Hyrimoz

Hyrimoz

adalimumab

Manufacturer:

Sandoz

Distributor:

Zuellig Pharma

Marketer:

Zuellig Pharma
Concise Prescribing Info
Contents
Adalimumab
Indications/Uses
Moderate to severe, active RA in adult when the response to DMARDs has been inadequate, & severe, active & progressive RA in adult not previously treated w/ methotrexate, as monotherapy or in combination w/ methotrexate. Active polyarticular juvenile idiopathic arthritis in patients ≥2 yr who have had an inadequate response to ≥1 DMARDs as monotherapy or in combination w/ methotrexate. Active enthesitis-related arthritis in patient ≥6 yr who have had an inadequate response to, or who are intolerant of conventional therapy. Adult w/ severe active ankylosing spondylistis (AS) who have had an inadequate response to conventional therapy. Adult w/ severe axial spondyloarthritis w/o radiographic evidence of AS but w/ objective signs of inflammation by elevated CRP &/or MRI, who have had an inadequate response to, or are intolerant to NSAIDs. Active & progressive psoriatic arthritis in adult when the response to previous DMARDs has been inadequate. Moderate to severe chronic plaque psoriasis in adult who are candidates for systemic therapy. Severe chronic plaque psoriasis in childn & adolescents ≥4 yr who have had an inadequate response to are inappropriate candidates for topical therapy & phototherapies. Active moderate to severe hidradenitis suppurativa (acne inversa) in adult & adolescents ≥12 yr w/ an inadequate response to conventional systemic HS therapy. Moderate to severely active Crohn's disease in adult who have not responded despite a full & adequate course of therapy w/ a corticosteroid &/or an immunosuppressant; or who are intolerant to or have medical contraindication for such therapies. Moderate to severe active Crohn's disease in paed patients ≥6 yr who have had an inadequate response to conventional therapy including primary nutrition therapy & a corticosteroid &/or an immunomodulator, or who are intolerant to or have contraindications for such therapies. Moderate to severely active ulcerative colitis in adult who have had an inadequate response to conventional therapy including corticosteroids & 6-mercaptopurine or azathioprine, or who are intolerant to, or have medical contraindication for such therapies. Non-infectious intermediate, posterior & panuveitis in adult who have had an inadequate response to corticosteroids in patients in need of corticosteroid-sparing or in whom corticosteroid treatment is inappropriate. Paed chronic non-infectious anterior uveitis in patients ≥2 yr who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.
Dosage/Direction for Use
SC RA Adult 40 mg as a single dose every other wk. Monotherapy: May increase dose to 40 mg every wk or 80 mg every other wk. Ankylosing spondylitis, axial spondyloarthritis w/o radiographic evidence of AS & psoriatic arthritis 40 mg as single dose every other wk. Psoriasis Adult Initially 80 mg, followed by 40 mg every other wk starting 1 wk after the initial dose. Carefully reconsider treatment >16 wk in unresponsive patients. If inadequate response >16 wk, may be increased to 40 mg every wk or 80 mg every other wk. If adequate response is achieved, dose may be subsequently reduced to 40 mg every other wk. Hidradenitis suppurativa Adult Initially 160 mg at Day 1 (as four 40 mg in 1 day or two 40 mg/day for 2 consecutive days), followed by 80 mg 2 wk later at Day 15 (given as two 40 mg in 1 day). Continue w/ 40 mg every wk or 80 mg every other wk on Day 29. Carefully reconsider treatment >12 wk in patients w/ no improvement. Re-introduce 40 mg every wk or 80 mg every other wk, if interrupted. Adolescent 12 yr weighing at least 30 kg 80 mg at wk 0, followed by 40 mg every other wk starting at wk 1. Patients w/ inadequate response to 40 mg every other wk may increase to 40 mg every wk or 80 mg every other wk. Carefully reconsider treatment >12 wk in patients w/ no improvement. Moderate to severe active Crohn's disease Adult 80 mg at wk 0, followed by 40 mg at wk 2. In case there is a need for a more rapid response: 160 mg at wk 0 (as four 40 mg in 1 day or as two 40 mg/day for 2 consecutive days), 80 mg at wk 2 (as two 40 mg in 1 day). After induction treatment: 40 mg every other wk. If inadequate response to 40 mg every other wk, patient may benefit from an increase in dose to 40 mg every wk or 80 mg every other wk. Patients who have not responded by wk 4 may benefit from continued maintenance therapy through wk 12. Paed 6-17 yr weighing ≥40 kg Induction dose: 80 mg at wk 0 & 40 mg at wk 2. In case there is need for a more rapid response: 160 mg at wk 0 & 80 mg at wk 2 may be used. Maintenance dose starting at wk 4: 40 mg every other wk, <40 kg Induction dose: 40 mg at wk 0 & 20 mg at wk 2. In case there is a need for a more rapid response: 80 mg at wk 0 & 40 mg at wk 2 may be used. Moderate to severe ulcerative colitis Adult 160 mg at wk 0 & 80 mg at wk 2. After induction treatment: 40 mg every other wk. If inadequate response to 40 mg every other wk, may benefit from an increase in dose to 40 mg every wk or 80 mg every other wk. Uveitis Adult Initially 80 mg, followed by 40 mg given every other wk starting 1 wk after the initial dose. Paed patient ≥2 yr weighing ≥30 kg Initially 80 mg 1 wk prior to the start of maintenance therapy. 40 mg every other wk in combination w/ methotrexate, weighing <30 kg Initially 40 mg 1 wk prior to the start of maintenance therapy. Polyarticular juvenile idiopathic arthritis Patients ≥2 yr weighing >30 kg 40 mg every other wk. Enthesitis related arthritis Patient ≥6 yr weighing ≥30 kg 40 mg every other wk. Plaque psoriasis Patients 4-17 yr weighing ≥30 kg Initially 40 mg, followed by 40 mg given every other wk starting 1 wk after the initial dose. Carefully consider therapy >16 wk in patients not responding w/in this time period.
Contraindications
Hypersensitivity. Active TB or other severe 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. Should not be initiated in patients w/ active infections including chronic or localised infections until infections are controlled. Risk of developing infections in impaired lung function. Patients w/ history of recurring infection or w/ underlying conditions which may predispose to infections, including concomitant use w/ immunosuppressives. Evaluate for both active or inactive TB before initiating therapy; must not initiate if active TB is diagnosed; must start w/ anti-TB prophylaxis treatment before initiating therapy. Perform appropriate screening test ie, tuberculin skin test & chest X-ray; risk of false negative tuberculin skin test results especially in patients who are severely ill or immunocompromised. Consider use of anti-TB prophylaxis treatment before initiating treatment in patients w/ several or significant risk factors for TB despite a negative test result & w/ past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Closely monitor for infections, including TB, before, during & 4 mth after treatment; patients who develop a new infection while undergoing treatment; signs & symptoms of active HBV infection throughout therapy & for several mth following termination of therapy. Test for HBV infection prior to treatment. Discontinue use if patient develops a new serious infection or sepsis; suspected invasive fungal infection; in patients who develop HBV reactivation; w/ confirmed significant haematologic abnormalities; who develop new or worsening symptoms of CHF. Patients w/ preexisting or recent onset central or peripheral nervous system demyelinating disorders; consider discontinuation if any of these disorders develop. Perform neurologic evaluation in patients w/ non-infectious intermediate uveitis prior to initiating therapy & regularly during treatment. Increased risk for lymphoma & leukaemia in RA patients w/ long-standing, highly active, inflammatory disease; risk for the development of malignancies in childn & adolescents; hepatosplenic T-cell lymphoma on concomitant use w/ azathioprine or 6-mercaptopurine used in inflammatory bowel disease. Patients w/ history of malignancy or continued treatment following development of malignancy. Examine for presence of non-melanoma skin cancer prior to & during treatment in patients w/ medical history of extensive immunosuppressant therapy or psoriasis patients w/ a history of PUVA treatment. Melanoma & merkel cell carcinoma; COPD & patients w/ increased risk for malignancy due to heavy smoking. Patients w/ ulcerative colitis at increased risk for dysplasia or colon carcinoma, or who had a prior history of dysplasia or colon carcinoma should be screened for dysplasia at regular intervals before & throughout therapy. Mild heart failure (NYHA class I/II). Do not give further treatment to patient who develops lupus-like syndrome & is positive for Abs against double-stranded DNA. Long-term treatment on the development of autoimmune diseases. Concomitant use w/ other biologic DMARDS (eg, anakinra & abatacept) or other TNF-antagonists. Patients requiring surgery must be closely monitored for infections. Patients undergoing arthroplasty. Small bowel obstruction. Minor influence on the ability to drive & use machines. Renal & hepatic impairment. Consider adequate contraception in women of childbearing potential for at least 5 mth after treatment. Pregnancy. Childn 4-17 yr w/ paed ulcerative colitis. Concurrent use w/ live vaccines eg, BCG vaccine is not recommended in infants exposed to adalimumab in utero 5 mth following the mother's last inj during pregnancy. Elderly >65 yr.
Adverse Reactions
Lower & upper resp tract infections, pneumonia, sinusitis, pharyngitis, nasopharyngitis & viral pneumonia herpes; leukopenia, neutropenia, agranulocytosis, anaemia; increased lipids & liver enzymes; headache; abdominal pain, nausea, vomiting; rash including exfoliative rash; musculoskeletal pain; inj site erythema. Systemic infections including sepsis, candidiasis & influenza, intestinal infections including viral gastroenteritis, skin & soft tissue infections including paronychia, cellulitis, impetigo, necrotising 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 & joint infections; skin cancer excluding melanoma, including basal cell carcinoma & squamous cell carcinoma, benign neoplasm; leukocytosis, thrombocytopenia; hypersensitivity, allergies/seasonal allergy; hypokalaemia, increased uric acid, abnormal blood Na, hypocalcaemia, hyperglycaemia, hypophosphatemia, dehydration; mood alterations including depression, anxiety, insomnia; paraesthesias including hypoesthesia, 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 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, pyrexia; coagulation & bleeding disorders including prolonged activated partial thromboplastin time, positive autoantibody test including double stranded DNA Ab; increased blood lactate dehydrogenase; impaired healing. Leukemia; anaphylaxis; multiple sclerosis, demyelinating disorders (eg, optic neuritis, Guillain-Barré syndrome; cardiac arrest; pulmonary fibrosis; intestinal perforation; hepatitis, hepatitis B reactivation, autoimmune hepatitis; erythema multiforme, Stevens-Johnson syndrome, angioedema, cutaneous vasculitis, lichenoid skin reaction; lupus-like syndrome.
Drug Interactions
Possible risk of infections including serious infections w/ anakinra & abatacept.
ATC Classification
L04AB04 - adalimumab ; Belongs to the class of tumor necrosis factor alpha (TNF-alpha) inhibitors. Used as immunosuppressants.
Presentation/Packing
Form
Hyrimoz soln for inj 40 mg/0.8 mL
Packing/Price
1's
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