Secukinamab- Cosentyx-@- (Jan 2015) - Dermatological
Drug Name:Secukinamab- Cosentyx-@- (Jan 2015) - Dermatological
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:
Live Vaccines: Live vaccines should not be given with COSENTYX.
Indication:
COSENTYX (secukinumab) injection, for subcutaneous use COSENTYX
(secukinumab) for injection, for subcutaneous use
Initial U.S. Approval: 2015
Proprietary Name- COSENTYX*
Established Name- Secukinamab
Applicant- NPS Pharmaceuticals INC
Indication- For the treatment of Moderate to Severe Plaque Psoriasis
in adult Patients who areCandidates for Systemic Therapy
or Phototherapy
Approval Date- 1/21/2015
Approved by U.S.FDA on 30-06-2015 (Ref- FDA approved List- 2015)
NEW MOLECULAR ENTITY AND NEW THERAPEUTIC BIOLOGICAL
PRODUCTS APPROVED FOR 2015
Certain drugs are classified as New molecular Emtities- NME- for FDA review
Many of these products contain active moieties that have not been approved
by FDA previously, either as a single ingredient or as part of a combination
products; these products frequently provide important new therapies for the
patients.
Some drugs are characterized as NMEs for administrative purposes ,but
nonetheless contain certain active moieties in products that have been
previously approved by FDA. For example, CDER classifies biological
products submitted in an application under section 351(a) of the Public
Service Act as NME for purposes of FDA review, regardless of whether
the agency previously approved a related active moiety in a different
product.
FDAs classification of a drug as an -NME- for review purposes is distinct
from FDAs determination of whether a drug is a - New Chemical Entity or - NCE-
within the meaning of the Federal Food,Drug, and Cosmetic Act
No.2
Drug Name - Secukinumab
Active Ingredient- Cosentyx
Date of approval - 1/21/2015
FDA-approved use - To treat adults with moderate-to-severe Plaque Psoriasis
Approved by US FDA on 1/21/2015- (Ref- FDA approved List- 2015)
INDICATIONS AND USAGE
COSENTYX is a human interleukin-IL-17A antagonist indicated for the treatment
of moderate to severe plaque psoriasis in adult patients who are candidates
for systemic therapy or phototherapy.
Adverse Reaction:
Most common adverse reactions (> 1%) are nasopharyngitis, diarrhea, and upper
respiratory tract infection.
Contra-Indications:
CONTRAINDICATIONS
Serious hypersensitivity reaction to secukinumab or to any of the excipients.
WARNINGS AND PRECAUTIONS
Infections: Serious infections have occurred. Caution should be exercised
when considering the use of COSENTYX in patients with a chronic infection or
a history of recurrent infection. If a serious infection develops, discontinue
COSENTYX until the infection resolves.
Tuberculosis (TB): Prior to initiating treatment with COSENTYX, evaluate for TB.
Crohn’s Disease: Exacerbations observed in clinical trials. Caution should be
exercised when prescribing COSENTYX to patients with active Crohn’s disease.
Hypersensitivity Reactions: If an anaphylactic reaction or other serious
allergic reaction occurs, discontinue COSENTYX immediately and initiate
appropriate therapy.
Dosages/ Overdosage Etc:
INDICATIONS AND USAGE
COSENTYX is a human interleukin-IL-17A antagonist indicated for the treatment
of moderate to severe plaque psoriasis in adult patients who are candidates
for systemic therapy or phototherapy.
DOSAGE AND ADMINISTRATION
Recommended dose is 300 mg by subcutaneous injection at Weeks 0, 1, 2, 3
and 4 followed by 300 mg every 4 weeks.
For some patients, a dose of 150 mg may be acceptable.
See Full Prescribing Information for preparation of the Sensoready® pen
and prefilled syringe.
Reconstitute COSENTYX lyophilized powder in a vial with Sterile Water for Injection.
Reconstitution should be performed by a healthcare provider.
DOSAGE FORMS AND STRENGTHS
Injection: 150 mg/mL solution in a single-use Sensoready® pen
Injection: 150 mg/mL solution in a single-use prefilled syringe
For Injection: 150 mg, lyophilized powder in a single-use vial for reconstitution for
healthcare professional use only
Patient Information:
PATIENT COUNSELING INFORMATION
Advise the patient to read FDA-approved patient labeling
[Medication Guide and Instructions for Use].
Patient Counseling
Instruct patients to read the Medication Guide before starting COSENTYX therap
y and to reread the Medication Guide each time the prescription is renewed.
Advise patients of the potential benefits and risks of COSENTYX.
Infections
Inform patients that COSENTYX may lower the ability of their immune system
to fight 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
Hypersensitivity
Advise patients to seek immediate medical attention if they experience any
symptoms of serious hypersensitivity reactions
Instruction on Injection Technique
Perform the first self-injection under the supervision of a qualified healthcare
professional. If a patient or caregiver is to administer COSENTYX,
instruct him/her in injection techniques and assess their ability to inject
subcutaneously to ensure the proper administration of COSENTYX .
Instruct patients or caregivers in the technique of proper syringe and needle
disposal, and advise them not to reuse these items. Instruct patients to
inject the full amount of COSENTYX (1 or 2 subcutaneous injections of 150 mg)
according to the directions provided in the Medication Guide and Instructions
for Use.
Dispose of needles, syringes and pens in a puncture-resistant container.
Manufactured by:
Novartis Pharmaceuticals Corporation
East Hanover, New Jersey 07936
US License Number 1244
Pharmacology/ Pharmacokinetics:
CLINICAL PHARMACOLOGY
1. Mechanism of Action
Secukinumab is a human IgG1 monoclonal antibody that selectively binds to 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. Secukinumab inhibits the release of proinflammatory
cytokines and chemokines
2. Pharmacokinetics
Absorption
Following a single subcutaneous dose of either 150 mg (one-half the recommended dose)
or 300 mg in plaque psoriasis patients, secukinumab reached peak mean
(+ SD) serum concentrations (Cmax) of 13.7 ± 4.8 mcg/mL and 27.3 ± 9.5 mcg/mL,
respectively, by approximately 6 days post dose.
Pregnancy and lactation:
USE IN SPECIFIC POPULATIONS
1. Pregnancy
Pregnancy Category B
There are no adequate and well controlled trials of COSENTYX in pregnant women.
COSENTYX should be used during pregnancy only if the potential benefit justifies
the potential risk to the fetus.
2.Nursing Mothers
It is not known whether secukinumab is excreted in human milk or absorbed systemically
after ingestion. Because many drugs are excreted in human milk, caution should be
exercised when COSENTYX is administered to a nursing woman.
3. Pediatric Use
Safety and effectiveness of COSENTYX in pediatric patients have not been evaluated.
4. Geriatric Use
Of the 3430 plaque psoriasis subjects exposed to COSENTYX in clinical trials,
a total of 230 were 65 years or older, and 32 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 years and older was
not sufficient to determine whether they responded differently from younger
subjects
