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Adagen

Last reviewed on RxList: 5/2/2018
Adagen Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 5/2/2018

Adagen (pegademase bovine) Injection is an enzyme called adenosine deaminase (ADA) used for enzyme replacement therapy for the treatment of severe combined immunodeficiency disease (SCID) associated with a deficiency of adenosine deaminase. Common side effects of Adagen include:

  • headache
  • injection site reactions (swelling, redness, pain, or hives).

The dosage of Adagen Injection is individualized. The recommended dosing schedule is 10 U/kg for the first dose, 15 U/kg for the second dose, and 20 U/kg for the third dose. The usual maintenance dose is 20 U/kg per week. Adagen may interact with vidarabine eye ointment (Vira-A). Tell your doctor all medications and supplements you use. During pregnancy, it is unknown if Adagen will be harmful to a fetus. Tell your doctor if you are pregnant or could become pregnant during treatment. It is unknown if this drug is harmful to a nursing baby. Consult your doctor before breastfeeding.

Our Adagen (pegademase bovine) Injection Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Adagen Consumer Information

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
  • pale or yellowed skin, dark colored urine, fever, confusion or weakness; or
  • signs of infection--fever, chills, sore throat, mouth sores, flu symptoms, skin sores or swelling.

Common side effects may include:

  • headache; or
  • redness or itching where the medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Adagen (Pegademase Bovine)

Adagen Professional Information

SIDE EFFECTS

Clinical experience with ADAGEN® (pegademase bovine) Injection 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® (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, thrombocytopenia and autoimmune thrombocytopenia.

Dermatological events: injection site erythema, urticaria.

Lymphomas

To report SUSPECTED ADVERSE REACTIONS, contact Sigma-Tau Pharmaceuticals, Inc. at 1-888-393-4584 or by email at [email protected] or contact the FDA at 1-800-FDA-1088 or www.fda.gov/safety/medwatch.

Read the entire FDA prescribing information for Adagen (Pegademase Bovine)

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© Adagen Patient Information is supplied by Cerner Multum, Inc. and Adagen Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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