Promacta

The active ingredient in Promacta is eltrombopag olamine. It is a thrombopoietin receptor agonist (TPO), which means it works like TPO. TPO is a natural hormone that stimulates bone marrow to produce more blood cells.

This means it increases the number of platelets, red blood cells, and white blood cells in your body. This is significant because maintaining a healthy quantity of these components reduces your risk of bleeding, helps to fight infections, and ensures that enough oxygen is delivered throughout your body. This medicine is used after a splenectomy (surgery to remove the spleen) and when other medicines (eg, steroids or immunoglobulin) have not worked well enough, like corticosteroids.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using Promacta. However, the following is a synopsis of the general guidelines for the use of Promacta:

• You can take Promacta on an empty stomach, at least 1 hour before or 2 hours after eating, with a meal containing fewer than 50 milligrams of calcium, or at least 2 hours before or 4 hours after eating calcium-rich foods (dairy products, calcium-fortified juices, certain fruits and vegetables).
• Swallow the tablet whole, without crushing, chewing, breaking, or mixing it with food or liquids.
• Use only cool or cold water to mix the oral suspension powder. Each time you mix the medicine, use a new dosing syringe to measure the water and provide the appropriate dose.
• You may require periodic medical tests to monitor your blood cell counts and liver function. Your eyes may also need to be examined for signs of cataracts.
• Promacta is typically taken for six months. It may take up to four weeks for the medication to stop heavy bleeding episodes.

The most common side effects of Promacta seen in clinical trials include:

• Nausea.
• Tiredness.
• Fever.
• Back pain.
• Vision changes.
• Cough.
• Headache.
• Muscle pain.
• Urinary tract infection.

Some individuals may experience serious side effects while using Promacta. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Symptoms of liver disease and damage include stomach bloating, black stool or urine, fatigue, confusion, and yellowing (jaundice) of the skin or eyes.
• Increased risk of blood clots in the liver. Symptoms include abdominal pain, nausea, vomiting, and diarrhea.
• Increased risk of blood clots in the legs (redness, discomfort, tenderness, swelling of the skin), the lungs (cough, difficulty breathing, chest pain), the heart (chest pain, pain in the arms or shoulders, pain in the neck or jaw), and stroke.
• Allergic reaction to the medication, such as a skin rash, swelling, or hives.

These are not all of the possible side effects of Promacta. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Promacta, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including:

• A blood clot.
• Blood cancer.
• Bleeding difficulties.
• Cataracts.
• Surgery to remove the spleen.
• If you are of Eastern or Southeast Asian descent.
• Liver disease (unless you are receiving hepatitis C treatment).

Boxed Warning

In patients with chronic hepatitis C, eltrombopag in combination with interferon and ribavirin may raise the risk of hepatic decompensation and severe, potentially fatal hepatotoxicity. Monitor liver function and cease dose as recommended.

There are no contraindications with Promacta.

It depends on the condition for which you are taking Promacta. For example, for ITP, it takes 1 to 2 weeks for platelet levels to begin climbing. Platelet levels in severe and refractory aplastic anaemia may not rise for up to four months. The duration of treatment for long-term hepatitis C is determined by whether you are taking other antiviral drugs in addition to Promacta. In addition, your dose may need to be changed depending on your platelet counts.

When Promacta is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• Antacids containing calcium, magnesium, or aluminium.
• Vitamin and mineral supplements containing aluminium, calcium, iron, magnesium, selenium, or zinc.
• Blood thinners such as alteplase, clopidogrel, dipyridamole, warfarin, enoxaparin, apixaban, ticlopidine, and others.
• Cholesterol-lowering medications such as atorvastatin, ezetimibe, fluvastatin, pitavastatin, pravastatin, rosuvastatin, or simvastatin.

Low platelet count in long-term ITP patients:

Adults and children aged 6 and up: The typical starting dose is 50 mg taken orally once daily.

Children aged 1 to 5 years old: The typical starting dose is 25 mg taken orally once a day.

Your healthcare provider will change your dose based on your platelet count. The maximum daily dose is 75 mg. If you have liver problems or are of East or Southeast Asian heritage, your dose may be reduced.

Low platelet count in persons with chronic hepatitis C:

The typical starting dose is 25 mg taken orally once daily. Your healthcare provider will change your dose based on your platelet count. The maximum daily dose is 100 mg.

Severe aplastic anaemia as a first-line treatment:

Adults and children aged 12 and up: The typical starting dose is 150 mg taken orally once daily for 6 months.

Children aged 6 to 11 years old: The typical starting dose is 75 mg orally once daily for six months.

Children aged 2–5 years old: The starting dose will be determined by your child's weight. The typical starting dose is 2.5 mg/kg taken orally once daily for 6 months.

If you have liver problems or are of East or Southeast Asian heritage, your dose may be reduced.

Severe aplastic anaemia with no response to treatment (refractory):

Adults and children aged 2 and up: The typical starting dose is 50 mg taken orally once daily.

Your healthcare provider will change your dose based on your platelet count. The maximum daily dose is 150 mg. If you have liver problems or are of East or Southeast Asian heritage, your dose may be reduced.

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Store at room temperature and keep out of reach of children.

Novartis is the company that manufactures Promacta.

There are several lower-cost generic versions available of Promacta.

When you stop taking Promacta, you may be more likely to have bleeding or thrombocytopenia than you were while taking it. Monitor yourself for bleeding, and if you see any major bleeding, contact your healthcare practitioner right away.

May harm an unborn baby. Do not use if you are pregnant. Use effective birth control while taking Promacta and for at least 7 days following your last dose. Inform your doctor if you become pregnant.

Talk to your doctor if you are already breastfeeding or if you have any plans to breastfeed. It is not recommended to breastfeed while taking this medication.