美国批准一种治疗Ⅱ型糖尿病口服药片Tradjenta上市

美国药管局表示，在约3800名Ⅱ型糖尿病患者参与的8项双盲临床试验中，这种药物的安全性和有效性得到展现，其主要副作用包括上呼吸道感染、流鼻涕、喉咙痛、肌肉痛和头痛等。

美国食品和药物管理局2日批准一种治疗Ⅱ型糖尿病的口服药片Tradjenta（通用名“利拉利汀”）上市，利拉利汀可用于改善Ⅱ型糖尿病患者血糖控制能力。

Ⅱ型糖尿病又称成年发病型糖尿病，是最常见的糖尿病，其特点是胰岛素抵抗，即自体能够产生胰岛素，但体内组织对胰岛素的作用不敏感，正常量的胰岛素起不到正常的降血糖作用。利拉利汀通过抑制二肽基肽酶－4，提高一种激素的水平，而这种激素可刺激胰岛素释放，进而改善服用者的血糖控制。

美国药管局表示，在约3800名Ⅱ型糖尿病患者参与的8项双盲临床试验中，这种药物的安全性和有效性得到展现，其主要副作用包括上呼吸道感染、流鼻涕、喉咙痛、肌肉痛和头痛等。

利拉利汀由位于美国康涅狄格州的勃林格殷格翰制药公司出品，可单独服用，也可与其他现有药物联合使用。

Tradjenta
Generic Name: linagliptin
Date of Approval: May 2, 2011
Company: Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company
FDA Approves Tradjenta

The U.S. Food and Drug Administration (FDA) has approved Tradjenta (linagliptin) tablets, a prescription medication used along with diet and exercise to lower blood sugar in adults with type 2 diabetes. Tradjenta can be used as monotherapy or in combination with other commonly prescribed medications for type 2 diabetes — metformin, sulfonylurea or pioglitazone — and demonstrated reductions in hemoglobin A1C (HbA1C or A1C) levels up to 0.7 percent (compared to placebo). A1C is measured in people with diabetes to provide an index of blood sugar control for the previous two to three months. Tradjenta should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis (increased ketones in the blood or urine). It has not been studied in combination with insulin.

Tradjenta belongs to a class of prescription medications called dipeptidyl peptidase-4 (DPP-4) inhibitors and is the first member of its class to be approved at one dosage strength (5 mg, once daily). With Tradjenta, no dose adjustment is recommended for patients with kidney or liver impairment. Tradjenta is a tablet that can be taken with or without food. Tradjenta lowers blood sugar in a glucose-dependent manner by increasing incretin levels, which increase insulin levels after meals and throughout the day.

Tradjenta Patient Information
Read this Patient Information before you start taking Tradjenta and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or your treatment.

What is Tradjenta?
Tradjenta is a prescription medicine used along with diet and exercise to lower blood sugar in adults with type 2 diabetes.
Tradjenta is not for people with type 1 diabetes.
Tradjenta is not for people with diabetic ketoacidosis (increased ketones in the blood or urine).
It is not known if Tradjenta is safe and effective when used with insulin.
It is not known if Tradjenta is safe and effective in children.
Who should not take Tradjenta?
Do not take Tradjenta if you:

are allergic to linagliptin or any of the ingredients in Tradjenta. See the end of this leaflet for a complete list of ingredients in Tradjenta.
Symptoms of a serious allergic reaction to Tradjenta are:

rash
raised red patches on your skin (hives)
swelling of your face, lips, and throat that may cause difficulty breathing or swallowing
Before using Tradjenta
Before you take Tradjenta, tell your doctor if you:

have any other medical conditions
are pregnant or planning to become pregnant. It is not known if Tradjenta will harm your unborn baby. If you are pregnant, talk with your doctor about the best way to control your blood sugar while you are pregnant.
are breastfeeding or plan to breastfeed. It is not known if Tradjenta passes into your breast milk. Talk with your doctor about the best way to feed your baby if you take Tradjenta.
Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tradjenta may affect the way other medicines work, and other medicines may affect how Tradjenta works.

Especially tell your doctor if you take

other medicines that can lower your blood sugar
rifampin (Rifadin, Rimactane, Rifater, Rifamate), an antibiotic that is used to treat tuberculosis
Ask your doctor or pharmacist for a list of these medicines if you are not sure if your medicine is one that is listed above.

Know the medicines you take. Keep a list of them and show it to your doctor and pharmacist when you get a new medicine.

How should I take Tradjenta?
Take Tradjenta one time each day exactly as your doctor tells you to take it.
Talk with your doctor if you do not understand how to take Tradjenta.
Your doctor will tell you when to take Tradjenta.
Take Tradjenta with or without food.
If you miss a dose, take it as soon as you remember. If you do not remember until it is time for your next dose, skip the missed dose and go back to your regular schedule.
Do not take two doses of Tradjenta at the same time.
Your doctor may tell you to take Tradjenta along with other diabetes medicines. Low blood sugar can happen more often when Tradjenta is taken with certain other diabetes medicines. See Tradjenta side effects
If you take too much Tradjenta, call your doctor or Poison Control Center at 1-800-222-1222 or go to the nearest hospital emergency room right away.
When your body is under some types of stress, such as fever, trauma (such as a car accident), infection, or surgery, the amount of diabetes medicine that you need may change. Tell your doctor right away if you have any of these conditions and follow your doctor's instructions.
Check your blood sugar as your doctor tells you to.
Stay on your prescribed diet and exercise program while taking Tradjenta.
Talk to your doctor about how to prevent, recognize and manage low blood sugar (hypoglycemia), high blood sugar (hyperglycemia), and complications of diabetes.
Your doctor will check your diabetes with regular blood tests, including your blood sugar levels and your hemoglobin A1C. Tradjenta side effects
Tradjenta may cause serious side effects, including:

low blood sugar (hypoglycemia). If you take Tradjenta with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin, your risk of getting low blood sugar is higher. The dose of your sulfonylurea medicine or insulin may need to be lowered while you take Tradjenta.
Signs and symptoms of low blood sugar may include:

headache
drowsiness
weakness
dizziness
confusion
irritability
hunger
fast heart beat
sweating
feeling jittery
The most common side effects of Tradjenta include:

stuffy or runny nose and sore throat
Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Tradjenta. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store Tradjenta?
Store Tradjenta at 59°F to 86°F (15°C to 30°C).
Keep Tradjenta and all medicines out of the reach of children.

General information about the safe and effective use of Tradjenta.

Medicines are sometimes prescribed for purposes other than those listed in Patient Information leaflets. Do not use Tradjenta for a condition for which it was not prescribed. Do not give Tradjenta to other people, even if they have the same symptoms you have. It may harm them.

This Patient Information summarizes the most important information about Tradjenta. If you would like more information, talk with your doctor.

You can ask your pharmacist or doctor for information about Tradjenta that is written for health professionals.

For more information, go to www.tradjenta.com or call Boehringer Ingelheim Pharmaceuticals, Inc. at 1-800-542-6257, or (TTY) 1-800-459-9906.

What are the ingredients in Tradjenta?
Active Ingredient: linagliptin

Inactive Ingredients: mannitol, pregelatinized starch, corn starch, copovidone, and magnesium stearate. The film coating contains the following inactive ingredients: hypromellose, titanium dioxide, talc, polyethylene glycol, and red ferric oxide.

What is type 2 diabetes?
Type 2 diabetes is a condition in which your body does not make enough insulin, and or the insulin that your body produces does not work as well as it should. Your body can also make too much sugar. When this happens, sugar (glucose) builds up in the blood. This can lead to serious medical problems.

The main goal of treating diabetes is to lower your blood sugar to a normal level. High blood sugar can be lowered by diet and exercise, and by certain medicines when necessary.