Belimumab

Class and Category

Pharmacologic class: Monoclonal antibody

Therapeutic class: Immunosuppressant

Indications and Dosages

To treat active, autoantibody-positive systemic lupus erythematosus (SLE) in patients who are receiving standard therapy

I.V. INFUSION

Adults and children age 5 and older: 10 mg/kg infused over 1 hr every 2 wk for first 3 doses followed by 10 mg/kg infused over 1 hr every 4 wk.

SUBCUTANEOUS INJECTION

Adults: 200 mg once wk injected into the abdomen or thigh.

Adults transitioning from intravenous therapy: 200 mg once wk injected into the abdomen or thigh, with first dose given 1 to 4 wk after the last I.V. dose.

Mechanism of Action

Blocks the binding of soluble B-cell lym-phocyte stimulator protein, a B-cell survival factor, to its receptors on B cells. This action causes cell death, which helps to relieve the signs and symptoms of active, autoantibody-positive, systemic lupus erythematosus.

Incompatibilities

Dextrose intravenous solutions are incompatible with belimumab.

Contraindications

Hypersensitivity to belimumab or its components.

Interactions

DRUGS

Live virus vaccines: Possibly suppressed immune response and increased adverse effects of vaccine

Adverse Reactions

CNS: Anxiety, depression, fatigue, fever, headache, insomnia, migraines, myalgia, progressive multifocal leukoencephalopathy, suicidal ideation

CV: Bradycardia, hypotension

EENT: Nasopharyngitis, pharyngitis, sinusitis

GI: Diarrhea, nausea

GU: Cystitis, lupus nephritis, UTI

HEME: Leukopenia

MS: Extremity pain, myalgia

RESP: Bronchitis, dyspnea, pneumonia, upper respiratory tract infection

SKIN: Cellulitis, pruritus, rash, urticaria

Other: Anaphylaxis, angioedema, antibelimumab antibody formation, flu-like symptoms, infusion reactions, injection site reactions (erythema, hematoma, induration, pain, pruritus), malignancies, serious infections

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Childbearing Considerations

PREGNANCY

• Drug may cause fetal harm. Drug actively crosses placental barrier with largest amount transferred in the third trimester, which may affect fetal immune response in utero.
• Use with caution only if the benefit to the mother outweighs the potential risk to the fetus.
• Monitor neonate and infant if drug exposure occurred in utero for B-cell reduction and other immune dysfunction.

LACTATION

• It is not clear if drug is present in breast milk.
• Patient should check with prescriber before breastfeeding.

REPRODUCTION

Women of childbearing age should avoid pregnancy by using effective contraception during drug therapy and for at least 4 months after final dose of the drug.

Nursing Considerations

• Know that belimumab should not be used to treat patients who are receiving drug therapy to treat a chronic infection. Monitor patient closely for signs and symptoms of infections during belimumab therapy. If present, notify prescriber. If the infection is determined to be new, belimumab therapy may have to be interrupted until infection is resolved.
• Be aware that patient should be premedicated prior to receiving belimumab intravenously to prevent hypersensitivity and infusion reactions before each dose of belimumab. Patients with a history of multiple drug allergies or significant hypersensitivity may be at increased risk. If an infusion reaction still occurs, slow or temporarily stop the infusion, as ordered. If a serious hypersensitivity reaction occurs, discontinue drug immediately and notify prescriber. Know that a nonacute hypersensitivity reaction that may be evident as facial edema, fatigue, headache, myalgia, nausea, and rash may occur up to a week after an infusion.
• Remove vial for intravenous use from refrigerator and allow to stand 10 to 15 minutes prior to reconstitution. Use aseptic technique when reconstituting with 1.5 ml of sterile water for injection, USP for a 120-mg vial and 4.8 ml of sterile water for injection, USP when reconstituting a 400-mg vial. When injecting diluent solution into the vial, direct stream of sterile water toward the side of the vial to minimize foaming. Gently swirl the vial for 60 seconds every 5 minutes until the powder is dissolved. Do not shake or refrigerate during this process. It typically takes 10 to 15 minutes for powder to dissolve but may take as long as 30 minutes. Once reconstituted, protect from sunlight.
• When using a mechanical reconstitution device, do not exceed 500 rpm, and swirl no longer than 30 minutes.

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• Use only 0.9% sodium chloride injection, USP (normal saline) to further dilute the drug being prepared for intravenous administration. Withdraw amount of normal saline from the infusion bag or bottle equivalent to the vial contents of reconstituted drug required for the patient’s dose. Then add the required volume of the reconstituted solution of the drug into the infusion bag or bottle. Gently invert the bag or bottle to mix the solution. Discard any unused solution left in the vial(s). The solution should be stored in the refrigerator protected from direct sunlight, if not used immediately.
• Know that the total time from the drug being reconstituted to completion of infusion should not exceed 8 hours.
• Infuse belimumab intravenously over 1 hour separately from any other medication given concomitantly intravenously.
• Be aware that vials containing belimumab are intended for intravenous use only and autoinjectors and prefilled syringes are intended for subcutaneous use only.
• Know that the first subcutaneous injection of belimumab should be given under the supervision of a healthcare professional.
• Remove the autoinjector or prefilled syringe from the refrigerator and allow it to sit at room temperature for 30 minutes prior to administering. Do not warm the drug any other way. The solution should appear clear to opalescent and colorless to pale yellow. Discard if the product exhibits discoloration or particulate matter or if the autoinjector or prefilled syringe is accidentally dropped on a hard surface. Use a different injection site each week; do not give the injection into areas where the skin is bruised, hard, red, or tender.

WARNING Monitor the patient for a hypersensitivity reaction following the administration of belimumab because hypersensitivity reactions, including anaphylaxis, may occur on the same day of infusion. Notify the prescriber immediately if a reaction occurs, because death has occurred with some patients experiencing hypersensitivity reactions. Expect to provide emergency medical treatment as ordered and indicated by the severity of the reaction.

• Monitor African; American patients closely during belimumab therapy for decreased effectiveness, because clinical trials have shown the response rate may be lower in these patients.
• Watch for evidence of infection (such as cough, fever, malaise, pain) because patients receiving immunosuppressants such as belimumab are at increased risk for serious infections such as bronchitis, cellulitis, pneumonia, and urinary tract infection. If patient develops an infection, notify prescriber, monitor patient closely, and know that drug therapy may be interrupted until infection is gone.
• Be aware that other biologic therapies, such as B-cell targeted therapies or intravenous cyclophosphamide therapy, are not recommended during belimumab therapy because potential drug interactions are unknown.

PATIENT TEACHING

1. Instruct patient who will be self-injecting belimumab, as a subcutaneous injection, how to administer the injection and dispose of needle and syringe after injection.
2. Tell patient to remove the autoinjector or prefilled syringe from the refrigerator and allow it to sit at room temperature for 30 minutes prior to administering. Tell patient not to warm the drug in any other way. Have patient inspect the solution. The solution should appear clear to opalescent and colorless to pale yellow. Instruct patient to discard if product exhibits discoloration or particulate matter or if the autoinjector or prefilled syringe is accidentally dropped on a hard surface. Tell patient to use a different injection site each week and not to give the injection into areas where the skin is bruised, hard, red, or tender.
3. Advise patient that if a subcutaneous dose is missed, she should administer a dose as soon as she remembers. Then patient can resume dosing on the usual day of administration or start a new weekly schedule from the day that the missed dose was administered. Tell patient not to administer two doses on the same day.
4. Instruct patient to report any signs of a hypersensitivity reaction such as difficulty breathing, hives, itching, or a rash to prescriber, and to seek medical attention immediately.
5. Caution patient to report new or worsening depression, suicidal thoughts, or other mood changes.
6. Tell patient to contact the prescriber if he develops new or worsening neurologic symptoms such as confusion, difficulty talking or walking, dizziness, loss of balance, memory loss, or vision problems.
7. Advise patient not to receive any immunization with live vaccines for 30 days before or concurrently with belimumab and to avoid contact with anyone who has an infection.
8. Tell female patient of childbearing age to use effective contraception during treatment and for at least 4 months after the final treatment because of potential adverse effects to infants exposed to drug in utero. Advise her to notify prescriber if pregnancy occurs and encourage her to enroll in the belimumab pregnancy registry.
9. Encourage patient to report any persistent, severe, or unusual signs and symptoms to prescriber because drug may increase risk for cancer.

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