Orenitram

Generic name: treprostinil (oral)
Drug class: Agents for pulmonary hypertension

Medically reviewed by A Ras MD.

What is Orenitram used for?

Orenitram is a prescription medicine that is used to treat high blood pressure in the lungs.

Description

Orenitram is an extended-release osmotic tablet for oral administration. Orenitram is formulated as the diolamine salt of treprostinil, a tricyclic benzindene analogue of prostacyclin. The chemical name is Acetic acid, 2-[[(1R,2R,3aS,9aS)-2,3,3a,4,9,9a-hexahydro-2-hydroxy-1-[(3S)-3-hydroxyoctyl]-1H-benz[f]inden-5-yl]oxy]-, complexed with 2,2′-iminobis[ethanol] (1:1). The molecular formula is C23H34O5.C4H11NO2, the molecular weight is 495.65, and it has the following structural formula:

Orenitram tablets are formulated in five strengths, which contain 0.125 mg of treprostinil (equivalent to 0.159 mg treprostinil diolamine), 0.25 mg of treprostinil (equivalent to 0.317 mg treprostinil diolamine), 1 mg of treprostinil (equivalent to 1.27 mg treprostinil diolamine), 2.5 mg of treprostinil (equivalent to 3.17 mg treprostinil diolamine), or 5 mg of treprostinil (equivalent to 6.35 mg treprostinil diolamine). The formulations also contain xylitol, maltodextrin, sodium lauryl sulfate, magnesium stearate, cellulose acetate, triethyl citrate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, and talc. In addition, tablets may contain colorants FD&C Blue #2, iron oxide yellow, and iron oxide red. The imprint ink contains shellac glaze, ethanol, isopropyl alcohol USP, iron oxide black, n-butyl alcohol, and propylene glycol.

Orenitram is designed to release treprostinil at a near zero-order rate using an osmotic tablet technology. The tablet core is coated with a semi-permeable membrane and has a laser-drilled aperture through the membrane. Upon contact with water (e.g., after ingestion), the core tablet absorbs water through the semi-permeable membrane. The water dissolves the water-soluble treprostinil diolamine and the water-soluble osmotic excipients, which creates hydrostatic pressure within the membrane, eventually forcing the drug across the membrane at a controlled rate.

Mechanism of Action

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

Before taking Orenitram, tell your doctor:

If you are allergic to Orenitram; 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 Orenitram 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 Orenitram?

Tell all of your health care providers that you take Orenitram. 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 Orenitram 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 Orenitram 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.
The tablet shell does not dissolve. If you have a certain bowel problem (diverticulosis), this may be a problem. Talk with your doctor.
If you are 65 or older, use Orenitram 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 Orenitram best taken?

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

Take Orenitram with food.
Do not swallow whole. Do not chew, break, or crush.
Do not take chipped or broken tablets.

What do I do if I miss a dose?

Take a missed dose as soon as you think about it, with food.
If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
Do not take 2 doses at the same time or extra doses.
If you miss 2 doses, call your doctor.

What are the side effects of Orenitram 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.
Signs of low potassium levels like muscle pain or weakness, muscle cramps, or a heartbeat that does not feel normal.

What are some other side effects of Orenitram?

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.
Pain in arms or legs.
Stomach pain.
You may see the tablet shell in your stool. This is normal and not a cause for concern.

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 do I store and/or throw out Orenitram?

Store at room temperature in a dry place. Do not store in a bathroom.
Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Label

PRINCIPAL DISPLAY PANEL – 0.125 MG TABLET BLISTER PACK CARTON

Orenitram®
(treprostinil)
EXTENDED-RELEASE TABLETS
0.125 mg
per tablet
Swallow whole.
Do not split, chew,
crush, or break tablets.
10 Tablets
(1 x 10 tablet blister pack)
Pharmacist:
Dispense the accompanying Patient
Information Leaflet to each patient.
Rx Only
NDC 66302-300-02