Approved Drug Label (PDF)
5
Warnings and Precautions
5.9
Autoimmunity
Additions
and/or revisions underlined:
Treatment
with adalimumab products may result in the formation of autoantibodies and,
rarely, in the development of a lupus-like syndrome or autoimmune hepatitis
[see Adverse Reactions (6.1, 6.3)].
If a patient develops symptoms and findings suggestive of a lupus-like
syndrome or autoimmune hepatitis following treatment with SIMLANDI,
discontinue treatment and evaluate the patient.
6
Adverse Reactions
6.1
Clinical Trials Experience
Additions
and/or revisions underlined:
.
. .
Less
Common Adverse Reactions in Rheumatoid Arthritis Clinical Studies
Other
infrequent serious adverse reactions that do not appear in the Warnings and
Precautions or Adverse Reaction sections that occurred at an incidence of less
than 5% in adalimumab-treated subjects in RA studies (RA-I, RA-II, RA-III,
and RA-IV) were:
Body As A Whole: Pain in extremity, pelvic pain,
surgery, thorax pain
Cardiovascular
System: Arrhythmia,
atrial fibrillation, chest pain, coronary artery disorder, heart arrest,
hypertensive encephalopathy, myocardial infarct, palpitation, pericardial
effusion, pericarditis, syncope, tachycardia
.
. .
Uveitis
Clinical Studies
Adalimumab
has been studied in 464 adult subjects with uveitis (UV) in placebo-controlled
and open-label extension studies and in 90 pediatric subjects with uveitis
(Study PUV-I) [see Clinical Studies
(14.10, 14.11)]. The safety profile for subjects with UV treated with
adalimumab was similar to the safety profile seen in subjects with RA.
6.2
Immunogenicity
.
. .
Table
2. Anti-Adalimumab Antibody Development Determined by ELISA and ECL Assay in
Patients Treated with Adalimumab
Addition
and/or revision underlined of: “No correlation of antibody development to
safety or efficacy outcomes was observed” to the key section of table;
please refer to label for complete information.
6.3
Postmarketing Experience
Additions
and/or revisions underlined:
.
. .
Hepato-biliary
disorders: Liver
failure, hepatitis, autoimmune hepatitis
.
. .
8
Use in Specific Populations
8.4
Pediatric Use
Additions
and/or revisions underlined:
The
safety and effectiveness of SIMLANDI have not been established in pediatric
patients with psoriatic arthritis, ankylosing spondylitis, or plaque psoriasis.
The
safety and effectiveness of SIMLANDI have been established for:
- reducing
signs and symptoms of moderately to severely active polyarticular JIA in
pediatric patients 2 years of age and older.
- the
treatment of moderately to severely active Crohn’s disease in pediatric
patients 6 years of age and older.
- the
treatment of moderate to severe hidradenitis suppurativa in patients 12 years
of age and older.
- the
treatment of non-infectious intermediate, posterior, and panuveitis in
pediatric patients 2 years of age and older.
A
pediatric assessment
for SIMLANDI demonstrates that SIMLANDI is safe and effective for pediatric
patients in an indication for which Humira® (adalimumab) is
approved. However, SIMLANDI is not approved for such indication due to
marketing exclusivity for Humira (adalimumab).
.
. .
Juvenile
Idiopathic Arthritis
The
safety and effectiveness
of SIMLANDI for the treatment of moderately to severely active
polyarticular JIA have been established in pediatric patients 2 years of age
and older. Use for this indication is supported by evidence from an adequate
and well-controlled study (Study JIA) of adalimumab in patients 4 to 17
years of age [see Clinical Studies
(14.2)] and a safety study (Study JIA-II) of adalimumab in
patients 2 to <4 years of age where the safety profile was similar to
patients 4 to 17 years of age[see Adverse
Reactions (6.1)]. Adalimumab products have not been studied in patients
with polyarticular JIA less than 2 years of age or in patients with a weight
below 10 kg.
The
safety of adalimumab in pediatric patients in the polyarticular JIA
trials was generally similar to that observed in adults with certain exceptions
[see Adverse Reactions (6.1)].
The
safety and effectiveness of SIMLANDI have not been established in pediatric
patients with JIA less than 2 years of age.
.
. .
Pediatric
Uveitis
The
safety and effectiveness of SIMLANDI for the treatment of non-infectious,
intermediate, posterior, and panuveitis have been established in pediatric
patients 2 years of age and older. Use of SIMLANDI for this indication is
supported by evidence from adequate and well-controlled studies of adalimumab
in adults and a 2:1 randomized, controlled clinical study of adalimumab in 90
pediatric patients [see Clinical Studies
(14.11)]. The safety and effectiveness of SIMLANDI have not been
established in pediatric patients with uveitis less than 2 years of age.
Hidradenitis
Suppurativa
Use
of SIMLANDI in pediatric patients 12 years of age and older for the treatment
of moderate to severe HS is supported by evidence from adequate and
well-controlled studies of adalimumab in adult HS patients.
Additional
population pharmacokinetic modeling and simulation predicted that weight-based
dosing of adalimumab in pediatric patients 12 years of age and older can
provide generally similar exposure to adult HS patients. The course of HS is
sufficiently similar in adult and adolescent patients to allow extrapolation of
data from adult to adolescent patients. The recommended dosage in pediatric
patients 12 years of age or older is based on body weight [see Dosage and Administration (2.7), Clinical Pharmacology (12.3), and
Clinical Studies (14.9)].
The
safety and effectiveness of SIMLANDI have not been established in patients less
than 12 years of age with HS.
8.5
Geriatric Use
Additions
and/or revisions underlined:
In
clinical studies of RA (Studies RA-I, RA-II, RA-III, and RA-IV), a total
of 519 subjects 65 years of age and older, including 107 subjects 75 years of
age and older, received adalimumab. No overall difference in effectiveness was
observed between these subjects and younger adult subjects.
.
. .
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
MEDICATION
GUIDE
Additions
and/or revisions underlined:
.
. .
What is SIMLANDI?
SIMLANDI
is a medicine called a Tumor Necrosis Factor (TNF) blocker. SIMLANDI is used:
- To
reduce the signs and symptoms of:
.
. .
- moderate
to severe hidradenitis suppurativa (HS) in people 12 years and older.
.
. .
- To
treat non-infectious intermediate, posterior, and panuveitis in adults and
children 2 years of age and older.
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