Exemptia

Exemptia

adalimumab

Manufacturer:

Mega Lifesciences

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Adalimumab
Indications/Uses
Moderate to severe active RA; severe, active & progressive RA. Moderate to severe active polyarticular juvenile idiopathic arthritis in ped patients ≥2 yr; active enthesitis-related arthritis in patients ≥6 yr. Active & progressive psoriatic arthritis in adults. Active ankylosing spondylitis & axial spondyloarthritis w/o radiographic evidence of ankylosing spondylitis in adults. Moderate to severe active Crohn's disease who have had inadequate response to conventional therapy or who are intolerant to or have medical contraindications for such therapies in adult & ped patients ≥6 yr. Moderate to severe active ulcerative colitis in adults who have had an inadequate response to conventional therapy or who are intolerant to or have medical contraindications for such therapies. Moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. Moderate to severe hidradenitis suppurativa.
Dosage/Direction for Use
SC RA Adult 40 mg every other wk. Patients w/ RA not receiving methotrexate May increase frequency to 40 mg every wk. Juvenile idiopathic arthritis Patients ≥2 yr & weighing ≥30 kg 40 mg every other wk, 15 kg to <30 kg 20 mg every other wk, 10 kg to <15 kg 10 mg every other wk. Enthesitis related arthritis 24 mg/m2 up to a max single dose of 40 mg every other wk. Psoriatic arthritis Adult 40 mg every other wk. Ankylosing spondylitis & axial spondyloarthritis w/o radiographic evidence of ankylosing spondylitis Adult 40 mg every other wk. Crohn's disease Adult & ped patients ≥40 kg Initially 80 mg (Day 1) followed by 40 mg on Day 15 & further followed by 40 mg every other wk. Rapid response: Initially 160 mg (as four 40 mg inj in 1 day or two 40 mg inj daily for 2 consecutive days) followed by 80 mg 2 wk later (Day 15). After 2 wk (Day 29), begin a maintenance dose of 40 mg every other wk. Patients who experience insufficient response May increase dosing frequency to 40 mg every wk. Ped patient <40 kg Initially 40 mg on Day 1 followed by 20 mg on Day 15 & further followed by 20 mg every other wk. Rapid response: Initially 80 mg on Day 1 (as two 40 mg inj in 1 day), followed by 40 mg 2 wk later (Day 15). After 2 wk (Day 29), begin a maintenance dose of 20 mg every other wk. May increase dosing frequency to 20 mg every wk if insufficient response is experienced. Ulcerative colitis Initially 160 mg (Day 1) (as four 40 mg inj in 1 day or two 40 mg inj daily for 2 consecutive days) followed by 80 mg 2 wk later (Day 15). After 2 wk (Day 29), begin maintenance dose of 40 mg every other wk. Patients who experience insufficient response May increase dosing frequency to 40 mg every wk. Plaque psoriasis Initially 80 mg, followed by 40 mg every other wk starting from wk one after initial dose. Hidradenitis suppurativa 160 mg (Day 1) (as four 40 mg inj in 1 day or two 40 mg inj daily for 2 consecutive days), followed by 80 mg 2 wk later (Day 15). After 2 wk (Day 29), begin maintenance dose of 40 mg every other wk.
Contraindications
Hypersensitivity. Moderate to severe heart failure. Active TB or other severe infections eg, sepsis & opportunistic infections.
Special Precautions
Monitor patients taking TNF-antagonists or w/ impaired lung function, prior to, during & after treatment. Patients who have been exposed to TB (including those travelled through high-risk TB areas) or endemic mycoses eg, histoplasmosis, blastomycosis & coccidioidomycosis; concomitant use w/ immunosuppressives. Discontinue treatment if a new serious infection or sepsis; symptoms of fever, malaise, wt loss, sweats, cough, dyspnea &/or pulmonary infiltrates or other serious systemic illness w/ or w/o concomitant shock, invasive fungal infection; serious allergic reactions (eg, anaphylaxis, allergic rash, fixed drug reaction, non-specified drug reaction or urticaria); haematologic reactions (eg, pancytopaenia, aplastic anaemia, cytopenia & blood dyscrasias); new or worsening symptoms of CHF; symptoms of lupus-like syndrome develops. Serious infections. Examine patients for both active or latent TB infection & current immunosuppressive therapy prior to administration. Do not initiate treatment in patients w/ active TB. Perform HBV infection test prior to administration, & monitor for signs & symptoms for active HBV infection. Discontinue treatment & initiate anti-viral therapy if HBV reactivation occurs. Multiple sclerosis & Guillain-Barré syndrome. Malignancies in RA patients w/ long-standing highly active, inflammatory disease; COPD patients & heavy smokers. Examine for non-melanoma skin cancer especially those w/ history of extensive immunosuppressant therapy or psoriasis patients w/ history of PUVA treatment. Lymphoma & leukemia. Concomitant use w/ live vaccines; anakinra, infliximab, etanercept, abatacept, certolizumab pegol or golimumab. Small bowel obstruction. Patients undergoing surgical procedures or arthroplasty during therapy. May influence ability to drive & use machines. Women should use adequate contraception during treatment & for a further 5 mth after last dose. Live vaccinations to infants exposed to adalimumab in utero is not recommended for at least 5 mth after mother's last inj. Pregnancy & lactation (breast-feeding is not recommended for at least 5 mth after last inj). Elderly >65 yr.
Adverse Reactions
Resp tract infections including lower & upper resp tract infection, pneumonia, sinusitis, pharyngitis, nasopharyngitis & pneumonia herpes viral); leucopaenia (including neutropaenia & agranulocytosis), anaemia; increased lipids; headache; abdominal pain, nausea & vomiting; elevated liver enzymes; rash (including exfoliative rash); musculoskeletal pain; inj site reaction including inj site erythema. Systemic infections including sepsis, candidiasis & flu, intestinal infections including viral gastroenteritis, skin & soft tissue infections including paronychia, cellulitis, impetigo, necrotizing fasciitis & herpes zoster, ear infections, oral infections including herpes simplex, oral herpes & tooth infections, reproductive tract infections including vulvovag mycotic infection, UTI including pyelonephritis, fungal infections; skin cancer excluding melanoma (including basal cell carcinoma & squamous cell carcinoma) benign neoplasm; leucocytosis, thrombocytopaenia; hypersensitivity, allergies including seasonal allergy; hypokalaemia, increased uric acid, abnormal blood Na, hypocalcaemia, hyperglycaemia, hypophosphataemia, dehydration; mood alterations including depression, anxiety, insomnia; paraesthesias (including hypoaesthesia), migraine, sciatica; visual impairment, conjunctivitis; vertigo; tachycardia; HTN, flushing, haematoma; asthma, dyspnoea, cough; GI haemorrhage, dyspepsia, GERD, sicca syndrome; worsening or new onset of psoriasis including palmoplantar pustular psoriasis, urticaria, bruising (including purpura), dermatitis (including eczema), onychoclasis, hyperhydrosis, alopecia, pruritus; muscle spasms including increased blood creatine phosphokinase; renal impairment, haematuria; chest pain, oedema; coagulation & bleeding disorders (including prolonged activated partial thromboplastin time), positive autoantibody test (including double stranded DNA Ab), increased blood lactate dehydrogenase; impaired healing.
Drug Interactions
ATC Classification
L04AB04 - adalimumab ; Belongs to the class of tumor necrosis factor alpha (TNF-alpha) inhibitors. Used as immunosuppressants.
Presentation/Packing
Form
Exemptia inj 40 mg/0.8 mL
Packing/Price
1's
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