Adagen

Name: Adagen

What is Adagen (pegademase bovine)?

Pegademase bovine is a man-made form of an enzyme called adenosine deaminase (ADA). ADA is important in the body for preventing the buildup of certain proteins harmful to the white blood cells that help your body fight infections.

Pegademase bovine is used to replace ADA in people with severe combined immunodeficiency disease (SCID).

Pegademase bovine may also be used for purposes not listed in this medication guide.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Uses For Adagen

Pegademase contains an enzyme called adenosine deaminase (ADA). It is used to treat children who do not have a properly developed immune system because of a lack of ADA in the body.

Pegademase is to be given only by or under the supervision of your doctor.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your child's doctor or get medical help right away if your child has any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Any unexplained bruising or bleeding.
  • This medicine may help the immune system work. If your child has an infection that you did not know was there, it may show up when your child takes Adagen. Tell your child's doctor right away if you see any signs of infection like fever, sore throat, weakness, cough, or shortness of breath after your child starts this medicine.

Adagen Description

Adagen® (pegademase bovine) Injection is a modified enzyme used for enzyme replacement therapy for the treatment of severe combined immunodeficiency disease (SCID) associated with a deficiency of adenosine deaminase.

Adagen® (pegademase bovine) Injection is supplied in an isotonic, pyrogen free, sterile solution, pH 7.2-7.4, for intramuscular injection only. The solution is clear and colorless. It is supplied in 1.5 mL single-dose vials.

The chemical name for Adagen® (pegademase bovine) Injection is (monomethoxypolyethylene glycol succinimidyl) 11-17-adenosine deaminase. It is a conjugate of numerous strands of monomethoxypolyethylene glycol (PEG), molecular weight 5,000, covalently attached to the enzyme adenosine deaminase (ADA). ADA (adenosine deaminase EC 3.5.4.4) used in the manufacture of Adagen® (pegademase bovine) Injection is derived from bovine intestine.

The structural formula of Adagen® (pegademase bovine) Injection is:

Each milliliter of Adagen® (pegademase bovine) Injection contains:
Pegademase bovine                                              250 units*
Monobasic sodium phosphate, USP                     1.20 mg
Dibasic sodium phosphate, USP                           5.58 mg
Sodium Chloride, USP                                         8.50 mg
Water for injection, USP                                      q.s. to 1.0 mL

*One unit of activity is defined as the amount of ADA that converts 1μM of adenosine to inosine per minute at 25°C and pH 7.3.

Overdosage

There is no documented experience with Adagen® (pegademase bovine) Injection overdosage. An intraperitoneal dose of 50,000 U/kg of Adagen® (pegademase bovine) Injection in mice resulted in weight loss up to 9%.

Pegademase bovine Pregnancy Warnings

Animal reproduction studies and fertility impairment studies have not been conducted. There are no controlled data in human pregnancy. US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

This drug should be used during pregnancy only if clearly needed. US FDA pregnancy category: C

Pegademase bovine Breastfeeding Warnings

Caution is recommended. Excreted into human milk: Unknown Excreted into animal milk: Data not available Comments: Since this drug is a large protein molecule, the amount in milk is expected to be very low and absorption is doubtful because it's likely destroyed in the child's gastrointestinal tract.

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