TESLASCAN
Clinical safety rating: caution
Comprehensive clinical and safety monograph for TESLASCAN (TESLASCAN).
Teslascan is a manganese-based paramagnetic contrast agent that enhances T1-weighted magnetic resonance imaging (MRI). Manganese ions shorten the T1 relaxation time of protons, increasing signal intensity in tissues where it accumulates.
| Metabolism | Teslascan undergoes minimal metabolism; it is primarily eliminated unchanged in the urine. No significant hepatic metabolism occurs. |
| Excretion | 70% renal (unchanged drug), 30% fecal (biliary excretion). |
| Half-life | Terminal elimination half-life is 6.2 hours in patients with normal renal function (CrCl > 60 mL/min). In patients with moderate renal impairment (CrCl 30-60 mL/min), half-life increases to 9.5 hours; in severe impairment (CrCl < 30 mL/min), half-life exceeds 15 hours. |
| Protein binding | Approximately 93% bound to plasma proteins, predominantly albumin. |
| Volume of Distribution | Volume of distribution is 0.35 L/kg, indicating distribution largely confined to extracellular fluid. |
| Bioavailability | Bioavailability is 100% for intravenous administration; not administered via other routes. |
| Onset of Action | Intravenous administration: Onset of contrast enhancement occurs immediately after injection, with peak enhancement within 1-2 minutes. |
| Duration of Action | Duration of diagnostic contrast enhancement is 30-60 minutes post-injection, sufficient for completion of multiphasic imaging protocols. |
0.1 mL/kg (0.1 mmol/kg) intravenous bolus injection.
| Dosage form | INJECTABLE |
| Renal impairment | No dose adjustment required for mild to moderate renal impairment; not recommended in severe renal impairment (GFR <30 mL/min/1.73 m²) due to increased risk of nephrogenic systemic fibrosis. |
| Liver impairment | No specific dose adjustment recommendations for hepatic impairment; use with caution in severe hepatic impairment. |
| Pediatric use | 0.1 mL/kg (0.1 mmol/kg) intravenous bolus injection; not approved for neonates. |
| Geriatric use | No specific dose adjustment recommended; consider renal function due to age-related decline in GFR. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for TESLASCAN (TESLASCAN).
| Breastfeeding | No data on excretion in human milk. Manganese-based compounds may transfer into breast milk, posing risk of neonatal manganese accumulation. Discontinue breastfeeding during therapy and for 10 days after last dose. |
| Teratogenic Risk | Pregnancy Category X. Teslascan (mangafodipir trisodium) is contraindicated in pregnancy due to known teratogenic effects in animal studies. First trimester: highest risk for developmental abnormalities; second and third trimesters: risk of fetal harm, including potential for manganese accumulation. Use only if benefit clearly outweighs risk in life-threatening conditions. |
■ FDA Black Box Warning
No FDA black box warning is currently present for Teslascan.
| Serious Effects |
["Known hypersensitivity to Teslascan or any of its components","Severe renal impairment (eGFR <30 mL/min/1.73m²) due to risk of nephrogenic systemic fibrosis (NSF)"]
| Precautions | ["Contrast-induced nephropathy in patients with renal impairment","Hypersensitivity reactions including anaphylaxis","Extravasation risk leading to tissue necrosis","Use caution in patients with pre-existing liver disease"] |
Loading safety data…
| Fetal Monitoring | Fetal ultrasound for structural abnormalities if inadvertent exposure occurs. Monitor maternal liver and renal function due to manganese excretion; assess for extrapyramidal symptoms from manganese deposition. |
| Fertility Effects | In animal studies, reduced fertility and impaired spermatogenesis observed at high doses. Clinical relevance unknown; advise pre-treatment fertility counseling for patients of childbearing potential. |