Dosage Forms for this Indication Dosage Form Concentration Route Fixed Doses
Powder 10 MIU (single-dose) 10 MIU/mL IM, SC N/A
Solution 25 MIU multidose 10 MIU/mL IM, SC N/A
Pen 5 MIU/dose multidose 25 MIU/mL SC 2.5, 5.0, 10.0
Pen 10 MIU/dose multidose 50 MIU/mL SC 5.0, 10.0

NOTE: INTRON A Powder for Injection does not contain a preservative. The vial must be discarded after reconstitution and withdrawal of a single dose.

Chronic Hepatitis B Pediatrics
(see DOSAGE and ADMINISTRATION, General section)

Dose
The recommended dose of INTRON A for the treatment of chronic hepatitis B is 3 million IU/m2 three times a week (TIW) for the first week of therapy followed by dose escalation to 6 million IU/m2 TIW (maximum of 10 million IU TIW) administered subcutaneously for a total duration of 16 to 24 weeks.

Dosage Forms for this Indication Dosage Form Concentration Route Fixed Doses
Powder 10 MIU (single-dose) 10 MIU/mL SC N/A
Solution 25 MIU multidose 10 MIU/mL SC N/A
Pen 3 MIU/dose multidose 15 MIU/mL SC 1.5, 3.0, 4.5, 6.0
Pen 5 MIU/dose multidose 25 MIU/mL SC 2.5, 5.0, 7.5, 10.0
Pen 10 MIU/dose multidose 50 MIU/mL SC 5.0, 10.0, 15.0, 20.0

NOTE: INTRON A Powder for Injection does not contain a preservative. The vial must be discarded after reconstitution and withdrawal of a single-dose.

Dose adjustment
If severe adverse reactions or laboratory abnormalities develop during INTRON A therapy, the dose should be modified (50% reduction) or discontinued if appropriate, until the adverse reactions abate. If intolerance persists after dose adjustment, INTRON A therapy should be discontinued.

For patients with decreases in white blood cell, granulocyte or platelet counts, the following guidelines for dose modification should be followed:

INTRON A Dose White Blood Cell Count Granulocyte Count Platelet Count
Reduce 50% <1.5 × 109/L <0.75 × 109/L <50 × 109 /L
Permanently Discontinue <1.0 × 109/L <0.5 × 109/L <25 × 109 /L

INTRON A therapy was resumed at up to 100% of the initial dose when white blood cell, granulocyte, and/or platelet counts returned to normal or baseline values.

PREPARATION AND ADMINISTRATION

Reconstitution of INTRON® A Powder for Injection
The reconstituted solution is clear and colorless to light yellow. The INTRON A powder reconstituted with Sterile Water for Injection USP is a single-use vial and does not contain a preservative. DO NOT RE-ENTER VIAL AFTER WITHDRAWING THE DOSE. DISCARD UNUSED PORTION (see DOSAGE and ADMINISTRATION). Once the dose from the single-dose vial has been withdrawn, the sterility of any remaining product can no longer be guaranteed. Pooling of unused portions of some medications has been linked to bacterial contamination and morbidity.

Intramuscular, Subcutaneous, or Intralesional Administration
Inject 1 mL Diluent (Sterile Water for Injection USP) for INTRON A into the INTRON A vial. Swirl gently to hasten complete dissolution of the powder. The appropriate INTRON A dose should then be withdrawn and injected intramuscularly, subcutaneously, or intralesionally (see MEDICATION GUIDE for detailed instructions).

Please refer to the MEDICATION GUIDE for detailed, step-by-step instruct