Eltrombopag, ELTROMDX, Eltrombopag 25mg

Manufacturer: Laos Daxiong Pharmaceutical

Introduction: Eltrombopag is a thrombopoietin receptor agonist that works by inducing and stimulating the differentiation and proliferation of megakaryocytes (especially large cells found in the bone marrow). It is suitable for the treatment of thrombocytopenia in patients with chronic immune thrombocytopenic purpura (ITP) who have poor response to glucocorticoids, immunoglobulins or splenectomy. Currently, Eltrombopag has been approved in more than 100 countries around the world for the treatment of thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura (ITP), and has been approved in 43 countries for the treatment of thrombocytopenia in patients with chronic hepatitis C (CHC) in order to initiate and maintain interferon-based standard liver disease therapy.

【Drug name】

Name: Eltrombopag Tablets

Product Name: ELTROMDX

English Name: Eltrombopag Tablets

【Specification】

25 mg

【Indications】

ELTROMDX is a prescription medicine used to treat low platelet counts in adults and children 1 year and older 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:

• Chronic hepatitis C virus (HCV) infection leading to low platelet counts before and during interferon therapy.

• Severe aplastic anemia (SAA), when other drugs to treat SAA are ineffective.

ELTROMDX is used to try to increase the platelet count to reduce the risk of bleeding.

ELTROMDX is not used to normalize platelet counts.

ELTROMDX is used to treat certain people with low platelet counts caused by chronic ITP, chronic HCV, or SAA. It is not used to treat low platelet counts caused by other conditions or diseases.

It is not known whether ELTROMDX is safe and effective when used with other antiviral medicines 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 dose】

• Take ELTROMDX exactly as your healthcare provider tells you to. Your healthcare provider will prescribe the right ELTROMDX tablet for you.

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

• Do not stop taking ELTROMDX without talking to your healthcare provider first. Do not change the dose or schedule on which you take ELTROMDX unless your healthcare provider tells you to change.

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

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

• Take ELTROMDX tablets whole. Do not crush ELTROMDX tablets 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 ELTROMDX dose as needed.

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

【side effect】

Liver problems. If you have chronic hepatitis C virus and are taking ELTROMDX along with interferon and ribavirin,

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

Signs and symptoms of liver problems:

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

• Pain in the upper right stomach area (abdomen)

• Unusually dark urine

• Puzzled

• Unusual tiredness

• Swelling of the stomach (abdomen)

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

• High platelet counts and higher risk of blood clots. If your platelet count is too high during treatment with ELTROMDX, your risk of blood clots increases. If your platelet count is normal or low, your risk of blood clots may also increase during treatment with ELTROMDX. You can have serious problems or die from certain forms of blood clots, such as those that travel to your lungs or cause a heart attack or stroke. Your healthcare provider will check your platelet counts and change your dose or stop ELTROMDX if your platelet count is too high. Tell your healthcare provider right away if you have signs and symptoms of blood clots in the legs, such as swelling, pain, or tenderness in the legs. People with chronic liver disease may be at risk for blood clots in the stomach. Tell your healthcare provider right away if you have stomach pain that could be a symptom of this type of blood clot.

• New or worsening cataracts (clouding of the lens of the eye). New or worsening 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 vision while taking ELTROMDX.

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

• Nausea • Vomiting • Diarrhea • Back pain • Rash

• Abnormal liver function tests • Tingling, itching, or burning of the skin • Muscle pain

• “Flu”-like symptoms (influenza), including fever, headache, tiredness, cough, sore throat and body aches • Upper respiratory tract infection. Symptoms may include runny nose, nasal congestion and sneezing

• Urinary tract infection. Symptoms may include painful, frequent or urgent need to urinate, a low-grade fever in some people, and pain or burning when urinating . • Pain or swelling (inflammation) in the throat or mouth (oropharyngeal pain and pharyngitis).

When used to treat chronic ITP, the most common side effects of ELTROMDX in children 1 year and older are:

• Cough • Toothache • Diarrhea • Rash • Fever

• Stomach (abdominal) pain • Abnormal liver function tests

• Pain or swelling in the nose or throat (inflammation, oropharyngeal pain) • Runny or stuffy nose (rhinitis)

• Soreness or swelling in the throat or mouth (inflammation, nasopharyngitis) • Upper respiratory tract infection. Symptoms may include runny nose, nasal congestion, and sneezing.

When ELTROMDX is used with other medicines to treat chronic HCV, the most common side effects are:

• Fever • Fatigue • Cough • Headache • Itching

• Nausea • Chills • Diarrhea • Hair loss

• Feeling weak • Loss of appetite • Swelling in your ankles, feet, and legs

• Difficulty sleeping • Muscle pain • Low red blood cell count (anemia)

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

When ELTROMDX is used to treat severe aplastic anemia, the most common side effects are:

• Nausea • Dizziness • Fatigue • Cough • Abdominal pain

• Diarrhea • Bruising • Headache • Shortness of breath • Fever

• Muscle cramps • Sore nose or throat • Joint pain

• Pain in your arms, legs, hands, or feet • Abnormal liver function tests • Runny nose

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

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, talk with your healthcare provider or pharmacist. Get medical advice about side effects.

【Storage】

• Store ELTROMDX tablets at room temperature between 68°F and 86°F (20°C and 30°C).

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

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