50 mg / ml solution for infusion
Human normal immunoglobulin (IVIg)
What Octagam is and what it is used for
What Octagam is:
Octagam is a solution containing human normal immunoglobulin (IgG) (solution containing human antibodies ) for intravenous administration ( infusion into a vein). Immunoglobulins are normal components in the body and form part of the body’s immune system. Octagam contains all subgroups of IgG that occur in healthy people. Appropriate doses of this medicine can restore abnormally low levels of IgG to normal levels.
Octagam contains many antibodies against various infectious agents.
What Octagam is used for:
Octagam is given as a substitution treatment to children, adolescents (0-18 years), and adults in different patient groups:
- Patients with congenital antibody deficiency (primary immunodeficiency syndrome, such as congenital agammaglobulinemia and hypogammaglobulinaemia , common variable immunodeficiency, severe combined immunodeficiency).
- Patients who have developed an antibody deficiency (secondary immunodeficiency) of a particular disease and / or treatment and who suffer from severe or recurrent infection .
Octagam can also be given as a treatment for the following autoimmune diseases (immune modulation):
- In patients with immunological thrombocytopenia (ITP), a condition in which platelets break down and therefore decrease in number, and who are at high risk of bleeding or who need to correct the number of platelets before surgery.
- In patients with Kawasaki disease, a condition that leads to inflammation of various organs.
- In patients with Guillain-Barré syndrome , a condition that can lead to inflammation in certain parts of the nervous system.
- In patients with chronic inflammatory demyelinating polyneuropathy (CIDP), a disease that leads to chronic inflammation in the peripheral parts of the nervous system which causes muscle weakness and / or numbness, especially in the legs and arms.
- In patients with multifocal motor neuropathy (MMN), a condition characterized by slowly progressing disparate weakness in the arms and legs without loss of sensation.
Human normal immunoglobulin (IVIg) contained in Octagam may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before using Octagam
Do not use Octagam
- if you are allergic to human immunoglobulin or any of the other ingredients of Octagam (listed in section 6)
- if you have immunoglobulin A ( IgA ) deficiency and if you have developed antibodies to IgA immunoglobulin .
Warnings and cautions
Talk to your doctor or pharmacist before using Octagam.
When you are given Octagam, it is strongly recommended that the product name and batch number be recorded so that a list of used manufacturing batches is compiled.
Some side effects may occur more often
- at high infusion rate
- if you are taking Octagam for the first time, or, in rare cases, when it has been a long time since the last infusion
- when you have an untreated infection or an underlying chronic inflammation .
In case of side effects, either the infusion rate must be reduced or the infusion stopped. The treatment that needs to be given depends on the type of side effect and its severity.
Circumstances and conditions that increase the risk of side effects
- In very rare cases, thromboembolic events such as Heart attack, stroke or blood clot in a vein in the calves or in a blood vessel in the lungs occur after administration of Octagam. These types of events are more common, but are still very rare, in patients with risk factors such as obesity, old age, high blood pressure , previous side effects of this kind, long periods of immobility and use of certain hormones (eg p -pills ). Make sure you get enough fluids. Octagam should also be administered as slowly as possible.
- If you have a history of kidney problems or if you have had certain risk factors such as diabetes , obesity or are over 65 years of age, Octagam should be given as slowly as possible as cases of acute kidney failure , although very rare, have been reported in patients with such risk factors. Tell your doctor if any of the above conditions apply or apply to you.
- Patients with blood group A, B or AB and patients with certain inflammatory conditions have a higher risk of red blood cells being destroyed (so-called hemolysis ) when administering immunoglobulins.
When can the infusion be slowed down or stopped?
- Severe headache and stiffness in the neck may exceptionally occur several hours to 2 days after treatment with Octagam.
- Allergic reactions are rare, but can cause anaphylactic shock , even in patients who have tolerated previous treatments well.
- In very rare cases, transfusion -induced acute lung injury (TRALI) may occur after receiving immunoglobulins including Octagam. This leads to non-cardiac accumulation of fluid in the airways of the lungs. TRALI is recognized through difficulty breathing, normal heart function and elevated body temperature (fever). Symptoms usually appear within 1 to 6 hours after treatment.
Tell your doctor or healthcare provider immediately if you notice the above side effects during or after an Octagam infusion. He or she decides whether the infusion rate should be reduced or whether the infusion should be stopped completely or if further measures are required.
- Sometimes immunoglobulin solutions such as Octagam can trigger a decrease in the number of white blood cells . This condition usually resolves on its own within 1-2 weeks.
Virus security
When medicines are made from human blood or plasma, special measures are taken to prevent the transmission of infection to patients. This includes
- a careful selection of blood and plasma donors to ensure that people at risk of being infected are excluded;
- as well as testing of individual donations and plasma pools for signs of virus / infection.
- steps in the management of blood and plasma that can inactivate or secrete any viruses .
Nevertheless, the risk of transmission of infection can not be completely ruled out when drugs made from human blood or plasma are given. This also applies to new, hitherto unknown viruses and other types of infection.
The measures taken are considered effective against enveloped viruses such as human immunodeficiency virus ( HIV ), hepatitis B virus, and hepatitis C virus.
The measures may have a limited effect on non-enveloped viruses such as hepatitis A virus and parvovirus B19.
No association was found between immunoglobulins and hepatitis A and parvovirus B19. This may be because the product contains antibodies against these infections which protect against infection.
Children and young people
No specific or supplementary warning texts or precautions need to be applied to children and adolescents.
Other medicines and Octagam
The infusion line can be flushed with either normal saline or 5% glucose solution after administering Octagam.
Concomitant use of loop diuretics should be avoided.
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, or if you have been vaccinated in the last three months.
Octagam may reduce the effects of vaccinations against live attenuated viruses, such as measles, rubella, mumps, and chickenpox.
After administration of this product, it should be 3 months before vaccination with live virus vaccines is given. For measles, the risk of reduced effect can be up to 1 year.
Effect on blood tests
If you have a blood test after taking Octagam, tell your doctor that you have received human normal immunoglobulin as this treatment may affect the results.
Blood glucose tests
Some systems for blood glucose tests (so-called glucometer tests) incorrectly interpret the maltose found in Octagam as glucose. This can lead to glucose levels during an infusion and up to 15 hours after the end of the infusion being incorrectly read as elevated and to insulin treatment being given unnecessarily, which can lead to life-threatening hypoglycemia (decreased blood sugar level).
In addition, true hypoglycemia can remain untreated if the low blood sugar level is not detected due to an incorrectly elevated glucose reading.
Therefore, when Octagam or other maltose-containing products are used, blood glucose should be measured using a test system that applies glucose-specific methods. Systems based on glucose dehydrogenase pyrroloquinoline quinone (GDH PQQ) or oxidoreductase methods for glucose staining should not be used.
Read the product information for the blood glucose test carefully – including the information on the test strips – to determine if the system is suitable for use with parenteral products containing maltose. If you are not sure, ask your treating physician to determine if the system is suitable for use with parenteral products containing maltose.
Octagam with food, drink and alcohol
No effects were noted. When using Octagam, adequate fluid supply to the patient before infusion should be considered.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
The safety of the drug during use in human pregnancy has not been established in controlled clinical trials. It should therefore be given with caution to pregnant and lactating women. Drugs with immunoglobulins have been shown to pass through the placenta, increasing in size during the last third of pregnancy. Clinical experience with immunoglobulins does not indicate that adverse effects can be expected during pregnancy or in the fetus and newborn.
Immunoglobulins are excreted in breast milk. No adverse effects on breastfed newborns/infants are expected.
Clinical experience with immunoglobulins does not suggest that adverse effects can be expected on the ability to conceive.
Driving and using machines
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Octagam has no or negligible effect on the ability to drive and use machines. However, patients who experience side effects during treatment should wait until they stop before using vehicles or machines.
Octagam contains sodium
This medicine contains 35 mg of sodium (the main ingredient in table salt/table salt) per 100 ml. This corresponds to 1.75% of the maximum recommended daily intake of sodium for adults.
This should be considered if you have been prescribed a low-salt (sodium-poor) diet.
How to use Octagam
Your doctor will decide if you need Octagam and in what dose. Octagam is given as an intravenous infusion ( infusion into a vein) by healthcare professionals. Dosage and dosage regimen depends on why you are receiving the medicine and may need to be adjusted individually for each patient.
- If you have any further questions on the use of this product, ask your doctor or pharmacist.
Use for children and adolescents
Administration ( intravenous ) of Octagam in children and adolescents (0-18 years) does not differ from administration in adults.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact your doctor as soon as possible if you suffer from any of the following serious side effects ( all of which are very rare and may occur in up to 1 in 10,000 infusions ).
In some cases, your doctor may need to stop treatment and reduce the dose or stop treatment:
- Swelling of the face, tongue and trachea which can cause severe breathing difficulties
- Sudden allergic reaction with shortness of breath, rash, wheezing and drop in blood pressure
- Stroke that can cause weakness and / or loss of sensation along one side of the body
- Heart attack that causes chest pain
- Blood clots that cause pain and swelling of the arms and legs
- Blood clot in the lung that causes chest pain and shortness of breath
- Anemia that causes shortness of breath or pallor
- Severe kidney disease that can make you unable to urinate
- Acute transfusion – caused lung injury (TRALI) that causes difficulty breathing, blue skin, fever and drop in blood pressure.
- Severe headache in combination with any of the following symptoms, stiff neck, drowsiness, fever, photosensitivity, nausea, vomiting (this may be a sign of meningitis ).
If you get any of these symptoms, contact your doctor as soon as possible.
The following side effects have also been reported:
Common side effects ( may affect up to 1 in 10 people ):
- Hypersensitivity ( allergic reaction )
- Headache
Uncommon side effects ( may affect up to 1 in 100 people ):
- Lack of white blood cells
- Changes in heart rhythm
- Blood pressure changes
- Vomiting
- Back pain
- Chest pain
- Overindulge
- Nausea
- Fever
- Fatigue
- Skin reactions at the injection site
- Abnormal values in blood test reports relating to liver function
Additional adverse reactions that did not occur in clinical trials but that have also been reported:
- Excess fluid in the body
- Too low sodium level in the blood
- Feeling of anxiety, worry, confusion or anxiety
- Migraine
- Speech difficulties
- Unconsciousness
- Dizziness
- Stinging sensation in the skin
- Impaired sensation on touch or decreased sensitivity
- Light sensitivity
- Involuntary muscle contractions
- Impaired vision
- Angina pectoris
- Palpitation is
- Temporary blue discoloration of lips or other parts of the skin
- Circulatory collapse or shock
- Venous inflammation
- Pale skin color
- Cough
- Respiratory disorders
- Pulmonary edema (accumulation of fluid in the lung)
- Bronchospasm (difficulty breathing or wheezing)
- Respiratory failure
- Acid deficiency in the blood
- Diarrhea, abdominal pain
- Hives , itching
- Reddening of the skin
- Rash
- Skin flaking
- Skin inflammation
- Hair loss
- Pain in joints or muscles
- Muscle weakness or stiffness
- Severe painful muscle contractions
- Neck pain, pain in legs or arms
- Kidney pain
- Skin swelling ( edema )
- Hemorrhoids, increased sweating
- Feeling of discomfort in the chest
- Flu-like symptoms
- Feeling of cold or feeling of heat or general feeling of illness and weakness
- Drowsiness
- Burning sensation
- Incorrect reading of blood glucose values
How to store Octagam
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label and carton.
Do not store above 25 ° C. Do not freeze. Store in the original package. Sensitive to light.
Do not use Octagam if the solution is cloudy, contains precipitates, or has a strong color.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
- The active substance is human normal immunoglobulin (human antibody ) 50 mg / ml (at least 95% is immunoglobulin G).
- The other ingredients are maltose and water for injections.
- Components used in the packaging for Octagam are latex free.
What the medicine looks like and contents of the pack
Octagam 50 mg / ml is a solution for infusion and is available in vials (20 ml = 1 g) and infusion vials (50 ml = 2.5 g, 100 ml = 5 g, 200 ml = 10 g and 500 ml = 25 g).
Pack sizes:
1 gi 20 ml
2.5 g in 50 ml
5 in 100 ml
10 in 200 ml
25 g 500 ml
2 x 10 g 2 x 200 ml
3 x 10 gi 3 x 200 ml
Not all pack sizes may be marketed.
The solution is clear or slightly opalescent, colorless, or yellowish.
Marketing Authorization Holder and Manufacturer
Octapharma AB
Lars Forssells gata 23
112 75 Stockholm
Other manufacturers
OCTAPHARMA Pharmazeutika Produktionsges.mbH
Oberlaaer Strasse 235
AT-1100 Vienna
AUSTRIA
OCTAPHARMA SAS
70-72, rue du Maréchal Foch
BP 33
F-67381 Lingolsheim
FRANCE
This medicinal product is authorized under the European Economic Area under the names:
| Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Germany, Denmark, Estonia, Finland, France, Hungary, Iceland, Italy, Lithuania, Luxembourg, Latvia, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Sweden, Great Britain | Octagam |
| Spain | Octagamocta |