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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Send the page ” ” to a friend, relative, colleague or yourself. We do not record any personal information packate above. Intravenous and subcutaneous human monoclonal antibody insdrt inhibits B lymphocyte stimulator BLyS Used with standard therapy for active autoantibody-positive, systemic lupus erythematosus SLE in adults Infusion reactions possible with IV use; serious hypersensitivity reactions and infections have been reported with subcutaneous and IV use.

Consider premedication to attenuate infusion- and hypersensitivity-related reactions. Discontinue the infusion immediately if the patient experiences a serious hypersensitivity reaction.

Belimumab has not been evaluated and is not recommended in patients with severe active lupus nephritis or severe active central nervous system lupus or in combination with other biologic products or intravenous cyclophosphamide.

If transitioning from intravenous to subcutaneous therapy, administer the first subcutaneous dose 1 to 4 weeks after the last intravenous dose. Visually inspect parenteral products for particulate matter and discoloration prior to administration whenever solution and container permit. Remove drug vial from refrigerator and allow to stand 10 to 15 minutes to reach room temperature. When reconstituting, direct the stream of sterile water toward the side of the pxckage to minimize foaming.

Gently swirl the vial for 60 seconds. Allow the vial to sit at room temperature during reconstitution, gently swirling the vial for 60 seconds every 5 minutes until the powder is dissolved. Reconstitution is typically complete within 10 to 15 minutes after the sterile water has been added, but it may take up to 30 minutes.

If a mechanical reconstitution device unsert is used to reconstitute belimumab, it should not exceed rpm and the vial swirled for no longer than 30 minutes. Once reconstitution is complete, the solution should be opalescent and colorless to pale yellow, and without particles. Small air bubbles, however, are expected and acceptable. Protect reconstituted solution from sunlight. If not used immediately, protect the reconstitued vial from direct sunlight and refrigerate at 2 to 8 degrees Pacckage 36 to 46 degrees F.

The total time from reconstitution of inset to completion of infusion should not exceed 8 hours. Once reconstituted, the belimumab injection in the vial must be inserf diluted to prepare the IV infusion.

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Belimumab is NOT compatible with Dextrose solutions. Dilute belimumab in 0. From the diluent infusion bag, withdraw and discard a volume equal to belumumab volume of the reconstituted solution of belimumab required for the patient’s dose.

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Then add the reconstituted solution of belimumab to the infusion bag or bottle. Gently invert the bag or bottle to mix the solution.

Discard any unused belimumab solution that remains in the vials. Once diluted, the infusion may be stored at 2 to 8 degrees C 36 to 46 degrees F or pakcage temperature. The total time from reconstitution to completion of infusion should not exceed 8 hours. Administration of IV infusion: Administer belimumab by belimumzb infusion only; do not give as an IV push or bolus.

Only healthcare packagr prepared to manage anaphylaxis should administer belimumab by infusion. Consider administering premedication for prophylaxis against infusion reactions and hypersensitivity reactions. Infuse over 1 hour; administration may be slowed or interrupted if infusion reaction occurs. Do not administer belimumab concomitantly in the same IV line with other agents. Belimumab is available as both a prefilled syringe and as an auto-injector for subcutaneous use.

BENLYSTA® (belimumab) for injection – GlobalRPH

Each device contains mg belimumab. Patients may use the prefilled syringe or auto-injector after proper training. Preparation for use of the prefilled syringe or auto-injector: Remove prefilled syringe or auto-injector from refrigerator and allow 30 minutes to reach room temperature. Do not warm in any other way. Inspect syringe or autoinjector for particulate matter and discoloration prior to administration.

Belimumab should be clear to opalescent and colorless to pale yellow. It is normal to see 1 or more air bubbles in the solution. Do not use the autoinjector or prefilled syringe if dropped on a hard surface. Storage of unopened prefilled syringes or autoinjectors: Protect from light and store refrigerated at 2 to 8 degrees C 36 to 46 degrees F until time of use. Do not freeze and do not use if the injection has been frozen.

Avoid exposure to heat. Subcutaneous administration sites include the abdomen and thigh. Do not inject within 2 inches of the umbilicus. Do not administer where skin is tender, bruised, erythematous, or hard. For the pre-filled syringe, insert the entire needle into the pinched area of the skin at a slight degree angle using a dart-like motion.

Push the plunger all the way down until all of the solution is injected. While keeping your hold on the syringe, slowly move your thumb back, allowing the plunger to rise up. The needle will automatically rise up into the needle guard. For the auto-injector, position the auto-injector straight over the injection site at a degree angle.

Make sure the gold needle guard is flat on the skin. To start the injection, firmly press the auto-injector all the way down onto the injection site and hold in place. A “click” will be heard at the start of the injection. Continue to hold the auto-injector down until you see that the purple indicator has stopped moving. A second “click” may be heard.

The injection may take up to 15 seconds to complete. When the injection is complete, lift the injector from the injection site. Dispose of any used pre-filled syringes or auto-injectors immediately after use. Rotate sites of injection with each dose. If a dose is missed, administer as soon as possible. Thereafter, the patient can resume dosing on their usual day of administration or start a new weekly schedule from the day that the missed dose was administered.

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Do not give 2 doses on the same day. Belimumab use carries a risk of serious hypersensitivity reactions or anaphylaxis. The drug is contraindicated in patients who have had anaphylaxis with belimumab. Administration of belimumab requires an experienced clinician prepared to manage anaphylaxis and infusion-related reactions. Consider premedication to attenuate such responses.

Monitor all patients during and for an appropriate period of time after belimumab administration. If serious hypersensitivity reactions develop during belimumab administration, discontinue the infusion immediately and treat accordingly.

The infusion rate may be slowed or interrupted should an infusion reaction develop. It is important to note that hypersensitivity reactions may present as infusion reactions. While most hypersensitivity reactions have occurred acutely, some appear later.

Non-acute hypersensitivity reactions including rash, nausea, fatigue, myalgia, headache, and facial edema, have been reported and typically occurred up to a week following the most belimuab infusion. Adverse events associated with the infusion may also occur. Serious infusion reactions excluding hypersensitivity reactions were reported in 0. The most common infusion reactions were headache, nausea, and skin reactions.

Due to overlap in signs and symptoms, it was not possible to distinguish between hypersensitivity reactions and infusion reactions in all cases. Advise patients and caregivers of the signs and symptoms of hypersensitivity and to seek immediate medical help if symptoms develop. Exercise caution if belimumab is considered for use in patients with a chronic infection. Do not initiate belimumab therapy in patients receiving any therapy for chronic infection.

Serious and sometimes fatal infections have been reported in clinical trials with belimumab or other immunosuppressive agents. Belimumab may cause leukopenia, and patients with immunosuppression may be more susceptible to infection.

Consider interrupting belimumab in pwckage who develop a new infection during treatment. Cases of JC virus-associated progressive multifocal leukoencephalopathy PML have been reported, some fatal, in patients with systemic lupus erythematosus receiving immunosuppressants, including belimumab. Treatment with immunosuppressants and impaired immune function are risk factors for PML. A diagnosis of PML should be considered in any patient presenting with new-onset or deteriorating neurological signs and symptoms.

Consultation with a neurologist or other appropriate specialist may be warranted. Consider discontinuation of immunosuppressant therapy, including belimumab, in patients with confirmed PML.

There may be an increased risk of mortality in patients receiving belimumab. There were more deaths reported with belimumab than with placebo during the controlled period of the clinical trials. Out of 2, patients receiving intravenous belimumab in 3 clinical trials, a total of 14 deaths occurred during the placebo-controlled, double-blind treatment periods: No single cause of belomumab predominated.

Etiologies included infection, cardiovascular disease, and suicide. Among patients receiving subcutaneous belimumab in controlled trials, 5 deaths occurred 3 belimumab; 2 placebo.