Remodulin

What is Remodulin?

Remodulin is a prescription medication that is used to treat high blood pressure in the lungs.

Description

Remodulin (treprostinil) Injection is a sterile solution of treprostinil, a prostacyclin mimetic, formulated for subcutaneous or intravenous administration. Remodulin is supplied in 20-mL multidose vials in five strengths, containing 20 mg, 50 mg, 100 mg, 200 mg, or 400 mg (1 mg/mL, 2.5 mg/mL, 5 mg/mL, 10 mg/mL, or 20 mg/mL) of treprostinil. Each mL also contains 5.3 mg sodium chloride (except for the 10 mg/mL and 20 mg/mL strengths, which contain 4.0 mg sodium chloride), 3 mg metacresol, 6.3 mg sodium citrate dihydrate, 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]-1H-benz[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:

Sterile Diluent for Remodulin is a high-pH (pH~10.4) glycine diluent supplied in a 50-mL vial containing 50 mL of Sterile Diluent for Remodulin. Each vial contains 94 mg glycine, 73.3 mg sodium chloride, sodium hydroxide (to adjust pH), and water for injection.

Mechanism of Action

The major pharmacologic actions of treprostinil are direct vasodilation of pulmonary and systemic arterial vascular beds, and inhibition of platelet aggregation.

Before taking Remodulin, tell your doctor:

• If you are allergic to Remodulin; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have liver disease.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Remodulin with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Remodulin?

• Tell all of your health care providers that you take Remodulin. This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how Remodulin affects you.
• To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down stairs.
• You may bleed more easily. Be careful and avoid injury. Use a soft toothbrush and an electric razor.
• Do not stop taking Remodulin all of a sudden without calling your doctor. Signs of high pressure in the lungs like shortness of breath, dizziness, or weakness may get worse. Talk with your doctor.
• People who get Remodulin in a vein may have a higher risk of a very bad infection. These kinds of infections may be deadly. Talk with your doctor.
• If you are having signs of withdrawal or if you think that the pump is not working, get medical help right away.
• Always have a backup system close by in case you need to use it.
• If you are 65 or older, use Remodulin with care. You could have more side effects.
• Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.

How is Remodulin best taken?

Use Remodulin as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given into the vein or the fatty part of the skin nonstop.
• Your doctor may teach you how to give Remodulin.
• Wash your hands before and after use.
• You may need to mix Remodulin with another fluid before you use it. If you do, be sure you know the right kind of fluid to use. Talk with the doctor or pharmacist if you are not sure.
• Do not use if the solution is cloudy, leaking, or has particles.
• Do not use if the solution changes color.
• Throw away needles in a needle/sharp disposal box. Do not reuse needles or other items. When the box is full, follow all local rules for getting rid of it. Talk with a doctor or pharmacist if you have any questions.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

What are the side effects of Remodulin that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of bleeding like throwing up or coughing up blood; vomit that looks like coffee grounds; blood in the urine; black, red, or tarry stools; bleeding from the gums; abnormal vaginal bleeding; bruises without a cause or that get bigger; or bleeding you cannot stop.
• Very bad dizziness or passing out.
• Shortness of breath, a big weight gain, or swelling in the arms or legs.
• Trouble breathing that is new or worse.
• A burning, numbness, or tingling feeling that is not normal.
• Pain and irritation where Remodulin goes into the body.

What are some other side effects of Remodulin?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Dizziness or headache.
• Flushing.
• Jaw pain.
• Diarrhea.
• Upset stomach or throwing up.
• Irritation where the shot is given.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How supplied/store

Remodulin is supplied in 20-mL multidose vials as sterile solutions in water for injection, individually packaged in cartons. Unopened vials of Remodulin are stable until the date indicated when stored at 25°C (77°F), with excursions permitted to 2-30°C (36-86°F). A single vial of Remodulin should be used for no more than 30 days after the initial introduction into the vial.

Remodulin Injection is supplied as:

Label

1 MG/ML VIAL CARTON

• REMODULIN®
  (treprostinil) Injection
• 20 mg/20 mL
  (1 mg/mL)
• For Subcutaneous or
  Intravenous Infusion Only
• 20 mL multidose vial
• United
  Therapeutics
  CORPORATION

2.5 MG/ML VIAL CARTON

• REMODULIN®
  (treprostinil) Injection
• 50 mg/20 mL
  (2.5 mg/mL)
• For Subcutaneous or
  Intravenous Infusion Only
• 20 mL multidose vial
• United
  Therapeutics
  CORPORATION

5 MG/ML VIAL CARTON

• REMODULIN®
  (treprostinil) Injection
• 100 mg/20 mL
  (5 mg/mL)
• For Subcutaneous or
  Intravenous Infusion Only
• 20 mL multidose vial
• United
  Therapeutics
  CORPORATION

10 MG/ML VIAL CARTON

• REMODULIN®
  (treprostinil) Injection
• 200 mg/20 mL
  (10 mg/mL)
• For Subcutaneous or
  Intravenous Infusion Only
• 20 mL multidose vial
• United
  Therapeutics
  CORPORATION

20 MG/ML VIAL CARTON

• REMODULIN®
  (treprostinil) Injection
• 400 mg/20 mL
  (20 mg/mL)
• For Subcutaneous or
  Intravenous Infusion Only
• 20 mL multidose vial
• United
  Therapeutics
  CORPORATION

50 ML VIAL BOX

• NDC 66302-150-50
• STERILE DILUENT
  FOR REMODULIN®
• 1 x 50 mL
  VIAL
• Contains drug diluent for use only
  with intravenous infusion of
  REMODULIN® (treprostinil) Injection
• Each vial contains 94 mg glycine,
  73.3 mg sodium chloride, sodium
  hydroxide (added to adjust pH), and
  Water for Injection.
• For dilution information see package
  insert for REMODULIN® (treprostinil)
  Injection.
• Store at 20 – 25°C (68 – 77°F), excursions
  permitted to 15 – 30°C (59 – 86°F)
  [See USP Controlled Room Temperature].