Dosing & Uses
Dosage Forms & Strengths
solution for injection
- 555MBq/mL (15mCi/mL)
Pheochromocytoma or Paraganglioma
Indicated for iobenguane scan-positive, unresectable, locally advanced or metastatic pheochromocytoma or paraganglioma in patients who require systemic anticancer therapy
Administer thyroid blockade and other pre- and concomitant medications as recommended
Dosimetric dose
-
The recommended dosimetric dose administered as an IV injection is
- Patients weighing >50 kg: 185-222 MBq (5 or 6 mCi)
- Patients weighing ≤50 kg: 3.7 MBq/kg (0.1 mCi/kg)
Dosimetry and biodistribution assessment
-
Following the dosimetric dose
- Acquire anterior/posterior whole body gamma camera images within 1 hr of the dosimetric dose and prior to patient voiding (Day 0; Scan 1)
- Acquire additional images on Day 1 or 2 following patient voiding (Scan 2)
- Acquire additional images between Days 2-5 following patient voiding (Scan 3)
- For each individual patient, calculate the radiation dose estimates to normal organs and tissues per unit activity (D [organ]) of administered dose using data extracted from the 3 images scanned
- Calculate in accordance with the Medical Internal Radiation Dose (MIRD) schema or related methodology
- Whenever possible, use patient-specific organ masses (eg, estimated from imaging)
Therapeutic dose
- Recommended therapeutic dose is based on body weight and reduced, if necessary, based on the dosimetry data
- Administer a total of 2 therapeutic doses IV a minimum of 90 days apart
-
Weight-based dose per therapeutic cycle
- Patients weighing >62.5 kg: 18,500 MBq (500 mCi)
- Patients weighing ≤62.5 kg: 296 MBq/kg (8 mCi/kg)
-
Determine if dose reduction needed based on critical organ limits
- Calculate the estimated critical organ absorbed-dose by multiplying the dosimetry-derived radiation absorbed-dose per unit activity (D [organ]) by weight-based therapeutic total activity (Aw)
- See full prescribing information for details regarding adsorbed dose threshold values for radiation toxicity in critical organs and determine if vital dose adjustments are needed
Thyroid blockade and other pre- and concomitant medication
-
Thyroid blockade
- Administer inorganic iodine starting at least 24 hr before and continuing for 10 days after each iobenguane I 131 dose
-
Hydration
- Instruct patients to increase fluid intake to at least 2 liters a day starting at least 1 day before and continuing for 1 week after each dose to minimize irradiation to the bladder
-
Drugs that reduce catecholamine uptake or deplete stores
- Discontinue drugs that reduce catecholamine uptake or deplete catecholamine stores for at least 5 half-lives before administration of either the dosimetry dose or a therapeutic dose of iobenguane I 131
- Do not administer these drugs until at least 7 days after each dose
- See Cautions and Interactions
-
Antiemetics
- Administer antiemetics 30 minutes before administering each iobenguane I 131 dose
Dosage Modifications
Myelosuppression
- Do not administer the first therapeutic dose for platelet counts <80,000/mcL or ANC counts <1,200/mcL
- Do not administer the second therapeutic dose until platelets and neutrophils return to baseline or to the normal range
-
Reduce the second therapeutic dose for the following
- Platelet count <25,000/mcL, ANC <500/mcL, or life-threatening anemia for >7 days
- Febrile neutropenia
- Platelet count <50,000/mcL with active bleeding
Myelosuppression, recommended dose reduction for second dose
-
Weight >62.5 kg
- If first therapeutic dose was weight based: Reduce the second therapeutic dose to 425 mCi
- If first therapeutic dose was reduced based on critical organ limits: Reduce second therapeutic dose to 85% of the first dose
-
Weight ≤62.5 kg
- If first therapeutic dose was weight based: Reduce the second therapeutic dose to 7 mCi/kg
- If first therapeutic dose was reduced based on critical organ limits: Reduce second therapeutic dose to 85% of the first dose
Pneumonitis
- Do not administer the second therapeutic dose if pneumonitis is diagnosed after the first therapeutic dose
Renal impairment
- The radiation dose to patients with renal impairment may be increased owing to the delayed elimination of the drug
- Adjust the therapeutic dose based on radiation exposure estimates from the dosimetry assessment
- Severe renal impairment (CrCl <30 mL/min) or end-stage renal disease: Not studied
Dosage Forms & Strengths
solution for injection
- 555MBq/mL (15mCi/mL)
Pheochromocytoma or Paraganglioma
Indicated in adults and children aged ≥12 years for iobenguane scan positive, unresectable, locally advanced or metastatic pheochromocytoma or paraganglioma in who require systemic anticancer therapy
Administer thyroid blockade and other pre- and concomitant medications as recommended
Dosimetric dose
-
The recommended dosimetric dose administered as an IV injection is
- Patients weighing >50 kg: 185-222 MBq (5 or 6 mCi)
- Patients weighing ≤50 kg: 3.7 MBq/kg (0.1 mCi/kg)
Dosimetry and biodistribution assessment
-
Following the dosimetric dose
- Acquire anterior/posterior whole body gamma camera images within 1 hr of the dosimetric dose and prior to patient voiding (Day 0; Scan 1)
- Acquire additional images on Day 1 or 2 following patient voiding (Scan 2)
- Acquire additional images between Days 2-5 following patient voiding (Scan 3)
- For each individual patient, calculate the radiation dose estimates to normal organs and tissues per unit activity (D [organ]) of administered dose using data extracted from the 3 images scanned
- Calculate in accordance with the Medical Internal Radiation Dose (MIRD) schema or related methodology
- Whenever possible, use patient specific organ masses (eg, estimated from imaging)
Therapeutic dose
- Recommended therapeutic dose is based on body weight and reduced, if necessary, based on the dosimetry data
- Administer a total of 2 therapeutic doses IV a minimum of 90 days apart
-
Weight-based dose per therapeutic cycle
- Patients weighing >62.5 kg: 18,500 MBq (500 mCi)
- Patients weighing ≤62.5 kg: 296 MBq/kg (8 mCi/kg)
-
Determine if dose reduction needed based on critical organ limits
- Calculate the estimated critical organ absorbed-dose by multiplying the dosimetry-derived radiation absorbed-dose per unit activity (D [organ]) by weight based therapeutic total activity (Aw)
- See full prescribing information for details regarding adsorbed dose threshold values for radiation toxicity in critical organs and determine if vital dose adjustments are needed
Thyroid blockade and other pre- and concomitant medication
-
Thyroid blockade
- Administer inorganic iodine starting at least 24 hr before and continuing for 10 days after each iobenguane I 131 dose
-
Hydration
- Instruct patients to increase fluid intake to at least 2 liters a day starting at least 1 day before and continuing for 1 week after each dose to minimize irradiation to the bladder
-
Drugs that reduce catecholamine update or deplete stores
- Discontinue drugs that reduce catecholamine uptake or deplete catecholamine stores for at least 5 half-lives before administration of either the dosimetry dose or a therapeutic dose of iobenguane I 131
- Do not administer these drugs until at least 7 days after each dose
- See Cautions and Interactions
-
Antiemetics
- Administer antiemetics 30 minutes before administering each iobenguane I 131 dose
Dosage Modifications
Myelosuppression
- Do not administer the first therapeutic dose for platelet counts <80,000/mcL or ANC counts <1,200/mcL
- Do not administer the second therapeutic dose until platelets and neutrophils return to baseline or to the normal range
-
Reduce the second therapeutic dose for the following
- Platelet count <25,000/mcL, ANC <500/mcL, or life-threatening anemia for >7 days
- Febrile neutropenia
- Platelet count <50,000/mcL with active bleeding
Myelosuppression, recommended dose reduction for second dose
-
Weight >62.5 kg
- If first therapeutic dose was weight based: Reduce the second therapeutic dose to 425 mCi
- If first therapeutic dose was reduced based on critical organ limits: Reduce second therapeutic dose to 85% of the first dose
-
Weight ≤62.5 kg
- If first therapeutic dose was weight based: Reduce the second therapeutic dose to 7 mCi/kg
- If first therapeutic dose was reduced based on critical organ limits: If first therapeutic dose was reduced based on critical organ limits: Reduce second therapeutic dose to 85% of the first dose
Pneumonitis
- Do not administer the second therapeutic dose if pneumonitis is diagnosed after the first therapeutic dose
Renal impairment
- The radiation dose to patients with renal impairment may be increased owing to the delayed elimination of the drug
- Adjust the therapeutic dose based on radiation exposure estimates from the dosimetry assessment
- Severe renal impairment (CrCl <30 mL/min) or end-stage renal disease: Not studied
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (0)
Serious - Use Alternative (65)
- amitriptyline
amitriptyline will decrease the level or effect of iobenguane I 131 by Other (see comment). Avoid or Use Alternate Drug. Based on the mechanism of action of iobenguane, drugs that reduce catecholamine uptake or that deplete catecholamine stores may interfere with iobenguane uptake into cells, and thus, reduce iobenguane efficacy. Discontinue interfering drugs for at least 5 half-lives before administration of either the dosimetry or an iobenguane dose. Do not administer these drugs until at least 7 days after each iobenguane dose.
- amoxapine
amoxapine will decrease the level or effect of iobenguane I 131 by Other (see comment). Avoid or Use Alternate Drug. Based on the mechanism of action of iobenguane, drugs that reduce catecholamine uptake or that deplete catecholamine stores may interfere with iobenguane uptake into cells, and thus, reduce iobenguane efficacy. Discontinue interfering drugs for at least 5 half-lives before administration of either the dosimetry or an iobenguane dose. Do not administer these drugs until at least 7 days after each iobenguane dose.
- amphetamine
amphetamine will decrease the level or effect of iobenguane I 131 by Other (see comment). Avoid or Use Alternate Drug. Based on the mechanism of action of iobenguane, drugs that reduce catecholamine uptake or that deplete catecholamine stores may interfere with iobenguane uptake into cells, and thus, reduce iobenguane efficacy. Discontinue interfering drugs for at least 5 half-lives before administration of either the dosimetry or an iobenguane dose. Do not administer these drugs until at least 7 days after each iobenguane dose.
- amphetamine polistirex
amphetamine polistirex will decrease the level or effect of iobenguane I 131 by Other (see comment). Avoid or Use Alternate Drug. Based on the mechanism of action of iobenguane, drugs that reduce catecholamine uptake or that deplete catecholamine stores may interfere with iobenguane uptake into cells, and thus, reduce iobenguane efficacy. Discontinue interfering drugs for at least 5 half-lives before administration of either the dosimetry or an iobenguane dose. Do not administer these drugs until at least 7 days after each iobenguane dose.
- armodafinil
armodafinil will decrease the level or effect of iobenguane I 131 by Other (see comment). Avoid or Use Alternate Drug. Based on the mechanism of action of iobenguane, drugs that reduce catecholamine uptake or that deplete catecholamine stores may interfere with iobenguane uptake into cells, and thus, reduce iobenguane efficacy. Discontinue interfering drugs for at least 5 half-lives before administration of either the dosimetry or an iobenguane dose. Do not administer these drugs until at least 7 days after each iobenguane dose.
- atomoxetine
atomoxetine will decrease the level or effect of iobenguane I 131 by Other (see comment). Avoid or Use Alternate Drug. Based on the mechanism of action of iobenguane, drugs that reduce catecholamine uptake or that deplete catecholamine stores may interfere with iobenguane uptake into cells, and thus, reduce iobenguane efficacy. Discontinue interfering drugs for at least 5 half-lives before administration of either the dosimetry or an iobenguane dose. Do not administer these drugs until at least 7 days after each iobenguane dose.
- benzphetamine
benzphetamine will decrease the level or effect of iobenguane I 131 by Other (see comment). Avoid or Use Alternate Drug. Based on the mechanism of action of iobenguane, drugs that reduce catecholamine uptake or that deplete catecholamine stores may interfere with iobenguane uptake into cells, and thus, reduce iobenguane efficacy. Discontinue interfering drugs for at least 5 half-lives before administration of either the dosimetry or an iobenguane dose. Do not administer these drugs until at least 7 days after each iobenguane dose.
- black cohosh
black cohosh will decrease the level or effect of iobenguane I 131 by Other (see comment). Avoid or Use Alternate Drug. Based on the mechanism of action of iobenguane, drugs that reduce catecholamine uptake or that deplete catecholamine stores may interfere with iobenguane uptake into cells, and thus, reduce iobenguane efficacy. Discontinue interfering drugs for at least 5 half-lives before administration of either the dosimetry or an iobenguane dose. Do not administer these drugs until at least 7 days after each iobenguane dose.
- bupropion
bupropion will decrease the level or effect of iobenguane I 131 by Other (see comment). Avoid or Use Alternate Drug. Based on the mechanism of action of iobenguane, drugs that reduce catecholamine uptake or that deplete catecholamine stores may interfere with iobenguane uptake into cells, and thus, reduce iobenguane efficacy. Discontinue interfering drugs for at least 5 half-lives before administration of either the dosimetry or an iobenguane dose. Do not administer these drugs until at least 7 days after each iobenguane dose.
- caffeine
caffeine will decrease the level or effect of iobenguane I 131 by Other (see comment). Avoid or Use Alternate Drug. Based on the mechanism of action of iobenguane, drugs that reduce catecholamine uptake or that deplete catecholamine stores may interfere with iobenguane uptake into cells, and thus, reduce iobenguane efficacy. Discontinue interfering drugs for at least 5 half-lives before administration of either the dosimetry or an iobenguane dose. Do not administer these drugs until at least 7 days after each iobenguane dose.
- carvedilol
carvedilol will decrease the level or effect of iobenguane I 131 by Other (see comment). Avoid or Use Alternate Drug. Based on the mechanism of action of iobenguane, drugs that reduce catecholamine uptake or that deplete catecholamine stores may interfere with iobenguane uptake into cells, and thus, reduce iobenguane efficacy. Discontinue interfering drugs for at least 5 half-lives before administration of either the dosimetry or an iobenguane dose. Do not administer these drugs until at least 7 days after each iobenguane dose.
- clomipramine
clomipramine will decrease the level or effect of iobenguane I 131 by Other (see comment). Avoid or Use Alternate Drug. Based on the mechanism of action of iobenguane, drugs that reduce catecholamine uptake or that deplete catecholamine stores may interfere with iobenguane uptake into cells, and thus, reduce iobenguane efficacy. Discontinue interfering drugs for at least 5 half-lives before administration of either the dosimetry or an iobenguane dose. Do not administer these drugs until at least 7 days after each iobenguane dose.
- clonidine
clonidine will decrease the level or effect of iobenguane I 131 by Other (see comment). Avoid or Use Alternate Drug. Based on the mechanism of action of iobenguane, drugs that reduce catecholamine uptake or that deplete catecholamine stores may interfere with iobenguane uptake into cells, and thus, reduce iobenguane efficacy. Discontinue interfering drugs for at least 5 half-lives before administration of either the dosimetry or an iobenguane dose. Do not administer these drugs until at least 7 days after each iobenguane dose.
- cocaine topical
cocaine topical will decrease the level or effect of iobenguane I 131 by Other (see comment). Avoid or Use Alternate Drug. Based on the mechanism of action of iobenguane, drugs that reduce catecholamine uptake or that deplete catecholamine stores may interfere with iobenguane uptake into cells, and thus, reduce iobenguane efficacy. Discontinue interfering drugs for at least 5 half-lives before administration of either the dosimetry or an iobenguane dose. Do not administer these drugs until at least 7 days after each iobenguane dose.
- desipramine
desipramine will decrease the level or effect of iobenguane I 131 by Other (see comment). Avoid or Use Alternate Drug. Based on the mechanism of action of iobenguane, drugs that reduce catecholamine uptake or that deplete catecholamine stores may interfere with iobenguane uptake into cells, and thus, reduce iobenguane efficacy. Discontinue interfering drugs for at least 5 half-lives before administration of either the dosimetry or an iobenguane dose. Do not administer these drugs until at least 7 days after each iobenguane dose.
- desvenlafaxine
desvenlafaxine will decrease the level or effect of iobenguane I 131 by Other (see comment). Avoid or Use Alternate Drug. Based on the mechanism of action of iobenguane, drugs that reduce catecholamine uptake or that deplete catecholamine stores may interfere with iobenguane uptake into cells, and thus, reduce iobenguane efficacy. Discontinue interfering drugs for at least 5 half-lives before administration of either the dosimetry or an iobenguane dose. Do not administer these drugs until at least 7 days after each iobenguane dose.
- deutetrabenazine
deutetrabenazine will decrease the level or effect of iobenguane I 131 by Other (see comment). Avoid or Use Alternate Drug. Based on the mechanism of action of iobenguane, drugs that reduce catecholamine uptake or that deplete catecholamine stores may interfere with iobenguane uptake into cells, and thus, reduce iobenguane efficacy. Discontinue interfering drugs for at least 5 half-lives before administration of either the dosimetry or an iobenguane dose. Do not administer these drugs until at least 7 days after each iobenguane dose.
- dexmethylphenidate
dexmethylphenidate will decrease the level or effect of iobenguane I 131 by Other (see comment). Avoid or Use Alternate Drug. Based on the mechanism of action of iobenguane, drugs that reduce catecholamine uptake or that deplete catecholamine stores may interfere with iobenguane uptake into cells, and thus, reduce iobenguane efficacy. Discontinue interfering drugs for at least 5 half-lives before administration of either the dosimetry or an iobenguane dose. Do not administer these drugs until at least 7 days after each iobenguane dose.
- dextroamphetamine
dextroamphetamine will decrease the level or effect of iobenguane I 131 by Other (see comment). Avoid or Use Alternate Drug. Based on the mechanism of action of iobenguane, drugs that reduce catecholamine uptake or that deplete catecholamine stores may interfere with iobenguane uptake into cells, and thus, reduce iobenguane efficacy. Discontinue interfering drugs for at least 5 half-lives before administration of either the dosimetry or an iobenguane dose. Do not administer these drugs until at least 7 days after each iobenguane dose.
- diethylpropion
diethylpropion will decrease the level or effect of iobenguane I 131 by Other (see comment). Avoid or Use Alternate Drug. Based on the mechanism of action of iobenguane, drugs that reduce catecholamine uptake or that deplete catecholamine stores may interfere with iobenguane uptake into cells, and thus, reduce iobenguane efficacy. Discontinue interfering drugs for at least 5 half-lives before administration of either the dosimetry or an iobenguane dose. Do not administer these drugs until at least 7 days after each iobenguane dose.
- doxepin
doxepin will decrease the level or effect of iobenguane I 131 by Other (see comment). Avoid or Use Alternate Drug. Based on the mechanism of action of iobenguane, drugs that reduce catecholamine uptake or that deplete catecholamine stores may interfere with iobenguane uptake into cells, and thus, reduce iobenguane efficacy. Discontinue interfering drugs for at least 5 half-lives before administration of either the dosimetry or an iobenguane dose. Do not administer these drugs until at least 7 days after each iobenguane dose.
- droxidopa
droxidopa will decrease the level or effect of iobenguane I 131 by Other (see comment). Avoid or Use Alternate Drug. Based on the mechanism of action of iobenguane, drugs that reduce catecholamine uptake or that deplete catecholamine stores may interfere with iobenguane uptake into cells, and thus, reduce iobenguane efficacy. Discontinue interfering drugs for at least 5 half-lives before administration of either the dosimetry or an iobenguane dose. Do not administer these drugs until at least 7 days after each iobenguane dose.
- duloxetine
duloxetine will decrease the level or effect of iobenguane I 131 by Other (see comment). Avoid or Use Alternate Drug. Based on the mechanism of action of iobenguane, drugs that reduce catecholamine uptake or that deplete catecholamine stores may interfere with iobenguane uptake into cells, and thus, reduce iobenguane efficacy. Discontinue interfering drugs for at least 5 half-lives before administration of either the dosimetry or an iobenguane dose. Do not administer these drugs until at least 7 days after each iobenguane dose.
- ephedrine
ephedrine will decrease the level or effect of iobenguane I 131 by Other (see comment). Avoid or Use Alternate Drug. Based on the mechanism of action of iobenguane, drugs that reduce catecholamine uptake or that deplete catecholamine stores may interfere with iobenguane uptake into cells, and thus, reduce iobenguane efficacy. Discontinue interfering drugs for at least 5 half-lives before administration of either the dosimetry or an iobenguane dose. Do not administer these drugs until at least 7 days after each iobenguane dose.
- epinephrine
epinephrine will decrease the level or effect of iobenguane I 131 by Other (see comment). Avoid or Use Alternate Drug. Based on the mechanism of action of iobenguane, drugs that reduce catecholamine uptake or that deplete catecholamine stores may interfere with iobenguane uptake into cells, and thus, reduce iobenguane efficacy. Discontinue interfering drugs for at least 5 half-lives before administration of either the dosimetry or an iobenguane dose. Do not administer these drugs until at least 7 days after each iobenguane dose.
- guanfacine
guanfacine will decrease the level or effect of iobenguane I 131 by Other (see comment). Avoid or Use Alternate Drug. Based on the mechanism of action of iobenguane, drugs that reduce catecholamine uptake or that deplete catecholamine stores may interfere with iobenguane uptake into cells, and thus, reduce iobenguane efficacy. Discontinue interfering drugs for at least 5 half-lives before administration of either the dosimetry or an iobenguane dose. Do not administer these drugs until at least 7 days after each iobenguane dose.
- imipramine
imipramine will decrease the level or effect of iobenguane I 131 by Other (see comment). Avoid or Use Alternate Drug. Based on the mechanism of action of iobenguane, drugs that reduce catecholamine uptake or that deplete catecholamine stores may interfere with iobenguane uptake into cells, and thus, reduce iobenguane efficacy. Discontinue interfering drugs for at least 5 half-lives before administration of either the dosimetry or an iobenguane dose. Do not administer these drugs until at least 7 days after each iobenguane dose.
- isocarboxazid
isocarboxazid will decrease the level or effect of iobenguane I 131 by Other (see comment). Avoid or Use Alternate Drug. Based on the mechanism of action of iobenguane, drugs that reduce catecholamine uptake or that deplete catecholamine stores may interfere with iobenguane uptake into cells, and thus, reduce iobenguane efficacy. Discontinue interfering drugs for at least 5 half-lives before administration of either the dosimetry or an iobenguane dose. Do not administer these drugs until at least 7 days after each iobenguane dose.
- labetalol
labetalol will decrease the level or effect of iobenguane I 131 by Other (see comment). Avoid or Use Alternate Drug. Based on the mechanism of action of iobenguane, drugs that reduce catecholamine uptake or that deplete catecholamine stores may interfere with iobenguane uptake into cells, and thus, reduce iobenguane efficacy. Discontinue interfering drugs for at least 5 half-lives before administration of either the dosimetry or an iobenguane dose. Do not administer these drugs until at least 7 days after each iobenguane dose.
- levomilnacipran
levomilnacipran will decrease the level or effect of iobenguane I 131 by Other (see comment). Avoid or Use Alternate Drug. Based on the mechanism of action of iobenguane, drugs that reduce catecholamine uptake or that deplete catecholamine stores may interfere with iobenguane uptake into cells, and thus, reduce iobenguane efficacy. Discontinue interfering drugs for at least 5 half-lives before administration of either the dosimetry or an iobenguane dose. Do not administer these drugs until at least 7 days after each iobenguane dose.
- linezolid
linezolid will decrease the level or effect of iobenguane I 131 by Other (see comment). Avoid or Use Alternate Drug. Based on the mechanism of action of iobenguane, drugs that reduce catecholamine uptake or that deplete catecholamine stores may interfere with iobenguane uptake into cells, and thus, reduce iobenguane efficacy. Discontinue interfering drugs for at least 5 half-lives before administration of either the dosimetry or an iobenguane dose. Do not administer these drugs until at least 7 days after each iobenguane dose.
- lisdexamfetamine
lisdexamfetamine will decrease the level or effect of iobenguane I 131 by Other (see comment). Avoid or Use Alternate Drug. Based on the mechanism of action of iobenguane, drugs that reduce catecholamine uptake or that deplete catecholamine stores may interfere with iobenguane uptake into cells, and thus, reduce iobenguane efficacy. Discontinue interfering drugs for at least 5 half-lives before administration of either the dosimetry or an iobenguane dose. Do not administer these drugs until at least 7 days after each iobenguane dose.
- lorcaserin
lorcaserin will decrease the level or effect of iobenguane I 131 by Other (see comment). Avoid or Use Alternate Drug. Based on the mechanism of action of iobenguane, drugs that reduce catecholamine uptake or that deplete catecholamine stores may interfere with iobenguane uptake into cells, and thus, reduce iobenguane efficacy. Discontinue interfering drugs for at least 5 half-lives before administration of either the dosimetry or an iobenguane dose. Do not administer these drugs until at least 7 days after each iobenguane dose.
- methamphetamine
methamphetamine will decrease the level or effect of iobenguane I 131 by Other (see comment). Avoid or Use Alternate Drug. Based on the mechanism of action of iobenguane, drugs that reduce catecholamine uptake or that deplete catecholamine stores may interfere with iobenguane uptake into cells, and thus, reduce iobenguane efficacy. Discontinue interfering drugs for at least 5 half-lives before administration of either the dosimetry or an iobenguane dose. Do not administer these drugs until at least 7 days after each iobenguane dose.
- methyldopa
methyldopa will decrease the level or effect of iobenguane I 131 by Other (see comment). Avoid or Use Alternate Drug. Based on the mechanism of action of iobenguane, drugs that reduce catecholamine uptake or that deplete catecholamine stores may interfere with iobenguane uptake into cells, and thus, reduce iobenguane efficacy. Discontinue interfering drugs for at least 5 half-lives before administration of either the dosimetry or an iobenguane dose. Do not administer these drugs until at least 7 days after each iobenguane dose.
- milnacipran
milnacipran will decrease the level or effect of iobenguane I 131 by Other (see comment). Avoid or Use Alternate Drug. Based on the mechanism of action of iobenguane, drugs that reduce catecholamine uptake or that deplete catecholamine stores may interfere with iobenguane uptake into cells, and thus, reduce iobenguane efficacy. Discontinue interfering drugs for at least 5 half-lives before administration of either the dosimetry or an iobenguane dose. Do not administer these drugs until at least 7 days after each iobenguane dose.
- mirtazapine
mirtazapine will decrease the level or effect of iobenguane I 131 by Other (see comment). Avoid or Use Alternate Drug. Based on the mechanism of action of iobenguane, drugs that reduce catecholamine uptake or that deplete catecholamine stores may interfere with iobenguane uptake into cells, and thus, reduce iobenguane efficacy. Discontinue interfering drugs for at least 5 half-lives before administration of either the dosimetry or an iobenguane dose. Do not administer these drugs until at least 7 days after each iobenguane dose.
- modafinil
modafinil will decrease the level or effect of iobenguane I 131 by Other (see comment). Avoid or Use Alternate Drug. Based on the mechanism of action of iobenguane, drugs that reduce catecholamine uptake or that deplete catecholamine stores may interfere with iobenguane uptake into cells, and thus, reduce iobenguane efficacy. Discontinue interfering drugs for at least 5 half-lives before administration of either the dosimetry or an iobenguane dose. Do not administer these drugs until at least 7 days after each iobenguane dose.
- nadolol
nadolol will decrease the level or effect of iobenguane I 131 by Other (see comment). Avoid or Use Alternate Drug. Based on the mechanism of action of iobenguane, drugs that reduce catecholamine uptake or that deplete catecholamine stores may interfere with iobenguane uptake into cells, and thus, reduce iobenguane efficacy. Discontinue interfering drugs for at least 5 half-lives before administration of either the dosimetry or an iobenguane dose. Do not administer these drugs until at least 7 days after each iobenguane dose.
- naphazoline
naphazoline will decrease the level or effect of iobenguane I 131 by Other (see comment). Avoid or Use Alternate Drug. Based on the mechanism of action of iobenguane, drugs that reduce catecholamine uptake or that deplete catecholamine stores may interfere with iobenguane uptake into cells, and thus, reduce iobenguane efficacy. Discontinue interfering drugs for at least 5 half-lives before administration of either the dosimetry or an iobenguane dose. Do not administer these drugs until at least 7 days after each iobenguane dose.
- norepinephrine
norepinephrine will decrease the level or effect of iobenguane I 131 by Other (see comment). Avoid or Use Alternate Drug. Based on the mechanism of action of iobenguane, drugs that reduce catecholamine uptake or that deplete catecholamine stores may interfere with iobenguane uptake into cells, and thus, reduce iobenguane efficacy. Discontinue interfering drugs for at least 5 half-lives before administration of either the dosimetry or an iobenguane dose. Do not administer these drugs until at least 7 days after each iobenguane dose.
- nortriptyline
nortriptyline will decrease the level or effect of iobenguane I 131 by Other (see comment). Avoid or Use Alternate Drug. Based on the mechanism of action of iobenguane, drugs that reduce catecholamine uptake or that deplete catecholamine stores may interfere with iobenguane uptake into cells, and thus, reduce iobenguane efficacy. Discontinue interfering drugs for at least 5 half-lives before administration of either the dosimetry or an iobenguane dose. Do not administer these drugs until at least 7 days after each iobenguane dose.
- penbutolol
penbutolol will decrease the level or effect of iobenguane I 131 by Other (see comment). Avoid or Use Alternate Drug. Based on the mechanism of action of iobenguane, drugs that reduce catecholamine uptake or that deplete catecholamine stores may interfere with iobenguane uptake into cells, and thus, reduce iobenguane efficacy. Discontinue interfering drugs for at least 5 half-lives before administration of either the dosimetry or an iobenguane dose. Do not administer these drugs until at least 7 days after each iobenguane dose.
- phendimetrazine
phendimetrazine will decrease the level or effect of iobenguane I 131 by Other (see comment). Avoid or Use Alternate Drug. Based on the mechanism of action of iobenguane, drugs that reduce catecholamine uptake or that deplete catecholamine stores may interfere with iobenguane uptake into cells, and thus, reduce iobenguane efficacy. Discontinue interfering drugs for at least 5 half-lives before administration of either the dosimetry or an iobenguane dose. Do not administer these drugs until at least 7 days after each iobenguane dose.
- phenelzine
phenelzine will decrease the level or effect of iobenguane I 131 by Other (see comment). Avoid or Use Alternate Drug. Based on the mechanism of action of iobenguane, drugs that reduce catecholamine uptake or that deplete catecholamine stores may interfere with iobenguane uptake into cells, and thus, reduce iobenguane efficacy. Discontinue interfering drugs for at least 5 half-lives before administration of either the dosimetry or an iobenguane dose. Do not administer these drugs until at least 7 days after each iobenguane dose.
- phentermine
phentermine will decrease the level or effect of iobenguane I 131 by Other (see comment). Avoid or Use Alternate Drug. Based on the mechanism of action of iobenguane, drugs that reduce catecholamine uptake or that deplete catecholamine stores may interfere with iobenguane uptake into cells, and thus, reduce iobenguane efficacy. Discontinue interfering drugs for at least 5 half-lives before administration of either the dosimetry or an iobenguane dose. Do not administer these drugs until at least 7 days after each iobenguane dose.
- propranolol
propranolol will decrease the level or effect of iobenguane I 131 by Other (see comment). Avoid or Use Alternate Drug. Based on the mechanism of action of iobenguane, drugs that reduce catecholamine uptake or that deplete catecholamine stores may interfere with iobenguane uptake into cells, and thus, reduce iobenguane efficacy. Discontinue interfering drugs for at least 5 half-lives before administration of either the dosimetry or an iobenguane dose. Do not administer these drugs until at least 7 days after each iobenguane dose.
- protriptyline
protriptyline will decrease the level or effect of iobenguane I 131 by Other (see comment). Avoid or Use Alternate Drug. Based on the mechanism of action of iobenguane, drugs that reduce catecholamine uptake or that deplete catecholamine stores may interfere with iobenguane uptake into cells, and thus, reduce iobenguane efficacy. Discontinue interfering drugs for at least 5 half-lives before administration of either the dosimetry or an iobenguane dose. Do not administer these drugs until at least 7 days after each iobenguane dose.
- pseudoephedrine
pseudoephedrine decreases effects of iobenguane I 131 by receptor binding competition. Avoid or Use Alternate Drug. If clinically appropriate, discontinue drugs that compete for NE receptor sites for at least 5 half-lives; may cause false-negative imaging results. Do not administer pseudoephedrine until at least 7 days after each iobenguane dose.
- rasagiline
rasagiline will decrease the level or effect of iobenguane I 131 by Other (see comment). Avoid or Use Alternate Drug. Based on the mechanism of action of iobenguane, drugs that reduce catecholamine uptake or that deplete catecholamine stores may interfere with iobenguane uptake into cells, and thus, reduce iobenguane efficacy. Discontinue interfering drugs for at least 5 half-lives before administration of either the dosimetry or an iobenguane dose. Do not administer these drugs until at least 7 days after each iobenguane dose.
- safinamide
safinamide will decrease the level or effect of iobenguane I 131 by Other (see comment). Avoid or Use Alternate Drug. Based on the mechanism of action of iobenguane, drugs that reduce catecholamine uptake or that deplete catecholamine stores may interfere with iobenguane uptake into cells, and thus, reduce iobenguane efficacy. Discontinue interfering drugs for at least 5 half-lives before administration of either the dosimetry or an iobenguane dose. Do not administer these drugs until at least 7 days after each iobenguane dose.
- selegiline
selegiline will decrease the level or effect of iobenguane I 131 by Other (see comment). Avoid or Use Alternate Drug. Based on the mechanism of action of iobenguane, drugs that reduce catecholamine uptake or that deplete catecholamine stores may interfere with iobenguane uptake into cells, and thus, reduce iobenguane efficacy. Discontinue interfering drugs for at least 5 half-lives before administration of either the dosimetry or an iobenguane dose. Do not administer these drugs until at least 7 days after each iobenguane dose.
- selegiline transdermal
selegiline transdermal will decrease the level or effect of iobenguane I 131 by Other (see comment). Avoid or Use Alternate Drug. Based on the mechanism of action of iobenguane, drugs that reduce catecholamine uptake or that deplete catecholamine stores may interfere with iobenguane uptake into cells, and thus, reduce iobenguane efficacy. Discontinue interfering drugs for at least 5 half-lives before administration of either the dosimetry or an iobenguane dose. Do not administer these drugs until at least 7 days after each iobenguane dose.
- serdexmethylphenidate/dexmethylphenidate
serdexmethylphenidate/dexmethylphenidate will decrease the level or effect of iobenguane I 131 by Other (see comment). Avoid or Use Alternate Drug. Based on the mechanism of action of iobenguane, drugs that reduce catecholamine uptake or that deplete catecholamine stores may interfere with iobenguane uptake into cells, and thus, reduce iobenguane efficacy. Discontinue interfering drugs for at least 5 half-lives before administration of either the dosimetry or an iobenguane dose. Do not administer these drugs until at least 7 days after each iobenguane dose.
- sotalol
sotalol will decrease the level or effect of iobenguane I 131 by Other (see comment). Avoid or Use Alternate Drug. Based on the mechanism of action of iobenguane, drugs that reduce catecholamine uptake or that deplete catecholamine stores may interfere with iobenguane uptake into cells, and thus, reduce iobenguane efficacy. Discontinue interfering drugs for at least 5 half-lives before administration of either the dosimetry or an iobenguane dose. Do not administer these drugs until at least 7 days after each iobenguane dose.
- St John's Wort
St John's Wort will decrease the level or effect of iobenguane I 131 by Other (see comment). Avoid or Use Alternate Drug. Based on the mechanism of action of iobenguane, drugs that reduce catecholamine uptake or that deplete catecholamine stores may interfere with iobenguane uptake into cells, and thus, reduce iobenguane efficacy. Discontinue interfering drugs for at least 5 half-lives before administration of either the dosimetry or an iobenguane dose. Do not administer these drugs until at least 7 days after each iobenguane dose.
- tetrabenazine
tetrabenazine will decrease the level or effect of iobenguane I 131 by Other (see comment). Avoid or Use Alternate Drug. Based on the mechanism of action of iobenguane, drugs that reduce catecholamine uptake or that deplete catecholamine stores may interfere with iobenguane uptake into cells, and thus, reduce iobenguane efficacy. Discontinue interfering drugs for at least 5 half-lives before administration of either the dosimetry or an iobenguane dose. Do not administer these drugs until at least 7 days after each iobenguane dose.
- timolol
timolol will decrease the level or effect of iobenguane I 131 by Other (see comment). Avoid or Use Alternate Drug. Based on the mechanism of action of iobenguane, drugs that reduce catecholamine uptake or that deplete catecholamine stores may interfere with iobenguane uptake into cells, and thus, reduce iobenguane efficacy. Discontinue interfering drugs for at least 5 half-lives before administration of either the dosimetry or an iobenguane dose. Do not administer these drugs until at least 7 days after each iobenguane dose.
- tizanidine
tizanidine will decrease the level or effect of iobenguane I 131 by Other (see comment). Avoid or Use Alternate Drug. Based on the mechanism of action of iobenguane, drugs that reduce catecholamine uptake or that deplete catecholamine stores may interfere with iobenguane uptake into cells, and thus, reduce iobenguane efficacy. Discontinue interfering drugs for at least 5 half-lives before administration of either the dosimetry or an iobenguane dose. Do not administer these drugs until at least 7 days after each iobenguane dose.
- tramadol
tramadol will decrease the level or effect of iobenguane I 131 by Other (see comment). Avoid or Use Alternate Drug. Based on the mechanism of action of iobenguane, drugs that reduce catecholamine uptake or that deplete catecholamine stores may interfere with iobenguane uptake into cells, and thus, reduce iobenguane efficacy. Discontinue interfering drugs for at least 5 half-lives before administration of either the dosimetry or an iobenguane dose. Do not administer these drugs until at least 7 days after each iobenguane dose.
- tranylcypromine
tranylcypromine will decrease the level or effect of iobenguane I 131 by Other (see comment). Avoid or Use Alternate Drug. Based on the mechanism of action of iobenguane, drugs that reduce catecholamine uptake or that deplete catecholamine stores may interfere with iobenguane uptake into cells, and thus, reduce iobenguane efficacy. Discontinue interfering drugs for at least 5 half-lives before administration of either the dosimetry or an iobenguane dose. Do not administer these drugs until at least 7 days after each iobenguane dose.
- trimipramine
trimipramine will decrease the level or effect of iobenguane I 131 by Other (see comment). Avoid or Use Alternate Drug. Based on the mechanism of action of iobenguane, drugs that reduce catecholamine uptake or that deplete catecholamine stores may interfere with iobenguane uptake into cells, and thus, reduce iobenguane efficacy. Discontinue interfering drugs for at least 5 half-lives before administration of either the dosimetry or an iobenguane dose. Do not administer these drugs until at least 7 days after each iobenguane dose.
- valbenazine
valbenazine will decrease the level or effect of iobenguane I 131 by Other (see comment). Avoid or Use Alternate Drug. Based on the mechanism of action of iobenguane, drugs that reduce catecholamine uptake or that deplete catecholamine stores may interfere with iobenguane uptake into cells, and thus, reduce iobenguane efficacy. Discontinue interfering drugs for at least 5 half-lives before administration of either the dosimetry or an iobenguane dose. Do not administer these drugs until at least 7 days after each iobenguane dose.
- venlafaxine
venlafaxine will decrease the level or effect of iobenguane I 131 by Other (see comment). Avoid or Use Alternate Drug. Based on the mechanism of action of iobenguane, drugs that reduce catecholamine uptake or that deplete catecholamine stores may interfere with iobenguane uptake into cells, and thus, reduce iobenguane efficacy. Discontinue interfering drugs for at least 5 half-lives before administration of either the dosimetry or an iobenguane dose. Do not administer these drugs until at least 7 days after each iobenguane dose.
- yohimbine
yohimbine will decrease the level or effect of iobenguane I 131 by Other (see comment). Avoid or Use Alternate Drug. Based on the mechanism of action of iobenguane, drugs that reduce catecholamine uptake or that deplete catecholamine stores may interfere with iobenguane uptake into cells, and thus, reduce iobenguane efficacy. Discontinue interfering drugs for at least 5 half-lives before administration of either the dosimetry or an iobenguane dose. Do not administer these drugs until at least 7 days after each iobenguane dose.
Monitor Closely (1)
- siponimod
siponimod and iobenguane I 131 both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution if coadministered because of additive immunosuppressive effects during such therapy and in the weeks following administration. When switching from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs to avoid unintended additive immunosuppressive effects.
Minor (0)
Adverse Effects
>10% All Grades
Lymphopenia (96%)
Anemia (93%)
Thrombocytopenia (91%)
Increased INR (85%)
Neutropenia (84%)
Nausea (78%)
Fatigue (71%)
Vomiting (58%)
Increased alkaline phosphatase (53%)
Increased AST (50%)
Dry mouth (48%)
Increased ALT (43%)
Sialadenitis (39%)
Dizziness (34%)
Headache (32%)
Decreased appetite (30%)
Diarrhea (25%)
Dysgeusia (24%)
Hypotension (24%)
Abdominal pain (23%)
Hypertension (20%)
Constipation (19%)
Cough (18%)
Dyspnea (18%)
Back pain (17%)
Dehydration (16%)
Decreased weight (16%)
Upper respiratory tract infection (16%)
Pain in extremity (15%)
Oropharyngeal pain (14%)
Pyrexia (14%)
Urinary tract infection (11%)
>10% Grades 3-4
Lymphopenia (78%)
Neutropenia (59%)
Thrombocytopenia (50%)
Fatigue (26%)
Anemia (24%)
Increased INR (18%)
Nausea (16%)
Dizziness (13%)
Hypertension (11%)
1-10% All Grades
Dyspepsia (10%)
Injection site pain (10%)
Hyperhidrosis (10%)
Alopecia (10%)
Tachycardia (10%)
1-10% Grades 3-4
Vomiting (10%)
Constipation (7%)
Dyspnea (7%)
Abdominal pain (6%)
Headache (6%)
Increased alkaline phosphatase (5%)
Decreased appetite (5%)
Dehydration (4%)
Hypotension (4%)
Diarrhea (3%)
Tachycardia (3%)
Dry mouth (2%)
Pyrexia (2%)
Upper respiratory tract infection (2%)
Increase AST/ALT (2%)
Back pain (2%)
Urinary tract infection (1%)
Sialadenitis (1%)
Decreased weight (1%)
Dysgeusia (1%)
1-10% Other
Prolonged prothrombin time (9%)
Palpitations (9%)
Proteinuria (9%)
Insomnia (9%)
Epistaxis (9%)
Orthostatic hypotension (9%)
Chills (8%)
Syncope and presyncope (8%)
Arthralgia (8%)
Neck pain (8%)
Dry skin (8%)
Rash (8%)
Petechiae (7%)
Pain in jaw (7%)
Dysphagia (7%)
Renal failure (7%)
Nasal congestion (7%)
Chest pain (6%)
Muscle spasms (6%)
Candida infection (6%)
Abdominal distension (6%)
Gastroesophageal reflux disease (6%)
Decreased TSH (5%)
Hypothyroidism (3%)
Stomatitis (3%)
Pulmonary embolism (3%)
Warnings
Contraindications
None
Cautions
Treatment contributes to a patient’s overall long-term radiation exposure; cumulative radiation exposure is associated with an increased risk for cancer; risks of radiation are greater in pediatric patients than in adults
Severe and prolonged myelosuppression reported; monitor blood cell counts weekly for up to 12 weeks or until levels return to baseline or the normal range; withhold and dose reduce as recommended based on severity of cytopenia (see Dosage Modifications)
Secondary malignancies may develop, including myelodysplastic syndrome, leukemia, and nonhematologic malignancies
Hypothyroidism may occur; initiate thyroid-blocking medication starting at least 1 day before and continuing for 10 days after each dose to reduce risk of hypothyroidism or thyroid neoplasia; evaluate for hypothyroidism and measure TSH levels before initiating and annually thereafter
May worsen preexisting hypertension; monitor blood pressure frequently during the first 24 hr after each dose
Renal toxicity reported, including decreased GFR, renal failure, or acute kidney injury; monitory renal function during and after treatment; patients with baseline renal impairment may be at higher risk; perform more frequent assessments of renal function in patients with mild or moderate impairment
Fatal pneumonitis reported in 1 patient in clinical trials; monitor for signs and symptoms of pneumonitis and treat appropriately
Based on its mechanism of action, can cause fetal harm (see Pregnancy)
May cause infertility in males and females; the recommended cumulative dose of 37 GBq results in a radiation absorbed dose to the testes and ovaries within the range where temporary or permanent infertility can be expected following external beam radiotherapy (see Pregnancy)
Drug interaction overview
- Based on the mechanism of action of iobenguane, drugs that reduce catecholamine uptake or that deplete catecholamine stores may interfere with iobenguane uptake into cells and therefore interfere with dosimetry calculations or the efficacy of iobenguane I 131
- Discontinue drugs that reduce catecholamine uptake or deplete catecholamine stores (see list below) for at least 5 half-lives before administration of either the dosimetry or a therapeutic dose of iobenguane I 131
- Do not administer the following list of drugs until at least 7 days after each iobenguane I 131 dose
Drugs that may interfere with iobenguane cell uptake
- CNS stimulants or amphetamines (eg, cocaine, methylphenidate, dextroamphetamine)
- Norepinephrine and dopamine reuptake inhibitors (eg, phentermine)
- Norepinephrine and serotonin reuptake inhibitors (eg, tramadol)
- Monoamine oxidase inhibitors (eg, phenelzine, linezolid)
- Central monoamine-depleting drugs (eg, reserpine)
- Nonselective beta-adrenergic blocking drugs (eg, labetalol)
- Alpha agonists or alpha/beta agonists (eg, pseudoephedrine, phenylephrine, ephedrine, phenylpropanolamine, naphazoline)
- Tricyclic antidepressants or norepinephrine reuptake inhibitors (eg, amitriptyline, bupropion, duloxetine, mirtazapine, venlafaxine)
- Botanicals that may inhibit reuptake of norepinephrine, serotonin, or dopamine (eg, ephedra, ma huang, St John’s Wort, yohimbine)
Pregnancy
Pregnancy
There are no available data regarding use in pregnant women
Based on its mechanism of action, can cause fetal harm (see Mechanism of Action)
No animal studies using iobenguane I 131 have been conducted to evaluate its effect on female reproduction and embryo-fetal development; however, all radiopharmaceuticals have the potential to cause fetal harm
Advise pregnant women of the risk to a fetus
Pregnancy testing
- Verify pregnancy status in females of reproductive potential prior to initiating treatment
Contraception
- Females: Advise women of reproductive potential to use effective contraception during treatment with and for 7 months following the final dose
- Males: Advise males with female partners of reproductive potential to use effective contraception during treatment and for 4 months following the final dose
Infertility
- The recommended cumulative dose of 37 GBq results in a radiation absorbed dose to the testes and ovaries within the range where temporary or permanent infertility can be expected following external beam radiotherapy
Lactation
There are no data on the presence of iobenguane I 131 in human milk or its effects on the breastfed infant or milk production
No lactation studies in animals were conducted
Because of the potential risk for serious adverse reactions in breastfed infants, advise women not to breastfeed during treatment and for 80 days after the final dose
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
Mechanism of Action
Iobenguane is similar in structure to the neurotransmitter norepinephrine (NE) and is subject to the same uptake and accumulation pathways as NE; iobenguane is taken up by the NE transporter in adrenergic nerve terminals and accumulates in adrenergically innervated tissues (eg, heart, lungs, adrenal medulla, salivary glands, liver, spleen) as well as tumors of neural crest origin
Pheochromocytoma and paraganglioma (PPGL) are tumors of neural crest origin that express high levels of the NE transporter on their cell surfaces; following IV administration, iobenguane I 131 is taken up and accumulates within pheochromocytoma and paraganglioma cells, and radiation resulting from radioactive decay of I 131 causes cell death and tumor necrosis
Absorption
Characterized following a dosimetric dose
Peak plasma concentration: 0.06 microCi/mL
AUC: 1 microCi·h/mL
Distribution
Protein bound: 61-63%
Vd: 2893 mL/kg
Half-life, distribution: 0.37 hr
Metabolism
Does not undergo hepatic metabolism
Elimination
Half-life, terminal: 35 hr
Clearance: 62 mL/hr/kg
Excretion
- 50% urine (within 24 hr); 80% (within 120 hr)
- Excreted most unchanged (93-94%)
Administration
IV Preparation
Refer to the Package Handling Instructions supplied with the frozen vial
Discard if the temperature recording device displays an alarm icon indicating that the temperature exceeded -70°C during shipment
Use aseptic technique and radiation shielding when administering solution
Use tongs when handling vial to minimize radiation exposure
Confirm the amount of radioactivity in the radiopharmaceutical vial with an appropriate dose calibrator before and after administration
Inspect visually for particulate matter and discoloration prior to administration whenever solution and container permit; should solution should appear clear, colorless to pale yellow, and without any particulate matter; discard if particulate matter or discoloration is observed
Dosimetric dose
- Thaw the vial to room temperature in lead pot
- Do not heat or refreeze
- Confirm complete thawing and gently swirl to ensure homogeneity
- Insert a venting unit (consisting of a needle, 0.2-micron sterile filter, and a charcoal filter) to avoid pressurizing the contents of the vial during dilution; swirl gently to ensure homogeneity
- Add sufficient volume of 0.9% NaCl to the vial to yield a concentration of 1 mCi/mL (37 MBq/mL); again, swirl gently to ensure homogeneity
- Draw the dosimetric dose into a 10-mL shielded syringe and place in the dose calibrator to ensure that the activity is within 10% of dose; discard unused medicinal product or waste material in accordance with local and federal laws for biohazards
- Maintain at room temperature and administer within 8 hr of retrieval from frozen storage
Therapeutic dose
- Thaw the appropriate number of vials (2 or 3) to room temperature in lead pots; do not heat or refreeze; swirl vial(s) to ensure homogeneity
- Insert a venting unit into each vial to avoid pressurizing the contents of the vial during dilution; insert a venting unit into a sterile 50-mL glass vial and transfer the entire contents of the 2 therapeutic vial(s) into a 50-mL glass vial
Measure the radioactivity
- If radioactivity in the 50-mL glass vial exceeds the therapeutic dose, withdraw and discard the appropriate volume using a shielded syringe and then add 0.9% NaCl to a total volume of 50 mL
- If radioactivity in the 50-mL glass vial is less than the therapeutic dose, use a shielded syringe to withdraw the appropriate volume from a third vial and add to the 50-mL glass vial; add 0.9% NaCl to a total volume of 50 mL
- Swirl gently to ensure homogeneity
- Remove the venting unit and place the 50-mL glass vial into a dose calibrator to ensure that the activity is within 10% of therapeutic dose
- Maintain at room temperature and administer within 8 hr of retrieval from frozen storage
- Discard unused medicinal product or waste material in accordance with local and federal laws for biohazards
IV Administration
Dosimetric dose
- Administer IV over 60 seconds
Therapeutic dose
- Verify line patency by infusing 250 mL of 0.9% NaCl (primary IV line) at recommended rate of 200 mL/hr
- Insert a venting unit into the 50-mL glass vial containing the therapeutic dose
- Assemble a second IV line using a 19-ga x 5-in aspirating needle, 24-in M-M arterial pressure tubing, and a primary set specific connector
- Clamp the second IV line and connect it to the primary IV line using the primary set specific connector
- Flush the second intravenous line by releasing the clamp and then reclamp the second IV line
- Insert the needle of the second IV line into the 50-mL glass vial containing the therapeutic dose
- Ensure the needle reaches the bottom of the glass vial without touching the sides of the vial
- Clamp the primary IV line just above the second intravenous line and remove the clamp from the secondary IV line
- Administer the therapeutic dose over 30 minutes at a recommended rate of 100 mL/hr for adults; for pediatric patients 12 years and older, administer over 60 minutes at a recommended rate of 50 mL/hr
- Clamp the secondary IV line when the first air bubbles form
- Remove the clamp from the primary IV line to flush any residual therapeutic dose within this IV line with at least 50 mL of 0.9% NaCl
- Remove the clamp from the secondary IV line to flush any residual drug in the secondary IV line into the 50-mL glass vial
Storage
Product vial is in a lead-shielded container placed in a resealable plastic bag
Product shipped on dry ice in a USA DOT Type A Radioactive package
Store frozen at -70°C (-94°F)
Shelf life: 6 days post calibration time
Discard appropriately at 144 hr
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Azedra Therapeutic intravenous - | 337.5 mCi/22.5 mL vial |  | |
| Azedra Dosimetric intravenous - | 30 mCi/2 mL vial |  |
Copyright © 2010 First DataBank, Inc.
Formulary
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