Formulari Ubat KKM (FUKKM)

# Generic Name MDC Category Indications Pres. Restrictions Dosage
1621 Typhoid Vaccine Capsule J07AP01000C1001XX B Active immunization against typhoid fever in adult and child 6 years of age or older ADULT and CHILD 6 years of age or older, 1 capsule on days 1, 3 and 5
1622 Typhoid Vaccine Injection J07AP02000P3001XX B Active immunization against typhoid fever in adult and child more than 2 years 0.5 ml single IM injection into the deltoid or vastus lateralis, may reimmunize with 0.5 ml IM every 3 years if needed.
1623 Ulipristal Acetate 30mg Tablet G03AD02-122-T10-01-XXX A Emergency contraception within 120 hours (5 days) of unprotected sexual intercourse for sexual assault victim. - 30mg orally as soon as possible, but no later than 120 hours (5 days) after unprotected sexual intercourse or contraceptive failure.
1624 Umeclidinium 62.5mcg and Vilanterol 25mcg inhalation R03AL03-989-A20-01-XXX A* Indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD). None One inhalation daily
1625 Upadacitinib 15mg Extended-Release Film Coated Tablet L04AA44-020-T50-01-XXX A* 1. Indicated for the treatment of severe atopic dermatitis in adults and adolescents 12 years and older who are candidates for systemic therapy.

2. Indicated for the treatment of active psoriatic arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more DMARDs. May be used as monotherapy or in combination with methotrexate.

3. Indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs). Upadacitinib may be used as monotherapy or in combination with methotrexate.

4. For the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent.

5. For the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent.		 Indication 1 (severe atopic dermatitis):
i. As fourth line of treatment in patients who have failed / have contraindications / experienced adverse events to: 
• Intensive and optimized topical treatment 
• Phototherapy 
• At least two immunosuppressants 
ii. To be prescribed by Dermatologists only.

Indication 2 (active psoriatic arthritis): To be prescribed by Rheumatologist only

Indication 3 (moderate to severe active rheumatoid arthritis):
i. To be prescribed after failing/ intolerance/ contraindicated to csDMARDs (as per Malaysian Consensus on Biologic Usage) and one biologic DMARDs.
ii. To be prescribed by Rheumatologist only

Indication 4 (active ulcerative colitis):
As a second line therapy and to be prescribed by gastroenterologists experienced in inflammatory bowel disease management.

Indication 5 (Crohn's disease) - None		 Indication 1 (severe atopic dermatitis):
Adults: The recommended dose of upadacitinib is 15 mg or 30 mg once daily based on individual patient presentation (Refer to package insert). The lowest effective dose for maintenance should be considered.

Adolescents (from 12 to 17 years of age): The recommended dose of upadacitinib is 15 mg once daily for adolescents weighing at least 40 kg.

Upadacitinib can be used with or without concomitant topical therapies (Refer package insert)

Indication 2 & 3 (active psoriatic arthritis & moderate to severe active rheumatoid arthritis): 15 mg once daily

Indication 4 (active ulcerative colitis):
Induction
The recommended induction dose of upadacitinib is 45 mg once daily for 8 weeks.

Maintenance
The recommended maintenance dose of upadacitinib is 15 mg or 30 mg once daily based on individual patient presentation.

Indication 5 (Crohn's disease)
Induction
The recommended induction dose of upadacitinib is 45 mg once daily for 12 weeks.

Maintenance
The recommended maintenance dose of upadacitinib is 15 mg or 30 mg once daily based on individual patient presentation.
1626 Upadacitinib 30mg Extended-Release Film Coated Tablet L04AA44-020-T50-02-xxx A* 1. For the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent.

2. For the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent.		 Indication 1 (active ulcerative colitis)
As a second line therapy and to be prescribed by gastroenterologists experienced in inflammatory bowel disease management.

Indication 2 (Crohn's disease) - None		 Indication 1 (active ulcerative colitis)
Induction
The recommended induction dose of upadacitinib is 45 mg once daily for 8 weeks.

Maintenance
The recommended maintenance dose of upadacitinib is 15 mg or 30 mg once daily based on individual patient presentation.

Indication 2 (Crohn's disease)
Induction
The recommended induction dose of upadacitinib is 45 mg once daily for 12 weeks.

Maintenance
The recommended maintenance dose of upadacitinib is 15 mg or 30 mg once daily based on individual patient presentation.

1627 Upadacitinib 45mg Extended-Release Film Coated Tablet L04AF03-020-T50-01-xxx A* 1. For the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent.

2. For the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent.		 Indication 1 (active ulcerative colitis)
As a second line therapy and to be prescribed by gastroenterologists experienced in inflammatory bowel disease management.

Indication 2 (Crohn's disease) - None		 Indication 1 (active ulcerative colitis)
Induction
The recommended induction dose of upadacitinib is 45 mg once daily for 8 weeks.

Maintenance
The recommended maintenance dose of upadacitinib is 15 mg or 30 mg once daily based on individual patient presentation.

Indication 2 (Crohn's disease)
Induction
The recommended induction dose of upadacitinib is 45 mg once daily for 12 weeks.

Maintenance
The recommended maintenance dose of upadacitinib is 15 mg or 30 mg once daily based on individual patient presentation.

1628 Urofollitropin (FSH) 150 IU Injection G03GA04-000-P30-02-XXX A* For stimulation of follicular growth in the treatment of infertility To be individualised. Initial: 75 IU-150 IU daily for 7 days and then may be increased or decreased by 75 IU/day according to follicular response.
Max : 450 IU/day. In-vitro fertilisation: Initial: 150 IU daily from Cycle Day 2 or Day 3 until sufficient follicular development is attained.
1629 Urofollitropin (FSH) 75 IU Injection G03GA04-000-P30-01-XXX A* For stimulation of follicular growth in the treatment of infertility - To be individualised. Initial: 75 IU-150 IU daily for 7 days and then may be increased or decreased by 75 IU/day according to follicular response.
Max : 450 IU/day.

In-vitro fertilisation: Initial: 150 IU daily from Cycle Day 2 or Day 3 until sufficient follicular development is attained
1630 Urokinase 250,000 IU Injection B01AD04-000-P40-04-XXX A Treatment of thromboembolic disease such as mycocardial infarction, peripheral artery occlusion, pulmonary embolism, retinal artery thrombosis and other ophthalmologic use ADULT: Acute pulmonary embolism: IV loading dose 4400 iu/kg over 10 mins, maintenance 4400 iu/kg/hour for 12 hours. Peripheral vascular occlusion: infuse 2500 iu/ml into clot at a rate of 4000 iu/min for 2 hours. This may be repeated up to 4 times. Hyphaema: 5000 IU in 2 ml saline solution is injected and withdrawn repeatedly over the iris. If residual clot remains, leave 0.3ml in the anterior chambers for 24-48 hours to facilitate futher dissolution
1631 Ursodeoxycholic Acid 250 mg Capsule A05AA02-000-C10-01-XXX A Cholestatic liver diseases (eg. primary biliary cholangitis, primary cholangitis etc.) - 10-15 mg/kg daily in 2 to 3 divided doses

Dosing is individualised based on body weight and according to product insert/protocol
1632 Ustekinumab 90 mg/ml Injection L04AC05000P3002XX A* Treatment of moderate to severe plaque psoriasis in adults who failed to, or who have contraindication to, or are intolerant to conventional systemic therapies including ciclosporin, methotrexate and photochemotherapy (PUVA). Body weight less than 100kg: Initial dose of 45 mg SC, followed by 45 mg 4 weeks later, then every 12 weeks thereafter. Body weight more than 100 kg: initial dose 90 mg SC, followed by 90 mg 4 weeks later, & then every 12 weeks thereafter.
1633 Valganciclovir 450mg Tablet J05AB14-110-T10-01-XXX A* For the prevention of cytomegalovirus (CMV) disease in CMV-negative patients who have received a solid organ transplant from a CMV-positive donor None For adult patients who have received other than kidney transplant, the recommended dose is 900 mg (two 450 mg tablets) once a day starting within 10 days of transplantation until 100 days post-transplantation. For adult patients who have received a kidney transplant, the recommended dose is 900 mg (two 450 mg tablets) once a day starting within 10 days of transplantation until 200 days post-transplantation.
1634 Valproic Acid and Sodium Valproate (ER) 500mg Tablet N03AG01-520-T50-01-XX B i) In the treatment of generalized or partial epilepsy, particularly with the following patterns of seizures:absence, myoclonic, tonic-clonic, atonic-mixed as well as, for partial epilepsy:simple or complex seizures, secondary generalized seizures, specific syndrome (West, Lennox-Gastatut).
ii) Treatment and prevention of mania associated with bipolar disorders.		 None i) Adults: Dosage should start at 500mg daily increasing by 200mg at three-day intervals until control is achieved. This is generally within the dosage range 1000mg to 2000mg per day.
Children: >20KG: 500mg/day (irrespective of weight) with spaced increases until control is achieved.

ii) Initial dose of 1000mg/day, to be increase rapidly as possible to achieve lowest therapeutic dose, which produce desired clinical effects. Recommend initial dose is 1000mg & 2000mg daily. Max dose 3000mg daily.
1635 Valsartan 160 mg and Hydrochlorothiazide 12.5 mg Tablet C09DA03935T1005XX A/KK Hypertension in patients intolerant to ACE inhibitors Initial: Valsartan/Hydrochlorothiazide 80/12.5mg once daily
Max: Valsartan/Hydrochlorothiazide 320/25mg once daily

Dosing is individualised and according to product insert / protocol.
1636 Valsartan 160 mg Tablet C09CA03000T1002XX A/KK Patients intolerant to ACE inhibitors in:
i) Heart failure
ii) Post myocardial infarction
iii) Hypertension		 i) Initial: 40mg twice daily.
Titrate up to highest tolerated dose.
Max: 320mg daily in divided doses

ii) Initial: 20mg twice daily
Titrate up to 160mg over next few weeks.
Max: 160mg twice daily

iii) 80mg or 160mg once daily
Max: 320mg daily

Dosing is individualised and according to package insert / protocol.
1637 Valsartan 80 mg and Hydrochlorothiazide 12.5 mg Tablet C09DA03-935-T10-01-XXX A/KK Hypertension in patients intolerant to ACE inhibitors Initial: Valsartan/Hydrochlorothiazide 80/12.5mg once daily
Max: Valsartan/Hydrochlorothiazide 320/25mg once daily

Dosing is individualised and according to product insert / protocol.
1638 Valsartan 80 mg Tablet C09CA03-000-T10-01-XXX A/KK Patients intolerant to ACE inhibitors in:
i) Heart failure
ii) Post myocardial infarction
iii) Hypertension		 i) Initial: 40mg twice daily.
Titrate up to highest tolerated dose.
Max: 320mg daily in divided doses

ii) Initial: 20mg twice daily
Titrate up to 160mg over next few weeks.
Max: 160mg twice daily

iii) 80mg or 160mg once daily
Max: 320mg daily

Dosing is individualised and according to package insert / protocol.
1639 Vancomycin HCl 500mg Injection J01XA01-110-P40-01-XXX A* i. Treatment of infections due to susceptible gram-positive organisms which cannot be treated with other agents (eg. MRSA and Enterococcus sp.)
ii. Treatment of severe staphylococcal infections in patients who cannot receive or who have failed to respond to the penicillins and cephalosporins.		 None Slow IV infusion.
ADULT: 15-20mg/kg q 8-12 hours, not to exceed 2gm per dose.
NEONATE up to 1 week, 15 mg/kg initially, then 10 mg/kg every 12 hours.
INFANT 1 - 4 weeks, 15 mg/kg initially then 10 mg/kg every 8 hours.
CHILD over 1 month, 10 mg/kg every 6 hours
1640 Varenicline Tartrate 0.5mg Tablet N07BA03123T1001XX A/KK Smoking cessation treatment 0.5 mg once daily for Day 1-3, then 0.5 mg twice daily for Day 4-7, then 1 mg twice daily; duration of treatment is 12 weeks
1641 Varenicline Tartrate 1mg Tablet N07BA03123T1002XX A/KK Smoking cessation treatment 0.5 mg once daily for Day 1-3, then 0.5 mg twice daily for Day 4-7, then 1 mg twice daily; duration of treatment is 12 weeks
1642 Varicella Virus Vaccine Live Attenuated Injection J07BK01000P4001XX A* Immunisation against varicella virus infection. 0.5ml by SC. Dosing is according to product insert.
1643 Vasopressin 20 units/ml Injection H01BA01000P3001XX A i) Pituitary diabetes insipidus ii) Oesophageal variceal bleeding i) 5 - 20 units SC or IM every 4 hours ii) 20 units in 100 - 200 ml 5% dextrose saline over 15 minutes as infusion which may be repeated after at intervals of 1 - 2 hours. Maximum: 4 doses
1644 Vedolizumab 300mg powder for concentrate for solution for infusion L04AA33-000-P41-01-XXX A* i) Indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to tumour necrosis factor-alpha (TNF-α) antagonist.

ii) Indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response with, lost response to, or were intolerant to tumour necrosis factor-alpha (TNFα) antagonist.		 None 300 mg administered by intravenous infusion at zero, two and six weeks and then every eight weeks thereafter.
1645 Venetoclax 100mg Film Coated Tablet L01XX52-000-T32-01-XXX A* Indicated in combination with azacitidine, or decitabine, or low dose cytarabine for the treatment of newly diagnosed acute myeloid leukaemia (AML) in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy. To be prescribed by Consultant Haematologist only. The recommended dosage and ramp-up of venetoclax depends on the combination agent. Follow the dosing schedule, including the 3-day or 4-day dose ramp-up, as following:
Day 1: 100mg,
Day 2: 200mg,
Day 3: 400mg,
Day 4 and beyond: 400mg orally once daily of each 28-day cycle in combination with azacitidine or decitabine OR 600mg orally once daily of each 28-day cycle in combination with low-dose cytarabine.
Continue venetoclax, in combination with azacitidine or decitabine or low-dose cytarabine until disease progression or unacceptable toxicity.
1646 Venetoclax 10mg Film Coated Tablet L01XX52-000-T32-02-XXX A* Indicated in combination with azacitidine, or decitabine, or low dose cytarabine for the treatment of newly diagnosed acute myeloid leukaemia (AML) in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy. To be prescribed by Consultant Haematologist only. The recommended dosage and ramp-up of venetoclax depends on the combination agent. Follow the dosing schedule, including the 3-day or 4-day dose ramp-up, as following:
Day 1: 100mg,
Day 2: 200mg,
Day 3: 400mg,
Day 4 and beyond: 400mg orally once daily of each 28-day cycle in combination with azacitidine or decitabine OR 600mg orally once daily of each 28-day cycle in combination with low-dose cytarabine.
Continue venetoclax, in combination with azacitidine or decitabine or low-dose cytarabine until disease progression or unacceptable toxicity.
1647 Venetoclax 50mg Film Coated Tablet L01XX52-000-T32-03-XXX A* Indicated in combination with azacitidine, or decitabine, or low dose cytarabine for the treatment of newly diagnosed acute myeloid leukaemia (AML) in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy. To be prescribed by Consultant Haematologist only. The recommended dosage and ramp-up of venetoclax depends on the combination agent. Follow the dosing schedule, including the 3-day or 4-day dose ramp-up, as following:
Day 1: 100mg,
Day 2: 200mg,
Day 3: 400mg,
Day 4 and beyond: 400mg orally once daily of each 28-day cycle in combination with azacitidine or decitabine OR 600mg orally once daily of each 28-day cycle in combination with low-dose cytarabine.
Continue venetoclax, in combination with azacitidine or decitabine or low-dose cytarabine until disease progression or unacceptable toxicity.
1648 Venlafaxine HCl 150 mg Extended Release Capsule N06AX16110C2002XX A* i) Depression ii) Generalized anxiety disorder iii) Social anxiety disorder (social phobia) iv) Panic disorder i), ii) & iii) ADULT: 75 mg once daily. May increase dose by 75 mg/day every 4 days to a maximum dose of 225 mg/day, (severe depression: max: 375mg/day) iv) 37.5 mg/day for the first 4-7 days after which the dose should be increased to 75 mg once daily. CHILD and ADOLESCENT under 18 years not recommended.
1649 Venlafaxine HCl 75 mg Extended Release Capsule N06AX16110C2001XX A* i) Depression
ii) Generalized anxiety disorder
iii) Social anxiety disorder (social phobia)
iv) Panic disorder		 i), ii) & iii) ADULT: 75 mg once daily. May increase dose by 75 mg/day every 4 days to a maximum dose of 225 mg/day, (severe depression: max: 375mg/day) iv) 37.5 mg/day for the first 4-7 days after which the dose should be increased to 75 mg once daily. CHILD and ADOLESCENT under 18 years not recommended
1650 Verapamil HCl 2.5 mg/ml Injection C08DA01110P3001XX A/KK Supraventricular tachycardia Initially 5-10mg given by slow IV over at least 2 minutes. The dose can be repeated 10mg 30 minutes after the first dose if the initial response is not adequate.

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