ASH Clinical News Advances in Hematology Research & Patient Care: Hi | Page 9
INTERVIEWS
IMBRUVICA® (ibrutinib) capsules
Hepatic Impairment: Ibrutinib is metabolized in the liver. In a hepatic
impairment study, data showed an increase in ibrutinib exposure.
Following single dose administration, the AUC of ibrutinib increased
2.7-, 8.2- and 9.8-fold in subjects with mild (Child-Pugh class A),
moderate (Child-Pugh class B), and severe (Child-Pugh class C) hepatic
impairment compared to subjects with normal liver function. The
safety of IMBRUVICA has not been evaluated in patients with hepatic
impairment.
Monitor patients for signs of IMBRUVICA toxicity and follow dose
modification guidance as needed. It is not recommended to administer
IMBRUVICA to patients with moderate or severe hepatic impairment
(Child-Pugh classes B and C) [see Dosage and Administration (2.5) and
Clinical Pharmacology (12.3) in Full Prescribing Information].
Females and Males of Reproductive Potential: Advise women to avoid
becoming pregnant while taking IMBRUVICA because IMBRUVICA can
cause fetal harm [see Use in Specific Populations].
Plasmapheresis: Management of hyperviscosity in patients with
WM may include plasmapheresis before and during treatment with
IMBRUVICA. Modifications to IMBRUVICA dosing are not required.
PATIENT COUNSELING INFORMATION
See FDA-approved patient labeling (Patient Information).
• Hemorrhage:
Inform patients of the possibility of bleeding, and to report any signs
or symptoms (blood in stools or urine, prolonged or uncontrolled
bleeding). Inform the patient that IMBRUVICA may need to be
interrupted for medical or dental procedures [see Warnings and
Precautions].
• Infections:
Inform patients of the possibility of serious infection, and to report any
signs or symptoms (fever, chills, weakness, confusion) suggestive of
infection [see Warnings and Precautions].
• Atrial Fibrillation:
Counsel patients to report any signs of palpitations, lightheadedness,
dizziness, fainting, shortness of breath, and chest discomfort [see
Warnings and Precautions].
• Second primary malignancies:
Inform patients that other malignancies have occurred in patients
who have been treated with IMBRUVICA, including skin cancers and
other carcinomas [see Warnings and Precautions].
• Tumor lysis syndrome:
Inform patients of the potential risk of tumor lysis syndrome and
report any signs and symptoms associated with this event to their
healthcare provider for evaluation [see Warnings and Precautions].
• Embryo-fetal toxicity:
Advise women of the potential hazard to a fetus and to avoid
becoming pregnant [see Warnings and Precautions].
• Inform patients to take IMBRUVICA orally once daily according
to their physician’s instructions and that the capsules should be
swallowed whole with a glass of water without being opened,
broken, or chewed at approximately the same time each day [see
Dosage and Administration (2.1) in Full Prescribing Information].
• Advise patients that in the event of a missed daily dose of IMBRUVICA,
it should be taken as soon as possible on the same day with a
return to the normal schedule the following day. Patients should not
take extra capsules to make up the missed dose [see Dosage and
Administration (2.5) in Full Prescribing Information].
• Advise patients of the common side effects associated with
IMBRUVICA [see Adverse Reactions]. Direct the patient to a
complete list of adverse drug reactions in PATIENT INFORMATION.
• Advise patients to inform their health care providers of all concomitant
medications, including prescription medicines, over-the-counter
drugs, vitamins, and herbal products [see Drug Interactions].
• Advise patients that they may experience loose stools or diarrhea,
and should contact their doctor if their diarrhea persists. Advise
patients to maintain adequate hydration.
Active ingredient made in China.
Distributed and Marketed by:
Pharmacyclics LLC
Sunnyvale, CA USA 94085
and
Marketed by:
Janssen Biotech, Inc.
Horsham, PA USA 19044
Patent http://www.imbruvica.com
IMBRUVICA® is a registered trademark owned by Pharmacyclics LLC
© Pharmacyclics LLC 2015
© Janssen Biotech, Inc. 2015
Future Directions and
Challenges in Treating
Sickle Cell Disease: An
Interview with Griffin
Rodgers, MD
Patients with sickle
cell disease (SCD)
face chronic and
often debilitating
complications,
but have limited
treatment
options. Several
presentations at
this year’s ASH
annual meeting
focused on
promising new
Griffin Rodgers, MD
treatments for
pediatric and adult patients with SCD – including
gene therapy and a potentially disease-modifying
oral hemoglobin modifier.
ASH Clinical News spoke with Griffin Rodgers,
MD, director of the National Institutes of Health’s
National Institute of Diabetes and Digestive and
Kidney Disease, about the available treatments for
patients with SCD and the challenges to improving
patients’ experiences. Dr. Rodgers was chair of the
session, “Optimizing Therapy in Sickle Cell Disease,”
at this year’s annual meeting.
ASH Clinical News: Where are we – patients with sickle
cell disease (SCD) and the providers who care for them
– now in the management of SCD in the United States?
Gri