SILIQ- brodalumab injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

BRODALUMAB (UNII: 6ZA31Y954Z) (BRODALUMAB - UNII:6ZA31Y954Z)

Available from:

Bausch Health US LLC

INN (International Name):

BRODALUMAB

Composition:

BRODALUMAB 210 mg

Administration route:

SUBCUTANEOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

SILIQ ® is indicated for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy and have failed to respond or have lost response to other systemic therapies. SILIQ is contraindicated in patients with Crohn’s disease because SILIQ may cause worsening of disease [see Warnings and Precautions ( 5.5)]. Risk Summary There are no human data on SILIQ use in pregnant women to inform a drug-associated risk. Human IgG antibodies are known to cross the placental barrier; therefore, SILIQ may be transmitted from the mother to the developing fetus. In a combined embryofetal development and pre- and postnatal development study, no adverse developmental effects were observed in infants born to pregnant monkeys after subcutaneous administration of brodalumab during organogenesis through parturition at doses up to 26 times the maximum recommended human dose (MRHD) [see Data]. The estimated background risk of major birth defects and misca

Product summary:

SILIQ (brodalumab) Injection is available in a single-dose prefilled syringe containing a sterile, preservative-free clear to slightly opalescent, colorless to slightly yellow solution practically free from particles.

Authorization status:

Biologic Licensing Application

Patient Information leaflet

SILIQ- BRODALUMAB INJECTION
Bausch Health US LLC
----------
MEDICATION GUIDE
SILIQ ®(SIL-EEK)
(brodalumab)
Injection, for subcutaneous use
What is the most important information I should know about SILIQ?
SILIQ may cause serious side effects, including:
•
Suicidal thoughts or behavior have happened insome people treated with
SILIQ. Some people
have ended their own lives. Your risk of suicidal thoughts and
behavior may be increased if you
have a history of suicidal thoughts or depression. It is not known if
SILIQ causes suicidal thoughts
or behavior. Get medical help right away if you or your caregiver
notice any of the following
symptoms:
•
new or worsening depression or anxiety
•
thoughts of suicide, dying, or hurting yourself
•
changes in behavior or mood
•
acting on dangerous impulses
•
attempt to commit suicide
Your healthcare provider will give you a SILIQ Patient Wallet Card
about symptoms you should get
medical help for right away. Carry the card with you at all times
during treatment with SILIQ and show it
to all of your healthcare providers.
•
Serious infections.SILIQ may lower the ability of your immune system
to fight infections and may
increase your risk of infections. Your healthcare provider will check
you for tuberculosis (TB)
before starting treatment with SILIQ and may treat you for TB before
you begin treatment with
SILIQ if you have a history of TB or have active TB. Your healthcare
provider should watch you
closely for signs and symptoms of infection and TB during and after
treatment with SILIQ.
Tell your healthcare provider right away if you have an infection or
have symptoms of an
infection, including:
•
fever, sweats, or chills
•
muscle aches
•
cough
•
shortness of breath
•
sore throat or difficulty swallowing
•
warm, red, or painful skin or sores on your body
•
diarrhea or stomach pain
•
burning when you urinate or urinate more often than normal
See “What are the possible side effects of SILIQ?”for more
information about side effects.
What is SILIQ?
SILIQ

Summary of Product characteristics

SILIQ- BRODALUMAB INJECTION
BAUSCH HEALTH US LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SILIQ SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR SILIQ.
SILIQ
(BRODALUMAB) INJECTION, FOR SUBCUTANEOUS USE
INITIAL U.S. APPROVAL: 2017
WARNING: SUICIDAL IDEATION AND BEHAVIOR
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
SUICIDAL IDEATION AND BEHAVIOR, INCLUDING COMPLETED SUICIDES, HAVE
OCCURRED IN
PATIENTS TREATED WITH SILIQ. ( 5.1, 6.1)
PRIOR TO PRESCRIBING, WEIGH POTENTIAL RISKS AND BENEFITS IN PATIENTS
WITH A HISTORY OF
DEPRESSION AND/OR SUICIDAL IDEATION OR BEHAVIOR. ( 5.1)
PATIENTS WITH NEW OR WORSENING SUICIDAL THOUGHTS AND BEHAVIOR SHOULD
BE REFERRED
TO A MENTAL HEALTH PROFESSIONAL, AS APPROPRIATE. ( 5.1)
ADVISE PATIENTS AND CAREGIVERS TO SEEK MEDICAL ATTENTION FOR
MANIFESTATIONS OF
SUICIDAL IDEATION OR BEHAVIOR, NEW ONSET OR WORSENING DEPRESSION,
ANXIETY, OR OTHER
MOOD CHANGES. ( 5.1)
SILIQ IS AVAILABLE ONLY THROUGH A RESTRICTED PROGRAM CALLED THE SILIQ
REMS PROGRAM.
( 5.2)
INDICATIONS AND USAGE
SILIQ is a human interleukin-17 receptor A (IL-17RA) antagonist
indicated for the treatment of moderate to
severe plaque psoriasis in adult patients who are candidates for
systemic therapy or phototherapy and
have failed to respond or have lost response to other systemic
therapies. ( 1)
DOSAGE AND ADMINISTRATION
Administer 210 mg of SILIQ by subcutaneous injection at Weeks 0, 1,
and 2 followed by 210 mg every 2
weeks. ( 2.1)
DOSAGE FORMS AND STRENGTHS
Injection: 210 mg/1.5 mL solution in a single-dose prefilled syringe.
( 3)
CONTRAINDICATIONS
Crohn’s disease ( 4)
WARNINGS AND PRECAUTIONS
Infections:Serious infections have occurred. Consider the risks and
benefits prior to initiating SILIQ in
patients with a chronic infection or a history of recurrent infection.
Instruct patients to seek medical
advice if signs or symptoms of clinically important chronic or acute
infection occur. If a serious infection
develops, disc