Promacta

1 What is Promacta?

Brand: Promacta

Generic: Eltrombopag

Promacta is used in the management of thrombocytopenia (low platelets in the blood) in adults. It is also used in children 1 year of age and older with a blood disorder called chronic idiopathic thrombocytopenic purpura (ITP).

This medicine is used after a splenectomy (surgery to remove the spleen). It is also used together with other medicines, such as steroids or immunoglobulin, especially when they have not worked well enough.

 is also used to treat thrombocytopenia in patients with chronic hepatitis C, along with interferon therapy. Platelets help clot the blood, so a person with thrombocytopenia may have bleeding problems. Promacta works by stimulating the bone marrow to produce more platelets.

Promacta is also used to treat severe aplastic anemia (SAA) in patients who have received other medicines to treat SAA when those medications did not work well. This medicine is available only with your doctor's prescription.

2 What to Know Before Using

Before using Promacta, you must know all about the risks and complications associated with it. This is a decision needs to be reached by both you and your medical doctor.

It is important that you inform your medical doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals.

For non-prescription products, read the label or package ingredients carefully. Pediatric safety and efficacy studies have not been established to treat ITP in children younger than 1 years of age, or in children with thrombocytopenia associated with chronic hepatitis C or with severe aplastic anemia.

Appropriate geriatric studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of eltrombopag in the elderly. However, elderly patients are more likely to have age-related liver problems, which may require caution or an adjustment in the dose for patients receiving eltrombopag.

Pregnancy studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose or other precautions may be necessary.

When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines. These medicines include:

  • Aluminum
  • Calcium
  • Ciprofloxacin
  • Dasabuvir
  • Eluxadoline
  • Fluvoxamine
  • Gemfibrozil
  • Iron
  • Magnesium
  • Mexiletine
  • Pixantrone
  • Propafenone
  • Selenium
  • Simvastatin
  • Topotecan
  • Trimethoprim
  • Zileuton
  • Zinc

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Atorvastatin
  • Doxorubicin
  • Doxorubicin
  • Hydrochloride
  • Liposome
  • Fluvastatin
  • Levothyroxine
  • Lopinavir
  • Methotrexate
  • Nateglinide
  • Penicillin G
  • Pravastatin
  • Repaglinide
  • Rifampin
  • Rosuvastatin

It is possible that other interactions may occur. This is because certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur.

Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine or give you special instructions about the use of food, alcohol, or tobacco.

Calcium rich food daily food, and tobacco. The presence of other medical problems may affect the use of this medicine. Inform your doctor when you have any other medical problems, especially Antiphospholipid syndrome or ATIII deficiency or Factor V Leiden (blood clotting disorder) or liver disease or severe liver damage.

This medicine needs to be used with great caution. It is also known that this medicine may cause increased problems associated with blood clotting such as thromboembolism.

The doctor must check for bleeding problems or blood clots, history of or Cataracts, history of or Liver disease (including cirrhosis). The use of this medicine may make this condition worse and must be used with caution. The effects may be increased because of slower removal of the medicine from the body.

3 Proper Usage

Proper usage of Promacta requires strict adherence to your doctor’s orders. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

Tell your doctor if you have Asian relatives, such as Filipino, Chinese, Japanese, Korean, or Taiwanese. You may need a lower dose of this medicine. This medicine comes with a medication guide.

Read and follow these instructions carefully. Ask your doctor if you have any questions. It is best to take this medicine on an empty stomach or at least 1 hour before or 2 hours after a meal.

If you are taking antacids, multivitamins, or other products (such as dairy products or juices) that contain aluminum, calcium, iron, magnesium, selenium, or zinc, take these at least 4 hours before or 2 hours after eltrombopag.

Swallow the tablet whole. Do not crush, break, or chew it. Do not mix it with food or liquids. If you are using the oral suspension: Mix the powder with water only. Do not use hot water to mix it.

After mixing, take it immediately. Use the dosing syringe that comes with the package. The average household teaspoon may not hold the right amount of liquid. The dose of this medicine will be different for different patients.

Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For oral dosage forms (suspension, tablets): For severe aplastic anemia in adults, at first, 50 milligrams (mg) once a day should be used. Some patients may start at a lower dose.

Your doctor may adjust your dose if needed. However, the dose is usually not more than 150 mg per day. In children, the use and dose must be determined by your doctor.

For thrombocytopenia with ITP in adults and children 6 years of age and older; at first, 50 milligrams (mg) should be taken once a day. Some patients may start at a lower dose.

Your doctor may adjust your dose if needed. However, the dose is usually not more than 75 mg per day. In children between the age of 1 to 5 years, at first, 25 milligrams (mg) can be used once a day.

Your doctor may adjust your dose if needed. However, the dose is usually not more than 75 mg per day. In children younger than 1 year of age, the use and dose must be determined by your doctor.

For thrombocytopenia with chronic hepatitis C: Adults At first, 25 milligrams (mg) once a day. Your doctor may adjust your dose if needed. However, the dose is usually not more than 100 mg per day.

Children Use and dose must be determined by your doctor. In the case of missed doses, skip the missed dose and go back to your regular dosing schedule. Never double doses after skipping a dose.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing. Keep out of the reach of children. Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use. Throw away any unused liquid within 30 minutes of mixing it.

4 Precautions to Take

Before using Promacta, there are some precautions you must take. It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly.

Blood tests will be needed while you are using this medicine. Eltrombopag may cause serious liver problems.

Check with your doctor right away if you start having nausea or vomiting, dark urine, light-colored stools, right upper stomach pain, unusual tiredness, or yellow eyes or skin while you are using this medicine.

Blood clotting problems may occur while you are using this medicine. Check with your doctor right away if you have pain, swelling, or tenderness in your leg, or shortness of breath and pain in your chest.

Do not stop taking this medicine without checking first with your doctor. Your doctor will check your platelet levels and progress when you stop taking the medicine. This medicine may cause cataracts or make them worse.

Check with your doctor right away if you have blurred vision, difficulty in reading, or any other change in vision while you are taking this medicine. Your doctor may want your eyes to be checked by an ophthalmologist (eye doctor).

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription medicines and herbal or vitamin supplements.

5 Potential Side Effects

As with many medications, there are several potential side effects associated with Promacta. All of these side effects may not occur if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

The most common side effects that can occur include:

  • bloating or swelling of the face, arms, hands, lower legs or feet
  • body ache or pain
  • chills or fever
  • cough
  • the difficulty with breathing
  • headache
  • loss of voice
  • pale skin
  • rapid weight gain
  • a runny nose
  • a sore throat
  • tingling of the hands or feet
  • troubled breathing with exertion
  • unusual tiredness or weakness
  • unusual weight gains or loss
  • yellow eyes or skin

The less common side effects include:

  • pain the bladder
  • blindness
  • blurred or decreased vision
  • bruising
  • burning
  • crawling
  • itching
  • numbness
  • prickling
  • "pins and needles" or tingling feelings
  • diarrhea
  • the general feeling of discomfort or illness
  • hoarseness
  • joint pain
  • lower back or side pain
  • muscle aches and pains
  • nausea
  • pinpoint, red spots on the skin
  • redness of the eye
  • shivering
  • sweating
  • tender
  • swollen glands in the neck
  • trouble sleeping
  • trouble swallowing
  • voice changes
  • vomiting

Some of the incidences that are not known include:

  • the pain the chest
  • redness or swelling in the legs or arms

It is also possible that some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine.

Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

The more common side effects include:

  • decreased appetite
  • the difficulty with moving
  • hair loss or thinning of the hair
  • itching skin
  • lack or loss of strength
  • muscle aching or cramping
  • muscle pains
  • stiffness swollen joints.

The other less common side effects include:

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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