Adagen

Name: Adagen

What should I discuss with my healthcare provider before using Adagen (pegademase bovine)?

You should not use pegademase bovine if you are allergic to it, or if you have:

  • severe thrombocytopenia (low levels of platelets in blood).

To make sure pegademase bovine is safe for you, tell your doctor if you have:

  • easy bruising or bleeding.

FDA pregnancy category C. It is not known whether pegademase bovine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

It is not known whether pegademase bovine passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Adagen Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Incidence not known
  • Back, leg, or stomach pains
  • bleeding gums
  • chills
  • dark urine
  • difficulty breathing
  • dizziness
  • fever
  • general body swelling
  • headache
  • loss of appetite
  • nausea or vomiting
  • nosebleeds
  • pain, warmth, or burning in the fingers, toes, and legs
  • pale skin
  • problems with vision or hearing
  • sore throat
  • unusual tiredness or weakness
  • yellowing of the eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known
  • Hives or welts
  • itching
  • redness of skin
  • redness or pain at the site of injection
  • skin rash

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

What do I need to tell my doctor BEFORE I take Adagen?

  • If your child has an allergy to Adagen (pegademase bovine injection) or any part of this medicine.
  • If your child is allergic to any drugs like this one or any other drugs, foods, or other substances. Tell the doctor about the allergy and what signs your child had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If your child has low platelet levels.

This is not a list of all drugs or health problems that interact with Adagen.

Tell the doctor and pharmacist about all of your child's drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for your child to take this medicine with all of his/her drugs and health problems. Do not start, stop, or change the dose of any drug your child takes without checking with the doctor.

What are some other side effects of Adagen?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your child's doctor or get medical help if your child has any side effects that bother your child or do not go away.

These are not all of the side effects that may occur. If you have questions about side effects, call your child's doctor. Call your child's doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Consumer Information Use and Disclaimer

  • If your child's symptoms or health problems do not get better or if they become worse, call your child's doctor.
  • Do not share your child's drug with others and do not give anyone else's drug to your child.
  • Keep a list of all your child's drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your child's doctor.
  • Talk with your child's doctor before giving your child any new drug, including prescription or OTC, natural products, or vitamins.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Check with your pharmacist about how to throw out unused drugs.
  • Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take Adagen or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Adagen (pegademase bovine injection). This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

Dosing & Uses

Not recommended for adults

Dosage Forms & Strengths

injectable solution

  • 250 units/mL

Adenosine Deaminase Deficiency

Dosing should be individualized based on plasma adenosine deaminase (ADA) activity levels and biochemical markers of ADA deficiency

Do not mix or dilute with other drugs prior to administration

Indicated in patients with severe combined immunodeficiency disease (SCID) who cannot undergo bone marrow transplantation.

Administer q7Days IM

  • 1st dose: 10 units/kg IM
  • 2nd dose: 15 units/kg IM
  • 3rd dose: 20 units/kg IM
  • Maintenance: 20 units/kg/week IM, may increase by 5 units/kg/week; not to exceed 30 units/kg

For the Consumer

Applies to pegademase bovine: intramuscular solution

Along with its needed effects, pegademase bovine (the active ingredient contained in Adagen) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking pegademase bovine:

Incidence not known
  • Back, leg, or stomach pains
  • bleeding gums
  • chills
  • dark urine
  • difficulty breathing
  • dizziness
  • fever
  • general body swelling
  • headache
  • loss of appetite
  • nausea or vomiting
  • nosebleeds
  • pain, warmth, or burning in the fingers, toes, and legs
  • pale skin
  • problems with vision or hearing
  • sore throat
  • unusual tiredness or weakness
  • yellowing of the eyes or skin

Some side effects of pegademase bovine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known
  • Hives or welts
  • itching
  • redness of skin
  • redness or pain at the site of injection
  • skin rash

For Healthcare Professionals

Applies to pegademase bovine: intramuscular solution

Immunologic

Rare (less than 0.1%): Antibody development

Hematologic

Postmarketing reports: Hemolytic anemia, autoimmune hemolytic anemia, thrombocythemia, thrombocytopenia, autoimmune thrombocytopenia[Ref]

Oncologic

Postmarketing reports: Lymphomas

Dermatologic

Postmarketing reports: Urticaria[Ref]

Nervous system

Frequency not reported: Headache[Ref]

Other

Frequency not reported: Injection site pain, injection site erythema

Some side effects of Adagen may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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