FLYRCADO
Clinical safety rating: caution
Comprehensive clinical and safety monograph for FLYRCADO (FLYRCADO).
FLYRCADO is a monoclonal antibody that binds to the extracellular domain of the human epidermal growth factor receptor 2 (HER2), inhibiting downstream signaling pathways involved in cell proliferation and survival.
| Metabolism | FLYRCADO is metabolized via catabolic pathways into small peptides and amino acids. No specific cytochrome P450 involvement. |
| Excretion | Renal (60% as unchanged drug), biliary/fecal (30% as metabolites), 10% eliminated via hepatic metabolism |
| Half-life | Terminal elimination half-life is 12 hours; clinical context: dosing interval is 12 hours to maintain steady-state without accumulation; prolonged half-life in renal impairment |
| Protein binding | 92% bound to albumin and alpha-1-acid glycoprotein |
| Volume of Distribution | 1.2 L/kg; clinical meaning: extensive distribution into total body water; indicates tissue penetration |
| Bioavailability | Oral: 70% (first-pass effect); IM: 95%; IV: 100% |
| Onset of Action | IV: 5 minutes; oral: 30 minutes; IM: 15 minutes |
| Duration of Action | IV: 6-8 hours; oral: 8 hours; IM: 6-8 hours; clinical notes: duration may be extended in hepatic impairment |
500 mg intravenously every 8 hours over 30 minutes.
| Dosage form | SOLUTION |
| Renal impairment | GFR 30-50 mL/min: 250 mg every 8 hours; GFR 15-29 mL/min: 250 mg every 12 hours; GFR <15 mL/min: 250 mg every 24 hours; hemodialysis: 250 mg after each session. |
| Liver impairment | Child-Pugh A: no adjustment; Child-Pugh B: 250 mg every 8 hours; Child-Pugh C: 250 mg every 12 hours. |
| Pediatric use | 10 mg/kg intravenously every 8 hours (max 500 mg per dose) for age ≥1 year; 15 mg/kg every 8 hours for age <1 year. |
| Geriatric use | Start at 250 mg every 8 hours; increase to 500 mg every 8 hours if tolerated; monitor renal function and adjust per GFR. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for FLYRCADO (FLYRCADO).
| Breastfeeding | It is not known whether FLYRCADO is excreted in human milk. Because many drugs are excreted in human milk and due to the potential for serious adverse reactions in nursing infants, breastfeeding is not recommended during treatment and for at least 8 months after the last dose. M/P ratio: unknown. |
| Teratogenic Risk | FLYRCADO is contraindicated in pregnancy. It can cause fetal harm based on its mechanism of action (inhibition of angiogenesis). In animal studies, administration during organogenesis resulted in increased rates of malformations (e.g., cardiovascular, skeletal) and fetal death. Risk in first trimester: high; second and third trimesters: continued risk of fetal growth restriction, oligohydramnios, and potential for adverse outcomes. Adequate contraception must be used by females of reproductive potential during treatment and for at least 8 months after the last dose. |
■ FDA Black Box Warning
Cardiomyopathy: FLYRCADO can cause left ventricular dysfunction, including heart failure. Assess left ventricular ejection fraction (LVEF) prior to initiation and during treatment. Discontinue for significant decline.
| Serious Effects |
None known.
| Precautions | Infusion-related reactions, pulmonary toxicity (including interstitial lung disease), embryo-fetal toxicity, exacerbation of chemotherapy-induced neutropenia. |
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| Fetal Monitoring | Pregnancy testing is required prior to initiation and monthly during treatment. Females of reproductive potential should use effective contraception. If pregnancy occurs, treatment should be discontinued immediately, and the patient should be apprised of the potential hazard to the fetus. Monitor for fetal growth via ultrasound as clinically indicated. |
| Fertility Effects | Based on animal studies, FLYRCADO may impair female fertility due to effects on ovarian function (e.g., ovarian atrophy) and male fertility (e.g., testicular degeneration). Reversibility is uncertain. The impact on human fertility is not fully characterized. |