Index of drugs

Complementary therapy in adult patients with active, seropositive systemic lupus erythematosus (SLE) with a high degree of disease activity (eg with the presence of anti-dsDNA antibodies and with low complement levels) despite the use of standard treatment.

1 vial contains 120 mg or 400 mg belimumab.

A human IgG1λ monoclonal antibody specific for soluble human B-cell stimulating protein (BLyS, also referred to as BAFF and TNFSF13B). It blocks the binding of soluble BLyS, the B lymphocyte survival factor, to its receptors on these lymphocytes. It does not bind directly to B cells but by joining BLyS it prevents the survival of B lymphocytes, including B autoreactive lymphocytes, and also reduces B cell differentiation into immunoglobulin-producing plasma cells. Final T_0,5 belimumab is 19.4 days.

Hypersensitivity to the components of the preparation.

Due to the lack of tests, the use of the preparation is not recommended in the following cases: severe active CNS, severe active lupus nephritis, HIV infection, hepatitis B or C history or currently, hypogammaglobulinemia (IgG <400 mg / dl) or IgA deficiency (IgA <10 mg / dl), condition after transplantation of an important organ or stem cells of the haematopoietic system / bone marrow or after renal transplantation. Due to the lack of tests, caution should be used in patients with severe renal impairment and when the product is used concomitantly with other targeted therapies targeting B lymphocytes or with cyclophosphamide. Administration of the preparation may cause hypersensitivity reactions and intravenous infusion reactions, which may be serious and fatal. In case of severe hypersensitivity reactions, administration should be discontinued. Responses to the intravenous infusion were more common during the first two infusions, and their frequency usually decreased during subsequent infusions. In patients with a history of multidrug-allergy or significant hypersensitivity, the risk may be greater. Delayed appearance of acute hypersensitivity reactions and recurrence of clinically relevant reactions after appropriate initial treatment of symptoms have been observed. Serious reactions have been reported in patients several hours after the infusion. Patients should be informed about the risk of severe or life-threatening hypersensitivity reactions on the day of the infusion or the Next day, possible symptoms and possible relapse and the importance of immediate medical attention. Lower-grade hypersensitivity reactions of lesser severity were also observed, including rash, nausea, fatigue, muscle pain, headache, and facial edema. Use with caution in patients with chronic infections or with a history of recurring infections. Patients receiving any treatment for chronic infections should not start treatment with the medicine. Patients who develop infection during treatment with the product should be carefully monitored. The risk associated with the use of the drug in patients with active or latent tuberculosis is unknown. Patients receiving the treatment for SLE have reported progressive multifocal leukoencephalopathy (PML). Physicians should pay special attention to symptoms that may suggest PML that may go unnoticed by the patient (eg, signs and symptoms of cognitive, neurological or psychiatric functions). If new symptoms are detected or when symptoms worsen, a neurological consultation should be ordered and a diagnosis appropriate for PML should be considered. If PML is suspected, discontinue administration until PML is excluded. Live vaccines should not be given for 30 days prior to or concurrent with the medicine. There are no data available on the secondary transmission of infection from people receiving live vaccines to patients treated with the medicine. Due to its mechanism of action, belimumab may have an adverse effect on the response to vaccination. The effectiveness of vaccinations performed during drug treatment is unknown.Limited data suggest that the drug does not have a significant effect on the ability to maintain a protective immune response to vaccination made before its use. In a partial study, it was observed that in a small group of patients who had previously received tetanus, pneumococcal or influenza vaccination, antibody titers were maintained after belimumab treatment. Available data are insufficient to determine the ability of people receiving the preparation to produce immunity after receiving the vaccination. Immunomodulatory agents may increase the risk of developing malignancies - caution should be exercised when considering treatment with belimumab in patients with a history of malignancy, as well as when considering continuing such treatment in patients who have been diagnosed with cancer. Patients with malignant tumors within the last 5 years have not been studied, except for skin cancer (basal cell or squamous cell), as well as cervical cancer that has been completely removed surgically or treated appropriately. The safety and efficacy of the preparation in children under 18 years have not been established. Do not administer the preparation as an intravenous bolus.

The drug should not be used during pregnancy, unless it is absolutely necessary. Because maternal antibodies (IgG) are secreted into breast milk, a decision should be made whether to discontinue breast-feeding or to discontinue drug treatment, taking into account the benefits of breastfeeding for the baby and the benefits of treatment for the woman. Women of childbearing potential must use effective contraception during treatment with the preparation and for at least 4 months after the last dose.

Very common: bacterial infections (eg bronchitis, cystitis), diarrhea, nausea. Common: viral gastroenteritis, pharyngitis, nasopharyngitis, leukopenia, hypersensitivity reactions (hypotension, angioneurotic edema, urticaria or other forms of rash, pruritus and dyspnoea), depression, insomnia, migraine, pain in the extremities, reactions for intravenous infusion (bradycardia, muscle pain, headache, rash, urticaria, fever, hypotension, hypertension, dizziness and pain in the joints), fever. Uncommon: anaphylactic reactions, angioneurotic edema. Rare: delayed type hypersensitivity reactions delayed. There have been cases of opportunistic infections.

Treatment with the medicine should be started and supervised by a qualified doctor experienced in the diagnosis and treatment of SLE. Drug infusions should be performed by qualified medical personnel trained in conducting therapy using infusions. The drug should be administered in a place where immediate resources are available to treat hypersensitivity reactions. Before the infusion of belimumab, pre-medication can be used including the antihistamine with or without an antipyretic medication.
Intravenously. Adults: 10 mg / kg infusion at day 0, day 14 and day 28, then every 4 weeks. The infusion should last for 1 hour. Due to the risk of delayed reactions, patients should remain under clinical observation for several hours, at least after the first two intravenous infusions. If no improvement in disease control is observed after 6 months of treatment, discontinuation should be considered.
Elderly patients are not recommended unless the expected benefit outweighs the potential risk. When use in the elderly is considered necessary, no dose adjustment is necessary. No dosage adjustment is necessary in patients with mild, moderate or severe renal impairment. Patients with hepatic impairment are unlikely to require dose adjustments.