Intratect

Human normal immunoglobulin.

The active substance of Intratect is human immunoglobulin for intravenous administration.
Intratect contains 50 g/l human normal immunoglobulin of which at least 96% is immunoglobulin G (IgG). The maximum immunoglobulin A (IgA) content is 900 micrograms /ml.
Excipients/Inactive Ingredients: The other ingredients are: glycine and water for injections.

Intratect is an extract of human blood which contains antibodies (the body's own defensive substances) to diseases, available in the form of an infusion solution. The solution is ready for infusion into a vein (a "drip").
Intratect contains human normal immunoglobulin (antibodies) from blood donated by a broad spectrum of the population and is likely to contain antibodies to most common infectious diseases. Adequate doses of Intratect can restore normal values when blood levels of Immunoglobulin G are low.

Intratect is used in adults, and children and adolescents (0-18 years) who do not have sufficient antibodies (replacement therapy) in cases of: Patients born with lack of antibodies (primary immunodeficiency syndromes).
Hypogammaglobulinemia and repeated bacterial infections in patients with chronic lymphocytic leukaemia, in whom prophylactic antibiotics have failed.
Hypogammaglobulinaemia and repeated bacterial infections in plateau phase multiple myeloma patients who have failed to respond to pneumococcal immunisation.
Hypogammaglobulinaemia in patients after allogeneic haematopoietic stem cell transplantation (HSCT).
Congenital AIDS with recurrent bacterial infections.
Intratect is also used in adults, and children and adolescents (0-18 years) to treat inflammatory disorders (immunomodulation) such as: Primary immune thrombocytopenia (ITP, where a patient has reduced blood platelets) when the patient will have surgery in the near future or is at risk of bleeding.
Guillain-Barré syndrome (a disease that damages nerves and may lead to generalised palsy).
Kawasaki disease (a disease in children which causes inflammations of several organs of the body and where the arteries in the heart become enlarged).

The dose and dosage regimen is dependant on the indication. In replacement therapy the dose may need to be individualised for each patient dependent on the pharmacokinetic and clinical response. The following dose regimens are given as a guideline: Replacement therapy in primary immunodeficiency syndromes: The dose regimen should achieve a trough level of IgG (measured before the next infusion) of at least 5 - 6 g/l. Three to six months are required after the initiation of therapy for equilibration to occur.
The recommended starting dose is 8 - 16 ml (0.4 - 0.8 g)/kg body weight (b.w.) given once, followed by at least 4 ml (0.2 g)/kg b.w. every three to four weeks. The dose required to achieve a trough level of 5-6 g/l is of the order of 4 - 16 ml (0.2 - 0.8 g)/kg b.w./month. The dosage interval when steady state has been reached varies from 3 - 4 weeks.
Trough levels should be measured in order to adjust the dose and dosage interval.
Hypogammaglobulinaemia and recurrent bacterial infections in patients with chronic lymphocytic leukaemia, in whom prophylactic antibiotics have failed; hypogammaglobulinaemia and recurrent bacterial infections in plateau phase multiple myeloma patients who have failed to respond to pneumococcal immunisation; congenital AIDS with recurrent bacterial infections: The recommended dose is 4 - 8 ml (0.2 - 0.4 g)/kg b.w. every three to four weeks.
Hypogammaglobulinaemia in patients after allogeneic haematopoietic stem cell transplantation: The recommended dose is 4-8 ml (0.2-0.4 g)/kg every three to four weeks. The trough levels should be maintained above 5 g/l.
Primary immune thrombocytopenia: There are two alternative treatment schedules: 16 - 20 ml (0.8 - 1 g)/kg b.w. on day one, this dose may be repeated once within 3 days.
8 ml (0.4 g)/kg b.w. given daily for two to five days. The treatment can be repeated if relapse occurs.
Guillain Barré syndrome: 8 ml (0.4 g)/kg b.w./day over 5 days.
Kawasaki disease: 32 - 40 ml (1.6 - 2.0 g)/kg b.w. should be administered in divided doses over two to five days or 40 ml (2.0 g)/kg b.w. as a single dose. Patients should receive concomitant treatment with acetylsalicylic acid.
The dosage recommendations are summarised in the following table: (See table.)

Click on icon to see table/diagram/image

Paediatric population: The posology in children and adolescents (0-18 years) is not different to that of adults as the posology for each indication is given by body weight and adjusted to the clinical outcome of the above mentioned conditions.
Intratect is intended for intravenous administration (infusion into a vein). It is given by a doctor or nurse. The dose will depend on the condition and the body weight. The doctor will know the right amount to give.
At the beginning of the infusion the patient will receive Intratect at a slow rate. The doctor may then gradually increase the infusion rate. The infusion rate and its frequency are dependent on the reason the patient is being given Intratect.
Use in children and adolescents: The posology in children and adolescents (0-18 years) is not different to that of adults as the posology for each indication is given by body weight and adjusted to the clinical outcome of the previously mentioned conditions.
For replacement therapy in patients with a weak immune system (immunodeficiency) and for patients with congenital AIDS, the infusion is given every 3 to 4 weeks.
To treat inflammatory disorders (immunomodulation) the infusion may be given as followed: Primary immune thrombocytopenia: for the treatment of an acute episode an infusion is given on day 1, this dose may be repeated once in 3 days. Alternatively a lower dosage may be given daily for 2 to 5 days.
Guillain Barré syndrome: the infusion is given for 5 days.
Kawasaki disease: the infusion should be administered over 2 to 5 days or as a single dose.
For hypogammaglobulinaemia in patients after allogeneic haematopoietic stem cell transplantation to treat infection and prevent rejection, the infusion is given every 3 to 4 weeks. Where there is lack of antibody production, the infusion is given every month until there are normal levels of antibodies.
If the patient misses an infusion: Intratect will be given in the hospital by a doctor or nurse so it is unlikely to miss an infusion. However, tell the doctor if the patient missed an infusion.
Method of administration: Intratect is intended for intravenous infusion. During the infusion, an initial rate of no more than 1.4 ml/kg/h for 30 minutes must not be exceeded. If well tolerated, the rate of administration may gradually be increased to a maximum of 1.9 ml/ kg/h for the remainder of the infusion.

If the patient receives more Intratect than necessary: An overdose can lead to fluid overload and increased thickness of the blood, especially in elderly patients or patients with impaired heart or kidney function. If too much Intratect is given, tell the doctor, who will decide if the infusion should be stopped and an alternative treatment given.
For any further questions on the use of this medicine, ask the doctor or nurse.

Do not use Intratect: If the patient is allergic to human immunoglobulin or any of the other ingredients of this medicine (listed in Description). An allergic reaction may include rash, itching, difficulty breathing or swelling of the face, lips, throat or tongue.
If the patient has an immunoglobulin A deficiency, especially if with antibodies against immunoglobulin A in the blood.

Talk to the doctor, pharmacist or nurse before using Intratect if the patient: Suffers from a condition with low antibody levels in the blood (hypo- or agammaglobulinemia).
Has not received this medicine before or if there has been a long interval (e.g. several weeks) since last receipt (the patient will need to be closely monitored during infusion and for an hour after infusion has stopped).
Has been given Intratect recently (the patient will need to be observed during the infusion and for at least 20 minutes after infusion).
Has had a reaction to other antibodies (in rare cases the patient may be at risk of allergic reactions).
Has or has had a kidney disorder.
Has received medicines that may harm the kidneys (if kidney function worsens, stop treatment with Intratect).
The doctor will take special care if the patient is overweight, elderly, diabetic, or if suffering from high blood pressure, low blood volume (hypovolaemia), if blood is thicker than normal (high blood viscosity), if patient has been bed-ridden or immobile for some time (immobilisation) or if with problems with the blood vessels (vascular diseases) or other risks for thrombotic events (blood clots).
Please note - reactions: The patient will be carefully observed during the infusion period with Intratect to make sure that the patient does not suffer a reaction. The doctor will make sure that the rate at which Intratect is infused is suitable.
For any of the following signs of a reaction, i.e. sudden wheeziness, difficulty in breathing, fast pulse, swelling of the eyelids, face, lips, throat or tongue, rash or itching (especially affecting the whole body) during the infusion of Intratect, tell the doctor immediately. The rate of infusion can be slowed or the infusion can be stopped altogether.
Information on transmission of infectious agents: Intratect is made from human plasma (the liquid part of blood). When medicines are made from human blood or plasma, it is important to prevent infections being passed on to patients. Blood donors are tested for viruses and infections. Manufacturers of these products also process the blood or plasma to inactivate or remove viruses. Despite these measures, when medicines prepared from human blood or plasma are given, the possibility of passing on infection cannot be totally excluded.
The measures taken are considered effective for enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B virus and hepatitis C virus.
The measures taken may be of limited value against non-enveloped viruses such as hepatitis A virus and parvovirus B19.
Immunoglobulins have not been associated with hepatitis A or parvovirus B19 infections possibly because the antibodies against these infections, which are contained in the product, are protective.
Effects on blood tests: Intratect can affect blood tests. If the patient has a blood test after receiving Intratect, please inform the person taking the blood or the doctor that the patient received Intratect.
Driving and using machines: The ability to drive and operate machines may be impaired by some adverse reactions associated with Intratect. Patients who experience adverse reactions during treatment should wait for these to resolve before driving or operating machines.
Certain severe adverse drug reactions may be related to the rate of infusion. The recommended infusion rate given under "Method of administration" must be closely followed. Patients must be closely monitored and carefully observed for any symptoms throughout the infusion period.
Any infusion-related adverse events should be treated by lowering the infusion rate or by stopping the infusion.
In all patients, intravenous immunoglobulin administration requires: Adequate hydration prior to the initiation of the infusion of intravenous immunoglobulin; monitoring of urine output; monitoring of serum creatinine levels; avoidance of concomitant use of loop diuretics.
It is strongly recommended that every time Intratect is administered to a patient, the name and batch number of the product is recorded.
In case of shock, standard medical treatment for shock should be implemented.
Thrombosis: Care should be used when normal immunoglobulin products are given to individuals determined to be at increased risk of thrombosis.
Patients at increased risk of thrombosis include those with acquired or hereditary hypercoagulable states, prolonged immobilization, in-dwelling vascular catheters, advanced age, estrogen use, a history of venous or arterial thrombosis, cardiovascular risk factor (including history of atherosclerosis and/or impaired cardiac output), and hyperviscosity (including cryoglobulins, fasting chylomicronemia and/or high triglyceride levels, and monoclonal gammopathies).
Patients at risk for thrombosis should receive normal immunoglobulin products at the slowest infusion rate practicable, and these individuals should be monitored for thrombotic complications.
Consideration should also be given to measurement of baseline blood viscosity in individuals at risk of hyperviscosity.
Hemolysis: Heightened awareness of the potential for hemolysis is recommended in individuals receiving normal immunoglobulin products, particularly those who are determined to be at increased risk.
Patients at increased risk for hemolysis following treatment with normal immunoglobulin include those with non-O blood group types, those who have underlying associated inflammatory conditions, and those receiving high cumulative doses of normal immunoglobulin over the course of several days.
Patients receiving normal immunoglobulin products should be monitored for hemolysis, particularly those at increased risk.
Clinical symptoms and signs of hemolysis include fever, chills and dark urine. If these occur, appropriate laboratory testing should be obtained.

If the patient is pregnant or breast-feeding, thinks she may be pregnant or is planning to have a baby, ask the doctor for advice before taking this medicine. The doctor will decide if Intratect may be used during pregnancy and breast-feeding.

Like all medicines, this medicine can cause side-effects, although not everybody gets them.
Frequencies outlined as follows have been generally calculated based on number of patients treated if not otherwise specified, e.g. by number of infusions.
For any of the following effects, tell the doctor immediately: rash; itching; wheezing; difficulty in breathing; swelling of the eyelids, face, lips, throat or tongue; extremely low blood pressure with symptoms like dizziness, confusion, fainting, fast pulse.
This can be an allergic or a serious allergic reaction (anaphylactic shock) or a hypersensitivity reaction.
The following side effects have been reported during clinical trials with Intratect 50 g/l: Common: may occur with up to 1 in 10 infusions: headache, fever.
Uncommon: may occur with up to 1 in 100 infusions: mildly increased breakdown of red blood cells in the blood vessels (haemolysis), disturbed sense of taste, high blood pressure, inflammation of a superficial vein, feeling sick (nausea), vomiting, abdominal pain, rash with raised spots, chills, feeling hot, increased body temperature, positive blood test for antibodies against red blood cells.
The following side effects have been reported spontaneously with Intratect: Not known (frequency cannot be estimated from the available data): severe chest pain or chest pressure (angina pectoris); shivering or trembling (rigors); (anaphylactic) shock, allergic reaction; difficulty in breathing (dyspnoea); low blood pressure; back pain; decrease in number of white blood cells (leukopenia).
Human immunoglobulin preparations in general may cause the following additional side effects: Uncommon (may affect up to 1 in 100 patients): headache, dizziness; nausea, vomiting; joint pain, moderate low back pain; low blood pressure; chills, fever; allergic reactions.
Rare (may affect up to 1 in 1,000 patients): a sudden fall in blood pressure and in isolated cases an anaphylactic shock, temporary skin reactions.
Very rare (may affect up to 1 in 10,000 patients): thromboembolic reactions such as: heart attack (cardial infarction), stroke, blood clots in blood vessels in the lung (pulmonary embolism), blood clots in a vein (deep vein thromboses).
Not known (frequency cannot be estimated from the available data): temporary acute inflammation of the protective membranes covering the brain and spinal cord (meningitis), results of blood tests which indicate that the renal function is impaired and/or sudden kidney failure, decrease in the number of red blood cells due to a breakdown of these cells in the blood vessels ((reversible) haemolytic reactions).
If a side effect occurs, the infusion rate will be decreased or stopped.
Reporting of side effects: If any side effects occur, talk to the doctor, pharmacist or nurse. This includes any side effects not listed.

Other medicines and Intratect: Tell the doctor if the patient is using, has recently used or might use any other medicines.
Intratect can reduce the effectiveness of some vaccines such as: measles, rubella, mumps, chicken pox.
The patient may have to wait up to 3 months before some vaccines can be given and up to a year before a measles vaccine can be administered.

Instructions for handling and disposal: Do not use Intratect after the expiry date.
The product must be brought to room or body temperature before use.
The solution should be clear or slightly opalescent and colourless or pale yellow. Solutions that are cloudy or have deposits should not be used.
The product once opened should be used immediately.
Any unused product or waste material should be disposed of in accordance with local requirements.
Incompatibilities: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

Keep the vial in the outer carton in order to protect from light.
Do not store above 25°C. Do not freeze.

Vaccines, Antisera & Immunologicals

J06BA - Immunoglobulins, normal human ; Used in passive immunizations.

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