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FDA批准每日使用一次的Lantus下注射剂治疗糖尿病

2011-07-14 17:44:08 作者：新特药房来源：中国新特药网天津分站浏览次数：176 文字大小：【大】【中】【小】

简介：Aventis制药公司宣布FDA已批准Lantus(R)(Ⅰ)［insulin glargine(来源于rDNA)注射剂］用于治疗Ⅱ型和Ⅰ型糖尿病。Aventis公司计划今年晚些时候使患者可以使用该产品。实验表明每天临睡前皮下注射(Ⅰ)一次，可治 ...

关键字：Lantus® (insulin glargine)注射剂糖尿病

Aventis制药公司宣布FDA已批准Lantus(R)(Ⅰ)［insulin glargine(来源于rDNA)注射剂］用于治疗Ⅱ型和Ⅰ型糖尿病。Aventis公司计划今年晚些时候使患者可以使用该产品。

实验表明每天临睡前皮下注射(Ⅰ)一次，可治疗需要使用长效胰岛素来控制高血糖症的Ⅱ型糖尿病人成患者和患Ⅰ型糖尿病的成人和儿童患者。研究显示每天一次给(Ⅰ)能维持相对稳定的浓度/时间关系达24小时以上。

(Ⅰ)是一种重组的人类胰岛素类似物--一种与人类胰岛素非常相似的生物合成胰岛素。(Ⅰ)是长效药，因此Ⅱ型或Ⅰ型糖尿病患者仅需每天在临睡前给药一次。(Ⅰ)的化学结构调节其从皮下组织释放进入循环系统，使释放相对稳定，在长达24小时内不出现血糖明显降低。

对照的临床实验表明，就控制代谢而言，(Ⅰ)显示与NPH人胰岛素相似疗效，在临床研究中，(Ⅰ)与NPH人类胰岛素相比较，显示吸收更慢更持久并且在24小时内浓度/时间关系相对稳定，没有明显的峰值。

人类胰岛素方法可能伴有低血糖症，糖尿病性视网膜病恶化，脂肪营养不良，皮肤反应(如注射部位反应，瘙痒和皮疹)，过敏反应，钠潴留和水肿。低血糖症是胰岛素制剂，包括(Ⅰ)在内的药物最常见的副作用。对于所有胰岛素制剂，低血糖症发生的时间由于药物配方不同而不同。所有糖尿病患者应监测血糖，并在
医务人员监督下小心改变胰岛素水平。在对成人患者的临床研究中发现，治疗中易发生注射部位疼痛(的发生率为2.7%，而NPH为0.7%)。注射部位的疼痛通常是轻微的，并不导致治疗的中断。

(Ⅰ)不能用其他的胰岛素或溶液稀释或与之混合，因为这可能引起延迟作用的发生。

(Ⅰ)新药审批申请于1999年4月22日在美国和欧洲同时提交。

Lantus

Generic Name: insulin glargine, recombinant (Subcutaneous route)

IN-su-lin GLAR-jeen, ree-KOM-bi-nant

Commonly used brand name(s):

In the U.S.

Lantus

Available Dosage Forms:

Solution

Therapeutic Class: Antidiabetic

Pharmacologic Class: Insulin, Long Acting

Uses For Lantus

Insulin glargine is a type of insulin. Insulin is one of many hormones that help the body turn the food we eat into energy. This is done by using the glucose (sugar) in the blood as quick energy. Also, insulin helps us store energy that we can use later. When you have type 2 diabetes mellitus, your body does not produce enough insulin, or the insulin produced is not used properly. This causes you to have too much sugar in your blood. Like other types of insulin, insulin glargine is used to keep your blood sugar level close to normal. Insulin glargine is a long-acting insulin that works slowly over about 24 hours. You may have to use insulin glargine in combination with another type of insulin or with a type of oral diabetes medicine to keep your blood sugar under control.

This medicine is available only with your doctor's prescription.

Before Using Lantus

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

This medicine has been tested in a limited number of children 6 years of age or older. In effective doses, the medicine has not been shown to cause different side effects or problems than it does in adults.

Geriatric

This medicine has been tested in a limited number of patients 65 years of age or older and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Pregnancy

Pregnancy Category Explanation

All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of Lantus

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

Each package of insulin glargine contains a patient information sheet. Read this sheet carefully and make sure you understand:

How to prepare the medicine.
How to inject the medicine.
How to dispose of syringes, needles, and injection devices.

It is best to use a different place on the body for each injection (e.g., abdomen, thigh, or upper arm). If you have questions about this, contact a member of your health care team.

Since insulin glargine lowers the blood glucose over 24 hours, it should be taken once daily at bedtime

Follow carefully the special meal plan your doctor gave you. This is the most important part of controlling your condition, and is necessary if the medicine is to work properly. Also, exercise regularly and test for sugar in your blood or urine as directed.

For injection dosage form:
- For type 2 diabetes mellitus:
  - Adults, teenagers, and children 6 years of age or older—The dose is based on your blood sugar and must be determined by your doctor.
  - Children up to 6 years of age—Use and dose must be determined by your doctor.

Storage

Store in the refrigerator. Do not freeze.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

After a cartridge has been inserted into a pen, store the cartridge and pen at room temperature, not in the refrigerator.

Precautions While Using Lantus

Never share insulin pens or cartridges with others under any circumstances. It is not safe for one pen to be used for more than one person. Sharing needles or pens can result in transmission of hepatitis viruses, HIV, or other blood-borne illnesses.

Your doctor will want to check your progress at regular visits, especially during the first few weeks you take this medicine.

It is very important to follow carefully any instructions from your health care team about:

Alcohol—Drinking alcohol may cause severe low blood sugar. Discuss this with your health care team.
Other medicines—Do not take other medicines during the time you are taking insulin glargine unless they have been discussed with your doctor. This especially includes nonprescription medicines such as aspirin, and medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems.
Counseling—Other family members need to learn how to prevent side effects or help with side effects if they occur. Also, patients with diabetes may need special counseling about diabetes medicine dosing changes that might occur because of lifestyle changes, such as changes in exercise and diet. Furthermore, counseling on contraception and pregnancy is needed because of the problems that can occur in patients with diabetes during pregnancy.
Travel—Keep a recent prescription and your medical history with you. Be prepared for an emergency as you would normally. Make allowances for changing time zones and keep your meal times as close as possible to your usual meal times.

In case of emergency—There may be a time when you need emergency help for a problem caused by your diabetes. You need to be prepared for these emergencies. It is a good idea to:

Wear a medical identification (ID) bracelet or neck chain at all times. Also, carry an ID card in your wallet or purse that says that you have diabetes and a list of all of your medicines.
Keep an extra supply of insulin glargine and syringes with needles or injection devices on hand in case high blood sugar occurs.
Keep some kind of quick-acting sugar handy to treat low blood sugar.
Have a glucagon kit and a syringe and needle available in case severe low blood sugar occurs. Check and replace any expired kits regularly.

Too much insulin glargine can cause hypoglycemia (low blood sugar). Low blood sugar also can occur if you use insulin glargine with another antidiabetic medicine, delay or miss a meal or snack, exercise more than usual, or drink alcohol. Symptoms of low blood sugar must be treated before they lead to unconsciousness (passing out). Different people may feel different symptoms of low blood sugar. It is important that you learn which symptoms of low blood sugar you usually have so that you can treat it quickly.

Symptoms of low blood sugar include anxiety; behavior change similar to being drunk; blurred vision; cold sweats; confusion; difficulty in thinking; dizziness or lightheadedness; drowsiness; excessive hunger; fast heartbeat; headache; irritability or abnormal behavior; nervousness; nightmares; restless sleep; shakiness; slurred speech; and tingling in the hands, feet, lips, or tongue.

If symptoms of low blood sugar occur, eat glucose tablets or gel, corn syrup, honey, or sugar cubes; or drink fruit juice, nondiet soft drink, or sugar dissolved in water to relieve the symptoms. Also, check your blood for low blood sugar. Get to a doctor or a hospital right away if the symptoms do not improve. Someone should call for emergency help immediately if severe symptoms such as convulsions (seizures) or unconsciousness occur. Have a glucagon kit available, along with a syringe and needle, and know how to use it. Members of your household also should know how to use it.

Hyperglycemia (high blood sugar) may occur if you do not take enough or skip a dose of your antidiabetic medicine, overeat or do not follow your meal plan, have emotional stress or infection, or do not exercise as much as usual.

Symptoms of high blood sugar include blurred vision; drowsiness; dry mouth; flushed, dry skin; fruit-like breath odor; increased urination; ketones in urine; loss of appetite; stomachache, nausea, or vomiting; tiredness; troubled breathing (rapid and deep); unconsciousness; and unusual thirst.

If symptoms of high blood sugar occur, check your blood sugar level and then call your doctor for instructions.

Lantus Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Convulsions (seizures)
unconsciousness

Check with your doctor as soon as possible if any of the following side effects occur:

More common

Low blood sugar, including anxious feeling; behavior change similar to being drunk; blurred vision; cold sweats; confusion; cool, pale skin; difficulty in thinking; dizziness or lightheadedness; drowsiness; excessive hunger; fast heartbeat; headache; nausea; nervousness; nightmares; restless sleep; shakiness; slurred speech; and tingling in the hands, feet, lips, or tongue

Less common or rare

Allergic reaction, including fast pulse, shortness of breath, skin rash or itching over the entire body, sweating, and wheezing

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common or rare