Formulari Ubat KKM (FUKKM)

# Generic Name MDC Category Indications Pres. Restrictions Dosage
601 Ethinylestradiol 20mcg & Drospirenone 3mg Tablet G03AA12-954-T10-02-XXX A* i)Oral contraception
ii)Treatment of acne vulgaris in women seeking oral contraception.
iii) Treatment of symptoms of premenstrual dysphoric disorder (PMDD) in women who choose to use an oral contraceptive as their method of contraception.		 None 1 tab daily for 28 consecutive days starting on 1st day of menstrual bleeding.
602 Ethinylestradiol 20mcg & Levonorgestrel 100mcg Tablet G03AA07-954-T10-02-XXX A/KK i) Oral Contraceptive.
ii) Treatment of moderate acne vulgaris not controlled by conventional therapy (e.g. topical preparations and oral antibiotics) in post-menarchal, premenopausal women more than or 14 years who accept contraception.		 None 1 tablet daily for 21 consecutive days, followed by a 7 -day tablet free interval before the next pack is started
603 Ethionamide 250mg Tablet J04AD03-000-T10-01-XXX A* As second-line therapy in the treatment of Multi Drug Resistant Tuberculosis only in combination with other efficacious agents and only when therapy with isoniazid, rifampicin, or other first-line agents has failed. None ADULT: 15-20mg/kg daily, in divided doses if necessary; maximum dose 1g/day. CHILD: 10-20mg/kg in 2-3 divided doses or 15mg/kg/24hrs as a single daily dose.
604 Ethyl Chloride 100ml Spray N01BX01000A4001XX C For minor surgical procedures including lancing boils, incision and drainage of small abscesses, pain due to athletic injuries and pain due to injection administration Spray to affected area at a distance of about 30cm until a fine white film is produced
605 Etomidate 20 mg/10 ml Injection N01AX07000P3001XX A* Induction of general anaesthesia for haemodynamically unstable patients Adult: 300 mcg/kg given slowly over 30-60 seconds into a large vein in the arm. Child: Up to 30% more than the standard adult dose. Elderly: 150-200 mcg/kg, subsequently adjusted according to effects.
606 Etonogestrel 68mg Implant G03AC08-000-P10-01-XXX A/KK Contraception None Subdermal insertion: A single implant is effective for 3 years (to be removed 3 years from the date of insertion)
607 Etoposide 100 mg/5 ml Injection L01CB01000P3001XX A* i) For treatment of children with solid tumours, juvenile myelomonocytic leukemia (JMML) and Langerhan cell histiocytosis
ii) Leukaemia, lymphoma
iii) solid tumour		 i) CHILD: 60-120 mg/m2/day by IV for 3 - 5 days every 3 - 6 weeks depending on protocols
ii) Maintenance or palliative chemotherapy for elderly acute myeloid leukemia, consolidation therapy for acute lymphoblastic leukemia, stem cell mobilization (Refer to protocol)
iii) 100 mg/m2 by IV every other day for 3 doses repeated every 3-4 weeks
608 Etoposide 50mg capsule L01CB01000C1003XX A* Treatment of small cell lung cancer and malignant lymphomas Normal adult dose is 175mg-200mg daily for 5 consecutive days orally, followed by recession (withdrawal) interval of 3 weeks. Repeat administration as necessary. Increase or reduce dose as appropriate, according to the particular disease or symptoms.
609 Etoricoxib 120 mg Tablet M01AH05000T1002XX A* i)Acute and chronic treatment of signs and symptoms of osteoarthritis (OA) and rheumatoid arthritis (RA) ii)Acute gouty arthritis iii)Acute pain i) OA: 60 mg once daily. RA: 90 mg once daily ii & iii) Acute gouty arthritis and acute pain: 120 mg once daily (Given the exposure to COX-2 inhibitors, doctors are advised to use the lowest effective dose for the shortest possible duration of treatment)
610 Etoricoxib 60 mg Tablet M01AH05000T1003XX A* i)Acute and chronic treatment of signs and symptoms of osteoarthritis (OA) and rheumatoid arthritis (RA)
ii)Acute gouty arthritis
iii)Acute pain		 i) OA: 60 mg once daily. RA: 60mg once daily and may be increased to 90mg once daily if needed.Once the patient is stabilized, down-titration to 60mg once daily may be appropriate.
ii & iii) Acute gouty arthritis and acute pain: 120 mg once daily (Given the exposure to COX-2 inhibitors, doctors are advised to use the lowest effective dose for the shortest possible duration of treatment)
611 Etoricoxib 90 mg Tablet M01AH05000T1001XX A/KK i)Acute and chronic treatment of signs and symptoms of osteoarthritis (OA) and rheumatoid arthritis (RA) ii)Acute gouty arthritis iii)Acute pain i) OA: 60 mg once daily. RA: 60mg once daily and may be increased to 90mg once daily if needed.Once the patient is stabilized, down-titration to 60mg once daily may be appropriate.
ii & iii) Acute gouty arthritis and acute pain: 120 mg once daily (Given the exposure to COX-2 inhibitors, doctors are advised to use the lowest effective dose for the shortest possible duration of treatment)
612 Everolimus 0.25mg tablet L04AA18000T1001XX A* Indicated for the prophylaxis of organ rejection in adult patients at low to moderate immunological risk receiving an allogeneic renal or cardiac transplant in combination with ciclosporin for microemulsion and corticosteroids. An initial dose regimen of 0.75 mg b.i.d., which is recommended for the general kidney and heart transplant population. The daily dose of everolimus should always be given orally in two divided doses (b.i.d.).
613 Everolimus 0.75mg tablet L04AA18000T1003XX A* Indicated for the prophylaxis of organ rejection in adult patients at low to moderate immunological risk receiving an allogeneic renal or cardiac transplant in combination with ciclosporin for microemulsion and corticosteroids. An initial dose regimen of 0.75 mg b.i.d., which is recommended for the general kidney and heart transplant population. The daily dose of everolimus should always be given orally in two divided doses (b.i.d.).
614 Evolocumab 140 mg/mL Pre-filled Autoinjector C10AX13-000-P30-01-xxx A* Evolocumab is indicated as an adjunct to diet and standard of care therapy (including moderate- to high-intensity statin therapy alone or in combination with other lipid-lowering therapy), to reduce the risk of myocardial infarction, stroke, and coronary revascularization in adult patients with atherosclerotic cardiovascular disease. 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 subcutaneous dosage of evolocumab is either 140 mg every 2 weeks OR 420 mg once monthly.
615 Exemestane 25 mg Tablet L02BG06000T1001XX A* Treatment of post-menopausal women with advanced breast cancer whose disease has progressed following tamoxifen and non-steroidal aromatase inhibitors 25 mg once daily
616 Ezetimibe 10 mg Tablet C10AX09000T1001XX A/KK i) Co-administration with statins for patients who have chronic heart disease or are chronic heart disease equivalent or familial hypercholesterolaemia with target LDL-C not achieved by maximum dose of statins ii) Monotherapy in patients with documented biochemical intolerance to statins None 10 mg once daily. Not recommended for children less than 10 years old
617 Ezetimibe 10mg & Simvastatin 20mg Tablet C10BA02-000-T10-01-XX A* Primary hypercholesterolemia None Usual starting dose: 10/20 mg/day
618 Ezetimibe 10mg & Simvastatin 40mg Tablet C10BA02-000-T10-03-XX A* Primary hypercholesterolemia None Usual starting dose: 10/20 mg/day
619 Factor IX Injection B02BD04-000-P99-01-XXX A Prevention and control of bleeding in patients with factor IX deficiency due to haemophilia B Number of factor IX units required =
body weight (kg) x desired factor IX increase (%) x 1.0 IU/kg
Dosing is individualised and according to product insert/protocol.
620 Factor IX, Factor II & Factor X in combination 500IU/vial injection B02BD01000P4002XXX A* i) Treatment and perioperative prophylaxis of bleeding in acquired deficiency of prothrombin complex factors, such as deficiency caused by treatment with vitamin K antagonists, or in case of overdose of vitamin K antagonists, when rapid correction of the deficiency is required.
ii) Treatment and prophylaxis of bleeding in patients with single or multiple congenital deficiencies of factor IX, II or X when purified specific coagulation factor product is not available.

Cautionary Notes:
i) in serious life threatening haemorrhage, or if urgent immediate clinical requirement for reversal of anticoagulated state is required (especially if baseline INR >4), a 3-factor PCC lacking factor VII may not be as effective as 4-factor PCC in providing timely haemostasis.
ii) The use of pure factor IX concentrates is recommended for the treatment of Haemophilia B (factor IX deficiency) as opposed to PCC in view of risks of thrombosis or disseminated intravascular coagulation (DIC). PCC should not be used in patients with inhibitors.		 25 – 50 IU/kg, depending on the INR
621 Factor IX, Factor II, Factor VII and Factor X In Combination Injection B02BD01000P4001XX A* i) Treatment and perioperative prophylaxis of bleeding in acquired deficiency of the prothrombin complex coagulation factors, such as deficiency caused by treatment with vitamin K antagonists, or in case of overdose of vitamin K antagonists, when rapid correction of the deficiency is required. ii) Treatment and perioperative prophylaxis of bleeding in congenital deficiency of any of the vitamin K dependent coagulation factors only if purified specific coagulation factor product is not available. Amount and frequency of administration should be calculated on an individual patient basis. Individual dosage requirements can only be identified on the basis of regular determinations of the individual plasma levels of the coagulation factors of interest or on the global tests of the prothrombin complex levels (INR, Quick's test) and a continuous monitoring of the clinical condition of the patient. An approximate calculation is as follows: Required dose (IU) = body weight (kg) x desired factor rise (IU/dl or % of normal) x reciprocal of the estimated recovery, i.e. Factor II = 53 Factor VII = 59 Factor IX = 77 Factor X = 56 As product may differ from one to another, it is strongly advised to refer to the manufacturer (product insert) in regards to dosing calculation.
622 Factor VIIa (Recombinant) eptacog alfa (activated) 100 KIU (2 mg) Injection B02BD08000P4005XX A* Treatment of bleeding episodes and prevention of excessive bleeding in connection with surgery in patients with inherited or acquired haemophilia with inhibitors to coagulation factors VIII or IX Initially 4.5 KIU (90 mcg)/kg body weight IV bolus over 2-5 minutes, followed by 3-6 KIU (60-120 mcg)/kg body weight depending on type & severity of haemorrhage or surgery performed. Dosing interval: initially 2-3 hour to obtain haemostasis and until clinically improved. If continued therapy is needed, dose interval can be increased successively to every 4, 6, 8 or 12 hours
623 Factor VIIa (Recombinant) eptacog alfa (activated) 50 KIU (1 mg) Injection B02BD08000P4004XX A* Treatment of bleeding episodes and prevention of excessive bleeding in connection with surgery in patients with inherited or acquired haemophilia with inhibitors to coagulation factors VIII or IX Initially 4.5 KIU (90 mcg)/kg body weight IV bolus over 2-5 minutes, followed by 3-6 KIU (60-120 mcg)/kg body weight depending on type & severity of haemorrhage or surgery performed. Dosing interval: initially 2-3 hour to obtain haemostasis and until clinically improved. If continued therapy is needed, dose interval can be increased successively to every 4, 6, 8 or 12 hours
624 Factor VIII (Human blood coagulation factor) & Von Willebrand factor Injection B02BD06000P4002XX A* i)The treatment and prophylaxis of haemorrhage or surgical bleeding in Von Willebrand Disease (VWD) when 1-deamino-8-D-arginine vasopressin (desmopressin, DDAVP) treatment alone is ineffective or contraindicated. ii)The treatment and prophylaxis of bleeding associated with factor VIII deficiency due to haemophilia A. i. Von Willebrand Disease: Spontaneous Bleeding Episodes: Initially, factor VIII 12.5-25 IU/kg and ristocetin cofactor 25-50 IU/kg followed by factor VIII 12.5 IU/kg and ristocetin cofactor 25 IU/kg subsequently every 12-24 hrs. Minor Surgery: Factor VIII 30 IU/kg and ristocetin cofactor 60 IU/kg daily. Major Surgery: Initially, factor VIII 30-40 IU/kg and ristocetin cofactor 60-80 IU/kg followed by factor VIII 15-30 IU/kg and ristocetin cofactor 30-60 IU/kg subsequently every 12-24 hrs. Prophylaxis: Factor VIII 12.5-20 IU/kg and ristocetin cofactor 25-40 IU/kg 3 times weekly. ii. Hemophilia A therapy: Minor haemorrage: 10-15 IU/kg every 12-24 hours. Moderate to severe haemorrhage: 15-40 IU/kg every 8 to 24 hours. Minor surgery: Loading dose 20-30 IU/kg, maintenance dose 15-30 IU/kg. Major surgery: Loading dose 40-50 IU/kg, maintenance dose 10-40 IU/kg. Prophylaxis: 25-40 IU/kg three times weekly As product may differ from one to another, it is strongly advised to refer to the manufacturer (product insert) in regards to dosing calculation.
625 Factor VIII Inhibitor Bypassing Activity Injection B02BD03000P4001XX A i)Treatment and prophylaxis of hemorrhages in hemophilia A and B patients with inhibitors.
ii) Treatment and prophylaxis of hemorrhages in non-hemophilic patients who have developed inhibitors to Factors VIII, IX and XI.
iii)Treatment of patients with acquired inhibitors to Factors X and XIII.
iv)In the combination with Factor VIII concentrate for a long-term therapy to achieve a complete and permanent elimination of the Factor VIII inhibitor so as to allow for regular treatment with Factor VIII concentrate as in patients without inhibitor.		 As a general guideline, a dose of 50 to 100IU/kg body weight is recommended, not exceeding an individual dose of 100IU/kg bw and a maximum daily dose of 200IU/kg bw.
626 Factor VIII Injection B02BD02999P9901XX A Prevention and control of bleeding in patients with factor VIII deficiency due to classical haemophilia A Dose varies according to the patient and the circumstances of the bleeding. i) Mild to moderate: Usually a single dose of 10-15units/kg. ii) More serious haemorrhage/minor surgery:Initially 15-25 units/kg followed by 10-15 units/kg every 8 - 12 hours if required iii) Severe haemorrhage/major surgery: Initial : 40 - 50 units/kg followed by 20 - 25 units/kg every 8-12 hrs.
627 Famotidine 20mg Film-Coated Tablet A02BA03-000-T10-01-XXX B i) Duodenal and gastric ulcer
ii) Gastro Esophageal Reflux Disease (GERD)
iii) Zollinger Ellison Syndrome		 None i) Duodenal ulcer: 40 mg once daily at bedtime or 20 mg 2 times daily. Gastric ulcer: 40 mg once daily at bedtime.

ii) Gastro-oesophageal reflux: Oral, 20 mg 2 times daily for up to 6 weeks. The recommended oral dose for oesophagitis due to gastro-oesophageal reflux disease is 20 to 40 mg 2 times daily for up to 12 weeks.

iii) Gastric hypersecretory conditions (eg. Zollinger-Ellison syndrome): Oral, 20 mg every 6 hours, the dosage being adjusted as needed and therapy continued for as long as clinically indicated. Doses up to 160 mg every 6 hours have been administered to some patients with severe Zollinger Ellison syndrome.
628 Famotidine 40mg Film-Coated Tablet A02BA03-000-T10-02-XXX B i) Duodenal and gastric ulcer
ii) Gastro Esophageal Reflux Disease (GERD)
iii) Zollinger Ellison Syndrome		 None i) Duodenal ulcer: 40 mg once daily at bedtime or 20 mg 2 times daily. Gastric ulcer: 40 mg once daily at bedtime.

ii) Gastro-oesophageal reflux: Oral, 20 mg 2 times daily for up to 6 weeks. The recommended oral dose for oesophagitis due to gastro-oesophageal reflux disease is 20 to 40 mg 2 times daily for up to 12 weeks.

iii) Gastric hypersecretory conditions (eg. Zollinger-Ellison syndrome): Oral, 20 mg every 6 hours, the dosage being adjusted as needed and therapy continued for as long as clinically indicated. Doses up to 160 mg every 6 hours have been administered to some patients with severe Zollinger Ellison syndrome.
629 Faricimab 6mg/0.05ml Solution for Intravitreal Injection S01LA09-000-P30-01-xxx A* i. Treatment of adult patients with neovascular (wet) age-related macular degeneration (nAMD).
ii. Treatment of adult patients with diabetic macular edema (DME)		 Indication i & ii:
1. No cardiovascular or thromboembolic event at least 3 months prior
2. No ocular/systemic infection 3 months prior
3. To be prescribed by Ophthalmologist only
Indication i:
The recommended dose is 6 mg (0.05 mL solution) administered by intravitreal injection every 4 weeks (monthly) for the first 3 doses.

Thereafter, an assessment of disease activity based on anatomic and/or visual outcomes is recommended 16 and/or 20 weeks after treatment initiation so that treatment can be individualised. In patients without disease activity, administration of faricimab every 16 weeks (4 months) should be considered. In patients with disease activity, treatment every 8 weeks (2 months) or 12 weeks (3 months) should be considered. There is limited safety data on treatment intervals of 8 weeks or less between injections.

Indication ii:
The recommended dose is 6 mg (0.05 mL solution) administered by intravitreal injection every 4 weeks (monthly); 3 or more consecutive, monthly injections may be needed.

Thereafter, treatment is individualised using a treat-and-extend approach. Based on the physician’s judgement of the patient’s anatomic and/or visual outcomes, the dosing interval may be extended, in increments of up to 4 weeks. If anatomic and/or visual outcomes change, the treatment interval should be adjusted accordingly, and interval reduction should be implemented if anatomic and/or visual outcomes deteriorate. Treatment intervals shorter than 4 weeks and longer than 4 months between injections have not been studied.
630 Fat Emulsion 10% for IV Infusion Injection B05BA02000P6001XX A Source of lipid in patients needing IV nutrition Dose to be individualised. ADULT usual lipid requirement 2-3 g/kg/day. INFANT 0.5 - 1 g/kg/day

Halaman-halaman