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עמוד הבית / אופזורו / מידע מעלון לרופא

אופזורו OPTZURO (AVATROMBOPAG AS MALEATE)

תרופה במרשם תרופה בסל נרקוטיקה ציטוטוקסיקה

צורת מתן:

פומי : PER OS

צורת מינון:

טבליות מצופות פילם : FILM COATED TABLETS

Special Warning : אזהרת שימוש

4.4   Special warnings and precautions for use
Thrombotic/thromboembolic events

Patients with chronic liver disease are known to be at increased risk for thromboembolic events. Portal vein thrombosis has been reported at an increased frequency in patients with chronic liver disease who had platelet counts > 200 x 109/L receiving a thrombopoietin receptor agonist (see section 4.8). In patients with chronic immune thrombocytopenia, thromboembolic events (arterial or venous) occurred in 7% (9/128) of patients receiving avatrombopag (see section 4.8).

Optzuro was not studied in patients with prior thromboembolic events. Consider the potential increased thrombotic risk when administering Optzuro to patients with known risk factors for thromboembolism, including but not limited to genetic prothrombotic conditions (e.g.
Factor V Leiden, Prothrombin 20210A, Antithrombin deficiency or Protein C or S deficiency), acquired risk factors (e.g. antiphospholipid syndrome), advanced age, patients with prolonged periods of immobilisation, malignancies, contraceptives and hormone replacement therapy, surgery/trauma, obesity and smoking. Optzuro should not be administered to patients with chronic liver disease or chronic immune thrombocytopenia in an attempt to normalise platelet counts.

QTc prolongation with concomitant medicinal products

At exposures similar to that achieved at the 40 mg and 60 mg dose, Optzuro did not prolong the QT interval to any clinically relevant extent. Mean QTc prolongation effects > 20 ms are not anticipated with the highest recommended therapeutic dosing regimen based on analysis of data from the pooled clinical trials in patients with chronic liver disease. However, caution must be exercised when Optzuro is co-administered with moderate or strong dual CYP3A4/5 and CYP2C9 inhibitors, or with moderate or strong CYP2C9 inhibitors, as these medicinal products can increase avatrombopag exposures.
Caution must also be exercised in patients with loss-of-function polymorphisms of CYP2C9, as these can increase avatrombopag exposure.

Reoccurrence of thrombocytopenia and bleeding after cessation of treatment in patients with chronic immune thrombocytopenia

Thrombocytopenia is likely to reoccur in ITP patients upon discontinuation of treatment with avatrombopag. Following discontinuation of avatrombopag, platelet counts return to baseline levels within 2 weeks in the majority of patients, which increases the bleeding risk and in some cases may lead to bleeding. There is an increased risk of bleeding if avatrombopag treatment is discontinued in the presence of anticoagulants or anti-platelet agents. Patients should be closely monitored for a decrease in platelet count and medically managed to avoid bleeding upon discontinuation of treatment with avatrombopag. It is recommended that, if treatment with avatrombopag is discontinued, ITP treatment be restarted according to current treatment guidelines. Additional medical management may include cessation of anticoagulant and/or antiplatelet therapy, reversal of anticoagulation, or platelet support.
Increased bone marrow reticulin

Increased bone marrow reticulin is believed to be a result of TPO receptor stimulation, leading to an increased number of megakaryocytes in the bone marrow, which may subsequently release cytokines.
Increased reticulin may be suggested by morphological changes in the peripheral blood cells and can be detected through bone marrow biopsy. Therefore, examinations for cellular morphological abnormalities using peripheral blood smear and complete blood count (CBC) prior to and during treatment with avatrombopag are recommended.

If a loss of efficacy and abnormal peripheral blood smear are observed in patients, administration of avatrombopag should be discontinued, a physical examination should be performed, and a bone marrow biopsy with appropriate staining for reticulin should be considered. If available, comparison to a prior bone marrow biopsy should be made. If efficacy is maintained and abnormal peripheral blood smear is observed in patients, the physician should follow appropriate clinical judgment, including consideration of a bone marrow biopsy, and the risk-benefit of avatrombopag and alternative ITP treatment options should be re-assessed.

Progression of existing myelodysplastic syndrome (MDS)

The effectiveness and safety of Optzuro have not been established for the treatment of thrombocytopenia due to MDS. Optzuro should not be used outside of clinical trials for the treatment of thrombocytopenia due to MDS.

There is a theoretical concern that TPO-R agonists may stimulate the progression of existing haematological malignancies such as MDS. TPO-R agonists are growth factors that lead to thrombopoietic progenitor cell expansion, differentiation and platelet production. The TPO-R is predominantly expressed on the surface of cells of the myeloid lineage.

The diagnosis of ITP in adults and elderly patients should have been confirmed by the exclusion of other clinical entities presenting with thrombocytopenia, in particular the diagnosis of MDS must be excluded. Consideration should be given to performing a bone marrow aspirate and biopsy over the course of the disease and treatment, particularly in patients over 60 years of age, for those with systemic symptoms or abnormal signs such as increased peripheral blast cells.

Severe hepatic impairment

There is limited information on the use of avatrombopag in patients with severe (Child-Pugh class C, MELD score > 24) hepatic impairment. Avatrombopag should only be used in such patients if the expected benefit outweighs the expected risks (see sections 4.2 and 5.2).

Patients with severe hepatic impairment should be supported in line with clinical practice by close monitoring for early signs of worsening or new onset hepatic encephalopathy, ascites, and thrombotic or bleeding tendency, through monitoring of liver function tests, tests used for assessing clotting status and through imaging of portal vasculature as needed.

Patients with Child-Pugh class C liver disease who take avatrombopag prior to an invasive procedure, should be evaluated on the day of the procedure for an unexpectedly high increase in platelet count.

Use in patients with chronic liver disease undergoing invasive procedures 
The objective of treatment with Optzuro is to increase platelet counts. While the benefit-risk profile for procedures that were not specifically included in the clinical trials is likely to be comparable, the efficacy and safety of avatrombopag have not been established in major surgeries like laparotomy, thoracotomy, open-heart surgery, craniotomy or excision of organs.


Retreatment for patients with chronic liver disease undergoing invasive procedures 
There is limited information on the use of avatrombopag in patients previously exposed to avatrombopag.

Co-administration with interferon preparations

Interferon preparations have been known to reduce platelet counts, therefore, this should be considered when co-administering avatrombopag with interferon preparations.

Lactose

Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.

Effects on Driving

4.7    Effects on ability to drive and use machines

Optzuro has no or negligible influence on the ability to drive and use machines.

פרטי מסגרת הכללה בסל

הטיפול בתרופה יינתן לטיפול באחד מאלה:א. חולה ב-ITP (immune thrombocytopenic purpura) כרונית או עיקשת (Persistent) הסובל מתרומבוציטופניה קשה (ספירת טסיות נמוכה מ-30,000) לאחר מיצוי טיפול בסטרואידים או אימונוגלובולינים.הטיפול לא יינתן בשילוב עם Eltrombopag או Romiplostim.ב. תרומבוציטופניה (ספירת טסיות נמוכה מ-50,000) בחולה עם מחלת כבד כרונית העומד לעבור פרוצדורה פולשנית.לעניין זה הטיפול יינתן בסמוך לפרוצדורה ולא כטיפול כרוני.
שימוש לפי פנקס קופ''ח כללית 1994 לא צוין
תאריך הכללה מקורי בסל 01/02/2023
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