Idelvion

Idelvion

Manufacturer:

CSL Behring

Distributor:

Primal
Concise Prescribing Info
Contents
Albutrepenonacog α
Indications/Uses
Treatment & prophylaxis of bleeding in patients w/ haemophilia B (congenital factor IX deficiency).
Dosage/Direction for Use
IV Individualised dose based on body wt, desired factor IX rise & reciprocal of observed recovery (0.77 dL/kg for patient ≥12 yr; 1 dL/kg for patient <12 yr). Max inj rate: 5 mL/min. On-demand treatment: Minor or moderate haemarthrosis, muscle bleeding (except iliopsoas) or oral bleeding 30-60 IU/dL required factor IX level. Maintenance dose after 24-72 hr if there is further evidence of bleeding. Life-threatening haemorrhages, deep muscle bleeding including iliopsoas 60-100 IU/dL required factor IX level. Repeat every 24-72 hr for 1st wk, then maintenance dose wkly until bleeding stops & healing is achieved. Minor surgery including uncomplicated tooth extraction 50-80 IU/dL required factor IX level (pre- & post-op). If needed, maintenance dose can be provided after 24-72 hr until bleeding stops & healing is achieved. Major surgery 60-100 IU/dL required factor IX level (pre- & post-op). Repeat every 24-72 hr for 1st wk, then maintenance dose 1-2 times wkly until bleeding stops & healing is achieved. Long-term prophylaxis Patient w/ severe haemophilia B Usual dose: 35-50 IU/kg once wkly. Some patients who are well-controlled on a once-wkly regimen might be treated w/ up to 75 IU/kg on 10- or 14-day interval. After a bleeding episode during prophylaxis, maintain prophylaxis regimen as closely as possible, w/ 2 doses administered at least 24 hr apart, but longer if deemed suitable for the patient. Ped patient 35-50 IU/kg once wkly.
Contraindications
Hypersensitivity. Known allergic reaction to hamster protein.
Special Precautions
Discontinue immediately if hypersensitivity occurs. Formation of inhibitor to factor IX. Evaluate for presence of inhibitor in patients experiencing allergic reactions. Potential risk of thrombotic complications. Initiate clinical surveillance for early signs of thrombotic & consumptive coagulopathy when administering to patients w/ liver disease, post-op patients, new-born infants, or to patients at risk of thrombotic phenomena or DIC. Increased CV risk in patients w/ existing CV risk factors. Risk of central venous access device (CVAD)-related complications including local infections, bacteraemia & catheter site thrombosis if CVAD is required. Safety & efficacy for use in immune tolerance induction has not been established. Contains 8.6 mg Na per vial. Should be used during pregnancy & lactation only if clearly indicated. Clinical studies did not include elderly subjects ≥65 yr; not known whether they respond differently from younger subjects.
Adverse Reactions
Hypersensitivity; headache, dizziness; rash; inj site reactions.
MIMS Class
Haemostatics
ATC Classification
B02BD04 - coagulation factor IX ; Belongs to the class of blood coagulation factors. Used in the treatment of hemorrhage.
Presentation/Packing
Form
Idelvion powd & solvent for soln for inj 250 IU
Packing/Price
1's
Form
Idelvion powd & solvent for soln for inj 500 IU
Packing/Price
1's
Form
Idelvion powd & solvent for soln for inj 1,000 IU
Packing/Price
1's
Form
Idelvion powd & solvent for soln for inj 2,000 IU
Packing/Price
1's
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