Meet Ashley

A young woman living with ADA-SCID, a rare, inherited disorder that damages the immune system.

INDICATION

Adagen® (pegademase bovine) Injection is indicated for enzyme replacement therapy for adenosine deaminase (ADA) deficiency in patients with severe combined immunodeficiency disease (SCID) who are not suitable candidates for – or who have failed – bone marrow transplantation.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

There is no evidence to support the safety and efficacy of Adagen as preparatory or support therapy for bone marrow transplantation. Since Adagen is administered by intramuscular injection, it should be used with caution in patients with thrombocytopenia and should not be used if thrombocytopenia is severe.

PRECAUTIONS

General

  • Any laboratory or clinical indication of a decrease in potency of Adagen should be reported immediately by telephone to Leadiant Biosciences, Inc. Tel. 1-866-792-5172.
  • Appropriate care to protect immune deficient patients should be maintained until improvement in immune function has been documented. The degree of immune function improvement may vary from patient to patient and, therefore, each patient will require appropriate care consistent with immunologic status.

Laboratory Tests

  • The treatment of SCID associated with ADA deficiency with Adagen should be monitored by measuring plasma ADA activity and red blood cell dATP levels.
  • Once treatment with Adagen has been initiated, a desirable range of plasma ADA activity (trough level before maintenance injection) should be 15-35 µmol/hr/mL and after 2 months of maintenance treatment with Adagen, red cell dATP levels should decrease to a range of ≤ 0.005 to 0.015 µmol/mL.
  • Failure to maintain adequate levels of plasma ADA activity in patients undergoing treatment with Adagen may lead to decline in immune function and increase risk of opportunistic infections.

Drug Interactions

  • There are no known drug interactions with Adagen. However, Vidarabine is a substrate for ADA and 2-deoxycoformycin is a potent inhibitor of ADA.

ADVERSE REACTIONS

  • Clinical experience with Adagen has been limited. The following adverse reactions were reported during clinical trials: headache in one patient and pain at the injection site in two patients.
  • The following adverse reactions have been identified during post-approval use of Adagen: hemolytic anemia, auto-immune hemolytic anemia, thrombocythemia, thrombocytopenia, autoimmune thrombocytopenia, lymphomas, injection site erythema, and urticaria.

To report SUSPECTED ADVERSE REACTIONS, contact Leadiant Biosciences, Inc. at 1-888-393-4584 or by email at drugsafety@leadiant.com or contact the FDA at 1-800-FDA-1088 or www.fda.gov/safety/medwatch.

Please see full prescribing information for contraindications, precautions and adverse reactions.

INDICATION

Adagen® (pegademase bovine) Injection is indicated for enzyme replacement therapy for adenosine deaminase (ADA) deficiency in patients with severe combined immunodeficiency disease (SCID) who are not suitable candidates for – or who have failed – bone marrow transplantation.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

There is no evidence to support the safety and efficacy of Adagen as preparatory or support therapy for bone marrow transplantation. Since Adagen is administered by intramuscular injection, it should be used with caution in patients with thrombocytopenia and should not be used if thrombocytopenia is severe.

PRECAUTIONS

General

  • Any laboratory or clinical indication of a decrease in potency of Adagen should be reported immediately by telephone to Leadiant Biosciences, Inc. Tel. 1-866-792-5172.
  • Appropriate care to protect immune deficient patients should be maintained until improvement in immune function has been documented. The degree of immune function improvement may vary from patient to patient and, therefore, each patient will require appropriate care consistent with immunologic status.

Laboratory Tests

  • The treatment of SCID associated with ADA deficiency with Adagen should be monitored by measuring plasma ADA activity and red blood cell dATP levels.
  • Once treatment with Adagen has been initiated, a desirable range of plasma ADA activity (trough level before maintenance injection) should be 15-35 µmol/hr/mL and after 2 months of maintenance treatment with Adagen, red cell dATP levels should decrease to a range of ≤ 0.005 to 0.015 µmol/mL.
  • Failure to maintain adequate levels of plasma ADA activity in patients undergoing treatment with Adagen may lead to decline in immune function and increase risk of opportunistic infections.

Drug Interactions

  • There are no known drug interactions with Adagen. However, Vidarabine is a substrate for ADA and 2-deoxycoformycin is a potent inhibitor of ADA.

ADVERSE REACTIONS

  • Clinical experience with Adagen has been limited. The following adverse reactions were reported during clinical trials: headache in one patient and pain at the injection site in two patients.
  • The following adverse reactions have been identified during post-approval use of Adagen: hemolytic anemia, auto-immune hemolytic anemia, thrombocythemia, thrombocytopenia, autoimmune thrombocytopenia, lymphomas, injection site erythema, and urticaria.

To report SUSPECTED ADVERSE REACTIONS, contact Leadiant Biosciences, Inc. at 1-888-393-4584 or by email at drugsafety@leadiant.com or contact the FDA at 1-800-FDA-1088 or www.fda.gov/safety/medwatch.

Please see full prescribing information for contraindications, precautions and adverse reactions.