Adagen Side Effects Center

Last updated on RxList: 10/6/2022
Adagen Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Adagen?

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.

What Are Side Effects of Adagen?

Adagen may cause serious side effects including:

  • hives,
  • difficulty breathing,
  • swelling of your face, lips, tongue, or throat,
  • dizziness,
  • 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,
  • chills,
  • sore throat,
  • mouth sores,
  • flu symptoms, and
  • skin sores or swelling

Get medical help right away, if you have any of the symptoms listed above.

Common side effects of Adagen include:

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

Seek medical care or call 911 at once if you have the following serious side effects:

  • Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
  • Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheadedness, or passing out;
  • Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

Dosage for Adagen

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.

What Drugs, Substances, or Supplements Interact with Adagen?

Adagen may interact with vidarabine eye ointment (Vira-A). Tell your doctor all medications and supplements you use.

Adagen During Pregnancy or Breastfeeding

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.

Additional Information

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.

SLIDESHOW

Digestive Disorders: Common Misconceptions See Slideshow
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.

QUESTION

About how much does an adult human brain weigh? See Answer
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)

© 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.

Health Solutions From Our Sponsors