treprostinil injection

Generic Name: treprostinil (injection) (tre PROS ti nil)
Brand Name: Remodulin

What is treprostinil injection?

Treprostinil dilates (widens) the arteries and decreases 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). This medicine improves your ability to exercise and can help prevent your condition from getting worse.

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

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

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Slideshow: Can Prescription Drugs Lead to Weight Gain?

What should I discuss with my healthcare provider before using treprostinil injection?

You should not use treprostinil if you are allergic to it.

To make sure treprostinil is safe for you, tell your doctor if you have:

  • kidney disease;

  • liver disease;

  • if you are using epoprostenol (Flolan); or

  • if you take medicine to treat high blood pressure (hypertension).

FDA pregnancy category B. Treprostinil is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether treprostinil passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

How is treprostinil injection given?

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Your doctor may want to give your first dose of this medicine in a hospital or clinic setting to quickly treat any serious side effects that occur.

Treprostinil is injected under the skin (subcutaneous), or directly into a vein (intravenous). The medicine enters the body through a catheter placed under your skin or into a vein.

Treprostinil is given as a continuous (around-the-clock) injection using an infusion pump. Your healthcare provider will give you specific instructions on how to use an infusion pump. Do not self-inject this medicine if you do not understand how to give the injection and properly dispose of used needles, IV tubing, and other items used to inject the medicine.

When given as an intravenous injection, treprostinil must be mixed with a liquid (diluent) before using it. If you are using the injections at home, be sure you understand how to properly mix and store the medicine.

Do not use treprostinil if it has changed colors or has particles in it. Call your pharmacist for new medication.

Use a disposable needle only once. Follow any state or local laws about throwing away used needles and syringes. Use a puncture-proof "sharps" disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets.

A central intravenous catheter may increase your risk of a serious infection called sepsis. If you use intravenous treprostinil, watch for symptoms such as: fever, flu symptoms, mouth and throat ulcers, rapid heart rate, or rapid and shallow breathing. Call your doctor right away if you have any of these conditions.

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

You should not reduce your dose or stop using treprostinil suddenly. Stopping suddenly may make your condition worse.

Call your doctor if you have new or worsening PAH symptoms such as feeling short of breath (even with mild exertion), tiredness, chest pain, and pale skin.

Store unopened vials (bottles) of treprostinil at room temperature away from moisture and heat. After the medicine has been placed into a syringe or pump, it should be given within 72 hours. If the medicine has been diluted (mixed with a liquid), you must use the medicine within 48 hours after mixing.

What happens if I miss a dose?

Call your doctor for instructions if you miss a dose of treprostinil.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include severe tingling or warmth under your skin, diarrhea, vomiting, or fainting.

What should I avoid while using treprostinil injection?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Treprostinil injection side effects

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

Call your doctor at once if you have:

  • pain, swelling, redness, bleeding, or a hard lump where your catheter is placed;

  • swelling in your hands or feet; or

  • a light-headed feeling, like you might pass out.

Common side effects may include:

  • mild irritation or swelling around the catheter;

  • headache or jaw pain;

  • dizziness;

  • diarrhea, nausea;

  • itching; or

  • flushing (warmth, redness or tingling).

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.

See also: Side effects (in more detail)

Treprostinil injection dosing information

Usual Adult Dose for Pulmonary Hypertension:

Oral formulation:
Initial dose: 0.25 mg orally every 12 hours with food
Recommended titration: 0.25 or 0.5 mg 2 times daily every 3 to 4 days (if 0.25 mg 2 times daily increments are not tolerated consider titrating slower)
-The total daily dose can be divided and given every 8 hours with food, titrating by increments of 0.125 mg 3 times daily.
Mean dose: 3.5 mg orally every 12 hours with food.
Maximum dose: Determined by tolerability. The maximum dose studied was 21 mg orally every 12 hours with food.

Infusion:
Initial dose: 1.25 nanogram/kg per minute by continuous infusion. The subcutaneous route is preferred but the drug may be administered by a central intravenous line if the subcutaneous route is not tolerated. The rate may be decreased to 0.625 nanogram/kg/minute if the initial dose is not tolerated by the patient.
Maintenance dose: The infusion rate may be increased in increments of no more than 1.25 nanogram/kg/minute per week for the first 4 weeks, and thereafter by no more than 2.5 nanograms/kg/minute per week. Dosage adjustments should be titrated to a dose where PAH symptoms are improved and adverse effects are minimized (headache, nausea, emesis, restlessness, anxiety, and infusion site pain or reaction). Although doses of up to 100 nanograms/kg/minute have been reported, there is little experience with doses greater than 40 nanograms/kg/minute.

Inhalation:
Use only with the Tyvaso (R) Inhalation System. Administer undiluted, as supplied. A single breath of Tyvaso (R) delivers approximately 6 mcg of treprostinil
Initial dosage: 3 breaths [18 mcg] per treatment session. If 3 breaths are not tolerated, reduce to 1 or 2 breaths. Administer in 4 separate treatment sessions each day approximately four hours apart, during waking hours.
Maintenance dose: Dosage should be increased by an additional 3 breaths at approximately 1-2 week intervals, if tolerated. Titrate to target maintenance dosage of 9 breaths or 54 mcg per treatment session as tolerated.

Usual Pediatric Dose for Pulmonary Hypertension:

Oral formulation: Safety and effectiveness have not been established in pediatric patients (less than 18 years of age).

Inhalation:
Less than 16 years: Safety and efficacy have not been established.
16 to 18 years:
Initial dose: 1.25 nanogram/kg per minute by continuous infusion. The subcutaneous route is preferred but the drug may be administered by a central intravenous line if the subcutaneous route is not tolerated. The rate may be decreased to 0.625 nanogram/kg/minute if the initial dose is not tolerated by the patient.
Maintenance dose: The infusion rate may be increased in increments of no more than 1.25 nanogram/kg/minute per week for the first 4 weeks, and thereafter by no more than 2.5 nanograms/kg/minute per week. Dosage adjustments should be titrated to a dose where PAH symptoms are improved and adverse effects are minimized (headache, nausea, emesis, restlessness, anxiety, and infusion site pain or reaction). There is little experience with doses greater than 40 nanograms/kg/minute.

What other drugs will affect treprostinil injection?

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with treprostinil, especially medicine used to prevent blood clots, such as:

  • dalteparin;

  • enoxaparin;

  • fondaparinux; or

  • tinzaparin.

This list is not complete. Other drugs may interact with treprostinil, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Where can I get more information?

  • Your doctor or pharmacist can provide more information about treprostinil injection.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 3.01. Revision Date: 2014-02-13, 8:37:49 PM.

Hide
(web1)