What is Promacta?

Eltrombopag is a man-made form of a protein that increases production of platelets (blood-clotting cells) in your body.
Eltrombopag 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.
Eltrombopag is usually given after other medications or surgery have been tried without successful treatment of symptoms.
Eltrombopag is not a cure for ITP and it will not make your platelet counts normal if you have this condition.
Eltrombopag may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Promacta?

Eltrombopag 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 eltrombopag, 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 eltrombopag 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 eltrombopag.
Avoid taking other medications, including antacids or vitamin and mineral supplements, within 4 hours before or after you take eltrombopag.
Eltrombopag 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 and liver function will need to be tested often. Visit your doctor regularly.
There are many other drugs that can interact with eltrombopag. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.
After you stop taking eltrombopag, 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 eltrombopag. Your blood will need to be tested weekly during this time.

What should I discuss with my healthcare provider before taking Promacta?

If you have any of these conditions, you may need a dose adjustment or special tests:

• liver disease
• kidney disease
• a bleeding or blood clotting disorder
• a blood cancer or bone marrow disorder
• if you have ever had cataracts or a blood clot
• if your spleen has been removed; or
• if you are of Eastern Asian descent

FDA pregnancy category C. It is not known whether eltrombopag will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.
If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of eltrombopag 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 eltrombopag 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.

Promacta Side Effects

What are the possible side effects of Promacta?
Get emergency medical help if you have any of these signs of an allergic reaction: 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)
* easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin; or
* blurred vision, eye pain, or seeing halos around lights
Less serious side effects may include:
* mild nausea, vomiting, upset stomach
* muscle pain
* numbness or tingly feeling
* redness of the eyes; or
* heavy vaginal bleeding
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 affect Promacta?

Many drugs can interact with eltrombopag. Below is just a partial list. Tell your doctor if you are using:

• acetaminophen (Tylenol)
• acyclovir (Zovirax)
• atazanavir (Reyataz)
• birth control pills
• fluvoxamine (Luvox)
• methotrexate (Rheumatrex, Trexall)
• penicillin G (Pfizerpen)
• 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), gemfibrozil (Lopid), pravastatin (Pravachol), or rosuvastatin (Crestor)
• diabetes medication you take by mouth, such as nateglinide (Starlix), pioglitazone (Actos), repaglinide (Prandin), rosiglitazone (Avandia)
• heart rhythm medication such as amiodarone (Cordarone, Pacerone), mexiletine (Mexitil), propafenone (Rythmol), verapamil (Calan, Covera, Isoptin)
• narcotic pain medication such as fentanyl (Actiq, Duragesic), hydrocodone (Lortab, Vicodin, Vicoprofen), oxycodone (OxyContin, Endocet, Percocet), and others
• an NSAID (non-steroidal anti-inflammatory drug) such as ibuprofen (Motrin, Advil), diclofenac (Cataflam, Voltaren), etodolac (Lodine), indomethacin (Indocin), meloxicam (Mobic), nabumetone (Relafen), naproxen (Aleve, Naprosyn), piroxicam (Feldene), and others; or
• stomach acid reducers such as cimetidine (Tagamet), esomeprazole (Nexium), famotidine (Pepcid), omeprazole (Prilosec)

This list is not complete and there are many other drugs that can interact with eltrombopag. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.

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 eltrombopag.

Promacta Dosage

How should I take Promacta?
Eltrombopag 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 exactly as prescribed by your doctor. Do not take in larger or smaller 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.
Take eltrombopag 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 eltrombopag.
Taking eltrombopag 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 and liver function will need to be tested often. Your eyes may also need to be checked for signs of cataract formation. Visit your doctor regularly.
It may take up to 4 weeks of taking this medicine before it is completely effective in preventing bleeding episodes. Keep taking the medication as directed and tell your doctor if you have any bruising or bleeding episodes after 4 weeks of treatment.
Store at room temperature away from moisture and heat.
After you stop taking eltrombopag, 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 eltrombopag. Your blood will need to be tested weekly during this time.
What happens if I overdose on Promacta?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
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 happens if I miss a dose of Promacta?
Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.