promacta package insert

xref PROMACTA is indicated for the treatment of patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy. CONTINUATION CRITERIA: Eltrombopag olamine (Promacta) is re-approved when ALL of the following are met: 1. 0000013336 00000 n Copyright 2022Novartis Pharmaceuticals Corporation. American Society of Hematology 2019 guidelines for immune . The most common adverse reactions (20%) in a single-arm, open-label trial in 43 patients with refractory SAA who received PROMACTA were nausea (33%), fatigue (28%), cough (23%), diarrhea (21%), and headache (21%). 0000004261 00000 n 0 Limitations of UsePROMACTA is not indicated for the treatment of patients with myelodysplastic syndromes (MDS). If liver test abnormalities persist, worsen, or recur, then permanently discontinue PROMACTA, ALT, AST, and bilirubin should be measured prior to initiation of PROMACTA, During treatment, increases in ALT levels should be managed based on recommendation in Dosing and Administration section for hepatic impairment, Thrombotic/thromboembolic complications may result from increases in platelet counts with PROMACTA, Reported thrombotic/thromboembolic complications included both venous and arterial events, and were observed at low and at normal platelet counts, Portal vein thrombosis has been reported in patients with chronic liver disease receiving PROMACTA, To minimize the risk for thrombotic/thromboembolic complications, do not use PROMACTA in an attempt to normalize platelet counts. promacta is used to treat adult patients with chronic immune thrombocytopenia (itp), who have not responded adequately to corticosteroids, immunoglobulins, or to Eltrombopag (Promacta) Eltrombopag is available as an oral tablet available in 12.5 mg, 25 mg, 50 mg, 75 mg, and 100 mg strengths Eltrombopag is also available as a liquid oral suspension The bottle of eltrombopag may contain a little bag that absorbs moisture and keeps the medicine dry. 0000005502 00000 n X. 2. Before sharing sensitive information, make sure you're on a federal government site. The most common adverse reactions in 2 randomized placebo-controlled clinical trials in thrombocytopenic patients with chronic hepatitis C (10% and greater than placebo) for PROMACTA were anemia (40%), pyrexia (30%), fatigue (28%), headache (21%), nausea (19%), diarrhea (19%), decreased appetite (18%), influenza-like illness (18%), asthenia (16%), insomnia (16%), cough (15%), pruritus (15%), chills (14%), myalgia (12%), alopecia (10%), and peripheral edema (10%). IMPORTANT SAFETY INFORMATION, INCLUDING BOXED WARNING, AND INDICATIONS, Prescribing Information for PROMACTA, including Boxed WARNING, and Medication Guide, In 2 controlled clinical trials in patients with chronic hepatitis C and thrombocytopenia, ascites and encephalopathy occurred more frequently with PROMACTA plus antivirals (7%) than antivirals alone (4%), Patients with low albumin levels (<3.5 g/dL) or model for end-stage liver disease score 10 at baseline had a greater risk for hepatic decompensation with PROMACTA plus antivirals, Discontinue PROMACTA if antiviral therapy is discontinued, 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, PROMACTA inhibits UGT1A1 and OATP1B1, which may lead to indirect hyperbilirubinemia. }HG;uLp A }S7%zai!*CXk-&2* '* Xj5zbO&h$B$P`oLP55 Tell your health care provider if you become pregnant or think you may be pregnant during treatment with PROMACTA. WARNING: RISK FOR HEPATIC DECOMPENSATION IN PATIENTS WITH CHRONIC HEPATITISC In patients with chronic hepatitis C, PROMACTA in combination with interferon and ribavirin may increase the risk of hepatic decompensation. %AZ>!%RgAZ6^_f::qZwEGZ&4:xN8Tn Y95 PROMACTA is used to try to raise platelet counts in order to lower your risk for bleeding. 0000012666 00000 n Important Safety Information for PROMACTA (eltrombopag). Kj-x6gNnji]# \MG 4Si^ % ^|^J~LEHgE1r9,NPRVbWb%1RzYlV'L6??s#6J6 q+Wumq>_W`_mEWN! Please see full Prescribing Information for PROMACTA, including Boxed WARNING, and Medication Guide. sYp:S_Zt?;5!ji~U;:r 4FX. Promacta (eltrombopag) is used to treat low blood platelet counts in adults with chronic immune (idiopathic) thrombocytopenia (ITP), when certain other medicines, or surgery to remove the spleen, have not worked well enough. PROMACTA is indicated for the treatment of patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy. 0000005037 00000 n /E@J After a month, if platelet count has not increased to at least 50 10 9 /L, increase Tavalisse dose to 150 mg twice daily. The .gov means its official.Federal government websites often end in .gov or .mil. 3TS1d;=`Mo`4$Qn@qvSL7lu' PROMACTA may affect the way certain medicines work. Cuts, scrapes, or incisions that are red, warm, swollen, or painful. Patient has ONE of the following: i. jIRzTlp6nktl!dMVf:*cxd~3{koK?M%K*Es[`Jh.^H[X#. 7q]OafVeN/W7?w/p8[}us2~'xv7Gv]*W[ms{/VTxqU9W PROMACTA is also used to treat your SAA when other medicines have not worked well enough. 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. What is the most important information I should know about PROMACTA? nosebleed. The American Society of Hematology 2011 evidence- Step 9. You may need a lower dose of PROMACTA, are pregnant or plan to become pregnant. Ht0zIS!CE2.eq{w l0Y[6nO\]gQ,i16*Q/~JQ>m3}~.Y*&CZx>vARtP0 [QY BMux]T (cP"( 4^%a- EiSJ-69 E Nl8a,A P8 -aEy'ZS- JYDr ^^4 ( ^xSxJEYN Qofs}qS .|G ^~ Monitor platelet counts monthly thereafter, Obtain CBCs with differentials, including platelet counts, weekly for at least 4 weeks following discontinuation of PROMACTA, When switching between the oral suspension and tablet, assess platelet counts weekly for 2 weeks, then follow standard monthly monitoring, Monitor CBCs with differentials, including platelet counts, every week prior to starting antiviral therapy. PROMACTA should be used only in patients with ITP whose degree of Reduce the initial dose of PROMACTA in patients with persistent or chronic ITP (adult and pediatric patients 6 years and older only) or refractory severe aplastic anemia who also have hepatic impairment (Child-Pugh Class A, B, C) [see Dosage and Administration (2.1, 2.3), Warnings and Precautions (5.2), Clinical Pharmacology (12.3)]. Avoid situations and medicines that may increase your risk of bleeding. TAVA_ITP-21052 0321. Promacta [package insert]. 2.1 Persistent or Chronic Immune Thrombocytopenia - Use the lowest dose of PROMACTA to achieve and maintain a platelet count greater than or equal to 50 x 109/L as necessary to reduce the risk . endstream endobj 3977 0 obj <>stream PROMACTA can cause serious side effects, including: Liver problems. L;N JLLf@+3^xzn3.yr;6K"X@ k/a6,[mo5 806p&YR sPN:d{1P/t3a`[OLSf q$3NU!|\7a0"x y8SmD_F03n&t2]^T`+v42] @`G#;[4RNKj hD tiredness. Take PROMACTA without a meal or with a meal low in calcium ( 50 mg). Monitor hepatic function and discontinue dosing as recommended. Immune Thrombocytopenia (ITP) a. 0000010100 00000 n Guidelines for the diagnosis and . 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. 0000011125 00000 n If platelet count is > 400 109/L, do not dose.Continue to assess the platelet count weekly. Obtain CBCs with differentials, including platelet counts, weekly during antiviral therapy until a stable platelet count is achieved, then monitor platelet counts monthly thereafter, Monitor clinical hematology tests regularly throughout therapy with PROMACTA and modify the dosage regimen of PROMACTA based on platelet counts, Hematologic response may take up to 16 weeks after starting PROMACTA. This site is for US health care professionals only. The maximal time patients could receive open-label PROMACTA was 9 weeks. Use of website is governed by the Terms of Use and Privacy Policy. Drug-drug interactions were evaluated using sections 7.1 and 12.3 of the most recent package insert available of each medication at the time of this study. Marsh JC, Ball SE, Cavenagh J, et al. hYmO8+Z_biUeiE=NWChD6U=3v:PV"7{g Promacta [package insert]. (2.4, 7.1, 12.3) Persistent or Chronic ITP: Initiate PROMACTA at 50 mg once daily for Revolade 25 mg film-coated tablets . Use the lowest dose of Tavalisse to achieve and maintain a platelet count at least 50 10 9 /L as necessary to reduce the risk of bleeding. gC 0000030840 00000 n Indication and Important Safety Information. Revolade 12.5 mg film-coated tablets . endstream endobj 3974 0 obj <>/Metadata 109 0 R/Outlines 130 0 R/Pages 3967 0 R/StructTreeRoot 138 0 R/Type/Catalog>> endobj 3975 0 obj <>/Font<>/ProcSet[/PDF/Text]>>/Rotate 0/StructParents 26/Tabs/S/Type/Page>> endobj 3976 0 obj <>stream joint pain. What should I avoid while taking PROMACTA? Keep a list of them and show it to your health care provider and pharmacist when you get a new medicine. Revolade 50 mg film-coated tablets . The most common side effects of PROMACTA in adults when used to treat persistent or chronicimmunethrombocytopenia(ITP) are: The most common side effects of PROMACTA in children 1year and older when used to treat persistent or chronic ITP are: The most common side effects when PROMACTA is used in combination with other medicines to treat chronic HCV are: The most common side effects associated with PROMACTA when used in combination with standard immunosuppressive therapy to treat severe aplastic anemia (SAA) reported more frequently than in patients with SAA when other medicines to treat SAA have not worked well enough are: The most common side effects when PROMACTA is used to treat SAA when other medicines to treat SAA have not worked well enough are: Laboratory tests may show abnormal changes to the cells in your bone marrow. Also known as Code name: SB-497115-GR Brand names: Eltrom, Promacta, Revolade References 2 AUSTEDO (deutetrabenazine) tablets AUSTEDO (deutetrabenazine) tablets FULL PRESCRIBING INFORMATION WARNING: DEPRESSION AND SUICIDALITY IN PATIENTS WITH HUNTINGTON'S DISEASE AUSTEDO can increase the risk of depression and suicidal thoughts and behavior If platelet count is > 200 109/L and 400 109/L for 2 consecutive weeks, reduce the dose by 1 mcg/kg. RISK OF HEPATOTOXICITY PROMACTA may increase the risk of severe and potentially life-threatening hepatotoxicity. 6RPkv{|&r=M6a* AtCVm1rqRbvR5Y W > %s8!mid9A[t"$w East Hanover, NJ: Novartis Pharmaceuticals Corporation; October 2021. Tell your health care provider about any bruising or bleeding that happens while you take or after you stop taking PROMACTA. Adult Persistent or Chronic Immune Thrombocytopenia, Pediatric Persistent or Chronic Immune Thrombocytopenia in Patients 1 Year of Age, WARNING: RISK FOR HEPATIC DECOMPENSATION IN PATIENTS WITH CHRONIC HEPATITIS C - In patients with chronic hepatitis C, PROMACTA in combination with interferon and ribavirin may increase the risk of+.

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