om failure to maintain adequate levels of plasma ADA activity [whether due to the development of antibody to ADAGEN® (pegademase bovine) Injection, to improper calculation of ADAGEN® (pegademase bovine) Injection dosage, to interruption of treatment or to improper storage of ADAGEN® (pegademase bovine) Injection with subsequent loss of activity]. If a persistent decline in plasma ADA activity occurs, immune function and clinical status should be monitored closely and precautions should be taken to minimize the risk of infection. If antibody to ADA or ADAGEN® (pegademase bovine) Injection is found to be the cause of a persistent fall in plasma ADA activity, then adjustment in the dosage of ADAGEN® (pegademase bovine) Injection and other measures may be taken to induce tolerance and restore adequate ADA activity.
Drug Interactions
There are no known drug interactions with ADAGEN® (pegademase bovine) Injection. However, Vidarabine is a substrate for ADA and 2′-deoxycoformycin is a potent inhibitor of ADA. Thus, the activities of these drugs and ADAGEN® (pegademase bovine) Injection could be substantially altered if they are used in combination with one another.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term carcinogenic studies in animals have not been performed with ADAGEN® (pegademase bovine) Injection nor have studies been performed on impairment of fertility.
ADAGEN® (pegademase bovine) Injection did not exhibit a mutagenic effect when tested against Salmonella typhimurium strains in the Ames assay.
Pregnancy
Pregnancy Category C. Animal reproduction studies have not been conducted with ADAGEN® (pegademase bovine) Injection. It is also not known whether ADAGEN® (pegademase bovine) Injection can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. ADAGEN® (pegademase bovine) Injection should be given to a pregnant woman only if clearly needed.
Nursing Mothers
It is not known whether ADAGEN® (pegademase bovine) Injection is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when ADAGEN® (pegademase bovine) Injection is administered to a nursing woman.
ADVERSE REACTIONS
Clinical experience with ADAGEN® (pegademase bovine) Injection has been limited. The following adverse reactions have been reported: 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® (pegademase bovine) Injection. Because these reactions are reported voluntarily from a very small population, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Hematologic events: hemolytic anemia, auto-immune hemolytic anemia, thrombocythemia
Dermatological events: injection site erythema, urticaria
OVERDOSAGE
There is no documented experience with ADAGEN® (pegademase bovine) Injection overdosage. An intraperitoneal dose of 50,000 U/kg of ADAGEN® (pegademase bovine) Injection in mice resulted in weight loss up to 9%.
DOSAGE AND ADMINISTRATION
Before prescribing ADAGEN® (pegademase bovine) Injection the physician should be thoroughly familiar with the details of this prescribing information. For further information
