Patient Medication Information: uses, side effects, how to take - Privigen
What is Privigen® used for?
Privigen® is a medication used to treat adults and children:
Who need antibody replacement therapy due to primary or secondary immune deficiency.
Primary Immune Deficiency (PID) patients are born with a reduced ability or inability to produce immunoglobulins. Secondary Immune Deficiency (SID) patients develop or acquire a reduced ability or inability to produce immunoglobulins due to environmental factors, certain diseases or certain therapies;
- Patients of above the age of 15 years who do not have enough blood platelets and who are at high risk of bleeding (immune thrombocytopenic purpura, ITP);
- Adults who suffer from chronic inflammatory demyelinating polyneuropathy (CIDP) which is a chronic disease characterised by inflammation of the peripheral nerves that causes muscle weakness and / or numbness mainly in the legs and upper limbs.
Serious Warnings and Precautions
- Immunoglobulin Intravenous (Human) (IVIG) products like Privigen® have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death, particularly in patients predisposed to acute renal failure.
There is clinical evidence of an association between the administration of
immunoglobulins and thromboembolic events such as myocardial infarction, stroke, pulmonary embolism and deep vein thrombosis. Therefore, caution should be exercised when prescribing and administering immunoglobulins.
- Risk factors for thromboembolic events include: advanced age, use of estrogens, in-dwelling central vascular catheters, history of vascular disease or thrombotic episodes, acquired or inherited hypercoagulable states, prolonged periods of immobilization, severe hypovolemia, diseases which increase blood viscosity and cardiovascular risk factors (including obesity, hypertension, diabetes mellitus).
- Thrombosis may occur even in the absence of known risk factors.
Privigen® is a highly purified product, called an immunoglobulin, made from human plasma.
Privigen® contains the antibody immunoglobulin G (IgG), which is found in the blood of healthy individuals to help combat germs, such as bacteria and viruses. Because it helps the body rid itself of these bacteria and viruses, IgG is important in helping the body fight disease and illness.
- Privigen® is supplied as a sterile liquid in single-use vials and is given by intravenous infusion.
How does Privigen® work?
Privigen® increases your levels of antibodies (in cases of Primary or Secondary Immune Deficiency or Immune Thrombocytopenia Purpura).
Privigen® is known as antibody replacement therapy, because it replaces the missing and much-needed IgG antibodies in people who have low levels of these infection-fighting proteins. By replacing these important antibodies, Privigen® helps make people with primary and secondary immune deficiency better able to avoid infections and fight them when they do occur.
The precise action of Privigen® in immune thrombocytopenic purpura is unknown, but it is believed to block platelet removal and therefore increase their number.
Likewise, the precise action of Privigen® in chronic inflammatory demyelinating polyneuropathy is not clear but it is believed to modify the pathway that leads to muscle weakness and / or numbness.
What are the ingredients in Privigen®?
Medicinal ingredients: Immunoglobulin Intravenous (Human)
Non-medicinal ingredients: L-proline
For a full listing of nonmedicinal ingredients, see Part I of the product monograph.
Privigen® comes in the following dosage forms:
Privigen® is a solution for intravenous infusion.
It is supplied in 2.5 g (25 mL bottle), 5 g (50 mL bottle), 10 g (100 mL bottle), 20 g (200 mL bottle) or 40 g (400 mL bottle). The concentration of the active ingredient is 10% or 100 g/L.
Do not use Privigen® if:
- People who have a history of severe allergic reactions to immunoglobulin treatment or have a condition known as selective IgA deficiency should not use Privigen®. Tell your doctor if you have ever had an allergic reaction due to either of these conditions. If a serious allergic reaction occurs at any time, stop the Privigen® treatment and contact your doctor or an emergency medical professional immediately.
Because clinical studies with pregnant women have not been conducted, if you are pregnant or think you may be pregnant, discuss with your doctor whether Privigen® is clearly needed. Please also consult your doctor about the use of this product if you are a nursing mother.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Privigen®. Talk about any health conditions or problems you may have, including if you:
- Are pregnant or think that you may be pregnant;
- Are nursing;
- Have a history of allergic or other adverse reactions to immunoglobulins;
- Recently have been vaccinated;
- Have been previously advised that you have IgA deficiency;
- Have a kidney disease;
- Have Hyperprolinemia (high levels of proline in the blood);
- You receive this medicine in high doses either on 1 day or over several days and you have a blood group A, B or AB and/or you have an underlying inflammatory condition. In these circumstances, it has been commonly reported that immunoglobulins increase the risk of breakdown of red blood cells (hemolysis).
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with Privigen®:
Privigen® can impair the efficacy of certain virus vaccines, such as measles, mumps, rubella
(also known by its abbreviation “MMR”), and varicella/chickenpox. Inform the immunizing physician of recent treatment with Privigen® so appropriate precautions can be taken.
- Other products must not be mixed with the Privigen® solution.
How to take Privigen®:
- Privigen® is injected intravenously.
- Your doctor will determine the appropriate dose for your treatment.
Usual dose:
The usual dose of Privigen® for patients with Primary and Secondary Immune Deficiency is 200 to 800 mg/kg body weight, every 3 to 4 weeks.
The usual dose of Privigen® for patients with Immune Thrombocytopenic Purpura is 1g/kg body weight for 2 consecutive days.
The usual starting dose of Privigen® for patients with chronic inflammatory demyelinating polyneuropathy is 2 g/kg bw divided over 2 to 5 consecutive days followed by maintenance doses of 1 g/kg bw over 1 to 2 consecutive days every 3 weeks.
Doses may be adjusted over time to achieve the desired clinical response and serum IgG levels.
Overdose:
Overdose can lead to fluid volume overload and hyperviscosity, particularly in patients at risk, including elderly patients or patients with cardiac or renal impairment.
If you think you, or a person you are caring for, have taken too much Privigen®, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms.
Missed Dose:
Inform your doctor if you missed a dose. Your next dose should be administered as soon as possible to ensure an adequate efficacy.
What are possible side effects from using Privigen®?
These are not all the possible side effects you may have when taking Privigen®. If you experience any side effects not listed here, tell your healthcare professional.
The following symptoms are common. If any of the listed symptoms occur, are severe or if they worry you, talk to your doctor or pharmacist:
- Anemia
- Chills
- Diarrhea
- Fatigue/tiredness
- Fever
- Headache
- High Blood Pressure (hypertension)
- Hypersensitivity
- Influenza (flu) like symptoms
- Nausea
- Pain
- Physical weakness (asthenia)
- Skin disorder (rash, itching, hives)
- Vomiting
Routine laboratory tests may uncommonly reveal changes to liver or kidney functions as well changes in blood count.
If the following symptoms occur, stop your medication and call your doctor or pharmacist without delay:
Anaphylactic shock: A rapid occurring severe allergic reaction that involves the whole body.
The symptoms to watch for are: Hives, swelling of the lips, tongue or throat, difficulty in breathing, low blood pressure, faintness, abdominal pain, nausea and vomiting.
- Hemolytic anemia/hemolysis (where you have too few red blood cells caused either by red blood cells dying early or dying because their cell membrane has been disrupted). The symptoms to watch for include: Fatigue, weakness, dizziness, headache, rapid heartbeat, ringing in the ears.
The following symptoms occur rarely but if they occur, you need to talk to your doctor or pharmacist about them:
Aseptic meningitis: Tell your doctor if you experience the following signs and symptoms:
severe headache, neck stiffness, drowsiness, fever, increased light sensitivity of the eye (photophobia), nausea, and vomiting after receiving Privigen. These symptoms might indicate aseptic meningitis, a temporary and reversible non-infectious inflammation of the protective membranes surrounding the brain and spinal cord. If you have a recurrence of aseptic meningitis with intravenous immunoglobulin treatment, your doctor will ask you about the emergence or worsening of your symptoms which may progress to swelling of the brain (brain oedema). Your doctor will decide if further tests are necessary and whether Privigen infusion should be continued.
- Blood clots (thromboembolism): If you are overweight, are elderly, have diabetes, have been bedridden for a long time, have high blood pressure, have low blood volume, have problems with your blood vessels, have an increased tendency for blood clotting or have a disease or a condition which causes your blood to thicken. In these circumstances, immunoglobulins may increase the risk of heart attack, stroke, blood clots in the lung, or blockage of a blood vessel in the leg, although only very rarely.
- Transfusion-related Acute Lung Injury (TRALI): Non-heart related accumulation of fluid in the air spaces of the lungs causing severe difficulty in breathing, chest pain, chest discomfort, painful respiration typically appearing within 1 to 6 hours after receiving treatment.
- Acute renal failure: If you have or had previously problems with your kidneys or take medicinal products that may harm your kidneys. In these circumstances, immunoglobulins may increase the risk of serious rapid loss of kidney function although only very rarely.
- Abnormally low level of specific white blood cells called neutrophils (decreased neutrophils counts).
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
Visiting the Web page on Adverse Reaction Reporting
(https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
We recommend that CSL Behring Canada be copied when reporting suspected side effects, at the following address:
AdverseReporting@CSLBehring.com
Storage:
Privigen® is supplied in single-use vials. It contains no preservatives, so any unused portion should be discarded immediately after injection. When stored either in the refrigerator or at room temperature (at +2˚C to +25˚C), Privigen® can be used until the expiration date on its label. Do not use after the expiration date. Do not freeze Privigen®. Keep the vial in its box during storage.
Keep out of reach and sight of children.
If you want more information about Privigen®:
- Talk to your healthcare professional
Find the full product monograph that is prepared for healthcare professionals and includes this
Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html; the manufacturer’s website (http://www.cslbehring.ca), or by calling 1-866-773-7721.