Pegademase Discontinued

Pegademase is a prescription medication used to treat the symptoms of Adenosine Deaminase Deficiency.

• Pegademase is available under the following different brand names: Adagen

Common side effects of Pegademase include:

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

Serious side effects of Pegademase include:

• hives
• difficulty breathing
• swelling of the 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
• skin sores or swelling

Rare side effects of Pegademase include:

• none 

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

• 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;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

• Injection should be administered every 7 days as an intramuscular injection. 
• 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. 
• Further increases of 5 U/kg/week may be necessary, but a maximum single dose of 30 U/kg should not be exceeded. 

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Pegademase has severe interactions with no other drugs.
• Pegademase has serious interactions with the following drug:
  • Pentostatin
• Pegademase has moderate interactions with the following drugs:
  • Pegloticase
  • Pegvaliase
• Pegademase has minor interactions with no other drugs:

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Use as a preparatory/support therapy for bone marrow transplantation.
• Severe thrombocytopenia

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Pegademase?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Pegademase?”

Cautions

• Use caution in patients with thrombocytopenia; contraindicated in patients with severe thrombocytopenia.
• Monitor plasma ADA activity & red blood cell dATP levels.
• Development of antibodies reported, which may result in rapid clearance; adjust the dose as necessary in patients developing antibodies.
• Risk for infection increases in patients that are not able to maintain adequate levels of plasma ADA.
• Not a substitute for bone marrow transplant

Pregnancy and Lactation

• Use with caution if the benefits outweigh the risks during pregnancy
• Lactation
  • Not known if distributed into breast milk, use caution