Remodulin

DRUG DESCRIPTION

Remodulin (treprostinil) Injection is a sterile solution of treprostinil formulated for subcutaneous or intravenous administration. Remodulin (treprostinil sodium) is supplied in 20 mL multidose vials in four strengths, containing 20 mg, 50 mg, 100 mg, or 200 mg (1 mg/mL, 2.5 mg/mL, 5 mg/mL or 10 mg/mL) of treprostinil. Each mL also contains 5.3 mg sodium chloride (except for the 10 mg/mL strength which contains 4.0 mg sodium chloride), 3 mg metacresol, 6.3 mg sodium citrate, and water for injection. Sodium hydroxide and hydrochloric acid may be added to adjust pH between 6.0 and 7.2.

Treprostinil is chemically stable at room temperature and neutral pH.

Treprostinil is (1R,2R,3aS,9aS)-[[2,3,3a,4,9,9a-Hexahydro-2-hydroxy-1-[(3S)-3-hydroxyoctyl]-1Hbenz[f]inden-5-yl]oxy]acetic acid. Treprostinil has a molecular weight of 390.52 and a molecular formula of C23H34O5.

The structural formula of treprostinil is: REMODULIN® (treprostinil) Injection Package Insert

REMODULIN® (treprostinil) Structural Formula Illustration

What are the possible side effects of treprostinil injection (Remodulin)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • new or worsening PAH symptoms such as feeling short of breath (even with mild exertion), tiredness, chest pain, and pale skin;
  • swelling in your hands or feet; or
  • feeling like you might pass out.

Less serious side effects may include:

    ...

Read All Potential Side Effects and See Pictures of Remodulin »

What are the precautions when taking treprostinil sodium (Remodulin)?

Before using treprostinil, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver problems, kidney problems, bleeding problems.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Caution is advised when using this drug in the elderly...

Read All Potential Precautions of Remodulin »


Remodulin Consumer (continued)

SIDE EFFECTS: Nausea, vomiting, diarrhea, headache, dizziness, jaw pain, flushing, or redness/swelling/pain at the injection site may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: new/worsening swelling of the arms/legs, mental/mood changes (e.g., restlessness, nervousness).

To avoid infection, follow your health care professional's instructions for proper handling of this medication. Tell your doctor immediately if you develop any signs of infection (e.g., fever, chills).

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using treprostinil, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver problems, kidney problems, bleeding problems.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Caution is advised when using this drug in the elderly because they may be more sensitive to its effects.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.


Remodulin Patient Information Including Side Effects

Brand Names: Remodulin

Generic Name: treprostinil injection (Pronunciation: tre PROS ti nil)

  • What is treprostinil injection (Remodulin)?
  • What are the possible side effects of treprostinil injection (Remodulin)?
  • What is the most important information I should know about treprostinil injection (Remodulin)?
  • What should I discuss with my healthcare provider before using treprostinil injection (Remodulin)?
  • How is treprostinil injection given (Remodulin)?
  • What happens if I miss a dose (Remodulin)?
  • What happens if I overdose (Remodulin)?
  • What should I avoid while using treprostinil injection (Remodulin)?
  • What other drugs will affect treprostinil injection (Remodulin)?
  • Where can I get more information?

What is treprostinil injection (Remodulin)?

Treprostinil dilates (or widens) the arteries and decrease the amount of blood clotting platelets in your body. These effects lower blood pressure in the pulmonary artery that leads from the heart to the lungs.

Treprostinil is used to treat pulmonary arterial hypertension (PAH). It improves your ability to exercise and prevents your condition from getting worse.

Treprostinil may also be used for other purposes not listed in this medication guide.

What are the possible side effects of treprostinil injection (Remodulin)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • new or worsening PAH symptoms such as feeling short of breath (even with mild exertion), tiredness, chest pain, and pale skin;
  • swelling in your hands or feet; or
  • feeling like you might pass out.

Less serious side effects may include:

  • pain, swelling, redness, bleeding, or a hard lump where your catheter is placed;
  • dizziness;
  • mild skin rash;
  • headache or jaw pain;
  • flushing (warmth, redness or tingling); or
  • diarrhea or nausea.

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 FDA at 1-800-FDA-1088.

What is the most important information I should know about treprostinil injection (Remodulin)?

Before using this medication, tell your doctor if you have low blood pressure, liver or kidney disease, or a bleeding or blood clotting disorder.

Treprostinil is given as an continuous (around-the-clock) injection using an infusion pump. The medicine enters the body through a catheter placed under your skin or into a vein. Your doctor, nurse, or pharmacist will give you specific instructions on how to use an infusion pump and inject your medicine.

Your doctor may want you to be in a hospital when you start using treprostinil. This is so you can be watched for any signs of serious side effects from the medicine.

You will probably have to use this medicine for several months or years to control your condition and keep it from getting worse.

It is important to use treprostinil regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely. Make sure you have a backup infusion pump and infusion sets available so as not to interrupt your treatment if one infusion pump stops working.

Call your doctor if your symptoms do not improve or if they get worse.

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