Remodulin

Remodulin is a prostacyclin analogue which is given by injections to treat individuals with pulmonary arterial hypertension (high blood pressure in the arteries supplying to the lungs from the heart).

Treprostinil causes dilatation of the blood vessels that supply to the lungs, thereby reducing the workload on the heart. This prescription-only product is available as Solution form.

Before using Remodulin, you must know all about the risks and complications associated with it. Together with your doctor, you can decide whether the medication will do you more goods than the harms.

Here are some factors to be considered before deciding to use this medicine:

Allergies: Inform your doctor about the allergies you have, such as to this medication, other medications, or to foods, dyes, or preservatives.

Pediatric: Safety and efficacy of this medicine in children 16 years or younger have not been well documented.

Geriatric: It may be used in elderly after adjusting the doses.

Pregnancy: It falls under pregnancy category C for all trimesters, meaning that due to lack of sufficient studies, it’s not clear if this medication is safe for use in pregnancy.

Breastfeeding: Use only after assessing risks and benefits of the use.

Drug Interactions: Taking two medicines together can be harmful due to possible interactions. In other cases, even if there is a possible interaction between two medicines your doctor may advise you to take them together after adjusting the dose or issuing precautions.

Though usually not recommended, your doctor may decide, after adjusting dose or frequency of one or both medicines, to use this medicine with any of the following medicines:

• Alipogene Tiparvovec
• Recombinant alteplase
• Anagrelide
• Apixaban
• Ardeparin
• Aspirin
• Bivalirudin
• Certoparin
• Dabigatran
• Etexilate
• Dalteparin
• Danaparoid
• Desirudin
• Dipyridamole
• Edoxaban
• Enoxaparin
• Eptifibatide
• Fluoxetine
• Fondaparinux
• Heparin
• Lepirudin
• Levomilnacipran
• Nadroparin
• Parnaparin
• Phenindione
• Phenprocoumon
• Pixantrone
• Protein C
• Reviparin
• Tinzaparin
• Vilazodone
• Vortioxetine
• Warfarin

Other Interactions: Taking your medicine together with certain foods or items such as alcohol or tobacco may cause undesirable interactions. Talk to your doctor to know if using this medicine with food, alcohol, or tobacco is safe.

Inform your doctor about the following conditions, if any:

• Liver problems: Use cautiously.

Proper usage of Remodulin requires strict adherence to your doctor’s orders. The medicine is infused under your skin or into a vein by using a specialized pump. Instructions on the use of the pump are given by a nurse or other trained health professional.

Here are some points to consider:

Use exactly the same amount of the medicine as recommended by your doctor. The instructions for preparation of the medicine and use of the pump are given by your doctor or nurse.

Remodulin is continuously infused using a portable pump. To ensure continuous infusion, you have to clearly understand how to use a particular type or model of the pump.

For subcutaneous (under the skin) infusion, the medicine must be infused through different sites in the body. The sites of infusion should be rotated to prevent injury to a specific part. It’s better to note down the infusion sites.

Make sure you know the authorized person to call in case any problem arises.

A second infusion pump is required when the first pump fails to function. Therefore, maintain a 24-hour backup pump.

If your doctor asks you to use this medicine for years, learn more about the chronic treatment from him/her.

Dosing: For best results, follow your doctor to know what amount of medicine you should take in a single dose. The doses of a medicine can differ according to the conditions for which it is being prescribed.

Remember your doses can differ. Consult your doctor if you have anything to ask.

The doses of treprostinil injections for pulmonary arterial hypertension are:

• Adults: The doses depend on upon your body weight. Starting with 1.25 nanograms (ng) per kilogram (kg) body weight per minute, the doses may be adjusted as needed.
• Children: Your doctor will decide the use and dose.

Missed Dose: If you remember you have missed a dose, consult your doctor or pharmacist for instructions.

Storage:

• Store in a closed container at room temperature.
• Keep away from heat, moisture, and direct light.
• Do not freeze.
• Keep away from children.
• Discard any unused or expired medicines.
• The vial containing this medicine is usable within 30days from the date of opening, when properly stored.
• The syringe used for administering any medicine should be sterile. Therefore, avoid sharing the syringe.
• The filled syringe should be used within 3 days after filling.
• Avoiding repeated use of the syringes and needles.
• Dispose of the used syringes and needles properly.

Before using Remodulin, there are some precautions you must take. Your progress should be regularly monitored to determine if you are responding to the treatment or your doses need to be adjusted.

Call your doctor immediately if you start having a fever or develop any sign indicating an infection or a reaction at the site of infusion. You may feel dizzy while taking this medicine, due to lowered blood pressure.

Do not let your body temperature rise rapidly while taking this medicine. Therefore, it’s better to avoid saunas, hot baths, or sunbathing or intense physical exercises.

Never discontinue this medicine without consulting your doctor beforehand. If suggested by your doctor, take with you a medical identification card indicating your intake of this medicine.

As with many medications, there are several potential side effects associated with Remodulin.

Consult your doctor immediately if you have any of the following side effects:

More common: 

• Collection of blood or toughened skin at the injection site
• Dryness, reddening, warmth or irritation of the skin
• Dizziness or fainting
• Facial flushing
• Swelling

Less common: 

• Blurry vision
• Confusion
• Excessive tiredness or weakness
• Feeling dizzy or fainting when changing position
• Unexpected sweating

Seek emergency medical attention if you have any of the Symptoms of Overdose, including:

• Blurry vision
• Confusion
• Diarrhea
• Excessive tiredness or weakness
• Feeling dizzy or fainting when changing position
• Facial flushing
• Headache
• Nausea and vomiting
• Unexpected sweating

Some non-serious side effects usually go away on their own without requiring medical intervention. You may also ask your doctor to learn more about how you may prevent or reduce the side effects.

Talk to your doctor if the side effects persist or worry you, including:

More common: 

• Diarrhea
• Dizziness
• Headache
• Itchy skin
• Jaw pain
• Nausea
• Pain at infusion site
• Rash

The side effects of the medicine are not limited to the ones listed above. Call your doctor immediately if you experience any side effects that are uncommon or worry you. To report side effects to the FDA, contact at 1-800-FDA-1088.