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Qivigy (immune globulin human-kthm)
immune globulin (human)
Black Box Warnings .
Thrombosis
may occur with immune globulin products; risk factors include advanced age, prolonged immobilization, hypercoagulable conditions, venous or arterial thrombosis history, estrogen use, indwelling central vascular catheter, hyperviscosity, and cardiovascular disease risk; thrombosis may occur in patients without risk factors; ensure adequate hydration before administration; give minimum dose at lowest infusion rate practicable in patients at risk; monitor for signs/symptoms of thrombosis and assess blood viscosity in patients with hyperviscosity risk
Renal Dysfunction/Acute Renal Failure
renal dysfunction, acute renal failure, osmotic nephrosis, and death reported with intravenous immune globulin (IVIG) use; patients predisposed to acute renal failure including those with pre-existing renal impairment, diabetes mellitus, volume depletion, sepsis, paraproteinemia, >65 yo, or receiving nephrotoxic drugs; ensure adequate hydration before administration; administer IVIG at minimum dose and lowest infusion rate practicable in patients at risk; IVIG products containing sucrose as stabilizer accounted for disproportionate share of renal dysfunction/failure cases; this product does not contain sucrose
Adult Dosing .
Dosage forms: INJ
Special Note
- [drug name clarification]
- Info: nonproprietary name = immune globulin human-kthm
- [uses, dosing may vary]
- Info: refer to institution protocols and pkg insert prior to prescribing
primary immunodeficiency
- [300-800 mg/kg/dose IV q3-4wk]
- Info: adjust dose based on trough IgG levels and clinical response; give 400 mg/kg/dose IV x1 ASAP if measles exposure; if maintenance dose <400 mg/kg/dose IV q3-4wk and measles exposure risk, give 400 mg/kg/dose IV x1 just prior to exposure
idiopathic thrombocytopenic purpura (off-label)
- [1000 mg/kg/dose IV x1 on day 1, may give additional dose x1 on subsequent day]
- Alt: 400 mg/kg/dose IV qd x5 days; Info: may repeat q3-4wk prn
secondary immunodeficiency, B-CLL associated (off-label)
- [400 mg/kg/dose IV q3-4wk]
chronic inflammatory demyelinating polyneuropathy (off-label)
- [1000 mg/kg/dose IV q3wk]
- Start: 2000 mg/kg/total dose IV divided over 2-5 days, infused daily; Alt: 500 mg/kg/dose IV qd x2 days, given q3wk
myasthenia gravis (off-label)
- [400 mg/kg/dose IV qd x5 days]
- Max: 1000 mg/kg/day; Alt: 1000 mg/kg/dose IV qd x2 days
renal dosing
- [see below]
- renal impairment: not defined, caution advised; Info: use minimum dose and infusion rate practicable
- HD/PD: not defined
hepatic dosing
- [not defined]
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- caution: IgA deficiency
- caution: nephrotoxic agent use, concurrent
- caution: patients >65 yo
- caution: renal impairment
- caution: renal impairment risk
- caution: paraproteinemia
- caution: migraine history
- caution: thrombosis risk
- caution: hyperviscosity
- caution: A blood group
- caution: AB blood group
- caution: B blood group
- caution: inflammatory disorder
- caution: high-dose use
- caution: volume overload (immune thrombocytopenia use)
Drug Interactions .
Overview
immune globulin
immunoglobulin
- immunomodulatory effects (immune globulin)
- nephrotoxicity
- thrombogenic effects
- monitor renal function; nephrotoxicity risk may be higher with sucrose-containing immune globulins, may vary depending on route of administration
Contraindicated
- cidofovir
Avoid/Use Alternative
- aldesleukin
- amikacin
- amikacin inhaled
- bumetanide
- clofarabine
- efgartigimod alfa
- ethacrynic acid
- foscarnet
- furosemide
- ganciclovir
- gentamicin
- immune globulin
- mannitol
- methotrexate
- nipocalimab
- oxaliplatin
- pentamidine
- polymyxin B
- pozelimab
- rozanolixizumab
- streptomycin
- streptozocin
- tenofovir disoproxil
- tobramycin
- tobramycin inhaled
- torsemide
- tranexamic acid
- vaccinia immune globulin
- valganciclovir
Monitor/Modify Tx
- abemaciclib
- abrocitinib
- acyclovir
- adefovir dipivoxil
- adenovirus vaccine, live
- aflibercept
- alectinib
- aliskiren
- allopurinol
- amiloride
- aminocaproic acid
- amphotericin
- angiotensin II
- anthrax immune globulin
- anti-inhibitor coagulant complex
- antihemophilic factor (factor VIII)/von Willebrand factor complex
- asciminib
- asparaginase
- aspirin
- atidarsagene autotemcel
- auranofin
- avatrombopag
- axitinib
- azilsartan medoxomil
- balsalazide
- baricitinib
- bazedoxifene
- benazepril
- bevacizumab
- binimetinib
- bleomycin
- botulism immune globulin
- brolucizumab
- C1 esterase inhibitor
- cabozantinib
- calaspargase
- candesartan cilexetil
- capecitabine
- captopril
- carboplatin
- carfilzomib
- celecoxib
- chlorothiazide
- chlorthalidone
- chorionic gonadotropin
- cisplatin
- clindamycin
- clozapine
- coagulation factor IX
- coagulation factor VIIa
- coagulation factor XIII A-subunit
- colistimethate
- concizumab
- copper histidinate
- creatine
- cyclophosphamide
- cyclosporine
- cytomegalovirus immune globulin
- danazol
- darbepoetin alfa
- deferasirox
- deferoxamine
- deflazacort
- dengue vaccine, live
- desogestrel (contraceptive)
- deuruxolitinib
- dexamethasone
- diclofenac
- diclofenac topical
- dienogest (contraceptive)
- diflunisal
- drospirenone (contraceptive)
- drospirenone (hormone replacement)
- eculizumab
- eltrombopag
- enalapril
- enalaprilat
- epirubicin
- epoetin alfa
- estetrol (contraceptive)
- estradiol (contraceptive)
- estradiol (hormone replacement)
- estrogens, conjugated (hormone replacement)
- estrogens, esterified (hormone replacement)
- ethinyl estradiol (contraceptive)
- ethinyl estradiol (hormone replacement)
- ethynodiol (contraceptive)
- etodolac
- etonogestrel (contraceptive)
- everolimus
- factor XIII concentrate
- faricimab
- fedratinib
- fenofibrate
- fenofibric acid
- fenoprofen
- fibrinogen (human)
- fitusiran
- flucytosine
- flurbiprofen
- follitropin
- fosinopril
- fruquintinib
- hepatitis B immune globulin
- hydrochlorothiazide
- hydroxocobalamin IV
- ibuprofen
- ibuprofen lysine
- ifosfamide
- indapamide
- indomethacin
- iodixanol
- iohexol
- iomeprol
- iopamidol
- iopromide
- iothalamate meglumine
- ioversol
- irbesartan
- ketoprofen
- ketorolac
- lazertinib
- lenalidomide
- lenvatinib
- levonorgestrel (contraceptive)
- levonorgestrel (hormone replacement)
- lifileucel
- lisinopril
- lithium
- lomustine
- losartan
- luspatercept
- lusutrombopag
- lutetium Lu 177 vipivotide tetraxetan
- magnesium citrate
- magnesium salicylate
- measles/mumps/rubella vaccine, live
- meclofenamate
- medroxyprogesterone (contraceptive)
- medroxyprogesterone (hormone replacement)
- mefenamic acid
- megestrol
- meloxicam
- menotropins
- mesalamine
- mesalamine rectal
- methoxy polyethylene glycol-epoetin beta
- methyltestosterone
- metolazone
- mitomycin
- moexipril
- momelotinib
- nabumetone
- naproxen
- necitumumab
- neomycin
- nintedanib
- norelgestromin (contraceptive)
- norethindrone (contraceptive)
- norethindrone (hormone replacement)
- norgestimate (contraceptive)
- norgestrel (contraceptive)
- nusinersen
- obinutuzumab
- olaparib
- olmesartan medoxomil
- olsalazine
- ospemifene
- oxaprozin
- pacritinib
- pamidronate
- paromomycin
- pazopanib
- pegaspargase
- pemetrexed
- penicillamine
- pentostatin
- perindopril
- piroxicam
- plazomicin
- polyethylene glycol
- polyethylene glycol/electrolytes
- pomalidomide
- ponatinib
- porfimer
- progesterone (hormone replacement)
- progesterone vaginal (hormone replacement)
- prothrombin complex concentrate (human)
- quinapril
- raloxifene
- ramipril
- ramucirumab
- ranibizumab
- ravulizumab
- Rho(D) immune globulin
- ritlecitinib
- rituximab
- romiplostim
- ropeginterferon alfa-2b
- ruxolitinib
- ruxolitinib topical
- salsalate
- segesterone (contraceptive)
- sipuleucel-T
- sirolimus
- sitagliptin
- sodium tetradecyl sulfate
- sotatercept
- sparsentan
- spironolactone
- sulfate bowel prep
- sulindac
- sunitinib
- tacrolimus
- tamoxifen
- telavancin
- telmisartan
- temsirolimus
- tenofovir alafenamide
- testosterone
- thalidomide
- tiopronin
- tivozanib
- tofacitinib
- tolmetin
- toremifene
- trametinib
- trandolapril
- tretinoin
- triamterene
- upadacitinib
- vadadustat
- valacyclovir
- valoctocogene roxaparvovec
- valsartan
- vamorolone
- vancomycin
- varicella vaccine, live
- varicella zoster immune globulin
- voclosporin
- von Willebrand factor
- vorinostat
- willow bark
- ziv-aflibercept
- zoledronic acid
- zonisamide
- zopapogene imadenovec
Adverse Reactions .
Serious Reactions
- hypersensitivity reaction, severe
- anaphylaxis
- Stevens-Johnson syndrome
- erythema multiforme
- nephrotoxicity
- hyperproteinemia
- hyponatremia
- pseudohyponatremia
- hyperviscosity
- thromboembolism
- aseptic meningitis
- hemolytic anemia
- transfusion-related acute lung injury
- viral transmission risk
Common Reactions
- headache
- cough
- infusion reaction
- nausea
- vomiting
- rash
- urticaria
- fever
- rigors
- flushing
- back pain
- fatigue
- asthenia
- chest tightness
- muscle cramps
- blood pressure lability
- URI
- BUN or Cr elevated
Safety/Monitoring .
Monitoring Parameters
BUN/Cr at baseline, then periodically; urine output if acute renal failure risk; vital signs during infusion; blood viscosity at baseline, signs/symptoms of thrombosis if hyperviscosity risk; consider Hgb or Hct at baseline, then within 36-96h post-infusion if hemolysis risk
Pregnancy/Lactation .
Pregnancy
Clinical Summary
may use during pregnancy; no known risk of fetal harm based on human data
Lactation
Clinical Summary
may use while breastfeeding; no known risk of infant harm based on human data; no human data available to assess effects on milk production
Pharmacology .
Metabolism: for immune globulin: other; CYP450: unknown
Excretion: for immune globulin: other; Half-life: 20-72 days; Info: half-life varies among patients
Subclass: Immunoglobulins ; Myasthenia Gravis ; Neuropathy/Neuralgia
Mechanism of Action
for immune globulin: exact mechanism of action unknown; reestablishes normal immunoregulatory pathways
Formulary .
No Formulary Selected
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