Promacta eltrombopag olamine 25 mg Powder, For Suspension — NDC 0078-0697-61 (Billing 00078-0697-61)

1 INDICATIONS AND USAGE PROMACTA is a thrombopoietin receptor agonist indicated: for the treatment of thrombocytopenia in adult and pediatric patients 1 year and older with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. PROMACTA should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding. ( 1.1 ) for the treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy.

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. ( 1.2 ) in combination with standard immunosuppressive therapy for the first-line treatment of adult and pediatric patients 2 years and older with severe aplastic anemia. ( 1.3 ) for the treatment of patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy.

( 1.3 ) Limitations of Use: PROMACTA is not indicated for the treatment of patients with myelodysplastic syndrome (MDS). ( 1.4 ) Safety and efficacy have not been established in combination with direct-acting antiviral agents used without interferon for treatment of chronic hepatitis C infection. ( 1.4 )

1.1Treatment of Thrombocytopenia in Patients With Persistent or Chronic Immune Thrombocytopenia PROMACTA is indicated for the treatment of thrombocytopenia in adult and pediatric patients 1 year and older with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. PROMACTA should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding.

1.2Treatment 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. 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.

1.3Treatment of Severe Aplastic Anemia PROMACTA is indicated in combination with standard immunosuppressive therapy (IST) for the first-line treatment of adult and pediatric patients 2 years and older with severe aplastic anemia. PROMACTA is indicated for the treatment of patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy.

1.4Limitations of Use PROMACTA is not indicated for the treatment of patients with myelodysplastic syndromes (MDS) [see Warnings and Precautions (5.3)] . Safety and efficacy have not been established in combination with direct-acting antiviral agents used without interferon for treatment of chronic hepatitis C infection.

2 DOSAGE AND ADMINISTRATION Take PROMACTA without a meal or with a meal low in calcium (≤ 50 mg). Take PROMACTA at least 2 hours before or 4 hours after any medications or products containing polyvalent cations, such as antacids, calcium-rich foods, and mineral supplements. ( 2.4 , 7.1 , 12.3 ) Persistent or Chronic ITP: Initiate PROMACTA at 50 mg orally once daily for most adult and pediatric patients 6 years and older, and at 25 mg orally once daily for pediatric patients aged 1 to 5 years.

Dose reductions are needed for patients with hepatic impairment and some patients of East-/Southeast-Asian ancestry. Adjust to maintain platelet count greater than or equal to 50 x 10 9 /L. Do not exceed 75 mg per day.

( 2.1 , 8.6 , 8.7 ) Chronic Hepatitis C-associated Thrombocytopenia: Initiate PROMACTA at 25 mg orally once daily for all patients. Adjust to achieve target platelet count required to initiate antiviral therapy. Do not exceed a daily dose of 100 mg.

( 2.2 ) First-line Severe Aplastic Anemia: Initiate PROMACTA orally once daily at 2.5 mg/kg (in pediatric patients aged 2 to 5 years old), 75 mg (pediatric patients aged 6 to 11 years old), or 150 mg for patients aged 12 years and older concurrently with standard immunosuppressive therapy. Reduce initial dose in patients of East-/Southeast-Asian ancestry. Modify dosage for toxicity or elevated platelet counts.

( 2.3 , 8.7 ) Refractory Severe Aplastic Anemia: Initiate PROMACTA orally at 50 mg once daily. Reduce initial dose in patients with hepatic impairment or patients of East-/Southeast-Asian ancestry. Adjust to maintain platelet count greater than 50 x 10 9 /L.

Do not exceed 150 mg per day. ( 2.3 , 8.6 , 8.7 )

2.1Persistent or Chronic Immune Thrombocytopenia Use the lowest dose of PROMACTA to achieve and maintain a platelet count greater than or equal to 50 x 10 9 /L as necessary to reduce the risk for bleeding. Dose adjustments are based upon the platelet count response. Do not use PROMACTA to normalize platelet counts [see Warnings and Precautions (5.4)].

In clinical trials, platelet counts generally increased within 1 to 2 weeks after starting PROMACTA and decreased within 1 to 2 weeks after discontinuing PROMACTA [see Clinical Studies (14.1)] . Initial Dose Regimen: Adult and Pediatric Patients 6 Years and Older with ITP: Initiate PROMACTA at a dose of 50 mg orally once daily, except in patients who are of East-/Southeast-Asian ancestry or who have mild to severe hepatic impairment (Child-Pugh class A, B, C). For patients of East-/Southeast-Asian ancestry with ITP, initiate PROMACTA at a reduced dose of 25 mg orally once daily [see Use in Specific Populations (8.7), Clinical Pharmacology (12.3)].

For patients with ITP and mild, moderate, or severe hepatic impairment (Child-Pugh class A, B, C), initiate PROMACTA at a reduced dose of 25 mg orally once daily [see Use in Specific Populations (8.6), Clinical Pharmacology (12.3)] . For patients of East-/Southeast-Asian ancestry with ITP and hepatic impairment (Child-Pugh class A, B, C), consider initiating PROMACTA at a reduced dose of 12.5 mg orally once daily [see Clinical Pharmacology (12.3)] . Pediatric Patients with ITP Aged 1 to 5 Years: Initiate PROMACTA at a dose of 25 mg orally once daily [see Use in Specific Populations (8.7), Clinical Pharmacology (12.3)] .

Monitoring and Dose Adjustment: After initiating PROMACTA, adjust the dose to achieve and maintain a platelet count greater than or equal to 50 x 10 9 /L as necessary to reduce the risk for bleeding. Do not exceed a dose of 75 mg daily. Monitor clinical hematology and liver tests regularly throughout therapy with PROMACTA and modify the dosage regimen of PROMACTA based on platelet counts as outlined in Table 1.

During therapy with PROMACTA, assess complete blood counts (CBCs) with differentials, including platelet counts, weekly until a stable platelet count has been achieved. Obtain CBCs with differentials, including platelet counts, monthly thereafter. When swi… [Excerpted — this section continues on DailyMed.]

3 DOSAGE FORMS AND STRENGTHS Tablets 12.5 mg tablets —– round, biconvex, white, film-coated tablets debossed with “GS MZ1” and 12.5 on one side. Each tablet, for oral administration, contains eltrombopag olamine, equivalent to 12.5 mg of eltrombopag free acid. 25 mg tablets —– round, biconvex, orange, film-coated tablets debossed with “GS NX3” and 25 on one side.

Each tablet, for oral administration, contains eltrombopag olamine, equivalent to 25 mg of eltrombopag free acid. 50 mg tablets —– round, biconvex, blue, film-coated tablets debossed with “GS UFU” and 50 on one side. Each tablet, for oral administration, contains eltrombopag olamine, equivalent to 50 mg of eltrombopag free acid.

75 mg tablets —– round, biconvex, pink, film-coated tablets debossed with “GS FFS” and 75 on one side. Each tablet, for oral administration, contains eltrombopag olamine, equivalent to 75 mg of eltrombopag free acid. For Oral Suspension 12.5 mg packet —– contains a reddish-brown to yellow powder for reconstitution.

25 mg packet —– contains a reddish-brown to yellow powder for reconstitution. Tablets: 12.5 mg, 25 mg, 50 mg, and 75 mg ( 3 ) For oral suspension: 12.5 mg and 25 mg ( 3 )

17 PATIENT COUNSELING INFORMATION 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 (5.4)] . 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 (5.5)] .

Drug Interactions Advise patients to take PROMACTA at least 2 hours before or 4 hours after calcium-rich 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)] . Lactation Advise women not to breastfeed during treatment with PROMACTA [see Use in Specific Populations (8.2)] . Administration of PROMACTA For patients with persistent or chronic ITP, therapy with PROMACTA is administered to achieve and maintain a platelet count greater than or equal to 50 x 10 9 /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)] . Advise patients to take PROMACTA without a meal or with a meal low in calcium (≤ 50 mg) and at least 2 hours before or 4 hours after other medications (e.g., antacids) and calcium-rich foods [see Dosage and Administration (2.4)] . 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] . Inform patients or caregivers to use a new oral dosing syringe to prepare each dose of PROMACTA for oral suspension [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 T2025-27

This Medication Guide has been approved by the U.S. Food and Drug Administration Revised: June 2025 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.

If your healthcare provider tells you to stop your treatment with interferon and ribavirin, you will also need to stop taking PROMACTA. PROMACTA 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 PROMACTA and during your treatment.

Your healthcare provider may stop your treatment with PROMACTA 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: 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 persistent or chronic immune 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) in combination with other medicines to treat SAA, as the first treatment for adults and children 2 years of age and older. 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 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 PROMACTA is safe and effective when used with other antiviral medicines to treat chronic hepatitis C. It is not known if PROMACTA is safe and effective in children: younger than 1 year with ITP with low blood platelet counts due to chronic hepatitis C whose severe aplastic anemia (SAA) has not improved after previous treatments younger than 2 years when used in combination with other medicines to treat SAA as the first treatment for SAA Before you take PROMACTA, 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-/Southeast-Asian 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. Tell your healthcare provider if you become pregnant or think you may be pregnant during treatment with PROMACTA.

Females who are able to become pregnant, should use effective birth control (contraception) during treatment with PROMACTA and for at least 7 days after stopping treatment with PROMACTA. 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 PROMACTA.

Talk to your healthcare provider about the best way to feed your baby during this time. Tell your health… [Excerpted — this section continues on DailyMed.]

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 information you need to know before taking PROMACTA for oral suspension: Do not take PROMACTA for oral suspension or give it to someone else until you have been shown how to properly mix and give a dose of PROMACTA for oral suspension. Your healthcare provider or nurse will show you how to mix 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 the 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 your child, or if you damage or lose any of the supplies in your kit. Do not re-use the oral dosing syringe. Use a new single-use oral dosing syringe to prepare each dose of PROMACTA for oral suspension.

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 30 Single-use 20 mL oral dosing syringes (Use a new (single-use) oral dosing syringe to prepare each dose of PROMACTA for oral suspension) You will need the following to give a 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 single-use 20 mL oral dosing syringe (Use a new (single-use) oral dosing syringe to prepare each dose of PROMACTA for oral suspension) 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) This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Revised: June 2025 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.

Place 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. Note: Use a new (single-use) oral dosing syringe to prepare each dose of PROMACTA for oral suspension. Figure 1.

Step 3. Place the tip of 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.

Figure 2. 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 packets Dose Number of 12.5 mg Packets Needed 12.5 mg dose 1 packet 25 mg dose 2 packets 50 mg dose 4 packets 75 mg dose 6 packets 25 mg packets Dose Number of 25 mg Packets Needed 12.5 mg dose 1 packet (Note: See Step 9 for instructions on how to give a 12.5 mg dose using a 25 mg packet.) 25 mg dose 1 packet 50 mg dose 2 packets 75 mg dose 3 packe… [Excerpted — this section continues on DailyMed.]