来法莫林(Xenleta)的用法用量:用药指南,剂量调整,特殊人群用药

In 2019, Xenleta was approved by the FDA for marketing in the United States. Oral tablets and intravenous injections were approved at the same time, and must be used under the guidance of a doctor.

Lefamoren (Xenleta) usage and dosage

1. Oral administration

Take oral tablets on an empty stomach (i.e. at least 1 hour before a meal or at least 2 hours after a meal). Swallow tablets whole with 6-8 ounces of water; do not cut, chew, or crush.

2. Dosage

600 mg every 12 hours for 5 days.

3. Prescription limit

The maximum dose is 600 mg every 12 hours for 5 days.

4. Treatment of missed doses

If you miss a dose of famolin and you remember it within 4 hours after the scheduled dose, you should take it as soon as possible and take the next dose at the original time.

If you miss a dose and do not remember it until more than 4 hours after the scheduled time, skip the dose and take the next dose at the originally scheduled time.

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.

Lefamoren (Xenleta) dose adjustment

1. Patients with hepatic insufficiency

(1), mild hepatic insufficiency (Child-Pugh A grade): No dose adjustment is required.

(2) Moderate or severe hepatic insufficiency (Child-Pugh class B or C): Not recommended; no pharmacokinetic studies have been conducted, and adverse reactions need to be monitored.

2. Patients with renal insufficiency

Mild, moderate or severe renal insufficiency, including patients receiving hemodialysis: No dose adjustment is required.

3. Elderly patients

No specific dosage recommendations.

Lefamorelin (Xenleta) Use in Special Populations

1. Pregnancy

There are no data on the use of Lefamorelin in pregnant women to assess the risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes associated with the drug. Based on animal studies, use by pregnant women may cause harm to the fetus.

If a pregnant woman accidentally takes lefamorelin or becomes pregnant while taking the drug, her exposure to lefamorelin should be reported to the Lefamorelin Pregnancy Pharmacovigilance Program.

2. Lactation period

It is unclear whether lefamoren will be distributed into human milk, affect milk secretion or affect nursing infants. In rats, lefamoren is distributed into breast milk.

Due to the potential risk of serious adverse reactions (such as QT interval prolongation) in nursing infants, women should not breastfeed while taking Lefamolin and within 2 days after the last dose.

3. Women of childbearing potential

For women of childbearing potential, a pregnancy test should be performed before starting famolin treatment.

It is recommended that women of childbearing potential use effective contraception during treatment with Lefamolin and within 2 days after the last dose.

4. Pediatric use

The safety and effectiveness in patients under 18 years of age have not been established.

5. Geriatric Use

No overall differences in safety or effectiveness were observed between elderly patients and younger adults.

6. Hepatic insufficiency

Metabolic disorders related to hepatic insufficiency may lead to prolongation of the QT interval. Patients with hepatic insufficiency should monitor their electrocardiogram during treatment with lefamoren.

It is not recommended for use in patients with moderate or severe hepatic impairment. The pharmacokinetics of oral lefamoren have not been studied in patients with hepatic impairment.

7. Renal insufficiency

Metabolic disorders associated with renal failure requiring dialysis may result in prolongation of the QT interval, and electrocardiograms should be monitored in such patients during treatment with lefamorelin. Renal insufficiency does not affect the pharmacokinetics of lefamorelin.