Usual Adult Dose for Hypoplasminogenemia

• Recommended Dosing: 6.6 mg/kg IV every 2 to 4 days. The final plasminogen concentration is 5.5 mg/mL.

• Initiate dosing every 3 days.
• Obtain trough plasminogen activity level 72 hours after the initial dose and prior to the second dose (initiate same time of the day as the first dose).
• If the plasminogen activity level is less than 10% above baseline, change dosing frequency to every 2 days.
• If the plasminogen activity level is 10% or greater but at least 20% or less than baseline, maintain dosing frequency every 3 days.
• If the plasminogen activity level is greater than 20% above baseline, change dosing frequency to every 4 days.

• If lesions do not resolve by 12 weeks or there are new lesions, increase dosing frequency to 1-day increments, every 4 to 8 weeks up to every 2 days dosing while reassessing clinical improvement of lesions. If lesions are still not resolved after 12 weeks, check trough levels then follow the guideline below:
• Trough level 10% or greater above baseline, consider other treatment options for the lesions in addition to plasminogen treatment.
• Trough level less than 10% above baseline, obtain a second trough level to confirm. If a low plasminogen activity level is confirmed, consider discontinuing the treatment due to possible formation of neutralizing antibodies.
• If lesions resolve by 12 weeks, continue the original dosing frequency and monitor for lesions every 12 weeks.

Usual Pediatric Dose for Hypoplasminogenemia

• Recommended Dosing: 6.6 mg/kg IV every 2 to 4 days. The final plasminogen concentration is 5.5 mg/mL.

• Initiate dosing every 3 days.
• Obtain trough plasminogen activity level 72 hours after the initial dose and prior to the second dose (initiate same time of the day as the first dose).
• If the plasminogen activity level is less than 10% above baseline, change dosing frequency to every 2 days.
• If the plasminogen activity level is 10% or greater but at least 20% or less than baseline, maintain dosing frequency every 3 days.
• If the plasminogen activity level is greater than 20% above baseline, change dosing frequency to every 4 days.

• If lesions do not resolve by 12 weeks or there are new lesions, increase dosing frequency to 1-day increments, every 4 to 8 weeks up to every 2 days dosing while reassessing clinical improvement of lesions. If lesions are still not resolved after 12 weeks, check trough levels then follow the guideline below:
• Trough level 10% or greater above baseline, consider other treatment options for the lesions in addition to plasminogen treatment.
• Trough level less than 10% above baseline, obtain a second trough level to confirm. If a low plasminogen activity level is confirmed, consider discontinuing the treatment due to possible formation of neutralizing antibodies.
• If lesions resolve by 12 weeks, continue the original dosing frequency and monitor for lesions every 12 weeks.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Precautions

US FDA requires a medication guide to assure safe use. For additional information: www.fda.gov/drugs/drug-safety-and-availability/medication-guides

CONTRAINDICATIONS: Hypersensitivity to plasminogen or other components of this drug

Safety and efficacy have not been established in children younger than 11 months.
Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• For IV use only.
• Read the manufacturer's product label for additional supplies needed and important reconstitution and administration techniques.
• Detailed training and instructions should be provided for patients/caregivers who prefer to independently administer.
• Treatment for patients with respiratory lesions should be performed in a clinical setting equipped to handle serious adverse reactions.
• Counsel patients of child-bearing age that the effects of this drug on pregnancy and breastfeeding are unknown.
• Safety and efficacy have not been established for older adult patients aged 65 years and above.

• This drug should be stored at temperature of 2C to 25C (36F to 77F) in its original container until ready to use. Do not freeze.
• Administer this medication within 3 hours of reconstitution, and do not refrigerate.
• Store diluent and syringe disc filters at 20C to 25C (68F and 77F).

• The manufacturer's product information should be consulted for important details.

• The manufacturer's product information should be consulted.

• Hypersensitivity: signs and symptoms
• Hematologic: new and recurrent lesions for bleeding; pain, mucosal bleeding, and tissue passage
• Infection: signs and symptoms

• Read the US FDA-approved Patient Information and Instructions for Use.
• This medication can cause bleeding. Seek emergency care for uncontrolled bleeding. Anticoagulants and antiplatelets may also interfere with this drug.
• Discontinue infusion and contact your doctor as soon as signs and symptoms of a hypersensitivity reaction occur.