Dosing and uses of L-arginine, RGene-10 (arginine)
Adult dosage forms and strengths
intravenous solution
- 30g/300mL
Pituitary Stimulation
Used as a diagnostic pituitary stimulant to measure human growth hormone (hGH) reserve for conditions such as panhypopituitarism, pituitary dwarfism, chromophobe adenoma, postsurgical craniopharyngioma, hypophysectomy, pituitary trauma, acromegaly, gigantism, and problems of growth and stature
300 mL (30 g) IV infused over 30 minutes
Test procedure
- Schedule AM
- Fast overnight and continue through test period
- Place patient on bed rest for at least 30 minutes before infusion begins
- Take sample draws at -30, 0, 30, 60, 90, 120 and 150 minutes
- To confirm negative response to insulin hypoglycemia test allow 1 day waiting period after insulin test patients may not respond during first test, second test may be performed after 1 day waiting period
Hemoglobinopathies & Thalassemia (Orphan)
Indicated for treatment of beta-hemoglobinopathies and beta-thalassemia
Orphan indication sponsor
- Perrine, Susan P, MD; Boston University, Cancer Research Center; Boston, MA 02118
Pediatric dosage forms and strengths
intranvenous solution
- 30g/300mL
Pituitary Stimulation
Used as a diagnostic pituitary stimulant to measure human growth hormone (hGH) reserve for conditions such as panhypopituitarism, pituitary dwarfism, chromophobe adenoma, postsurgical craniopharyngioma, hypophysectomy, pituitary trauma, acromegaly, gigantism, and problems of growth and stature
0.5 g/kg IV infused over 30 minutes; not to exceed 30 g/dose
Test procedure
- Schedule AM
- Fast overnight and continue through test period
- Place patient on bed rest for at least 30 minutes before infusion begins
- Take sample draws at -30, 0, 30, 60, 90, 120 and 150 minutes
- To confirm negative response to insulin hypoglycemia test allow 1 day waiting period after insulin test patients may not respond during first test, second test may be performed after 1 day waiting period
L-arginine, RGene-10 (arginine) adverse (side) effects
1-10%
Headache (3%)
Flushing (3%)
Nausea (3%)
Vomiting (3%)
Numbness (3%)
Local venous irritation (3%)
<1%
Macular rash
Swelling of hands and feet
Hematuria
Hyperkalemia
Skin burn/necrosis
Loss of consciousness
Perioral tingling
Warnings
Contraindications
Hypersensitivity to product or components
Cautions
Hypersensitivity reactions, including anaphylaxis reported
Confirm with 2nd test if diagnosis results show hGH deficiency; allow 1 day waiting period between tests
Avoid overdosage in pediatric patients (risk of causing metabolic acidosis, cerebral edema, or death)
Administer IV route only
Electorlyte imbalances including hypophosphatemia, hyponatremia (following overdose) and acidosis, and hyperkalemia reported with arginine infusions; risk may increase in renal impairment, diabetes mellitus, and hepatic impairment
Not intended for therapeutic use
Use caution in patients with electrolyte imbalance
Use caution in diabetes mellitus (may lead to life-threatening hyperkalemia)
Tissue damage may occur with extravasation
Avoid use in myocardial infarction
Use caution in impaired renal function or electrolyte imbalance
Pregnancy and lactation
Pregnancy category: B
Lactation: Enters breast milk, use caution
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of L-arginine, RGene-10 (arginine)
Mechanism of action
Induces rise of human growth hormone (HGH); patients with impaired pituitary function have lower or no increase in plasma concentration of growth hormone following arginine administration; used as test for pituitary function
Pharmacokinetics
Peak serum time: ~20-30 min (IV)
Half-life: 0.7-1.3 hr
Vd: ~33 L/kg following 30 g IV dose
Administration
IV Preparation
A special air-inletting, air-filtering set w/ bacterial air filter is required
No airway needle is needed
Remove metal seal and metal disc from bottle to expose rugger stopper
Do not contaminate target site of stopper
With shut-off clamp closed, remove sterility protector from spike of administration set and immediately insert set with quick trust into center of stopper with bottle upright on table (ie, push straight in, DO NOT twist)
Invert bottle to establish fluid level in drip chamber and to check for vacuum by observing rising air bubbles
Discard bottle if no vacuum or solution not clear
Clear tubing of air and proceed with infusion
Patients ≤59 kg: Withdraw weight based dose from a sealed bottle and place in a separate container for IV infusion to avoid inadvertent administration of the total volume from the commercially available container
IV Administration
Infuse through indwelling needle or soft catheter; take blood samples from contralateral arm
Infuse over 30 min
Storage
Avoid excessive heat, store at 25 C
Do not use solution previously frozen
