Promacta 12.5 Mg Tablet Thrombopoietic Growth Factors

GENERIC NAME(S): Eltrombopag

OTHER NAME(S): Promacta Tablet

WARNINGS:

Rarely, eltrombopag has caused severe (possibly fatal) liver problems. Get medical help right away if you develop symptoms of liver problems (such as persistent nausea, stomach/abdominal pain, dark urine, yellowing eyes/skin).

People with a certain liver problem (chronic hepatitis C) who are taking this medication with ribavirin and interferon may sometimes experience worsening of their liver problem. Get medical help right away if you have any very serious side effects, including symptoms of liver problems, stomach/abdominal swelling, or mental/mood changes. Talk with your doctor about the risks and benefits of this medication.

To help decrease the risk of liver problems, your doctor will order laboratory tests (liver function tests) before you start eltrombopag and while you are taking it. Keep all medical and lab appointments.

Who should not take Promacta 12.5 Mg Tablet Thrombopoietic Growth Factors?

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Uses

Uses

This medication is used to treat low platelet levels in people who have a certain blood disorder called chronic immune (idiopathic) thrombocytopenia purpura (ITP) or who have chronic hepatitis C. It may also be used to treat people with a certain blood disorder (aplastic anemia). Platelets are a type of blood cell needed to form blood clots and prevent bleeding. Eltrombopag decreases your risk of bleeding by increasing the number of platelets. Eltrombopag acts like a certain natural substance (thrombopoietin) that causes the body to produce platelets.

How to use Promacta 12.5 Mg Tablet Thrombopoietic Growth Factors

Read the Medication Guide provided by your pharmacist before you start using eltrombopag and each time you get a refill. If you have any questions, consult your doctor or pharmacist.

Take this medication by mouth as directed by your doctor, usually once daily. Take it without a meal or with a meal low in calcium (50 milligrams or less). Ask your doctor or pharmacist for details.

Take this medication at least 2 hours before or 4 hours after taking any products that contain magnesium, aluminum, or calcium-rich foods (containing more than 50 milligrams calcium). Some examples include antacids, dairy products (such as milk, yogurt), calcium-enriched juice, vitamins/minerals, quinapril, certain forms of didanosine (chewable/dispersible buffered tablets or pediatric oral solution), and sucralfate. Follow the same instructions with bismuth subsalicylate, iron, selenium, and zinc. These products may keep eltrombopag from working well.

The manufacturer directs not to split, chew, or crush the tablet before taking it, and not to mix it with food or liquid. However, many similar drugs (immediate-release tablets) can be split, chewed, or crushed. Follow your doctor's directions on how to take this medication. The manufacturer also states that the powder from the tablet may stain surfaces.

If you are using the suspension powder, read the manufacturer's Instructions for Use before you start using this medication. Ask your health care provider if you have any questions. Carefully follow the directions to mix and use each dose. Use the provided mixing bottle to mix each dose with cool or cold water. Gently and slowly shake the mixing bottle for at least 20 seconds to mix the water with the powder. After mixing, give this medication right away. Use the provided special measuring device (oral syringe) to prepare and give each dose. Do not use a household spoon because you may not get the correct dose. Do not re-use the oral syringe. Use a new oral syringe for each dose. If not used right away, the mixed medication may be stored at room temperature for up to 30 minutes. After 30 minutes, throw away any unused mixture, or any mixture left in the bottle. Clean the mixing supplies as directed.

Take this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day. The dosage is based on your medical condition, response to treatment, age, and lab tests. Your doctor will order blood tests (platelet counts) to find the right dose for you. Keep all medical/lab appointments. Follow your doctor's directions carefully. If you are of Asian descent or if you have liver problems, your doctor may direct you to start with a lower dose because you may be more sensitive to its effects.

Your risk of bleeding may increase when you stop using eltrombopag. After your last dose, your doctor should order a blood test once a week for at least 4 weeks to check your platelet count. Tell your doctor right away if you develop any bleeding/bruising.

Ask your doctor if you should continue taking your other medications for ITP (such as corticosteroids, azathioprine, danazol) while you are using eltrombopag.

Tell your doctor if your condition (bleeding/bruising) does not get better or if it gets worse.

Side Effects

Side Effects

See also Warning section.

Nausea, diarrhea, headache, muscle pain, and tingling/numbness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: vision changes.

This medication may rarely cause serious problems from blood clots in the heart, brain, legs, or lungs (such as heart attack, stroke, deep vein thrombosis, pulmonary embolism), especially if your platelet counts are too high. Keep all medical/lab test appointments. Get medical help right away if you have any symptoms of a blood clot, including: sudden shortness of breath, chest/jaw/left arm pain, coughing up blood, sudden dizziness/fainting, pain/swelling/warmth in the groin/legs, trouble speaking, weakness on one side of the body.

Eltrombopag can commonly cause a rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe reaction. Get medical help right away if you develop any rash.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Precautions

Before using eltrombopag, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood clots/clotting problems (such as Factor V Leiden), other blood disorders (such as blood cancer, myelodysplastic syndrome), certain eye problem (cataracts), liver disease.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Although this medication increases platelets and decreases the risk of bleeding, continue to avoid activities that can increase your risk of bleeding (such as contact sports, using sharp objects like razors and nail cutters).

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using eltrombopag. Eltrombopag may harm an unborn baby. Ask about reliable forms of birth control while using this medication and for 7 days after stopping treatment. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.

It is unknown if this medication passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

Interactions

Interactions

See also How to Use.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

This medication may interfere with certain lab tests (creatinine and bilirubin), possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.

Overdose

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Do not share this medication with others.

Lab and/or medical tests (such as complete blood count, eye exams) should be done before you start taking this medication and while you are taking it. Keep all medical and lab appointments. See also Warnings section. Consult your doctor for more details.

Missed Dose

If you miss a dose, skip the missed dose. Take your next dose at the regular time. Do not take more than 1 dose in 24 hours. Do not double the dose to catch up.

Storage

Different brands and forms of this medication have different storage needs. Check the product package for storage instructions or ask your pharmacist. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.Information last revised August 2020. Copyright(c) 2020 First Databank, Inc.

Images
Promacta 12.5 mg tablet
Promacta 12.5 mg tableticonicon
Promacta 12.5 mg tablet

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GS MZ1 12.5
Promacta 50 mg tablet
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Promacta 50 mg tablet

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GS UFU 50
Promacta 25 mg tablet
Promacta 25 mg tableticonicon
Promacta 25 mg tablet

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GS NX3 25
Promacta 75 mg tablet
Promacta 75 mg tableticonicon
Promacta 75 mg tablet

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GS FFS 75
Promacta 12.5 mg tablet
Promacta 12.5 mg tablet

color
white
shape
round
imprint
GS MZ1 12.5
This medicine is a white, round, film-coated, tablet imprinted with "GS MZ1 12.5".
Promacta 50 mg tablet
Promacta 50 mg tablet

color
blue
shape
round
imprint
GS UFU 50
This medicine is a blue, round, film-coated, tablet imprinted with "GS UFU 50".
Promacta 25 mg tablet
Promacta 25 mg tablet

color
orange
shape
round
imprint
GS NX3 25
This medicine is a orange, round, film-coated, tablet imprinted with "GS NX3 25".
Promacta 75 mg tablet
Promacta 75 mg tablet

color
pink
shape
round
imprint
GS FFS 75
This medicine is a pink, round, film-coated, tablet imprinted with "GS FFS 75".

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Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, except as may be authorized by the applicable terms of use.

CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.