Hyrimoz

Hyrimoz

adalimumab

Manufacturer:

Sandoz

Distributor:

Zuellig
Concise Prescribing Info
Contents
Adalimumab
Indications/Uses
As monotherapy or in combination w/ methotrexate for treatment of moderate to severe, active RA in adults when the response to disease-modifying anti-rheumatic drugs (DMARDs) including methotrexate has been inadequate; severe, active & progressive RA in adults not previously treated w/ methotrexate; active polyarticular juvenile idiopathic arthritis in patients 13-17 yr who have had an inadequate response to ≥1 DMARDs. Treatment of adults w/ severe active ankylosing spondylitis who have had an inadequate response to conventional therapy. Treatment of active & progressive psoriatic arthritis in adults when response to previous DMARD therapy has been inadequate. Treatment of moderate to severe chronic plaque psoriasis in adults who failed to respond or who have a contraindication to or who are intolerant to other systemic therapy including cyclosporine, methotrexate or PUVA. Treatment of severely active Crohn's disease in adults 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 contraindications for such therapies.
Dosage/Direction for Use
SC Adult RA 40 mg every other wk as a single dose. In monotherapy, some patients who experience a decrease in response to 40 mg every other wk may benefit from an increase in dosage to 40 mg every wk. Ankylosing spondylitis, psoriatic arthritis 40 mg every other wk as a single dose. Psoriasis Initially 80 mg, followed by 40 mg every other wk starting 1 wk after initial dose. Crohn's disease 80 mg at wk 0 followed by 40 mg at wk 2. If more rapid response is needed: 160 mg at wk 0, 80 mg at wk 2. After induction treatment: 40 mg every other wk. Some patients who experience a decrease in response to 40 mg every other wk may benefit from an increase in dosage to 40 mg every wk. Paed 13-17 yr weighing ≥30 kg Polyarticular juvenile idiopathic arthritis 40 mg every other wk.
Contraindications
Hypersensitivity. Acute TB or other severe infections eg, sepsis & opportunistic infections. Moderate to severe heart failure (NYHA class III/IV).
Special Precautions
Discontinue immediately & initiate appropriate therapy in case of anaphylactic reaction or other serious allergic reaction. Risk of serious infections; TB including reactivation & new onset of TB; opportunistic infections including invasive fungal infections. Closely monitor patients for infections, including TB, before, during & after treatment. Do not initiate in patients w/ active infections including chronic or localised infections until infections are controlled. Reactivation of hepatitis B in patients who are chronic carriers of HBV. Test for HBV infection before treatment initiation. Rare reports of malignancies & lymphoproliferative disorders w/ TNF-antagonists. Haematologic reactions. Cases of worsening CHF. May result in formation of autoimmune Abs. Caution in patients w/ pre-existing or recent-onset central or peripheral nervous system demyelinating disorders; patients w/ mild heart failure (NYHA class I/II); surgery patients. May receive concurrent vaccinations, except for live vaccines. Administration of live vaccines (eg, BCG vaccine) to infants exposed to adalimumab in utero is not recommended for 5 mth following the mother's last adalimumab inj during pregnancy. Not recommended w/ other biologic DMARDs (eg, anakinra & abatacept). Minor influence on the ability to drive & use machines. Women of childbearing potential should consider the use of adequate contraception to prevent pregnancy & continue its use for at least 5 mth after the last Hyrimoz treatment. Pregnancy. Elderly.
Adverse Reactions
Resp tract infections; inj site reaction; headache; musculoskeletal pain; leucopaenia, anaemia; increased lipids; abdominal pain, nausea, vomiting; elevated liver enzymes; rash. Systemic infections, intestinal infections, skin & soft tissue infections, ear infections, oral infections, reproductive tract infections, UTI, fungal infections, joint infections; skin cancer excluding melanoma, benign neoplasm; leucocytosis, thrombocytopenia; hypersensitivity, allergies; hypokalaemia, increased uric acid, blood Na abnormal, 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; chest pain, oedema, pyrexia; dermatitis, onychoclasis, hyperhidrosis, alopecia, pruritus; muscle spasms; renal impairment, haematuria; coagulation & bleeding disorders, autoantibody test positive; increased blood lactate dehydrogenase; impaired healing.
Drug Interactions
Risk of serious infections w/ other biologic DMARDs (eg, 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
Hyrimoz soln for inj 40 mg/0.8 mL
Packing/Price
2 × 1's
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