Formulari Ubat KKM (FUKKM)

# Generic Name MDC Category Indications Pres. Restrictions Dosage
781 Inclisiran 284 mg/1.5ml Solution for Injection in Pre-Filled Syringe C10AX16-520-P50-01-xxx A* Inclisiran is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet:
• in combination with a statin or statin with other lipid-lowering therapies in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin, or
• in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated.		 As a third-line therapy for:
• Patient with history of ST-elevated myocardial infarction (STEMI) or non-ST elevated myocardial infarction (NSTEMI) AND
• DM or target organ damage or >3 CV risk factors AND/OR CKD with eGFR<60mL/min/1.73 m2 AND
• Unable to achieve LDL-C goal (<1.8mmol/L) or require 50% LDL-C reduction from baseline despite maximally tolerated dose of statin and ezetimibe; AND optimum adherence to statin and ezetimibe
 The recommended dose is 284 mg inclisiran administered as a single subcutaneous injection: initially, again at 3 months, followed by every 6 months.
782 Indacaterol acetate/ glycopyrronium bromide/ mometasone furoate 150/50/160mcg inhalation powder hard capsules R03AL12-986-A20-01-XXX A As a maintenance treatment of asthma in adult patients not adequately controlled with a maintenance combination of a long-acting beta2-agonist and a high dose of an inhaled corticosteroid who experienced one or more asthma exacerbations in the previous year. None one capsule to be inhaled once daily.
783 Indacaterol Maleate 110mcg & Glycopyrronium Bromide 50mcg inhalation powder hard capsules R03AL04-989-C11-01-XXX A/KK As a once-daily maintenance bronchodilator treatment to relieve symptoms and reduce exacerbations in adult patients with chronic obstructive pulmonary disease (COPD). Patients with inhaler coordination problem. (Only applies to Primary Care settings) One capsule inhalation daily.
784 Indacaterol Maleate 150mcg Inhalation Capsule R03AC18-253-C99-01-XXX A/KK Maintenance bronchodilator treatment of airflow obstruction in adult patients with chronic obstructive pulmonary disease (COPD). The diagnosis of COPD should be confirmed by spirometry Once-daily inhalation of the content of one 150/300 microgram capsule. Maximum dose is 300 microgram once-daily.
785 Indomethacin 25mg Capsule M01AB01000C1001XX B Pain and inflammation in rheumatic disease 50 - 200 mg daily in divided doses, with food. Child not recommended.
786 Infliximab 100 mg Injection L04AB02000P4001XX A* i) Rheumatoid arthritis (moderate to severe), in combination with methotrexate
ii) Ankylosing spondylitis in patients with active disease despite treatment with methotrexate
iii) Crohn's Disease in patients who have an inadequate response to conventional therapies.
iv) Fistulizing Crohn's Disease in patients who have an inadequate response to conventional therapies
v) Ulcerative Colitis in patients who have an inadequate response to conventional therapies		 i) Rheumatoid arthritis: ADULT over 18 years old: 3 mg/kg at 0, 2, 6 weeks, then every 8 weeks; May increase to 10 mg/kg or increase dosing frequency to 4 weekly for patients with incomplete response. Discontinue if no response by 12 weeks of initial infusion or after dose adjustment
ii) Ankylosing spondylitis: ADULT over 18 years: 5 mg/kg IV over 2 hour given at week 0, 2, and 6 then every 6-8 weeks. Discontinue if no response by 6 weeks of initial infusion.
iii), iv) & v) 5 mg/kg given as an intravenous infusion over a 2-hour period followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter
787 Infliximab 120mg/mL Subcutaneous injection in Pre-Filled Pen L04AB02-000-P50-01-xxx A* i) Rheumatoid arthritis (moderate to severe), in combination with methotrexate
ii) Ankylosing spondylitis in patients with active disease despite treatment with methotrexate
iii) Crohn's Disease in patients who have an inadequate response to conventional therapies
iv) Fistulizing Crohn's Disease in patients who have an inadequate response to conventional therapies
v) Ulcerative Colitis in patients who have an inadequate response to conventional therapies		 Indikasi i:
To be prescribed for active disease after failing / intolerance / contraindicated to standard therapy and IV Infliximab.

Indikasi iii, iv and v:
(a) Not for induction therapy
(b) Restricted to patients requiring dose intensification (increase dose / frequency) during maintenance therapy, up to an equivalent intravenous infliximab dose of less than 10 mg/kg every 4 weeks.
 Indikasi i:
Treatment with subcutaneous formulation should be initiated 4 weeks after loading intravenous doses of infliximab. Recommended maintenance dose is 120 mg once every 2 weeks. Must be given concomitantly with methotrexate.

Indikasi ii. - v.
Treatment with subcutaneous formulation should be initiated 4 weeks after loading intravenous doses of infliximab. Recommended maintenance dose is 120 mg once every 2 weeks.
788 Influenza Vaccine (Inactivated) Injection J07BB02963P30XXXX B i) Prophylaxis of influenza for frontliners (KKM staff and essential services personnel).
ii) Prophylaxis of influenza in high risk groups. Refer to current recommendation by WHO for selection of product of inactivated influenza vaccines.		 0.25ml to 1.0ml by IM. Dosing is according to product insert and WHO recommendations.
789 Insulin Aspart 100 IU/ml Injection A10AB05000P3001XX A/KK Diabetic Type 1 and 2 in patients that still experienced hypoglycaemia with use of human insulin Tertakluk kepada arahan surat Ketua Pengarah Kesihatan dengan no. ruj.: KKM.600-34/1/3 Jld.4(21) bertarikh 21 Ogos 2024 dan garis panduan berkaitan yang dikeluarkan dari semasa ke semasa. Dose to be individualised. The average daily insulin requirement is between 0.5 to 1.0 units/kg body weight
790 Insulin Aspart 30% and Protaminated Insulin Aspart 70% 100 U/ml Injection A10AD05000P3001XX A/KK Diabetic type 1 and 2 in patients that still experienced hypoglycaemia with use of human insulin Dose to be individualised. The average daily insulin requirement is between 0.5 to 1.0 units/kg body weight
791 Insulin Degludec/ Insulin Aspart 70/30 Solution for Injection in Pre- Filled Pen 100 Units/mL A10AD06-925-P50-01-001 A* Treatment of Type-2 Diabetes Mellitus in adults

(A* - Must be prescribed by Endocrinologist)		 For patients who remained uncontrolled OR experienced recurrent hypoglycaemia with multiple daily dosing of human/analogue basal-bolus/premixed insulin. Treatment initiation: 10 units with meal(s) followed by individual dosage adjustments. Once or twice daily with the main meal(s)
Treatment switching: Can be administered alone, in combination with oral antidiabetic medicinal products, and in combination with bolus insulin.
• Convert unit-to-unit to once or twice daily Insulin Degludec/Insulin Aspart at the same total insulin dose as the patient’s previous total daily basal or premix insulin dose.
• Patients switching from basal/bolus insulin therapy will need to convert their dose based on individual needs. In general, patients are initiated on the same number of basal units.
792 Insulin Detemir 100 IU/ml Injection in Prefilled syringe/cartridge A10AE05000P5001XX A/KK i)Type 1 Diabetes patients on basal bolus regimen, whom experience hypoglycaemia with conventional insulin, to be used in combination with rapid or short-acting insulin.
ii)Type 2 Diabetes patients on oral anti-diabetics and basal insulin regimen or basal bolus insulin regimen whom experience hypoglycaemia with conventional basal insulin.		 Individualized dose given via SC once or twice daily. Initiate at a dose of 10IU or 0.1-0.2IU/kg. For twice daily dosing, the evening dose can be administered either with the evening meal, at bedtime, or 12 hours after the morning dose.
793 Insulin Glargine 300 IU/ 3 ml Injection (Prefilled Pen) A10AE04-000-P50-01-XXX A/KK i) Diabetes mellitus type I in adults and child over 6 years
ii) Diabetes mellitus type II in adult		 ADULT and CHILD over 6 years: individualised dose given by SC, once daily at the same time every day.
Adult patients who are insulin naive may be initiated with 10IU daily.
794 Insulin Glargine 300 IU/ml injection (Prefilled Pen) A10AE04-000-P50-02-XXX A/KK Diabetes mellitus type I and II in adults For usage by Endocrinologists/Physicians (in hospitals):
Patient must meet the following criteria:
i) Patients on insulin not reaching treatment goals defined as high fasting plasma glucose (FPG ≥ 7 mmol/L) and/or HbA1c ≥ 6.5% after 6 months of therapy and/or;
ii) patients with a high risk of hypoglycaemia as determined by the following risk factors: Advancing age; Severe cognitive impairment; Poor health knowledge; Increased A1c; Hypoglycaemia unawareness; long standing insulin therapy; Renal impairment; Neuropathy.

Note: Can be prescribed/dispensed only to patients in diabetic clinic/registered under DMTAC programme.

For usage by Family Medicine Specialists (in health clinics):
Patient must meet all the following criteria:
i) Patient on high dose insulin >30units per injection;
ii) Patient with BMI >35kg/m2; and
iii) Patient who develops significant hypoglycaemia with Insulin Glargine 100units/ml or Insulin Detemir 100units/ml after ruling out other causes of hypoglycaemia.

Note: Used for a trial of 3 months, if during this period patients still develop similar episodes of hypoglycaemia, revert back to human insulins or refer patients to Endocrinologist.		 Initiation: Patient with type 1 diabetes: Once daily with mealtime insulin and requires individual dose adjustments; Patient with type 2 diabetes: 0.2units/kg followed by individual dose adjustment. Please refer to the product information leaflet for details of dosage information (switching, etc).
795 Insulin Glulisine 100u/ml solution for injection in pre-filled pen 3ml A10AB06000P5001XX A/KK Treatment of adults, adolescents and children 6 years or older with diabetes mellitus, where treatment with insulin is required. Tertakluk kepada arahan surat Ketua Pengarah Kesihatan dengan no. ruj.: KKM.600-34/1/3 Jld.4(21) bertarikh 21 Ogos 2024 dan garis panduan berkaitan yang dikeluarkan dari semasa ke semasa. Glulisine should be given shortly (0-15 min) before or soon after meals.
Glulisine should be used in regimens that include an intermediate or long acting insulin or basal insulin analogue and can be used with oral hypoglycaemic agents. The dosage of Apidra should be individually adjusted.
796 Insulin Lispro 100 IU/ml Injection in Prefilled syringe/cartridge A10AB04000P5001XX A* i) As initial therapy in children with Type 1 diabetes
ii)Type 1 diabetes patients on basal bolus regimen, not controlled or experience hypoglycaemia with conventional insulin, to be used in combination with long-acting insulin
iii)Type 2 diabetes patients on basal bolus or premixed regimen, not controlled or experience hypoglycaemia with conventional insulin, to be used in combination with intermediate-acting insulin or long-acting insulin iv)Patients with diabetes in pregnancy with poor postprandial control or experience hypoglycaemia with conventional short-acting insulin		 Dose to be individualized. The average daily insulin requirement is between 0.5 to 1.0 units/kg body weight, given within 15 minutes before meal.
797 Insulin Lispro 25% & Insulin Lispro Protamine 75% 100 U/ml Suspension for Injection in Prefilled Syringe/Cartridge A10AD04000P5001XX A* Patients with Type 2 diabetes whom experience hypoglycemia with the use of human premixed insulin. Dose to be individualized.
The average daily insulin requirement is between 0.5 to 1.0 units/kg body weight
798 Insulin Lispro 50% & Insulin Lispro Protamine 50% 100U/ml Suspension for Injection in Prefilled Syringe/Cartridge A10AD04000P5002XX A* Patients with Type 2 diabetes whom experience hypoglycemia with the use of human premixed insulin. Dose to be individualized. The average daily insulin requirement is between 0.5 to 1.0 units/kg body weight.
799 Insulin Recombinant Neutral Human Short Acting 100 IU/ml Injection in 10ml vial A10AB01000P3001XX B Diabetes mellitus Dose to be individualised. The average daily insulin requirement is between 0.3-1.0 units/kg body weight/day. Daily insulin requirement may be higher in patients with insulin resistance, and lower in patients with residual, endogenous insulin production.
800 Insulin Recombinant Neutral Human Short-acting 100IU/ml Penfill and Refill A10AB01000P5001XX B Diabetes mellitus Dose to be individualised. The average daily insulin requirement is between 0.3-1.0 units/kg body weight/day. Daily insulin requirement may be higher in patients with insulin resistance, and lower in patients with residual, endogenous insulin production.
801 Insulin Recombinant Synthetic Human Intermediate-Acting 100IU/ml in Vial for Injection A10AC01000P3001XX B Diabetes mellitus Dose to be individualised. The daily insulin requirement is usually between 0.3 and 1.0IU/kg /day
802 Insulin Recombinant Synthetic Human Premixed 100IU/ml in Vial for Injection A10AD01000P3001XX B Diabetes mellitus Dose to be individualised. The average daily insulin requirement is between 0.3-1.0 units/kg body weight/day. Daily insulin requirement may be higher in patients with insulin resistance, and lower in patients with residual, endogenous insulin production.
803 Insulin Recombinant Synthetic Human, Intermediate-Acting 100 IU/ml Penfill and Refill A10AC01000P5001XX B Insulin dependent diabetes mellitus, non insulin dependent diabetes unresponsive to treatment to diet or oral hypoglycaemics, hyperkalaemia to assure proper utilisation of glucose and reduce glucosuria in non diabetic patients receiving parenteral nutrition Dose to be individualised. The daily insulin requirement is usually between 0.3 and 1.0IU/kg /day
804 Insulin Recombinant Synthetic Human, Premixed 100 IU/ml Penfill and Refill A10AD01000P5001XX B Insulin dependent diabetes mellitus, non insulin dependent diabetes unresponsive to treatment to diet or oral hypoglycaemics, hyperkalaemia to assure proper utilisation of glucose and reduce glucosuria in non diabetic patients receiving parenteral nutrition Dose to be individualised. The average daily insulin requirement is between 0.5-1.0 units/kg body weight
805 Interferon Alfa - 2a 3 MIU Injection L03AB04000P3001XX A* For the treatment of i) Hairy cell leukaemia ii) Chronic myelogenous leukaemia iii) AIDS related Kaposi's Sarcoma iv) Chronic hepatitis B v) Chronic hepatitis C vi) Advanced renal cell carcinoma i) Initial : 3 MIU SC daily. If intolerant, 1.5 MIU daily or 3 MIU 3 times a week or 1.5 MIU 3 times a week. Maintenance : 1.5-3 MIU SC 3 times a week ii) Patient > 18 years : 3 MIU daily (days 1-3), 6 MIU daily (days 4-6), 9 MIU daily (days 7-84) iii) Patient > 18 years : Initially escalating dose to 18-36 MIU SC/IM for 10-12 weeks. Maintenance: up to 36 MIU 3 times a week iv)2.5-5 MIU/m2 SC 3 times a week for 4-6 months. CHILD: up to 10 MIU/m2 BSA v) Monotherapy : Initial : 3 - 6 MIU SC 3 times a week for 6 months. Maintenance : 3 MIU 3 times a week for an additional 6 months. vi) As an adjunct to cytotoxic chemotherapy: An escalating dose of 3 MIU 3 times a week for 1 week, then 9 MIU 3 times a week for 1 week, then 18 MIU 3 times a week thereafter for 3-12 months SC
806 Interferon Alfa-2b 18 MIU Injection L03AB05000P5001XX A For the treatment of i) Hairy cell leukaemia ii) Chronic myelogenous leukaemia iii) AIDS related Kaposi's sarcoma iv) Chronic hepatitis B v) Chronic hepatitis C vi) Advanced renal cell carcinoma i) 2 MIU SC or IM 3 times a week ii) Patient more than 18 years: 3 - 9 MIU 3 - 5 times a week or daily depending on response iii) Patient more than 18 years. Initially escalating dose to 18-36 MIU SC/IM for 10-12 weeks. Maintenance: up to 36 MIU 3 times weekly iv) 2.5-5 MIU/m2 SC 3 times weekly for 4-6 month. CHILD: up to 10 MIU/m2 BSA v) 3 MIU for 12 months vi) As an adjunct to cytotoxic chemotherapy: An escalating dose of 3 million IU 3 times/week for 1 week, then 9 million IU 3 times/week for 1 week, then 18 million IU 3 times/week thereafter for 3-12 month SC or IM
807 Interferon Alfa-2b 30 MIU Multidose Injection Pen L03AB05000P5002XX A For the treatment of i) Hairy cell leukaemia ii) Chronic myelogenous leukaemia iii) AIDS related Kaposi's sarcoma iv) Chronic hepatitis B v) Chronic hepatitis C vi) Advanced renal cell carcinoma i) 2 MIU SC or IM 3 times a week ii) Patient more than 18 years: 3 - 9 MIU 3 - 5 times a week or daily depending on response iii) Patient more than 18 years. Initially escalating dose to 18-36 MIU SC/IM for 10-12 weeks. Maintenance: up to 36 MIU 3 times weekly iv) 2.5-5 MIU/m2 SC 3 times weekly for 4-6 month. CHILD: up to 10 MIU/m2 BSA v) 3 MIU for 12 months vi) As an adjunct to cytotoxic chemotherapy: An escalating dose of 3 million IU 3 times/week for 1 week, then 9 million IU 3 times/week for 1 week, then 18 million IU 3 times/week thereafter for 3-12 month SC or IM
808 Interferon Alpha - 2a 4.5 MIU Injection L03AB04000P3002XX A* For the treatment of i) Hairy cell leukaemia ii) Chronic myelogenous leukaemia iii) AIDS related Kaposi's Sarcoma iv) Chronic hepatitis B v) Chronic hepatitis C vi) Advanced renal cell carcinoma i) 2 MIU SC or IM 3 times a week ii) Patient more than 18 years: 3 - 9 MIU 3 - 5 times a week or daily depending on response iii) Patient more than 18 years. Initially escalating dose to 18-36 MIU SC/IM for 10-12 weeks. Maintenance: up to 36 MIU 3 times weekly iv) 2.5-5 MIU/m2 SC 3 times weekly for 4-6 month. CHILD: up to 10 MIU/m2 BSA v) 3 MIU for 12 months vi) As an adjunct to cytotoxic chemotherapy: An escalating dose of 3 million IU 3 times/week for 1 week, then 9 million IU 3 times/week for 1 week, then 18 million IU 3 times/week thereafter for 3-12 month SC or IM
809 Interferon Alpha 2b 3 MIU Injection L03AB05000P3001XX A* For the treatment of i) Hairy cell leukaemia ii) Chronic myelogenous leukaemia iii) AIDS related Kaposi's sarcoma iv) Chronic hepatitis B v) Chronic hepatitis C vi) Advanced renal cell carcinoma i) 2 MIU/m2 SC or IM 3 times a week ii) 4 - 5 MIU/m2 SC daily. Treatment must be discontinued after 8 to 12 weeks of treatment if at least a partial haematological remission or a clinically meaningful cytoreduction has not been achieved iii) Patient > 18 years : 30 MIU/m2 SC or IM three times a week until disease progression or maximal response has been achieved after 16 weeks of treatment. iv) 5 MIU daily or 10 MIU three times a week for 16 weeks. CHILD : 3 MIU/m2 three times a week for the first week of therapy followed by dose escalation to 6 MIU/m2 (maximum of 10MIU) three times a week SC for a total duration of 16 to 24 weeks v) 3 MIU SC or IM 3 times a week.
810 Interferon beta -1b 250mcg (8MIU) Injection L03AB08000P4001XX A* i) Relapsing-remitting multiple sclerosis (RRMS): Reduction of frequency and degree of severity of clinical relapses in ambulatory patients characterized by at least two attacks of neurological dysfunction over the preceding two year period, followed by complete or incomplete recovery
ii) Secondary progressive multiple sclerosis (SPMS):Reduction of frequency and severity of clinical relapses and for slowing the progression of disease		 0.25 mg (8 MIU) by SC injection every other day

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