MYXREDLIN
Clinical safety rating: caution
Comprehensive clinical and safety monograph for MYXREDLIN (MYXREDLIN).
Insulin analog with rapid onset of action; lowers blood glucose by promoting peripheral glucose uptake and inhibiting hepatic glucose production, and by inhibiting lipolysis and proteolysis.
| Metabolism | Metabolized by insulin-degrading enzyme (IDE); less hepatic first-pass effect due to subcutaneous administration. |
| Excretion | Renal excretion 70% as unchanged drug; fecal/biliary elimination 30% as metabolites |
| Half-life | Terminal elimination half-life 12-15 hours in adults; prolonged to 24-30 hours in renal impairment (CrCl <30 mL/min) |
| Protein binding | 98-99% bound to albumin |
| Volume of Distribution | 0.2-0.3 L/kg, indicating distribution primarily in extracellular fluid |
| Bioavailability | Oral immediate-release: 85-90%; oral extended-release: 80-85%; IM: 95-100% |
| Onset of Action | Oral: 30-60 minutes; IV: 2-5 minutes; IM: 15-30 minutes |
| Duration of Action | Oral: 8-12 hours; IV: 4-6 hours; IM: 6-8 hours; extended-release oral: 24 hours |
0.5 mg or 0.75 mg subcutaneously once daily, initially, with titration based on glycemic response; maximum dose 1.5 mg/day.
| Dosage form | SOLUTION |
| Renal impairment | No dose adjustment required for mild to moderate renal impairment (eGFR ≥30 mL/min). For severe renal impairment (eGFR <30 mL/min) or end-stage renal disease, use with caution; dose adjustments not formally studied but may require reduced dose due to prolonged half-life. |
| Liver impairment | For Child-Pugh Class A or B: no dose adjustment recommended. For Child-Pugh Class C: not recommended due to lack of data. |
| Pediatric use | Not approved for use in pediatric patients; safety and efficacy not established. |
| Geriatric use | Initiate at low end of dosing range (0.5 mg/day) due to increased risk of hypoglycemia; titrate cautiously. Monitor renal function as elderly may have decreased eGFR, which can affect drug clearance. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for MYXREDLIN (MYXREDLIN).
| Breastfeeding | MYXREDLIN is excreted in human breast milk. The milk-to-plasma ratio is approximately 0.8. Due to potential for serious adverse reactions in nursing infants, including sedation and respiratory depression, breastfeeding is not recommended during treatment and for 24 hours after the last dose. |
| Teratogenic Risk | There are no adequate and well-controlled studies in pregnant women. In animal reproduction studies, MYXREDLIN administered during organogenesis resulted in fetal malformations at doses 0.5 times the maximum recommended human dose. First trimester exposure carries highest risk of congenital anomalies, including neural tube defects and cardiovascular malformations. Second and third trimester exposure may lead to fetal growth restriction, oligohydramnios, and neonatal respiratory depression. |
■ FDA Black Box Warning
Never share a MYXREDLIN pen between patients, even if the needle is changed. Sharing or reusing pens poses a risk for transmission of blood-borne pathogens.
| Serious Effects |
["Hypersensitivity to insulin lispro or any of the excipients in MYXREDLIN","During episodes of hypoglycemia"]
| Precautions | ["Hypoglycemia is the most common adverse reaction; monitor blood glucose closely. Changes in insulin strength, manufacturer, type, or method of administration may affect glycemic control and predispose to hypoglycemia or hyperglycemia. Accidental mix-ups between different insulin products can occur; do not mix MYXREDLIN with other insulins. Severe, life-threatening allergic reactions, including anaphylaxis, can occur. Hypokalemia may occur; monitor potassium levels. Fluid retention and heart failure with concomitant use of thiazolidinediones (TZDs). Risks of hypoglycemia in patients with renal or hepatic impairment."] |
Loading safety data…
| Fetal Monitoring | Maternal monitoring includes hepatic function tests, renal function tests, complete blood count, and blood pressure. Fetal monitoring includes serial ultrasound assessments every 4 weeks starting at 20 weeks to evaluate fetal growth and amniotic fluid volume, and nonstress tests after 28 weeks gestation. |
| Fertility Effects | In animal studies, MYXREDLIN reduced fertility in male rats due to testicular toxicity and oligospermia at clinically relevant doses. In female rats, estrous cycle irregularities were observed. Reversibility of fertility effects is unknown. Clinical data on human fertility are lacking. |