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Kalydeco的用法用量？
(lvacaftor) The recommended dosages for adults and pediatric patients 6 years and older and for pediatric patients 2.21 months to < 6 years old are different. The usage and dosage of Kalydeco are described in detail below.
About Kalydeco
Kalydeco (lvacaftor) is a drug jointly developed by Vertex Pharmaceuticals Co., Ltd. and CFFT, a non-profit drug research organization affiliated with The Cystic Fibrosis Foundation. On January 31, 2012, Kalydeco was officially approved by the FDA for the treatment of cystic fibrosis caused by the G551D mutation.
Clinical studies have shown that Kalydeco can significantly improve lung function, reduce the level of chloride ions in sweat, and cause patients to gain weight. And the FDA lists it as the first drug to treat the underlying cause of cystic fibrosis, rather than to alleviate the symptoms.
Recommended dosage for adults and pediatric patients 6 years and older
Kalydeco is indicated for adults and pediatric patients 6 years of age and older at 150 mg taken orally every 12 hours (total daily dose 300 mg) with fatty food.
Recommended dosage for pediatric patients 1 month to < 6 years of age
The recommended dosage of Kalydeco (oral granules) for pediatric patients 1 month to less than 6 years of age is based on body weight and is shown in Table 1. Take Kalydeco with fatty foods.
Table 1: Recommended doses of Kalydeco oral granules by body weight in pediatric patients 1 month to less than 6 years of age
|
Age |
Weight (kg) |
KALYDECO DOSAGE |
|
1 month to < 2 months*† |
3 kg or more |
1 sachet every 12 hours (contains 5.8 mg ivacaftor) |
|
2 months to < 4 months*† |
3 kg or more |
1 sachet every 12 hours (contains 13.4 mg ivacaftor) |
|
4 months to < 6 months† |
5 kg or more |
1 sachet every 12 hours (contains 25 mg ivacaftor) |
|
6 months to < 6 years |
5 kg to < 7 kg |
1 sachet every 12 hours (contains 25 mg ivacaftor) |
|
|
7 kg to < 14 kg |
1 sachet every 12 hours (contains 50 mg ivacaftor) |
|
|
14 kg or more |
1 sachet every 12 hours (contains 75 mg ivacaftor) |
Dosing information
Take Kalydeco tablets or oral granules with fatty foods. Examples include eggs, butter, peanut butter, cheese pizza, whole milk dairy products (such as whole milk, cheese, yogurt, breast milk or infant formula), etc.
1. Tablet administration instructions: Swallow the whole tablet.
2. Instructions for administration of oral granules
Give each dose of Kalydeco oral granules immediately before or after eating fatty foods. Mix the entire contents of each package of oral granules with one teaspoon (5 mL) of age-appropriate soft food or liquid (at or below room temperature). Some examples of soft foods or liquids might include plain fruits or vegetables, yogurt, applesauce, water, breast milk, infant formula, milk, or juice. Food or liquids should be at or below room temperature. Once mixed, this product should be completely consumed within 1 hour.
Missed dose of Kalydeco
Patients should be informed of the steps to take if they miss a dose of Kalydeco:
1. If a dose of Kalydeco is missed within 6 hours of the usual dose, the patient should be instructed to take the prescribed dose of Kalydeco as soon as possible with a fatty meal.
2. If more than 6 hours have elapsed since Kalydeco was usually taken, the missed dose should not be taken and the patient should resume the regular dosing schedule.
3. Patients should be advised to contact their healthcare provider if they have questions.
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