Revolade

The recommended starting dose of Revolade (Eltrombopag) for adults and children over 6 years of age, for the treatment of ITP is 50 mg taken once daily. Depending on your platelet counts after 2 to 3 weeks, your doctor may increase your dose to a maximum of 75 mg daily.

Children between the ages of 1 and 6 years of age should be given a starting dose of 25 mg taken by mouth once daily, only if they are able to swallow tablets whole. The tablets should not be crushed and mixed with water.

The starting dose for people with chronic hepatitis C is 25 mg taken once daily. This dose may be increased every 2 weeks to a maximum of 100 mg once daily.

The starting dose for people with SAA is 50 mg taken once daily. This dose may be increased every 2 weeks to a maximum of 150 mg once daily.

Revolade (Eltrombopag) tablets should be swallowed whole with water. Do not crush or chew the tablets, or crush the tablets to mix in water. Revolade (Eltrombopag) should be taken at least 2 hours before or 4 hours after antacids, dairy products, mineral supplements or any other products containing aluminum, calcium, iron, magnesium, selenium and zinc. It may be taken with food that contains very little or no calcium.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important that Revolade (Eltrombopag) be taken exactly as prescribed by your doctor. If it is necessary to stop taking Revolade (Eltrombopag), your doctor should do regular blood tests to ensure that your platelet count does not fall too low.

If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store Revolade (Eltrombopag) at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

In addition to its desired action, this medication may cause some adverse effects, notably: it may increase your risk of cataracts; it may cause headaches; it may cause diarrhea; it may cause muscle pain; it may cause nausea and vomiting. Each person may react differently to a treatment. If you think this medication may be causing adverse effects (including those described here, or others), talk to your health care professional. He or she can help you to determine whether or not the medication is the source of the problem.

12.5 mg
Each white, round, biconvex, film-coated tablet, embossed with ‘GS MZ1' and '12.5', contains 12.5 mg of Revolade (Eltrombopag) as Revolade (Eltrombopag) olamine. Nonmedicinal ingredients: magnesium stearate, mannitol, microcrystalline cellulose, povidone, sodium starch glycolate, hypromellose, macrogol, titanium dioxide, and polysorbate.

25 mg
Each white, round, biconvex, film-coated tablet, debossed with "GS NX3" and "25", contains 25 mg of Revolade (Eltrombopag) as Revolade (Eltrombopag) olamine. Nonmedicinal ingredients: magnesium stearate, mannitol, microcrystalline cellulose, povidone, sodium starch glycolate, hypromellose, macrogol, titanium dioxide, and polysorbate.

50 mg
Each brown, round, biconvex, film-coated tablet, debossed with "GS UFU" and "50", contains 50 mg of Revolade (Eltrombopag) as Revolade (Eltrombopag) olamine. Nonmedicinal ingredients: magnesium stearate, mannitol, microcrystalline cellulose, povidone, sodium starch glycolate, hypromellose, macrogol, titanium dioxide, iron oxide yellow, and iron oxide red.

75 mg
Each pink, round, biconvex, film-coated tablet, debossed with "GS FFS" and "75", contains 75 mg of Revolade (Eltrombopag) as Revolade (Eltrombopag) olamine. Nonmedicinal ingredients: magnesium stearate, mannitol, microcrystalline cellulose, povidone, sodium starch glycolate, hypromellose, macrogol, titanium dioxide, iron oxide red, and iron oxide black.

Do not take Revolade (Eltrombopag) if you:

• are allergic to Revolade (Eltrombopag) or any ingredients of the medication
• have severely reduced liver function

There may be an interaction between Revolade (Eltrombopag) and any of the following:

• aluminum hydroxide
• asunaprevir
• Bosentan
• calcium supplements (e.g., calcium carbonate, calcium citrate)
• Cyclosporine
• Deferiprone
• Ezetimibe
• fexofenadine
• grazoprevir
• Irinotecan
• iron (e.g., ferrous fumarate, ferrous gluconate, ferrous sulfate)
• lopinavir
• magnesium (e.g., magnesium hydroxide, magnesium oxide)
• Methotrexate
• multivitamins
• olmesartan
• Pazopanib
• Repaglinide
• rifampin
• ritonavir
• sacubitril
• saquinavir
• selenium
• simeprevir
• "statin" anticholesterol medications (e.g., Atorvastatin, Lovastatin, Simvastatin)
• Sucralfate
• Sulfasalazine
• Topotecan
• Valsartan
• zinc

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Revolade (Eltrombopag). Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Revolade (Eltrombopag).

HEALTH CANADA ADVISORY

August 25, 2016

Health Canada has issued new restrictions concerning the use of Revolade (Revolade (Eltrombopag)). To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.

Blood cell changes: Revolade (Eltrombopag) stimulates cells in the bone marrow that produce platelets as well as other blood cells. Sometimes this causes changes in the blood cells or bone marrow, which can increase the risk of bone marrow cell disorders and blood cancers. Your doctor will do regular blood tests to identify changes in the blood cells or bone marrow before it becomes severe.

The increased speed of blood cell formation may cause certain blood diseases such as blood cancers to progress. Speak to your doctor if you have concerns about this.

Blood Clots: Revolade (Eltrombopag) may increase the chance of blood clot formation, causing reduction of blood flow to organs or the extremities.

If you have a history of clotting you may be at increased risk of experiencing blood clot-related problems such as heart attack, stroke, or clots in the deep veins of your leg. Discuss with your doctor how Revolade (Eltrombopag) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Revolade (Eltrombopag), and whether any special monitoring is needed.

If you experience symptoms such as sharp pain and swelling in the leg, difficulty breathing, chest pain, blurred vision, or difficulty speaking, contact your doctor immediately.

Cataracts: Revolade (Eltrombopag) has been reported to cause cataracts or to worsen them for people who had the beginnings of cataracts before taking the medication. If you notice changes in your vision while taking Revolade (Eltrombopag), speak with your doctor.

Dizziness: Revolade (Eltrombopag) may cause dizziness, particularly when rising from a sitting or lying position. Rise slowly to help reduce this effect. Dizziness may also affect your ability to drive or operate machinery. Avoid these and other hazardous tasks until you have determined how Revolade (Eltrombopag) affects you.

Hepatitis C infection: People with chronic hepatitis C infection may be at an increased risk of liver failure and death when being treated with interferon and ribavirin. This is more likely to occur when taking Revolade (Eltrombopag) as well.

Kidney function: Kidney Disease or reduced kidney function may cause Revolade (Eltrombopag) to not be as effective. If you have reduced kidney function or kidney disease, discuss with your doctor how Revolade (Eltrombopag) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Revolade (Eltrombopag), and whether any special monitoring is needed.

Liver function: Liver disease or reduced liver function may cause Revolade (Eltrombopag) to build up in the body, causing side effects. If you have liver problems, discuss with your doctor how Revolade (Eltrombopag) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Revolade (Eltrombopag), and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking Revolade (Eltrombopag).

Additionally, Revolade (Eltrombopag) may reduce liver function and can cause life-threatening liver failure. If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

People with severely reduced liver function should not take Revolade (Eltrombopag).

People of East Asian descent: When treating ITP and SAA, people of East Asian heritage (Chinese, Japanese, Taiwanese, Thai, or Korean) may need to start at a lower dose of Revolade (Eltrombopag). The dose for treating hepatitis C does not need to be adjusted.

Stopping Revolade (Eltrombopag): When you stop taking Revolade (Eltrombopag), your platelet count will return to what it was before you started taking Revolade (Eltrombopag), usually within 4 weeks. The reduced number of platelets in the blood can make it difficult to stop cuts from bleeding. If you notice any signs of bleeding, such as frequent nosebleeds, unexplained bruising, or black and tarry stools, notify your doctor as soon as possible. Your doctor should check your platelet counts regularly for at least 4 weeks after you stop taking Revolade (Eltrombopag).

Pregnancy: Revolade (Eltrombopag) should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking Revolade (Eltrombopag), contact your doctor immediately.

Breast-feeding: It is not known if Revolade (Eltrombopag) passes into breast milk. If you are a breast-feeding mother and are taking Revolade (Eltrombopag), it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using Revolade (Eltrombopag) to treat any condition have not been established for children less than 1 year of age. Children who can swallow tablets may be prescribed Revolade (Eltrombopag) to treat ITP. It should not be given to children who cannot swallow whole tablets. There is no information regarding the safety and effectiveness of using Revolade (Eltrombopag) to treat chronic hepatitis C infection or severe Aplastic Anemia in children less than 18 years of age.

This medication is typically used only once a day. However, your pharmacist may have suggested a different schedule that is more appropriate for you. This medication should be swallowed whole. It should not be split, crushed or chewed. It is not advisable to stop using this product suddenly, particularly if you have been on it for several weeks. If you are considering stopping the medication, talk to your pharmacist first. It must be used regularly and continuously to maintain its beneficial effects. Be sure to keep an adequate supply on hand. To ensure effectiveness, avoid taking milk, dairy products, antacids or calcium supplements for at least 4 hours before and 2 hours after this medication. Also avoid mineral supplements (iron, magnesium or zinc).