NovoEight

NovoEight

Manufacturer:

Novo Nordisk
Concise Prescribing Info
Contents
Turoctocog α [human coagulation factor VIII (rDNA)]
Indications/Uses
Treatment & prophylaxis of bleeding in patients of all age groups w/ haemophilia A (congenital factor VIII deficiency).
Dosage/Direction for Use
IV On-demand treatment: Required IU: body wt (kg) x desired factor VIII rise (%) (IU/dL) x 0.5 (IU/kg per IU/dL). Prophylaxis Long term prophylaxis against bleeding in patient w/ severe haemophilia A Recommended dose: 20-40 IU/kg every 2nd day or 20-50 IU/kg 3 times wkly. Adult & adolescent (>12 yr) 40-60 IU/kg every 3rd day or twice wkly may be applicable. Childn <12 yr 25-50 IU/kg every 2nd day or 25-60 IU/kg 3 times wkly. Recommended infusion rate: 1-2 mL/min.
Contraindications
Hypersensitivity. Known allergic reaction to hamster proteins.
Special Precautions
Discontinue if symptoms of hypersensitivity occur. Carefully monitor all patients for the development of inhibitors. Patients w/ existing CV risk factors. Substitution therapy w/ factor VIII may increase CV risk. Consider risk of central venous access device (CVAD)-related complications including local infections, bacteraemia & catheter site thrombosis if CVAD is required. Contains 30.5 mg Na/reconstituted vial. Should be used during pregnancy & lactation only if clearly indicated. No experience in elderly >65 yr.
Adverse Reactions
In previously untreated patients: FVIII inhibition. Flushing, thrombophlebitis superficial, rash, rash erythematous, haemarthrosis, muscle haemorrhage, cough, pyrexia, catheter site erythema, anti factor VIII ab +ve, vomiting, infusion related reaction, thrombosis in device. In previously treated patients: Inj site reactions, increased hepatic enzymes, incorrect dose administered.
MIMS Class
Haemostatics
ATC Classification
B02BD02 - coagulation factor VIII ; Belongs to the class of blood coagulation factors. Used in the treatment of hemorrhage.
Presentation/Packing
Form
NovoEight powd for soln for inj 250 IU
Packing/Price
(+ 4 mL solvent (pre-filled syringe)) 1's
Form
NovoEight powd for soln for inj 500 IU
Packing/Price
(+ 4 mL solvent (pre-filled syringe)) 1's
Form
NovoEight powd for soln for inj 1,000 IU
Packing/Price
(+ 4 mL solvent (pre-filled syringe)) 1's
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Already a member? Sign in
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Already a member? Sign in