Adagen

DRUG 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:

ADAGEN (pegademase bovine) Structural Formula Illustration

x ? 114 oxyethylene groups per PEG strand.
y ? 11-17 primary amino groups of lysine onto which succinyl PEG is attached.

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

What are the possible side effects of pegademase bovine (Adagen)?

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:

    ...

Read All Potential Side Effects and See Pictures of Adagen »

What are the precautions when taking pegademase bovine (Adagen)?

Consult your...

Read All Potential Precautions of Adagen »

What are the possible side effects of pegademase bovine (Adagen)?

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:

    ...

Read All Potential Side Effects and See Pictures of Adagen »

What are the precautions when taking pegademase bovine (Adagen)?

Consult your...

Read All Potential Precautions of Adagen »


Adagen Consumer (continued)

SIDE EFFECTS: Consult your pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Consult your pharmacist.


Adagen Patient Information Including Side Effects

Brand Names: Adagen

Generic Name: pegademase bovine (Pronunciation: peg AD e mase BOE vine)

  • What are pegademase bovine (Adagen)?
  • What are the possible side effects of pegademase bovine (Adagen)?
  • What is the most important information I should know about pegademase bovine (Adagen)?
  • What should I discuss with my healthcare provider before using a pegademase bovine (Adagen)?
  • How should I use pegademase bovine (Adagen)?
  • What happens if I miss a dose (Adagen)?
  • What happens if I overdose (Adagen)?
  • What should I avoid while using pegademase bovine (Adagen)?
  • What other drugs will affect pegademase bovine (Adagen)?
  • Where can I get more information?

What are pegademase bovine (Adagen)?

Pegademase bovine is the enzyme called adenosine deaminase (ADA). Without ADA, certain proteins accumulate that harm white blood cells. White blood cells are important for protecting the body from infection.

Pegademase bovine is used to replenish ADA which allows an increase in white blood cells and decreases the risk of infection in conditions such as severe combined immunodeficiency disease (SCID).

Pegademase bovine may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of pegademase bovine (Adagen)?

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:

  • headache;
  • 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.

What is the most important information I should know about pegademase bovine (Adagen)?

Do not administer an injection if you are unsure how to properly do so, how much to inject, or how often to inject the medication. Call your doctor, nurse, or pharmacist to go over the instructions with you.

Contact your doctor if you develop a fever; chills; sore throat; congestion; or redness, pain, or swelling around a wound or sore while using pegademase bovine. These may be signs of infection.

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