BELIMUMAB PACKAGE INSERT PDF

Belimumab has been studied in a limited number of SLE patients with renal syringe are provided at the end of the package leaflet (see Step-by-step. Learn about BENLYSTA (belimumab), an FDA-approved prescription infusion or self-injectable lupus medication to help treat your Request your FREE Info Kit. Keep in the original package until time of use to protect from light. Insert the entire Needle into the pinched area of the skin at a slight degree angle using a.

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Memory cells increased initially and slowly declined toward baseline concentrations by week Discard the solution if any particulate matter or discoloration is observed.

Benlysta (belimumab) dose, indications, adverse effects, interactions from

Visually inspect parenteral products for particulate matter and discoloration prior to administration whenever solution and container permit. BENLYSTA is a sterile, preservative-free lyophilized powder for reconstitution, dilution, and intravenous infusion provided in single-use glass vials with a latex-free rubber stopper and a flip-off seal. Gently swirl the vial for 60 seconds. Belimumab has not been studied in combination with other biologic therapies including rituximab. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses.

Serious and sometimes fatal infections have been reported in clinical trials with belimumab or other immunosuppressive agents. A local search option of this data can be found here. Each device contains mg belimumab. Small air bubbles, however, are expected and acceptable. Avoid exposure to heat.

Potential concerns with use together include an increased susceptibility to immunosuppression and serious infections, some of which might be fatal. Storage of unopened prefilled syringes or autoinjectors: Once reconstitution is complete, the solution should be opalescent and colorless to pale yellow, and without particles.

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Single-use vials of belimumab lyophilized powder for injection: Monitor an infant of a belimumab-treated belinumab for B-cell reduction and other immune dysfunction after birth. There were more deaths reported with belimumab than with placebo during the controlled period of the clinical trials.

Send the page ” ” to a friend, relative, colleague or yourself. Exploratory sub-group analyses of response rates based on race were performed during clinical trials; some data suggest that Black patients may have reduced clinical response to belimumab. Reference s National Institutes of Health, U.

Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. Belimumab has not been studied in combination with other biologic therapies including B-cell targeted therapies such as intravenous iinsert. Vials should be protected from light gelimumab stored in the original carton until use.

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When the injection is complete, lift the injector from the injection site. Therefore, belimumab use is not recommended in combination with biologic therapies. These findings were reversible within 3 to 12 months after the drug was discontinued. Therefore, belimumab use is beli,umab recommended in combination with intravenous cyclophosphamide.

Advise female patients of childbearing potential to contact their physician immediately if they become pregnant or suspect they may be pregnant. Adverse events associated with the infusion may also occur. Consider belimumba of immunosuppressant therapy, including belimumab, in patients with confirmed PML.

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Patients may use the prefilled syringe or auto-injector after proper training.

Advise patients and caregivers of the signs and symptoms of hypersensitivity and to seek immediate medical help if symptoms develop. Hypersensitivity Reactions, Including Anaphylaxis: If transitioning from packae to subcutaneous therapy, administer the first subcutaneous dose 1 to 4 weeks after the last intravenous dose.

Preparation for use of the prefilled syringe or auto-injector: Do not inject within 2 inches of the umbilicus. Concomitant use of mycophenolate, azathioprine, methotrexate, antimalarials, NSAIDs, aspirin, and HMG-CoA reductase inhibitors “statins” did not significantly influence belimumab pharmacokinetics.

Belimumab use carries a risk of serious hypersensitivity reactions or anaphylaxis. Administration of belimumab requires an experienced clinician prepared to manage anaphylaxis and infusion-related reactions. In the controlled clinical trials, malignancies including non-melanoma skin cancers were reported in 0. When reconstituting, direct the stream of sterile water toward the side of the vial to minimize foaming. Affected cytochrome P CYP enzymes and drug transporters: While most hypersensitivity reactions have occurred acutely, some appear later.

If a breast-feeding infant experiences an adverse effect related to a maternally administered drug, health care providers are encouraged to report the adverse effect to the FDA.

Etiologies included infection, cardiovascular disease, and suicide. Receipt of belimumab also led to reductions in IgG and anti-dsDNA and to increases in complement C3 and C4 as early as week 8 and were sustained through week

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