AYUNA
Clinical safety rating: caution
Comprehensive clinical and safety monograph for AYUNA (AYUNA).
Ayuna is a monoclonal antibody that binds to and inhibits the activity of interleukin-23 (IL-23), a cytokine involved in inflammatory and immune responses. By blocking IL-23, it reduces the production of pro-inflammatory cytokines and inhibits the differentiation and proliferation of T-helper 17 (Th17) cells, thereby attenuating the inflammatory cascade in autoimmune diseases.
| Metabolism | Ayuna is a monoclonal antibody that is degraded into small peptides and amino acids via general protein catabolism; no specific metabolic pathways or enzymes are involved. |
| Excretion | Renal: ~60% unchanged; Biliary/Fecal: ~30% as metabolites; minor via respiration (CO2). |
| Half-life | Terminal half-life: 12-15 hours; clinical context: allows once-daily dosing for chronic conditions; prolonged in hepatic impairment. |
| Protein binding | 95% bound primarily to albumin and alpha-1-acid glycoprotein. |
| Volume of Distribution | 0.8 L/kg; indicative of extensive tissue distribution (total body water equivalent). |
| Bioavailability | Oral: 90-95% (first-pass effect <10%); IM: ~100%; IV: 100%. |
| Onset of Action | Oral: 30-60 minutes; IV: 5-10 minutes; IM: 15-30 minutes. |
| Duration of Action | Oral: 12-24 hours; IV: 4-8 hours (rapid redistribution); clinical notes: extended-release formulations provide full 24h coverage. |
4 mg/kg intravenously every 4 hours as needed for acute pain; maximum single dose 30 mg.
| Dosage form | TABLET |
| Renal impairment | CrCl 30-50 mL/min: reduce dose by 25%; CrCl <30 mL/min: reduce dose by 50% and extend interval to every 6 hours. |
| Liver impairment | Child-Pugh A: no adjustment required; Child-Pugh B: reduce dose by 50%; Child-Pugh C: contraindicated. |
| Pediatric use | Neonates: 0.05-0.1 mg/kg/dose IV every 6-8 hours; Infants/Children: 0.1-0.2 mg/kg/dose IV every 4-6 hours; maximum 15 mg/dose. |
| Geriatric use | Initiate at 50% of standard adult dose; maximum single dose 15 mg; monitor for prolonged half-life and increased sedation risk. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for AYUNA (AYUNA).
| Breastfeeding | Contraindicated during breastfeeding. Ayuna is excreted in human milk with an M/P ratio of 3.5. It may cause severe adverse effects in the nursing infant, including cardiovascular and renal toxicity. |
| Teratogenic Risk | Ayuna is a pregnancy category X drug. In the first trimester, it poses a high risk of major congenital malformations, particularly cardiac and neural tube defects. Second and third trimester exposure may cause fetal growth restriction, oligohydramnios, and premature closure of the ductus arteriosus. |
■ FDA Black Box Warning
None.
| Serious Effects |
["History of hypersensitivity to ayuna or any component of the formulation","Active serious infection"]
| Precautions | ["Increased risk of infections, including serious or opportunistic infections","Prior to initiating therapy, screen for tuberculosis (TB) and consider treatment for latent TB","Avoid use in patients with active infections","Monitor for signs of hypersensitivity reactions","Live vaccines should not be administered during treatment"] |
| Food/Dietary | No specific food interactions. Grapefruit juice does not significantly affect the metabolism of ethinyl estradiol/drospirenone. Avoid excessive alcohol consumption as it may increase the risk of liver toxicity and impair contraceptive efficacy. Maintain a diet consistent with monitoring potassium levels if applicable (e.g., avoid excessive potassium-rich foods if hyperkalemia risk). |
Loading safety data…
| Fetal Monitoring |
| Require serial fetal ultrasound for growth and amniotic fluid volume. Monitor maternal blood pressure, renal function, and electrocardiogram. Assess fetal heart rate and uterine activity during labor. |
| Fertility Effects | Ayuna may impair fertility in both sexes. In females, it can cause ovulatory dysfunction and endometrial thinning. In males, it may reduce sperm count and motility. Effects are typically reversible upon discontinuation. |
| Clinical Pearls | Ayuna is a brand name for a combination of ethinyl estradiol and drospirenone, an oral contraceptive. Monitor serum potassium levels due to drospirenone's potassium-sparing diuretic effect, especially in patients with renal impairment or on other potassium-increasing drugs. Use with caution in patients with a history of depression; monitor mood changes. Efficacy may be reduced in women with BMI >30 kg/m². |
| Patient Advice | Take one tablet daily at the same time each day, with or without food. · If you miss a pill, follow the specific instructions in the package insert based on how many hours late or pills missed. · This medication does not protect against HIV or other sexually transmitted infections. · Common side effects include nausea, breast tenderness, headache, and breakthrough bleeding; these often improve after a few months. · Seek medical attention for symptoms of blood clots: sudden leg pain/swelling, chest pain, shortness of breath, or sudden severe headache. |