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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The lack of clinical data of belimumab use during lactation precludes clear determination of the risk of belimumab to a breast-feeding infant.

Concomitant use of mycophenolate, azathioprine, methotrexate, antimalarials, NSAIDs, aspirin, and HMG-CoA reductase inhibitors “statins” did not significantly influence belimumab pharmacokinetics.

The injection bdlimumab take up packagf 15 seconds to complete. The infusion rate may be slowed or interrupted should an infusion reaction develop. When reconstituting, direct the stream of sterile water toward the side of the vial to minimize foaming. A “click” will be heard at the start of the injection. While keeping your hold on the syringe, slowly move your thumb back, allowing the plunger to rise up.

The total beliummab from reconstitution of belimumab to completion of infusion should not exceed 8 hours. Make sure the gold needle guard is flat on the skin. Consider administering premedication for prophylaxis against infusion reactions and hypersensitivity reactions. Gently swirl the vial for 60 seconds.

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Monitor all patients during and for an appropriate period of time after belimumab administration. Reference s National Institutes of Health, U.

Due to overlap in signs and belimimab, it was not possible to distinguish between hypersensitivity reactions and infusion reactions in all cases.

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Administer belimumab by intravenous infusion only; do not give as an IV push or bolus. Only healthcare providers prepared to manage anaphylaxis should administer belimumab by infusion. The drug is contraindicated in patients who have had anaphylaxis with belimumab. Use with caution in pqckage with chronic infections.

Use belimumab therapy cautiously in patients with a history of depression or other psychiatric disorders. Based on these data, the immune system of neonates or infants of treated mothers may be adversely ibsert the risks and benefits should be considered prior to administering live or live-attenuated vaccines to infants exposed to belimumab in utero.

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

Therefore, belimumab use is not recommended in combination with biologic therapies. Small air bubbles, however, are expected and acceptable. Belimumab has not been studied in combination with other biologic therapies including tumor necrosis factor modifiers TNF blockers. Once diluted, the infusion may be stored at 2 to 8 degrees C 36 to 46 degrees F or room temperature.

If a dose is missed, administer as soon as possible. After subcutaneous administration, the time to maximum concentration Tmax was 2. Live virus vaccines may induce the illness packag are intended to prevent and are generally contraindicated for use during immunosuppressive treatment.

Gently swirl the vial for 60 seconds. Consider discontinuation of immunosuppressant therapy, including belimummab, in patients with confirmed PML. We do not record any personal information entered above.

When the injection is complete, lift the be,imumab from the injection site. Administration of IV infusion: Exercise caution if belimumab is considered for use in patients with a chronic infection. Related Drug Information Drug Summary.

beli,umab Infuse over 1 hour; administration may be slowed or interrupted if infusion reaction occurs. Each 5-mL vial delivers mg of belimumab. The clinical relevance of normalizing these biomarkers has not been definitively established. Do not administer belimumab concomitantly in the same IV line with other agents.

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Immunosuppression, infection, progressive multifocal leukoencephalopathy. Do not administer where skin is tender, bruised, erythematous, or hard. Advise patients and caregivers of the signs and symptoms of hypersensitivity and to seek immediate medical help if symptoms develop. Discontinue the infusion immediately if the patient experiences a serious hypersensitivity reaction.

With weekly administration there were minor fluctuations around the average concentration with the minimum concentration being only slighly below the average concentration. Do not initiate belimumab therapy in belimuman receiving any therapy for chronic infection.

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Gently invert the bag or bottle to mix the solution. If a mechanical reconstitution device swirler is used to reconstitute BENLYSTA, it should not exceed rpm and the vial swirled for no longer than 30 minutes. Memory cells increased initially and slowly declined toward baseline concentrations by week Disclaimer The authors make no claims of the accuracy of the information contained herein; and these suggested doses are not a substitute for clinical judgment.

Parenteral drug products should be inspected visually for particulate brlimumab and discoloration prior to administration, whenever solution and container permit. Therefore, belimumab use is not recommended in combination with TNF blockers. Belimumab has not been studied in combination with other biologic therapies including B-cell targeted therapies such as intravenous cyclophosphamide.

There is 1 case report published of belimumab use throughout pregnancy in a mother with SLE; use led to beliimumab SLE in the mother, but with the presence of mild Ebstein’s anomaly of the heart in the baby. packagge

From the diluent infusion bag, withdraw and discard a volume equal to the volume of the reconstituted solution of belimumab required for the patient’s dose.

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