Abrilada

Abrilada

adalimumab

Manufacturer:

Pfizer

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Adalimumab
Indications/Uses
Monotherapy or in combination w/ MTX or other DMARDs to reduce signs & symptoms, induce major clinical response & remission, inhibit progression of structural damage & improve physical function in adults w/ moderate to severe active RA. Monotherapy or in combination w/ DMARDs to reduce signs & symptoms of active arthritis, inhibit progression of structural damage & improve physical function in patients w/ psoriatic arthritis. Reduce signs & symptoms in patients w/ active ankylosing spondylitis (AS); non-radiographic axial spondyloarthritis (nr-axSpA) w/ objective signs of inflammation by elevated C-reactive protein &/or MRI, who have had inadequate response to or are intolerant to NSAIDs. Moderate to severe chronic plaque psoriasis in adults who are candidates for systemic- or phototherapy & when other systemic therapies are medically less appropriate. Moderate to severe active Crohn's disease in adults w/ inadequate response to conventional therapy or who have lost response to or are intolerant to infliximab. Moderate to severe active ulcerative colitis in adults w/ inadequate response to conventional therapy including corticosteroids & 6-mercaptopurine (6-MP) or azathioprine (AZA) or who are intolerant to or have medical CI for such therapies. Active moderate to severe hidradenitis suppurativa (HS) in adults w/ inadequate response to conventional systemic HS therapy. Non-infectious intermediate, posterior & panuveitis in adults w/ inadequate response to corticosteroids, in patients in need of corticosteroid-sparing, or in whom corticosteroid treatment is inappropriate.
Dosage/Direction for Use
SC RA, psoriatic arthritis, AS & nr-axSpA 40 mg single dose every other wk. RA 40 mg every wk or 80 mg every other wk in patient not taking concomitant MTX. Plaque psoriasis Initially 80 mg followed by 40 mg every other wk starting 1 wk after initial dose. May be increased to 40 mg every wk or 80 mg every other wk. Dose may be subsequently reduced to 40 mg every other wk if adequate response is achieved. Crohn's disease Induction: 80 mg at wk 0 followed by 40 mg at wk 2. For more rapid response: 160 mg at wk 0 (160 mg in 1 day or 80 mg daily for 2 consecutive days) & 80 mg at wk 2. After induction, 40 mg every other wk. May be increased to 40 mg every wk or 80 mg every other wk. Ulcerative colitis 160 mg at wk 0 (160 mg in 1 day or 80 mg daily for 2 consecutive days) & 80 mg at wk 2. After induction, 40 mg every other wk. May be increased to 40 mg every wk or 80 mg every other wk. Then 40 mg every other wk thereafter. HS Initially 160 mg at Day 1 (160 mg in 1 day or 80 mg daily for 2 consecutive days), followed by 80 mg 2 wk later at Day 15, then continue w/ 40 mg every wk or 80 mg every other wk on Day 29. Uveitis Initially 80 mg followed by 40 mg every other wk starting 1 wk after initial dose.
Contraindications
Hypersensitivity. Active TB or other infections eg, sepsis, opportunistic infections. Moderate to severe heart failure (NYHA class III/IV).
Special Precautions
Discontinue use if anaphylactic reaction or other serious allergic reaction occurs; new serious infection or sepsis develops; confirmed significant hematologic abnormalities; new or worsening CHF symptoms occur. Not to be initiated in patients w/ active infections including chronic or localized infections until controlled; if active TB is diagnosed. History of recurring infection or w/ underlying conditions predisposed to infections. HBV reactivation; opportunistic infections including invasive fungal infections; preexisting or recent-onset central or peripheral nervous system demyelinating disorders; immunosuppression; malignancies including lymphoma & lymphoproliferative disorders; mild heart failure (NYHA class I/II); COPD patients; heavy smoking. Formation of autoimmune Ab. Closely monitor for infections including TB before, during & after treatment. Evaluate for both active or inactive (latent) TB infection prior to initiation. Perform neurological evaluation in patients w/ non-infectious intermediate uveitis prior to & regularly during treatment. Examine patients w/ medical history of extensive immunosuppressant therapy or psoriasis patients w/ history of PUVA treatment for presence of non-melanoma skin cancer prior to & during treatment. Screen for dysplasia in patients w/ ulcerative colitis at increased risk for, or w/ prior history of dysplasia or colon carcinoma. Patients undergoing arthroplasty. Not recommended in concomitant use w/ other biologic DMARDS (eg, anakinra & abatacept) or other TNF-antagonists. Combination w/ AZA or 6-MP. Concomitant use w/ live vaccines. May affect ability to drive & use machines. Women of childbearing potential should use effective contraception during & for 5 mth after treatment. Pregnancy & lactation. Childn <2 yr. Elderly >65 yr.
Adverse Reactions
Resp tract infections; leukopenia, anemia; increased lipids; headache; abdominal pain, nausea, vomiting; elevated liver enzymes; rash; musculoskeletal pain; inj site reaction. Systemic, intestinal, skin, soft tissue, oral, reproductive tract, ear, fungal & joint infections, UTI; skin cancer excluding melanoma, benign neoplasm; leucocytosis, thrombocytopenia; hypersensitivity, allergies; hypokalaemia, increased uric acid, abnormal blood Na, hypocalcaemia, hyperglycaemia, hypophosphatemia, dehydration; mood alterations, anxiety, insomnia; paraesthesias, migraine, nerve root compression; visual impairment, conjunctivitis, blepharitis, eye swelling; vertigo; tachycardia; HTN, flushing, haematoma; asthma, dyspnoea, cough; GI haemorrhage, dyspepsia, GERD, sicca syndrome; worsening or new onset of psoriasis, urticaria, bruising, dermatitis, onychoclasis, hyperhidrosis, alopecia, pruritus; muscle spasms; renal impairment, haematuria; chest pain, oedema, pyrexia; coagulation & bleeding disorders, +ve autoAb tests, increased blood LDH; impaired healing.
Drug Interactions
Decreased Ab formation w/ MTX. Not recommended in combination w/ anakinra, abatacept.
MIMS Class
Disease-Modifying Anti-Rheumatic Drugs (DMARDs) / Immunosuppressants
ATC Classification
L04AB04 - adalimumab ; Belongs to the class of tumor necrosis factor alpha (TNF-alpha) inhibitors. Used as immunosuppressants.
Presentation/Packing
Form
Abrilada soln for inj (pre-filled pen) 40 mg/0.8 mL
Packing/Price
1's
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