Lumicef

Lumicef

brodalumab

Manufacturer:

Kyowa Kirin

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Brodalumab
Indications/Uses
Moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy & have failed to respond or have lost response to other systemic therapies. Generalized pustular psoriasis in adults who have had inadequate response to conventional therapies. Ankylosing spondylitis in adults who respond inadequately to conventional therapies. Non-radiographic axial spondyloarthritis in adults who respond inadequately to conventional therapies.
Dosage/Direction for Use
SC Recommended dose: 210 mg at wk 0, 1, & 2 followed by 210 mg every 2 wk.
Contraindications
History of hypersensitivity. Serious infection; active TB & Crohn's disease.
Special Precautions
Discontinue treatment if patient develops signs & symptoms of inflammatory bowel or experiences exacerbation of pre-existing inflammatory bowel disease. Not to be inj in sensitive or abnormal areas of skin (eg, scratch, redness, sclerosis, thickness, scaling, or other abnormalities), or sites of psoriasis. Increased risk of infections. Possible onset of malignant tumors. Patients w/ infection or suspected infection; in state or history of depression, or history of suicidal ideation or suicidal attempt; inflammatory bowel disease (including Crohn's disease & ulcerative colitis); history of TB or suspected tuberculous infection. Closely observe any onset of infection. Fully consider applicability of conventional therapies for the indications before commencing treatment. Perform chest X-ray exam, interferon-γ release assay or tuberculin test & chest CT scan before treatment administration. Regularly perform chest x-ray to closely monitor potential onset of TB while undergoing treatment. Concomitant use w/ live vaccines; immunosuppressant or phototherapy. Avoid concomitant use w/ other biologic. Renal & hepatic impairment. Women who may possibly be pregnant. Pregnancy. Avoid breastfeeding. Childn & adolescents <18 yr. Elderly.
Adverse Reactions
URTI, nasopharyngitis, headache, arthralgia, pruritus, fatigue & oral candidiasis. Candidiasis, sinusitis, bronchitis, flu, UTI, herpes infection, pharyngitis; rash, psoriasis; nausea/vomiting; abnormal LFT; inj site reaction (including pain, erythema, haemorrhage, swelling & induration), malaise.
Drug Interactions
Concurrent use w/ live vaccines. Increased exposure of midazolam.
MIMS Class
Immunosuppressants
ATC Classification
L04AC12 - brodalumab ; Belongs to the class of interleukin inhibitors. Used as immunosuppressants.
Presentation/Packing
Form
Lumicef soln for inj 210 mg/1.5 mL
Packing/Price
1's
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