Exemptia

Exemptia

adalimumab

Manufacturer:

Zydus Cadila

Distributor:

Maxxcare

Marketer:

Mega Lifesciences
Concise Prescribing Info
Contents
Adalimumab
Indications/Uses
Moderate to severe, active RA; severe, active & progressive RA in adults. Moderate to severe active polyarticular juvenile idiopathic arthritis (JIA) in ped patients ≥2 yr. Active enthesitis related arthritis in patients ≥6 yr. Active & progressive psoriatic arthritis (PsA) in adults. Active ankylosing spondylitis (AS) & axial spondyloarthritis w/o radiographic evidence of AS in adults. Moderate to severe active Crohn's disease (CD) in adults & ped patients ≥6 yr who have had inadequate response to conventional therapy or are intolerant to or have medical contraindications for such therapies. Moderate to severe active ulcerative colitis (UC) in adults who have had an inadequate response to conventional therapy or are intolerant to or have medical contraindications for such therapies.
Dosage/Direction for Use
SC RA, PsA, AS & axial spondyloarthritis w/o radiographic evidence of AS Adult 40 mg every other wk. Increasing frequency to every wk may benefit patient w/ RA not receiving methotrexate. JIA Patient ≥2 yr weighing 10-<15 kg (22-33 lbs) 10 mg every other wk, 15-<30 kg (33-66 lbs) 20 mg every other wk, >30 kg (66 lbs) 40 mg every other wk. Enthesitis related arthritis 24 mg/m2. Max single dose: 40 mg every other wk. CD Adult & ped patient ≥40 kg Initially 80 mg (day 1) followed by 40 mg (day 15) & further followed by 40 mg every other wk. For a more rapid response, initially 160 mg (four 40 mg inj in 1 day or two 40 mg inj/day for 2 consecutive days) on day 1, followed by 80 mg 2 wk later (day 15). Maintenance dose: 40 mg every other wk after 2 wk (day 29). Frequency may be increased to every wk if response is insufficient, ped patient <40 kg Initially 40 mg (day 1) followed by 20 mg (day 15) & further followed by 20 mg every other wk. For a more rapid response, initially 80 mg (two 40 mg inj in 1 day) on day 1, followed by 40 mg 2 wk later (day 15). Maintenance dose: 20 mg every other wk after 2 wk (day 29). Frequency may be increased to every wk if response is insufficient. UC Initially 160 mg (four 40 mg inj in 1 day or two 40 mg inj/day for 2 consecutive days) on day 1, followed by 80 mg 2 wk later (day 15). Maintenance dose: 40 mg every other wk after 2 wk (day 29). Frequency may be increased to every wk if response is insufficient.
Contraindications
Hypersensitivity. Moderate to severe heart failure. Active TB or other severe infections eg, sepsis & opportunistic infections.
Special Precautions
Patients taking TNF-antagonists or w/ impaired lung function are susceptible to serious infections & should be monitored before, during & after treatment. Risks & benefits of therapy should be reviewed prior to initiating treatment in patients exposed to TB or endemic mycoses eg, histoplasmosis, blastomycosis & coccidiomycosis. Concomitant use of immunosuppressives. Examine patients for active or latent TB & current immunosuppressive therapy prior to treatment. Do not initiate therapy if active TB is diagnosed. Discontinue use in cases of 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; HBV reactivation; serious allergic reactions (eg, anaphylaxis, allergic rash, fixed or non-specified drug reaction, urticaria); haematologic reactions (eg, pancytopaenia, aplastic anaemia, cytopaenia & blood dyscrasias); new or worsening symptoms of CHF; symptoms of lupus-like syndrome. Serious (eg, pneumonia, pyelonephritis, septic arthritis & septicemia) & opportunistic (invasive fungal) infections. Rarely, have been shown to be associated w/ exacerbation or new onset of central/peripheral nervous system demyelinating disorders (eg, multiple sclerosis & Guillain-Barré syndrome). RA patients w/ long-standing highly active, inflammatory disease are at a higher risk of experiencing malignancies (eg, lymphoma & leukemia). Caution in use in COPD patients & w/ increased risk for malignancy due to heavy smoking. Small bowel obstruction. Patients undergoing surgery or arthroplasty. Rare cases of hepatosplenic T-cell lymphoma on concomitant use w/ azathioprine or 6-mercaptopurine. Patients can receive vaccination (except live vaccination) while on treatment. Not recommended to be used w/ anakinra, infliximab, etanercept, abatacept, certolizumab pegol, golimumab. Examine for non-melanoma skin cancer prior to & during treatment especially in psoriasis patients w/ history of PUVA treatment. May result in vertigo & visual impairment which can influence ability to drive & use machines. Women should use adequate contraception during treatment & for 5 mth after last dose. Impaired renal &/or hepatic function. Live vaccinations to infants exposed to treatment in utero is not recommended for at least 5 mth after the mother's last inj. Pregnancy & lactation (breastfeeding 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 & herpes viral pneumonia); 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/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, hyperhidrosis, 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 autoAb test (including double stranded DNA Ab), increased blood lactate dehydrogenase; impaired healing.
Drug Interactions
Lower Ab formation, decreased clearance & increased efficacy w/ methotrexate. Combination w/ anakinra &/or abatacept is not recommended.
ATC Classification
L04AB04 - adalimumab ; Belongs to the class of tumor necrosis factor alpha (TNF-alpha) inhibitors. Used as immunosuppressants.
Presentation/Packing
Form
Exemptia soln for inj 40 mg/0.8 mL
Packing/Price
1's
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