Coagulation Factors Prescription rules

INN Tradename Dispensing rule Prescription rule

Treatment of bleeding episodes and perioperative management for
Recombinant Under direct patients with:
NovoSeven 1 mg
coagulation factor medical • Factor VII deficiency
vial
VIIa (Eptacog Alfa) supervision only • Glanzman thrombasthenia
• Hemophilia A with inhibitors
Plasma-derived Under direct
BERIATE 500 I.U ml Treatment of bleeding episodes and perioperative management of patients
Coagulation Factor medical
vial with Hemophilia A
VIII supervision only
Plasma-derived Under direct
Koate DVI 500 IU Treatment of bleeding episodes and perioperative management of patients
Coagulation Factor medical
vial with Hemophilia A
VIII supervision only
Factor VIII inhibitor
Under direct
bypassing fraction Feiba 500 I.U./10 ml Treatment of bleeding episodes and perioperative management in patients
medical
(anti-inhibitor vial with Hemophilia A with inhibitors
supervision only
coagulant complex)
Factor VIII inhibitor
Under direct
bypassing fraction Feiba 1000 I.U./20 Treatment of bleeding episodes and perioperative management in patients
medical
(anti-inhibitor ml vial with Hemophilia A with inhibitors
supervision only
coagulant complex)
Plasma-derived
Under direct
Coagulation Factor Immunate 500/375 Treatment of bleeding episodes and perioperative management in patients
medical
VIII + Human Von I.U./5ml vial with Hemophilia A and von Willebrand deficiency (VWD)
supervision only
Willebrand Factor
Plasma-derived
fanhdi FVIII 500 Under direct
Coagulation Factor Treatment of bleeding episodes and perioperative management in patients
IU/600 I.U VWF 10 medical
VIII + Human Von with Hemophilia A and von Willebrand deficiency (VWD)
ml supervision only
Willebrand Factor
Regular prophylaxis of severe/moderate (with severe bleeding phenotype)
Hemophilia A with elevated inhibitor levels in the following cases:
- Late Secondary prophylaxis after two or more joint bleeds positive target
joint with no osteochondral disease documented by physical examination
Outpatient
Recombinant and /or imaging study.
NovoEight 500 IU - dispensing for self
Factor 8 (VIII) - Tertiary prophylaxis after onset of joint disease documented by physical
Prefilled Syringe administration
Turoctocog alfa examination and plain radiographs.
allowed
Only Prescribed by a Hematology Consultant

Pre-authorization is issued once and renewed annually

Regular prophylaxis of severe/moderate (with severe bleeding phenotype)
Hemophilia A with elevated inhibitor levels in the following cases:
- Late Secondary prophylaxis after two or more joint bleeds positive target
joint with no osteochondral disease documented by physical examination
Outpatient
Recombinant and /or imaging study.
Xyntha 250 IU - dispensing for self
Factor 8 (VIII) - Tertiary prophylaxis after onset of joint disease documented by physical
Prefilled Syringe administration
Moroctocog Alfa examination and plain radiographs.
allowed
Only Prescribed by a Hematology Consultant

Pre-authorization is issued once and renewed annually

Regular prophylaxis of severe/moderate (with severe bleeding phenotype)
Hemophilia A with elevated inhibitor levels in the following cases:
- Late Secondary prophylaxis after two or more joint bleeds positive target
Outpatient
Recombinant joint with no osteochondral disease documented by physical examination
Xyntha 500 IU - dispensing for self
Factor 8 (VIII) and /or imaging study.
Prefilled Syringe administration
Moroctocog Alfa - Tertiary prophylaxis after onset of joint disease documented by physical
allowed
examination and plain radiographs.

Only Prescribed by a Hematology Consultant

 Pre-authorization is issued once and renewed annually
Regular prophylaxis of severe/moderate (with severe bleeding phenotype)
Hemophilia A with elevated inhibitor levels in the following cases:
- Late Secondary prophylaxis after two or more joint bleeds positive target
joint with no osteochondral disease documented by physical examination
Outpatient
Recombinant and /or imaging study.
Xyntha 1000 IU - dispensing for self
Factor 8 (VIII) - Tertiary prophylaxis after onset of joint disease documented by physical
Prefilled Syringe administration
Moroctocog Alfa examination and plain radiographs.
allowed
Only Prescribed by a Hematology Consultant

Pre-authorization is issued once and renewed annually

Outpatient • Regular prophylaxis of severe/moderate (with severe bleeding
Recombinant
BeneFIX 250 I.U/ 10 dispensing for self phenotype) Hemophilia B
coagulation factor
ml vial administration • Treatment of bleeding episodes and perioperative management in
IX (Nonacog alfa)
allowed patients with hemophilia B
Outpatient • Regular prophylaxis of severe/moderate (with severe bleeding
Recombinant phenotype) Hemophilia B
BeneFIX 500 I.U/5 dispensing for self
coagulation factor
IX (Nonacog alfa)
ml vial administration • Treatment of bleeding episodes and perioperative management in
allowed patients with hemophilia B
Outpatient • Regular prophylaxis of severe/moderate (with severe bleeding
Recombinant phenotype) Hemophilia B
Benefix 1000 I.U./ dispensing for self
coagulation factor
IX (Nonacog alfa)
10 ml vial administration • Treatment of bleeding episodes and perioperative management in
allowed patients with hemophilia B
Regular prophylaxis of severe/moderate (with severe bleeding phenotype)
Hemophilia A with elevated inhibitor levels in the following cases:
- Primary prophylaxis after the first joint bleed, before any occurrence of
osteochondral change in joint (in the absence of documented joint disease
Outpatient
determined by physical examination and/ or imaging study)
Hemlibra 30 mg/ml dispensing for self
Emicizumab - Early secondary prophylaxis: two or more bleeds / no joint damage / no
vial administration
target joint affection (3 or more bleeds in the same joint during 6 months)
allowed
Only Prescribed by a Hematology Consultant

Pre-authorization is issued once and renewed annually

Regular prophylaxis of severe/moderate (with severe bleeding phenotype)
Hemophilia A with elevated inhibitor levels in the following cases:
- Primary prophylaxis after the first joint bleed, before any occurrence of
osteochondral change in joint (in the absence of documented joint disease
Outpatient
determined by physical examination and/ or imaging study)
Hemlibra 60 dispensing for self
Emicizumab - Early secondary prophylaxis: two or more bleeds / no joint damage / no
mg/0.4ml vial administration
target joint affection (3 or more bleeds in the same joint during 6 months)
allowed
Only Prescribed by a Hematology Consultant

Pre-authorization is issued once and renewed annually

Regular prophylaxis of severe/moderate (with severe bleeding phenotype)
Hemophilia A with elevated inhibitor levels in the following cases:
- Primary prophylaxis after the first joint bleed, before any occurrence of
osteochondral change in joint (in the absence of documented joint disease
Outpatient
determined by physical examination and/ or imaging study)
Hemlibra 105 dispensing for self
Emicizumab - Early secondary prophylaxis: two or more bleeds / no joint damage / no
mg/0.7ml vial administration
target joint affection (3 or more bleeds in the same joint during 6 months)
allowed
Only Prescribed by a Hematology Consultant

Pre-authorization is issued once and renewed annually