Remodulin

Generic Name: treprostinil (Injection route)

tre-PROS-ti-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 injection is used to treat the symptoms of pulmonary arterial hypertension. This is 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.

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Treprostinil belongs to the group of agents called prostaglandins. Prostaglandins occur naturally in the body and are involved in many biological functions. Treprostinil works by relaxing blood vessels and increasing the supply of blood to the lungs, which reduces 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

Appropriate studies have not been performed on the relationship of age to the effects of treprostinil injection in children 16 years of age and younger. Safety and efficacy have not been established.

Geriatric

Appropriate studies have not been performed on the relationship of age to the effects of treprostinil injection in the geriatric population. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require an adjustment in the dose for patients receiving treprostinil.

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. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Alipogene Tiparvovec
  • Alteplase, Recombinant
  • Apixaban
  • Aspirin
  • Dipyridamole
  • Eptifibatide
  • Fluoxetine
  • Levomilnacipran
  • Pixantrone
  • Vortioxetine

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:

  • Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of Remodulin

A nurse or other trained health professional will teach you or a caregiver how to give this medicine. The medicine is given as an infusion through a catheter that is placed directly under your skin or into a vein. Do not use more medicine than your doctor tells you to.

Your doctor or nurse will teach you how to prepare the medicine and how to use the pump for the infusion. Treprostinil must be given continuously by a portable pump. The instructions for the pump may vary depending on the particular make and model. You will be given detailed instructions on how to use and care for your pump and accessories. Make sure you understand all of the instructions before giving yourself an infusion.

If you are receiving the medicine under your skin, you will be shown the body areas where the infusion can be given. Use a different body area each time you start an infusion. Keep track of where you give each infusion to make sure you rotate body areas.

Ask your doctor who to call if you have any problems with the infusion pump. You may be given a second infusion pump to have in case the first pump stops working. Make sure you have access to this pump as a backup at all times.

You will need to continue using this medicine for a long period of time, possibly for many years. Talk with your doctor if you have any concerns about this.

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.

  • For injection dosage form (solution):
    • For pulmonary arterial hypertension:
      • Adults—Dose is based on body weight and must be determined by your doctor. The initial dose is usually 1.25 nanograms (ng) per kilogram (kg) of body weight per minute. Your doctor may increase or decrease your dose as needed.
      • Children—Use and dose must be determined by your doctor.

Missed Dose

Call your doctor or pharmacist for instructions.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine vial (glass container) in the original carton at room temperature. Keep the carton away from heat, moisture, and direct light. Do not freeze.

Look at the liquid in the vial. If the liquid has particles or specks in it or if the liquid has changed color, do not use the vial.

After you open the vial and use your first dose, the medicine will keep for up to 30 days at room temperature. You will use a syringe to take medicine from the vial and insert the syringe into the pump. The medicine in the syringe can be used for up to 72 hours.

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.

Precautions While Using Remodulin

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 dose if needed.

Report any signs of an infection or reaction at the catheter site to your doctor right away. Also, if you develop a sudden fever, contact your doctor as soon as possible.

This medicine may cause your blood pressure to decrease, which can cause dizziness, lightheadedness, or fainting. Avoid getting overheated during exercise or hot weather while you are using this medicine. Saunas, hot baths, or sunbathing may make you feel dizzy or faint if you get overheated.

Do not suddenly stop using this medicine. Stopping the medicine suddenly may bring on symptoms of your condition and can be dangerous. Check with your doctor before stopping it completely.

Your doctor may want you to carry a medical identification card stating that you are using this medicine.

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
  • Accumulation of blood at the site of injection
  • dry, red, hot, or irritated skin
  • feeling faint, dizzy, or lightheaded
  • feeling of warmth or heat
  • flushing or redness of the skin, especially on face and neck
  • hardening of the skin at the site of injection
  • swelling
Less common
  • Blurred vision
  • confusion
  • dizziness, faintness, lightheadedness when getting up suddenly from a lying or sitting position
  • sudden sweating
  • unusual tiredness or weakness

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose
  • Blurred vision
  • confusion
  • diarrhea
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • feeling of warmth and redness of the face, neck, arms, and occasionally, upper chest
  • headache
  • nausea and vomiting
  • sudden sweating
  • unusual tiredness or weakness

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
  • itching skin
  • jaw pain
  • nausea
  • 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.

See also: Side effects (in more detail)

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