100 mg / ml (10%) solution for infusion
human normal immunoglobulin (IVIg)
What Privigen is and what it is used for
What Privigen is
Privigen belongs to a group of medicines called human normal immunoglobulin. Immunoglobulins are also called antibodies and are blood proteins that help the body fight infections in healthy people.
How Privigen works
Privigen contains immunoglobulins that have been produced from the blood of healthy people. The drug works in the same way as the natural immunoglobulins found in the blood.
What is Privigen used for?
Privigen is used for the treatment of adults and children (0-18 years) in the following situations:
- To increase abnormally low immunoglobulin levels in the blood so that they reach normal levels (replacement therapy):
- Patients born with the impaired ability or inability to produce immunoglobulins (primary immunodeficiency disease (PID)).
- Patients with an acquired immune deficiency (SID) who suffer from severe or recurrent infection, ineffective antimicrobial treatment, and either demonstrated specific antibody deficiency or an IgG serum level of <4g / l.
- To treat certain inflammatory diseases (immune modulation). There are 5 groups:
- Patients who do not have a sufficient number of platelets ( thrombocytes ) (primary immunological thrombocytopenia (ITP) and who are at high risk of bleeding or need surgery shortly.
- Patients with Guillain-Barré syndrome . This is an acute disease characterized by inflammation of the peripheral nerves, which causes severe muscle weakness, mainly in the legs and arms.
- Patients with Kawasaki disease. This is an acute illness that mainly affects young children. It is characterized by inflammation of the blood vessels throughout the body.
- Patients with chronic inflammatory demyelinating polyneuropathy (CIDP). This is a chronic disease characterized by inflammation of the peripheral nerves, which causes muscle weakness and/or numbness mainly in the legs and arms.
- Patients with multifocal motor neuropathy (MMN). This is a slowly progressive disease of the motor neuron with weakness in the arms and legs.
What you need to know before using Privigen
Do not use Privigen
→ Read this section carefully. You and your doctor should decide on the information before you receive Privigen.
DO NOT use Privigen
- if you are allergic to human immunoglobulins or proline.
- if you have developed antibodies against IgA immunoglobulins in your blood.
- if you suffer from hyperprolinemia type I or II (a genetic disease that causes high levels of the amino acid proline in the blood). This is an extremely rare disorder. Only a few genera with this disease are known in the world.
Warnings and cautions
What circumstances may increase the risk of side effects?
→ Before treatment, tell your doctor or healthcare professional if any of the following apply to you:
- You will receive this medicine in high doses, either on day 1 or for several days and you have blood type A, B, or AB and/or an underlying inflammatory disease. Under these circumstances, immunoglobulins have often been reported to increase the risk of red blood cell degradation ( hemolysis ).
- You are overweight, older, have diabetes, have been in bed for a long time, have high blood pressure, have too little blood volume ( hypovolemia ), have problems with blood vessels (vascular disease), and have an increased tendency to blood clots (thrombophilia or thrombotic episodes), or have a disease or condition that causes the blood to thicken (hypervisible blood). Under these circumstances, immunoglobulins may increase the risk of a heart attack (heart attack), stroke, blood clot in the lung ( pulmonary embolism ), or blockage of a blood vessel in the legs, but only in very rare cases.
- You have diabetes. Even if Privigen does not contain sugar, the product may have been diluted with a special sugar solution (5% glucose ), which may affect your blood sugar level.
- You have or have had kidney problems before or are taking medicines that can damage your kidneys (nephrotoxic drugs). Under these circumstances, immunoglobulins may increase the risk of severe renal impairment ( acute renal failure ), but only in very rare cases. Fatal renal failure has occurred in isolated cases in connection with hemolysis.
What type of monitoring is needed during infusion one?
For your safety, one infusion of Privigen will be given under the supervision of your doctor or healthcare professional. You will usually be observed throughout the infusion one and then for at least 20 minutes. Under certain conditions, special precautions may be necessary. Examples of such conditions are:
- you get Privigen with a high infusion rate or
- you receive Privigen for the first time or after a long break in treatment (eg several months)
In these cases, you will be closely monitored throughout the infusion one and for at least 1 hour thereafter.
When may you need to slow down or stop the infusion?
- You may be allergic (hypersensitive) to immunoglobulins without knowing it. However, true allergic reactions are rare. They can occur even if you have previously received human immunoglobulins and tolerated them well. This can especially happen if you have developed antibodies to IgA immunoglobulins. In these rare cases, allergic reactions such as a sudden drop in blood pressure or shock may occur (see also section 4 “Possible side effects”).
- In very rare cases, transfusion-related acute lung injury (TRALI) may occur after receiving immunoglobulins. This leads to an accumulation of fluid in the lungs that is not due to heart problems (non-cardiogenic pulmonary edema ). TRALI is characterized by difficulty breathing (difficulty breathing), bluish skin (cyanosis), abnormally low blood oxygen levels ( hypoxia ), decreased blood pressure ( hypotension ), and increased body temperature (fever). The symptoms usually appear during or within 6 hours after receiving the treatment.
→ Tell your doctor or healthcare professional immediately if you notice any such reactions while receiving an infusion of Privigen. He or she will decide whether to slow down the infusion rate or to stop the infusion altogether.
Blood tests
→ Tell your doctor that you are being treated with Privigen before any blood tests.
Once you have received Privigen, the results of certain blood tests (serological tests) may be impaired for some time.
Safety information regarding your infection
Privigen is made from human blood plasma (this is the liquid part of the blood).
When medicines are made from human blood or plasma, certain measures are taken to prevent infection from being transmitted to patients. These include:
- careful selection of blood and plasma donors to ensure that those who may have an infection are excluded;
- testing of each donor and plasma pool for signs of viruses/infections,
- introduction of steps in the preparation of blood or plasma that can inactivate or remove viruses.
Despite these measures, the risk of transmitting infectious agents can not be completely ruled out when administering medicinal products derived from human blood or plasma. This also applies to any unknown or new viruses and other types of infection.
Measures taken are considered effective against enveloped viruses, such as human immunodeficiency virus ( HIV ), hepatitis B virus, and hepatitis C virus, as well as against enveloped viruses such as hepatitis A virus and parvovirus B19.
Immunoglobulins have not been associated with hepatitis A or parvovirus B19 infections, possibly because antibodies to these infections, which are present in the product, have a protective effect.
- It is strongly recommended that each time you receive a dose of Privigen, note the product name and batch number to have a list of the batches that have been used.
Other medicines and Privigen
→ Tell your doctor or healthcare professional if you are taking, have recently taken, or might take any other medicines.
Concomitant use of drugs that increase the excretion of water from the body (loop diuretics) should be avoided during treatment with Privigen. Your doctor will decide if you should use or continue treatment with loop diuretics.
Vaccinations
→ Tell the vaccinating doctor that you are being treated with Privigen before the vaccination is given.
Once you have received Privigen, the effect of some vaccinations may be reduced. The vaccinations that are affected are vaccinations with live, attenuated virus vaccines, such as vaccinations against measles, mumps, rubella, and chickenpox. Such vaccinations should be postponed for at least 3 months after the last infusion of Privigen. In the case of measles vaccinations, this deterioration can persist for up to 1 year. Therefore, the vaccinating doctor should check the effect of the measles vaccination.
Pregnancy and breastfeeding
→ If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or healthcare professional for advice before taking this medicine. Your doctor will decide if you can receive Privigen during pregnancy or while you are breastfeeding.
Nevertheless, drugs containing antibodies have been used in pregnant and lactating women. Long-term experience has shown that no harmful effects during pregnancy or in the newborn are expected.
If you receive Privigen while you are breastfeeding, the antibodies in this medicine will also be present in your breast milk. Thus, your child can also receive the protective antibodies.
Driving and using machines
During treatment with Privigen, patients may experience effects such as dizziness or nausea that may affect their ability to drive and use machines. If this happens, do not drive or use machines until these effects have disappeared.
Privigen contains proline
You must not take this medicine if you have hyperprolinaemia (see also section 2 “What you need to know before using Privigen”).
→ Tell your doctor before treatment.
Sodium content
This medicine contains less than 2.3 mg sodium (the main ingredient in table salt/table salt) per 100 ml. This corresponds to 0.12% of the highest recommended daily intake of sodium for adults.
3. How to use Privigen
Privigen is for intravenous infusion only ( intravenous infusion ). It is usually given by your doctor or healthcare professional.
Your doctor will calculate the correct dose for you taking into account your weight, the specific circumstances described in section 2 “Warnings and precautions” and your response to treatment. The dose calculation for children and younger patients does not differ from that for adults. of infusion one, you will receive Privigen at a low infusion rate, if you tolerate this well your doctor may gradually increase the infusion rate.
If you have received too much Privigen
Overdose is highly unlikely as Privigen is usually given under medical supervision. If you, despite this, receive too much Privigen, your blood may become too thick (hypervisible), which may increase the risk of blood clots forming. This can especially happen if you are a patient at risk for it, for example, if you are elderly or if you suffer from a heart or kidney disease. Tell your doctor if you know you have any medical problems.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Any side effects can be reduced or even avoided altogether by giving Privigen at a slow rate. Such side effects can occur even if you have previously received human immunoglobulins ( antibodies ) and have tolerated them well.
In rare and isolated cases, the following side effects have been reported with immunoglobulin preparations:
- severe hypersensitivity reactions, such as a sudden drop in blood pressure or anaphylactic shock (eg you may feel dizzy, faint when standing up, have cold hands and feet, abnormal heartbeat or chest pain, or blurred vision) even if you have not shown any hypersensitivity to the previous infusion er.
→ Tell your doctor or healthcare professional immediately if you notice any such signs during infusion with Privigen. He or she will decide if the infusion rate should be reduced or if the infusion should be stopped completely.
- formation of blood clots that can be transported away by the blood circulation (thromboembolic reactions) and cause e.g. myocardial infarction (eg if you experience sudden chest pain or shortness of breath), stroke (eg if you experience a sudden onset of muscle weakness, loss of sensation and/or impaired balance, decreased alertness or difficulty speaking), blood clots in the pulmonary arteries (t. eg if you experience chest pain, difficulty breathing or coughing up blood), deep vein thrombosis (eg if you get redness, feeling hot, pain, tenderness or swelling in one or both legs).
- chest pain, chest discomfort, painful breathing due to transfusion-related lung injury (TRALI)
→ Tell a doctor or healthcare professional immediately if you get any of the above symptoms. Anyone with such symptoms should be taken immediately to the hospital’s emergency department for examination and treatment.
- temporary non-infectious meningitis ( reversible aseptic meningitis )
→ Tell your doctor or healthcare professional immediately if you feel stiff in the neck and also have one or more of the following symptoms: fever, nausea, vomiting, headache, abnormal photosensitivity, and mental disorders.
- increase in creatinine levels in the blood
- proteins
- acute renal failure
- transient decrease in red blood cell count ( reversible hemolytic anemia/hemolysis), anemia, leukopenia, and anisocytosis (including microcytosis).
Adverse reactions observed in controlled clinical trials and post-marketing experiences are presented in descending order of frequency:
Very common (may affect more than 1 in 10 people):
Headache, (including sinus headache, migraine, headache, tension headache), pain (including back pain, extremity pain, joint and skeletal pain ( arthralgia ), neck pain, facial pain), fever (including chills), flu-like illness (including runny nose) nose ( nasopharyngitis ) sore throat, (pharyngolaryngeal pain), blisters in the mouth and throat (oropharyngeal blisters), feeling of tightness in the throat).
Common (may affect up to 1 in 10 people):
A temporary decrease in red blood cell count ( anemia ), red blood cell degradation ( hemolysis including hemolytic anemia ) β, decreased white blood cell count ( leukopenia ), hypersensitivity, dizziness (including dizziness), hypertension ( hypertension ), redness (including hot flashes, hyperemia) ), hypotension (including decreased blood pressure ), shortness of breath ( dyspnoea including chest pain, chest discomfort, painful breathing), upset stomach (nausea), vomiting, loose stools (diarrhea), abdominal pain, skin problems (including rash, itching ( pruritus ), hives ( urticaria ), maculopapular rash, redness ( erythema ) scaling (skin exfoliation)), muscle pain (including muscle cramps and stiffness), fatigue, physical weakness ( asthenia ) and muscle weakness.
Routine laboratory tests can often show changes in liver function (hyperbilirubinemia) as well as changes in the number of blood cells (eg positive Coombs (direct) test), an increase in alanine aminotransferase, an increase in aspartate aminotransferase, increase in lactate dehydrogenase in the blood.
Uncommon (may affect up to 1 in 100 people):
Transient non-communicable meningitis ( reversible aseptic meningitis ), irregular shape of red blood cells (microscopic findings), presence of high platelets in the blood ( thrombocytosis ), drowsiness, tremors ( tremor ), palpitations, rapid pulse ( tachycardia ) blood supply to the legs such as causes pain when walking ( peripheral vascular disease), high levels of serum proteins in the urine ( proteinuria with elevated blood creatinine), pain at the injection site (including discomfort at the infusion site).
In isolated cases (post-marketing experience) the following have been observed in patients treated with Privigen: abnormally low levels of a certain type of white blood cell called neutrophils (decreased neutrophils ), anaphylactic shock, painful breathing due to transfusion-related acute lung injury (TRALI) and acute renal failure.
β Cases of hemolytic anemia after completion of a controlled clinical trial were observed with a significant decrease in frequency due to improvements in the manufacturing process of Privigen.
→ If you get any side effects, talk to your doctor or healthcare professional. This also applies to any side effects not mentioned in this information.
Also, read section 2 “What you need to know before using Privigen” for further information on the circumstances that increase the risk of side effects.
How to store Privigen
- Keep out of sight and reach of children.
- Do not use this medicine after the expiry date which is stated on the outer carton and vial label after EXP. The expiration date is the last day of the specified month.
- As the solution does not contain any preservative, healthcare professionals must inject it as soon as possible after opening the vial.
- Do not store above 25 ° C.
- Do not freeze.
- Keep the vial in the outer carton. Sensitive to light.
- Do not use this medicine if you notice that the solution is cloudy or contains particles.
Contents of the pack and other information
Content declaration
- The active substance is human, normally immunoglobulin ( IgG-type antibodies ). Privigen contains 100 mg/ml (10%) of human protein of which at least 98% is IgG. The approximate percentage distribution of the IgG subclasses is as follows:
| IgG 1 ………………………………………… ……… | 69% |
| IgG 2 ………………………………………… ……… | 26% |
| IgG 3 ………………………………………… ………. | 3% |
| IgG 4 ………………………………………… ………. | 2% |
The drug contains trace amounts of IgA (not more than 25 micrograms/ml).
- The other ingredients (excipients) are the amino acid proline, water for injections, and hydrochloric acid or sodium hydroxide (for pH adjustment).
What the medicine looks like and the contents of the pack
Privigen is available as an infusion solution.
The solution is clear or slightly shimmery and colorless to pale yellow.
Pack sizes:
1 vial (2.5 g / 25 ml, 5 g / 50 ml, 10 g / 100 ml, 20 g / 200 ml or 40 g / 400 ml),
3 vials (10 g / 100 ml or 20 g / 200 ml).
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
CSL Behring GmbH
Emil-von-Behring-Strasse 76
D-35041 Marburg
Germany