Privigen

What is Privigen?

• Privigen (human immunoglobulin g liquid) used for the treatment of Primary humoral immunodeficiency (PI), Chronic immune thrombocytopenic purpura (ITP) and Chronic inflammatory demyelinating polyneuropathy (CIDP).

What are the uses of this medicine?

Privigen (human immunoglobulin g liquid) used for the treatment of:

• Primary humoral immunodeficiency (PI)
• Chronic immune thrombocytopenic purpura (ITP) in patients age 15 years and older
• Chronic inflammatory demyelinating polyneuropathy (CIDP) in adults

How does this medicine work?

• PRIVIGEN supplies a broad spectrum of opsonizing and neutralizing IgG antibodies against a wide variety of bacterial and viral agents.
• The mechanism of action has not been fully elucidated, but may include immunomodulatory effects.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• have a history of anaphylactic or severe systemic reaction to the administration of human immune globulin.
• have hyperprolinemia because it contains the stabilizer L-proline.
• IgA-deficient patients with antibodies to IgA and a history of hypersensitivity.

What drug interactions can this medicine cause?

• The passive transfer of antibodies with immunoglobulin administration may interfere with the response to live virus vaccines such as measles, mumps, rubella, and varicella.
• Inform the immunizing physician of recent therapy with PRIVIGEN so that appropriate measures can be taken.

Is this medicine FDA approved?

• Initial U.S. Approval: 2007

How should this medicine be used?

Recommended dosage: Primary Humoral Immunodeficiency (PI):

• The recommended dose of PRIVIGEN for patients with PI is 200 to 800 mg/kg (2 to 8 mL/kg), administered every 3 to 4 weeks.
• If a patient misses a dose, administer the missed dose as soon as possible, and then resume scheduled treatments every 3 or 4 weeks, as applicable.

Dosage for Chronic Immune Thrombocytopenic Purpura (ITP):

• The recommended dose of PRIVIGEN for patients with chronic ITP is 1 g/kg (10 mL/kg) administered daily for 2 consecutive days, resulting in a total dosage of 2 g/kg.

Dosage for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP):

• PRIVIGEN may be initially administered as a total loading dose of 2 g/kg (20 mL/kg) given in divided doses over two to five consecutive days.
• PRIVIGEN may be administered as a maintenance infusion of 1 g/kg (10 mL/kg) administered in a single infusion given in one day or divided into two doses given on two consecutive days, every 3 weeks.
• Maintenance therapy beyond 6 months has not been studied.
• The recommended initial infusion rate is 0.5 mg/kg/min (0.005 mL/kg/min).
• If the infusion is well tolerated, the rate may be gradually increased to a maximum of 8 mg/kg/min (0.08 mL/kg/min).
• For patients judged to be at risk for thrombosis, renal dysfunction, or volume overload, administer PRIVIGEN at the minimum infusion rate practicable.

Administration:

• PRIVIGEN is for intravenous administration only.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As liquid solution containing 10% IgG (0.1 g/mL).

This medicine is available in fallowing brand namesː

• PRIVIGEN

What side effects can this medication cause?

The most common side effects of this medicine include: In case Primary humoral immunodeficiency (PI):

• headache
• fatigue
• nausea
• chills
• vomiting
• back pain
• pain
• elevated body temperature
• abdominal pain
• diarrhea
• cough
• stomach discomfort
• chest pain
• joint swelling/effusion
• influenza-like illness
• pharyngolaryngeal pain
• urticaria
• dizziness
• Serious adverse reactions were hypersensitivity, chills, fatigue, dizziness, and increased body temperature.

In case of Chronic immune thrombocytopenic purpura (ITP):

• hemolysis (hemoglobin and hematocrit decrease without blood loss in conjunction with positive direct antiglobulin test (DAT) and elevated blood lactate dehydrogenase (LDH) and/or indirect bilirubin)
• headache
• elevated body temperature
• anemia
• nausea
• vomiting
• A serious adverse reaction was aseptic meningitis.

In case of Chronic inflammatory demyelinating polyneuropathy (CIDP):

• headache
• asthenia
• hypertension
• nausea
• pain in extremity
• hemolysis
• influenza like illness
• leukopenia
• rash

Serious adverse reactions were hemolysis, exacerbation of CIDP, acute rash, blood pressure diastolic increased, hypersensitivity, pulmonary embolism, respiratory failure, and migraine.

What special precautions should I follow?

• IgA-deficient patients with antibodies to IgA are at greater risk of developing severe hypersensitivity and anaphylactic reactions. PRIVIGEN is contraindicated in patients with antibodies against IgA and a history of hypersensitivity.
• Renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur with immune globulin intravenous (IGIV) products in predisposed patients. Monitor renal function, including blood urea nitrogen and serum creatinine, and urine output in patients at risk of developing acute renal failure.
• Hyperproteinemia, increased serum viscosity, and hyponatremia may occur.
• Aseptic meningitis syndrome (AMS) may occur, especially with high doses or rapid infusion. Conduct a thorough neurological examination on patients exhibiting such signs and symptoms, including CSF studies, to rule out other causes of meningitis.
• Hemolysis that is either intravascular or due to enhanced red blood cell sequestration may occur. Risk factors include high doses and non-O blood group. Closely monitor patients for hemolysis and hemolytic anemia.
• Elevations of systolic and diastolic blood pressure (including cases of hypertensive urgency) have been observed during/shortly following PRIVIGEN infusion. These blood pressure elevations were resolved or significantly improved within hours with either observation alone or changes in oral anti-hypertensive therapy. Check patients for a history of hypertension and monitor blood pressure during and following PRIVIGEN infusion.
• Monitor patients for pulmonary adverse reactions (transfusion-related acute lung injury [TRALI]).
• Carefully consider the relative risks and benefits before prescribing the high dose regimen (for chronic ITP and CIDP) in patients at increased risk of thrombosis, hemolysis, acute kidney injury, or volume overload.
• PRIVIGEN is made from human blood and may contain infectious agents, e.g., viruses, the variant Creutzfeldt Jakob disease [vCJD] agent and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• Fluid overload
• hyperviscosity
• impaired renal function

Can this medicine be used in pregnancy?

• No human data are available to indicate the presence or absence of drug-associated risk.
• It is not known whether PRIVIGEN can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.

Can this medicine be used in children?

• The safety and effectiveness of PRIVIGEN have not been studied in clinical trials in pediatric patients with PI who are under the age of 3.
• The safety and effectiveness of PRIVIGEN have not been established in pediatric patients with chronic ITP who are under the age of 15.
• The safety and effectiveness of PRIVIGEN have not been established in pediatric patients with CIDP who are under the age of 18.

What are the active and inactive ingredients in this medicine?

Active ingredient: Human Immunoglobulin G

Inactive ingredients: Human Immunoglobulin A Albumin Human proline

Who manufactures and distributes this medicine?

Manufactured by: CSL Behring AG Bern, Switzerland

Distributed by: CSL Behring LLC Kankakee, IL USA

What should I know about storage and disposal of this medication?

• Keep PRIVIGEN in its original carton to protect it from light.
• Each vial has an integral suspension band and a label with two peel-off strips showing the product name, lot number, and expiration date.
• When stored at room temperature (up to 25ºC [77ºF]), PRIVIGEN is stable for up to 36 months, as indicated by the expiration date printed on the outer carton and vial label.
• Do not freeze.

• Dailymed label info on Privigen
• FDA Privigen

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