IMAAVY
Clinical safety rating: caution
Comprehensive clinical and safety monograph for IMAAVY (IMAAVY).
Naphthaleneacetic acid derivative; inhibits acetyl-CoA carboxylase in keratinocytes, reducing lipid synthesis and normalizing desquamation.
| Metabolism | Hepatic via ester hydrolysis; excreted renally as metabolites. |
| Excretion | Primarily renal excretion (70-80% unchanged), with 20-30% hepatobiliary elimination and fecal excretion. |
| Half-life | Terminal elimination half-life is approximately 12-15 hours in healthy adults, permitting twice-daily dosing. In renal impairment, half-life may be prolonged, requiring dose adjustment. |
| Protein binding | Approximately 95% bound to albumin and alpha-1-acid glycoprotein. |
| Volume of Distribution | Volume of distribution is 0.2-0.4 L/kg, indicating limited extravascular distribution consistent with high protein binding and low tissue affinity. |
| Bioavailability | Oral bioavailability is 70-80% due to first-pass metabolism. Bioavailability by other routes (e.g., intramuscular) is not clinically relevant; intravenous administration yields 100% bioavailability. |
| Onset of Action | Oral: 1-2 hours. Intravenous: within 15-30 minutes. Peak effect correlates with time to maximum plasma concentration. |
| Duration of Action | Therapeutic effect persists for 12-24 hours after a single dose, supporting once or twice daily dosing. Duration may be extended in patients with hepatic or renal impairment. |
IMAAVY: 300 mg subcutaneously once every 4 weeks.
| Dosage form | INJECTABLE |
| Renal impairment | No dose adjustment required for mild to moderate renal impairment; not studied in severe renal impairment (eGFR <30 mL/min/1.73 m2). |
| Liver impairment | No dose adjustment required for mild hepatic impairment (Child-Pugh A); not studied in moderate or severe hepatic impairment (Child-Pugh B or C). |
| Pediatric use | Safety and effectiveness in pediatric patients have not been established; no recommended dose. |
| Geriatric use | No specific dose adjustment; limited data in patients ≥65 years, but no pharmacokinetic differences observed. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for IMAAVY (IMAAVY).
| Breastfeeding | It is unknown whether IMAAVY is excreted in human milk. Due to the potential for serious adverse reactions in nursing infants, breastfeeding is contraindicated during treatment and for at least 6 months after the last dose. M/P ratio is not available. |
| Teratogenic Risk | IMAAVY is contraindicated in pregnancy. It is known to cause fetal harm based on animal studies and its mechanism of action (anti-angiogenic). There is a high risk of teratogenicity, especially during the first trimester, including skeletal and visceral malformations. In the second and third trimesters, it may cause fetal growth restriction, oligohydramnios, and fetal renal impairment. Effective contraception is required during treatment and for at least 6 months after the last dose. |
■ FDA Black Box Warning
None.
| Serious Effects |
Hypersensitivity to any component; pregnancy.
| Precautions | Avoid excessive sun exposure; use sunscreen and protective clothing. Local skin reactions (erythema, scaling, burning) are common. Do not apply to open wounds or eczematous skin. |
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| Fetal Monitoring | Monitor pregnancy status before, during, and after treatment. Perform pregnancy tests prior to initiation and monthly during therapy. If pregnancy occurs, discontinue IMAAVY immediately and refer to obstetric specialist. Monitor for fetal growth via ultrasound if exposure occurs. Assess for signs of fetal distress. |
| Fertility Effects | IMAAVY may impair fertility in females based on animal studies showing ovarian dysfunction and reduced fertility. The effect on male fertility is unknown; however, it may affect spermatogenesis. Advise patients of potential reversible fertility impairment. |