Formulari Ubat KKM (FUKKM)

# Generic Name MDC Category Indications Pres. Restrictions Dosage
871 Lanthanum Carbonate 1000mg Chewable Tablet V03AE03130T2004XX A* Phosphate binding agent for the treatment of hyperphosphataemia in dialysis patients with sustained hypercalcaemia of more than three months and secondary hyperparathyroidism Initial: 750 to 1500 mg/day in divided doses with meals, then titrate in increments of 750 mg/day at intervals of 2 to 3 weeks. Maintenance: 1500-3000 mg/day in divided doses. Max: 3750 g/day
872 Laronidase 2.9mg/5ml Injection A16AB05000P3001XX A* Hurler and Hurler-Scheie forms of Mucopolysaccharidosis I (MPS I) and for patients with the Scheie form who have moderate to severe symptoms 0.58 mg/kg of body weight administered once-weekly as an intravenous infusion
873 Latanoprost 0.005% and Timolol Maleate 0.5% eye drops S01ED51-990-D20-04-XXX A* For reduction of Intraocular Pressure (IOP) in patients with Open-angle Glaucoma (OAG) and Ocular Hypertension (OH) who are insufficiently responsive to topical beta-blocker. None 1 drop in the affected eye(s) once daily
874 Latanoprost 0.005% Eye Drops S01EE01-000-D20-01-XXX A* Reduction of elevated intraocular pressure in patients with open-angle glaucoma None 1 drop in the affected eye(s) once daily.
875 Leflunomide 10mg Tablet L04AA13000T1001XX A* i) Active rheumatoid arthritis
ii) Active psoriatic arthritis		 For indication:
i) 10 – 20 mg once daily
ii) Loading dose: 100 mg once daily for 3 days. Maintenance: 20 mg once daily
876 Leflunomide 20mg Tablet L04AA13000T1002XX A* i) Active rheumatoid arthritis
ii) Active psoriatic arthritis		 For indication:
i) 10 – 20 mg once daily
ii) Loading dose: 100 mg once daily for 3 days. Maintenance: 20 mg once daily
877 Lenalidomide 10 mg Capsule L04AX04000C1002XX A* Treatment of Multiple Myeloma in the following patients:
i) as monotherapy for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantations.
ii) in combination with dexamethasone for the treatment of previously untreated multiple myeloma patients who are not eligible for transplant.
iii) in combination with dexamethasone for the treatment of patients who have received at least one prior therapy.		 For indication:
i) 10 mg orally once daily continuously (on days 1 to 28 of repeated 28-day cycles) given until disease progression or intolerance. After 3 cycles of lenalidomide maintenance, the dose can be increased to 15 mg orally once daily if tolerated.
ii) & iii) 25 mg orally once daily on days 1 to 21 of repeated 28-day cycles.
878 Lenalidomide 15 mg Capsule L04AX04000C1003XX A* Treatment of Multiple Myeloma in the following patients:
i) as monotherapy for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantations.
ii) in combination with dexamethasone for the treatment of previously untreated multiple myeloma patients who are not eligible for transplant.
iii) in combination with dexamethasone for the treatment of patients who have received at least one prior therapy.		 For indication:
i) 10 mg orally once daily continuously (on days 1 to 28 of repeated 28-day cycles) given until disease progression or intolerance. After 3 cycles of lenalidomide maintenance, the dose can be increased to 15 mg orally once daily if tolerated.
ii) & iii) 25 mg orally once daily on days 1 to 21 of repeated 28-day cycles.
879 Lenalidomide 25 mg Capsule L04AX04000C1004XX A* Treatment of Multiple Myeloma in the following patients:
i) as monotherapy for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantations.
ii) in combination with dexamethasone for the treatment of previously untreated multiple myeloma patients who are not eligible for transplant.
iii) in combination with dexamethasone for the treatment of patients who have received at least one prior therapy.		 For indication:
i) 10 mg orally once daily continuously (on days 1 to 28 of repeated 28-day cycles) given until disease progression or intolerance. After 3 cycles of lenalidomide maintenance, the dose can be increased to 15 mg orally once daily if tolerated.
ii) & iii) 25 mg orally once daily on days 1 to 21 of repeated 28-day cycles.
880 Lenalidomide 5 mg Capsule L04AX04000C1001XX A* Treatment of Multiple Myeloma in the following patients:
i) as monotherapy for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantations.
ii) in combination with dexamethasone for the treatment of previously untreated multiple myeloma patients who are not eligible for transplant.
iii) in combination with dexamethasone for the treatment of patients who have received at least one prior therapy.		 For indication:
i) 10 mg orally once daily continuously (on days 1 to 28 of repeated 28-day cycles) given until disease progression or intolerance. After 3 cycles of lenalidomide maintenance, the dose can be increased to 15 mg orally once daily if tolerated.
ii) & iii) 25 mg orally once daily on days 1 to 21 of repeated 28-day cycles.
881 Lenvatinib 10mg Hard Capsule L01XE29-196-C11-01-xxx A* For the treatment of adult patients with progressive, locally advanced or metastatic, differentiated (papillary/follicular/Hürthle cell) thyroid carcinoma (DTC), refractory to radioactive iodine (RAI). None 24mg once daily
882 Lenvatinib 4mg Hard Capsule L01EX08-196-C11-01-XXX A* i. Indicated as monotherapy for the treatment of adult patients with advanced or unresectable hepatocellular carcinoma (HCC) who have received no prior systemic therapy
ii. For the treatment of adult patients with progressive, locally advanced or metastatic, differentiated (papillary/follicular/Hürthle cell) thyroid carcinoma (DTC), refractory to radioactive iodine (RAI).		 Indikasi i: Only for patients with Child-Pugh A Indikasi i:
The recommended daily dose of lenvatinib is 8 mg (two 4 mg capsules) once daily for patients with a body weight of < 60 kg and 12 mg (three 4 mg capsules) once daily for patients with a body weight of ≥ 60 kg.

Dose adjustments are based only on toxicities observed and not on body weight changes during treatment (Refer package insert for dosage adjustments)

Treatment should continue as long as clinical benefit is observed or until unacceptable toxicity occurs.

Indikasi ii:
24mg once daily
883 Letrozole 2.5 mg Tablet L02BG04000T1001XX A* i) Hormonal therapy in breast cancer in post-menopausal women if failed or contraindicated to tamoxifen
ii) Adjuvant treatment of postmenopausal women with early breast cancer (positive or unknown oestrogen or progesterone receptor status) who have received 5 years of adjuvant tamoxifen therapy (extended adjuvant therapy).		 None 2.5 mg once daily
884 Leucovorin Calcium (Calcium Folinate) 10mg/mL Injection V03AF03-237-P30-02-XXX A (i) Biochemical modulator for 5-Fluorouracil in the treatment of solid tumour;
(ii) As rescue for high dose methotrexate;
(iii) Megaloblastic anaemias due to deficiency of folic acid		 None i) 200mg/m2 by slow IV injection over a minimum 3 minutes, followed by 5-Fluorouracil or 20mg/m2 IV followed by 5-Fluorouracil. In both cases, treatment is repeated daily for 5 days; may repeat at 4-week intervals for 2 courses then 4- to 5-week intervals
ii) 15 mg (approximately 10mg/m2) every 6 hours for 10 doses, starting 24 hours after the beginning of the methotrexate infusion
iii) Up to 1 mg daily

Dosing is individualised and according to product insert/protocol
885 Leucovorin Calcium (Calcium Folinate) 15 mg Tablet V03AF03-390-T10-01-XXX A i) Treatment of folic acid antagonist overdose;
ii) Leucovorin (folinic acid) plus tegafur-uracil combination therapy is indicated for the treatment of colorectal cancer in: a) Metastatic stage, b) Adjuvant setting, c) Concurrent setting.		 None i) 15 mg every 6 hours for the next 48 - 72 hours;
ii) Metastatic stage: Leucovorin Calcium 30 mg TDS, Day 1-28, rest 7 days for 5 cycles
Adjuvant setting: Leucovorin Calcium 30 mg TDS, Day 1-28, rest 7 days for 5 cycles;
Concurrent setting: Leucovorin Calcium 25 mg /day, D8- D36, for 4 weeks.


Dosing is individualised and according to product insert/protocol

886 Leuprolide (Leuproreline) Acetate 11.25 mg Injection L02AE02-122-P50-02-XXX A* i) Endometriosis
ii) Hormonal therapy in advanced prostate cancer		 11.25 mg every 3 months
887 Leuprolide (Leuproreline) Acetate 22.5mg injection L02AE02-122-P20-01-XXXX A* Hormonal therapy in advanced prostate cancer. 22.5mg SC every 3 months
888 Leuprolide (Leuproreline) Acetate 3.75mg Injection L02AE02-122-P50-01-XXX A* i) Endometriosis
ii) Hormonal therapy in advanced prostate cancer		 None i) 3.75 mg monthly for 3 - 6 months
ii) 3.75 mg IM or SC injection monthly
889 Leuprolide (Leuproreline) Acetate 45mg Injection L02AE02-122-P40-01-XXX A* Hormonal therapy in advanced prostate cancer None 45mg SC every 6 months
890 Levetiracetam 100 mg/ml Oral Solution N03AX14-000-L99-01-XXX A* As adjunctive therapy in the treatment of partial onset seizures with or without secondary generalization in adults and children from 4 years of age with epilepsy None CHILD: 4-11 years and adolescent (12-17 years) less than 50 kg:
Initially 10 mg/kg twice daily, may be increased up to 30 mg/kg twice daily.
Dose changes should not exceed increments or decrements of 10 mg/kg two times daily twice weekly
891 Levetiracetam 100mg/ml Injection N03AX14-000-P30-01-XXX A* i) Monotherapy therapy in the treatment of partial onset seizures with or without secondary generalization in patients from age 16 years of age with newly diagnosed epilepsy
ii) Adjunctive treatment in partial onset seizures with or without secondary generalization in adults and children from 4 years of age with epilepsy; juvenile myoclonic epilepsy and idiopathic generalized tonic clonic epilepsy from 12 years of age		 To be initiated when conventional IV antiepileptic drugs failed to achieve control, or oral form is temporarily not feasible in seizure emergencies i) ADULTS and ADOLESCENT (from 16 years):
Starting dose: 250 mg twice daily, Increase dose to 500 mg twice daily after 2 week.
Dose can be further increased by 250 mg twice daily every 2 weeks depending upon the clinical response. Max: 1500 mg twice daily.

ii) ADULT more than 18 years and ADOLESCENT (12 to 17 years) more than or equal to 50 kg:
Initially 500 mg twice daily may be increased up to 1500 mg twice daily. Dose changes can be made in 500 mg twice daily increments or decrements 2 to 4 weekly.
CHILD (4 to 11 years) and ADOLESCENT (12 to 17 years) less than 50 kg : Initially 10 mg/kg twice daily, may be increased up to 30 mg/kg twice daily. Dose changes should not exceed increments or decrements of 10 mg/kg twice daily every 2 weeks.
CHILD more than or equal to 50 kg: Adult dose
892 Levetiracetam 250 mg Tablet N03AX14-000-T10-01-XXX A* i) Monotherapy therapy in the treatment of partial onset seizures with or without secondary generalization in patients from age 16 years of age with newly diagnosed epilepsy ii) Adjunctive treatment in partial onset seizures with or without secondary generalization in adults and children from 4 years of age with epilepsy; juvenile myoclonic epilepsy and idiopathic generalized tonic clonic epilepsy from 12 years of age i) Monotherapy ADULTS and ADOLESCENT (from 16 years):
Starting dose: 250 mg twice daily, Increase dose to 500 mg twice daily after 2 week.
Dose can be further increased by 250 mg twice daily every 2 week depending upon the clinical response. Max: 1500 mg twice daily.

ii) ADULT more than 18 years and ADOLESCENT (12-17 years) more than or equal to 50 kg:
Initially 500 mg twice daily may be increased up to 1500 mg twice daily. Dose changes can be made in 500 mg twice daily increments or decrements 2-4 weekly.
CHILD (4-11 years) and ADOLESCENT (12-17 years) less than 50 kg:
Initially 10 mg/kg twice daily, may be increased up to 30 mg/kg twice daily.
Dose changes should not exceed increments or decrements of 10 mg/kg twice daily every 2 weeks.
CHILD more than or equal to 50 kg: Adult dose
893 Levetiracetam 500 mg Tablet N03AX14-000-T10-02-XXX A* i) Monotherapy therapy in the treatment of partial onset seizures with or without secondary generalization in patients from age 16 years of age with newly diagnosed epilepsy
ii) Adjunctive treatment in partial onset seizures with or without secondary generalization in adults and children from 4 years of age with epilepsy; juvenile myoclonic epilepsy and idiopathic generalized tonic clonic epilepsy from 12 years of age		 None i) Monotherapy ADULTS and ADOLESCENT (from 16 years):
Starting dose: 250 mg twice daily, Increase dose to 500 mg twice daily after 2 week.
Dose can be further increased by 250 mg twice daily every 2 week depending upon the clinical response. Max: 1500 mg twice daily.

ii) ADULT more than 18 years and ADOLESCENT (12-17 years) more than or equal to 50 kg:
Initially 500 mg twice daily may be increased up to 1500 mg twice daily.
Dose changes can be made in 500 mg twice daily increments or decrements 2-4 weekly. CHILD (4-11 years) and ADOLESCENT (12-17 years) less than 50 kg : Initially 10 mg/kg twice daily, may be increased up to 30 mg/kg twice daily. Dose changes should not exceed increments or decrements of 10 mg/kg twice daily every 2 weeks.
CHILD more than or equal to 50 kg: Adult dose
894 Levobupivacaine 5mg/ml Injection N01BB10-110-P30-01-XXX A Production of local or regional anesthesia for surgery and obstetrics, and for postoperative pain management None Surgical anesthesia : Lumber epidural : 10 - 20 ml (50 - 150 mg) , caesarean section : 15 - 30 ml (75 - 150 mg), intrathecal: 3 ml (15 mg), peripheral nerve block : 1 - 40 ml, ilioinguinal/iliohypogastric block. CHILD : 0.25 - 0.5 ml/kg (1.25-2.5 mg/kg)
895 Levocetirizine Dihydrochloride 5mg Tablet R06AE09-110-T10-01-XXX A* Symptomatic treatment of allergic rhinitis (including persistent allergic rhinitis) and chronic idopathic urticaria None Children above 12 years and adults: 5 mg orally once daily (Swallow whole, do not chew/crush).
896 Levodopa 100 mg and Carbidopa 25 mg Tablet N04BA02000T1001XX B Parkinson's disease Patients not receiving Levodopa before, initially 100 - 125 mg 3 - 4 times daily adjusted according to response. Maintenance: 0.75 - 2 g in divided doses. In patients previously treated with Levodopa the dose should be about 20 - 25% of the dose previously being taken
897 Levodopa 100 mg, Benserazide 25 mg HBS capsule N04BA02977C1001XX B Parkinson's Disease Initial: 100/25 mg 1-2 times/day, increase every 3-4 days until therapeutic effect, optimal dosage: 400/100 mg to 800/200 mg/day divided into 4-6 doses. Dose: 200/50 mg used only when maintenance therapy is reached and not to exceed levodopa 1000-1200 mg/benserazide 250-300 mg per day
898 Levodopa 100mg, Carbidopa 25mg and Entacapone 200mg Tablet N04BA03977T1002XX A* Idiopathic Parkinson's disease The optimum daily dosage must be determined by careful titration of levodopa in each patient. The daily dose should preferably be optimised using 1 of the 4 available tablet strengths (50/12.5/200mg, 100/25/200mg, 150/37.5/200mg or 200/50/200mg levodopa/carbidopa/entacapone). Patients should be instructed to take only 1 tablet/dose administration. While the experience with total daily dosage >200 mg carbidopa is limited, the maximum recommended daily dose of entacapone is 2000 mg and therefore the maximum dose, for the strengths of 50/12.5/200 mg, 100/25/200 mg and 150/37.5/200 mg, is 10 tablets/day. Ten (10) tablets of the strength 150/37.5/200 mg equals carbidopa 375 mg/day. Therefore, using a maximum recommended daily dose of carbidopa 375 mg, the maximum daily dose of 200/50/200 mg is 7 tablets per day. The maximum total daily levodopa dose administered should not exceed 1500 mg.
899 Levodopa 150 mg, Carbidopa 37.5 mg and Entacapone 200 mg Tablet N04BA03977T1003XX A* Idiopathic Parkinson's disease The optimum daily dosage must be determined by careful titration of levodopa in each patient. The daily dose should preferably be optimised using 1 of the 4 available tablet strengths (50/12.5/200mg, 100/25/200mg, 150/37.5/200mg or 200/50/200mg levodopa/carbidopa/entacapone). Patients should be instructed to take only 1 tablet/dose administration. While the experience with total daily dosage >200 mg carbidopa is limited, the maximum recommended daily dose of entacapone is 2000 mg and therefore the maximum dose, for the strengths of 50/12.5/200 mg, 100/25/200 mg and 150/37.5/200 mg, is 10 tablets/day. Ten (10) tablets of the strength 150/37.5/200 mg equals carbidopa 375 mg/day. Therefore, using a maximum recommended daily dose of carbidopa 375 mg, the maximum daily dose of 200/50/200 mg is 7 tablets per day. The maximum total daily levodopa dose administered should not exceed 1500 mg.
900 Levodopa 200 mg, Benserazide 50 mg Tablet N04BA02977T1001XX B Parkinson's Disease Initial: 100/25 mg 1-2 times/day, increase every 3-4 days until therapeutic effect, optimal dosage: 400/100 mg to 800/200 mg/day divided into 4-6 doses. Dose: 200/50 mg used only when maintenance therapy is reached and not to exceed levodopa 1000-1200 mg/benserazide 250-300 mg per day

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