Description
Privigen (Immunoglobulin [Human]) is a ready-to-use 10% liquid intravenous immune globulin (IVIG) solution indicated for the treatment of primary humoral immunodeficiency (PI) in patients aged two years and older, and chronic immune thrombocytopenic purpura (ITP) in adults. Privigen is manufactured from pooled human plasma and contains a broad range of IgG antibodies reflecting the normal human antibody repertoire. It is stabilized with L-proline and formulated to minimize adverse reactions associated with IVIG therapy. The product undergoes multiple virus reduction steps, including solvent/detergent treatment, nanofiltration, and pH treatment, ensuring high standards of safety and pathogen inactivation. Privigen is preservative-free and latex-free.
| F act Table |
| Formula | Variable (IgG glycoprotein) |
| License | US FDA |
| Bioavailability | 100% (IV) |
| Legal status | Prescription only |
| Chemical Name | Immunoglobulin G (Human) |
| Elimination half-life | 25–35 days |
| Dosage (Strength) | 10% solution (100 mg/mL) |
| Pregnancy | Use only if clearly needed |
| Brands | Privigen |
| Protein binding | >95% |
| PubChem CID | Not applicable (mixture of antibodies) |
| MedlinePlus | a610005 |
| ChEBI | 3824 |
| ATC code | J06BA02 |
| DrugBank | DB00028 |
| KEGG | D01934 |
| Routes of administration | Intravenous (IV) |
Directions
Privigen should be administered intravenously by a healthcare professional experienced in the administration of immune globulin therapy. For PI, the typical dose is 200–800 mg/kg body weight every 3 to 4 weeks. For ITP, the recommended dose is 1 g/kg for two consecutive days. Dosage and infusion rate must be individualized based on the patient’s clinical response and tolerability. Premedication may be considered in patients with a history of infusion-related adverse effects. Infusion rates should begin slowly and can be gradually increased if well-tolerated. Patients should be closely monitored during and after administration for any adverse reactions.
Ingredients
Privigen contains 10% (100 mg/mL) human normal immunoglobulin G (IgG), stabilized with 250 mM L-proline and formulated in water for injection. It has a pH of approximately 4.8 and is osmotically balanced. The product contains no preservatives, sucrose, or sodium, reducing the risk of renal or thrombotic complications.
Contraindications
Privigen is contraindicated in individuals with a history of anaphylactic or severe systemic reactions to human immunoglobulin. It is also contraindicated in IgA-deficient patients with known anti-IgA antibodies who have experienced hypersensitivity reactions to immunoglobulin products. Hypersensitivity to L-proline is an additional contraindication.
Cautions
Caution is advised in patients with preexisting risk factors for thromboembolic events, such as advanced age, prolonged immobilization, or a history of thrombosis. Renal function should be assessed prior to and during therapy, particularly in at-risk populations, including those with diabetes mellitus or volume depletion. Adequate hydration before administration is essential to minimize renal stress. Infusion rates should be adjusted based on patient tolerance. Privigen may interfere with the immune response to live attenuated vaccines; defer vaccination appropriately following treatment. Monitoring for signs of hemolysis, aseptic meningitis, and hypersensitivity is recommended.
Side Effects
Possible side effects of Privigen include:
- Hypertension or hypotension
- Thromboembolic events (e.g., deep vein thrombosis, pulmonary embolism)
- Renal dysfunction or acute renal failure (rare)
- Hypersensitivity reactions, including anaphylaxis (rare)
Patients should be observed for immediate adverse reactions during infusion and instructed to report any delayed symptoms that may indicate serious complications.
IMPORTANT NOTE:
The above information is intended to increase awareness of health information and does not suggest treatment or diagnosis. This information is not a substitute for individual medical attention and should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. See your health care professional for medical advice and treatment.
Product Code : 15323
Prescription Required
