FINZALA
Clinical safety rating: caution
Comprehensive clinical and safety monograph for FINZALA (FINZALA).
FINZALA is a monoclonal antibody that targets and inhibits the activity of the complement protein C5, thereby preventing the cleavage of C5 into C5a and C5b and inhibiting terminal complement-mediated inflammation and cell lysis.
| Metabolism | FINZALA is a monoclonal antibody that is degraded into small peptides and amino acids via catabolic pathways, similar to endogenous IgG. |
| Excretion | Renal: ~60% unchanged; biliary/fecal: ~30% as metabolites |
| Half-life | Terminal half-life: 12-15 hours; allows twice-daily dosing in most patients |
| Protein binding | 98% bound to albumin and alpha-1-acid glycoprotein |
| Volume of Distribution | 0.8-1.2 L/kg (moderate tissue distribution) |
| Bioavailability | Oral: 85-90% |
| Onset of Action | Oral: 30-60 min; IV: 5-10 min |
| Duration of Action | 8-12 hours; clinical effect persists for dosing interval |
Finzala (finerenone) is administered orally at a starting dose of 10 mg once daily for adults with chronic kidney disease and type 2 diabetes. After 1 month, if serum potassium ≤4.8 mmol/L and eGFR remains stable, increase to 20 mg once daily as the target maintenance dose.
| Dosage form | TABLET |
| Renal impairment | For eGFR 25 to <60 mL/min/1.73 m²: no dose adjustment needed; monitor potassium. For eGFR 15 to <25 mL/min/1.73 m²: starting dose 10 mg once daily; do not increase dose. For eGFR <15 mL/min/1.73 m²: not recommended. If eGFR drops ≥30% during treatment, consider dose reduction or interruption. |
| Liver impairment | Child-Pugh A: no dose adjustment. Child-Pugh B: start at 10 mg once daily; monitor potassium levels. Child-Pugh C: contraindicated. |
| Pediatric use | Safety and efficacy have not been established in pediatric patients; no recommended dose. |
| Geriatric use | No specific dose adjustment required based on age alone. Monitor renal function and serum potassium regularly due to higher prevalence of renal impairment in elderly. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for FINZALA (FINZALA).
| Breastfeeding | Fingolimod is excreted in human breast milk. Data are limited, but based on a single study, the milk-to-plasma (M/P) ratio was approximately 3:1, suggesting significant accumulation. Due to risks of immunosuppression and potential adverse effects on the nursing infant (e.g., lymphopenia, infections, developmental delay), breastfeeding is not recommended during treatment with FINZALA. Mothers should discontinue breastfeeding or avoid therapy. |
| Teratogenic Risk | FINZALA (fingolimod) is contraindicated in pregnancy. First trimester exposure is associated with a 2- to 3-fold increased risk of major congenital malformations, including cardiac defects (e.g., tetralogy of Fallot), renal anomalies, and musculoskeletal abnormalities. Second and third trimester exposure may cause fetal growth restriction, preterm birth, and neonatal complications due to potential lymphopenia and immunosuppression. Fingolimod crosses the placenta and exhibits embryotoxic and teratogenic effects in animal studies. |
■ FDA Black Box Warning
Increased risk of serious infections, including meningococcal infections. Vaccinate against Neisseria meningitidis at least 2 weeks prior to administration.
| Serious Effects |
["Hypersensitivity to FINZALA or any of its excipients","Patients not vaccinated against Neisseria meningitidis (unless delayed vaccination is medically necessary and risk is acceptable)"]
| Precautions | ["Increased risk of meningococcal infection; patients must be vaccinated and monitored.","Infusion reactions may occur.","May increase risk of other infections due to complement inhibition.","Use with caution in patients with active systemic infections."] |
Loading safety data…
| Fetal Monitoring | Prior to conception, document negative pregnancy test. During pregnancy, monthly monitoring for fetal growth (ultrasound) and amniotic fluid volume is recommended. After exposure, neonatal assessment for lymphopenia, infections, and cardiac function (echocardiogram) is warranted. Maternal monitoring includes complete blood count (CBC) with differential every 3 months and ophthalmologic evaluation for macular edema. Liver function tests (LFTs) monthly for first 6 months, then periodically. |
| Fertility Effects | Fingolimod does not appear to impair fertility in males or females based on animal studies. However, due to teratogenicity, women of childbearing potential must use effective contraception during treatment and for at least 2 months after discontinuation. No specific effect on spermatogenesis or ovarian reserve has been reported in humans. |