Formulari Ubat KKM (FUKKM)

# Generic Name MDC Category Indications Pres. Restrictions Dosage
1 Chorionic Gonadotrophin Human (HCG) 5000IU Injection G03GA01-000-P40-01-XXX A* In the female:
i. Ovulation induction in subfertility due to anovulation or impaired follicle-ripening.
ii. Preparation of follicles for puncture in controlled ovarian hyperstimulation (for assisted reproductive technologies).
iii. Luteal phase support.


In the male:
iv)Hypogonadotropic hypogonadism(also cases of idiopathic dysspermias have shown a positive response to gonadotropins),
v) Delayed puberty associated with insufficient gonadotropic pituitary function
vi) cryptorchidism not due to an anatomic obstruction.
None i & ii: 5,000-10,000 IU stat once optimal stimulation of follicular growth is achieved.
iii: Up to three repeat injections of 1000 to 3000 IU may be given within 9 days following ovulation or embryo transfer (E.g.: on day 3, 6 and 9 after ovulation induction)

iv) 1000 - 2000 IU, two to three times per week
v)1500IU two to three times weekly for at least six months
vi) < 2 years of age: 250 IU twice weekly for six weeks
< 6 years of age: 500 - 1000 IU twice weekly for six weeks > 6 years of age: 1500 IU twice weekly for six weeks.

Dosing is individualised and according to product insert / protocol.
2 Erythropoietin Human Recombinant 10,000 IU Injection B03XA01-000-P50-05-XXX A* i) Treatment of anaemia associated with chronic renal failure. Dialysis patients who have haemoglobin less than 10 g/dL or are exhibiting symptoms of anaemia although haemoglobin more than 10 g/dL and pre-transplant cases

ii) Anaemia in cancer (non-myeloid malignancies) with concomitant chemotherapy
a) EPO Alfa: 150IU/kg three times weekly or 40,000IU once weekly

b) EPO Beta: 450IU/kg once weekly or 30,000 IU once weekly

Dosing is according to product insert.
3 Erythropoietin Human Recombinant 1000 IU Injection B03XA01-000-P50-01-XXX A* i) Treatment of anaemia associated with chronic renal failure. Dialysis patients who have haemoglobin less than 10 g/dL or are exhibiting symptoms of anaemia although haemoglobin more than 10 g/dL and pre-transplant cases

ii) Anaemia in cancer (non-myeloid malignancies) with concomitant chemotherapy
a) EPO Alfa: 150IU/kg three times weekly or 40,000IU once weekly

b) EPO Beta: 450IU/kg once weekly or 30,000 IU once weekly

Dosing is according to product insert.
4 Erythropoietin Human Recombinant 2000 IU Injection B03XA01-000-P50-02-XXX A i) Treatment of anaemia associated with chronic renal failure. Dialysis patients who have haemoglobin less than 10 g/dL or are exhibiting symptoms of anaemia although haemoglobin more than 10 g/dL and pre-transplant cases

ii) Anaemia in cancer (non-myeloid malignancies) with concomitant chemotherapy
a) EPO Alfa: 150IU/kg three times weekly or 40,000IU once weekly

b) EPO Beta: 450IU/kg once weekly or 30,000 IU once weekly

Dosing is according to product insert.
5 Erythropoietin Human Recombinant 3000 IU Injection B03XA01-000-P50-03-XXX A* i) Treatment of anaemia associated with chronic renal failure. Dialysis patients who have haemoglobin less than 10 g/dL or are exhibiting symptoms of anaemia although haemoglobin more than 10 g/dL and pre-transplant cases

ii) Anaemia in cancer (non-myeloid malignancies) with concomitant chemotherapy
a) EPO Alfa: 150IU/kg three times weekly or 40,000IU once weekly

b) EPO Beta: 450IU/kg once weekly or 30,000 IU once weekly

Dosing is according to product insert.
6 Erythropoietin Human Recombinant 4000 IU Injection B03XA01-000-P50-04-XXX A i) Treatment of anaemia associated with chronic renal failure. Dialysis patients who have haemoglobin less than 10 g/dL or are exhibiting symptoms of anaemia although haemoglobin more than 10 g/dL and pre-transplant cases

ii) Anaemia in cancer (non-myeloid malignancies) with concomitant chemotherapy
a) EPO Alfa: 150IU/kg three times weekly or 40,000IU once weekly

b) EPO Beta: 450IU/kg once weekly or 30,000 IU once weekly

Dosing is according to product insert.
7 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.
8 Follitropin Alpha (Recombinant Human FSH) 300IU/0.5ml Injection G03GA05-000-P30-02-XXX A* For the treatment of infertility in the following clinical situations:
i. Anovulation, including polycystic ovarian syndrome (PCOS), in women who have been unresponsive to treatment with clomiphene citrate.
ii. Controlled ovarian hyperstimulation to induce the development of multiple follicles for assisted reproductive technologies (ART).
None i) 75 - 150 IU daily, should commence within the first 7 days of the menstrual cycle and increased by 37.5 IU or 75 IU at 7 or 14 days interval. Max daily dose 225 IU
ii) 150 - 225 IU daily commencing on days 2 or 3 of the cycle. Max daily dose 450 IU.

Dosing is individualised and according to product insert/protocol.
9 Follitropin Alpha (Recombinant Human FSH) 75IU Injection G03GA05-000-P30-01-XXX A* For the treatment of infertility in the following clinical situations:
i. Anovulation, including polycystic ovarian syndrome (PCOS), in women who have been unresponsive to treatment with clomiphene citrate.
ii. Controlled ovarian hyperstimulation to induce the development of multiple follicles for assisted reproductive technologies (ART).
None i) 75 - 150 IU daily, should commence within the first 7 days of the menstrual cycle and increased by 37.5 IU or 75 IU at 7 or 14 days interval. Max daily dose 225 IU
ii) 150 - 225 IU daily commencing on days 2 or 3 of the cycle. Max daily dose 450 IU.

Dosing is individualised and according to product insert/protocol
10 Follitropin Beta (Recombinant Human FSH) 300IU Injection G03GA06-000-P30-02-XXX A* In females:
For the treatment of infertility in the following clinical situations:
i. Anovulation, including polycystic ovarian syndrome (PCOS), in women who have been unresponsive to treatment with clomiphene citrate.
ii. Controlled ovarian hyperstimulation to induce the development of multiple follicles for assisted reproductive technologies (ART).

In males:
iii.Deficient spermatogenesis due to hypogonadotrophic hypogonadism.
None i. Recommended starting dose: 50 IU daily, maintaining the starting dose for at least 7 days.
ii. Recommended starting dose: 100-225IU daily, maintaining the starting dose for at least the first 4 days.
iii. 450 IU per week preferrably divided into 3 doses i.e. 150 IU three times a week (concomitantly with hCG).

Dosing is individualised and according to product insert/protocol
11 Follitropin Beta (Recombinant Human FSH) 50IU Injection G03GA06-000-P30-01-XXX A* In females:
For the treatment of infertility in the following clinical situations:
i. Anovulation, including polycystic ovarian syndrome (PCOS), in women who have been unresponsive to treatment with clomiphene citrate.
ii. Controlled ovarian hyperstimulation to induce the development of multiple follicles for assisted reproductive technologies (ART).

In males:
iii.Deficient spermatogenesis due to hypogonadotrophic hypogonadism.
None i. Recommended starting dose: 50 IU daily, maintaining the starting dose for at least 7 days.
ii. Recommended starting dose: 100-225IU daily, maintaining the starting dose for at least the first 4 days.
iii. 450 IU per week preferrably divided into 3 doses i.e. 150 IU three times a week (concomitantly with hCG).

Dosing is individualised and according to product insert/protocol.
12 Human Albumin Injection B05AA01000P3001XX B i) Acute hypovolemic shock
ii) Hypoproteinaemia
iii) Restoration and maintenance of circulating blood volume in cases of volume deficiency where the use of a colloid is indicated.
Dosing is according to product insert/ protocol.
13 Human Normal Globulin Injection J06BA02-000-P30-01-XXX A i. Replacement therapy such as:
a) Primary immunodeficiency syndromes
b) Severe secondary hypogammabulinaemia and recurrent infections
c) Congenital or acquired immune deficiency syndrome with recurrent infections
d) Allogeneic haematopoietic stem cell transplantation (HSCT)

ii. Immunomodulation such as:
a) Immune thrombocytopenic purpura (ITP) in children or adults at high risk of bleeding or prior to surgical interventions to correct the platelet count
b) Guillain-Barre syndrome
c) Kawasaki disease
0.2-2g/kg as required

Dosing and frequency of administration are according to product insert and protocol.
14 Human Papillomavirus (Types 16, 18) Vaccine Injection J07BM02000P3001XX C+ For the prevention of cervical cancer due to papilloma virus. To be used as part of NIP only. Given by IM into deltoid region. ADULT and CHILD 10 - 25 years, 3 doses of 0.5 mL, at 0, 1 and 6 months
15 Human Papillomavirus (Types 6, 11, 16, 18) Vaccine Injection J07BM01000P3001XX C+ For the prevention of cervical cancer due to papilloma virus. To be used as part of NIP only. Given by IM into deltoid region or higher anterolateral thigh. ADULT and CHILD 9 - 26 years, 3 doses of 0.5 mL, at 0, 2 and 6 months
16 Immunoglobulin Tetanus Human 250 Units/Vial Injection J06BB02000P3001XX B Passive immunization against tetanus Prophylaxis of tetanus: IM 250 units. Treatment of tetanus: IM 30 - 300 units/kg
17 Insulin Recombinant Neutral Human Short Acting 100 IU/ml Injection in 10ml vial A10AB01000P3001XX B Diabetes mellitus Dose to be individualised. The average daily insulin requirement is between 0.3-1.0 units/kg body weight/day. Daily insulin requirement may be higher in patients with insulin resistance, and lower in patients with residual, endogenous insulin production.
18 Insulin Recombinant Neutral Human Short-acting 100IU/ml Penfill and Refill A10AB01000P5001XX B Diabetes mellitus Dose to be individualised. The average daily insulin requirement is between 0.3-1.0 units/kg body weight/day. Daily insulin requirement may be higher in patients with insulin resistance, and lower in patients with residual, endogenous insulin production.
19 Insulin Recombinant Synthetic Human Intermediate-Acting 100IU/ml in Vial for Injection A10AC01000P3001XX B Diabetes mellitus Dose to be individualised. The daily insulin requirement is usually between 0.3 and 1.0IU/kg /day
20 Insulin Recombinant Synthetic Human Premixed 100IU/ml in Vial for Injection A10AD01000P3001XX B Diabetes mellitus Dose to be individualised. The average daily insulin requirement is between 0.3-1.0 units/kg body weight/day. Daily insulin requirement may be higher in patients with insulin resistance, and lower in patients with residual, endogenous insulin production.