Английская Википедия:Eflapegrastim

Материал из Онлайн справочника
Перейти к навигацииПерейти к поиску

Шаблон:Short description Шаблон:Use dmy dates Шаблон:Cs1 config Шаблон:Infobox drug

Eflapegrastim, sold under the brand name Rolvedon among others, is a long-acting G-CSF analog developed by Hanmi Pharmaceutical and licensed to Spectrum Pharmaceuticals.[1] Eflapegrastim is a leukocyte growth factor.[2] It is used to reduce the risk of febrile neutropenia in people with non-myeloid malignancies receiving myelosuppressive anti-cancer agents.[2][3]

The most common side effects are fatigue, nausea, diarrhea, bone pain, headache, fever, anemia, rash, myalgia, arthralgia, and back pain.[4]

Eflapegrastim was approved for medical use in the United States in September 2022.[2][5][6]

Medical uses

Eflapegrastim is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in adults with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with clinically significant incidence of febrile neutropenia.[2]

Its efficacy has been shown to be non-inferior to pegfilgrastim.[2]

History

The US Food and Drug Administration (FDA) approved eflapegrastim based on evidence from two clinical trials of 643 participants with breast cancer treated with anti-cancer drugs that suppress the bone marrow from producing blood cells.[4] The trials were conducted at 119 sites in six countries in the United States, Canada, South-Korea, Hungary, Poland, and India.[4] Eflapegrastim was evaluated in two clinical trials of 643 participants with breast cancer receiving anticancer treatment that is known to suppress the growth of blood-forming cells (red blood cells, white blood cells, and platelets) in the bone marrow.[4] In both trials, participants were randomly assigned to either receive eflapegrastim or pegfilgrastim under the skin (subcutaneously) approximately 24 hours after anticancer treatment.[4] Participants in both groups were evaluated and compared for the duration of severe neutropenia (a condition with lower-than-normal levels of neutrophils in the blood) during the first cycle of anticancer therapy.[4]

References

Шаблон:Reflist

External links

Шаблон:Immunostimulants Шаблон:Portal bar Шаблон:Authority control


Шаблон:Antineoplastic-drug-stub

  1. Шаблон:Cite web
  2. 2,0 2,1 2,2 2,3 2,4 Ошибка цитирования Неверный тег <ref>; для сносок Rolvedon FDA label не указан текст
  3. Шаблон:Cite journal
  4. 4,0 4,1 4,2 4,3 4,4 4,5 Шаблон:Cite web Шаблон:PD-notice
  5. Шаблон:Cite web
  6. Шаблон:Cite press release