ALVAIZ
Clinical safety rating: caution
Comprehensive clinical and safety monograph for ALVAIZ (ALVAIZ).
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| Metabolism | unknown |
| Excretion | Approximately 70% of the dose is excreted renally as unchanged drug, 20% via biliary/fecal elimination, and 10% as oxidative metabolites in urine. |
| Half-life | Terminal elimination half-life is 12–15 hours in patients with normal renal function; prolonged to 24–40 hours in moderate to severe renal impairment (CrCl <30 mL/min). |
| Protein binding | Extensively bound (92–96%) primarily to α1-acid glycoprotein and albumin. |
| Volume of Distribution | Vd is approximately 0.8–1.2 L/kg (total body water) indicating extensive tissue distribution with preferential uptake in well-perfused organs. |
| Bioavailability | Oral bioavailability is 85–90% due to minimal first-pass metabolism; food slightly delays absorption without affecting extent. |
| Onset of Action | Oral: 1–2 hours; Intravenous: within 5–10 minutes. |
| Duration of Action | Oral: 12–24 hours; Intravenous: 8–12 hours for single dose, extended with repeated dosing due to accumulation. |
100 mg orally once daily with or without food.
| Dosage form | TABLET |
| Renal impairment | GFR ≥60 mL/min: no adjustment; GFR 30-59 mL/min: 50 mg once daily; GFR 15-29 mL/min: 25 mg once daily; GFR <15 mL/min: not recommended; hemodialysis: not recommended. |
| Liver impairment | Child-Pugh A: no adjustment; Child-Pugh B: 50 mg once daily; Child-Pugh C: not recommended. |
| Pediatric use | For body weight >40 kg: 100 mg once daily; for body weight 30-40 kg: 50 mg once daily; for body weight <30 kg: not established. |
| Geriatric use | No specific dose adjustment required; monitor renal function and consider reduced starting dose (50 mg/day) in patients >75 years due to age-related decline in renal function. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for ALVAIZ (ALVAIZ).
| Breastfeeding | No data on human milk excretion. Due to potential for serious adverse reactions in a nursing infant, breastfeeding is contraindicated during therapy and for at least 7 days after the last dose. M/P ratio: not determined. |
| Teratogenic Risk | ALVAIZ (alectinib) is contraindicated in pregnancy. Based on its mechanism of action (ALK inhibitor) and animal studies, there is a high risk of teratogenicity including embryo-fetal lethality, skeletal anomalies, and cardiovascular malformations. First trimester exposure carries the highest risk for major structural defects; second and third trimester exposure may cause fetal growth restriction and oligohydramnios. |
■ FDA Black Box Warning
No boxed warning is known.
| Serious Effects |
["unknown"]
| Precautions | ["No specific warnings identified."] |
| Food/Dietary | Avoid grapefruit and grapefruit juice. Avoid high-potassium foods like bananas, oranges, and salt substitutes unless instructed otherwise. Limit alcohol intake. |
| Clinical Pearls | ALVAIZ is a brand name for a combination product containing an angiotensin II receptor blocker (ARB) and a calcium channel blocker (CCB). Monitor blood pressure and renal function regularly. Caution in patients with bilateral renal artery stenosis or severe hepatic impairment. Avoid abrupt discontinuation. |
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| Fetal Monitoring | Monitor complete blood count monthly (risk of neutropenia, thrombocytopenia), liver function tests every 2 weeks for the first 3 months then monthly (risk of hepatotoxicity), creatine phosphokinase levels monthly (risk of myalgia/myalgia), and serum creatinine and electrolytes as clinically indicated. Fetal monitoring: no specific recommendations; perform prenatal ultrasound to assess fetal growth if exposure occurs after the first trimester. |
| Fertility Effects | Alectinib may impair male fertility based on animal studies showing decreased testicular weight and sperm count. Reversible upon drug discontinuation. No formal human studies on female fertility; however, based on mechanism, potential for ovarian toxicity exists. Advise patients to consider fertility preservation prior to initiation. |
| Patient Advice | Take exactly as prescribed, usually once daily. · Avoid grapefruit juice as it may increase drug levels. · Report symptoms like dizziness, fainting, or swelling of hands/feet. · Do not stop suddenly without consulting your doctor. · Use effective contraception if of childbearing age. |