ADYNOVATE 1500 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION

Land: Singapore

Språk: engelska

Källa: HSA (Health Sciences Authority)

Aktiva substanser:

Rurioctocog alfa pegol [Antihaemophilic Factor (Recombinant), PEGylated]

Tillgänglig från:

TAKEDA PHARMACEUTICALS (ASIA PACIFIC) PTE. LTD.

ATC-kod:

B02BD02

Läkemedelsform:

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

Sammansättning:

Rurioctocog alfa pegol [Antihaemophilic Factor (Recombinant), PEGylated] 1500 IU

Administreringssätt:

INTRAVENOUS

Receptbelagda typ:

Prescription Only

Tillverkad av:

Baxalta Manufacturing Sarl (bulk production and primary packager)

Bemyndigande status:

ACTIVE

Tillstånd datum:

2020-11-24

Produktens egenskaper

ADYNOVATE
Rurioctocog alfa pegol [Antihaemophilic Factor (Recombinant),
PEGylated]
1
INDICATIONS AND USAGE
ADYNOVATE, Rurioctocog alfa pegol [Antihaemophilic Factor
(Recombinant),
PEGylated], is a human antihaemophilic factor indicated in children
and adults with
haemophilia A (congenital factor VIII deficiency) for:

On-demand treatment and control of bleeding episodes

Perioperative management

Routine prophylaxis to reduce the frequency of bleeding episodes
Limitation of Use
ADYNOVATE is not indicated for the treatment of von Willebrand
disease.
2
DOSAGE AND ADMINISTRATION
FOR INTRAVENOUS USE AFTER RECONSTITUTION ONLY.
2.1
DOSE

One international unit corresponds to the activity of factor VIII
contained in one
millilitre of normal human plasma.


Dosage and duration of treatment depend on the severity of factor VIII
deficiency,
the location and extent of the bleeding, and the patient’s clinical
condition. Careful
monitoring of replacement therapy is necessary in cases of serious or
life-threatening
bleeding episodes.


Potency assignment is determined using a one-stage clotting assay.
Plasma factor
VIII levels can be monitored clinically using a one-stage clotting
assay.


Calculate the dose of ADYNOVATE based on the empirical finding that
one
international unit of ADYNOVATE per kg body weight increases the
plasma factor
VIII level by 2 IU per dL of plasma. Use the following formula to
estimate the
expected _in vivo _peak increase in factor VIII level expressed as IU
per dL (or % of
normal) and the dose to achieve a desired _in vivo _peak increase in
factor VIII level:

_Estimated Increment of factor VIII (IU/dL or % of normal) = [Total
Dose (IU)/body _
_weight (kg)] x 2 (IU/dL per IU/kg)_
_Dose (IU) = Body Weight (kg) x Desired factor VIII Rise (IU/dL or %
of Normal) x 0.5_
_(IU/kg per IU/dL)_

Patients vary in their pharmacokinetic (e.g., clearance, half-life,_
in vivo_ recovery)and
clinical response. Base the dose and frequency of ADYNOVATE on the
individual
clinical re