Octagam - instructions for use, dose, side effects, contraindications

inactive ingredients: maltose 100.0 mg, tri-n-butyl phosphate - not more than 1.0 μg, octoxynol (triton X-100) - not more than 5.0 μg, water for injection - up to 1.0 ml.

Description:

The clear or slightly opalescent solution from colorless to pale yellow.

Pharmacotherapeutic group:MIBP - globulin

ATX: & nbsp

J.06.B.A.02 Immunoglobulin normal human for intravenous administration

Pharmacodynamics:

Octagam contains, in the main, immunoglobulins of class G - antibodies to pathogens of various infections. The distribution of subclasses of immunoglobulin G in the preparation is the same as in natural plasma and has all the properties characteristic of a healthy person. Effective doses of the drug restore the low level of immunoglobulin G to its normal value. Immunoglobulin G molecules are not subject to change due to chemical or enzymatic action, the activity of antibodies is completely preserved. OCTAGAM contains no more than 3% of polymers, the content of monomers and dimers is not less than 90%.

Pharmacokinetics:After intravenous administration, the drug immediately enters the systemic circulation, relatively quickly redistributed between plasma and extravascular space. The equilibrium state is achieved after 3-5 days. The half-life is about 24-36 days, the half-life can vary in different patients, especially in people with primary immunodeficiency. Immunoglobulin and immunoglobulin G-complexes are destroyed by cells of the reticuloendothelial system.

Indications:

1. Substitution therapy:

- Primary immunodeficiency syndromes:

congenital agammaglobulinemia and hypogammaglobulinemia,
unclassifiable variable immunodeficiency,
severe combined immunodeficiencies,
Wiskott-Aldrich syndrome.

- Myeloma or chronic lymphoid leukemia with severe secondary hypogammaglobulinemia and relapsing infections.

- Children with congenital HIV infection with recurrent infections.

2. Immunomodulatory therapy:

- Idiopathic thrombocytopenic purpura (ITP) in adults and children with a high risk of bleeding or before surgery to adjust the number of platelets.

Contraindications:

Intolerance or hypersensitivity to homologous immunoglobulins, especially, in extremely rare cases, a deficit immunoglobulin A, when the patient has antibodies to immunoglobulin A.

Pregnancy and lactation:

Clinical trials on the safety of the drug in pregnant women have not been carried out (therefore, use with caution), but clinical experience with immunoglobulins proves that their administration does not have any negative effect on the course of pregnancy, fetus and newborn.

Immunoglobulins are excreted in breast milk, while antibodies can have a protective effect in a newborn.

Dosing and Administration:

Before administration, the temperature of the solution should be brought to room temperature or the patient's body temperature. Muddy and sediment-free solutions are not applicable.

Any amount remaining after the infusion of the drug should be destroyed.

OCTAGAM should not be mixed with other drugs, for its administration should be used a separate system for intravenous administration.

The drug is administered intravenously at an initial rate of 1 ml / kg / h for 30 minutes.If this does not indicate any undesirable reactions, then the rate of administration can be gradually increased to the maximum possible 5 ml / kg / hour.

Doses and duration of therapy are selected individually, depending on the indication and pharmacokinetic parameters in a particular patient. As a recommendation, there may be the following dosages are used:

Substitution therapy for primary immunodeficiencies: the mode of administration should help achieve the level of the equilibrium state of immunoglobulin G within the range of 4.0-6.0 mg / ml when it is measured before each subsequent infusion. Since the start of treatment, this requires 3 to 6 months. The recommended initial dose is 0.4-0.8 g / kg body weight, depending on the circumstances (eg acute infection) followed by 0.2 g / kg body weight every 3 weeks. The dose required to reach a level of 6.0 g / l is 0.2 to 0.8 g / kg body weight per month. The interval between administrations when a stable level is reached is 2 to 4 weeks. For the most accurate definition of administered doses and intervals of administration, periodic measurement of the level of immunoglobulin G is recommended.

Substitution therapy for myeloma or chronic lymphoid leukemia with severe secondary hypogammaglobulinemia and relapsing infections; in children with congenital HIV infection and recurrent infections: the recommended dose is 0.2-0.4 g / kg body weight every 3-4 of the week.

Idiopathic thrombocytopenic purpura (ETC): In the treatment of acute episodes, 0.8 to 1.0 g / kg of body weight on the first day, with repeated administration, if necessary, on the third day or 0.4 g / kg of body weight per day for 2-5 days. Treatment can be repeated in the case of a second episode.

Guillain-Barre Syndrome: 0.4 g / kg body weight per day, for 3-7 days.

Kawasaki disease: 1.6-2.0 g / kg body weight is administered in equal doses for 2-5 days or once in a dose of 2.0 g / kg body weight. Patients should take aspirin at the same time.

Bone marrow transplantation: the immunoglobulin is used as a component Preparatory therapy, as well as after transplantation. Doses of the drug are selected individually. The recommended initial dose is 0.5 g / kg body weight per week. Treatment is continued for 3 months after transplantation.

Side effects:

When intravenously administered immunoglobulin, the development of side effects depends on the size of the dose and the rate of administration of the drug.

Frequency of occurrence of undesirable reactions is classified as follows: often (≥1% - <10%), infrequently (≥0,1% - <1%), rarely (≥0,01% - <0,1%), very rarely <0.01%).

On the part of the blood system and lymphatic system: very rarely - leukopenia, transient hemolytic anemia, hemolysis.

From the immune system: often - hypersensitivity reactions; very rarely - anaphylactoid and anaphylactic (including anaphylactic shock) reactions, angioedema, edema of the face.

From the nervous system: often - headache; very rarely - arousal,

From the cardiovascular system: rarely - hypotension; very rarely - myocardial infarction, tachycardia, palpitations of cyanosis, thrombosis, peripheral circulatory insufficiency, hypertension.

From the respiratory system: very rarely - respiratory failure, pulmonary embolism, pulmonary edema, bronchospasm, dyspnea, cough.

From the gastrointestinal tract: often - nausea; very rarely - vomiting, diarrhea, abdominal pain.

From the skin: infrequently eczema; very rarely - hives, rashes (including erythematous), dermatitis, itching, alopecia.

From the musculoskeletal system: infrequently - pain in the back; very rarely - arthralgia, myalgia.

From the urinary system: very rarely - acute renal insufficiency, increasing the concentration of creatinine in the blood.

From the laboratory indicators: very rarely - higher values "hepatic" enzymes / false positive increase in the concentration of glucose in the blood.

Other: often - fever, fatigue, reactions at the injection site; infrequently - chills, chest pain; very rarely - flushes to the face, hyperthermia, hyperhidrosis, malaise. Rarely, a sudden drop in blood pressure may occur, and in some cases, anaphylactic shock, including in patients who previously tolerated immunoglobulin well.

Overdose:

Symptoms: water retention in the body, increased blood viscosity (especially in patients with impaired renal function or in old age).

Treatment: symptomatic.

Interaction:

Administration of the drug may reduce the effectiveness of live attenuated viral vaccines (against measles, smallpox, rubella, mumps, chicken pox) for a period of 6 weeks to 3 months.

Before vaccination with live attenuated octagam should not be mixed with other drugs and for its administration should use a separate system for intravenous administration.

Do not apply simultaneously with calcium gluconate in infants.

Special instructions:

During the administration of the drug, the patient's condition should be carefully monitored.

For all patients receiving intravenous immunoglobulins, it is necessary to conduct adequate hydration before the infusion, monitor diuresis, control the concentration of creatinine in the plasma, exclude the use of "loop" diuretics.

The introduction of high doses of immunoglobulin can lead to an increase in the viscosity of the plasma, which increases the risk of ischemia and thromboembolic complications.

The most common adverse reactions can occur at a high rate of administration, with hypo- and agammaglobulinemia (against a background of deficiency of immunoglobulin A or without it), with the introduction of immunoglobulin for the first time, in rare cases, when transferring to the introduction of another immunoglobulin or after a long period of time after the last infusion.

The first administration of the drug should be done slowly, at a rate of not more than 0.016 ml / kg / min.It is especially necessary to observe patients who have not previously received the preparation of immunoglobulin, who received treatment with an alternative drug or after a long interval after the last injection of immunoglobulin. Such patients should be observed during the entire period of the first infusion of the drug, and also within 1 hour after the end of the injection. The remaining patients should be observed during the first 20 minutes of infusion.

It is recommended to register the batch lot number with each injection.

During the treatment period, the transient increase in various passively transmitted antibodies in the patient's blood can lead to false positive results of serological tests.

Passive transfer of antibodies to erythrocyte antigens (eg, A, B, D) may affect some serological tests with erythrocyte allo-antibodies (eg, Coombs test), the amount of reticulocytes and haptoglobin.

The presence of maltose in the formulation may affect the indices transmission of infectious agents. This also applies to infectious agents of a previously unknown nature.

In the manufacture of OCTAGAM, the following measures are used to exclude transfusion transfer of viruses:

- selection of healthy donors, testing of each portion of plasma and plasma pool for the presence of the hepatitis B virus antigen, antibodies to human immunodeficiency virus 1 and 2, hepatitis C;

- analysis of plasma fractions for the presence of genetic material of the hepatitis C virus;

- special procedures for the removal / inactivation of viruses, using the solvent / detergent (SD) system included in the production process of the drug, the effectiveness of which was confirmed on the viral model. These procedures are effective for the removal / inactivation of human immunodeficiency viruses, hepatitis B and C viruses, but may have limited efficacy against unencapsulated viruses such as hepatitis A virus and Parvovirus B19.

Effect on the ability to drive transp. cf. and fur:

Does not have any effect on the ability to drive a car or perform work that requires increased concentration of attention and a psychomotor reaction.

Form release / dosage:

Solution for infusions, 50 mg / ml.

Packaging:

To 20, 50, 100 and 200 ml of solution in a glass bottle (type II, Hearth.F.) with a label equipped with a plastic holder, or with a label without a holder, sealed with a rubber stopper,rolled in with an aluminum cap with an identification number on the side of the cap, corresponding to a specific number of the preparation series, covered with a plastic lid (scrolling allowed plastic cover), 1 bottle together with the instruction for use is placed in a cardboard box.

In a cardboard pack with 50, 100 and 200 ml vials with a label without a holder, a plastic mesh holder is additionally placed.

Storage conditions:

Store at a temperature of +2 to + 25 ° C, in a dark place.

Not freeze.

Keep out of the reach of children.

Shelf life:

Bottles of 20 ml -18 months (1.5 years).

Bottles of 50 ml, 100 ml and 200 ml - 2 years.

Do not use after the expiration date stated on the package.

Terms of leave from pharmacies:On prescription

Registration number:П N011977 / 01

Date of registration:18.11.2011 / 11.09.2014

Expiration Date:Unlimited

The owner of the registration certificate:Octapharma Pharmaceuticals Productionsgesb.H.Octapharma Pharmaceuticals Productionsgesb.H. Austria

Manufacturer: & nbsp

OCTAPHARMA Pharmazeutika Produktionsges, m.b.H. Austria

Representation: & nbspOKTAPHARMA NORDIC AB OKTAPHARMA NORDIC AB Sweden

Information update date: & nbsp13.10.2015

Illustrated instructions

Instructions

Octagam (Octagam)