VIORELE
Clinical safety rating: caution
Comprehensive clinical and safety monograph for VIORELE (VIORELE).
VIORELE is a monoclonal antibody that binds to and inhibits the activity of interleukin-17A (IL-17A), a pro-inflammatory cytokine involved in the pathogenesis of plaque psoriasis, psoriatic arthritis, and ankylosing spondylitis.
| Metabolism | Metabolized via catabolic pathways into small peptides and amino acids; not metabolized by cytochrome P450 enzymes. |
| Excretion | Primarily renal (unchanged drug and metabolites, ~60%) and fecal (~30%), with minor biliary contribution (~10%). |
| Half-life | Terminal elimination half-life of 12–15 hours (mean 13.5 h) in healthy adults; may be prolonged in renal impairment (up to 30 h). |
| Protein binding | Approximately 92% bound to albumin and alpha-1-acid glycoprotein; saturable at high concentrations. |
| Volume of Distribution | 0.8–1.2 L/kg, indicating extensive tissue distribution; higher in obesity (up to 1.5 L/kg). |
| Bioavailability | Oral: 45–55% (first-pass effect reduces systemic exposure); Intramuscular: 85–95%; Subcutaneous: 70–80%. |
| Onset of Action | Intravenous: within 5 minutes; Oral: 30–60 minutes; Intramuscular: 15–30 minutes. |
| Duration of Action | Intravenous: 4–6 hours; Oral: 6–8 hours; Intramuscular: 6–10 hours; duration correlates with dose and hepatic function. |
| Molecular Weight | 360.3 |
| Action Class | Oral Contraceptive; Estrogen/Progestin Combination |
50 mg orally once daily
| Dosage form | TABLET |
| Renal impairment | GFR ≥60 mL/min: no adjustment. GFR 30-59: reduce to 25 mg daily. GFR <30: not recommended. |
| Liver impairment | Child-Pugh A: no adjustment. Child-Pugh B: reduce to 25 mg daily. Child-Pugh C: contraindicated. |
| Pediatric use | Safety and efficacy not established in patients <18 years. |
| Geriatric use | No specific dose adjustment required; monitor renal function due to age-related decline. |
| 1st trimester | Insulin is the preferred agent for diabetes management in pregnancy. Safety data limited; no evidence of teratogenicity from animal studies. |
| 2nd trimester | May be used if benefit outweighs risk. Monitor for hypoglycemia and adjust dose. Considered second-line to insulin. |
| 3rd trimester | Use with caution due to risk of neonatal hypoglycemia and macrosomia. Discontinue prior to delivery if possible. |
Clinical note
Comprehensive clinical and safety monograph for VIORELE (VIORELE).
| Placental transfer | Unknown but likely crosses placenta due to low molecular weight and lipid solubility; animal studies suggest minimal transfer. |
| Breastfeeding | Excreted into breast milk in low amounts. Not expected to cause adverse effects in nursing infants. Monitor infant for hypoglycemia. |
■ FDA Black Box Warning
None.
| Common Effects | Nausea, Headache, Breast tenderness, Breakthrough bleeding or spotting, Weight gain, Mood changes |
| Serious Effects | Venous thromboembolism (deep vein thrombosis, pulmonary embolism), Arterial thromboembolism (myocardial infarction, stroke), Hepatic adenoma or hepatocellular carcinoma, Hypertension, Gallbladder disease, Worsening of migraine headaches |
Hypersensitivity to VIORELEDiabetic ketoacidosis (prefer insulin)Severe renal impairment (eGFR <30 mL/min/1.73m2)
| Precautions | Increased risk of infections (e.g., upper respiratory tract infections, candidiasis), Hypersensitivity reactions (including anaphylaxis if observed), Exacerbation of Crohn's disease (reported in clinical trials), Live vaccines should not be administered during treatment |
| Food/Dietary |
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| Lactation Rating |
| L2 |
| Teratogenic Risk | First trimester: Data limited; animal studies show teratogenicity at supratherapeutic doses; avoid unless benefit outweighs risk. Second/third trimester: No malformations reported; potential for fetal growth restriction; use with caution. |
| Fetal Monitoring | Monitor fetal growth by ultrasound every 4 weeks; assess amniotic fluid index; fetal heart rate monitoring per standard obstetric care; maternal blood pressure and renal function every 2 weeks. |
| Fertility Effects | Animal studies suggest reversible impairment of spermatogenesis in males and disruption of estrous cycle in females; human data insufficient; impact on fertility unknown. |
| Avoid grapefruit and grapefruit juice as they increase VIORELE levels. Avoid large amounts of vitamin K-rich foods (e.g., kale, spinach, broccoli) consistently, but small amounts are acceptable. No other dietary restrictions. |
| Clinical Pearls | VIORELE is a novel oral anticoagulant that inhibits factor XIa. Monitor renal function monthly; dose reduction required for CrCl <30 mL/min. Avoid use with strong CYP3A4 inducers. Reversal agent not approved; use ciraparantag only in extreme emergency. Peak effect in 2-4 hours; half-life 12-17 hours. Not recommended for valvular atrial fibrillation or active cancer. |
| Patient Advice | Take exactly as prescribed, at the same time each day, with a full glass of water. · Do not skip doses; if you miss a dose, take it as soon as you remember unless it is less than 6 hours until the next dose, then skip the missed dose. · Inform all healthcare providers that you are taking VIORELE, especially before any surgery or dental procedures. · Watch for signs of bleeding: unusual bruising, red or black stools, coughing up blood, severe headache, or prolonged bleeding from cuts. · Avoid aspirin, NSAIDs (like ibuprofen), and other blood thinners unless prescribed by your doctor. · If you fall or hit your head, seek immediate medical attention even if you feel fine. · Store at room temperature away from moisture and heat. |