YO10 - A Case Study: Exposure of Nilotinib in Pregnancy with Chronic Myeloid Leukemia: Is It Safe?

Date 18 December 2016
Event ESMO Asia 2016 Congress
Session Poster lunch
Topics Anticancer Agents
Cancer and Pregnancy
Presenter Rachman Fadhilla
Authors R. Fadhilla1, I.R. Ardiansyah1, M.C.R. Sucipto1, F. Barry1, K. Julianti1, A. Mardliyah1, A.K. Hanawi1, S. Adhinugroho1, I.N.A. Wiratama1, W. Djatmiko2
  • 1Departement Of Medicine, Faculty Of Medicine, Jenderal Soedirman University, 53112 - Purwokerto/ID
  • 2Departement Of Internal Medicine, Prof. Dr. Margono Soekarjo General Hospital (RSMS), 53112 - Purwokerto/ID


Case Summary


Chronic Myeloid Leukemia (CML) is a myelo-proliferative disorder that arises in the hematopoietic stem cell compartment. CML is affecting approximately 100.000 people per year globally. In the recent years, one of the preferred treatment for CML is Tyrosine Kinase Inhibitors (TKI) such as Nilotinib. Nilotinib works as TKI agent by stopping BCR-ABL, C-KIT, and PDGFR-β enzymes from working, which stop CML progression. However, the safety of Nilotinib administration during pregnancy is still debatable.

Case presentation

A 35 year-old woman was diagnosed with CML in June 2015 based on the results PCR gene BCR-ABL (+) type b2a2 at P210. Patient started to take nilotinib treatment in the dose 600 mg/day (400 mg at morning and 200 mg at night). After 11 weeks of treatment, patient was in sixth weeks of pregnancy thus the Nilotinib treatment was stopped immediately. Interferon-α, as cytoreduction, was given while white blood cell (WBC) count was more than 50.000 /µL in second and third trimester gestation up to one week before delivery. Patient gave birth at 37th weeks of gestation using sectio caesaria method. She restarted the administration of Nilotinib in 8 weeks after delivery.


Nilotinib corrected splenomegaly and leukocytosis on patient. Physical and blood count examinations after 11 weeks of treatment showed the spleen became normal and WBC count was 4860 /µL. The patient’s baby was born with 3.7 kg birthweight without any congenital and physical abnormalities based on anamnesis and physical examination. The examination using Infant Chart Growth and Denver II chart until 4 month-old also didn’t show any development problems.


In this case, the exposure of nilotinib at first trimester pregnancy showed no major abnormalities in patient and fetus. We suggest further studies of nilotinib as treatment agent in pregnancy with CML, but still ethically appropriate.

Keyword : Nilotinib, CML, pregnancy, BCR-ABL