Taking TAVALISSE with certain other medicines may affect how the other medicines work or how TAVALISSE works.
TAVALISSE- fostamatinib tabletRigel Pharmaceuticals, Inc. TAVALISSE is indicated for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.
If interrupted, resume TAVALISSE at next lower daily dose (refer to Table 1) when ALT/AST are no longer elevated (below 1.5 × ULN) and total BL remains less than 2 × ULN.
0000003875 00000 n 82 39 Tavalisse Prices, Coupons and Patient Assistance Programs. Table 1: Dose Reduction Schedule, Table 2: Recommended Dose Modifications and Management for Specific Adverse Reactions, Rigel Pharmaceuticals, Inc. product information by RSS, ALT = alanine aminotransferase; AST = aspartate aminotransferase; BP = blood pressure; BL = bilirubin; ULN = upper limit of normal; LFT = liver function tests (AST, ALT, total BL with fractionation if elevated, alkaline phosphatase); AST/ALT = AST or ALT, Stage 1: systolic between 130-139 or diastolic between 80-89 mmHg, Stage 2: systolic at least 140 or diastolic at least 90 mmHg, Hypertensive crisis: systolic over 180 and/or diastolic over 120 mmHg, AST/ALT is 3 × ULN or higher and less than 5 × ULN. trailer <<6356A972BBD14C639E3B6FA7A1564C7D>]/Prev 406905>> startxref 0 %%EOF 120 0 obj <>stream 0000089327 00000 n i1b],���H�g����p��K:��BN���L��X��>�). 0000211068 00000 n
Initiate TAVALISSE at a dose of 100 mg taken orally twice daily. Resume TAVALISSE at next lower daily dose (refer to Table 1). Nausea, rash, dizziness, tiredness, respiratory infection, chest pain, and stomach (abdomen) pain.
© 2020 Rigel Pharmaceuticals, Inc. All rights reserved. Additional medications in the ‘Prescription Medications’ section by. 0000028326 00000 n The most common side effects of TAVALISSE include: These are not all the side effects of TAVALISSE. Resume TAVALISSE at the next lower daily dose (refer to Table 1). Consider interruption or dose reduction of TAVALISSE if ALT/AST and TBL remain in this category (AST/ALT is 3 to 5 × ULN; and total BL remains less than 2 × ULN).
Within the ‘Prescription Medications’ section: Use Trial Bulletin to search for clinical trials involving this product: All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent. Recheck LFTs every 72 hours until ALT/AST values are no longer elevated (below 1.5 × ULN) and total BL remains less than 2 × ULN. 0000011487 00000 n
0000006131 00000 n TAVALISSE can harm your unborn baby. %PDF-1.4 %���� TAVALISSE is a prescription medication used to treat adults with low platelet counts due to chronic immune thrombocytopenia (ITP) when a prior treatment for ITP has not worked well enough. TAVALISSE is an oral medicine that can help you manage chronic immune thrombocytopenia (ITP) by protecting your platelets from destruction, Increased platelet count seen within weeks of starting treatment in most patients, Treatment benefits seen for 3 years and beyond, Works in a different way to limit platelet destruction and raise platelet counts over time, Offers the convenience of a pill that can be taken with or without food. If absolute neutrophil count decreases (ANC less than 1.0 × 10. TAVALISSE is a prescription medication used to treat adults with low platelet counts due to chronic immune thrombocytopenia (ITP) when a prior treatment for ITP has not worked well enough.
TAVALISSE dose modification is recommended based on individual safety and tolerability. It is not known if TAVALISSE is safe and effective in children.
Recheck LFTs every 72 hours until ALT/AST are below 1.5 × ULN) and total BL remains less than 2 × ULN.
0000159022 00000 n TAVA_ITP-20145 0820. All Rights Reserved.
If patient is symptomatic (e.g., nausea, vomiting, abdominal pain): AST/ALT is 5 × ULN or higher and total BL is less than 2 × ULN, AST/ALT is 3 × ULN or higher and total BL is greater than 2 × ULN, Elevated unconjugated (indirect) BL in absence of other LFT abnormalities, Monitor CBCs, including platelet counts, monthly until a stable platelet count (at least 50 × 10. For example, if a patient is on the maximum dose at the time of an adverse reaction, the first dose reduction would be from 300 mg/day to 200 mg/day.
If diarrhea improves to mild (Grade 1), resume TAVALISSE at the next lower daily dose (refer to Table 1).
Tavalisse (fostamatinib) is a member of the miscellaneous coagulation modifiers drug class and is commonly used for Idiopathic Thrombocytopenic Purpura.
are pregnant or plan to become pregnant. If AST and ALT decrease, recheck until ALT and AST are no longer elevated (below 1.5 × ULN) and total BL remains less than 2 × ULN; resume TAVALISSE at next lower daily dose (refer to Table 1). TAVALISSE is a prescription medication used to treat adults with low platelet counts due to chronic immune thrombocytopenia (ITP) when a prior treatment for ITP has not worked well enough. Use the lowest dose of TAVALISSE to achieve and maintain a platelet count at least 950 … SOUTH SAN FRANCISCO, Calif., July 9, 2020 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) today announced that Grifols S.A., its collaborative partner in Europe, has launched TAVLESSE ® in Germany and the United Kingdom.
You may report side effects to FDA, at 1-800-FDA-1088. 0000161729 00000 n Initiate or increase dosage of antihypertensive medication, and adjust as needed until BP is controlled. Initiate TAVALISSE at a dose of 100 mg taken orally twice daily. It is not known if TAVALISSE is safe and effective in children.
Use the lowest dose of TAVALISSE to achieve and maintain a platelet count at least 50 × 109 /L as necessary to reduce the risk of bleeding.
0000087842 00000 n TAVALISSE may be taken with or without food.
0000021770 00000 n
82 0 obj <> endobj xref
0000071234 00000 n 0000003623 00000 n If symptom(s) become severe (Grade 3 or above), temporarily interrupt TAVALISSE. Your healthcare provider will check your blood pressure regularly during treatment with TAVALISSE.
0000010899 00000 n This week's news is a good way for Rigel Pharmaceuticals to kick off 2020. 0000005901 00000 n
0000011119 00000 n 0000000016 00000 n Continue TAVALISSE with frequent monitoring since isolated increase in unconjugated (indirect) BL may be due to UGT1A1 inhibition. TAVALISSE and RIGEL ONECARE are registered trademarks of Rigel Pharmaceuticals, Inc. RIGEL ONECARE is a patient support center sponsored by Rigel Pharmaceuticals, Inc. 1180 Veterans Blvd, South San Francisco, CA 94080. 0000004183 00000 n
If BP returns to less than the target BP, resume TAVALISSE at same daily dose.
If repeat BP is 160/100 mmHg or higher for more than 4 weeks despite aggressive antihypertensive treatment, discontinue TAVALISSE.
The recommended dose modifications for adverse reactions are provided in Table 2. https://medlibrary.org/lib/rx/meds/tavalisse-1/. New or worsening high blood pressure is common in people treated with TAVALISSE and can be severe. For more information, ask your healthcare provider or pharmacist. 0000001937 00000 n
It is not known if TAVALISSE is safe and effective in children. 0000015583 00000 n If AST/ALT persist at 5 × ULN or higher for 2 weeks or more, discontinue TAVALISSE. 0000002927 00000 n If BP remains 160/100 mmHg or higher for more than 4 weeks despite aggressive antihypertensive therapy, interrupt or discontinue TAVALISSE. Manage diarrhea using supportive measures (e.g., dietary changes, hydration and/or antidiarrheal medication) early after the onset until symptom(s) have resolved.
Call your doctor for medical advice about side effects.
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Before you take TAVALISSE, tell your healthcare provider about all of your medical conditions, including if you: Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. TAVALISSE can cause serious side effects including: High blood pressure (hypertension).
TAVALISSE is a prescription medication used to treat adults with low platelet counts due to chronic immune thrombocytopenia (ITP) when a prior treatment for ITP has not worked well enough.
Management of some adverse reactions may require dose-interruption, reduction, or discontinuation. 0000021935 00000 n 0000004219 00000 n 0000024190 00000 n 0000004133 00000 n
0000025644 00000 n
After a month, if platelet count has not increased to at least 50 x 109/L, increase TAVALISSE dose to 150 mg twice daily. While it removes a significant amount of uncertainty surrounding the business and the Tavalisse … 0000189767 00000 n Monitor liver function tests (LFTs) (e.g., ALT, AST, and bilirubin) monthly. 0000127161 00000 n 0000022392 00000 n
0000015331 00000 n If BP remains 140/90 mmHg or higher for more than 8 weeks, reduce TAVALISSE to next lower daily dose (refer to Table 1). Your healthcare provider will check if you are pregnant before starting treatment with TAVALISSE.
Initiate or increase dosage of antihypertensive medication, and adjust as needed until BP is controlled.
Rigel Pharmaceuticals, Inc. 1 INDICATIONS AND USAGE TAVALISSE is indicated for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment. 0000001076 00000 n 0000015888 00000 n
0000002348 00000 n TAVALISSE can cause serious side effects including: Your healthcare provider may change your dose, temporarily stop, or permanently stop treatment with TAVALISSE if you have side effects. After a month, if platelet count has not increased to at least 50 × 109 /L, increase TAVALISSE dose to 150 mg twice daily. Monitor blood pressure every 2 weeks until establishment of a stable dose, then monthly thereafter. 0000015070 00000 n
0000001874 00000 n 0000010278 00000 n 0000027048 00000 n h�b```f``)f`c`��`b@ !�G� �Ù��� Initiate or increase dosage of antihypertensive medication for patients with increased cardiovascular risk, and adjust as needed until BP is controlled. 0000011647 00000 n If the BP target is not met after 8 weeks, reduce TAVALISSE to next lower daily dose (refer to Table 1). Tavalisse Prices.
It is not known if TAVALISSE is safe and effective in children.
0000002123 00000 n
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