Privigen Infusion
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Privigen

Important Safety Information

Privigen is intravenous immune globulin therapy used to treat patients with primary immunodeficiency (PI), chronic inflammatory demyelinating polyneuropathy, or patients 15 years of age or older with chronic immune thrombocytopenic purpura. Since the medication is derived from human plasma, there’s always a risk of virus transmission, as well as Chreutzfeldt-Jakob disease (CJD) and its variant (vCJD).

Privigen is contraindicated in patients with a medical history of anaphylactic or severe systemic reaction to human immune globulin. Patients with hyperprolinemia, IgA-deficiencies, and/or a history of hypersensitivity should also avoid treatment with Privigen.

Talk with your doctor about your medical history, as well as all of the medications you’re currently taking — regardless of whether they are prescription, over-the-counter, vitamins, or herbal supplements. Certain medical conditions — especially in patients with renal dysfunction — may require treatment at the minimum dosage and infusion rate possible. Your doctor may also have to monitor for signs and symptoms of thrombosis and assess blood viscosity in patients who are at a higher risk for hyperviscosity.

There is unknown data about how Privigen would affect a fetus. Therefore, talk with your doctor if you’re pregnant, there’s a possibility you may be pregnant, or you’re planning on conceiving. Also, discuss if you’re currently breastfeeding.

What is the most important information I should know about Privigen?

Privigen may interfere with a person’s response to live virus vaccines and could lead to misinterpretation of serologic testing. You should talk to your doctor about Privigen alternatives if you’ve recently had a vaccine.

Certain patients who undergo treatment with Privigen are at a higher risk of thrombosis. These include those of advanced age, a history of venous or arterial thrombosis, hypercoagulable conditions, prolonged immobilization, use of estrogens, indwelling vascular catheters, hyperviscosity, and cardiovascular risk factors.

Side Effects of Privigen

As with all prescription medications, using Privigen carries a risk of side effects. These could range in severity from person to person. The most common ones include:

  • Headaches
  • Chills
  • Back pain
  • Chest pain
  • Joint swelling
  • Flu-like symptoms
  • Nausea
  • Vomiting
  • Diarrhea
  • Coughing
  • Stomach discomfort

Some side effects may be an indication of a more serious, life-threatening condition. Tell your doctor immediately if you experience any of the following symptoms;

  • Dizziness
  • Fever
  • Hypersensitivity

Also, tell your doctor if you experience symptoms of aseptic meningitis syndrome. Signs may include sensitivity to light, loss of appetite, severe headaches, stomach ache, body aches, vomiting, and/or fatigue.

Tell your doctor if you experience any negative side effects. You are also encouraged to report such side effects to the Food and Drug Administration (FDA) by visiting www.fda.gov/medwatch, or by calling 1-800-FDA-1088.

Indications

Privigen is intravenous immune globulin therapy used to treat patients with primary immunodeficiency (PI), chronic inflammatory demyelinating polyneuropathy, or patients 15 years of age or older with chronic immune thrombocytopenic purpura. The recommended dosage will vary depending on the medical condition being treated and the patient’s age.

Please refer to the full prescribing information.