Formulari Ubat KKM (FUKKM)

# Generic Name MDC Category Indications Pres. Restrictions Dosage
1381 Ritonavir 100mg Capsule J05AE03-000-C10-01-XXX A* Progressive or advanced HIV infection in combination with other antiretroviral agents. Criteria for use:
a) Clinical AIDS
b) CD4 less than 350 cells or
c) Viral load more than 10,000 copies/ml		 ADULT: (Single PI) initially 300 mg twice daily, increase by 100 mg twice daily increments to 600 mg twice daily. (Dual PI) Initially 200mg BD, then increase by 100mg BD & reaching 400mg BD within 2 wk.
1382 Ritonavir 80mg/ml Solution J05AE03-000-L99-01-XXX A* Progressive or advanced HIV infection in combination with other antiretroviral agents. Criteria for use:
a) Clinical AIDS
b) CD4 less than 350 cells or
c) Viral load more than 10,000 copies/ml		 ADULT: 400 - 600 mg twice daily. CHILD: >1 month, initiate at dise of 25mg/m2 twice daily, titrate dose upward every 2-3 days by 50mg/m2 twice daily (maximum dose 600mg twice daily)
1383 Rituximab 10mg/ml Injection L01XC02000P3001XX A* i) Treatment of patients with relapsed or chemo-resistant low grade or follicular B-cell Non-Hodgkin's lymphoma
ii) Adjunctive therapy with combination chemoagents for aggressive Non-Hodgkin Lymphoma
iii) Severe active rheumatoid arthritis with inadequate response or intolerance to other disease-modifying anti-rheumatic drugs (DMARDs) including one or more tumour necrosis factor (TNF) inhibitor therapies
iv) Maintenance in relapsed/ refractory follicular lymphoma after response to induction therapy		 i) 375 mg/m2 BSA administered as an IV infusion through a dedicated line once weekly for 4 weeks
ii) Combination with CHOP (cyclophosphamide, doxorubicin, prednisone and vincristine) as 375 mg/m2 BSA on day 1 of each chemotherapy cycle for 8 cycles after IV administration of the glucocorticoid component of CHOP.
iii) 1000 mg IV infusion followed by a second 1000 mg IV infusion two weeks later
iv) 375mg/m2 BSA once every 3 months until disease progression or for a maximum period of two years.
1384 Rituximab 1400mg/11.7ml solution for subcutaneous injection L01XC02-000-P30-04-XXX A* i) Treatment of patients with relapsed or chemo-resistant low grade or follicular B-cell Non-Hodgkin's lymphoma;
ii) Adjunctive therapy with combination chemo-agents for aggressive Non-Hodgkin Lymphoma;
iii) Maintenance in relapsed/ refractory follicular lymphoma after response to induction therapy.		 i) As monotherapy, first cycle with rituximab (IV formulation) 375mg/m2 administered as an intravenous infusion, followed by subsequent cycles with rituximab SC at a fixed dose of 1400mg per cycle, once weekly. In total: 4 weeks.
ii) Combination with CHOP (cyclophosphamide, doxorubicin, prednisone and vincristine): first dose with rituximab (IV formulation) 375 mg/m2 administered as an intravenous infusion followed by subsequent cycles with rituximab SC injected at a fixed dose of 1400mg per cycle. In total: for up to 8 cycles. Rituximab should be administered on day 1 of each chemotherapy cycle after IV administration of the glucocorticoid component of CHOP.
iii) 1400mg SC once every 3 months until disease progression or for a maximum period of two years.

Note:
• Premedication consisting of an anti-pyretic, antihistamine (e.g. paracetamol and diphenhydramine) and glucocorticoids, before each administration of rituximab.
• All patients must always receive their first dose of rituximab by intravenous administration (using intravenous formulation) at a dose of 375mg/m2 body surface area. The subcutaneous formulation of 1400mg should only be given at the second or subsequent cycles.
• Patients who were not able to receive the full rituximab intravenous infusion dose should continue to receive subsequent cycles with rituximab IV doses.
• Subcutaneous formulation is not intended for intravenous administration and should be given via subcutaneous injection only. The 1400 mg strength is intended for subcutaneous use in non-Hodgkin lymphoma (NHL) only.
1385 Rivaroxaban 10 mg Tablet B01AX06000T1001XX A* i. Prevention of venous thromboembolism in patients undergoing elective hip or knee replacement surgery
ii. Treatment of deep vein thrombosis (DVT), and prevention of recurrent DVT and pulmonary embolism (PE) following an acute DVT in adults
iii. Treatment of Pulmonary Embolism (PE), and prevention of recurrent DVT and pulmonary embolism (PE) following an acute PE in adults		 None Indication i:
10 mg once daily. Initial dose should be taken 6 to 10 hour post-surgery provided that haemostasis has been established. Duration of treatment: Major hip surgery 5 weeks. Major knee surgery 2 weeks

Indication ii & iii
15mg BD for 21 days, followed by 20mg OD
Dose reduction to 15mg OD for renal impairment (CrCl 15 to 49 ml/min)
1386 Rivaroxaban 15 mg Tablet B01AX06000T1002XX A* i) Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation with one or more risk factors, such as Congestive heart failure (CHF), hypertension, age ≥ 75 yrs, diabetes mellitus, prior stroke or transient ischaemic attack.
ii)Treatment of deep vein thrombosis (DVT), and prevention of recurrent DVT and pulmonary embolism (PE) following an acute DVT in adults.
iii) Treatment of Pulmonary Embolism (PE), and prevention of recurrent DVT and pulmonary embolism (PE) following an acute PE in adults.		 i) 20mg once daily or 15mg once daily (CrCl 15 – 49 ml/min)
ii) & (iii) 15mg BD for 21 days, followed by 20mg OD
1387 Rivaroxaban 20 mg Tablet B01AX06000T1003XX A* i)Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation with one or more risk factors, such as Congestive heart failure (CHF), hypertension, age ≥ 75 yrs, diabetes mellitus, prior stroke or transient ischaemic attack.
ii)Treatment of deep vein thrombosis (DVT), and prevention of recurrent DVT and pulmonary embolism (PE) following an acute DVT in adults.
iii) Treatment of Pulmonary Embolism (PE), and prevention of recurrent DVT and pulmonary embolism (PE) following an acute PE in adults.		 i) 20mg once daily or 15mg once daily (CrCl 15 – 49 ml/min)
ii) & (iii) 15mg BD for 21 days, followed by 20mg OD
1388 Rivastigmine 1.5mg Capsule N06DA03123C1001XX A* Mild to moderately severe dementia associated with Alzheimer's or Parkinson's disease For psychiatrists and neurologists only. Initial dose 1.5 mg 2 times daily, may increase by 1.5 mg 2 times daily every 2 weeks to maximum of 6 mg 2 times daily.
If treatment is interrupted for several days, should be reinitiated at the lowest daily dose
1389 Rivastigmine 13.3mg/24hr Transdermal Patch N03DA03123M7003XX A* i) Mild to moderately severe dementia of the Alzheimer's type
ii) Severe dementia of the Alzheimer's type
iii) Mild to moderately severe dementia associated with Parkinson's disease		 Use as second line/alternative option if the first line medication with oral tablet failed or patients are not able to tolerate the oral medication. Initial: 4.6mg/24hr once daily
Maintenance: 9.5mg/24hr once daily after a minimum of 4 weeks and then 13.3mg/24hr if tolerated

Dosing is individualised and according to product insert.
1390 Rivastigmine 2 mg/ml Oral Solution N06DA03123L9901XX A* Mild to moderately severe dementia associated with Alzheimer's or Parkinson's disease For psychiatrists and neurologists only. Initial dose 1.5 mg 2 times daily. May be increased after a minimum of 2 weeks of treatment to 3 mg 2 times daily. Subsequently to 4.5 mg 2 times daily, up to maximum of 6 mg 2 times daily.
If treatment is interrupted for several days, should be reinitiated at the lowest daily dose
1391 Rivastigmine 3mg Capsule N06DA03123C1002XX A* Mild to moderately severe dementia associated with Alzheimer's or Parkinson's disease For psychiatrists and neurologists only. Initial dose 1.5 mg 2 times daily, may increase by 1.5 mg 2 times daily every 2 weeks to maximum of 6 mg 2 times daily. If treatment is interrupted for several days, should be reinitiated at the lowest daily dose
1392 Rivastigmine 4.5 mg Capsule N06DA03123C1003XX A* Mild to moderately severe dementia associated with Alzheimer's or Parkinson's disease For psychiatrists and neurologists only. Initial dose 1.5 mg 2 times daily, may increase by 1.5 mg 2 times daily every 2 weeks to maximum of 6 mg 2 times daily.
If treatment is interrupted for several days, should be reinitiated at the lowest daily dose
1393 Rivastigmine 4.6mg/24hr Transdermal Patch N06DA03123M7001XX A* i) Mild to moderately severe dementia of the Alzheimer's type
ii) Severe dementia of the Alzheimer's type
iii) Mild to moderately severe dementia associated with Parkinson's disease		 Use as second line/alternative option if the first line medication with oral tablet failed or patients are not able to tolerate the oral medication Initial: 4.6mg/24hr once daily
Maintenance: 9.5mg/24hr once daily after a minimum of 4 weeks and then 13.3mg/24hr if tolerated

Dosing is individualised and according to product insert.
1394 Rivastigmine 6 mg Capsule N06DA03123C1004XX A* Mild to moderately severe dementia associated with Alzheimer's or Parkinson's disease For psychiatrists and neurologists only. Initial dose 1.5 mg 2 times daily, may increase by 1.5 mg 2 times daily every 2 weeks to maximum of 6 mg 2 times daily.
If treatment is interrupted for several days, should be reinitiated at the lowest daily dose
1395 Rivastigmine 9.5 mg/24hr Transdermal Patch N06DA03123M7002XX A* i) Mild to moderately severe dementia of the Alzheimer's type
ii) Severe dementia of the Alzheimer's type
iii) Mild to moderately severe dementia associated with Parkinson's disease		 Use as second line/alternative option if the first line medication with oral tablet failed or patients are not able to tolerate the oral medication Initial: 4.6mg/24hr once daily
Maintenance: 9.5mg/24hr once daily after a minimum of 4 weeks and then 13.3mg/24hr if tolerated

Dosing is individualised and according to product insert.
1396 Rocuronium Bromide 10mg/ml Injection M03AC09-320-P30-01-XXX A* As an adjunct to general anaesthesia to facilitate endotracheal intubation, to provide skeletal muscle relaxation during surgery and to facilitate mechanical ventilation in adults, children and infants from one month of age. None Adult: Initial: 0.6mg/kg. Higher doses of 1 mg/kg may be used for intubation during rapid sequence induction of anaesthesia. Maintenance: 0.15mg/kg (may reduce to 0.075-0.1 mg/kg if inhalational anaesthesia is used) or by infusion at a rate of 0.3-0.6mg/kg/hr (0.3-0.4mg/kg/hr if inhalational anaesthesia is used). Doses should be based on ideal body weight for obese patients weighing >30% above the ideal body weight.

Child: Infants and children >1 mth: Initially: 0.6mg/kg. Maintenance: 0.15mg/kg or by infusion at a rate of 0.3-0.6mg/kg/hr, maintenance doses may be required more frequently than in adult patients. Elderly/patients with hepatic and/or biliary tract disease and/or renal impairment: Initially: 0.6mg/kg. Maintenance: 0.075-0.1 mg/kg or by infusion at a rate of 0.3-0.4mg/kg/hr.
1397 Ropinirole HCI 2 mg Extended Release Tablet N04BC04110T5003XX A* Treatment of idiopathic Parkinson?s disease. It may be used as monotherapy or in combination with levodopa ADULT: Initially 2 mg once daily for the 1st week. May be increased by 2 mg at ≥1 week intervals. Max: 24 mg/day. Switching from ropinirole immediate-realease to prolonged-release tablet; dose of ropinirole prolonged release tablet should be based on the total daily dose of ropinirole immediate-release tab the patient was taking. Tablets should be taken at a similar time each day with or without food, must be swallowed whole and must not be chewed, crushed or divided.
1398 Ropinirole HCI 4 mg Extended Release Tablet N04BC04110T5004XX A* Treatment of idiopathic Parkinson?s disease. It may be used as monotherapy or in combination with levodopa ADULT: Initially 2 mg once daily for the 1st week. May be increased by 2 mg at ≥1 week intervals. Max: 24 mg/day. Switching from ropinirole immediate-realease to prolonged-release tablet; dose of ropinirole prolonged release tablet should be based on the total daily dose of ropinirole immediate-release tab the patient was taking. Tablets should be taken at a similar time each day with or without food, must be swallowed whole and must not be chewed, crushed or divided.
1399 Ropinirole HCl 0.25 mg Tablet N04BCO4-110-T10-01-XXX A* i) Treatment of idiopathic Parkinson's disease. It may be used as monotherapy or in combination with levodopa
ii) Treatment of restless leg syndrome		 i) 0.25 mg 3 times daily gradually increasing till adequate response obtained up to a maximum of 24 mg/day. Most patients need 3-9 mg/day
ii) Initial: 0.25mg ON for 2 days then increased if tolerated to 0.5mg ON. Further dose increment of 0.5mg/week can be made until optimal response is achieved
1400 Ropinirole HCl 1 mg Tablet N04BCO4-110-T10-02-XXX A* i) Treatment of idiopathic Parkinson's disease. It may be used as monotherapy or in combination with levodopa
ii) Treatment of restless leg syndrome		 i) 0.25 mg 3 times daily gradually increasing till adequate response obtained up to a maximum of 24 mg/day. Most patients need 3-9 mg/day
ii) Initial: 0.25mg ON for 2 days then increased if tolerated to 0.5mg ON. Further dose increment of 0.5mg/week can be made until optimal response is achieved
1401 Ropivacaine HCl 2 mg/ml Injection N01BB09110P3001XX A* i) Surgical anaesthaesia including obstetrics
ii) Acute pain management		 Dose adjusted according to patient physical status and nature of procedure.
i) Lumbar epidural: 15-25 ml of 7.5 mg/ml solution; Caesarean section, 15-20 ml of 7.5 mg/ml solution in incremental doses ( max . total dose 150 mg).
ii) lumbar epidural: 10-20 ml of 2mg/ml solution followed by 10-15 ml of 2 mg/ml solution at interval at of least 30 minutes. Labour pain 6-10 ml/hour of 2mg/ml solution
1402 Ropivacaine HCl 7.5 mg/ml Injection N01BB09110P3002XX A* i) Surgical anaesthaesia including obstetrics
ii) Acute pain management		 Dose adjusted according to patient physical status and nature of procedure.
i) Lumbar epidural: 15-25 ml of 7.5 mg/ml solution; Caesarean section, 15-20 ml of 7.5 mg/ml solution in incremental doses ( max . total dose 150 mg).
ii) lumbar epidural: 10-20 ml of 2mg/ml solution followed by 10-15 ml of 2 mg/ml solution at interval at of least 30 minutes. Labour pain 6-10 ml/hour of 2mg/ml solution
1403 Rosuvastatin 10 mg Tablet C10AA07390T1002XX A/KK Dyslipidaemia not responsive to atorvastatin 40mg or equivalent doses of other statins Initially 5-10 mg once daily (5mg in patients with pre-disposing factors to myopathy), increased if necessary at intervals of at least 4 weeks to 20 mg once daily, increased after further 4 weeks to 40 mg daily ONLY in severe hypercholesterolemia with high cardiovascular risk. Patient of Asian origin, patients on concomitant ciclosporin/fibrate and patients with risk factors for myopathy/rhabdomyolysis (including personal/family history of muscular disorders/toxicity), the maximum dose should be 20 mg daily
1404 Rosuvastatin 20mg Tablet C10AA07390T1003XX A/KK Dyslipidaemia not responsive to atorvastatin 40 mg or equivalent doses of other statins Initially 5-10 mg once daily (5mg in patients with pre-disposing factors to myopathy), increased if necessary at intervals of at least 4 weeks to 20 mg once daily, increased after further 4 weeks to 40 mg daily ONLY in severe hypercholesterolemia with high cardiovascular risk. Patient of Asian origin, patients on concomitant ciclosporin/fibrate and patients with risk factors for myopathy/rhabdomyolysis (including personal/family history of muscular disorders/toxicity), the maximum dose should be 20 mg daily
1405 Ruxolitinib 15mg tablet L01XE18162T1002XX A* For the treatment of disease-related splenomegaly or symptoms in adult patients with:
i) primary myelofibrosis (also known as chronic idiopathic myelofibrosis); or
ii) post-polycythemia vera myelofibrosis; or
iii) post-essential thrombocythemia myelofibrosis.		 None The recommended starting dose:
i) Platelet count between 100,000/mm³ and 200,000/mm³: 15 mg twice daily for patients
ii) Platelet count of >200,000/mm³: 20 mg twice daily for patients
iii) Platelet counts between 50,000/mm³ and <100,000/mm³:
Limited information to recommend a starting dose for patients. The maximum recommended starting dose in these patients is 5 mg twice daily and the patients should be titrated cautiously.
1406 Ruxolitinib 20mg tablet L01XE18-162-T10-03-XXX A* For the treatment of disease-related splenomegaly or symptoms in adult patients with:
i) primary myelofibrosis (also known as chronic idiopathic myelofibrosis); or
ii) post-polycythemia vera myelofibrosis; or
iii) post-essential thrombocythemia myelofibrosis.		 None The recommended starting dose:
i) Platelet count between 100,000/mm³ and 200,000/mm³: 15 mg twice daily for patients
ii) Platelet count of >200,000/mm³: 20 mg twice daily for patients
iii) Platelet counts between 50,000/mm³ and <100,000/mm³: Limited information to recommend a starting dose for patients.
The maximum recommended starting dose in these patients is 5 mg twice daily and the patients should be titrated cautiously.
1407 Ruxolitinib 5mg tablet L01XE18-162-T10-01-XXX A* For the treatment of disease-related splenomegaly or symptoms in adult patients with:
i) primary myelofibrosis (also known as chronic idiopathic myelofibrosis); or
ii) post-polycythemia vera myelofibrosis; or
ii) post-essential thrombocythemia myelofibrosis.		 None The recommended starting dose:
i) Platelet count between 100,000/mm³ and 200,000/mm³: 15 mg twice daily for patients
ii) Platelet count of >200,000/mm³: 20 mg twice daily for patients
iii) Platelet counts between 50,000/mm³ and <100,000/mm³:
Limited information to recommend a starting dose for patients. The maximum recommended starting dose in these patients is 5 mg twice daily and the patients should be titrated cautiously.
1408 Sacubitril/ Valsartan 100 mg tablet C09DX04-000-T32-02-XXX A* To reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure. i. For heart failure patients with reduced ejection fraction
ii. NYHA class II-IV
iii. Second line for patients intolerant of or not responding to ACEi or ARB.		 The recommended starting dose of sacubitril/valsartan is one tablet of 100 mg twice daily.
The dose should be doubled at 2-4 weeks to the target dose of one tablet of 200 mg twice daily, as tolerated by the patient.

For the following patients, initiate with sacubitril/valsartan 50 mg twice daily.
- Not currently on ACEI/ ARB
- Switching from low dose of ACEI/ ARB
- In patients with systolic BP ≥100 to 110 mmHg.
- In patients with moderate renal impairment (eGFR 30-60 ml/min/1.73 m2)
- In patients with moderate hepatic impairment (Child-Pugh B classification)

For patients "Not currently on ACEI/ ARB" and "switching from low dose of ACEI/ ARB", double the dose every 3-4 weeks to achieve the target dose of 200 mg twice daily as tolerated by the patient.
1409 Sacubitril/ Valsartan 50 mg tablet C09DX04-000-T32-01-XXX A* To reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure. i. For heart failure patients with reduced ejection fraction
ii. NYHA class II-IV
iii. Second line for patients intolerant of or not responding to ACEi or ARB.		 The recommended starting dose of sacubitril/valsartan is one tablet of 100 mg twice daily.
The dose should be doubled at 2-4 weeks to the target dose of one tablet of 200 mg twice daily, as tolerated by the patient.

For the following patients, initiate with sacubitril/valsartan 50 mg twice daily.
- Not currently on ACEI/ ARB
- Switching from low dose of ACEI/ ARB
- In patients with systolic BP ≥100 to 110 mmHg.
- In patients with moderate renal impairment (eGFR 30-60 ml/min/1.73 m2)
- In patients with moderate hepatic impairment (Child-Pugh B classification)

For patients "Not currently on ACEI/ ARB" and "switching from low dose of ACEI/ ARB", double the dose every 3-4 weeks to achieve the target dose of 200 mg twice daily as tolerated by the patient.
1410 Sacubitril/Valsartan 200 mg tablet C09DX04-000-T32-03-XXX A* To reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure. i. For heart failure patients with reduced ejection fraction
ii. NYHA class II-IV
iii. Second line for patients intolerant of or not responding to ACEi or ARB.		 The recommended starting dose is one tablet of 100 mg twice daily.
The dose should be doubled at 2-4 weeks to the target dose of one tablet of 200 mg twice daily, as tolerated by the patient.

For the following patients, initiate with sacubitril/valsartan 50 mg twice daily.
- Not currently on ACEI/ ARB
- Switching from low dose of ACEI/ ARB
- In patients with systolic BP ≥100 to 110 mmHg.
- In patients with moderate renal impairment (eGFR 30-60 ml/min/1.73 m2)
- In patients with moderate hepatic impairment (Child-Pugh B classification)

For patients "Not currently on ACEI/ ARB" and "switching from low dose of ACEI/ ARB", double the dose every 3-4 weeks to achieve the target dose of 200 mg twice daily as tolerated by the patient.

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