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Formulari Ubat KKM (FUKKM)
| # | Generic Name | MDC | Category | Indications | Pres. Restrictions | Dosage |
|---|---|---|---|---|---|---|
| 31 | Tocilizumab 20 mg/ml Injection | L04AC07-000-P30-01-001 | A* | Indicated for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients: i) with inadequate respond or intolerance to conventional disease- modifying antirheumatic drugs (DMARDS) ii) who has failed antitumour necrosis factors (antiTNFs) iii) where TNF is contraindicated (patients with history of pulmonary tuberculosis [PTB]) It also can be used as monotherapy or with combination with methotrexate (MTX) and/ or other DMARDS. | Recommended dose for rheumatoid arthritis of tocilizumab for adult patients is 8mg/kg given once every 4 weeks as a single-drip IV infusion over 1 hour. It should be diluted to 100 ml by a healthcare professional with sterile 0.9% w/v sodium chloride solution over 1 hour. For patients whose body weight is more than 100kg, doses exceeding 800mg per infusion are not recommended | |
| 32 | Tofacitinib citrate 5mg film coated tablet | L04AA29136T3201XX | A* | Indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. It may be used as monotherapy or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (DMARDs). | One tablet twice daily | |
| 33 | Triamcinolone Acetonide 40 mg/ml Injection | H02AB08-351-P30-02-XXX | A/KK | Allergies, dermatoses, rheumatoid arthritis and inflammatory opthalmic diseases | - | 40-80 mg deep into the gluteal muscle |
| 34 | Upadacitinib 15mg Extended-Release Film Coated Tablet | L04AA44-020-T50-01-XXX | A* | 1. Indicated for the treatment of severe atopic dermatitis in adults and adolescents 12 years and older who are candidates for systemic therapy. 2. Indicated for the treatment of active psoriatic arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more DMARDs. May be used as monotherapy or in combination with methotrexate. 3. Indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs). Upadacitinib may be used as monotherapy or in combination with methotrexate. 4. For the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent. 5. For the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent. | Indication 1 (severe atopic dermatitis): i. As fourth line of treatment in patients who have failed / have contraindications / experienced adverse events to: • Intensive and optimized topical treatment • Phototherapy • At least two immunosuppressants ii. To be prescribed by Dermatologists only. Indication 2 (active psoriatic arthritis): To be prescribed by Rheumatologist only Indication 3 (moderate to severe active rheumatoid arthritis): i. To be prescribed after failing/ intolerance/ contraindicated to csDMARDs (as per Malaysian Consensus on Biologic Usage) and one biologic DMARDs. ii. To be prescribed by Rheumatologist only Indication 4 (active ulcerative colitis): As a second line therapy and to be prescribed by gastroenterologists experienced in inflammatory bowel disease management. Indication 5 (Crohn's disease) - None | Indication 1 (severe atopic dermatitis): Adults: The recommended dose of upadacitinib is 15 mg or 30 mg once daily based on individual patient presentation (Refer to package insert). The lowest effective dose for maintenance should be considered. Adolescents (from 12 to 17 years of age): The recommended dose of upadacitinib is 15 mg once daily for adolescents weighing at least 40 kg. Upadacitinib can be used with or without concomitant topical therapies (Refer package insert) Indication 2 & 3 (active psoriatic arthritis & moderate to severe active rheumatoid arthritis): 15 mg once daily Indication 4 (active ulcerative colitis): Induction The recommended induction dose of upadacitinib is 45 mg once daily for 8 weeks. Maintenance The recommended maintenance dose of upadacitinib is 15 mg or 30 mg once daily based on individual patient presentation. Indication 5 (Crohn's disease) Induction The recommended induction dose of upadacitinib is 45 mg once daily for 12 weeks. Maintenance The recommended maintenance dose of upadacitinib is 15 mg or 30 mg once daily based on individual patient presentation. |