eltrombopag

eltrombopag is available as a 12.5 mg, 25 mg, 50 mg, and 75 mg oral tablet and a 12.5 mg and 25 mg oral suspension.

eltrombopag is a thrombopoietin receptor agonist and is used for the following:

• Low platelet count in people with immune thrombocytopenic purpura (ITP) when other medications haven’t worked – adults and children
• Low platelet count in people with long-term hepatitis C – adults only
• Used alone or with other medications in people who can’t make enough blood cells (severe aplastic anemia) – adults and children

eltrombopag is a thrombopoietin receptor (TPO) agonist, meaning it acts like TPO. TPO is a natural hormone that tells your bone marrow to make more blood cells. By working like TPO, eltrombopag raises the level of platelets, red blood cells, and white blood cells in your body. This is important because having a healthy level of these components helps to lower your risk for bleeding, fight against infections, and makes sure enough oxygen is carried throughout your body.

eltrombopag is dosed as follows:

Low platelet count in people with long-term ITP:

• Adults and children ages 6 and older: The typical starting dose is 50 mg by mouth once daily
• Children ages 1 to 5 years old: The typical starting dose is 25 mg by mouth once daily
• Your healthcare provider will adjust your dose based on your platelet levels. The maximum dose is 75 mg a day. Your dose might be lowered if you’re of East Asian or Southeast Asian descent, or if you have liver problems

Low platelet count in people with long-term hepatitis C:

• The typical starting dose is 25 mg by mouth once daily. Your healthcare provider will adjust your dose based on your platelet levels. The maximum dose is 100 mg a day

Severe aplastic anemia as a first-choice treatment:

• Adults and children ages 12 and older: The typical starting dose is 150 mg by mouth once daily for 6 months
• Children ages 6 to 11 years old: The typical starting dose is 75 mg by mouth once daily for 6 months
• Children ages 2 to 5 years old: The starting dose will depend on your child’s weight. The typical starting dose is 2.5 mg/kg by mouth once daily for 6 months
• Your dose might be lowered if you’re of East Asian or Southeast Asian descent, or if you have liver problems

Severe aplastic anemia that hasn’t responded to treatment (refractory):

• Adults and children ages 2 and older: The typical starting dose is 50 mg by mouth once daily
• Your healthcare provider will adjust your dose based on your platelet levels. The maximum dose is 150 mg a day.
• Your dose might be lowered if you’re of East Asian or Southeast Asian descent, or if you have liver problems

eltrombopag is a safe and effective treatment when used for FDA licensed indications. However, like all medications, they may give you unwanted side effects. You should always discuss potential side effects with your physician to ensure the medication is suitable and right for you.

Common side effects of eltrombopag:

• Low red blood cell levels
• Fever
• Tiredness
• Headache
• Nausea
• Diarrhea
• Cough

Serious side effects are rare with eltrombopag. Contact your healthcare provider immediately if you experience any of the following.

• Liver damage: stomach swelling, dark stool or urine, tiredness, confusion, and yellowing of the skin or eyes
• Blood clot in the liver: nausea, vomiting, abdominal pain, and diarrhea
• Other types of blood clots: legs, (redness, pain, tenderness, swelling of the skin), lungs (cough, difficulty breathing, chest pain), heart attack (chest pain, pain in the arms or shoulders, pain in the neck or jaw), stroke (difficulty speaking, numbness on one side of the body, confusion)

The following medications may interact with eltrombopag:

• Polyvalent Cations (Chelation): Take eltrombopag at least 2 hours before or 4 hours after any medications or products such as antacids, dairy products, and mineral supplements to avoid significant reduction in absorption of eltrombopag
• Transporters: Use caution when concomitantly administering eltrombopag and drugs that are substrates of OATP1B1 (e.g. atorvastatin, bosentan, ezetimibe, fluvastatin, glyburide, olmesartan, pitavastatin, pravastatin, rosuvastatin repaglinide, rifampin, simvastatin acid, SN-38 [active metabolite of irinotecan], valsartan) or breast cancer resistance protein (BCRP) (e.g., imatinib, irinotecan, lapatinib, methotrexate, mitoxantrone, rosuvastatin,sulfasalazine, topotecan). Monitor patients closely for signs and symptoms of excessive exposure to the drugs that are substrates of OATP1B1 or BCRP and consider reduction of the dose of these drugs, if appropriate. In  clinical trials with eltrombopag, a dose reduction of rosuvastatin by 50% was recommended

Various FDA-approved generic manufacturers

It is not known if eltrombopag will harm an unborn baby. Tell your healthcare provider if you become pregnant or think you may be pregnant during treatment with eltrombopag.
o Females who are able to become pregnant, should use effective birth control (contraception) during treatment with eltrombopag and for at least 7 days after stopping treatment with eltrombopag. Talk to your healthcare provider about birth control methods that may be right for you during this time.

• PROMACTA