belimumab


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belimumab

(be-li-moo-mab) ,

Benlysta

(trade name)

Classification

Therapeutic: immunosuppressants
Pharmacologic: monoclonal antibodies
Pregnancy Category: C

Indications

Treatment of active autoantibody-positive systemic lupus erythematosus (SLE) in patients currently receiving standard therapy.

Action

A monoclonal antibody produced by recombinant DNA technique that specifically binds to B-lymphocyte stimulator protein (BLyS), thereby inactivating it.

Therapeutic effects

↓ survival of B cells, including auroreactive ones and ↓ differentiation into immunoglobulin-producing plasma cells. Result is ↓ disease activity with lessened damage/improvement in mucocutaneous, musculoskeletal and immunologic manifestations of SLE.

Pharmacokinetics

Absorption: IV administration results in complete bioavailability.
Distribution: Unknown.
Metabolism and Excretion: Unknown.
Half-life: 19.4 days.

Time/action profile (reduction in activated B cells)

ROUTEONSETPEAKDURATION
IV8 wkunknown52 wk†
†With continuous treatment.

Contraindications/Precautions

Contraindicated in: Hypersensitivity;Concurrent use of other biologicals or cyclophosphamide;Concurrent use of live vaccines; Lactation: Breast feeding not recommended.
Use Cautiously in: Infections (consider temporary withdrawal for acute infections, treat aggressively);Previous history of depression or suicidal ideation (may worsen); Geriatric: may be more sensitive to drug effects, consider age-related changes in renal, hepatic and cardiac function, concurrent drug therapy and chronic disease states; Obstetric: Use during pregnancy only if potential maternal benefit outweighs potential fetal risk; women with childbearing potential should use adequate contraception during and for 4 mo following treatment.

Adverse Reactions/Side Effects

Central nervous system

  • depression (most frequent)
  • insomnia (most frequent)
  • migraine (most frequent)

Gastrointestinal

  • nausea (most frequent)
  • diarrhea (most frequent)

Genitourinary

  • cystitis

Hematologic

  • leukopenia

Musculoskeletal

  • extremity pain (most frequent)

Miscellaneous

  • allergic reactions including anaphylaxis
  • infection (life-threatening)
  • infusion reactions (most frequent)
  • fever (most frequent)

Interactions

Drug-Drug interaction

↑ risk of adverse reactions and ↓ immune response to live vaccines ; should not be given concurrently.

Route/Dosage

Oral (Adults) 10 mg/kg every two wks for three doses, then every four wks.

Availability

Lyophilized powder for IV administration (requires reconstitution and dilution: 120 mg/vial, 400 mg/vial

Nursing implications

Nursing assessment

  • Monitor patient for signs of anaphylaxis (hypotension, angioedema, urticaria, rash, pruritus, wheezing, dyspnea, facial edema) during and following injection. Medications (antihistamines, corticosteroids, epinephrine) and equipment should be readily available in the event of a severe reaction. Discontinue belimumab immediately if anaphylaxis or other severe allergic reaction occurs.
  • Monitor for infusion reactions (headache, nausea, skin reactions, bradycardia, myalgia, headache, rash, urticaria, hypotension). There is insufficient evidence to determine whether premedication diminishes frequency or severity. Infusion rate may be slowed or interrupted if an infusion reaction occurs.
  • Assess for signs of infection (fever, dyspnea, flu-like symptoms, frequent or painful urination, redness or swelling at the site of a wound), including tuberculosis, prior to injection. Belimumab is contraindicated in patients with active infection. New infections should be monitored closely; most common are upper respiratory tract infections, bronchitis, and urinary tract infections. Signs and symptoms of inflammation may be lessened due to suppression from belimumab. Infections may be fatal, especially in patients taking immunosuppressive therapy. If patient develops a serious infection, consider discontinuing belimumab until infection is controlled.
  • Assess mental status and mood changes. Inform health care professional if patient demonstrates significant ↑ in depressed mood, anxiety, nervousness, or insomnia.

Potential Nursing Diagnoses

Risk for infection (Adverse Reactions)

Implementation

  • Consider premedication for prophylaxis against infusion reactions and hypersensitivity reactions.
  • Intravenous Administration
  • pH: 6.5.
  • Intermittent Infusion: Remove belimumab from refrigerator and allow to stand 10–15 min to reach room temperature. Reconstitute 120 mg vial with 1.5 mL and 400 mg vial with 4.8 mL of Sterile Water for Injection by directing stream toward side if vial to minimize foaming. Swirl gently for 60 seconds. Allow vial to site at room temperature during reconstitution, swirling gently for 60 seconds every 5 min until powder is dissolved. Do not shake. Reconstitution usually takes 10–15 min, but may take up to 30 min. Protect from sunlight. Solution is opalescent and colorless to pale yellow and without particles. Small bubbles are expected and acceptable. Concentration: 80 mg/mL.Diluent: 0.9% NaCL. Remove volume of patient's dose from a 250 mL infusion bag and discard. Replace with required amount of reconstituted solution. Gently invert bag to mix. Do not administer solutions that are discolored or contain particulate matter. Discard unused solution in vial. If not used immediately, refrigerate and protect from light. Solution is stable for 8 hrs.
  • Rate: Infuse over 1 hr; may slow or interrupt rate if patient develops an infusion reaction.
  • Y-Site Incompatibility: Do not administer with dextrose solutions or other solutions or medications.

Patient/Family Teaching

  • Instruct patient to read Medication Guide prior to each treatment session.
  • Caution patient to notify health care professional immediately if signs of infection (fever, sweating, chills, muscle aches, cough, shortness of breath, blood in phlegm, weight loss, warm, red or painful skin or sores, diarrhea or stomach pain, burning on urination, urinary frequency, feeling tired), severe rash, swollen face, or difficulty breathing occurs while taking.
  • Advise patient to report signs and symptoms of anaphylaxis to health care professional immediately.
  • Advise patient, family, and caregivers to look for depression and suicidality, especially during early therapy or dose changes. Notify health care professional immediately if thoughts about suicide or dying, attempts to commit suicide; new or worse depression or anxiety; agitation or restlessness; panic attacks; insomnia; new or worse irritability; aggressiveness; acting on dangerous impulses, mania, or other changes in mood or behavior or if symptoms of serotonin syndrome occur.
  • Caution patient to avoid receiving live vaccines for 30 days before and during belimumab therapy.
  • Advise women of childbearing potential to use adequate contraception and to avoid breast feeding during and for at least 4 mos after final treatment.

Evaluation/Desired Outcomes

  • Improvement in mucocutaneous, musculoskeletal, and immunologic disease activity in patients with SLE.
References in periodicals archive ?
Standard of care spans the spectrum of limited courses of non-selective as well as Cox-2 selective NSAIDS, antimalarials, antimetabolites, including MTX, AZA, MMF, and leflunomide, and belimumab.
For the primary efficacy endpoint (Systemic Lupus Erythematosus Responder Index (SRI) at Week 52), significantly more patients treated with belimumab administered subcutaneously plus SoC (60.
GlaxoSmithKline is also conducting three other registries: the Belimumab (Benlysta) Pregnancy Registry for patients with systemic lupus erythematosus treated with belimumab (877-681-6296 / belimumab.
Contract award: delivery of biological medicine for belimumab pharmacies institute of rheumatology (25 / pn / 2014 / cu).
The data from the trials show us that belimumab won't be the perfect drug for every patient, but there may be a substantial number of patients who may be helped.
The priority review from the FDA means the drug, also known as belimumab and submitted to the agency on June 9, should be reviewed in six months rather than the normal 10.
Drug profiles discussed in this report are ACP-01, belimumab, beperminogene perplasmid, CCX-168, gevokizumab, immune globulin (human), Monoclonal Antibodies to Antagonize GPR4 for Vascular Inflammation, PF-1355, rituximab biosimilar, Stempeucel, tocilizumab and Vascostem.
Contract notice: Delivery of biological medicine belimumab for pharmacy institute of rheumatology (25 / pn / 2014 / jw).
PARIS -- The live birth rate among women taking belimumab for systemic lupus erythematosus is similar to the background rate for women with the disorder, a study showed.
Benlysta, known generically as belimumab, is given once a month by intravenous infusion.
Belimumab should be approved for reducing disease activity in adults with active autoantibody--positive systemic lupus erythematosus who are on standard treatment, a Food and Drug Administration advisory panel recommended in a 13-2 vote.
The other agent is the immunomodulator belimumab (Benlysta; C), which is indicated for the treatment of systemic lupus erythematosus.