טבע מודיעה על התוויה ובקבוקונים מעודכנים עבור זריקת ®GRANIX בארה"ב

®GRANIX מותווית להפחתת משך נויטרופניה חריפה בבוגרים ובילדים מגיל חודש ומעלה עם גידולים א-מיאלודיים המקבלים תרופות נגד סרטן מסוג מיאלוסופרסיה הקשורים בהישנות בעל משמעות קלינית של חום נויטרופני.

ירושלים, 6 באוגוסט, 2018 – טבע תעשיות פרמצבטיות בע"מ (NYSE and TASE: TEVA)  הודיעה היום כי מינהל המזון והתרופות האמריקאי (FDA) אישר את זריקת ®tbo-filgrastim) GRANIX) עם בקבוקון חדש והתוויה מעודכנת למטופלים ילדים מגיל חודש ומעלה. ®GRANIX  מותווית להפחתת משך נויטרופניה חריפה בבוגרים ובילדים מגיל חודש ומעלה עם גידולים א-מיאלודיים המקבלים תרופות נגד סרטן מסוג מיאלוסופרסיה הקשורים בהישנות בעל משמעות קלינית של חום נויטרופני.

הבקבוקונים החדשים יהיו זמינים לשימוש במינונים 300mcg/1mL ו- 480mcg/1.6mL בבקבוקונים לשימוש יחיד. מזרקים הממולאים מראש ימשיכו להיות זמינים גם כן.

"התוויית הילדים החדשה והבקבוקונים החדשים של ®GRANIX מרחיבים את מגוון הטיפולים היכולים לתת ערך למטופלים ולמטפלים", אמר ברנדן אוג'ריידי, סמנכ"ל בכיר, מנהל החטיבה המסחרית בצפון אמריקה בטבע.

®GRANIX אושר על ידי ה-FDA באוגוסט 2012. בקבוקוני ®GRANIX צפויים להיות זמינים בארה"ב בקרוב.

Important Safety Information

  • Contraindication: GRANIX is contraindicated in patients with a history of serious allergic reactions to filgrastim or pegfilgrastim products.
  • Fatal Splenic Rupture: Splenic rupture, including fatal cases, can occur following the administration of filgrastim products. Evaluate patients who report upper abdominal or shoulder pain for an enlarged spleen or splenic rupture. Discontinue GRANIX if splenic rupture is suspected or confirmed.
  • Acute Respiratory Distress Syndrome (ARDS): ARDS can occur in patients receiving filgrastim products. Evaluate patients who develop fever and lung infiltrates or respiratory distress after receiving GRANIX, for ARDS. Discontinue GRANIX in patients with ARDS.
  • Serious Allergic Reactions: Serious allergic reactions, including anaphylaxis, can occur in patients receiving GRANIX. Reactions can occur on initial exposure. The administration of antihistamines‚ steroids‚ bronchodilators‚ and/or epinephrine may reduce the severity. Permanently discontinue GRANIX in patients with serious allergic reactions. Do not administer GRANIX to patients with a history of serious allergic reactions to filgrastim or pegfilgrastim.
  • Sickle Cell Disorders: Severe and sometimes fatal sickle cell crises can occur in patients with sickle cell disorders receiving filgrastim products. Discontinue GRANIX if sickle cell crisis occurs.
  • Glomerulonephritis: Glomerulonephritis can occur in patients receiving filgrastim products.  The diagnoses were based on azotemia, hematuria (microscopic and macroscopic), proteinuria, and renal biopsy. Generally, events of glomerulonephritis resolved after dose reduction or discontinuation of the filgrastim product.  If glomerulonephritis is suspected, evaluate for cause. If causality is likely, consider dose-reduction or interruption of GRANIX.
  • Capillary Leak Syndrome (CLS): CLS can occur in patients receiving filgrastim products and is characterized by hypotension, hypoalbuminemia, edema and hemoconcentration.  Episodes vary in frequency, severity and may be life-threatening if treatment is delayed.  Patients who develop symptoms of CLS should be closely monitored and receive standard symptomatic treatment, which may include a need for intensive care.
  • Potential for Tumor Growth Stimulatory Effects on Malignant Cells: The granulocyte colony-stimulating factor (G-CSF) receptor, through which GRANIX acts, has been found on tumor cell lines. The possibility that GRANIX acts as a growth factor for any tumor type, including myeloid malignancies and myelodysplasia, diseases for which GRANIX is not approved, cannot be excluded.
  • Leukocytosis: White blood cell counts of 100‚000/mm3 or greater were observed in approximately 2% of patients receiving filgrastim products at dosages above 5 mcg/kg/day.  In patients with cancer receiving GRANIX as an adjunct to myelosuppressive chemotherapy‚ to avoid the potential risks of excessive leukocytosis‚ it is recommended that GRANIX therapy be discontinued if the ANC surpasses 10‚000/mm3 after the chemotherapy-induced ANC nadir has occurred.  Monitor CBCs at least twice weekly during therapy. Dosages of GRANIX that increase the ANC beyond 10‚000/mm3 may not result in any additional clinical benefit.  In patients with cancer receiving myelosuppressive chemotherapy‚ discontinuation of filgrastim products therapy usually resulted in a 50% decrease in circulating neutrophils within 1 to 2 days‚ with a return to pretreatment levels in 1 to 7 days.
  • Simultaneous Use with Chemotherapy and Radiation Therapy Not Recommended: The safety and efficacy of filgrastim products, including GRANIX, given simultaneously with cytotoxic chemotherapy have not been established. Because of the potential sensitivity of rapidly dividing myeloid cells to cytotoxic chemotherapy‚ do not use GRANIX in the period 24 hours before through 24 hours after the administration of cytotoxic chemotherapy. The safety and efficacy of GRANIX have not been evaluated in patients receiving concurrent radiation therapy. Avoid the simultaneous use of GRANIX with chemotherapy and radiation therapy.
  • Nuclear Imaging: Increased hematopoietic activity of the bone marrow in response to growth factor therapy has been associated with transient positive bone-imaging changes.  Consider this when interpreting bone-imaging results.
  • Aortitis: Aortitis has been reported in patients receiving another filgrastim product.  It may occur as early as the first week after start of therapy.  Manifestations may include generalized signs and symptoms such as fever, abdominal pain, malaise, back pain, and increased inflammatory markers (e.g., c reactive protein and white blood cell count).  Consider aortitis in patients who develop these signs and symptoms without known etiology.  Discontinue GRANIX if aortitis is suspected.
  • Most common treatment-emergent adverse reaction: Most common adverse reaction (≥1%) to GRANIX is bone pain.

Please see Full Prescribing Information for GRANIX here.

אודות טבע

טבע תעשיות פרמצבטיות בע"מ (NYSE & TASE: TEVA) היא מובילה עולמית בגנריקה, עם טיפולים חדשניים בתחומים נבחרים, כולל מערכת העצבים המרכזית, כאב ונשימה. אנו מספקים תרופות גנריות באיכות גבוהה בכמעט כל תחום טיפולי בכדי להתמודד עם צרכי מטופלים אשר אינם זוכים למענה. יש לנו נוכחות מבוססת בגנריקה, תרופות מקור, תרופות ללא מרשם וייצור חומרים כימיים פעילים, ובונים על גבי מורשת בת יותר מ-115 שנה עם מערך מו"פ מאוחד, בסיס תפעולי חזק ותשתית גלובלית נרחבת. אנו חותרים לפעול באופן אחראי ברמה החברתית והסביבתית. המטה שלנו ממוקם בישראל, יש לנו מתקני ייצור ומחקר בכל העולם, ואנו מעסיקים 45,000 עובדים המחויבים לאפשר לשפר את חייהם של מיליוני מטופלים. למידע נוסף על החברה, בקרו באתר www.Teva.co.il

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include risks relating to:

  • uncertainties relating to the potential benefits and success of our new structure and recent senior management changes as well as the potential success and our ability to effectively execute a restructuring plan;
  • our generics medicines business, including: that we are substantially more dependent on this business, with its significant attendant risks, following our acquisition of Allergan plc’s worldwide generic pharmaceuticals business (“Actavis Generics”); our ability to realize the anticipated benefits of the acquisition (and any delay in realizing those benefits) or difficulties in integrating Actavis Generics; the increase in the number of competitors targeting generic opportunities and seeking U.S. market exclusivity for generic versions of significant products; price erosion relating to our generic products, both from competing products and as a result of increased governmental pricing pressures; and our ability to take advantage of high-value biosimilar opportunities;
  • our specialty medicines business, including: competition for our specialty products, especially Copaxone®, our leading medicine, which faces competition from existing and potential additional generic versions and orally-administered alternatives; our ability to achieve expected results from investments in our product pipeline; competition from companies with greater resources and capabilities; and the effectiveness of our patents and other measures to protect our intellectual property rights;
  • our substantially increased indebtedness and significantly decreased cash on hand, which may limit our ability to incur additional indebtedness, engage in additional transactions or make new investments, and may result in a downgrade of our credit ratings;
  • our business and operations in general, including: our ability to develop and commercialize additional pharmaceutical products; manufacturing or quality control problems, which may damage our reputation for quality production and require costly remediation; interruptions in our supply chain; disruptions of our or third party information technology systems or breaches of our data security; the failure to recruit or retain key personnel;the restructuring of our manufacturing network, including potential related labor unrest; the impact of continuing consolidation of our distributors and customers; variations in patent laws that may adversely affect our ability to manufacture our products; our ability to consummate dispositions on terms acceptable to us; adverse effects of political or economic instability, major hostilities or terrorism on our significant worldwide operations; and our ability to successfully bid for suitable acquisition targets or licensing opportunities, or to consummate and integrate acquisitions;
  • compliance, regulatory and litigation matters, including: costs and delays resulting from the extensive governmental regulation to which we are subject; the effects of reforms in healthcare regulation and reductions in pharmaceutical pricing, reimbursement and coverage; potential additional adverse consequences following our resolution with the U.S. government of our FCPA investigation; governmental investigations into sales and marketing practices; potential liability for sales of generic products prior to a final resolution of outstanding patent litigation; product liability claims; increased government scrutiny of our patent settlement agreements; failure to comply with complex Medicare and Medicaid reporting and payment obligations; and environmental risks;
  • other financial and economic risks, including: our exposure to currency fluctuations and restrictions as well as credit risks; the significant increase in our intangible assets, which may result in additional substantial impairment charges; potentially significant increases in tax liabilities; and the effect on our overall effective tax rate of the termination or expiration of governmental programs or tax benefits, or of a change in our business;


and other factors discussed in our Annual Report on Form 20-F for the year ended December 31, 2016 (“Annual Report”), including in the section captioned “Risk Factors,” and in our other filings with the U.S. Securities and Exchange Commission, which are available at www.sec.gov and www.tevapharm.com. Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements. 

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