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Privigen Medication

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privigen IVIG

Privigen Medication

What is Privigen Immune Globulin Intravenous?

Privigen I is a 10 percent liquid human IgG derived from human plasma. It is supplied in a single, ready-to-use, sterile, 10% vial.  It is stable at room temperature for the period of its expected lifespan (up to 36 months). In addition, Privigen medication has a distribution of IgG subclasses that is similar to normal serum.

 

Approximately 99.2 percent of the composition comprises IgG. The remaining 8 percent is composed of monomers and dimers. At undetectable levels (1.8 mg/ml), IgA is present in the sample of Privigen IVIG.

 

Privigen drug is stabilized at a pH of 4.8 by the amphiphilic amino acid L-proline (250 mmol/l), which is present in high concentrations in the solution.

 

This formulation is intended to reduce denaturation, degradation, aggregation of IgG to the greatest extent possible.

 

L-proline prevents the formation of excessive amounts of idiotype/anti-idiotype dimers during storage.  This prevents the development of inflammatory reactions following intravenous administration of the compound.  It is well established that decreasing Privigen IgG dimer formation leads to an improvement in clinical tolerability.

 

Strict controls are in place to reduce the potential for pathogen transmission through this therapeutic product.  This includes donation control and plasma pools screening.

 

Speak to a Specialist about Privigen Copay Assistance

 

Manufacturer Process

Privigen’s manufacturer process includes four validated steps:

The virus and prion elimination capabilities of Privigen IVIG are enough to prevent the transmission of well-known and new pathogens.

 

 

Indications and Uses

Privigen medication works by boosting the immune system.  This reduces the risk of infection for people with a weakened immune system.

It is used to treat a variety of conditions. Normal human blood is used to manufacture Privigen.   It contains a high concentration of certain defensive substances (antibodies) that fight against infection.

 

Furthermore, Privigen is used to increase the number of blood platelets in people who have a specific blood disorder such as chronic idiopathic thrombocytopenic purpura-ITP.

 

Platelets are an important component that helps contribute to the formation of blood clots that stop bleeding.  In addition, Privigen may be used to treat a specific type of muscle weakness. For example, multifocal motor neuropathy, nerve disorders such as peripheral neuropathy, and chronic inflammatory demyelinating polyneuropathy-CIDP.

 

According to the Privigen manufacturer, Privigen may also be used to prevent certain blood vessel disorders in individuals with Kawasaki syndrome.

 

 

Treatment/Therapy

 

Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Privigen helps alleviate the disability and improve the neuromuscular function of CIDP patients.

 

Chronic Immune Thrombocytopenic Purpura (ITP)

Privigen increases the platelet counts in patients with ITP who are 15 years of age or older.

 

Primary Humoral Immunodeficiency (PI)

  • Privigen Is An Fda-approved Pi Replacement Therapy.
  • Wiskott-aldrich Syndrome
  • Common Variable Immunodeficiency (CVID)
  • X-linked Agammaglobulinemia
  • Scid (Severe Combined Immunodeficiencies)
  • Congenital Agammaglobulinemia
  • Congenital Agammaglobulinemia

 

These are all examples of primary humoral immune deficiencies.

 

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Pediatric Uses

Treatment of CIDP

According to the manufacturer, it has not been established whether Privigen is safe and effective in CIDP patients (who are less than 18 years old)

 

Treatment of Chronic ITP (Chronic Idiopathic Thrombocytopenic Purpura)

The safety and efficacy of Privigen has not been determined in chronic ITP who are under the age of 15 years old.

 

Treatment of Primary Humoral Immunodeficiency

A study was conducted to investigate the efficacy and safety of Privigen infusion for the treatment of PI. The study included 31 participants (12 adolescents and 19 children) who had previously been diagnosed with PI.

The study showed that there was no significant difference in the efficacy and safety of Privigen use in both the adult and pediatric tested samples. However, there was no data about the efficacy and safety of Privigen in PI patients under the age of 3 years old.

 

 

Uses In Specific Populations

Use In Lactating Mothers

Risk Summary

When it comes to determining whether a situation is Privigen drug-related, there is no human data available. Breastfeeding has numerous developmental and health benefits. Concerns about Privigen’s clinical necessity and possible Privigen side effects on the breastfed child must be considered.

 

Use In Pregnancy

Risk Summary

There is no human data available to determine whether or not there is a Privigen drug-related risk in pregnancy.

 

Privigen has not been subjected to animal reproduction studies as of this writing. It is unknown if Privigen medication will cause harm to the developing fetus or impair women’s ability to reproduce when administered.

 

After 30 weeks of pregnancy, immunoglobulins from the mother’s circulation begin to cross the placenta in more significant quantities.

 

During pregnancy, Privigen IVIG should only be used as needed. It is estimated that the background risk of significant congenital disabilities and miscarriage in clinically recognized pregnancies in the United States is 2-4 percent and 15-20 percent in clinically recognized pregnancies, respectively, in the general population of The United States.

 

 

Prescribing Information

Dosing for CIDP (Chronic Inflammatory Demyelinating Polyneuropathy)

The loading dose is 20 mL/kg (2 g/kg) over two to five days is recommended. Based on the patient’s weight, Privigen infusions (maintenance) can be given as a single dose or two doses every three weeks.

 

No research has been done on maintenance therapy after six months.

 

The manufacturer recommends an initial infusion rate of 0.005 mL/kg/min (0.5 mg/kg/min).

 

In some cases, the Privigen infusion rate can be increased to 0.08 mL/kg/min (8 mg/kg) if tolerated.

Privigen should be given at the lowest possible rate to patients at risk of volume overload, thrombosis, or renal dysfunction.

 

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Dosing For Chronic Immune Thrombocytopenic Purpura (Itp)

Chronic ITP patients should receive a Privigen dose of 10 mL/kg (1 g/kg) over two days for a total of 2 g/kg.

 

Privigen IVIG is also prescribed for the treatment of acute ITP. In patients who are at risk of volume overload, acute kidney injury, hemolysis, or thrombosis, it is important to carefully weigh the risks and benefits of the treatment.

 

 

Dosing for Primary Humoral Immunodeficiency (PI)

Patients with PI may require different levels of immunoglobulin therapy at other times of their lives because the half-life of Privigen IgG varies significantly from one patient to the next.

 

With the help of clinical response monitoring, it is possible to determine the appropriate dose.

 

Privigen is prescribed for patients with a dose of 2 to 8 mL/kg (200 to 800 mg/kg) every 3 to 4 weeks.

 

If the patient misses a dose, give him/her the missed dose then resume the next infusion every three or four weeks from the missed dose.

 

To achieve desired serum IgG levels and clinical responses, dosage should be tailored to each individual.

 

 

Infusion Rate Chart

Recommended Dosage Of Privigen

IndicationDosagePrivigen infusion Rate (Initial)Privigen infusion Rate as tolerated (Maintenance)
Privigen infusion Rate as tolerated (Maintenance)Loading privigen dosing: 20 mL/kg (2 g/kg) administered in half doses over a period of 2 to 5 days. Maintenance privigen dosing: 10 mL/kg (1 g/kg) administered in 1 to 2 infusions on consecutive days, every 3 weeks0.005 mL/kg/min (0.5 mg/kg/min)0.005 mL/kg/min (0.5 mg/kg/min)
Chronic Immune Thrombocytopenic Purpura (ITP)10 mL/kg (1 g/kg) for 2 consecutive days0.005 mL/kg/min (0.5 mg/kg/min)Increase to 0.04 mL/kg/min (4 mg/kg/min)
Primary Immunodeficiency (PI)2-8 mL/kg (200-800 mg/kg) every 3-4 weeks0.005 mL/kg/min (0.5 mg/kg/min)Increase to 0.08 mL/kg/min (8 mg/kg/min)

 

Common Side Effects

Common Privigen side effects include:

  • Headache
  • Nausea
  • Flushing (tingly feeling, redness, or warmth)
  • Fever
  • Minor chest pain
  • Tired feeling
  • Dizziness
  • Low levels of iron in the blood (anemia),
  • Chills
  • Fatigue
  • Vomiting
  • Back or joint pain
  • Muscle cramps

 

 

Contraindication Of Privigen Infusion

  • Privigen infusion should not be used in patients with IgA deficiency or anti-IgA antibodies.
  • Privigen infusion should not be used in patients with hyperprolinemia because Privigen contains the stabilizer L-proline.
  • History of severe systemic or anaphylactic reactions is a contraindication to Privigin use.

 

Ask an IVIg Specialist about Privigen Side Effects

 

Privigen Infusion Side Effects

 

Hypersensitivity

It is possible to experience severe hypersensitivity reactions on giving Privigen infusion.

 

Immediately discontinue the Privigen infusion and seek appropriate medical attention if you experience an allergic reaction.

 

Epinephrine should be available immediately to treat acute hypersensitivity reactions. Although Privigen immunoglobulin contains trace amounts of IgA (25 mcg/mL), it is not toxic. Anti-IgA antibodies may develop in individuals with IgA deficiency as a result of receiving blood components containing IgA. Anaphylactic reactions are also possible (including anaphylaxis and shock).

 

Privigen immunoglobulin may cause severe anaphylactic and hypersensitivity reactions in patients with known IgA antibodies.

 

Transmissible Infectious Agents

Because Privigen immunoglobulin is made from human plasma, it can spread infectious agents (e.g., viruses, the Creutzfeldt Jakob disease agent, and the variant Creutzfeldt Jakob disease agent).

 

Virus inactivation/removal steps during the manufacturing process of Privigen have all been identified as beneficial in reducing the likelihood of viral transmission.

 

Interference with Laboratory Tests

Because Privigen immunoglobulin preparations contain passively transferred antibodies, serological test results may be misinterpreted.

 

Volume Overload

When considering whether to prescribe a high-dose Privigen infusion (for chronic inflammatory polyneuropathy demyelinating and chronic immune thrombocytopenic purpura), physicians must carefully consider the risks and benefits to patients who are at risk of volume overload, acute kidney injury, hemolysis, and thrombosis.

 

Hypertension

Privigen infusion raised patients’ systolic blood pressure to 180 mm Hg and diastolic to 120 mm Hg (hypertensive urgency). After a few hours, the blood pressure returned to normal, either by observation or by modifying oral antihypertensive therapy. Patients with a history of hypertension were more likely than other patients to have elevated blood pressure. Whether the patient has a history of hypertension or currently taking antihypertensive medication, the blood pressure should be monitored before, during, and after Privigen infusion.

 

Hemolysis

Privigen immunoglobulins may contain hemolysin-like blood group antibodies that coat red blood cells in vivo (RBCs). This may result in a positive DAT (Coombs’ test) and hemolysis. Increased RBC sequestration can cause delayed hemolytic anemia after Privigen IVIG therapy.

 

Privigen infusion therapy has been associated with acute intravascular hemolysis. Privigen medication has been linked to disseminated intravascular coagulation (DIC) and severe hemolysis-related acute renal failure/acute renal dysfunction. High privigen doses (e.g., privigen 2g/kg) are given in a single privigen dose or over several days. Other patient factors, besides underlying inflammatory conditions (such as elevated erythrocyte sedimentation rate or CRP, C-reactive protein), may increase the risk of hemolysis after Privigen IVIG administration.

 

Still, their significance has not been established yet. It has been reported that hemolysis can occur as a side effect of Privigen IVIG treatment for various conditions, including chronic ITP, CIDP, and PI.

 

Patients with the above risk factors, anemia, and cardiovascular or pulmonary compromise should be closely monitored for hemolysis-related symptoms.

 

Higher-risk patients should have appropriate laboratory testing performed before the treatment initiation, approximately 36 hours after the Privigen infusion, and again 7 to 10 days later.

 

Other tests to monitor the treatment should be done as well. Clinically suspected hemolysis or a significant hemoglobin or hematocrit decrease requires additional laboratory testing to confirm the diagnosis. It is essential to perform adequate cross-matching in patients who develop hemolysis and clinically substantial anemia due to privigen IVIG to avoid the exacerbation of the existing hemolysis.

 

Thrombosis

The use of Privigen immune globulin products can result in thrombosis as a side effect.

Risk factors may include the following:

  • Cardiovascular risk factors
  • Hyperviscosity
  • Advanced age
  • Indwelling central vascular catheters
  • Prolonged immobilization Hypercoagulable conditions
  • Use of estrogens
  • History of venous or arterial thrombosis
  • Hypercoagulable conditions

Thrombosis can occur even without known risk factors. If you have a patient who is at risk for hyperviscosity, you should have them tested.

 

This includes people who have cryoglobulins, fasting chylomicronemia, and significantly elevated triglycerides and people who have monoclonal gammopathies.

 

Thrombosis-prone patients should receive Privigen medication at the lowest effective dose and Privigen infusion rate.

 

Before administering Privigen, make sure that the patients are adequately hydrated. Patients who are at risk for hyperviscosity should be closely monitored for thrombosis as well as hyperviscosity, according to the American Heart Association.

 

Aseptic Meningitis Syndrome (AMS)

Privigen and other human immune globulin products may cause AMS, which is a rare complication.

Patients experienced complete recovery within a few days of treatment discontinuation, with no complications. AMS usually manifests itself several hours to two days after receiving Privigen IVIG treatment.

The presence of AMS is indicated by the presence of the following signs and symptoms:

  • Nausea
  • Vomiting
  • Painful eye movements
  • Severe headache
  • Photophobia
  • Fever
  • Drowsiness
  • Nuchal rigidity

Despite high pleocytosis and protein levels in CSF, culture results are consistently negative.

 

Whenever these symptoms are present, patients should be subjected to a comprehensive neurological examination, including CSF studies, to rule out any other possible causes of meningitis.

 

Acute muscle syndrome may occur in patients receiving high doses of Privigen (Privigen 2g/kg) and rapid infusions.

 

Increased Serum Viscosity, Hyponatremia, And Hyperproteinemia

High serum viscosity, Hyponatremia, and Hyperproteinemia are all possible side effects of Privigen immunoglobulin IV products following treatment. It is most likely that the Hyponatremia is pseudo, as evidenced by decreased serum osmolality or an increase in the osmolar gap.

 

It is very important to differentiate between pseudo Hyponatremia and true Hyponatremia because treating Hyponatremia can cause volume loss, increased risk of thromboembolic events, increased serum viscosity.

 

Transfusion-Related Acute Lung Injury (TRALI)

Noncardiogenic pulmonary edema may occur as a side effect of treatment with immunoglobulin IV products, such as Privigen.

 

Treated respiratory distress syndrome (TRDS) is distinguished by the presence of significant respiratory distress syndrome (DRS) symptoms and pulmonary edema, hypoxia, and fever. Symptoms usually appear 1–6 hours after treatment.

 

Acute pulmonary reactions should be closely monitored. PER THE MANUFACTURER’S INSTRUCTIONS, if TRALI is suspected, physicians should test the product and the patient’s serum for anti-neutrophil and anti-human leukocyte antigen (HLA) antibodies. TRALI is a condition that can be effectively managed with oxygen therapy in conjunction with adequate ventilation support.

 

Acute Renal Failure and Renal Dysfunction

The use of Privigen immunoglobulin IV products in patients predisposed to renal dysfunction/acute renal failure can result in osmotic nephrosis, acute renal failure, and even death.

 

Renal dysfunction and acute renal failure are more common in patients who receive intravenous immunoglobulin products containing sucrose than in those who do not receive such products. Privigen medication does not contain any sucrose in any form whatsoever.

 

Because of the hemolysis caused by Privigen, it is possible to develop acute renal failure as a Privigen side effect. To prevent this, assure that patients are not dehydrated and that their renal function is monitored, including serum creatinine and BUN, before and after the initial Privigen infusion. Patients at risk for ARF (acute renal failure) must have their renal function and urine output monitored continuously.

 

If your renal function begins to deteriorate, you should consider stopping Privigen infusion. Assume a patient has a genetic predisposition to acute renal failure or pre-existing renal insufficiency. In that case, Privigen medication should be infused slowly.

 

 

Drug Interactions

Live Virus Vaccines

Immunoglobulin administration may alter the response of live vaccines such as varicella, rubella, mumps, measles, and other live vaccines.

 

Notify the immunizing physician of any current Privigen therapy to allow for the implementation of appropriate preventive measures.

 

 

Prices

Privigen Cash Cost

QuantityPrivigen cost (Per unit)Privigen Price
400 milliliters $15.92$6,367.46
200 milliliters$15.94$3,188.48
100 milliliters $15.99$1,598.99
50 milliliters $16.09$804.25

The cost of a 50-milliliter vial of Privigen solution 10% ranges from approximately $804 to $904. The cash prices vary based on the dispensing pharmacy.

 

Prices through insurance plans are different, as they are based on what type of coverage the patient has.

 

 

Copay Assistance

Low-income, uninsured, or underinsured individuals who meet certain criteria can benefit from Privigen PAPs (Privigen patient assistance programs). Free or discounted Privigen medications are frequently provided by pharmaceutical companies as part of their sponsorship to those who qualify.

 

Each program has its own set of eligibility requirements, which vary from one another.

The following are some foundations providing Privigen copay assistance:

  • Patient Access Network Foundation (PAN)
  • HealthWell Foundation Privigen Copay Program
  • My Source Privigen CSL Behring Patient Assistance Program
  • Privigen CSL Behring IgIQ Program (Privigen)

These Copay Assistance or Patient Assistance Program programs are only for US residents.

 

Get Privigen Copay Assistance – Speak to a Specialist

 

Common Questions

What Is Privigen Used To Treat?

IVIG is used to treat a variety of conditions including:

  • Certain infections
  • Primary humoral immunodeficiency
  • Chronic idiopathic thrombocytopenic purpura-ITP
  • Multifocal motor neuropathy
  • Peripheral neuropathy
  • Chronic inflammatory demyelinating polyneuropathy-CIDP
  • Certain blood vessel disorders (Kawasaki syndrome)

 

Does Privigen IVIG Cause Weight Gain?

There is currently no evidence that Privigen IVIG can cause weight gain, according to the available data.

 

Can Privigen Cause Blood Clots?

As stated earlier, it is used to treat the platelet disorders like chronic immune thrombocytopenic purpura.  However, Privigen IVIG increases the platelet count significantly, and therefore, there is a chance of clot formation, especially in older people.

To ensure this medication is safe for you, inform your doctor if you have any of the following:

  • long-term bed rest
  • Blood circulation problems
  • Heart problems
  • History of a blood clot
  • Diabetes
  • History of Stroke
  • Sepsis
  • kidney disease
  • History of estrogens use (hormone replacement therapy or birth control pills)

 

Is Privigen FDA approved?

Yes, it is an FDA-approved drug for the treatment of the following conditions:

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

 

 

References

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