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MEDICATION GUIDE
ALVAIZ™ (al-VAYZ)
(eltrombopag) tablets
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What is the most important information I should know about ALVAIZ?
ALVAIZ may cause serious side effects, including:
Liver problems:
- If you have chronic hepatitis C virus and take ALVAIZ with interferon and ribavirin treatment, ALVAIZ may increase your risk of liver problems. If your healthcare provider tells you to stop your treatment with interferon and ribavirin, you will also need to stop taking ALVAIZ.
- ALVAIZ may increase your risk of liver problems that may be severe and possibly life threatening. Your healthcare provider will do blood tests to check your liver function before you start taking ALVAIZ and during your treatment. Your healthcare provider may stop your treatment with ALVAIZ if you have changes in your liver function blood tests.
Tell your healthcare provider right away if you have any of these signs and symptoms of liver problems:
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- yellowing of the skin or the whites of the eyes (jaundice)
- unusual darkening of the urine
- unusual tiredness
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- right upper stomach area (abdomen) pain
- confusion
- swelling of the stomach area (abdomen)
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See “What are the possible side effects of ALVAIZ?” for other side effects of ALVAIZ.
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What is ALVAIZ?
ALVAIZ is a prescription medicine used to treat:
- adults and children 6 years of age and older with low blood platelet counts due to persistent or chronic immune thrombocytopenia (ITP), when other medicines to treat ITP or surgery to remove the spleen have not worked well enough.
- adults with
- low blood platelet counts due to chronic hepatitis C virus (HCV) infection before and during treatment with interferon.
- severe aplastic anemia (SAA) when other medicines to treat SAA have not worked well enough.
ALVAIZ is used to try to raise platelet counts in order to lower your risk for bleeding.
ALVAIZ is not used to make platelet counts normal.
ALVAIZ is not for use in people with a pre-cancerous condition called myelodysplastic syndrome (MDS), or in people with low platelet counts caused by certain other medical conditions or diseases.
It is not known if ALVAIZ is safe and effective when used with other antiviral medicines to treat chronic hepatitis C.
It is not known if ALVAIZ is safe and effective in children:
- younger than 6 years with persistent or chronic ITP
- with low blood platelet counts due to chronic hepatitis C
- whose severe aplastic anemia (SAA) has not improved after previous treatments
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Before you take ALVAIZ, tell your healthcare provider about all of your medical conditions, including if you:
- have liver problems
- have a precancerous condition called MDS or a blood cancer
- have or had a blood clot
- have a history of cataracts
- have had surgery to remove your spleen (splenectomy)
- have bleeding problems
- are of East-Asian or Southeast-Asian ancestry. You may need a lower dose of ALVAIZ.
- are pregnant or plan to become pregnant. It is not known if ALVAIZ will harm an unborn baby. Tell your healthcare provider if you become pregnant or think you may be pregnant during treatment with ALVAIZ.
- Females who are able to become pregnant, should use effective birth control (contraception) during treatment with ALVAIZ and for at least 7 days after stopping treatment with ALVAIZ. Talk to your healthcare provider about birth control methods that may be right for you during this time.
- are breastfeeding or plan to breastfeed. You should not breastfeed during your treatment with ALVAIZ. Talk to your healthcare provider about the best way to feed your baby during this time.
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Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. ALVAIZ may affect the way certain medicines work. Certain other medicines may affect the way ALVAIZ 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 ALVAIZ from working correctly. Take ALVAIZ at least 2 hours before or 4 hours after taking these products:
- antacid medicine 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.
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How should I take ALVAIZ?
- Take ALVAIZ exactly as your healthcare provider tells you to take it. Your healthcare provider will prescribe the dose of ALVAIZ tablets.
- Swallow ALVAIZ tablets whole. Do not split, chew, or crush ALVAIZ tablets and do not mix with food or liquids. Tell your healthcare provider if your or your child are not able to swallow ALVAIZ tablets whole. You will need to take a different medicine.
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Do not stop taking ALVAIZ without talking with your healthcare provider first. Do not change your dose or schedule for taking ALVAIZ unless your healthcare provider tells you to change it.
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The dose of ALVAIZ is not the same as other eltrombopag products. Do not change between ALVAIZ and other eltrombopag products unless your healthcare provider tells you.
- Take ALVAIZ without a meal or with a meal low in calcium (50 mg or less) and at least 2 hours before or 4 hours after eating calcium-rich foods, such as dairy products, calcium-fortified juices, and certain fruits and vegetables.
- Do not take more than 1 dose of ALVAIZ in 1 day.
- If you take too much ALVAIZ, you may have a higher risk of serious side effects. Call your healthcare provider right away.
- Your healthcare provider will check your platelet count during your treatment with ALVAIZ and change your dose of ALVAIZ as needed.
- Tell your healthcare provider about any bruising or bleeding that happens during treatment and after you stop taking ALVAIZ.
- If you have SAA, your healthcare provider may do tests to monitor your bone marrow during treatment with ALVAIZ.
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What should I avoid while taking ALVAIZ?
Avoid situations and medicines that may increase your risk of bleeding during treatment with ALVAIZ.
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What are the possible side effects of ALVAIZ?
ALVAIZ may cause serious side effects, including:
- See “What is the most important information I should know about ALVAIZ?”
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Increased risk of worsening of a precancerous blood condition called myelodysplastic syndrome (MDS) to acute myelogenous leukemia (AML). ALVAIZ is not for use in people with a precancerous condition called myelodysplastic syndromes (MDS). See “What is ALVAIZ?” If you have MDS and receive ALVAIZ, you have an increased risk that your MDS condition may worsen and become a blood cancer called AML. If your MDS worsens to become AML, you may have an increased risk of death from AML.
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High platelet counts and higher risk for blood clots. Your risk of getting a blood clot is increased if your platelet count is too high during treatment with ALVAIZ. Your risk of getting a blood clot may also be increased during treatment with ALVAIZ 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 ALVAIZ 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 (abdomen). Tell your healthcare provider right away if you have stomach-area (abdomen) pain, nausea, vomiting, or diarrhea as these may be symptoms of this type of blood clot.
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New or worsened cataracts ( a clouding of the lens in the eye). New or worsened cataracts can happen in people taking ALVAIZ. Your healthcare provider will check your eyes before and during your treatment with ALVAIZ. Tell your healthcare provider about any changes in your eyesight during treatment with ALVAIZ.
The most common side effects of ALVAIZ in adults and children include:
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- low red blood cell count (anemia)
- nausea
- fever
- abnormal liver function tests
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- cough
- tiredness
- headache
- diarrhea
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Laboratory test may show abnormal changes to the cells in your bone marrow.
Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all of the possible side effects of ALVAIZ. For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
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How should I store ALVAIZ tablets?
- Store ALVAIZ tablets at room temperature between 68°F to 77°F (20°C to 25°C).
- Keep ALVAIZ in the bottle given to you.
Keep ALVAIZ and all medicines out of the reach of children.
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General information about the safe and effective use of ALVAIZ.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use ALVAIZ for a condition for which it was not prescribed. Do not give ALVAIZ to other people, even if they have the same symptoms that you have. It may harm them.
You can ask your pharmacist or healthcare provider for information about ALVAIZ that is written for health professionals.
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What are the ingredients in ALVAIZ?
Active ingredient: eltrombopag choline
Inactive ingredients:
Tablet Core: anhydrous lactose, copovidone, croscarmellose sodium, edetate disodium dihydrate, magnesium stearate, poloxamer 188, polyethylene glycol 4000, povidone K12, silicified microcrystalline cellulose, and silicon dioxide
Coating:
- 9 mg tablets: FD&C Blue No. 1 aluminum lake, polyethylene glycol 3350, polyvinyl alcohol, talc, and titanium dioxide.
- 18 mg tablets: Hypromellose 2910, polyethylene glycol 4000, talc, and titanium dioxide.
- 36 mg tablets: Iron oxide red, iron oxide yellow, polyethylene glycol 3350, polyvinyl alcohol, talc, and titanium dioxide.
- 54 mg tablets: FD&C Red #40 aluminum lake, hypromellose 2910, iron oxide yellow, polyethylene glycol 400, and titanium dioxide.
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Manufactured For: Teva Pharmaceuticals, Parsippany, NJ 07054
For more information about call Teva at 1-888-832-2872.
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