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Use Following Induction Chemotherapy in Acute Myelogenous Leukemia
Leucomax (Novartis) (Leucomax (Novartis)) is indicated for use following induction chemotherapy in older adult patients with acute myelogenous leukemia (AML) to shorten time to neutrophil recovery and to reduce the incidence of severe and life-threatening infections and infections resulting in death. The safety and efficacy of Leucomax (Novartis) (Leucomax (Novartis)) have not been assessed in patients with AML under 55 years of age.
The term acute myelogenous leukemia, also referred to as acute non-lymphocytic leukemia (ANLL), encompasses a heterogeneous group of leukemias arising from various non-lymphoid cell lines which have been defined morphologically by the French-American- British (FAB) system of classification.
Use in Mobilization and Following Transplantation of Autologous Peripheral Blood Progenitor Cells
Leucomax (Novartis) (Leucomax (Novartis)) is indicated for the mobilization of hematopoietic progenitor cells into peripheral blood for collection by leukapheresis. Mobilization allows for the collection of increased numbers of progenitor cells capable of engraftment as compared with collection without mobilization. After myeloablative chemotherapy, the transplantation of an increased number of progenitor cells can lead to more rapid engraftment, which may result in a decreased need for supportive care. Myeloid reconstitution is further accelerated by administration of Leucomax (Novartis) (Leucomax (Novartis)) following peripheral blood progenitor cell transplantation.
Use in Myeloid Reconstitution After Autologous Bone Marrow Transplantation
Leucomax (Novartis) (Leucomax (Novartis)) is indicated for acceleration of myeloid recovery in patients with non-Hodgkin's lymphoma (NHL), acute lymphoblastic leukemia (ALL) and Hodgkin's disease undergoing autologous bone marrow transplantation (BMT). After autologous BMT in patients with NHL, ALL, or Hodgkin's disease, Leucomax (Novartis) (Leucomax (Novartis)) has been found to be safe and effective in accelerating myeloid engraftment, decreasing median duration of antibiotic administration, reducing the median duration of infectious episodes and shortening the median duration of hospitalization. Hematologic response to Leucomax (Novartis) (Leucomax (Novartis)) can be detected by complete blood count (CBC) with differential cell counts performed twice per week.
Use in Myeloid Reconstitution After Allogeneic Bone Marrow Transplantation
Leucomax (Novartis) (Leucomax (Novartis)) is indicated for acceleration of myeloid recovery in patients undergoing allogeneic BMT from HLAmatched related donors. Leucomax (Novartis) (Leucomax (Novartis)) has been found to be safe and effective in accelerating myeloid engraftment, reducing the incidence of bacteremia and other culture positive infections, and shortening the median duration of hospitalization.
Use in Bone Marrow Transplantation Failure or Engraftment Delay
Leucomax (Novartis) (Leucomax (Novartis)) is indicated in patients who have undergone allogeneic or autologous bone marrow transplantation (BMT) in whom engraftment is delayed or has failed. Leucomax (Novartis) (Leucomax (Novartis)) has been found to be safe and effective in prolonging survival of patients who are experiencing graft failure or engraftment delay, in the presence or absence of infection, following autologous or allogeneic BMT. Survival benefit may be relatively greater in those patients who demonstrate one or more of the following characteristics: autologous BMT failure or engraftment delay, no previous total body irradiation, malignancy other than leukemia or a multiple organ failure (MOF) score ≤ two. Hematologic response to Leucomax (Novartis) (Leucomax (Novartis)) can be detected by complete blood count (CBC) with differential performed twice per week.
Leucomax (Novartis) is a synthetic (man-made) version of a substance that is naturally produced in your body called a colony stimulating factor. It helps the bone marrow to make new white blood cells.
When certain cancer medicines are used to fight cancer cells, they also affect the white blood cells that fight infections. Leucomax (Novartis) is used to prevent or reduce the risk of infection while you are being treated with cancer medicines. Leucomax (Novartis) is also used to help the bone marrow recover after a bone marrow transplantation, and for a process called peripheral blood progenitor cell collection in cancer patients.
Leucomax (Novartis) is available only with your doctor's prescription.
Neutrophil Recovery Following Chemotherapy in Acute Myelogenous Leukemia
The recommended dose is 250mcg/m²/day administered intravenously over a 4 hour period starting approximately on day 11 or four days following the completion of induction chemotherapy, if the day 10 bone marrow is hypoplastic with < 5% blasts. If a second cycle of induction chemotherapy is necessary, Leucomax (Novartis) (Leucomax (Novartis)) should be administered approximately four days after the completion of chemotherapy if the bone marrow is hypoplastic with < 5% blasts. Leucomax (Novartis) (Leucomax (Novartis)) should be continued until an ANC > 1500 cells/mm³ for 3 consecutive days or a maximum of 42 days. Leucomax (Novartis) (Leucomax (Novartis)) should be discontinued immediately if leukemic regrowth occurs. If a severe adverse reaction occurs, the dose can be reduced by 50% or temporarily discontinued until the reaction abates.
In order to avoid potential complications of excessive leukocytosis (WBC > 50,000 cells/mm³ or ANC > 20,000 cells/mm³) a CBC with differential is recommended twice per week during Leucomax (Novartis) (Leucomax (Novartis)) therapy. Leucomax (Novartis) (Leucomax (Novartis)) treatment should be interrupted or the dose reduced by half if the ANC exceeds 20,000 cells/mm³.
Mobilization of Peripheral Blood Progenitor Cells
The recommended dose is 250 mcg/m²/day administered IV over 24 hours or SC once daily. Dosing should continue at the same dose through the period of PBPC collection. The optimal schedule for PBPC collection has not been established. In clinical studies, collection of PBPC was usually begun by day 5 and performed daily until protocol specified targets were achieved. If WBC > 50,000 cells/mm³, the Leucomax (Novartis) (Leucomax (Novartis)) dose should be reduced by 50%. If adequate numbers of progenitor cells are not collected, other mobilization therapy should be considered.
Post Peripheral Blood Progenitor Cell Transplantation
The recommended dose is 250 mcg/m²/day administered IV over 24 hours or SC once daily beginning immediately following infusion of progenitor cells and continuing until an ANC > 1500 cells/mm³ for three consecutive days is attained.
Myeloid Reconstitution After Autologous or Allogeneic Bone MarrowTransplantation
The recommended dose is 250mcg/m²/day administered IV over a 2-hour period beginning two to four hours after bone marrow infusion, and not less than 24 hours after the last dose of chemotherapy or radiotherapy. Patients should not receive Leucomax (Novartis) (Leucomax (Novartis)) until the post marrow infusion ANC is less than 500 cells/mm³. Leucomax (Novartis) (Leucomax (Novartis)) should be continued until an ANC > 1500 cells/mm³ for three consecutive days is attained. If a severe adverse reaction occurs, the dose can be reduced by 50% or temporarily discontinued until the reaction abates. Leucomax (Novartis) (Leucomax (Novartis)) should be discontinued immediately if blast cells appear or disease progression occurs.
In order to avoid potential complications of excessive leukocytosis (WBC > 50,000 cells/mm³, ANC > 20,000 cells/mm³) a CBC with differential is recommended twice per week during Leucomax (Novartis) (Leucomax (Novartis)) therapy. Leucomax (Novartis) (Leucomax (Novartis)) treatment should be interrupted or the dose reduced by 50% if the ANC exceeds 20,000 cells/mm³.
Bone Marrow Transplantation Failure or Engraftment Delay
The recommended dose is 250 mcg/m²/day for 14 days as a 2-hour IV infusion. The dose can be repeated after 7 days off therapy if engraftment has not occurred. If engraftment still has not occurred, a third course of 500 mcg/m²/day for 14 days may be tried after another 7 days off therapy. If there is still no improvement, it is unlikely that further dose escalation will be beneficial. If a severe adverse reaction occurs, the dose can be reduced by 50% or temporarily discontinued until the reaction abates. Leucomax (Novartis) (Leucomax (Novartis)) should be discontinued immediately if blast cells appear or disease progression occurs.
In order to avoid potential complications of excessive leukocytosis (WBC > 50,000 cells/mm³, ANC > 20,000 cells/mm³) a CBC with differential is recommended twice per week during Leucomax (Novartis) (Leucomax (Novartis)) therapy. Leucomax (Novartis) (Leucomax (Novartis)) treatment should be interrupted or the dose reduced by half if the ANC exceeds 20,000 cells/mm³.
Preparation of Leucomax (Novartis) (Leucomax (Novartis))
- Liquid Leucomax (Novartis) (Leucomax (Novartis)) is formulated as a sterile, preserved (1.1% benzyl alcohol), injectable solution (500 mcg/mL) in a vial. Lyophilized Leucomax (Novartis) (Leucomax (Novartis)) is a sterile, white, preservative-free powder (250mcg) that requires reconstitution with 1mL SterileWater for Injection, USP, or 1 mL Bacteriostatic Water for Injection, USP.
- Liquid Leucomax (Novartis) (Leucomax (Novartis)) may be stored for up to 20 days at 2-8°C once the vial has been entered. Discard any remaining solution after 20 days.
- Lyophilized Leucomax (Novartis) (Leucomax (Novartis)) (250 mcg) should be reconstituted aseptically with 1.0 mL of diluent. The contents of vials reconstituted with different diluents should not be mixed together.
Sterile Water for Injection, USP (without preservative): Lyophilized Leucomax (Novartis) (Leucomax (Novartis)) vials contain no antibacterial preservative, and therefore solutions prepared with Sterile Water for Injection, USP should be administered as soon as possible, and within 6 hours following reconstitution and/or dilution for IV infusion. The vial should not be re-entered or reused. Do not save any unused portion for administration more than 6 hours following reconstitution.
Bacteriostatic Water for Injection, USP (0.9% benzyl alcohol): Reconstituted solutions prepared with Bacteriostatic Water for Injection, USP (0.9% benzyl alcohol) may be stored for up to 20 days at 2-8°C prior to use. Discard reconstituted solution after 20 days. Previously reconstituted solutions mixed with freshly reconstituted solutions must be administered within 6 hours following mixing. Preparations containing benzyl alcohol (including liquid Leucomax (Novartis) (Leucomax (Novartis)) and lyophilized Leucomax (Novartis) (Leucomax (Novartis)) reconstituted with Bacteriostatic Water for Injection) should not be used in neonates .
- During reconstitution of lyophilized Leucomax (Novartis) (Leucomax (Novartis)) the diluent should be directed at the side of the vial and the contents gently swirled to avoid foaming during dissolution. Avoid excessive or vigorous agitation; do not shake.
- Leucomax (Novartis) (Leucomax (Novartis)) should be used for SC injection without further dilution. Dilution for IV infusion should be performed in 0.9% Sodium Chloride Injection, USP. If the final concentration of Leucomax (Novartis) (Leucomax (Novartis)) is below 10 mcg/mL, Albumin (Human) at a final concentration of 0.1% should be added to the saline prior to addition of Leucomax (Novartis) (Leucomax (Novartis)) to prevent adsorption to the components of the drug delivery system. To obtain a final concentration of 0.1% Albumin (Human), add 1 mg Albumin (Human) per 1 Ml 0.9%SodiumChloride Injection, USP (e.g., use 1mL 5%Albumin [Human] in 50 mL 0.9% Sodium Chloride Injection, USP).
- An in-line membrane filter should NOT be used for intravenous infusion of Leucomax (Novartis) (Leucomax (Novartis)).
- Store liquid Leucomax (Novartis) (Leucomax (Novartis)) and reconstituted lyophilized Leucomax (Novartis) (Leucomax (Novartis)) solutions under refrigeration at 2-8°C (36-46°F); DO NOT FREEZE.
- In the absence of compatibility and stability information, no other medication should be added to infusion solutions containing Leucomax (Novartis) (Leucomax (Novartis)). Use only 0.9% Sodium Chloride Injection, USP to prepare IV infusion solutions.
- Aseptic technique should be employed in the preparation of all Leucomax (Novartis) (Leucomax (Novartis)) solutions. To assure correct concentration following reconstitution, care should be exercised to eliminate any air bubbles from the needle hub of the syringe used to prepare the diluent.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. If particulate matter is present or the solution is discolored, the vial should not be used.
How supplied
Liquid Leucomax (Novartis) (Leucomax (Novartis)) is available in vials containing 500 mcg/mL (2.8 x 10 IU/vial) Leucomax (Novartis).
Each dosage form is supplied as follows:
Lyophilized Leucomax (Novartis) (Leucomax (Novartis))
Carton of five vials of lyophilized Leucomax (Novartis) (Leucomax (Novartis)) 250 mcg (NDC 50419-002-33)
Liquid Leucomax (Novartis) (Leucomax (Novartis))
Carton of one multiple-use vial; each vial contains 1 mL of preserved 500 mcg/mL liquid Leucomax (Novartis) (Leucomax (Novartis)) (NDC 50419-050-14)
Carton of five multiple-use vials; each vial contains 1 mL of preserved 500 mcg/mL liquid Leucomax (Novartis) (Leucomax (Novartis)). (NDC 50419-050-30)
Storage
Leucomax (Novartis) (Leucomax (Novartis)) should be refrigerated at 2-8°C (36-46°F). Do not freeze or shake. Do not use beyond the expiration date printed on the vial.
Manufactured by: Bayer HealthCare Pharmaceuticals, LLC., Seattle, WA 98101. Revised April 2008. FDA rev date: 03/05/91
Ayrıca bakınız:
Leucomax (Novartis) hakkında bilmem gereken en önemli bilgi nedir??
Lökomax (Novartis) (Leucomax (Novartis)) kontrendikedir:
- kemik iliğinde veya periferik kanda aşırı lösemik miyeloid patlamaları olan hastalarda (≥% 10);
- GM-CSF'ye, mayadan türetilmiş ürünlere veya ürünün herhangi bir bileşenine karşı aşırı duyarlılığı olduğu bilinen hastalarda;
- kemoterapi ve radyoterapi ile birlikte kullanım için.
Hızla bölünen hematopoietik progenitör hücrelerin potansiyel duyarlılığı nedeniyle, Leucomax (Novartis) (Leucomax (Novartis)) sitotoksik kemoterapi veya radyoterapi ile eşzamanlı olarak veya kemoterapi veya radyoterapiden önceki veya sonraki 24 saat içinde uygulanmamalıdır. Kontrollü bir çalışmada, küçük hücreli akciğer kanseri olan hastalara Leucomax (Novartis) (Leucomax (Novartis)) ve eşzamanlı torasik radyoterapi ve kemoterapi veya Leucomax (Novartis) (Leucomax (Novartis)) olmadan özdeş radyoterapi ve kemoterapi verildi. Leucomax (Novartis) (Leucomax (Novartis)) ile randomize edilen hastalarda, yüksek mortalite ve derece 3 ve 4 enfeksiyon insidansı ve derece 3 ve 4 trombositopeni dahil olmak üzere advers olay insidansı anlamlı derecede yüksekti.
REFERANSLAR
11. Bunn P, Crowley J, Kelly K, vd Sınırlı evre küçük hücreli akciğer kanserinin tedavisinde granülosit-makrofaj koloni uyarıcı faktörlü veya içermeyen kemoradyoterapi: güneybatı onkoloji grubunun prospektif faz III randomize çalışması. JCO 1995; 13 (7): 1632-1641'de tarif edilmektedir.
Leucomax'ı (Novartis) tam olarak doktorunuz tarafından reçete edildiği gibi kullanın. Daha büyük veya daha küçük miktarlarda veya önerilenden daha uzun süre kullanmayın. Reçete etiketinizdeki talimatları izleyin.
Lökomax (Novartis), kemoterapi veya radyasyon almadan önce veya sonra 24 saat içinde kullanılmamalıdır.
Bu ilaç, güvenli ve etkili kullanım için hasta talimatları ile birlikte gelir. Bu talimatları dikkatlice izleyin. Herhangi bir sorunuz varsa doktorunuza veya eczacınıza sorun.
Lökomax (Novartis) bir damara veya deri altına enjekte edilir. Enjeksiyonları evde nasıl kullanacağınız gösterilebilir. Enjeksiyonu nasıl vereceğinizi tam olarak anlamıyorsanız ve kullanılmış iğneleri, şırıngaları, IV tüpünü ve ilacı enjekte etmek için kullanılan diğer maddeleri uygun şekilde atmıyorsanız bu ilacı kendi kendine enjekte etmeyin.
Bir damara enjekte edildiğinde, Leucomax (Novartis) yavaşça verilmelidir. IV infüzyonunun tamamlanması 24 saat kadar sürebilir.
Cildin altına her enjeksiyon yaptığınızda mideniz, uyluk veya üst kolunuzda farklı bir yer kullanın. Enjeksiyonu vermeden hemen önce, cilde bir dakika boyunca bir buz torbası uygulayın. Bakım sağlayıcınız ilacı enjekte etmek için vücudunuzdaki en iyi yerleri gösterecektir. Üst üste iki kez aynı yere enjekte etmeyin.
Lökomax (Novartis) tozu kullanılmadan önce bir sıvı (seyreltici) ile karıştırılmalıdır. Enjeksiyonları evde kullanıyorsanız, ilacı nasıl düzgün bir şekilde karıştıracağınızı ve saklayacağınızı anladığınızdan emin olun.
Karışık ilacı sallamayın, aksi takdirde köpüklenebilir. Renkleri değiştirmişse veya içinde parçacıklar varsa ilacı kullanmayın. Yeni bir reçete için doktorunuzu arayın.
Leucomax'ın (Novartis) durumunuza yardımcı olduğundan emin olmak için kanınızın sık sık test edilmesi gerekebilir. Bu, doktorunuzun size Leucomax (Novartis) ile ne kadar süre tedavi edileceğini belirlemesine yardımcı olacaktır. Karaciğer fonksiyonunuzun da test edilmesi gerekecektir. Doktorunuzu düzenli olarak ziyaret edin.
Sıvı ilacı buzdolabında saklayın, dondurmayın. Işıktan koruyun. Bir şırıngada dozunuzu ölçmeden önce ilacı çıkarabilir ve oda sıcaklığına ulaşmasına izin verebilirsiniz. Sonra ilacı buzdolabına iade edin. Kullanılmayan sıvıları 20 gün sonra atın. Leucomax (Novartis) tozunu bir seyreltici ile karıştırdıktan sonra buzdolabında saklayın ve 6 saat içinde kullanın. Dondurmayın. Işıktan koruyun. Tozu bakteriyostatik suyla karıştırdıysanız, bu karışımı buzdolabında 20 güne kadar saklayabilirsiniz.
Bir ilacın veya ilacın spesifik ve genel kullanımları vardır. Bir ilaç, bir hastalığı önlemek, bir süre boyunca bir hastalığı tedavi etmek veya bir hastalığı tedavi etmek için kullanılabilir. Hastalığın belirli semptomlarını tedavi etmek için de kullanılabilir. İlaç kullanımı hastanın aldığı forma bağlıdır. Enjeksiyon formunda veya bazen tablet formunda daha yararlı olabilir. İlaç tek bir rahatsız edici semptom veya hayatı tehdit eden bir durum için kullanılabilir. Bazı ilaçlar birkaç gün sonra durdurulabilirken, bazı ilaçların bundan faydalanabilmesi için uzun süre devam etmesi gerekir.Leucomax (Novartis), vücudunuzda yapılan belirli bir doğal maddenin insan yapımı bir versiyonudur. Vücudunuzun daha fazla beyaz kan hücresi yapmasına yardımcı olmak için kullanılır. Beyaz kan hücreleri enfeksiyonlarla savaşmanıza yardımcı olmak için önemlidir. Lökomax (Novartis), beyaz kan hücresi yapma yeteneği azalmış olan kişilere verilir (örneğin kemoterapi nedeniyle). Ayrıca bazı tedavi prosedürlerinde (kemik iliği / kök hücre nakli gibi) kullanılır.
Leucomax (Novartis) enjeksiyonu nasıl kullanılır
Leucomax (Novartis) kullanmaya başlamadan önce ve her doldurma işleminde eczacınızdan temin edildiyse Hasta Bilgi Broşürünü okuyun. Herhangi bir sorunuz varsa, doktorunuza veya eczacınıza sorunuz.
Bu ilaç, genellikle günde bir kez, cildin altına veya doktorunuzun yönlendirdiği bir damara enjeksiyon yoluyla verilir. Dozaj, tıbbi durumunuza, vücut boyutunuza, laboratuvar testlerine ve tedaviye yanıtınıza dayanır.
Bu ilacı evde kullanıyorsanız, tüm hazırlık ve kullanım talimatlarını sağlık uzmanınızdan ve ürün paketinden öğrenin. Oda sıcaklığına ulaşması için ilacı enjekte etmeden en az 30 dakika önce buzdolabından çıkarın. İlacı sallamayın. Kullanmadan önce, bu ürünü partikül veya renk değişikliği açısından görsel olarak kontrol edin. Her ikisi de varsa, sıvıyı kullanmayın.
Bu ilacı deri altına enjekte ediyorsanız, önce enjeksiyon bölgesini sürtünme alkolüyle temizleyin. Cilt altındaki yaralanmayı azaltmak için enjeksiyon bölgesini her seferinde değiştirin. Leucomax'ı (Novartis) çürük, hassas, kırmızı, sert veya yara izleri veya çatlakları olan cilde enjekte etmeyin.
En fazla faydayı elde etmek için bu ilacı düzenli olarak kullanın. Hatırlamanıza yardımcı olmak için her gün aynı saatte kullanın.
Bu ilaç, her tedavi döneminin ilk dozundan sonra reaksiyona neden olabilir. Kızarma, nefes darlığı, baş dönmesi, bayılma veya hızlı kalp atışı gibi ciddi bir reaksiyon belirtiniz varsa derhal doktorunuza veya hemşirenize söyleyin.
Tıbbi malzemelerin nasıl güvenli bir şekilde saklanacağını ve atılacağını öğrenin.
Kanser kemoterapisi veya radyasyon tedavisi alıyorsanız, bu ilacı kemoterapi veya radyasyon tedavisinden 24 saat önce veya 24 saat sonra kullanmamalısınız. Bu ilacı ne zaman kullanacağınız hakkında doktorunuza danışın.
Ayrıca bakınız:
Diğer ilaçlar Leucomax'ı (Novartis) etkileyecektir?
Belotecan: Granülosit Koloni Uyarıcı Faktörler Belotecan'ın nötropenik etkisini artırabilir. Terapi modifikasyonunu düşünün
Bleomisin: Granülosit Koloni Uyarıcı Faktörler Bleomisinin olumsuz / toksik etkisini artırabilir. Spesifik olarak, pulmoner toksisite riski arttırılabilir. Yönetim: Granülosit koloni uyarıcı faktörlerin 24 saat önce (pegfilgrastim için 14 gün) ve son bleomisin dozundan 24 saat sonra kullanılmasından kaçının. Terapi modifikasyonunu düşünün
Kortikosteroidler (Sistemik): Leucomax'ın (Novartis) terapötik etkisini artırabilir. Spesifik olarak, kortikosteroidler Leucomax'ın (Novartis) miyeloproliferatif etkilerini artırabilir. Tedaviyi izleyin
Siklofosfamid: Lökomax'ın (Novartis) olumsuz / toksik etkisini artırabilir. Spesifik olarak, pulmoner toksisite riski arttırılabilir. Tedaviyi izleyin
Lityum: Lökomax (Novartis) Lityumun olumsuz / toksik etkisini artırabilir. Spesifik olarak, miyeloproliferatif etkiler arttırılabilir. Tedaviyi izleyin
Solriamfetol: Hipertansiyonla İlişkili Ajanların hipertansif etkisini artırabilir. Tedaviyi izleyin
Tisagenlecleucel: Granülosit Kolonisi Uyarıcı Faktörler Tisagenlecleucel'in olumsuz / toksik etkisini artırabilir. Kombinasyondan kaçının
Topotekan: Granülosit Koloni Uyarıcı Faktörler Topotekanın olumsuz / toksik etkisini artırabilir. Spesifik olarak, interstisyel akciğer hastalığının gelişme riski artabilir. Granülosit Koloni Uyarıcı Faktörler Topotekanın miyelosüpresif etkisini artırabilir. Yönetim: Granülosit koloni uyarıcı faktörlerin 24 saat önce (pegfilgrastim için 14 gün) ve son topotekan dozundan 24 saat sonra kullanılmasından kaçının. Ek olarak, bu kombinasyonla interstisyel akciğer hastalığının gelişimi için hastaları yakından izleyin. Terapi modifikasyonunu düşünün
See also:
What are the possible side effects of Leucomax (Novartis)?
Autologous and Allogeneic Bone Marrow Transplantation
Leucomax (Novartis) (Leucomax (Novartis)) is generally well tolerated. In three placebo-controlled studies enrolling a total of 156 patients after autologous BMT or peripheral blood progenitor cell transplantation, events reported in at least 10% of patients who received IV Leucomax (Novartis) (Leucomax (Novartis)) or placebo were as reported in Table 6.
Table 6: Percent of AuBMT Patients Reporting Events
Events by Body System | Leucomax (Novartis) (n=79) | Placebo (n=77) | Events by Body System | Leucomax (Novartis) (n=79) | Placebo (n=77) |
Body, General | Metabolic, Nutritional Disorder | ||||
Fever | 95 | 96 | Edema | 34 | 35 |
Mucous membrane dis order | 75 | 78 | Peripheral edema | 11 | 7 |
Asthenia | 66 | 51 | Respiratory System | ||
Malaise | 57 | 51 | Dyspnea | 28 | 31 |
Sepsis | 11 | 14 | Lung disorder | 20 | 23 |
Digestive System | Hemic and Lymphatic System | ||||
Nausea | 90 | 96 | Blood dyscrasia | 25 | 27 |
Diarrhea | 89 | 82 | Cardiovascular System | ||
Vomiting | 85 | 90 | Hemorrhage | 23 | 30 |
Anorexia | 54 | 58 | Urogenital System | ||
GI disorder | 37 | 47 | Urinary tract disorder | 14 | 13 |
GI hemorrhage | 27 | 33 | Kidney function abnormal | 8 | 10 |
Stomatitis | 24 | 29 | Nervous System | ||
Liver damage | 13 | 14 | CNS disorder | 11 | 16 |
Skin and Appendages | |||||
Alopecia | 73 | 74 | |||
Rash | 44 | 38 |
No significant differences were observed between Leucomax (Novartis) (Leucomax (Novartis)) and placebo-treated patients in the type or frequency of laboratory abnormalities, including renal and hepatic parameters. In some patients with preexisting renal or hepatic dysfunction enrolled in uncontrolled clinical trials, administration of Leucomax (Novartis) (Leucomax (Novartis)) has induced elevation of serum creatinine or bilirubin and hepatic enzymes. In addition, there was no significant difference in relapse rate and 24 month survival between the Leucomax (Novartis) (Leucomax (Novartis)) and placebo-treated patients.
In the placebo-controlled trial of 109 patients after allogeneic BMT, events reported in at least 10% of patients who received IV Leucomax (Novartis) (Leucomax (Novartis)) or placebo were as reported in Table 7.
Table 7: Percent of Allogeneic BMT Patients Reporting Events
Events by Body System | Leucomax (Novartis) ( n =53) | Placebo (n=56) | Events by Body System | Leucomax (Novartis) (n=53) | Placebo (n=56) |
Body, General | Metabolic /Nutritional Disorders | ||||
Fever | 77 | 80 | Bilirubinemia | 30 | 27 |
Abdominal pain | 38 | 23 | Hyperglycemia | 25 | 23 |
Headache | 36 | 36 | Peripheral edema | 15 | 21 |
Chills | 25 | 20 | Increased creatinine | 15 | 14 |
Pain | 17 | 36 | Hypomagnesemia | 15 | 9 |
Asthenia | 17 | 20 | Increased SGPT | 13 | 16 |
Chest pain | 15 | 9 | Edema | 13 | 11 |
Back pain | 9 | 18 | Increased alk. phosphatase | 8 | 14 |
Digestive System | Respiratory System | ||||
Diarrhea | 81 | 66 | Pharyngitis | 23 | 13 |
Nausea | 70 | 66 | Epsitaxis | 17 | 16 |
Vomiting | 70 | 57 | Dyspnea | 15 | 14 |
Stomatitis | 62 | 63 | Rhinitis | 11 | 14 |
Anorexia | 51 | 57 | Hemic and Lymphatic System | ||
Dyspepsia | 17 | 20 | Thrombocytopenia | 19 | 34 |
Hematemesis | 13 | 7 | Leukopenia | 17 | 29 |
Dysphagia | 11 | 7 | Petechia | 6 | 11 |
GI hemorrhage | 11 | 5 | Agranulo cytosis | 6 | 11 |
Constipation | 8 | 11 | Urogenital System | ||
Skin and Appendages | Hematuria | 9 | 21 | ||
Rash | 70 | 73 | Nervous System | ||
Alopecia | 45 | 45 | Paresthesia | 11 | 13 |
Pruritis | 23 | 13 | Insomnia | 11 | 9 |
Musculo -skeletal System | Anxiety | 11 | 2 | ||
Bone pain | 21 | 5 | Laboratory Abnormalities* | ||
Arthralgia | 11 | 4 | High glucose | 41 | 49 |
Special Senses | Low albumin | 27 | 36 | ||
Eye hemorrhage | 11 | 0 | High BUN | 23 | 17 |
Cardio vascular System | Low calcium | 2 | 7 | ||
Hypertension | 34 | 32 | High cholesterol | 17 | 8 |
Tachycardia | 11 | 9 | |||
*Grade 3 and 4 laboratory abnormalities only. Denominators may vary due to missing laboratory measurements. |
There were no significant differences in the incidence or severity of GVHD, relapse rates and survival between the Leucomax (Novartis) (Leucomax (Novartis)) and placebo-treated patients.
Adverse events observed for the patients treated with Leucomax (Novartis) (Leucomax (Novartis)) in the historically-controlled BMT failure study were similar to those reported in the placebo-controlled studies. In addition, headache (26%), pericardial effusion (25%), arthralgia (21%) and myalgia (18%) were also reported in patients treated with Leucomax (Novartis) (Leucomax (Novartis)) in the graft failure study.
In uncontrolled Phase I/II studies with Leucomax (Novartis) (Leucomax (Novartis)) in 215 patients, the most frequent adverse events were fever, asthenia, headache, bone pain, chills and myalgia. These systemic events were generally mild or moderate and were usually prevented or reversed by the administration of analgesics and antipyretics such as acetaminophen. In these uncontrolled trials, other infrequent events reported were dyspnea, peripheral edema, and rash.
Reports of events occurring with marketed Leucomax (Novartis) (Leucomax (Novartis)) include arrhythmia, fainting, eosinophilia, dizziness, hypotension, injection site reactions, pain (including abdominal, back, chest, and joint pain), tachycardia, thrombosis, and transient liver function abnormalities.
In patients with preexisting edema, capillary leak syndrome, pleural and/or pericardial effusion, administration of Leucomax (Novartis) may aggravate fluid retention. Body weight and hydration status should be carefully monitored during Leucomax (Novartis) (Leucomax (Novartis)) administration.
Adverse events observed in pediatric patients in controlled studies were comparable to those observed in adult patients.
Acute Myelogenous Leukemia
Adverse events reported in at least 10% of patients who received Leucomax (Novartis) (Leucomax (Novartis)) or placebo were as reported in Table 8.
Table 8: Percent of AML Patients Reporting Events
Events by Body System | Leucomax (Novartis) ( n =52) | Placebo (n=47) | Events by Body System | Leucomax (Novartis) (n=52) | Placebo (n =47) |
Body, General | Metabolic/Nutritional Disorder | ||||
Fever (no infection) | 81 | 74 | Metabolic | 58 | 49 |
Infection | 65 | 68 | Edema | 25 | 23 |
Weight loss | 37 | 28 | Respiratory System | ||
Weight gain | 8 | 21 | Pulmonary | 48 | 64 |
Chills | 19 | 26 | Hemic and LymphaticSystem | ||
Allergy | 12 | 15 | Coagulation | 19 | 21 |
Sweats | 6 | 13 | Cardiovascular System | ||
Digestive System | Hemorrhage | 29 | 43 | ||
Nausea | 58 | 55 | Hypertension | 25 | 32 |
Liver | 77 | 83 | Cardiac | 23 | 32 |
Diarrhea | 52 | 53 | Hypotension | 13 | 26 |
Vomiting | 46 | 34 | Urogenital System | ||
Stomatitis | 42 | 43 | GU | 50 | 57 |
Anorexia | 13 | 11 | Nervous System | ||
Abdominal distention | 4 | 13 | Neuro-clinical | 42 | 53 |
Skin and Appendages | Neuro-motor | 25 | 26 | ||
Skin | 77 | 45 | Neuro-psych | 15 | 26 |
Alopecia | 37 | 51 | Neuro-sensory | 6 | 11 |
Nearly all patients reported leukopenia, thrombocytopenia and anemia. The frequency and type of adverse events observed following induction were similar between Leucomax (Novartis) (Leucomax (Novartis)) and placebo groups. The only significant difference in the rates of these adverse events was an increase in skin associated events in the Leucomax (Novartis) (Leucomax (Novartis)) group (p=0.002). No significant differences were observed in laboratory results, renal or hepatic toxicity. No significant differences were observed between the Leucomax (Novartis) (Leucomax (Novartis)) and placebo-treated patients for adverse events following consolidation. There was no significant difference in response rate or relapse rate.
In a historically-controlled study of 86 patients with acute myelogenous leukemia (AML), the Leucomax (Novartis) (Leucomax (Novartis)) treated group exhibited an increased incidence of weight gain (p=0.007), low serum proteins and prolonged prothrombin time (p=0.02) when compared to the control group. Two Leucomax (Novartis) (Leucomax (Novartis)) treated patients had progressive increase in circulating monocytes and promonocytes and blasts in the marrow which reversed when Leucomax (Novartis) (Leucomax (Novartis)) was discontinued. The historical control group exhibited an increased incidence of cardiac events (p=0.018), liver function abnormalities (p=0.008), and neurocortical hemorrhagic events (p=0.025).
Antibody Formation
Serum samples collected before and after Leucomax (Novartis) (Leucomax (Novartis)) treatment from 214 patients with a variety of underlying diseases have been examined for immunogenicity based on the presence of antibodies. Neutralizing antibodies were detected in five of 214 patients (2.3%) after receiving Leucomax (Novartis) (Leucomax (Novartis)) by continuous IV infusion (three patients) or subcutaneous injection (SC)(two patients) for 28 to 84 days in multiple courses. All five patients had impaired hematopoiesis before the administration of Leucomax (Novartis) (Leucomax (Novartis)) and consequently the effect of the development of anti-GM-CSF antibodies on normal hematopoiesis could not be assessed. Antibody studies of 75 patients with Crohn's disease receiving Leucomax (Novartis) (Leucomax (Novartis)) by subcutaneous injection with normal hematopoiesis and no other immunosuppressive drugs showed one patient (1.3%) with detectable neutralizing antibodies. The clinical relevance of the presence of these antibodies are unknown. Drug-induced neutropenia, neutralization of endogenous GM-CSF activity and diminution of the therapeutic effect of Leucomax (Novartis) (Leucomax (Novartis)) secondary to formation of neutralizing antibody remain a theoretical possibility. Serious allergic and anaphylactoid reactions have been reported with Leucomax (Novartis) (Leucomax (Novartis)) but the rate of occurrence of antibodies in such patients has not been assessed.
Human, recombinant GM-CSF, expressed in yeast. Glycoprotein that is 127 residues. Substitution of Leu23 leads to a difference from native protein.