Flolan

Flolan is a prescription medication used to pulmonary arterial hypertension in patients who have already been treated with other medicines that did not work well. Pulmonary hypertension is high blood pressure that occurs in the main artery that carries blood from the right side of the heart (the ventricle) to the lungs. When the smaller blood vessels in the lungs become more resistant to blood flow, the right ventricle must work harder to pump enough blood through the lungs.

Flolan belongs to a group of drugs called vasodilators, which help to relax the blood vessels within and around the lungs. This helps increase your ability to breathe, especially during exercise. It also acts as an anticoagulant, which decreases the chance of a blood clot.

This medication is available in an injectable form to be given directly into a vein (IV) by a healthcare professional. After starting Flolan in a clinical setting, you may be allowed to administer Flolan to yourself through a portable infusion pump. You must learn proper technique and have a backup pump available.

Common side effects include flushing, headache, nausea, and vomiting. Flolan can also cause dizziness. Do not drive or operate heavy machinery until you know how Flolan affects you.

Flolan is a prescription medication used to pulmonary arterial hypertension (high blood pressure in the lungs.)

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Glaxo SmithKline Pharmaceuticals

Serious side effects have been reported with Flolan. See the “Flolan Precautions” section.

Common side effects of Flolan include the following:

• dizziness
• flushing
• jaw pain
• headache
• musculoskeletal pain
• nausea
• vomiting

This is not a complete list of Flolan side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

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

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• diuretics such as acetazolamide (Diamox), amiloride (Midamor), bumetanide (Bumex), chlorothiazide (Diuril), chlorthalidone (Thalitone), ethacrynic acid (Edecrin), furosemide (Lasix), hydrochlorothiazide (Microzide, HCTZ), metolazone (Zaroxolyn), torsemide (Demadex), and triamterene (Dyrenium, Dyazide, Maxzide)
• medications to lower blood pressure including angiotensin-converting enzyme (ACE) inhibitors such as benazepril (Lotensin, Lotensin HCT), captopril (Capoten, Capozide), enalapril (Vasotec, Vaseretic), fosinopril (Monopril, Monopril HCT), lisinopril (Prinivil, Prinzide, Zestril, Zestoretic), moexipril (Univasc, Uniretic), quinapril (Accupril, Accuretic, Quinaretic), ramipril (Altace), and trandolapril (Mavik, Tarka); angiotensin receptor II blockers such as azilsartan (Edarbi), candesartan (Atacand), irbesartan (Avapro), losartan (Cozaar), olmesartan (Benicar), telmisartan (Micardis, Twynsta), valsartan (Diovan); beta blockers such as metoprolol (Toprol XL, Lopressor), carvedilol (Coreg), bisoprolol (Zebeta), betaxolol (Kerlone), nebivolol (Bystolic), and propranolol (Inderal); and calcium channel blockers such as nifedipine (Adalat, Nifedical, Procardia), amlodipine (Norvasc), verapamil (Calan, Isoptin, Covera, Verelan), and diltiazem (Cardizem)
• vasodilators such as doxazosin (Cardura), prazosin (Minipress), terazosin (Hytrin), clonidine (Catapres), hydralazine (Bidil, Hydra-Zide), and minoxidil
• antiplatelets (a type of blood thinner) such as clopidogrel (Plavix), aspirin, prasugrel (Effient), ticagrelor (Brilinta), ticlopidine (Ticlid), abciximab (ReoPro), eptifibatide (Integrilin), tirofiban (Aggrastat), and cilostazol (Pletal)
• anticoagulant (blood thinner) medications such as warfarin (Coumadin, Jantoven), heparin, enoxaparin (Lovenox), fondaparinux (Arixtra), rivaroxaban (Xarelto), and apixaban (Eliquis)

This is not a complete list of Flolan drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Flolan including the following:

• Pulmonary edema. Tell your healthcare provider right away if you have some or all of the following symptoms of pulmonary edema:
  • mild shortness of breath with exercise
  • cough
  • waking up feeling short of breath
  • having trouble lying flat in bed
• Rebound pulmonary hypertension. If Flolan is suddenly stopped or the dose is reduced drastically, you may experience pulmonary hypertension. Tell your healthcare provider right away if you have some or all of the following symptoms of rebound hypertension:
  • shortness of breath
  • dizziness
  • weakness or fatigue

Flolan can cause dizziness. Do not drive or operate heavy machinery until you know how Flolan affects you.

Do not take Flolan if you:

• are allergic to Flolan or to any of its ingredients
• have heart failure caused by reduced left ventricular ejection fraction

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Flolan, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Flolan, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Flolan or to any of its ingredients
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X – are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Flolan falls into category B. There are no well-done studies that have been done in humans with Flolan. In animal studies, pregnant animals were given this medication, and the babies did not show any medical issues related to this medication.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Flolan crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Flolan.

Take Flolan exactly as prescribed.

This medication is available in an injectable form to be given directly into a vein (IV) by a healthcare professional. After starting Flolan in a clinical setting, you may be allowed to administer Flolan to yourself through a portable infusion pump. You must learn proper technique and have a backup pump available.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Flolan at the same time.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight

Flolan should be initiated at a dose of 2 ng/kg/min administered by IV infusion. Patient response should be assessed every 15 minutes. The recommended dose range is 2 to 16 ng/kg/min.

If you take too much Flolan, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If Flolan is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Store Flolan powder at room temperature.
• Protect Flolan powder from light.
• Store the Flolan diluent at room temperature. Diluent is for one-time use; discard any unused diluent.
• Once Flolan is mixed with the diluent, use immediately or store in the refrigerator for up to 40 hours.
• Keep this and all medicines out of the reach of children.