Cobenfy(KarXT)的用法用量:用药指南,剂量调整,特殊人群用药

Cobenfy (KarXT) is an oral capsule preparation composed of xanomeline and trospium chloride. It exerts its therapeutic effects through the agonism of M1 and M4 receptors in the central nervous system.

Cobenfy (KarXT) usage and dosage

1. Recommended testing and monitoring before starting Cobenfy treatment and during treatment

Evaluate liver enzymes and bilirubin before starting treatment and during treatment as clinically necessary.

Assess heart rate at baseline and as clinically necessary during treatment.

2. Recommended dose

(1) The recommended starting dose is one 50mg/20mg capsule (containing 50mg xanomeline and 20mg trospium chloride) taken orally twice a day for at least two days.

(2). Increase the dose to take one 100mg/20mg capsule (containing 100mg xanomeline and 20mg trospium chloride) orally twice a day for at least five days.

(3). According to the patient's tolerance and response, the dose can be increased to oral administration of one 125mg/30mg capsule (containing 125mg xanomeline and 30mg trospium chloride) twice a day.

The maximum recommended dose is 125mg/30mg, taken orally twice daily.

3. Medication time

Cobenfy should be taken orally at least one hour before or two hours after a meal.

Cobenfy (KarXT) dosage adjustment

The recommended starting dose of Cobenfy for elderly patients is one 50mg/20mg capsule, taken orally twice daily.

Consider slower dose titration in elderly patients. The maximum recommended dose for elderly patients is one 100 mg/20 mg capsule twice daily.

The pictures come from public channels (such as the official website of the FDA, the official website of the original drug manufacturer, etc.) and are for reference only.

Cobenfy (KarXT) use in special populations

1. Pregnancy

There are currently no available data on the use of Cobenfy in pregnant women to assess drug-related risks of major birth defects, miscarriage or other adverse maternal and infant outcomes. Untreated schizophrenia presents risks to the mother (see Clinical Considerations).

In animal reproduction studies, oral administration of Cobenfy (KarXT) during organogenesis or during pregnancy and lactation resulted in adverse maternal clinical signs, weight loss, weight gain and food consumption, and/or maternal death.

Embryofetal and developmental toxicity at these maternally toxic doses includes fetal and neonatal weight loss, stillbirth, and/or neonatal death.

2. Lactation period

There is no data on whether Cobenfy (KarXT) is present in human milk, its effects on breastfed infants, or its effects on milk production. Cobenfy (KarXT) is present in animal milk, and when the drug is present in animal milk, it is likely that it will also be present in human milk.

The developmental and health benefits of breastfeeding should be considered, as well as the mother's clinical need for Cobenfy and any potential adverse effects of Cobenfy or the underlying maternal condition on the breastfed infant.

3. Pediatric use

The safety and effectiveness of Cobenfy in pediatric patients have not been determined.

4. Geriatric use

Controlled clinical studies of Cobenfy did not include patients over the age of 65, and it is impossible to determine whether their responses are different from those of younger adult patients.

Because Cobenfy may increase the risk of urinary retention in older patients, including older men with bladder outlet obstruction due to benign prostatic hyperplasia, slower dose titration and lower maximum doses are recommended in older patients.

5. Renal insufficiency

Cobenfy is not recommended for use in patients with moderate or severe renal impairment (eGFR <60mL/min).

6. Hepatic insufficiency

Cobenfy is contraindicated in patients with moderate or severe hepatic insufficiency, and is not recommended for use in patients with mild hepatic insufficiency.