"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...
Adagen Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
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 include headache, and swelling, redness, or pain at the injection site.
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.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Adagen in Detail - Patient Information: Side Effects
If you experience any of the following serious side effects, stop using the pegademase bovine and seek emergency medical treatment or contact your doctor immediately:
- an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives); or
- signs of infection such as sore throat, fever or congestion.
Other, less serious side effects may be more likely to occur. Continue to use the pegademase bovine and talk to your doctor if you experience:
- swelling, redness, or pain at the injection site.
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. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Adagen (Pegademase Bovine)
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Adagen FDA Prescribing 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.
To report SUSPECTED ADVERSE REACTIONS, contact Sigma-Tau Pharmaceuticals, Inc. at 1-888-393-4584 or by email at firstname.lastname@example.org 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)
Additional Adagen Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.