Medicinal Products

ENDOBULINE 50 mg / ml

Generic drug of the therapeutic class: Infectiology - Parasitology
active ingredients: normal human immunoglobulin
laboratory: Baxter

Powder and solvent for solution for injection
Box of 1 bottle of powder + 200 ml solvent bottle
All forms

Indication

- Substitution treatment:
. primary immunodeficiency with hypogammaglobulinemia or functional impairment of humoral immunity,
. secondary immunodeficiencies of humoral immunity, particularly chronic lymphocytic leukemia or myeloma with hypogammaglobulinemia and associated with recurrent infections,
. recurrent bacterial infections in children infected with HIV,
. hematopoietic stem cell allografts.
- Immunomodulatory treatment:
. idiopathic thrombocytopenic purpura (ITP) in adults and children in case of significant bleeding risk or before a medical or surgical procedure to correct the platelet count,
. Guillain and Barre syndrome of the adult,
. Kawasaki disease.

Dosage ENDOBULINE 50 mg / ml Powder and solvent for solution for injection Box of 1 vial of powder + vial of solvent of 200 ml

Dosage:
The dosage and interval between administrations depends on the intended use of the treatment (substitution) and half-life of normal human immunoglobulin intravenously (IVIg) in vivo in patients with immunodeficiency.
The following dosages are given for information only.
- Substitution treatment in cases of primary immunodeficiency:
The goal of treatment should be to ensure a residual IgG level (i.e., prior to the next administration of normal human immunoglobulin G) of at least 4 to 6 g / L. After the start of treatment with normal human immunoglobulin, the balance is achieved in 3 to 6 months. A loading dose of 0.4 to 0.8 g / kg can be recommended depending on the circumstances (infection) followed by an infusion of 0.2 g / kg every 3 weeks. The doses of normal human immunoglobulin required to reach a residual level of 4 to 6 g / L are of the order of 0.3 g / kg / month, with extremes of 0.2 to 0.8 g / kg / month. The interval of infusions varies from 15 days to 1 month. The occurrence of infections may require the temporary use of more frequent infusions.
In the replacement therapy for primary immunodeficiencies, a determination of serum IgG concentrations prior to each infusion is required to control the activity of the treatment and possibly adjust the dose or interval of administration.
- Substitution treatment for secondary immunodeficiency:
A dose of 0.2 to 0.4 g / kg can be recommended every 3 to 4 weeks.
- Idiopathic thrombocytopenic purpura (ITP):
For the attack treatment, 0.8 to 1 g / kg / day at day 1, possibly repeated at day 3, or 0.4 g / kg / day for 2 to 5 days. This treatment may be repeated if severe thrombocytopenia recurs.
- Guillain syndrome and Barré of the adult:
0.4 g / kg body weight / day for 5 days.
- Kawasaki disease:
1.6 to 2.0 g / kg administered in divided doses over 2 to 5 days or 2.0 g / kg as a single dose, together with acetylsalicylic acid.
- Allograft of hematopoietic stem cells:
. IVIG are usually used before and after allografting.
. IVIG has a preventive effect against the occurrence of infectious complications and reduces the frequency and severity of graft versus host disease in hematopoietic stem cell allograft recipients.
. The dosage is determined on an individual basis and usually begins with a dose of 0.5 g / kg / week from D-7 to D + 90.
In case of persistent defect in the production of antibodies, the dosage is currently recommended at 0.5 g / kg / month until D + 360.
Administration mode :
- This immunoglobulin preparation is in the form of a powder to be reconstituted extemporaneously with water for injections, according to the modalities described in the instructions for use, handling and disposal.
- Human normal immunoglobulin should be administered intravenously only once and immediately after reconstitution.
- The flow must be carefully controlled:
. in patients receiving IVIG for the first time, the flow rate should not exceed 0.5 ml / kg / h;
. in patients who have already received IVIG, the flow rate will be adjusted according to the clinical tolerance, without exceeding 1 ml / kg / h during the first 30 minutes, increasing gradually to a maximum of 4 ml / kg / h.
- Do not use a solution with a non-homogeneous appearance or containing a deposit.

Against indications

- This medicine is contraindicated in the following situations:
. known hypersensitivity to one of the constituents of the preparation;
. in patients with IgA deficiency and circulating anti-IgA antibodies.
- Administration of normal human immunoglobulin may impair the efficacy of live attenuated vaccines such as measles, rubella, mumps and chickenpox vaccines. After infusion of this drug, wait at least 6 weeks (preferably 3 months) before administering this type of vaccine.

Endobulin side effects

- Side effects related to the administration of normal human immunoglobulin are more common in patients with primary immunodeficiencies.
- As with other IVIg, chills-hyperthermia-like reactions sometimes accompanied by headache, nausea, vomiting, allergic manifestations, elevated or decreased blood pressure, arthralgia, and mild lumbago may occur occasionally.
- The risk of anaphylactic reaction is higher in the case of rapid intravenous infusion (see section titration and method of administration), in agammaglobulinemic patients with IgA deficiency or hypogammaglobulinemic patients who have never received immunoglobulins or whose last treatment by IgIV goes back more than 8 weeks. Rapid flow may even be responsible for arterial and venous thrombotic events, particularly in patients with vascular risk.
- Rare cases of hypotension and anaphylactic shock have been reported even in patients who have not had hypersensitivity reactions in previous injections.
- Rare cases of isolated hypertensive outbreaks have been reported in patients receiving IVIG.
- As with other IVIg, rare cases of skin reactions especially eczematous, regressive, rare cases of hemolytic anemia and / or regressive hemolysis and cases of elevated serum creatinine and / or acute renal failure and very severe rare cases of transient transaminase increase have been reported.
- Cases of aseptic meningeal reaction, particularly in patients with idiopathic thrombocytopenic purpura have been reported with normal human immunoglobulin. This meningeal involvement is reversible in a few days after stopping treatment.
- Rare cases of thrombosis have been reported with IVIG mainly in the elderly and in patients at risk of cerebral or cardiac ischemia, overweight or severe hypovolemia.

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