ABLAVAR
Clinical safety rating: caution
Comprehensive clinical and safety monograph for ABLAVAR (ABLAVAR).
Gadolinium-based contrast agent; shortens T1 and T2 relaxation times in magnetic resonance imaging, enhancing contrast between normal and abnormal tissues.
| Metabolism | Gadofosveset trisodium is primarily excreted unchanged by the kidneys. No significant metabolism occurs. No active metabolites. |
| Excretion | Renal: 100% as unchanged drug (gadolinium chelate) via glomerular filtration. |
| Half-life | Terminal elimination half-life approximately 1.5 hours in patients with normal renal function; prolonged to >30 hours in severe renal impairment (GFR <30 mL/min/1.73m²). |
| Protein binding | Negligible (<5%), not significantly bound to plasma proteins. |
| Volume of Distribution | 0.27–0.30 L/kg, indicating primarily extracellular distribution. |
| Bioavailability | Not applicable (administered only intravenously); intravenous bioavailability is 100%. |
| Onset of Action | Intravenous: Immediate onset of vascular enhancement (0–2 minutes post-injection). |
| Duration of Action | Rapid washout; enhancement persists for approximately 2–4 hours post-injection for contrast imaging; complete elimination within 24 hours in normal renal function. |
0.03 mL/kg (0.03 mmol/kg) intravenously as a single bolus injection at a rate of approximately 1 mL/second.
| Dosage form | SOLUTION |
| Renal impairment | Contraindicated in patients with acute or chronic severe renal dysfunction (GFR <30 mL/min/1.73m2). No dose adjustment needed for mild-moderate impairment. |
| Liver impairment | No specific dose adjustment recommended; caution in severe hepatic impairment due to potential gadolinium retention. |
| Pediatric use | 0.03 mL/kg (0.03 mmol/kg) intravenously as a single bolus; not recommended for children under 2 years due to lack of data. |
| Geriatric use | No specific dose adjustment; monitor renal function as elderly patients are more prone to renal impairment. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for ABLAVAR (ABLAVAR).
| Breastfeeding | Unknown if excreted in human milk. Due to potential for adverse reactions, discontinue nursing or discontinue drug. M/P ratio not available. |
| Teratogenic Risk | FDA Pregnancy Category B. No evidence of teratogenicity in animal studies. Limited human data; risk cannot be excluded. Avoid use in first trimester unless benefits outweigh risks. |
| Fetal Monitoring | Monitor fetal heart rate during and after administration due to potential for fetal bradycardia. Monitor maternal blood pressure and oxygen saturation. |
■ FDA Black Box Warning
WARNING: NEPHROGENIC SYSTEMIC FIBROSIS (NSF) - Gadolinium-based contrast agents increase the risk for NSF in patients with acute or chronic severe renal insufficiency (GFR < 30 mL/min/1.73m²) or acute kidney injury. Avoid use in these patients unless the diagnostic information is essential and not available with non-contrast MRI or other imaging modalities.
| Serious Effects |
History of allergic reaction to ABLAVAR or any of its components; patients with severe renal impairment (GFR < 30 mL/min/1.73m²) or acute kidney injury (unless benefit outweighs risk).
| Precautions | Risk of NSF in patients with severe renal impairment; acute kidney injury; chronic kidney disease (stage 4 or 5). Use lowest effective dose. Screen patients for renal impairment. Post-marketing reports of hypersensitivity reactions including anaphylaxis. Extravasation may cause local tissue injury. |
| Food/Dietary | No known food interactions. No dietary restrictions required before or after administration. |
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| Fertility Effects | No known effect on fertility based on animal studies. |
| Clinical Pearls | Ablavar is a gadolinium-based contrast agent (GBCA) specifically approved for magnetic resonance angiography (MRA). Do not use in patients with acute kidney injury or chronic severe renal failure (eGFR < 30 mL/min/1.73m²) due to risk of nephrogenic systemic fibrosis (NSF). Administer at 0.1 mmol/kg via slow IV injection (2 mL/sec). Residual gadolinium deposition in brain has been reported; use lowest effective dose. |
| Patient Advice | Tell your provider if you have kidney problems or are pregnant. · You may experience a cool sensation or mild pain at injection site. · Rare but serious risk of NSF with impaired kidney function. · Report any skin changes, muscle weakness, or joint stiffness after procedure. · Usually administered as a single dose; fasting is not required. |