Promacta

Eltrombopag is used to increase the number of platelets (cells that help the blood clot) to decrease the risk of bleeding in adults and children 1 year of age and older who have chronic immune thrombocytopenia (ITP; an ongoing condition that may cause unusual bruising or bleeding due to an abnormally low number of platelets in the blood) and who have not been helped or cannot be treated with other treatments, including medications or surgery to remove the spleen. Eltrombopag is also used to increase the number of platelets in people who have hepatitis C (a viral infection that may damage the liver) so that they can begin and continue treatment with interferon (Peginterferon, Pegintron, others) and ribavirin (Rebetol). Eltrombopag is also used to treat people with aplastic anemia (condition in which the body does not make enough new blood cells) who have not been helped with other medications. It is used to increase the number of platelets enough to decrease the risk of bleeding in people with ITP or to allow treatment with interferon and ribavirin in people with hepatitis C, but it is not used to increase the number of platelets to a normal level. Eltrombopag should not be used to treat people who have low numbers of platelets due to conditions other than ITP or hepatitis C. Eltrombopag is in a class of medications called thrombopoietin receptor agonists. It works by causing the cells in the bone marrow to produce more platelets.

Before taking eltrombopag,

• tell your doctor and pharmacist if you are allergic to eltrombopag, any other medications, or any of the ingredients in eltrombopag tablets. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: anticoagulants (blood thinners) such as warfarin (Coumadin, Jantoven); bosentan (Tracleer); cholesterol-lowering medications (statins) such as atorvastatin (Lipitor, in Caduet), fluvastatin (Lescol), pitavastatin (Livalo), pravastatin (Pravachol), rosuvastatin (Crestor), and simvastatin (Zocor, in Simcor, in Vytorin); ezetimibe (Zetia, in Vytorin); glyburide (Diabeta, Glynase, in Glucovance); imatinib (Gleevec); irinotecan (Camptosar); olmesartan (Benicar, in Azor, in Tribenzor, others); lapatinib (Tykerb); methotrexate (Trexall); mitoxantrone; repaglinide (Prandin, in PrandiMet): rifampin (Rimactane, Rifadin, in Rifamate, Rifater); sulfasalazine (Azulfidine); topotecan (Hycamtin), and valsartan (in Diovan HCT, in Entresto, in Exforge). Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with eltrombopag, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.
• if you are taking antacids containing calcium, aluminum, or magnesium (Maalox, Mylanta, Tums) or vitamin or mineral supplements containing calcium, iron, zinc or selenium, take them 2 hours before or 4 hours after you take eltrombopag.
• tell your doctor if you are of East Asian (Chinese, Japanese, Taiwanese, or Korean) descent and if you have or have ever had a cataract (clouding of the lens of the eye that may cause vision problems), blood clots, any condition that increases the risk that you will develop a blood clot, bleeding problems, or liver or kidney disease. Also tell your doctor if you have had surgery to remove your spleen.
• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while taking eltrombopag, call your doctor.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking eltrombopag.
• continue to avoid activities that may cause injury and bleeding during your treatment with eltrombopag. Eltrombopag is given to decrease the risk that you will experience severe bleeding, but there is still a risk that bleeding may occur.

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.

• 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.

Eltrombopag is a man-made form of a protein that increases production of platelets (blood-clotting cells) in your body. Eltrombopag can lower the risk of bleeding by increasing platelets in your blood.

Eltrombopag is used to prevent bleeding episodes in people with chronic immune thrombocytopenic purpura (ITP), a bleeding condition caused by a lack of platelets in the blood. This medicine is for use in adults and children who are at least 1 year old, after other medicines have been tried without success.

Eltrombopag is also used to prevent bleeding in adults with chronic hepatitis C who are treated with an interferon (such as Intron A, Infergen, Pegasys, PegIntron, Rebetron, Redipen, or Sylatron).

Eltrombopag is also used to treat severe aplastic anemia in adults after other medicines have been tried without success.

Eltrombopag is not a cure for ITP and it will not make your platelet counts normal if you have this condition.

Eltrombopag may also be used for purposes not listed in this medication guide.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

You could develop a blood clot if your platelet count gets too high while you are using eltrombopag. Call your doctor or get emergency medical help if you have:

• signs of a stroke--sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;

• signs of a blood clot in the stomach--severe stomach pain, vomiting, diarrhea;

• signs of a blood clot in the lung--chest pain, sudden cough, wheezing, rapid breathing, coughing up blood; or

• signs of a blood clot in your leg--pain, swelling, warmth, or redness in one or both legs.

Call your doctor at once if you have:

• vision changes, tunnel vision, eye pain, or seeing halos around lights;

• flu symptoms such as fever, cough, sore throat, headache, body aches, tired feeling;

• increased or frequent need to urinate;

• pain or burning when you urinate;

• pale skin, easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin; or

• liver problems--confusion, nausea, upper stomach pain, tiredness, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common side effects may include:

• nausea, vomiting, diarrhea, stomach pain;

• cold symptoms such as stuffy nose or sneezing;

• flu symptoms;

• mouth pain, tooth pain;

• muscle pain, back pain, headache;

• feeling weak or tired;

• itching, tingling, or burning under your skin;

• skin rash; or

• abnormal liver function tests.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all your current medicines and any you start or stop using, especially:

• a blood thinner (warfarin, Coumadin, Jantoven); or

• cholesterol medication--atorvastatin, ezetimibe, fluvastatin, pitavastatin, pravastatin, rosuvastatin, or simvastatin.

This list is not complete. Other drugs may interact with eltrombopag, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

• If you have an allergy to eltrombopag or any other part of this medicine.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you are breast-feeding or plan to breast-feed.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Promacta with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of a urinary tract infection (UTI) like blood in the urine, burning or pain when passing urine, feeling the need to pass urine often or right away, fever, lower stomach pain, or pelvic pain.
• Feeling very tired or weak.
• Very bad belly pain.
• Chest pain or pressure.
• Shortness of breath.
• Coughing up blood.
• Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
• Swelling, warmth, numbness, change of color, or pain in a leg or arm.
• Change in eyesight, eye pain, or very bad eye irritation.
• A burning, numbness, or tingling feeling that is not normal.
• Very upset stomach or throwing up.
• Very loose stools (diarrhea).
• Any bruising or bleeding while you take and after you stop taking Promacta.
• Very bad mouth pain or irritation.
• Feeling confused.
• Swelling of belly.
• Swelling in the arms or legs.
• Fever or chills.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Treatment of Thrombocytopenia in Patients with Chronic ITP

Promacta is indicated for the treatment of thrombocytopenia in adult and pediatric patients 1 year and older with chronic immune (idiopathic) thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.

Limitations of Use: Promacta should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding.

Treatment of Thrombocytopenia in Patients with Hepatitis C Infection

Promacta is indicated for the treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy.

Limitations of Use:

• Promacta should be used only in patients with chronic hepatitis C whose degree of thrombocytopenia prevents the initiation of interferon-based therapy or limits the ability to maintain interferon-based therapy. • Safety and efficacy have not been established in combination with direct-acting antiviral agents used without interferon for treatment of chronic hepatitis C infection.

Treatment of Severe Aplastic Anemia

Promacta is indicated for the treatment of patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy.

Promacta (eltrombopag) tablets contain eltrombopag olamine, a small molecule thrombopoietin (TPO) receptor agonist for oral administration. Eltrombopag interacts with the transmembrane domain of the TPO receptor (also known as cMpl) leading to increased platelet production.

Eltrombopag olamine is a biphenyl hydrazone. The chemical name for eltrombopag olamine is 3'-{(2Z)-2-[1-(3,4-dimethylphenyl)-3-methyl-5-oxo-1,5-dihydro-4H-pyrazol-4-ylidene]hydrazino}-2'-hydroxy-3-biphenylcarboxylic acid - 2-aminoethanol (1:2). It has the molecular formula C25H22N4O4•2(C2H7NO). The molecular weight is 564.65 for eltrombopag olamine and 442.5 for eltrombopag free acid. Eltrombopag olamine has the following structural formula:

Eltrombopag olamine is practically insoluble in aqueous buffer across a pH range of 1 to 7.4, and is sparingly soluble in water.

Promacta (eltrombopag) tablets contain eltrombopag olamine in the amount equivalent to 12.5 mg, 25 mg, 50 mg, 75 mg, or 100 mg of eltrombopag free acid. The inactive ingredients of Promacta tablets are: Tablet Core: magnesium stearate, mannitol, microcrystalline cellulose, povidone, and sodium starch glycolate. Coating: hypromellose (12.5-mg, 25-mg, 50-mg, and 75-mg tablets) or polyvinyl alcohol and talc (100-mg tablet), polyethylene glycol 400, titanium dioxide, polysorbate 80 (12.5-mg tablet), FD&C Yellow No. 6 aluminum lake (25-mg tablet), FD&C Blue No. 2 aluminum lake (50-mg tablet), Iron Oxide Red and Iron Oxide Black (75-mg tablet), or Iron Oxide Yellow and Iron Oxide Black (100-mg tablet).

Promacta (eltrombopag) for oral suspension packets contain a reddish-brown to yellow powder which produces a reddish-brown suspension when reconstituted with water. Each 25-mg packet delivers eltrombopag olamine equivalent to 25 mg of eltrombopag free acid. The inactive ingredients of Promacta for oral suspension are mannitol, sucralose, and xanthan gum.

Advise the patient or caregiver to read the FDA-approved patient labeling (Medication Guide and Instructions for Use).

Prior to treatment, patients should fully understand and be informed of the following risks and considerations for Promacta:

Risks

Hepatotoxicity

• Therapy with Promacta may be associated with hepatobiliary laboratory abnormalities [see Warnings and Precautions (5.2)].
• Advise patients with chronic hepatitis C and cirrhosis that they may be at risk for hepatic decompensation when receiving Promacta with alfa interferon therapy [see Warnings and Precautions (5.1)].
• Advise patients that they should report any of the following signs and symptoms of liver problems to their healthcare provider right away [see Warnings and Precautions (5.2)].
  • yellowing of the skin or the whites of the eyes (jaundice)
  • unusual darkening of the urine
  • unusual tiredness
  • right upper stomach area pain
  • confusion
  • swelling of the stomach area (abdomen)

Risk of Bleeding Upon Promacta Discontinuation

• Advise patients that thrombocytopenia and risk of bleeding may reoccur upon discontinuing Promacta, particularly if Promacta is discontinued while the patient is on anticoagulants or antiplatelet agents. Advise patients that during therapy with Promacta, they should continue to avoid situations or medications that may increase the risk for bleeding.

Thrombotic/Thromboembolic Complications

• Advise patients that too much Promacta may result in excessive platelet counts and a risk for thrombotic/thromboembolic complications [see Warnings and Precautions (5.3)].

Cataracts

• Advise patients to have a baseline ocular examination prior to administration of Promacta and be monitored for signs and symptoms of cataracts during therapy [see Warnings and Precautions (5.4)].

Drug Interactions

• Advise patients to take Promacta at least 2 hours before or 4 hours after foods, mineral supplements, and antacids which contain polyvalent cations such as iron, calcium, aluminum, magnesium, selenium, and zinc [see Dosage and Administration (2.4), Drug Interactions (7.1)].

Administration of Promacta

• For patients with chronic ITP, therapy with Promacta is administered to achieve and maintain a platelet count greater than or equal to 50 x 109/L as necessary to reduce the risk for bleeding [see Indications and Usage (1.1)].
• For patients with chronic hepatitis C, therapy with Promacta is administered to achieve and maintain a platelet count necessary to initiate and maintain antiviral therapy with pegylated interferon and ribavirin [see Indications and Usage (1.2)].
• Prior to use of the oral suspension, ensure patients or caregivers receive training on proper dosing, preparation, and administration [see Dosage and Administration (2.4)].
• Inform patients or caregivers how many packets to administer to get the full dose [see Instructions for Use].

The following are registered trademarks of their respective owners: PEGASYS/Hoffmann-La Roche Inc.; PEGINTRON/Schering Corporation.

Distributed by:
Novartis Pharmaceuticals Corporation
East Hanover, New Jersey 07936

©Novartis

T2017-73
July 2017

This Medication Guide has been approved by the U.S. Food and Drug Administration	Revised March 2017
MEDICATION GUIDE
Promacta® (pro-MAC-ta) (eltrombopag) tablets	Promacta® (pro-MAC-ta) (eltrombopag) for oral suspension
What is the most important information I should know about Promacta? Promacta can cause serious side effects, including: Liver problems. If you have chronic hepatitis C virus, and take Promacta with interferon and ribavirin treatment, Promacta may increase your risk of liver problems. 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 (abdomen) pain confusion swelling of the stomach area (abdomen) See “What are the possible side effects of Promacta?” for other side effects of Promacta. What is Promacta? Promacta is a prescription medicine used to treat adults and children 1 year of age and older with low blood platelet counts due to chronic immune (idiopathic) thrombocytopenia (ITP), when other medicines to treat ITP or surgery to remove the spleen have not worked well enough. Promacta is also used to treat people 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. Promacta is used to try to raise platelet counts in order to lower your risk for bleeding. Promacta is not used to make platelet counts normal. Promacta is for treatment of certain people with low platelet counts caused by chronic ITP, chronic HCV, or SAA, not low platelet counts caused by other conditions or diseases. It is not known if Promacta is safe and effective when used with other antiviral medicines that are approved to treat chronic hepatitis C. It is not known if Promacta is safe and effective in children with chronic hepatitis C or severe aplastic anemia or in children younger than 1 year with ITP.
What should I tell my healthcare provider before taking Promacta? Before you take Promacta, tell your healthcare provider about all of your medical conditions, including 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 bleeding problems are Asian and you are of Chinese, Japanese, Taiwanese, or Korean ancestry. You may need a lower dose of Promacta. are pregnant or plan to become pregnant. It is not known if Promacta will harm an unborn baby. 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.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. 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 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.
How should I take Promacta? Take Promacta exactly as your healthcare provider tells you to take it. Your healthcare provider will prescribe the dose of Promacta tablets or Promacta oral suspension that is right for you. If your healthcare provider prescribes Promacta oral suspension, see “Instructions for Use” that comes with your medicine for instructions on how to prepare and take your dose. Do not stop taking 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 2 hours before or 4 hours after eating dairy products and calcium-fortified juices. Take Promacta tablets whole. Do not crush Promacta tablets and mix with food or liquids. 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 risk of serious side effects. Call your healthcare provider right away. Your healthcare provider will check your platelet count during your treatment with Promacta and change your dose of Promacta as needed. Tell your healthcare provider about any bruising or bleeding that happens while you take and after you stop taking Promacta.
What should I avoid while taking Promacta? Avoid situations and medicines that may increase your risk of bleeding.
What are the possible side effects of Promacta? Promacta may cause serious side effects, including: See “What is the most important information I should know about Promacta?” Abnormal liver function tests. Your healthcare provider will order blood tests to check your liver before you start taking Promacta and during your treatment. In some cases treatment with Promacta may need to be stopped due to changes in your liver function tests. 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 Promacta. Your risk 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. Tell your healthcare provider right away if you have stomach area pain that may be a symptom of this type of blood clot. 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.
The most common side effects of Promacta in adults when used to treat chronic ITP are: nausea diarrhea upper respiratory tract infection. Symptoms may include runny nose, stuffy nose, and sneezing vomiting muscle aches urinary tract infection. 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 back pain ”flu”-like symptoms (influenza) including fever, headache, tiredness, cough, sore throat, and body aches skin tingling, itching, or burning rash
The most common side effects of Promacta in children 1 year and older when used to treat chronic ITP are: upper respiratory tract infection. Symptoms may include runny nose, stuffy nose, and sneezing. pain or swelling (inflammation) in your nose or throat (nasopharyngitis) cough diarrhea fever runny, stuffy nose (rhinitis) stomach (abdominal) pain pain or swelling (inflammation) in your throat or mouth (oropharyngeal pain) toothache rash abnormal liver function tests
The most common side effects when Promacta is used in combination with other medicines to treat chronic HCV are: low red blood cell count (anemia) fever tiredness headache nausea diarrhea decreased appetite “flu”-like symptoms (influenza) including fever, headache, tiredness, cough, sore throat, and body aches feeling weak trouble sleeping cough itching chills muscle aches hair loss swelling in your ankles, feet, and legs
The most common side effects when Promacta is used to treat severe aplastic anemia are: nausea feeling tired cough diarrhea headache Laboratory tests 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 the possible side effects of Promacta. 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.
How should I store Promacta tablets and oral suspension? Tablets: Store Promacta tablets at room temperature between 68°F to 77°F (20°C to 25°C). Keep Promacta tightly closed in the bottle given to you. The Promacta bottle may contain a desiccant pack to help keep your medicine dry. Do not remove the desiccant pack from the bottle. For oral suspension: Store Promacta for oral suspension at room temperature between 68°F to 77°F (20°C to 25°C). After mixing, Promacta should be taken right away but may be stored for no more than 30 minutes between 68°F to 77°F (20°C to 25°C). Throw away (discard) the mixture if not used within 30 minutes. Keep Promacta and all medicines out of the reach of children.
General information about the safe and effective use of Promacta Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Promacta for a condition for which it was not prescribed. Do not give Promacta to other people, even if they have the same symptoms that you have. It may harm them. You can ask your healthcare provider or pharmacist for information about Promacta that is written for health professionals.
What are the ingredients in Promacta? Tablets: Active ingredient: eltrombopag olamine. Inactive ingredients: Tablet Core: magnesium stearate, mannitol, microcrystalline cellulose, povidone, and sodium starch glycolate. Coating: hypromellose (12.5-mg, 25-mg, 50-mg, and 75-mg tablets) or polyvinyl alcohol and talc (100-mg tablet), polyethylene glycol 400, titanium dioxide, polysorbate 80 (12.5-mg tablet), and FD&C Yellow No. 6 aluminum lake (25-mg tablet), FD&C Blue No. 2 aluminum lake (50-mg tablet), Iron Oxide Red and Iron Oxide Black (75-mg tablet), or Iron Oxide Yellow and Iron Oxide Black (100-mg tablet). For oral suspension: Active ingredient: eltrombopag olamine. Inactive ingredients: mannitol, sucralose, xanthan gum. Distributed by: Novartis Pharmaceuticals Corporation East Hanover, New Jersey 07936 ©Novartis T2017-33 For more information about Promacta, go to www.Promacta.com or call 1-888-669-6682.

INSTRUCTIONS FOR USE

Promacta® (pro-MAC-ta)

(eltrombopag)

for oral suspension

Read all the Instructions for Use and follow the steps below to mix and give a dose of Promacta for oral suspension.

Important:

• Do not take Promacta for oral suspension or give it to someone else until you have been shown how to properly give Promacta for oral suspension. Your healthcare provider or nurse will show you how to prepare and give a dose of Promacta for oral suspension properly. • Promacta for oral suspension must be mixed with cool or cold water only. Do not use hot water to prepare the oral suspension. • Give the dose of suspension right away after mixing with water. If medicine is not given within 30 minutes, you will have to mix a new dose. Throw away (discard) the unused mixture into the trash. Do not pour it down the drain. • If Promacta for oral suspension comes in contact with your skin, wash the skin right away with soap and water. Call your healthcare provider if you have a skin reaction or if you have any questions. If you spill any powder or liquid, follow the clean up instructions in Step 12. • Contact your healthcare provider or pharmacist if you have any questions about how to mix or give Promacta to the child or if you damage or lose any of the supplies in your kit. • After you have used all 30 packets, throw all the remaining supplies (mixing bottle, lid with cap, and oral dosing syringe) away in the trash.

Each Promacta for oral suspension kit contains the following supplies:

30 packets of Promacta for oral suspension
1 Reusable mixing bottle with lid and cap
1 Reusable 20-mL oral dosing syringe

You will need the following to give a single dose of Promacta for oral suspension.

From the kit:

• prescribed number of packets • 1 reusable mixing bottle with lid and cap. NOTE: Due to its small size, the cap may pose a danger of choking to small children. • 1 reusable 20-mL oral dosing syringe

Not included in the kit:

• 1 clean glass or cup filled with drinking water • scissors to cut packet • paper towels or disposable cloth • disposable gloves (optional)

How do I prepare a dose of Promacta for oral suspension?
Step 1. Make sure that the mixing bottle, cap, lid and oral dosing syringe are dry before use. Remove the lid from the mixing bottle. • Prepare a clean, flat work surface. • Wash and dry your hands before preparing the medicine.
Step 2. Fill the oral dosing syringe with 20 mL of drinking water from the glass or cup. • Start with the plunger pushed all the way into the syringe. • Put the tip of the oral dosing syringe all the way into the water and pull back on the plunger to the 20 mL mark on the barrel of the oral dosing syringe.
Step 3. Place the oral dosing syringe into the open mixing bottle. Empty water into open mixing bottle by slowly pushing the plunger all the way into the oral dosing syringe.
Step 4. Take only the prescribed number of packets for one dose out of the kit. You may need to use more than one packet to prepare the entire dose. • 12.5-mg dose (1 packet); Note: See Step 9 for instructions on how to give a 12.5-mg dose. • 25-mg dose (1 packet) • 50-mg dose (2 packets) • 75-mg dose (3 packets)
Step 5. Add the prescribed number of packets to the mixing bottle. • Tap the top of each packet to make sure the contents fall to the bottom. • Cut off the top of the packet with scissors and empty the entire contents of the packet into the mixing bottle. • Make sure not to spill the powder outside the mixing bottle.
Step 6. Screw the lid tightly onto the mixing bottle. Make sure the cap is pushed onto the lid.
Step 7. Gently and slowly shake the mixing bottle back and forth for at least 20 seconds to mix the water with the powder. • To prevent the mixture from foaming, do not shake the mixing bottle hard.
How should I give a dose of Promacta for oral suspension?
Step 8. Make sure the plunger is pushed all the way into the oral dosing syringe. Pull cap off the mixing bottle lid and insert the tip of the oral dosing syringe into the hole in the lid.
Step 9. Transfer the mixture into the oral dosing syringe. The liquid will be dark brown in color. • Turn the mixing bottle upside down along with the oral dosing syringe. • Pull back the plunger: o to the 10 mL mark on the oral dosing syringe for a 12.5-mg dose only OR o until all the medicine is in the oral dosing syringe (25-mg, 50-mg, or 75-mg dose).
Step 10. Return the mixing bottle to the upright position and remove the oral dosing syringe from the mixing bottle.
Step 11. Giving a dose of Promacta for oral suspension to a child. • Place the tip of the oral dosing syringe into the inside of the child’s cheek. • Slowly push the plunger all the way down to give the entire dose. Make sure the child has time to swallow the medicine.
How should I clean up?
Step 12. Carefully clean up any spill of the powder or suspension with a damp paper towel or disposable cloth. • To avoid possibly staining your skin, consider using disposable gloves. • Throw away (discard) used paper towel or disposable cloth and gloves in the trash.
Step 13. Clean the mixing supplies. • Do not reuse any of the mixture remaining in the mixing bottle. • Throw away (discard) any mixture remaining in the mixing bottle in the trash. Do not pour down the drain. • Remove the plunger from the oral dosing syringe. • Rinse the mixing bottle, lid, oral dosing syringe, and plunger under running water and air dry. The mixing bottle may become stained from the medicine. This is normal. • Wash hands with soap and water.

How should I store Promacta for oral suspension?

• Store Promacta for oral suspension at room temperature between 68°F to 77°F (20°C to 25°C). • After mixing, Promacta should be taken right away but may be stored for no more than 30 minutes between 68°F to 77°F (20°C to 25°C). Throw away (discard) the mixture if not used within 30 minutes.

Keep Promacta and all medicines out of the reach of children.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Revised: March 2017

Distributed by:
Novartis Pharmaceuticals Corporation
East Hanover, New Jersey 07936

©Novartis

T2017-34

PRINCIPAL DISPLAY PANEL

NDC 0078-0684-15

Promacta®

(eltrombopag) Tablets

12.5 mg*

30 Tablets

Rx only

*Each tablet contains eltrombopag olamine equivalent to 12.5 mg of eltrombopag free acid.

Federal Law requires dispensing of Promacta® with the Medication Guide provided with this bottle.

Store between 20o and 25oC (68o to 77oF); excursions permitted to 15o to 30oC (59o to 86oF).

Do not use if printed safety seal under cap is broken or missing.

Dosage: See accompanying prescribing information.

Important: Use safety closures when dispensing this product unless otherwise directed by physicians or requested by purchaser.

Novartis

Made in Ireland

PRINCIPAL DISPLAY PANEL

NDC 0078-0685-15

Promacta®

(eltrombopag) Tablets

25 mg*

30 Tablets

Rx only

*Each tablet contains eltrombopag olamine equivalent to 25 mg of eltrombopag free acid.

Federal Law requires dispensing of Promacta® with the Medication Guide provided with this bottle.

Store between 20o and 25oC (68o to 77oF); excursions permitted to 15o to 30oC (59o to 86oF).

Do not use if printed safety seal under cap is broken or missing.

Dosage: See accompanying prescribing information.

Important: Use safety closures when dispensing this product unless otherwise directed by physicians or requested by purchaser.

Novartis

Made in Ireland

PRINCIPAL DISPLAY PANEL

NDC 0078-0686-15

Promacta®

(eltrombopag) Tablets

50 mg*

30 Tablets

Rx only

*Each tablet contains eltrombopag olamine equivalent to 50 mg of eltrombopag free acid.

Federal Law requires dispensing of Promacta® with the Medication Guide provided with this bottle.

Store between 20o and 25oC (68o to 77oF); excursions permitted to 15o to 30oC (59o to 86oF).

Do not use if printed safety seal under cap is broken or missing.

Dosage: See accompanying prescribing information.

Important: Use safety closures when dispensing this product unless otherwise directed by physicians or requested by purchaser.

Novartis

Made in Ireland

PRINCIPAL DISPLAY PANEL

NDC 0078-0687-15

Promacta®

(eltrombopag) Tablets

75 mg*

30 Tablets

Rx only

*Each tablet contains eltrombopag olamine equivalent to 75 mg of eltrombopag free acid.

Federal Law requires dispensing of Promacta® with the Medication Guide provided with this bottle.

Store between 20o and 25oC (68o to 77oF); excursions permitted to 15o to 30oC (59o to 86oF).

Do not use if printed safety seal under cap is broken or missing.

Dosage: See accompanying prescribing information.

Important: Use safety closures when dispensing this product unless otherwise directed by physicians or requested by purchaser.

Novartis

Made in Ireland

Promacta  eltrombopag olamine tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0078-0684 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ELTROMBOPAG OLAMINE (ELTROMBOPAG) ELTROMBOPAG 12.5 mg

Inactive Ingredients Ingredient Name Strength MAGNESIUM STEARATE   MANNITOL   CELLULOSE, MICROCRYSTALLINE   POVIDONES   SODIUM STARCH GLYCOLATE TYPE A POTATO   HYPROMELLOSES   POLYETHYLENE GLYCOL 400   TITANIUM DIOXIDE   FERRIC OXIDE RED   FERROSOFERRIC OXIDE

Product Characteristics Color WHITE Score no score Shape ROUND Size 10mm Flavor Imprint Code GS;MZ1;125 Contains

Packaging # Item Code Package Description 1 NDC:0078-0684-15 30 TABLET, FILM COATED in 1 BOTTLE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA022291 08/22/2016

Promacta  eltrombopag olamine tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0078-0685 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ELTROMBOPAG OLAMINE (ELTROMBOPAG) ELTROMBOPAG 25 mg

Inactive Ingredients Ingredient Name Strength MAGNESIUM STEARATE   MANNITOL   CELLULOSE, MICROCRYSTALLINE   POVIDONES   SODIUM STARCH GLYCOLATE TYPE A POTATO   HYPROMELLOSES   POLYETHYLENE GLYCOL 400   TITANIUM DIOXIDE   FERRIC OXIDE RED   FERROSOFERRIC OXIDE

Product Characteristics Color ORANGE Score no score Shape ROUND Size 10mm Flavor Imprint Code GS;NX3;25 Contains

Packaging # Item Code Package Description 1 NDC:0078-0685-15 30 TABLET, FILM COATED in 1 BOTTLE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA022291 05/24/2016

Promacta  eltrombopag olamine tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0078-0686 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ELTROMBOPAG OLAMINE (ELTROMBOPAG) ELTROMBOPAG 50 mg

Inactive Ingredients Ingredient Name Strength MAGNESIUM STEARATE   MANNITOL   CELLULOSE, MICROCRYSTALLINE   POVIDONES   SODIUM STARCH GLYCOLATE TYPE A POTATO   HYPROMELLOSES   POLYETHYLENE GLYCOL 400   TITANIUM DIOXIDE   FD&C BLUE NO. 2

Product Characteristics Color BLUE Score no score Shape ROUND Size 10mm Flavor Imprint Code GS;UFU;50 Contains

Packaging # Item Code Package Description 1 NDC:0078-0686-15 30 TABLET, FILM COATED in 1 BOTTLE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA022291 04/07/2016

Promacta  eltrombopag olamine tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0078-0687 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ELTROMBOPAG OLAMINE (ELTROMBOPAG) ELTROMBOPAG 75 mg

Inactive Ingredients Ingredient Name Strength MAGNESIUM STEARATE   MANNITOL   CELLULOSE, MICROCRYSTALLINE   POVIDONES   SODIUM STARCH GLYCOLATE TYPE A POTATO   HYPROMELLOSES   POLYETHYLENE GLYCOL 400   TITANIUM DIOXIDE   FERRIC OXIDE RED   FERROSOFERRIC OXIDE

Product Characteristics Color PINK Score no score Shape ROUND Size 10mm Flavor Imprint Code GS;FFS;75 Contains

Packaging # Item Code Package Description 1 NDC:0078-0687-15 30 TABLET, FILM COATED in 1 BOTTLE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA022291 04/01/2016

Labeler - Novartis Pharmaceuticals Corporation (002147023)

Revised: 07/2017   Novartis Pharmaceuticals Corporation

Before you take Promacta tell your doctor if you have kidney disease, blood cancer, a bone marrow disorder, high platelet levels, liver problems (if you are not being treated for hepatitis C), a history of cataracts or blood clot, if your spleen has been removed, or if you are of East Asian descent. Also tell your doctor about all other medications you use.

Take Promacta on an empty stomach, at least 1 hour before or 2 hours after a meal. Do not take this medication with milk. Avoid all dairy products or products that contain calcium (including fortified fruit juice) for at least 4 hours before or after you take Promacta.

If you have chronic hepatitis C, taking Promacta with ribavirin and interferon treatment can increase your risk of liver problems. Call your doctor at once if you have signs of liver problems: nausea, upper stomach pain, confusion, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

After you stop taking this medicine, your risk of bleeding may be even higher than it was before you started treatment. Be extra careful to avoid cuts or injury for at least 4 weeks after you stop taking this medicine. Your blood will need to be tested weekly during this time.

Avoid taking other medicines within 4 hours before or 2 hours after you take Promacta. This includes antacids, vitamins, mineral supplements, or any other product that contains aluminum, calcium, iron, magnesium, selenium, or zinc.

Avoid all dairy products or products that contain calcium (including fortified fruit juice) for at least 4 hours before or 2 hours after you take Promacta.

Avoid activities that may increase your risk of bleeding or injury. Use extra care to prevent bleeding while shaving or brushing your teeth.