Promacta

Generic Name: eltrombopag (el TROM boe pag)

What is Promacta?

Promacta is a man-made form of a protein that increases production of platelets (blood-clotting cells) in your body.

Promacta is used to prevent bleeding episodes in people with chronic immune thrombocytopenic purpura (ITP), a bleeding condition caused by a lack of platelets in the blood.

Promacta is usually given after other medications or surgery have been tried without successful treatment of symptoms. This medicine is not a cure for ITP and it will not make your platelet counts normal if you have this condition.

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

Important information about Promacta

Promacta is available only under a special program called PROMACTA Cares You must be enrolled in this program and sign all required agreements in order to take the medication. Read all program brochures and agreements carefully.

Before you take Promacta, tell your doctor if you have liver or kidney disease, cataract, a history of stroke or blood clot, or if you are of Eastern Asian descent. Also tell your doctor about all other medications you use.

Take Promacta on an empty stomach, at least 1 hour before or 2 hours after a meal. Do not take this medication with milk. Avoid all dairy products or products that contain calcium (including fortified fruit juice) for at least 4 hours before or after you take Promacta.

Avoid taking other medications, including antacids or vitamin and mineral supplements, within 4 hours before or after you take Promacta.

Promacta can cause harmful effects on your liver or bone marrow that may result in serious medical problems. To be sure this medication is not causing harmful effects, your blood cells and liver function will need to be tested often. Do not miss any scheduled appointments.

It may take up to 4 weeks of taking this medicine before it is completely effective in preventing bleeding episodes. For best results, keep taking the medication as directed. Talk with your doctor if you have any bruising or bleeding episodes after 4 weeks of treatment.

After you stop taking Promacta, your risk of bleeding may be even higher than it was before you started treatment. Be extra careful to avoid cuts or injury for at least 4 weeks after you stop taking Promacta. Your blood will need to be tested weekly during this time.

Before taking Promacta

If you have certain conditions, you may need a dose adjustment or special tests to safely take Promacta. Before you take this medication, tell your doctor if you have:

liver disease;

kidney disease;

cataract;

a history of stroke or blood clot; or

if you are of Eastern Asian descent.

FDA pregnancy category C. It is not known whether Promacta is harmful to an unborn baby. Before you take this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment

.

Your name may need to be listed on a pregnancy registry if you become pregnant while taking Promacta. The purpose of this registry is to track the outcome of the pregnancy and delivery to evaluate whether Promacta had any effect on the baby

It is not known whether eltrombopag passes into breast milk or if it could harm a nursing baby. Do not take this medication without telling your doctor if you are breast-feeding a baby.

Taking Promacta may increase your risk of developing blood cancers, especially if you have myelodysplastic syndrome (also called “preleukemia”). Talk with your doctor if you have concerns about this risk.

How should I take Promacta?

Promacta is available only under a special program called PROMACTA Cares You must be enrolled in this program and sign all required agreements in order to take the medication. Read all program brochures and agreements carefully.

Take this medication exactly as prescribed by your doctor. Do not take it in larger amounts or for longer than recommended. Follow the directions on your prescription label.

Your doctor may occasionally change your dose to make sure you get the best results from this medication.

Take Promacta on an empty stomach, at least 1 hour before or 2 hours after a meal. Do not take this medication with milk. Avoid all dairy products or products that contain calcium (including fortified fruit juice) for at least 4 hours before or after you take Promacta. Taking this medication long-term can cause harmful effects on your bone marrow that may result in serious blood cell disorders.

To be sure this medication is not causing harmful effects, your blood cells and liver function will need to be tested often. Your eyes may also need to be checked for signs of cataract formation. Do not miss any scheduled appointments.

It may take up to 4 weeks of taking this medicine before it is completely effective in preventing bleeding episodes. For best results, keep taking the medication as directed. Talk with your doctor if you have any bruising or bleeding episodes after 4 weeks of treatment.

After you stop taking Promacta, your risk of bleeding may be even higher than it was before you started treatment. Be extra careful to avoid cuts or injury for at least 4 weeks after you stop taking Promacta. Your blood will need to be tested weekly during this time.

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your Promacta injection.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose can cause slow heart rate, skin rash, or signs of a blood clot such as sudden numbness or weakness, sudden headache or confusion, problems with vision or speech, loss of balance, chest pain, sudden cough, and pain or swelling in one or both legs.

What should I avoid while taking Promacta?

Avoid taking other medications, including antacids or vitamin and mineral supplements, within 4 hours before or after you take Promacta.

Promacta side effects

Get emergency medical help if you have any of these signs of an allergic reaction to Promacta: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop taking this medication and call your doctor at once if you have a serious side effect such as:

nausea, pain in your upper stomach, low fever, loss of appetite;

dark urine, clay-colored stools;

jaundice (yellowing of the skin or eyes); or

blurred vision, eye pain, or seeing halos around lights.

Less Promacta serious side effects may include:

mild nausea, vomiting;

muscle pain;

numbness or tingly feeling;

redness of the eyes;

heavy vaginal bleeding; or

upset stomach.

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.

What other drugs will affect Promacta?

The following drugs can interact with Promacta. Tell your doctor if you are using any of these:

acyclovir (Zovirax);

antacids;

atazanavir (Reyataz);

birth control pills;

cimetidine (Tagamet);

famotidine (Pepcid);

fluvoxamine (Luvox);

gemfibrozil (Lopid);

methotrexate (Rheumatrex, Trexall);

rifampin (Rifadin, Rifater, Rifamate);

ticlopidine (Ticlid);

trimethoprim (Proloprim, Bactrim, Septra);

zileuton (Zyflo);

an antibiotic such as ciprofloxacin (Cipro), ofloxacin (Floxin), levofloxacin (Levaquin), lomefloxacin (Maxaquin), and others;

cholesterol-lowering medicines such as atorvastatin (Lipitor), fluvastatin (Lescol), or rosuvastatin (Crestor);

diabetes medication you take by mouth, such as nateglinide (Starlix), pioglitazone (Actos), repaglinide (Prandin), rosiglitazone (Avandia); or

heart rhythm medication such as amiodarone (Cordarone, Pacerone), mexiletine (Mexitil), propafenone (Rythmol), verapamil (Calan, Covera, Isoptin).

This list is not complete and there may be other drugs that can interact with Promacta. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.