (Cmax) was reached by approximately 6 days.
Distribution
The geometric mean (CV%) volume of distribution is 10.8 L (24%).
Elimination
The geometric mean (CV%) systemic clearance was 0.32 L/day (38%) and the half-life was approximately 23 days (23%).
Metabolism
The metabolic pathway of tildrakizumab has not been characterized. As a humanized IgG1/k monoclonal antibody, tildrakizumab is expected to be degraded into small peptides and amino acids via catabolic pathways in a manner similar to endogenous IgG.
Specific Populations
No clinically significant differences in the pharmacokinetics of tildrakizumab were observed based on age (=18 years).
No specific studies have been conducted to determine the effect of renal or hepatic impairment on the pharmacokinetics of tildrakizumab.
Body Weight Tildrakizumab concentrations were lower in subjects with higher body weight.
Drug Interaction Studies
Cytochrome P450 Substrates The AUCinf of dextromethorphan (CYP2D6 substrate) increased by 20% when used concomitantly with tildrakizumab 200 mg (two times the approved recommended dose) administered subcutaneously at Weeks 0 and 4 in subjects with plaque psoriasis.
No clinically significant changes in AUCinf of caffeine (CYP1A2 substrate), warfarin (CYP2C9 substrate), omeprazole (CYP2C19 substrate), and midazolam (CYP3A4 substrate) were observed.
Pregnancy and lactation:
USE IN SPECIFIC POPULATIONS
1. Pregnancy Risk Summary
Limited available data with ILUMYA 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, ILUMYA may be transferred from the mother to the fetus.
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.
2. Lactation 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
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.
Pediatric Use
Safety and effectiveness of ILUMYA in pediatric patients (<18 years of age) have not been established.
8.5 Geriatric Use
A total of 1083 subjects were exposed to ILUMYA 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 [see Clinical Pharmacology (12.3)].
OVERDOSAGE
In the event of overdosage, monitor the patient for any signs or symptoms of adverse reactions and administer appropriate symptomatic treatment immediately.
