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Revolade

Revolade

Eltrombopag

Revolade (Eltrombopag) belongs to the class of medications called thrombopoietin receptor agonists. It is used to increase the number of platelets in the blood for adults and children with chronic (long-term) immune thrombocytopenia purpura (ITP).

Available form

Tablet

Dosage

12.5mg, 25mg, 50mg, 75mg

Manufacturers

Novartis Pharmaceuticals, Teva

Generic brand of

Eltrombopag

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Revolade information

Dosage

Side Effects

Available Form

Contraindications

Precautions

Warnings

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.

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes Revolade (Eltrombopag). If you are concerned about side effects, discuss the risks and benefits of Revolade (Eltrombopag) with your doctor.

The following side effects have been reported by at least 1% of people taking Revolade (Eltrombopag). Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

abdominal pain
anxiety
blisters in the mouth
common cold
appetite changes
Constipation
cough
darkening skin colour
Diarrhea
discolouration of urine or feces
dry eyes
Dry Mouth
fatigue
feeling hot
flu-like symptoms (Fever, cough, sore throat, sudden lack of energy)
headache
increased sweating
itching
loss of appetite
Motion Sickness
nausea
numbness or tingling of the skin
sore mouth
sore throat, pain when swallowing
trouble sleeping
unusual hair loss or thinning hair
vomiting
weakness

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

aching muscles or bones
chest muscle pain
dizziness, lightheadedness or fainting when rising from a sitting or lying position
muscle and tendon pain
shortness of breath
signs of anemia (low red blood cells; e.g., dizziness, pale skin, unusual tiredness or weakness, shortness of breath)
signs of a blood clot in the arm or leg (tenderness, pain, swelling, warmth, or redness in the arm or leg) or lungs (sharp chest pain that is worse when breathing in, difficulty breathing, coughing, coughing up blood, sweating, or passing out)
signs of a blood clot in the spleen (severe pain in the upper left side of the abdomen, which may radiate to the left shoulder)
signs of clotting problems (e.g., unusual nosebleeds, bruising, blood in urine, coughing blood, bleeding gums, cuts that don't stop bleeding) after stopping the medication
signs of Depression (e.g., poor concentration, changes in weight, changes in sleep, decreased interest in activities, thoughts of suicide)
signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)
skin rash
swelling hands, ankles, or feet
symptoms of a urinary tract infection (e.g., pain when urinating, urinating more often than usual, low back or flank pain)
symptoms of low blood sugar (e.g., cold sweat, cool pale skin, headache, fast heartbeat, weakness)
unusual infections (symptoms may include fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness)
vision changes or blurred vision

Stop taking the medication and seek immediate medical attention if any of the following occur:

blood infection (e.g., rapid heartbeat, fever, shaking chills, nausea, vomiting, rapid breathing, decreased urination)
signs of bleeding in the stomach (e.g., bloody, black, or tarry stools, spitting up of blood, vomiting blood or material that looks like coffee grounds) after stopping Revolade (Eltrombopag)
signs of a Heart Attack (e.g., chest pain or pressure, pain extending through shoulder and arm, nausea and vomiting, sweating)
signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)
signs of Stroke (e.g., sudden or severe headache; sudden loss of coordination; vision changes; sudden slurring of speech; or unexplained weakness, numbness, or pain in the arm or leg)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking Revolade (Eltrombopag).

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.

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