Promacta

Promacta is a prescription medication used to prevent bleeding episodes in patients with chronic immune (idiopathic) thrombocytopenia (ITP) or chronic hepatitis C virus (HCV). Promacta belongs to a group of drugs called thrombopoietin receptor agonist, which work by causing the cells of the bone marrow to produce more platelets (cells that are needed for blood to clot).

This medication comes in tablet form and is taken once a day, on an empty stomach.

Common side effects of Promacta include nausea, diarrhea, runny or stuffy nose, and muscle aches.

Promacta is a prescription medicine used to treat low blood platelet counts to lower the risk for bleeding in adults with:

• chronic immune (idiopathic) thrombocytopenia (ITP), when other medicines to treat your ITP or surgery to remove the spleen have not worked well enough.
• chronic hepatitis C virus (HCV) infection before and during treatment with interferon.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• GlaxoSmithKline LLC

Promacta may cause serious side effects. See “Drug Precautions”.

The most common side effects of Promacta are:

• nausea
• diarrhea
• upper respiratory tract infection; symptoms may include runny nose, stuffy nose, and sneezing
• vomiting
• muscle aches
• urinary tract infections; symptoms may include frequent or urgent need to urinate, low fever in some people, pain or burning with urination
• pain or swelling (inflammation) in your throat or mouth (oropharyngeal pain and pharyngitis)
• abnormal liver function tests
• abnormal skin sensations such as tingling, itching, or burning
• back pain
• ‘flu’ symptoms (influenza); symptoms may include fever, headache, tiredness, cough, sore throat, and body aches
• rash

These are not all the possible side effects of Promacta. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects.

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal products. Promacta may affect the way certain medicines work. Certain other medicines may affect the way Promacta works.

Especially tell your healthcare provider if you take:

• certain medicines used to treat high cholesterol, called “statins”.
• a blood thinner medicine.

Certain medicines may keep Promacta from working correctly. Take Promacta either 4 hours before or 4 hours after taking these products:

• antacids used to treat stomach ulcers or heartburn.
• multivitamins or products that contain iron, calcium, aluminum, magnesium, selenium, and zinc which may be found in mineral supplements.

Ask your healthcare provider if you are not sure if your medicine is one that is listed above.

Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine.

Promacta can cause serious side effects, including:

• Liver problems: Promacta may damage your liver and cause serious illness and death. You must have blood tests to check your liver before you start taking Promacta and during treatment with Promacta. Your healthcare provider will order these blood tests. In some cases Promacta treatment may need to be stopped. Tell your healthcare provider right away if you have any of these signs and symptoms of liver problems:
  • yellowing of the skin or the whites of the eyes (jaundice)
  • unusual darkening of the urine
  • unusual tiredness
  • right upper stomach area pain
• Bone marrow changes (increased reticulin and possible bone marrow fibrosis): Long-term use of Promacta may cause changes in your bone marrow. These changes may lead to abnormal blood cells or your body making less blood cells. The mild form of these bone marrow changes is called “increased reticulin” which may progress to a more severe form called “fibrosis”. The mild form may cause no problems while the severe form may cause life-threatening blood problems. Signs of bone marrow changes may show up as abnormal results in your blood tests. Your healthcare provider will decide if abnormal blood test results mean that you should have bone marrow tests or if you should stop taking Promacta.
• High platelet counts and higher chance for blood clots: Your chance of getting a blood clot is increased if your platelet count is too high during treatment with Promacta. Your chance of getting a blood clot may also be increased during treatment with Promacta if you have normal or low platelet counts. You may have severe problems or die from some forms of blood clots, such as clots that travel to the lungs or that cause heart attacks or strokes. Your healthcare provider will check your blood platelet counts, and change your dose or stop Promacta if your platelet counts get too high. Tell your healthcare provider right away if you have signs and symptoms of a blood clot in the leg, such as swelling, pain, or tenderness in your leg.
  People with chronic liver disease may be at risk for a type of blood clot in the stomach area. Stomach area pain may be a symptom of this type of blood clot.
• Worsening of blood cancers: Promacta is not for use in people with blood cancer or a precancerous condition called myelodysplastic syndrome (MDS). If you have one of these conditions, Promacta may worsen your cancer or condition and may cause you to die sooner.
• New or worsened cataracts (a clouding of the lens in the eye): New or worsened cataracts have happened in people taking Promacta. Your healthcare provider will check your eyes before and during your treatment with Promacta. Tell your healthcare provider about any changes in your eyesight while taking Promacta.

When you are being treated with Promacta, your healthcare provider will closely monitor your dose of Promacta and blood tests, including platelet counts and liver tests.

Avoid situations and medicines that may increase your risk of bleeding.

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Promacta there are no specific foods that you must exclude from your diet when receiving Promacta.

Before you take Promacta, tell your healthcare provider if you:

• have liver or kidney problems
• have or had a blood clot
• have a history of cataracts
• have had surgery to remove your spleen (splenectomy)
• have a bone marrow problem, including a blood cancer or Myelodysplastic Syndrome (MDS)
• have bleeding problems
• are Asian and you are of Chinese, Japanese, Taiwanese, or Korean ancestry, you may need a lower dose of Promacta.
• have any other medical conditions
• are pregnant, think you may be pregnant, or plan to get pregnant. It is not known if Promacta will harm an unborn baby. 
• are breastfeeding or plan to breastfeed

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal products. 

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category C. There is a registry for women who become pregnant during treatment with Promacta. If you become pregnant, consider this registry. The purpose of the registry is to collect safety information about the health of you and your baby. Contact the registry as soon as you become aware of the pregnancy, or ask your healthcare provider to contact the registry for you. You and your healthcare provider can get information and enroll in the registry by calling 1-888-825-5249.

Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known if Promacta passes into your breast milk. You and your healthcare provider should decide whether you will take Promacta or breastfeed. You should not do both.

• Take Promacta exactly as your healthcare provider tells you. Do not stop using Promacta without talking with your healthcare provider first. Do not change your dose or schedule for taking Promacta unless your healthcare provider tells you to change it.
• Take Promacta on an empty stomach, either 1 hour before or 2 hours after eating food.
• Take Promacta at least 4 hours before or 4 hours after eating dairy products and calcium fortified juices.
• If you miss a dose of Promacta, wait and take your next scheduled dose. Do not take more than one dose of Promacta in one day.
• If you take too much Promacta, you may have a higher chance of serious side effects. Call your healthcare provider right away.
• Your healthcare provider will check your platelet count every week and change your dose of Promacta as needed. This will happen every week until your healthcare provider decides that your dose of Promacta can stay the same. After that, you will need to have blood tests every month. When you stop taking Promacta, you will need to have blood tests for at least 4 weeks to check if your platelet count drops too low.
• Tell your healthcare provider about any bruising or bleeding that happens while you take and after you stop taking Promacta.

Take Promacta exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

If you take too much Promacta call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If Promacta is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Store at room temperature between 59˚F to 86˚F (15˚C to 30˚C).
• Keep Promacta and all medicines out of the reach of children.

WARNING: RISK FOR HEPATOTOXICITY

Promacta may cause hepatotoxicity. Promacta, in combination with interferon and ribavirin in patients with chronic hepatitis C, may increase the risk of hepatic decompensation.

Measure serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), and bilirubin prior to initiation of Promacta, every 2 weeks during the dose adjustment phase, and monthly following establishment of a stable dose. If bilirubin is elevated, perform fractionation.

Evaluate abnormal serum liver tests with repeat testing within 3 to 5 days. If the abnormalities are confirmed, monitor serum liver tests weekly until the abnormality(ies) resolve, stabilize, or return to baseline levels.

Discontinue Promacta if ALT levels increase to ≥3X the upper limit of normal (ULN) in patients with normal liver function or ≥3X baseline in patients with pretreatment elevations in transaminases and are:

• progressive, or
• persistent for ≥4 weeks, or
• accompanied by increased direct bilirubin, or
• accompanied by clinical symptoms of liver injury or evidence for hepatic decompensation.