Adalimab is a tumor necrosis factor (TNF) blocker indicated
for treatment of:
Rheumatoid Arthritis (RA): Reducing signs and symptoms,
inducing major clinical response, inhibiting the progression of structural
damage, and improving physical function in adult patients with moderately to
severely active RA
Juvenile Idiopathic Arthritis (JIA): Reducing signs and
symptoms of moderately to severely active polyarticular JIA in patients 2 years
of age and older
Psoriatic Arthritis (PsA): Reducing signs and symptoms,
inhibiting the progression of structural damage, and improving physical function
in adult patients with active PsA
Ankylosing Spondylitis (AS): Reducing signs and symptoms in
adult patients with active AS
Adult Crohn’s Disease (CD): Reducing signs and symptoms and
inducing and maintaining clinical remission in adult patients with moderately
to severely active Crohn’s disease who have had an inadequate response to
conventional therapy. Reducing signs and symptoms and inducing clinical
remission in these patients if they have also lost response to or are
intolerant to infliximab
Pediatric Crohn’s Disease: Reducing signs and symptoms and
inducing and maintaining clinical remission in patients 6 years of age and
older with moderately to severely active Crohn’s disease who have had an
inadequate response to corticosteroids or immunomodulators such as
azathioprine, 6-mercaptopurine, or methotrexate
Ulcerative Colitis (UC): Inducing and sustaining clinical
remission in adult patients with moderately to severely active ulcerative
colitis who have had an inadequate response to immunosuppressants such as
corticosteroids, azathioprine or 6-mercaptopurine (6-MP). The effectiveness of
Adalimab has not been established in patients who have lost response to or were
intolerant to TNF blockers
Plaque Psoriasis (Ps): The treatment of adult patients with
moderate to severe chronic plaque psoriasis who are candidates for systemic
therapy or phototherapy and when other systemic therapies are medically less
appropriate
Hidradenitis Suppurative (HS): The treatment of moderate to
severe hidradenitis suppurativa
Abatacept: Increased risk of serious infection
Anakinra: Increased risk of serious infection
Live vaccines: Adalimab use should be avoided
Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing
Spondylitis: 40 mg every other week Some patients with RA not receiving
methotrexate may benefit from increasing the frequency to 40 mg every week.
Juvenile Idiopathic Arthritis:
- 10
kg to <15 kg: 10 mg every other week
- 15
kg to < 30 kg: 20 mg every other week
- ≥
30 kg: 40 mg every other week
Adult Crohn's Disease and Ulcerative Colitis:
- Initial
dose (Day 1): 160 mg (four 40 mg injections in one day or two 40 mg
injections per day for two consecutive days).
- Second
dose two weeks later (Day 15): 80 mg.
- Two
weeks later (Day 29): Maintenance dose of 40 mg every other week.
- For
patients with Ulcerative Colitis only: Adalimumab should only be
continued in patients who have shown evidence of clinical remission by
eight weeks (Day 57) of therapy.
Pediatric Crohn’s Disease:
- 17
kg to < 40 kg: Initial dose (Day 1): 80 mg (two 40 mg injections in
one day) , Second dose two weeks later (Day 15): 40 mg , Two weeks later
(Day 29): Maintenance dose of 20 mg every other week.
- ≥
40 kg: Initial dose (Day 1): 160 mg (four 40 mg injections in one day
or two 40 mg injections per day for two consecutive days) , Second dose
two weeks later (Day 15): 80 mg (two 40 mg injections in one day) , Two
weeks later (Day 29): Maintenance dose of 40 mg every other week.
Plaque Psoriasis:
- 80 mg
initial dose, followed by 40 mg every other week starting one week after
initial dose.
- Hidradenitis
Suppurativa: Initial dose (Day 1): 160 mg (given as four 40 mg
injection on Day 1 or as two 40 mg injections per day on Days 1 and 2,
Second dose two weeks later (Day 15): 80 mg (two 40 mg injections in one
day), Third (Day 29) and subsequent doses: 40 mg every week.
* চিকিৎসকের
পরামর্শ মোতাবেক ঔষধ সেবন করুন'
Adalimumab should not be administered to patients with known
hypersensitivity to Adalimumab or any of its components.
The most common adverse reaction with Adalimab was injection
site reactions (erythema and/or itching, hemorrhage, pain or swelling). The most
common adverse reactions leading to discontinuation of Adalimab in rheumatoid
arthritis were clinical flare reaction, rash and pneumonia.
- Other
adverse reactions of Adalimab includes- Gastrointestinal disorders:
Diverticulitis, large bowel perforations including perforations associated
with diverticulitis and appendiceal perforations associated with
appendicitis, pancreatitis.
- General
disorders and administration site conditions: Pyrexia.
- Hepato-biliary
disorders: Liver failure, hepatitis.
- Immune
system disorders: Sarcoidosis.
- Neoplasms
benign, malignant and unspecified (including cysts and polyps): Merkel
Cell Carcinoma (neuroendocrine carcinoma of the skin).
- Nervous
system disorders: Demyelinating disorders (e.g., optic neuritis,
Guillain-Barré syndrome).
- Cerebrovascular
accident Respiratory disorders: Interstitial lung disease, including
pulmonary fibrosis.
- Pulmonary
embolism Skin reactions: Stevens Johnson Syndrome, cutaneous vasculitis,
erythema multiforme, new or worsening psoriasis (all sub-types including
pustular and palmoplantar), alopecia.
- Vascular
disorders: Systemic vasculitis, deep vein thrombosis.
Pregnancy Category B. Adequate and well controlled studies
with Adalimumab have not been conducted in pregnant women. Adalimumab is an
IgG1 monoclonal antibody and IgG1 is actively transferred across the placenta
during the third trimester of pregnancy. Limited data from published literature
indicate that Adalimumab is present in low levels in human milk and is not
likely to be absorbed by a breastfed infant. However, no data is available on
the absorption of Adalimumab from breast milk in newborn or preterm infants.
Caution should be exercised when Adalimumab is administered to a nursing woman.
- Serious
infections: Adalimab should not be started during an active infection.
If an infection develops, should be carefully monitored and if infection
becomes serious Adalimab should be stopped.
- Invasive
fungal infections: For patients who develop a systemic illness on
Adalimab, empiric antifungal therapy should be considered for those who
reside or travel to regions where mycoses are endemic
- Malignancies:
Incidence of malignancies was greater in Adalimab-treated patients than in
controls
- Anaphylaxis
or serious allergic reactions may occur Hepatitis B virus reactivation:
HBV carriers should be monitored during and several months after therapy.
If reactivation occurs, Adalimab should be stopped and antiviral therapy
should be started
- Demyelinating
disease: Exacerbation or new onset, may occur Cytopenias, pancytopenia:
Patients should be advised to seek immediate medical attention if symptoms
develop, and should be considered stopping Adalimab
- Heart
failure: Worsening or new onset, may occur
- Lupus-like
syndrome: Adalimab should be stopped if syndrome develops
The maximum tolerated dose of Adalimab has not been
established in humans. Multiple doses up to 10 mg/kg have been administered to
patients in clinical trials without evidence of dose-limiting toxicities. In
case of overdosage, it is recommended that the patient be monitored for any
signs or symptoms of adverse reactions or effects and appropriate symptomatic
treatment instituted immediately.
Do not use beyond the expiration date on the container.
Adalimab must be refrigerated at 2-8° C. Do not freeze. Protect the pre-filled
syringe from exposure to light. Store in original carton until time of
administration.