Ixekizumab- Taltz -@- (March 2016)- Anti-psoriatics
Drug Name:Ixekizumab- Taltz -@- (March 2016)- Anti-psoriatics
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
1. Live Vaccinations
Avoid use of live vaccines in patients treated with TALTZ .
2. Cytochrome P450 Substrates
The formation of CYP450 enzymes can be altered by increased levels
of certain cytokines (e.g., IL-1, IL-6, IL-10, TNFá, IFN) during chronic
inflammation. Thus, TALTZ, an antagonist of IL-17A, could normalize
the formation of CYP450 enzymes.
Therefore, upon initiation or discontinuation of TALTZ in patients who
are receiving concomitant drugs which are CYP450 substrates,
particularly those with a narrow therapeutic index, consider monitoring
for effect (e.g., for warfarin) or drug concentration (e.g., for cyclosporine)
and consider dosage modification of the CYP450 substrate.
Indication:
DRUG INNOVATION - NOVEL DRUG APPROVALS FOR 2016
No Drug Name Active Ingredient Approval Date FDA-Approved use
on Approval date
4. Taltz Ixekizumab 3/22/2016 To treat adults with moderate-to-
severe plaque psoriasis Press Release Drug trials Snapshot
Approved by FDA on 3/22/2016 (Ref- FDA approved List- 2016)
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
TALTZ safely and effectively. See full prescribing information for TALTZ.
TALTZ (ixekizumab) injection, for subcutaneous use
Initial U.S. Approval: 2016
INDICATIONS AND USAGE
TALTZ ™ is a humanized interleukin-17A antagonist indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
Adverse Reaction:
ADVERSE REACTIONS
Most common (.1%) adverse reactions associated with TALTZ treatment
are injection site reactions, upper respiratory tract infections, nausea,
and tinea infections.
Contra-Indications:
CONTRAINDICATIONS
Serious hypersensitivity reaction to ixekizumab or to any of the excipients.
WARNINGS AND PRECAUTIONS
.
Infections: Serious infections have occurred. Instruct patients to seek medical
advice if signs or symptoms of clinically important chronic or acute infection occur.
If a serious infection develops, discontinue TALTZ until the infection resolves.
.
Tuberculosis (TB): Evaluate for TB prior to initiating treatment.
.
Hypersensitivity: If a serious allergic reaction occurs, discontinue TALTZ
immediately and initiate appropriate therapy.
.
Inflammatory Bowel Disease: Crohnfs disease and ulcerative colitis,
including exacerbations, occurred during clinical trials.
Patients who are treated with TALTZ and have inflammatory bowel
disease should be monitored closely.
Dosages/ Overdosage Etc:
INDICATIONS AND USAGE
TALTZ ™ is a humanized interleukin-17A 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 160 mg (two 80 mg injections) at Week 0,
followed by 80 mg at Weeks 2, 4, 6, 8, 10, and 12,
then 80 mg every 4 weeks.
DOSAGE FORMS AND STRENGTHS
Autoinjector Injection: 80 mg/mL solution in a single-dose prefilled autoinjector.
Prefilled Syringe
Injection: 80 mg/mL solution in a single-dose prefilled syringe.
OVERDOSAGE
In the event of overdosage, monitor the patient for any signs or symptoms
of adverse reactions and institute appropriate symptomatic treatment immediately.
Patient Information:
PATIENT COUNSELING INFORMATION
Advise the patient and/or caregiver to read the FDA-approved patient labeling
before the patient starts using TALTZ, and each time the prescription is renewed,
as there may be new information they need to know.
Instructions on Self-Administration: Provide guidance to patients and caregivers
on proper subcutaneous injection technique, including aseptic technique,
and how to use the autoinjector or prefilled syringe correctly
Use].
Infection: Inform patients that TALTZ may lower the ability of their immune system
to fight infections. Instruct patients of the importance of communicating
any history of infections to the healthcare provider, and contacting their
healthcare provider if they develop any symptoms of infection .
Allergic Reactions: Advise patients to seek immediate medical attention
if they experience any symptoms of serious hypersensitivity reactions .
Eli Lilly and Company, Indianapolis, IN 46285, USA
US License Number 1891
Product of Ireland
Copyright © yyyy, Eli Lilly and Company. All rights reserved.
Pharmacology/ Pharmacokinetics:
CLINICAL PHARMACOLOGY
1. Mechanism of Action
Ixekizumab is a humanized IgG4 monoclonal antibody that selectively binds
with the interleukin 17A (IL-17A) cytokine and inhibits its interaction with
the IL-17 receptor. IL-17A is a naturally occurring cytokine that is involved in
normal inflammatory and immune responses. Ixekizumab inhibits the release
of proinflammatory cytokines and chemokines.
2.Pharmacokinetics
Absorption
Following a single subcutaneous dose of 160 mg in subjects with plaque
psoriasis, ixekizumab reached peak mean (±SD) serum concentrations
(C max ) of 16.2 ±6.6 mcg/mL by approximately 4 days post dose.
Steady-state concentrations were achieved approximately 10 weeks
after switching from the 80 mg every 2 weeks dosing regimen to
the 80 mg every 4 weeks dosing regimen at Week 12.
The mean ±SD steady-state trough concentration was 3.5 ±2.5 mcg/mL.
In studies of subjects with plaque psoriasis, ixekizumab bioavailability
ranged from 60% to 81% following subcutaneous injection.
Administration of ixekizumab via injection in the thigh achieved a higher
bioavailability relative to that achieved using other injection sites
including the arm and abdomen.
Distribution
The mean (geometric CV%) volume of distribution at steady-state was
7.11 L (29%) in subjects with plaque psoriasis.
Elimination
The metabolic pathway of ixekizumab has not been characterized.
As a humanized IgG4 monoclonal antibody ixekizumab is expected
to be degraded into small peptides and amino acids via catabolic
pathways in the same manner as endogenous IgG.
The mean systemic clearance was 0.39 L/day (37%)and the mean
(geometric CV%) half-life was 13 days (40%) in subjects with plaque psoriasis.
Pregnancy and lactation:
USE IN SPECIFIC POPULATIONS
1. Pregnancy
Risk Summary
There are no available data on TALTZ use in pregnant women to inform
any drug associated risks. Human IgG is known to cross the placental barrier;
therefore, TALTZ may be transmitted from the mother to the developing fetus.
An embryofetal development study conducted in pregnant monkeys at doses
up to 19 times the maximum recommended human dose (MRHD) revealed
no evidence of harm to the developing fetus. When dosing was continued
until parturition, neonatal deaths were observed at 1.9 times the MRHD.
The clinical significance of these nonclinical findings is unknown.
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 to 4%
and 15 to 20%, respectively.
2. Lactation
Risk Summary
There are no data on the presence of ixekizumab in human milk, the effects
on the breastfed infant, or the effects on milk production. Ixekizumab was
detected in the milk of lactating cynomolgus monkeys.
The developmental and health benefits of breastfeeding should be
considered along with the mother’s clinical need for TALTZ and any
potential adverse effects on the breastfed infant from TALTZ or from
the underlying maternal condition.
4. Pediatric Use
The safety and effectiveness of TALTZ in pediatric patients (<18 years of age)
have not been evaluated.
5. Geriatric Use
Of the 4204 psoriasis subjects exposed to TALTZ, a total of 301 were 65
years or older, and 36 subjects were 75 years or older. Although no
differences in safety or efficacy were observed between older and younger
subjects, 6 number of subjects aged 65 and over is not sufficient to
determine whether they respond differently from younger subjects
6. OVERDOSAGE
In the event of overdosage, monitor the patient for any signs or symptoms
of adverse reactions and institute appropriate symptomatic treatment immediately.
