FRAIZERON LYVI
SECUKINUMAB · by NOVARTIS
Composition
Inj 150 mg: Secukinumab150 mg, lyophilized powder in a single-use vial for reconstitution
Indications & Dosage
Psoriatic arthritis, Ankylosing spondylitis: BY SC INJ: Adult: 150 mg every week for 5 doses, then maintenance 150 mg every month, review treatment if no response within 16 weeks. Psoriatic arthritis with concomitant moderate to severe plaque psoriasis or if inadequate response to anti-TNF a treatment, Plaque psoriasis: BY SC INJ: Adult: 300 mg every week for 5 doses, then maintenance 300 mg every month, review treatment if no response within 16 weeks.
Administration
Secukinumab lyophilized powder should be reconstituted with Sterile Water for Injection. Remove the vial of Secukinumab lyophilized powder from the refrigerator and allow 15 to 30 minutes to reach room temperature. Ensure the Sterile Water for Injection is at room temperature. Slowly inject 1 ml of Sterile Water into the vial containing lyophilized powder. Tilt the vial at an angle of approximately 45 degrees and gently rotate between the fingertips for approximately 1 minute. Do not shake or invert the vial. The reconstituted solution should be essentially free of visible particles, clear to opalescent, and colorless to slightly yellow. Do not use if the lyophilized powder has not fully dissolved or if the liquid contains visible particles, is cloudy or discolored.
Stability
Store lyophilized Secukinumab under refrigerated conditions 2C-8C (36F-46F). Do not freeze. It is recommended that after reconstitution, the solution should be used immediately. If not used immediately, it can be stored between 2o C-8C (35.6F-46.4F) for 24 hours or at room temperature for 4 hours. Discard the reconstituted solution if not used within 24 hours
Contraindications
Severe active infection, serious hypersensitivity reaction.
Precautions
History of recurrent infection, predisposition to infection, chronic infection, Crohns disease, patients with latent tuberculosis should complete anti-tuberculosis therapy first. Women of childbearing potential should use effective contraception during treatment and for at least 20 weeks after stopping treatment.
Interactions
Monoclonal antibodies
Pregnancy
Avoid in pregnancy
Lactation
Avoid during treatment and for up to 20 weeks after discontinuing treatment
Side Effects
Upper respiratory tract infections, diarrhoea, oral herpes, rhinorrhoea, conjunctivitis . neutropenia (mild and reversible), oral candidiasis, otitis externa, tinea pedis, exacerbations of inflammatory bowel disease. Rare: Anaphylactic reactions or other serious allergic reaction and cases of urticaria