Privigen

Privigen is a prescription medication used to treat primary humoral immunodeficiency (PI), chronic immune thrombocytopenia purpura (ITP), and chronic inflammatory demyelinating polyneuropathy (CIDP).

Privigen belongs to a group of drugs called immunotherapy. It is not known how Privigen works for PI, ITP, and CIDP.

This medication is available in an injectable form to be given directly into a vein (IV) by a healthcare professional.

Common side effects of Privigen include headache, pain, and nausea. Privigen can also cause dizziness. Do not drive or operate heavy machinery until you know how Privigen affects you.

Privigen is a prescription medication used to treat certain immune or inflammatory diseases, including:

• primary humoral immunodeficiency (PI) such as a humoral immune deficit in congenital agammaglobulinemia, common variable immunodeficiency (CVID), X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies
• chronic immune thrombocytopenic purpura (ITP)
• chronic inflammatory demyelinating polyneuropathy (CIDP)

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• CSL Behring GmbH

Serious side effects have been reported with Privigen. See the “Privigen Precautions” section.

Common side effects of Privigen include the following:

• headache
• pain
• nausea
• tiredness or lack of energy
• chills
• fever
• anemia
• vomiting
• diarrhea 
• high blood pressure
• pain
• joint swelling
• flu-like symptoms
• dizziness

This is not a complete list of Privigen side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effects that bother you or that do not go away.

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

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• live virus vaccines such as measles, mumps, rubella, chickenpox or varicella, or shingles

This is not a complete list of Privigen drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Privigen including the following:

• hypersensitivity (severe allergic reaction). Tell your healthcare provider about any signs or symptoms of hypersensitivity, including chest pain, swelling of the face or mouth, difficulty breathing or swallowing, or rash
• renal dysfunction and acute renal failure, or kidney problems. Your healthcare provider will monitor your kidney function. Tell your healthcare provider if you have any signs or symptoms of kidney problems including decreased urine output, sudden weight gain, swelling, or shortness of breath
• thrombosis, or blood clot. Tell your healthcare provider if you have any signs or symptoms of a blood clot including any pain or swelling with warmth in the arms or legs, shortness of breath, chest pain, or numbness or weakness on side of the body.
• aseptic meningitis syndrome. Tell your healthcare provider if you have any signs or symptoms including a severe headache, drowsiness, fever, sensitivity to light, painful eye movements, nausea, and vomiting.
• hemolysis, or break down of red blood cells.
• high blood pressure shortly after receiving Privigen. Your healthcare provider will monitor blood pressure after receiving Privigen.
• transfusion-related acute lung injury. Tell your healthcare provider if you have any difficulty breathing or fever.
• volume overload, especially with high-dose regimens.
• transmissible infectious agents since Privigen is made from human blood. Blood is screened to reduce the risk of transferring infectious agents.
• interference with some laboratory tests. Tell your healthcare provider that you are taking Privigen if you get lab tests done.

Privigen can cause dizziness. Do not drive or operate heavy machinery until you know how Privigen affects you.

Do not take Privigen if you:

• are allergic to Privigen or to any of its ingredients
• are allergic to immune globulin 
• are hyperprolinemia (high proline in the blood)
• have antibodies to IgA or a history of hypersensitivity to IgA

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Privigen, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Privigen, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Privigen or to any of its ingredients
• have hyperprolinemia (high proline in the blood)
• have immune system issues such as IgA deficiencies
• are expecting to or have received live vaccines
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

No studies have been done in animals, and no well-controlled studies have been done in pregnant women. Privigen should be given to a pregnant woman only if clearly needed.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Privigen crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Privigen.

This medication is available in an injectable form to be given directly into a vein (IV) by a healthcare professional.

If you miss a dose, call your healthcare provider.

The recommended dose of Privigen you receive is based on the condition being treated and your weight. 

• For primary humor immunodeficiency (PI), 200-800 mg/kg (2-8 mL/kg) every 3-4 weeks.
• For chronic immune thrombocytopenic purpura (ITP), 1 g/kg (10 mL/kg) for 2 consecutive days.
• For chronic inflammatory demyelinating polyneuropathy:

  Loading dose:

  2 g/kg (20 mL/kg) in divided doses over 2 to 5 consecutive days

  Maintenance dose:

  1 g/kg (10 mL/kg) administered in 1 to 2 infusions on consecutive days, every 3 weeks 

If Privigen is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

Keep all appointments with your doctor and the laboratory.

THROMBOSIS

• Thrombosis may occur with immune globulin products1-3, including Privigen. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling central vascular catheters, hyperviscosity, and cardiovascular risk factors. Thrombosis may occur in the absence of known risk factors.

RENAL DYSFUNCTION AND ACUTE RENAL FAILURE

• Renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur with immune globulin intravenous (IGIV) products in predisposed patients. Patients predisposed to renal dysfunction include those with any degree of pre-existing renal insufficiency, diabetes mellitus, age greater than 65, volume depletion, sepsis, paraproteinemia, or patients receiving known nephrotoxic drugs.
• Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products containing sucrose. Privigen does not contain sucrose.
• For patients at risk of thrombosis, renal dysfunction or failure, administer Privigen at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity .