Table 1.
USFDA-approval commercial IONPs
| Generic name of SPION | Ferumoxide | Ferumoxsil | Ferumoxytol |
|---|---|---|---|
| Trade name |
Feridex I.V (USA) Endorem (EU) |
Lumirem (USA) GastroMARK (EU) |
Feraheme (USA) Rienso (EU) |
| Approval date |
USFDA approval in 1996 Discontinued in 2008 |
USFDA approval in 1996 Discontinued in 2012 |
USFDA approval in 2009 |
| Coating | Dextran | Siloxane | Carboxymethyl-dextran |
| Size | 120–180 nm | 300 nm | 20–50 nm |
| Blood half-life | 10 min | NA | 14 h |
| Recommended dose | 30 μmol Fe kg−1 | 600 mL (105 mg Fe) | An initial 510 mg dose followed by a second 510 mg dose 3 to 8 days later |
| Administration route | Intravenously | Oral suspension | Intravenously |
| Application/indication | Visualization of liver tumors and metastasis | Contrast enhancement agent for MRI of gastrointestinal and examination of the bowel | Iron replacement therapy for the treatment of iron deficiency anemia in adult patients with chronic kidney disease |
| Human side Effects | Nausea, leg pain, headache, chest pain, hives, vasodilation | Nausea, vomiting, diarrhea, and cramps, iron overload, hiatal hernia | Hypotension, infusion site reactions, gastrointestinal complications, dizziness |
| Animals toxicology | Despite evidence of long-term toxicity, no iron overload, oxidative stress, pathological brain cell, and myelin changes were detected [298] | There are no carcinogens, genotoxicity, reproductive and developmental toxicity in vivo studies. No neurotoxic side effects have been reported (see Foot note link 14) |
Repeat-dose toxicity, reduction in body weight gain and food consumption, enhancement in pigmentation intensity, decrease in fetal weights and external and soft tissue fetal malformations in vivo studies. No neurotoxic side effects have been reported (see Foot note link 15) |