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Farxiga

全部名称：: 安达唐、Dapagliflozin、Farxiga、达格列净

适应症：: 1型糖尿病

上市状态：: 已批准上市

生产药企：: 阿斯利康（AstraZeneca）

规格：: 5mg；10mg

处方药物

关注度 8314

什么是Farxiga？

Farxiga (dapagliflozin) is an oral medication that may be given to certain people with diabetes, heart disease, or kidney disease to improve their outcomes. Specifically, Farxiga is used to:

Improve blood sugar control in adults and children aged 10 years and older with type 2 diabetes mellitus alongside diet and exercise
Lower the risk of going to hospital for heart failure in adults with type 2 diabetes who also have cardiovascular disease or multiple risk factors for cardiovascular disease
Reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visits in adults with heart failure
Lower the risk of further worsening of kidney disease, end-stage kidney disease (ESKD), death due to cardiovascular disease, and hospitalization for heart failure in adults with chronic kidney disease at risk of progression.

Farxiga mechanism of action involves preventing glucose reabsorption in the kidneys, and increasing how much is excreted in the urine. Farxiga works by inhibiting sodium-glucose cotransporter 2 (SGLT2), which is present in the proximal renal tubules and reabsorbs filtered glucose. By inhibiting this, Farxiga promotes the excretion of glucose in the urine.

Farxiga also works by reducing the amount of sodium reabsorbed by the kidneys and increasing how much reaches the distal tubule. This is thought to influence several physiological functions including lowering the preload and afterload of the heart, downregulating sympathetic activity, and decreasing pressure inside the kidneys.

Farxiga first gained FDA approval on January 8, 2014. There is no Farxiga generic.

与Farxiga类似的药物都有哪些？

Farxiga的副作用有哪些？

不良反应
重要不良反应描述见如下及说明书相应部分（参见注意事项）：
• 糖尿病患者的酮症酸中毒
• 血容量不足
• 尿脓毒症和肾盂肾炎
• 与胰岛素和胰岛素促泌剂合用引起低血糖
• 会阴坏死性筋膜炎（福尼尔坏疽）
• 生殖器真菌感染

The most common side effects of Farxiga are:

Female genital yeast infections (vaginal thrush)
Urinary tract infections
Nasopharyngitis (a runny or stuffy nose).

Serious side effects

Farxiga can cause the following serious side effects.

Diabetic ketoacidosis (increased ketones in your blood or urine) in people with type 1 diabetes and other ketoacidosis. Farxiga can cause ketoacidosis that can be life-threatening and may lead to death. Ketoacidosis is a serious condition that needs to be treated in a hospital. People with type 1 diabetes have a high risk of getting ketoacidosis. People with type 2 diabetes or pancreas problems also have an increased risk of getting ketoacidosis. Ketoacidosis can also happen in people who are sick, cannot eat or drink as usual, skip meals, are on a diet high in fat and low in carbohydrates (ketogenic diet), take less than the usual amount of insulin, or miss insulin doses, drink too much alcohol, have a loss of too much fluid from the body (volume depletion), or who have surgery. Ketoacidosis can happen even if your blood sugar is less than 250 mg/dL. Your healthcare provider may ask you to periodically check ketones in your urine or blood. Stop taking FARXIGA and call your healthcare provider or get medical help right away if you get any of the following:

nausea
tiredness
vomiting
trouble breathing
stomach area (abdominal) pain
ketones in your urine or blood.

If possible, check for ketones in your urine or blood, even if your blood sugar is less than 250 mg/dL.

Dehydration. Farxiga can cause some people to become dehydrated (the loss of body water and salt). Dehydration may cause you to feel dizzy, faint, lightheaded, or weak, especially when you stand up (orthostatic hypotension). There have been reports of sudden kidney injury in people with Type 2 diabetes who are taking Farxiga. You may be at a higher risk of dehydration if you:

take medicines to lower your blood pressure, including water pills (diuretics)
are on a low-salt diet
have kidney problems
are 65 years of age or older.

Talk to your healthcare provider about what you can do to prevent dehydration including how much fluid you should drink daily. Call your healthcare provider right away if you reduce the amount of food or liquid you drink, for example, if you cannot eat or you start to lose liquid from your body, for example from vomiting, diarrhea, or being in the sun too long.

Vaginal yeast infections. Women who take Farxiga may get vaginal yeast infections. Symptoms of a vaginal yeast infection include:

vaginal odor
white or yellowish vaginal discharge (discharge may be lumpy or look like cottage cheese)
vaginal itching.

Yeast infection of the penis (balanitis). Swelling of an uncircumcised penis may develop in men who take Farxiga which makes it difficult to pull back the skin around the tip of the penis. Other symptoms of yeast infection of the penis include:

redness, itching, or swelling of the penis
foul-smelling discharge from the penis
rash of the penis
pain in the skin around the penis.

Allergic reactions. Farxiga may cause an allergic reaction. Do not take Farxiga if you have a history of serious hypersensitivity reactions to dapagliflozin, Farxiga, or any of the inactive ingredients in the tablets. Serious reactions, including anaphylaxis and angioedema, have been reported.

Farxiga should not be used in patients with type 1 diabetes to improve blood sugar control because it may increase their risk of diabetic ketoacidosis.

Not recommended to improve blood sugar control in people with type 2 diabetes with moderate to severe kidney disease (an eGFR of less than 45 mL/min/1.73 m²) (likely to be ineffective in this setting).

Dosages of insulin or other medications that increase insulin release may need reducing to avoid the risk of hypoglycemia. Farxiga may increase the risk of hypoglycemia developing when combined with these medications.

Serious, life-threatening cases of necrotizing fasciitis of the perineum (Fournier’s Gangrene) have been reported in patients with diabetes prescribed Farxiga. If you develop pain or tenderness, redness, or swelling in your genital or perineal area, along with fever or malaise, see your doctor immediately.

Some side effects may be more likely to occur in older adults.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

特别注意事项

You should not use Farxiga if you are allergic to dapagliflozin, or if you have:

severe kidney disease (or if you are on dialysis)
diabetic ketoacidosis (call your doctor for treatment).

To make sure Farxiga is safe for you, tell your doctor if you:

have type 1 diabetes or have had diabetic ketoacidosis
have polycystic kidney disease
have a decrease in your insulin dose
have a serious infection
have a history of infection of the vagina or penis
have liver problems
have a history of urinary tract infections or problems with urination
are on a low sodium (salt) diet. Your healthcare provider may ask you to change your diet
are going to have surgery. Your healthcare provider may stop your Farxiga before you have surgery. Talk to your healthcare provider if you are having surgery about when to stop taking Farxiga and when to start it again
are eating less or there is a change in your diet
are dehydrated
have or have had problems with your pancreas, including pancreatitis or surgery on your pancreas
drink alcohol very often or drink a lot of alcohol in the short term (“binge” drinking)
are pregnant or plan to become pregnant
are breastfeeding or plan to breastfeed.

Pregnancy

Farxiga may cause harm to an unborn baby, especially the developing kidneys of an unborn baby. If you become pregnant while taking Farxiga, your healthcare provider may switch you to a different medicine to control your blood sugar. Talk to your healthcare provider about the best way to control your blood
sugar if you plan to become pregnant or while you are pregnant.

Breastfeeding

It is not known if Farxiga passes into your breast milk. You should not breastfeed if you take Farxiga.

哪些其他药物会影响Farxiga？

药物相互作用
阳性尿糖试验
对于正服用 SGLT2 抑制剂的患者，不建议采用尿糖试验监测血糖控制，因 SGLT2 抑制剂可增加尿糖排泄，将会导致尿糖试验结果呈阳性。建议采用其他方法监测血糖控制。
与 1，5 脱水葡萄糖醇（1，5-AG）的相互作用试验
不建议用 1，5-AG 来监测血糖，因为对使用 SGLT2 抑制剂治疗的患者来说使 1，5-AG 测量值不太可靠。建议采用其他方法监测血糖。

Other drugs may increase or decrease the effects of Farxiga on lowering your blood sugar. Tell your doctor about all your current medicines and any you start or stop using, especially:

Insulin or other oral diabetes medicines
A diuretic or "water pill", such as furosemide or HCTZ
Lithium.

Farxiga will increase urinary glucose excretion and will lead to positive urine glucose tests. Use alternative ways to monitor glycemic control. It also interferes with some other laboratory assays.

This list is not complete. Other drugs may interact with dapagliflozin, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Farxiga的用法用量

老年用药
不建议按年龄调整本品给药剂量。达格列净的 21 项双盲、对照、为改善血糖控制的临床有效性研究汇总显示， 5936 例达格列净治疗患者中共 1424 例（24% ）为 65 岁及 65 岁以上，其中 207 例（3.5% ）患者为 75 岁及 75 岁以上。在对照肾功能（eGFR）水平后，发现 65 岁以下患者和这些 65 岁及 65 岁以上患者的疗效相似。对于 ≥ 65 岁患者，为控制血糖，接受达格列净治疗后患者发生低血压不良反应的发生率高于安慰剂治疗患者（参见注意事项和不良反应）。
在 DAPA-HF 和 DAPA-CKD 研究中， 65 岁及以下患者和 65 岁以上患者的安全性和有效性相似。在 DAPA-HF 研究中， 4744 例 HFrEF 患者中有 2714（57% ）例患者年龄大于 65 岁。在 DAPA-CKD 研究中， 4304 例 CKD 患者中有 1818（42% ）例患者年龄大于 65 岁。

儿童用药
尚未确定达格列净在 18 岁以下儿童患者中的安全性与疗效。

Take Farxiga exactly as your doctor prescribed. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Farxiga is taken 1 time per day.
You may take Farxiga with or without food.
Your treatment may include dietary changes, exercise, weight control, and special medical care.

Your blood sugar will need to be checked often, and you may also need to test the level of ketones in your urine. Farxiga can cause life-threatening ketoacidosis. Even if your blood sugar is normal, contact your doctor if a urine test shows that you have high ketones in the urine.

During prolonged illness, you may become dehydrated. Call your doctor if you are sick with vomiting or diarrhea or if you eat or drink less than usual.

Patients should be well hydrated before starting treatment with Farxiga.

Recommended Farxiga dose for adults and children aged 10 and older for Type 2 diabetes to improve blood sugar control

Initial dose: Farxiga 5 mg once daily
May increase to 10 mg orally once a day for additional glycemic control if a lower dose has been tolerated
Maximum dose: Farxiga 10 mg/day

Usual adult dose of Farxiga for heart failure and kidney disease

Initial and maintenance dose: Farxiga 10 mg orally once a day
Maximum dose: Farxiga 10 mg/day.

如果我错过了一次应该怎么办？

尽快服药，但如果接近下次服药的时间，则跳过漏服的剂量。不要同时服用两剂。

如果我使用过量了应该怎么办？

立即寻求紧急医疗救助。

如何贮存

请在干燥、阴凉处保存，温度保持在20°C至25°C（68°F至77°F）之间。温度在15°C至30°C（59°F至86°F）范围内也可以接受。