Read Mosby's 2014 Nursing Drug Reference Online
Authors: Linda Skidmore-Roth
Canada only Side effects:
italics
= common;
bold
= life-threatening
Nurse Alert
(bel-a-ta′sept)
Nulojix
Func. class.:
Biologic response modifier
Chem. class.:
Fusion protein
Activated T lymphocytes are the mediators of immunologic rejection, this product is a selective T-cell costimulation blocker; blocks the CD28 mediated costimulation of T lymphocytes by binding to CD80 and CD86 on antigen-presenting cells; inhibits T lymphocyte proliferation and the production of the cytokines interleukin-2, interferon-gamma, interleukin-4, and TNF-alpha.
Kidney transplant rejection prophylaxis given with basiliximab induction, mycophenolate mofetil, corticosteroids
Hypersensitivity
Precautions:
Breastfeeding, child/infant/neonate, pregnancy (C), diabetes mellitus, progressive multifocal leukoencephalopathy, immunosuppression, sunlight exposure, TB
Black Box Warning:
Infection, organ transplant, requires an experienced clinician, secondary malignancy, posttransplant lymphoproliferation disorder
• Adult: IV
10 mg/kg rounded to the nearest 12.5 mg increment; give over 30 min the day of transplantation (day 1) but before transplantation, on day 5 approximately 96 hours after the day 1 dose 1, at the end of wk 2, at the end of wk 4, at the end of wk 8, and at the end of wk 12; maintenance dosage is 5 mg/kg rounded to the nearest 12.5 mg increment; give over 30 min at the end of wk 16 and every 4 wk ± 3 days thereafter; doses should be calculated on actual body weight on the transplantation day unless the patient’s weight varies by >10%
Available forms:
Powder for inj 250 mg
Black Box Warning:
Only providers skilled in the use of immunosuppressant and management of transplant should use these products
•
Visually inspect product for particulate matter, discoloration whenever sol/container permit, discard if present
•
Calculate the number of drug vials required to provide total inf dose
•
Reconstitute each vial/10.5 ml of sterile water for injection, 0.9% sodium chloride, D
5
W, using the silicone-free disposable syringe provided with each vial and an 18-21G needle. If silicone-free disposable syringe is dropped or becomes contaminated, use a new silicone-free disposable syringe from inventory. If you need additional silicone-free disposable syringes, call 1-888-685-6549. If the powder is accidentally reconstituted using a different syringe than the one provided, the sol may develop a few translucent particles. Discard any sol prepared using siliconized syringes.
•
Using aseptic technique, inject the diluent into the vial and direct the stream of diluent to the glass wall of the vial; to minimize foaming, rotate the vial and invert with gentle swirling until the contents are dissolved; do not shake when reconstituted (25 mg/ml), should be clear to slightly opalescent and colorless to pale yellow; do not use if opaque particles, discoloration, or other foreign particles are present.
•
Calculate the total volume of the reconstituted 25 mg/ml sol required to provide the total inf dose; further dilute this volume with a volume of inf fluid equal to
the volume of the reconstituted drug sol required to provide the prescribed dose. Use either NS or D
5
W if drug was reconstituted with SWFI; use NS if drug was reconstituted with NS; use D
5
W if drug was reconstituted with D
5
W. With the same silicone-free disposable syringe used for reconstitution, withdraw the required amount of belatacept sol from the vial, inject it into the inf container, gently rotate the inf container to ensure mixing; final conc in inf container should range (2-10 mg/ml). Volume of 100 ml will be appropriate for most patients and doses, but total inf volumes ranging from 50-250 ml may be used. Discard any unused drug sol remaining in the vials; after reconstitution, immediately transfer the reconstituted sol from the vial to the inf bag or bottle; complete within 24 hr.
•
Give over 30 min, use an inf set and a sterile, nonpyrogenic, low-protein-binding filter (0.2-1.2 mm), use a separate line
CNS:
Guillain-Barré syndrome, anxiety, dizziness, headache, fever, insomnia, tremor
EENT:
Pharyngitis, stomatitis
GI:
Abdominal pain, constipation, diarrhea, nausea, vomiting
GU:
Renal tubular necrosis, renal failure,
proteinuria, urinary incontinence
HEMA:
Anemia, neutropenia, leucopenia, leukoencephalopathy
INTEG:
Acne, alopecia
META:
Hypercholesterolemia, hyperglycemia, hyper/hypokalemia, hypocalcemia, hypophosphatemia, hypomagnesemia
MS:
Arthralgia
SYST:
Secondary malignancy, posttransplant lymphoproliferation disorder, wound dehiscence, BK-virus-associated neuropathy
Half-life, 6.1-15.1 days during receipt of 10 mg/kg IV doses; during receipt of 5 mg/kg IV doses, terminal half-life 3.1-11.9; steady-state by wk 8 after transplantation and by month 6 during maintenance phase
Increase:
Basiliximab induction, mycophenolate mofetil
Black Box Warning:
Transplant rejection: flulike symptoms, decreasing urinary output, malaise; some may experience pain in area (rare; monitor BUN/creatinine)
Black Box Warning:
Infection: monitor for fever, chills, increased WBC,
wound dehiscences
Black Box Warning:
Posttransplant lymphoproliferation disorder: may lead to secondary malignancy (lymphoma) or infectious mononucleosis-like lesions; may be treated with antivirals or immunosuppressant; product may need to be discontinued
•
Hyperlipidemia: monitor cholesterol, triglycerides; an antilipidemic may be needed
•
Storage: refrigerated, protected from light ≤24 hr; max 4 hr of the total 24 hr can be at room temp and room light
•
Therapeutic response: absence of renal transplant rejection
•
Reason for product and expected result
•
To avoid exposure to sunlight, tanning beds, risk of secondary malignancy
•
To avoid crowds, persons with known infections
•
That repeated lab test will be needed
•
To avoid with vaccines
•
That immunosuppressants will be needed for life to prevent rejection; teach symptoms of rejection and to call provider immediately
Canada only Side effects:
italics
= common;
bold
= life-threatening
Nurse Alert
(be-lim′ue-mab)
Benlysta
Func. class.:
Monoclonal antibody
Chem. class.:
Disease-Modifying Antirheumatic Drugs (DMARDs)
Inhibits B lymphocyte stimulator (BLyS), needed for B-cell survival; normally, soluble BLyS binds to its receptors on B cells and allows B-cell survival; binds BLyS and prevents binding to its receptors on B-cells
Active, autoantibody-positive, systemic lupus erythematosus (SLE) in combination with standard therapy
Hypersensitivity
Precautions:
Pregnancy (C), breastfeeding, children/infants, geriatric patients, African decent patients, depression, immunosuppression, infection, suicidal ideation, vaccination, secondary malignancy, cardiac disease; requires experienced clinician
• Adult: IV
10 mg/kg over 1 hr q2wk for the first 3 doses then q4wk
Available forms:
Powder for injection 120, 400 mg
•
Only health care providers prepared to manage anaphylaxis should administer this product; may give premedication for prophylaxis against infusion and hypersensitivity reactions
•
Visually inspect particulate matter and discoloration whenever sol and container permits
•
Give as IV inf only, do not give IV bolus or push; give over 1 hr and slow or stop if inf reactions occur
•
Do not give with any other agents in the same IV line
•
Allow to stand at room temp for 10-15 min before using
•
Reconstitute with the appropriate amount of sterile water for injection (80 mg/ml); add 1.5 ml of sterile water (120 mg/vial) or 4.8 ml of sterile water (400 mg/vial)
•
Direct the stream of sterile water toward the side of the vial to minimize foaming; gently swirl for 60 sec, allow to sit during reconstitution, gently swirl for 60 sec q5min until the powder is dissolved; do not shake; reconstitution is complete in 10 to 30 min
•
If a mechanical reconstitution device (swirler) is used, max 500 rpm swirled for ≤30 min.
•
Sol should be opalescent and colorless to pale yellow and without particles; small air bubbles are expected; protect from sunlight
•
Dilution: only dilute in normal saline for injection; dilute reconstituted sol with enough normal saline to 250 ml. From a 250-ml inf bag or bottle of normal saline, withdraw and discard a volume equal to the volume of the reconstituted sol required for dose; add the required volume of the reconstituted sol the infusion bag/bottle; gently invert to mix
•
Discard any unused sol
CNS:
Headache, dizziness, anxiety, depression, fever, insomnia, migraine,
suicidal ideation
CV:
Bradycardia, hypotension
GI:
Nausea, diarrhea
MISC:
Rash, dyspnea, cystitis, leukopenia, myalgia, rash, bronchitis, nasopharyngitis, pharyngitis
SYST:
Anaphylaxis, angioedema, antibody formation, secondary malignancy, infection, influenza
Terminal half-life 19.4 days; distribution half-life 1.75 days
•
SLE:
monitor for decreasing fever, malaise, fatigue, joint pain, myalgias
•
Suicidal ideation:
more common in those with preexisting depression
•
Infection:
determine if a chronic or acute infection is present, may be fatal when used with this product; do not begin therapy if any products are being used for a chronic infection; leucopenia may occur with this product and susceptibility to infections increased
•
Anaphylaxis,
infusion site reactions: if these occur, stop infusion
•
African descent patients:
use cautiously in these patients, may not respond to this product
•
Cardiac disease: monitor closely for cardiovascular side effects, bradycardia, hypotension
•
Pregnancy: determine if pregnant or if pregnancy is planned or suspected; if pregnant, call 1-877-681-6269 to enroll in registry
•
Storage in refrigerator or at room temp; total time from reconstitution to completion of inf max 8 hr
•
Positive response: Decreasing symptoms of SLE: decreasing fatigue, fever, malaise
•
To notify prescriber if pregnancy is planned or suspected, to use reliable contraception during and for 4 months after final treatment; to avoid breastfeeding
•
To seek treatment immediately for serious hypersensitive reactions
•
Not to receive vaccinations during treatment