Formulari Ubat KKM (FUKKM)

# Generic Name MDC Category Indications Pres. Restrictions Dosage
421 Cytarabine 100 mg/mL Injection L01BC01000P4002XX A i) Central nervous system lymphoma
ii) Meningeal leukemia
iii) Non Hodgkin's Lymphoma
iv) High dose cytarabine as conditioning to cytoreduce the disease before stem cell transplant for relapsed or refractory leukemia
v) As salvage for acute lymphocytic leukemia
vi) As salvage for acute myeloid leukemia
vii) As palliative chemotherapy in elderly acute myeloid leukemia/ myelodysplastic syndrome		 Standard doses 100 - 200 mg/m2 daily over 5 - 10 days. Higher doses for intensification/consolidation: 1000 - 3000 mg/m2 daily over 3 - 5 days depending on specific protocols. CHILD: Dose variable depending on disease and protocol. Range from 100 mg/m2 to 3 g/m2 twice daily. May be given as SC, IV bolus or infusion. Intrathecal dose: Less than 1 year: 15 mg, 1 - 2 years: 20 mg, 2 - 3 years: 25 mg, more than 3 years: 30 mg. (ENSURE THAT PREPARATION IS SUITABLE FOR INTRATHECAL USE)
422 D-Penicillamine 0.25g Capsule M01CC01-000-C10-01-XX A i) Treatment of severe lead poisoning, it is used as adjunctive treatment following initial treatment with another chelating agent. May also be used as sole therapy in the treatment of asymptomatic patients with moderately elevated blood concentrations.
ii) Wilson's Disease: to aid in elimination of copper ions		 None i) Heavy metal poisoning: 900mg-1800mg daily. Duration of treatment is dictated by the urinary heavy metal excretion. Simultaneous oral vitamin B6 replacement with at least 40mg daily is essential ii) Wilson's disease: 0.25g - 1.5g daily on an incremental basis. Maximal daily dose: 2g. Maintenance dose: 0.75g - 1g daily
423 Dabigatran Etexilate 110 mg Capsule B01AE07999C1002XX A* i) Prevention of venous thromboembolic events in patients who have undergone total knee replacement or total hip replacement surgery.
ii) Reduction of the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation (AF).
iii) Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) and prevention of recurrent DVT and PE in adults.		 i) Following total knee replacement: Initially ADULT 110mg (ELDERLY, 75 mg) within 1- 4 hours after surgery, then 220 mg (ELDERLY, 150 mg) once daily thereafter for 6-10 days Following total hip replacement: Initially ADULT 110 mg (ELDERLY, 75 mg) within 1- 4 hours after surgery, then 220 mg (ELDERLY, 150 mg) once daily thereafter for 28-35 days

ii) Recommended daily dose is 300mg taken orally as 150mg hard capsule twice daily. Therapy should be continued lifelong.
iii) Recommended daily dose is 300mg taken as one 150mg capsule BD following treatment with a parenteral anticoagulant for at least 5 days. The duration of therapy should be individualized after careful assessment of the treatment benefit against the risk for bleeding.

ii) & iii) For the following groups, the recommended daily dose is 220 mg taken as one 110mg capsule twice daily:
- Patients aged 80 years or above
-Patients who receive concomitant verapamil
Special patient population for renal impairment : Renal function should be assessed by calculating the creatinine clearance (CrCl) prior to initiation of treatment with Dabigatran to exclude patients for treatment with severe renal impairment (i.e. CrCl < 30 ml/min).
424 Dabigatran Etexilate 75 mg Capsule B01AE07999C1001XX A* Prevention of venous thromboembolic events in patients who have undergone total knee replacement or total hip replacement surgery Following total knee replacement: Initially ADULT 110 mg (ELDERLY, 75 mg) within 1- 4 hours after surgery, then 220 mg (ELDERLY, 150 mg) once daily thereafter for 6-10 days Following total hip replacement: Initially ADULT 110 mg (ELDERLY, 75 mg) within 1- 4 hours after surgery, then 220 mg (ELDERLY, 150 mg) once daily thereafter for 28-35 days
425 Dabigatran Etexilate150 mg Capsule B01AE07999C1003XX A* i) Reduction of the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation (AF)
ii) Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) and prevention of recurrent DVT and PE in adults.		 i) Recommended daily dose is 300mg taken orally as 150mg hard capsule twice daily. Therapy should be continued lifelong.

ii) Recommended daily dose is 300mg taken as one 150mg capsule BD following treatment with a parenteral anticoagulant for at least 5 days. The duration of therapy should be individualized after careful assessment of the treatment benefit against the risk for bleeding.

For the following groups, the recommended daily dose is 220 mg taken as one 110mg capsule twice daily:
- Patients aged 80 years or above -Patients who receive concomitant verapamil
Special patient population for renal impairment : Renal function should be assessed by calculating the creatinine clearance (CrCl) prior to initiation of treatment with Dabigatran to exclude patients for treatment with severe renal impairment (i.e. CrCl < 30 ml/min).
426 Dacarbazine 100 mg Injection L01AX04000P4001XX A* i) Malignant melanoma, sarcomas, neuroblastomas and other childhood solid tumours
ii) Hodgkin's Disease		 i) 250 mg/m2 for 5 days, may be repeated every 3 weeks ii) 375 mg/m2 IV every 2 weeks
427 Daclatasvir 30mg tablet J05AP07-110-T32-02-XXX A/KK To be used in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults. 60 mg once daily, to be taken orally with or without meals.

Dose recommendation when taking concomitant medicines:
i. Strong inhibitors of cytochrome P450 enzyme 3A4 (CYP3A4):
Reduce dose to 30 mg once daily when co-administered with strong inhibitors of CYP3A4.

ii. Moderate inducers of CYP3A4:
Increase dose to 90 mg once daily when co-administered with moderate inducers of CYP3A4.

Daclatasvir must be administered in combination with other medicinal products for the treatment of hepatitis C infection.

Dose modification of daclatasvir to manage adverse reactions is not recommended.
428 Daclatasvir 60mg tablet J05AP07-110-T32-01-XXX A/KK To be used in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults. None 60 mg once daily, to be taken orally with or without meals.

Dose recommendation when taking concomitant medicines:
i. Strong inhibitors of cytochrome P450 enzyme 3A4 (CYP3A4):
Reduce dose to 30 mg once daily when co-administered with strong inhibitors of CYP3A4.

ii. Moderate inducers of CYP3A4:
Increase dose to 90 mg once daily when co-administered with moderate inducers of CYP3A4.

Daclatasvir must be administered in combination with other medicinal products for the treatment of hepatitis C infection.

Dose modification of daclatasvir to manage adverse reactions is not recommended.
429 Dacomitinib monohydrate 15mg film-coated tablet L01XE47-010-T32-01-XXX A* First-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations. To be prescribed by Oncologist and Consultant Respiratory Physician only 45mg once daily to be taken with or without food
430 Danazol 100mg Capsule G03XA01-000-C10-01-XXX A/KK i) Endometriosis
ii) Benign breast disorders including gynaecomastia fibrocystic breast disease and pubertal breast hypertrophy
iii) Menorrhagia
iv) Prophylaxis of hereditary angioedema		 None i. 400mg daily in 2 to 4 divided doses, starting on the 1st day of the menstrual cycle; daily doses of 800mg are also employed.
ii. 100mg to 400mg daily in divided dose.
iii. 200 mg BD iv. 400 mg daily. Reduce to 200 mg daily after 2 months attack free period.

General dosing range: 200-800mg daily in 2 or 4 divided doses.

Dosing is individualised and according to product insert/protocol
431 Danazol 200mg Capsule G03XA01-000-C10-02-XXX A/KK i) Endometriosis
ii) Benign breast disorders including gynaecomastia fibrocystic breast disease and pubertal breast hypertrophy
iii) Menorrhagia
iv) Prophylaxis of hereditary angioedema		 None i. 400mg daily in 2 to 4 divided doses, starting on the 1st day of the menstrual cycle; daily doses of 800mg are also employed.
ii. 100mg to 400mg daily in divided dose.
iii. 200 mg BD iv. 400 mg daily. Reduce to 200 mg daily after 2 months attack free period.

General dosing range: 200-800mg daily in 2 or 4 divided doses.

Dosing is individualised and according to product insert/protocol
432 Dapagliflozin 10mg Tablet A10BX09-999-T32-01-XXX A/KK Indication 1:
Dapagliflozin is indicated for use as an add-on combination therapy in combination with other glucose-lowering medicinal products including insulin, to improve glycemic control in adult patients with type 2 diabetes mellitus when these, together with diet and exercise, do not provide adequate glycaemic control.

Indication 2:
Dapagliflozin is indicated to reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and established cardiovascular disease (CVD).

Indication 3:
To reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure (NYHA class ll-lV) with reduced ejection fraction.

Indication 4:
For cardiorenal protection in adult patients with chronic kidney disease, with or without Type 2 Diabetes Mellitus, with eGFR≥25mL/min/1.73m2 and urine albumin creatinine ratio (UACR) ≥200-5,000mg/m2 (or the equivalent in uPRC/u-dipstick) receiving stable treatment with ACEi or ARB (unless they are contraindicated or not tolerated).		 Indication 1:
Patients with HbA1c between 6.5%-10.0% while on single / combination anti-diabetic therapy.

Indication 2:
Patients with HbA1c not more than 10.0% while on adequate trial of metformin.

Indication 3:
Treatment to be initiated in hospital setting before continuation of treatment for stable patients by Family Medicine Specialist (FMS) in the primary care setting;
All patients must be counselled regarding risk of euglycemic ketoacidosis before initiation of treatment.

Indication 4:
In adult patients with underlying Type 2 Diabetes Mellitus, to be used only if HbA1c level <10%.
All patients must be counselled regarding risk of euglycemic ketoacidosis before initiation of treatment.



 10 mg once daily
433 Dapsone 100mg Tablet J04BA02-000-T10-01-XXX B i)Leprosy
ii) Dermatitis herpetiformis		 None i) ADULT: 6 - 10 mg/kg weekly/ 1.4mg/kg daily (around 50 - 100 mg daily). CHILD: 1 - 2 mg/kg/day. Maximum: 100 mg/day ii) ADULT: 50 - 300 mg daily
434 Darbepoetin alfa 120mcg/0.5ml injection B03XA02-000-P50-04-XXX A* i. Treatment of anaemia associated with chronic renal failure, including patients on dialysis and patients not on dialysis.
ii. Anemia with myelodysplastic syndrome		 For indication (i):
Patients who require higher doses of erythropoietin if it is more cost saving to use a long-acting agent instead of short-acting agents.		 Indication (i):
Haemodialysis patients:
Initial dose: 20mcg IV once weekly Initial dose for switched ESA-treated patient: 15 – 60mcg IV once weekly
Maintenance dose: 15 – 60mcg IV once weekly, then 30 – 120mcg IV biweekly.

Peritoneal dialysis patients and patients with chronic kidney disease not on dialysis:
Initial dose: 30mcg IV or SC biweekly Initial dose for switched ESA-treated patient: 30 – 120mcg IV or SC biweekly
Maintenance dose: 30 – 120mcg IV or SC biweekly, then 60 – 180mcg IV or SC once every four weeks.

Indication (ii):
Adults: 240mcg administered as a single subcutaneous injection once weekly. The dose should be decreased in view of the degree of anemic symptoms and the patient’s age.
435 Darbepoetin alfa 20mcg/0.5ml injection B03XA02-000-P50-01-XXX A* i. Treatment of anaemia associated with chronic renal failure, including patients on dialysis and patients not on dialysis.
ii. Anemia with myelodysplastic syndrome		 For indication (i):
Patients who require higher doses of erythropoietin if it is more cost saving to use a long-acting agent instead of short-acting agents		 Indication (i):
Haemodialysis patients:
Initial dose: 20mcg IV once weekly Initial dose for switched ESA-treated patient: 15 – 60mcg IV once weekly
Maintenance dose: 15 – 60mcg IV once weekly, then 30 – 120mcg IV biweekly.

Peritoneal dialysis patients and patients with chronic kidney disease not on dialysis:
Initial dose: 30mcg IV or SC biweekly Initial dose for switched ESA-treated patient: 30 – 120mcg IV or SC biweekly
Maintenance dose: 30 – 120mcg IV or SC biweekly, then 60 – 180mcg IV or SC once every four weeks.

Indication (ii):
Adults: 240mcg administered as a single subcutaneous injection once weekly. The dose should be decreased in view of the degree of anemic symptoms and the patient’s age.
436 Darbepoetin alfa 40mcg/0.5ml injection B03XA02-000-P50-03-XXX A* i. Treatment of anaemia associated with chronic renal failure, including patients on dialysis and patients not on dialysis.
ii. Anemia with myelodysplastic syndrome		 For indication (i):
Patients who require higher doses of erythropoietin if it is more cost saving to use a long-acting agent instead of short-acting agents.		 Indication (i):
Haemodialysis patients:
Initial dose: 20mcg IV once weekly Initial dose for switched ESA-treated patient: 15 – 60mcg IV once weekly
Maintenance dose: 15 – 60mcg IV once weekly, then 30 – 120mcg IV biweekly.

Peritoneal dialysis patients and patients with chronic kidney disease not on dialysis:
Initial dose: 30mcg IV or SC biweekly Initial dose for switched ESA-treated patient: 30 – 120mcg IV or SC biweekly
Maintenance dose: 30 – 120mcg IV or SC biweekly, then 60 – 180mcg IV or SC once every four weeks.

Indication (ii):
Adults: 240mcg administered as a single subcutaneous injection once weekly. The dose should be decreased in view of the degree of anemic symptoms and the patient’s age.
437 Daunorubicin HCl 20 mg Injection L01DB02110P4001XX A* i) Acute myeloblastic leukaemia (AML)
ii) Acute lymphoblastic leukemia (ALL)		 i) 45 - 60 mg/m2 IV daily for 3 - 5 days ii) 25 - 45 mg/m2 once a week for first 4 weeks during induction phase. Caution: Total cumulative dose of daunorubicin and doxorubicin must not exceed 500 mg/m2 due to risk of cardiotoxicity. CHILD: 30-45 mg/m2/dose infusion over 6 hours. Schedule depends on protocol. Need to check cardiac function closely by echocardiography every cumulative dose of 100mg/m2 to max. 360 mg/m2
438 Decitabine 50 mg Injection L01BC08000P3001XX A* Myelodysplastic syndromes (MDS) 3-day Regimen
15 mg/m2 by continuous IV infusion over 3 hours repeated every 8 hours for 3 days. Repeat this treatment cycle every 6 weeks for a minimum of 4 cycles.

5-day Regimen
Dose of 20 mg/m2 by continuous intravenous infusion over 1 hour repeated daily for 5 days. This cycle should be repeated every 4 weeks

Dosing is according to product insert /protocol
439 Deferasirox 125mg Dispersible Tablet V03AC03-000-T40-01-XXX A* Treatment of chronic iron overload due to blood transfusions (transfusional haemosiderosis) in adult and pediatric patients aged 2 years and above. Initial 20 mg/kg/day. Starting dose can also be based on transfusion rate and existing iron burden. In patients not adequately controlled with doses of 30mg/kg/day (e.g serum ferritin levels persistently above 2,500 microgram/L and not showing a decreasing trend over time), doses up to 40mg/kg/day may be considered.
440 Deferasirox 180mg Film Coated Tablets V03AC03-000-T32-02-XXX A* Treatment of chronic iron overload due to blood transfusions (transfusional haemosiderosis) in adult and paediatric patients aged 2 years and above. i. Exclude patients with renal impairment and moderate to severe transaminitis.
ii. To be prescribed by consultant hematologist, consultant physician and consultant paediatrician
 Recommended initial daily dose is 14mg/kg body weight.

An initial daily dose of 21mg/kg may be considered for patients receiving more than 14 mL/kg/month of packed red blood cells (approximately >4 units/month for an adult), and for whom the objective is reduction of iron overload.

An initial daily dose of 7 mg/kg may be considered for patients receiving less than 7 mL/kg/month of packed red blood cells (approximately <2 units/month for an adult), and for whom the objective is maintenance of the body iron level.

For patients already well-managed on treatment with deferoxamine, a starting dose of Deferasirox Film Coated Tablets that is numerically one third of the deferoxamine dose could be considered.

In patients not adequately controlled with doses of 21 mg/kg (e.g., serum ferritin levels persistently above 2500 μg/L and not showing a decreasing trend over time), doses of up to 28 mg/kg may be considered. Doses above 28 mg/kg are not recommended because there is only limited experience with doses above this level.
441 Deferasirox 250mg Dispersible Tablet V03AC03-000-T40-02-XX A* Treatment of chronic iron overload due to blood transfusions (transfusional haemosiderosis) in adult and pediatric patients aged 2 years and above. None Initial 20 mg/kg/day. Starting dose can also be based on transfusion rate and existing iron burden. In patients not adequately controlled with doses of 30mg/kg/day (e.g serum ferritin levels persistently above 2,500 microgram/L and not showing a decreasing trend over time), doses up to 40mg/kg/day may be considered.
442 Deferasirox 360mg film coated tablet V03AC03-000-T32-03- XXX A* Treatment of chronic iron overload due to blood transfusions (transfusional haemosiderosis) in adult and paediatric patients aged 2 years and above. None • Recommended initial dose is 14mg/kg body weight.
• An initial dose of 21mg/kg may be considered for patients receiving more than 14ml/kg/month of packed red blood cells, and for whom the objective is maintenance of the body iron level.
• An initial dose of 7mg/kg may be considered for patients receiving less than 7ml/kg/month of packed red blood cells, and for whom the objective is maintenance of the body iron level.
• For patients already well-managed on treatment with Deferoxamine, a starting dose of Deferasirox film- coated tablets that is numerically one third of the Deferoxamine dose could be considered.

In patients not adequately controlled with doses of 21mg/kg (e.g. serum ferritin levels persistently above 2,500 mcg/L and not showing a decreasing trend over time), doses of up to 28mg/kg may be considered. Doses above 28 mg/kg are not recommended because there is only limited experience with doses above this level.
443 Deferasirox 500 mg Dispersible Tablet V03AC03-000-T40-03-XXX A* Treatment of chronic iron overload due to blood transfusions (transfusional haemosiderosis) in adult and pediatric patients aged 2 years and above. None Initial 20 mg/kg/day. Starting dose can also be based on transfusion rate and existing iron burden. In patients not adequately controlled with doses of 30mg/kg/day (e.g serum ferritin levels persistently above 2,500 microgram/L and not showing a decreasing trend over time), doses up to 40mg/kg/day may be considered.
444 Deferasirox 90mg film coated tablet V03AC03-000-T32-01- XXX A* Treatment of chronic iron overload due to blood transfusions (transfusional haemosiderosis) in adult and paediatric patients aged 2 years and above. • Recommended initial dose is 14mg/kg body weight.
• An initial dose of 21mg/kg may be considered for patients receiving more than 14ml/kg/month of packed red blood cells, and for whom the objective is maintenance of the body iron level.
• An initial dose of 7mg/kg may be considered for patients receiving less than 7ml/kg/month of packed red blood cells, and for whom the objective is maintenance of the body iron level.
• For patients already well-managed on treatment with Deferoxamine, a starting dose of Deferasirox film- coated tablets that is numerically one third of the Deferoxamine dose could be considered.

In patients not adequately controlled with doses of 21mg/kg (e.g. serum ferritin levels persistently above 2,500 mcg/L and not showing a decreasing trend over time), doses of up to 28mg/kg may be considered. Doses above 28 mg/kg are not recommended because there is only limited experience with doses above this level.
445 Deferiprone 500 mg Tablet V03AC02-000-T10-01-XXX A* Treatment of iron overload in patients with thalassemia major for whom desferrioxamine therapy is contraindicated or inadequate.
Add on therapy to desferrioxamine for thalassemia patients with cardiac complication		 None 25 mg/kg 3 times a day for total daily dose of 75 mg/kg. Doses greater 100 mg/kg are not recommended
446 Degarelix 120mg Injection L02BX02-000-P40-01-001 A* Treatment of adult male patients with advanced hormone- dependent prostate cancer Patients who are contraindicated to Gonadotrophin Releasing Hormone (GnRH) agonist 240 mg administered as two consecutive subcutaneous injections of 120 mg each.
Maintenance dose* – monthly administration:
80 mg administered as one subcutaneous injection
*The first maintenance dose should be given one month after the starting dose.
447 Degarelix 80mg Injection L02BX02-000-P40-01-002 A* Treatment of adult male patients with advanced hormone- dependent prostate cancer. Patients who are contraindicated to Gonadotrophin Releasing Hormone (GnRH) agonist 240 mg administered as two consecutive subcutaneous injections of 120 mg each.
Maintenance dose* – monthly administration:
80 mg administered as one subcutaneous injection
*The first maintenance dose should be given one month after the starting dose.
448 Denosumab in 1.0 mL solution (60 mg/mL) Pre‐filled syringe (subcutaneous injection) M05BX04000P4001XX A* Post-Menopausal Osteoporosis. To be used by Orthopaedic Specialist, Rheumatologist, Endocrinologist and Geriatricians A single subcutaneous injection of 60 mg administered once every 6 months.
Patients should receive calcium and vitamin D supplements whilst undergoing treatment.
449 Desferrioxamine B Methanesulphonate 0.5g Injection V03AC01-196-P30-01-XX A i) Acute iron poisoning in children.
ii) Investigation and treatment of haemochromatosis.
iii) Diagnosis and treatment of aluminium toxicity in patients with renal failure and dialysis
iv) Chronic iron toxicity or overload		 None i) 2 g by IM immediately and 5 g by mouth after gastric lavage.
ii) 0.5 - 1.5 g by IM injection daily.
iii) Diagnosis: 5 mg per kg by slow intravenous infusion during the last hour of haemodialysis.
Treatment: 5 mg per kg once a week by slow intravenous infusion during the last hour of dialysis iv) 30 - 50 mg/kg
450 Desflurane Liquid N01AB07000L5001XX A i) Induction and maintenance of anaesthesia in adult ii) Maintenance of anaesthesia in infants & children ADULT: Induction , initially 3% in oxygen or nitrous oxide/oxygen and increased by 0.5%-1% every 2-3 breaths or as tolerated (up to 11%), until loss of consciousness. Maintenance: 2.5%-8.5% with or without concomitant nitrous oxide CHILD: maintenance, inhaled in concentrations of 5.2%-10% with or without concomitant nitrous oxide

Halaman-halaman