Dosage Forms for This Indication Dosage Form Concentration Route Fixed Doses
Powder 10 MIU (single-dose) 10 MIU/mL IM, SC N/A
Solution 18 MIU multidose 6 MIU/mL IM, SC N/A
Solution 25 MIU multidose 10 MIU/mL IM, SC N/A
Pen 3 MIU/dose multidose 15 MIU/mL SC 1.5, 3.0, 4.5
Pen 5 MIU/dose multidose 25 MIU/mL SC 2.5, 5.0 

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 develop, the dosage should be modified (50% reduction) or therapy should be temporarily withheld until the adverse reactions abate and then resume at 50% (1 MIU/m2 TIW).
If severe adverse reactions persist or recur following dosage adjustment, INTRON A should be permanently discontinued.
INTRON A should be discontinued for progressive disease or failure to respond after six months of treatment.

Malignant Melanoma
(see DOSAGE AND ADMINISTRATION, General section)

INTRON A adjuvant treatment of malignant melanoma is given in two phases, induction and maintenance.

Induction Recommended Dose
The recommended daily dose of INTRON A in induction is 20 million IU/m2 as an intravenous infusion, over 20 minutes, 5 consecutive days per week, for 4 weeks (see Dose Adjustment below).

Dosage Forms for This Indication Dosage Form Concentration Route
Powder 10 MIU 10 MIU/mL IV
Powder 18 MIU 18 MIU/mL IV
Powder 50 MIU 50 MIU/mL IV

NOTE: INTRON A Solution for Injection in vials or Multidose Pens is NOT recommended for intravenous administration and should not be used for the induction phase of malignant melanoma.

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
NOTE: Regular laboratory testing should be performed to monitor laboratory abnormalities for the purpose of dose modifications (see PRECAUTIONS, Laboratory Tests section).

INTRON A should be withheld for severe adverse reactions, including granulocyte counts >250/mm3 but <500/mm3 or SGPT/SGOT >5–10× upper limit of normal, until adverse reactions abate. INTRON A treatment should be restarted at 50% of the previous dose.
INTRON A should be permanently discontinued for:
Toxicity that does not abate after withholding INTRON A
Severe adverse reactions which recur in patients receiving reduced doses of INTRON A
Granulocyte count <250/mm3 or SGPT/SGOT of >10× upper limit of normal

Maintenance Recommended Dose
The recommended dose of INTRON A for maintenance is 10 million IU/m2 as a subcutaneous injection three times per week for 48 weeks (see Dose Adjustment below).

Dosage Forms for This Indication Dosage Form Concentration Route Fixed Doses
*
Patients receiving 50% dose reduction only
†
Patients receiving full dose only 
Powder 10 MIU (single-dose)* 10 MIU/mL SC N/A
Powder 18 MIU (single dose)† 18 MIU/mL SC N/A
Solution 18 MIU multidose 6 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 7.5, 10.0
Pen 10 MIU/dose multidose 50 MIU/mL SC 10.0, 15.0, 20.0

NOTE: INTRON A Powder for Injection does not contain a preservative. The vial must be discarded