法国药政机关批准了United therapeutics公司推出的Remodulin静脉注射液（曲前列尼尔）用于治疗肺动脉高压（PAH）。
Remodulin同样获批其皮下注射用于治疗原发性和遗传性的PAH，以消除因锻炼引起的症状。
United Therapeutics称，将完成对于静脉注射用的Remodulin的风险管理计划（RMP），以最大限度地降低静脉导管相关血流感染的风险。
公司还向美国食品药监局（FDA）提交了用于治疗PAH的缓释药片（口服曲前列尼尔）新药申请。
United Therapeutics的主席兼首席运营官Roger Jeffs说：“此次获批将给欧洲的PAH患者提供治疗的选择。”
Remodulin
Remodulin (treprostinil sodium) also called UT-15 and Uniprost, is a form of prostacyclin, a very powerful vasodilator that helps most PPH patients that take it.
The drug is made by United Therapeutics, Inc and was approved by the FDA for use within the United States in May 2002. Remodulin is the only the second FDA approved treatment (after Flolan) for PPH patients.
Remodulin is injected through a catheter into the patient, usually near the gut. The drug is slowly absorbed after being injected into fat cells. It then works it way to the blood vessels of the lung, relaxing them enabling the patient to breath easier. Some researchers believe it may also slow the PPH scarring process.
Remodulin has several advantages over Flolan treatment.
1) Remodulin is stable at room temperature for about 3 months (although it should be kept refrigerated), while Flolan requires an ice pack.
2) Remodulin comes packaged and does not need to be mixed. Flolan, which comes as a freeze dried powder, needs to be mixed each day.
3) The Remodulin pump (made by Minimed) is a small pager size item, makes little noise and can be placed in a water proof pack. Flolan requires a larger pump packed with ice and makes a whirling noise.
4) Remodulin lasts longer in the body than Flolan does. Remodulin stays in the body for several hours after injection, making a sudden interruption in treatment less severe than Flolan. Flolan only lasts a few minutes and must be constantly infused.
5) Perhaps the biggest advantage is that Remodulin, avoids the dangerous infections that can arise from the indwelling Flolan catheter.
The downside is that the injections are extremely painful. Pain at the point of injection is the biggest complaint and nearly 8% of patients cannot tolerate the pain and must try another therapy. After 6 months the pain subsides in some people. Other side effects can include jaw pain, foot cramps and flushing.
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RemodulinGeneric Name: treprostinil (Injection route)
tre-PROST-i-nil
Commonly used brand name(s):
In the U.S.
Remodulin
Available Dosage Forms:
Solution
Therapeutic Class: Antihypertensive
Pharmacologic Class: Prostaglandin
Uses For Remodulin
Treprostinil belongs to a group of agents called prostaglandins. Prostaglandins occur naturally in the body and are involved in many biological functions. Treprostinil is used to treat the symptoms of primary pulmonary hypertension, or the high blood pressure that occurs in the main artery that carries blood from the right side of the heart (the ventricle) to the lungs. When the smaller blood vessels in the lungs become more resistant to blood flow, the right ventricle must work harder to pump enough blood through the lungs. Treprostinil works by relaxing blood vessels and increasing the supply of blood to the lungs, reducing the workload of the heart.
This medicine is available only with your doctor's prescription.
Before Using Remodulin
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
Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of treprostinil in children with other age groups.
Geriatric
Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of treprostinil in the elderly with use in other age groups.
Pregnancy
| Pregnancy Category | Explanation | |
|---|---|---|
| All Trimesters | B | Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus. |
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.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
Kidney disease or
Liver disease—Treprostinil effects may increase because of slower removal of medicine from the body
Proper Use of Remodulin
Your doctor or nurse will teach you how to prepare the medicine and use the pump for administering the medicine. Treprostinil must be administered continuously by a portable pump that is operated by a small computer. The medicine will be delivered directly under your skin or into a vein through a catheter.
The instructions for the use of the pump may vary depending on the particular make and model of the pump. Your doctor or nurse will give you detailed instructions on how to use and care for the particular pump and accessories that you will use for administering your medicine.
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.
The amount of medicine that you take depends on the concentration of the medicine and the rate at which the infusion pump delivers the medicine.
For injection dosage form:
For pulmonary arterial hypertension:
Adults—Initially, 1.25 nanograms per kilogram (kg) (0.6 nanogram per pound) of body weight per minute. Your doctor may increase or decrease your dose as necessary. Your doctor may also need to use another similar medicine called epoprostenol (e.g., Flolan) to help treat your pulmonary arterial hypertension.
Children—Use and dose must be determined by your doctor.
Missed Dose
Call your doctor or pharmacist for instructions.
Storage
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
If the medicine has particles in it or is discolored, it should be discarded.
Precautions While Using Remodulin
Treprostinil has to be administered by a continuous subcutaneous (under the skin) or intravenous (into a vein) infusion and it must never be stopped suddenly.
It is important that your doctor check your progress at regular visits. This will allow your doctor to make sure the medicine is working properly and to change the dosage if needed.
Be sure to report any signs of infection or reaction at the catheter site to your doctor. Also, if you develop a sudden fever, contact your doctor as soon as possible.
Avoid the use of saunas, hot baths, or sunbathing, or other situations that may cause blood vessels to dilate, resulting in low blood pressure and increasing the possibility of dizziness, light-headedness, or fainting.
Do not suddenly stop using this medicine. Stopping suddenly may bring on symptoms of your condition and can be dangerous. Check with your doctor before stopping completely.
Your doctor may want you to carry a medical identification card stating that you are using this medicine.
Do not reuse syringes and needles. Put used syringes and needles in a puncture-resistant disposable container, or dispose of them as directed by your health care professional.
Remodulin 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
Edema, such as, swelling
infusion site reaction, such as, accumulation of blood at site of injection; dry, red, hot, or irritated skin; hardening of site of injection
vasodilation, such as, feeling of warmth or heat, flushing or redness of skin, especially on face and neck, feeling faint, dizzy, or light-headed
Less common
Hypotension, such as, blurred vision, confusion, dizziness, faintness, lightheadedness when getting up from a lying or sitting position, sudden sweating, unusual tiredness or weakness
Symptoms of Overdose
Get emergency help immediately if any of the following symptoms of overdose occur:
Diarrhea
flushing, such as, feeling of warmth and redness of the face, neck, arms, and occasionally, upper chest
headache
hypotension, such as, blurred vision, confusion, dizziness, faintness, lightheadedness when getting up from a lying or sitting position, sudden sweating, unusual tiredness or weakness
nausea and vomiting
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:
More common
Diarrhea
dizziness
headache
infusion site pain
jaw pain
nausea
pruritus, such as itching skin
rash
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.