【Drug Name】

Name: Eltrombopag Tablets

Product Name: ELTROMDX

【Specification】

25mg/50mg

【Indications】

ELTROMDX is a prescription medicine used to treat adults and children 1 year of age and older with low blood platelet counts due to chronic immune (idiopathic) thrombocytopenia (ITP), when other medicines to treat ITP or surgery to remove the spleen have not worked well enough.

ELTROMDX is also used to treat patients with:

• low blood platelet counts due to chronic hepatitis C virus (HCV) infection before and during treatment with interferon.

• severe aplastic anemia (SAA) when other medicines to treat SAA have not worked well enough.

ELTROMDX is used to try to raise platelet counts in order to lower your risk for bleeding.

ELTROMDX is not used to make platelet counts normal.

ELTROMDX is for treatment of certain people with low platelet counts caused by chronic ITP, chronic HCV, or SAA, not low platelet counts caused by other conditions or diseases.

It is not known if ELTROMDX is safe and effective when used with other antiviral medicines that are approved to treat chronic hepatitis C.

It is not known if ELTROMDX is safe and effective in children with chronic hepatitis C or severe aplastic anemia or in children younger than 1 year with ITP. 

【Recommended Dosage】

• Take ELTROMDX exactly as your healthcare provider tells you to take it. Your healthcare provider will prescribe the dose of ELTROMDX tablets.

• If your healthcare provider prescribes ELTROMDX oral suspension, see “Instructions for Use” that comes with your medicine for instructions on how to prepare and take your dose.

• Do not stop taking ELTROMDX without talking with your healthcare provider first. Do not change your dose or schedule for taking ELTROMDX unless your healthcare provider tells you to change it.

• Take ELTROMDX on an empty stomach, either 1 hour before or 2 hours after eating food.

• Take ELTROMDX at least 2 hours before or 4 hours after eating dairy products and calcium-fortified juices.

• Take ELTROMDXtablets whole. Do not crush ELTROMDXtablets and mix with food or liquids.

If you miss a dose of ELTROMDX, wait and take your next scheduled dose. Do not take more than one dose of ELTROMDX in one day.

• If you take too much ELTROMDX, you may have a higher risk of serious side effects. Call your healthcare provider right away.

• Your healthcare provider will check your platelet count during your treatment with ELTROMDX and change your dose of ELTROMDX as needed.

• Tell your healthcare provider about any bruising or bleeding that happens while you take and after you stop taking ELTROMDX. 

【Side Effects】

Liver problems. If you have chronic hepatitis C virus, and take ELTROMDX with interferon and ribavirin treatment,

ELTROMDX may increase your risk of liver problems. Tell your healthcare provider right away if you have any of these

signs and symptoms of liver problems:

• yellowing of the skin or the whites of the eyes (jaundice) 

• right upper stomach area (abdomen) pain

• unusual darkening of the urine 

• confusion

• unusual tiredness 

• swelling of the stomach area (abdomen)

• Abnormal liver function tests. Your healthcare provider will order blood tests to check your liver before you start taking ELTROMDX and during your treatment. In some cases treatment with ELTROMDX may need to be stopped due to changes in your liver function tests.

• High platelet counts and higher risk for blood clots. Your risk of getting a blood clot is increased if your platelet count is too high during treatment with ELTROMDX. Your risk of getting a blood clot may also be increased during treatment with ELTROMDX if you have normal or low platelet counts. You may have severe problems or die from some forms of blood clots, such as clots that travel to the lungs or that cause heart attacks or strokes. Your healthcare provider will check your blood platelet counts, and change your dose or stop ELTROMDX if your platelet counts get too high. Tell your healthcare provider right away if you have signs and s ymptoms of a blood clot in the leg, such as swelling, pain, or tenderness in your leg. People with chronic liver disease may be at risk for a type of blood clot in the stomach area. Tell your healthcare provider right away if you have stomach area pain that may be a symptom of this type of blood clot.

• New or worsened cataracts (a clouding of the lens in the eye). New or worsened cataracts have happened in people taking ELTROMDX. Your healthcare provider will check your eyes before and during your treatment with ELTROMDX. Tell your healthcare provider about any changes in your eyesight while taking ELTROMDX. 

The most common side effects of ELTROMDX in adults when used to treat chronic ITP are:

• nausea 

• pain or swelling (inflammation) in your throat or mouth (oropharyngeal pain and pharyngitis)

• diarrhea

• upper respiratory tract infection. Symptoms may include runny nose, stuffy nose, and sneezing 

• abnormal liver function tests

• back pain

• vomiting 

• ”flu”-like symptoms (influenza) including fever, headache, tiredness, cough, sore throat, and bodyaches

• muscle aches

• urinary tract infection. Symptoms may include aches frequent or urgent need to urinate, low fever in some people, pain or burning with urination.

• skin tingling, itching, or burning 

• rash

The most common side effects of ELTROMDXin children 1 year and older when used to treat chronic ITP are:

• upper respiratory tract infection. Symptoms may include runny nose, stuffy nose, and sneezing. 

• runny, stuffy nose (rhinitis) 

• stomach (abdominal) pain

• pain or swelling (inflammation) in your nose or throat  (oropharyngeal pain)

• pain or swelling (inflammation) in your throat or mouth (nasopharyngitis)

• cough 

• toothache

• diarrhea 

• rash

• fever 

• abnormal liver function tests

The most common side effects when ELTROMDX is used in combination with other medicines to treat chronic HCV are:

• low red blood cell count (anemia) 

• feeling weak

• fever 

• trouble sleeping

• tiredness 

• cough

• headache 

• itching

• nausea 

• chills

• diarrhea 

• muscle aches

• decreased appetite 

• hair loss

• “flu”-like symptoms (influenza) including fever, headache, tiredness, cough, sore throat, and body aches

• swelling in your ankles, feet, and legs

The most common side effects when ELTROMDX is used to treat severe aplastic anemia are:

• nausea 

• dizziness

• feeling tired 

• pain in the nose or throat

• cough 

• abdominal pain

• diarrhea 

• bruising

• headache 

• muscle spasms

• pain in arms, legs, hands, or feet 

• abnormal liver function tests

• shortness of breath 

• joint pain

• fever 

• runny nose

Laboratory tests may show abnormal changes to the cells in your bone marrow.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of ELTROMDX. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects.

【Storage】

• Store ELTROMDX tablets at room temperature between 68°F to 77°F (20°C to 25°C).

• Keep ELTROMDX tightly closed in the bottle given to you.

Keep ELTROMDX and all medicines out of the reach of children.