Download When treating patients with OFEV ® : Manage side effects if they arise

Management of liver
enzyme elevations
BEFORE STARTING OFEV®1
•C
onduct liver function tests (hepatic transaminase
and bilirubin levels)
DURING TREATMENT WITH OFEV®,
LIVER FUNCTION TESTS ARE
RECOMMENDED PERIODICALLY1
•C
onduct at each patient visit or as
clinically indicated
If transaminase (AST or
ALT) levels are >3x ULN
Dose reduction or
interruption of therapy
with OFEV® (nintedanib)
and close monitoring of
the patient are
recommended
When transaminases
return to baseline values
Therapy with OFEV® may be
reintroduced at a reduced
dose (100 mg twice daily),
which subsequently may be
increased to the full dose
(150 mg twice daily)
If liver test elevations are
associated with clinical
signs and symptoms of
liver injury (eg, jaundice)
Permanently discontinue
therapy with OFEV®
ALT, alanine aminotransferase; AST, aspartate aminotransferase;
ULN, upper limit of normal.
References: 1. OFEV® (nintedanib) summary of product
characteristics. Boehringer Ingelheim International GmbH.
November 2014. 2. Roila F, Herrstedt J, Aapro M, et al; ESMO/MASCC
Guidelines Working Group. Guideline update for MASCC and ESMO
in the prevention of chemotherapy- and radiotherapy-induced
nausea and vomiting: results of the Perugia consensus conference.
Ann Oncol. 2010;21(Suppl 5):v232-v243. 3. Guy’s and St Thomas’
NHS Foundation Trust. Diarrhoea. http://www.guysandstthomas.
nhs.uk/resources/patient-information/nutrition-and-dietetics/
diarrhoea.pdf. Published November 2012. Accessed September
23, 2014. 4. Guy’s and St Thomas’ NHS Foundation Trust. Low
fibre diet. http://www.guysandstthomas.nhs.uk/resources/patientinformation/nutrition-and-dietetics/low-fibre-diet.pdf. Published
November 2012. Accessed September 23, 2014. 5. Nutritionist
Resource. Diarrhoea. http://www.nutritionist-resource.org.uk/
articles/diarrhoea.html. Accessed September 26, 2014. 6. Guy’s and
St Thomas’ NHS Foundation Trust. Nausea and vomiting. http://www.
guysandstthomas.nhs.uk/resources/patient-information/nutritionand-dietetics/nausea-and-vomiting.pdf. Published November 2012.
Accessed September 23, 2014.
WHEN TREATING PATIENTS WITH OFEV®
Manage side effects if they arise
INDICATION AND USAGE
OFEV® (nintedanib) is indicated in adults for the
treatment of idiopathic pulmonary fibrosis (IPF).
© Boehringer Ingelheim International GmbH. All rights reserved.
December 2014.
Management of diarrhea
Management of nausea
and vomiting
BEFORE STARTING OFEV®
TREAT NAUSEA AND VOMITING AT THE FIRST SIGNS
•D
etermine which concomitant medications your
patients are taking; laxatives, stool softeners, and
certain other medicines or dietary supplements
can cause diarrhea
•A
sk patients to notify you if they experience
diarrhea, or if diarrhea persists or becomes severe
1
TREAT DIARRHEA AT THE FIRST SIGN1
1
2
3
Supportive medications
• Initiate antidiarrheals, such as
loperamide
Dose adjustment
• Interruption or reduction of dose of
OFEV® (nintedanib) may be required if
symptomatic treatment is ineffective
- Therapy with OFEV® may be resumed
at the full dose (150 mg twice daily)
or at a reduced dose (100 mg twice
daily), which subsequently may be
increased to the full dose
• If severe diarrhea persists despite
symptomatic treatment, therapy
with OFEV® should be discontinued
2
3
Supportive medications
• Initiate appropriate supportive care
including antiemetic therapy, such as
a dopamine receptor antagonist (eg,
metoclopramide) or an H1-antihistaminic
(eg, dimenhydrinate)1,2
• If antiemetic therapy is not sufficient,
treatment with a 5-HT3 antagonist
(eg, ondansetron or granisetron) may
be indicated2
Dose adjustment1
• Interruption or reduction of dose of
OFEV® may be required if symptomatic
treatment is ineffective
- Therapy with OFEV® may be resumed
at the full dose (150 mg twice daily)
or at a reduced dose (100 mg twice
daily), which subsequently may be
increased to the full dose
• If severe nausea and vomiting persist
despite symptomatic treatment, therapy
with OFEV® should be discontinued
Dietary changes
• Avoidance of certain foods/drinks
(see page 4 for detailed information)
Dietary changes
• Adequate hydration
•A
voidance of certain foods/drinks
(see page 4 for detailed information)
Dietary guidance to aid in
management of gastrointestinal
adverse events
Diarrhea3-5
Nausea and Vomiting6
Eat smaller amounts of food more frequently throughout
the day instead of a few large meals
Avoid fried, greasy, and spicy foods
Ensure that carbonated drinks lose their fizz before
drinking them
Drink plenty of fluids to
replace those lost through
diarrhea; mild, clear liquids,
such as apple juice, water,
clear broth, and ginger ale,
are best
Drink cool, clear liquids, such
as apple juice or ginger ale
Drink fluids slowly; they should
be at room temperature
Drink liquids at least an hour
before or after meal time
instead of with meals
Avoid coffee, tea, alcohol,
and sweet food and drinks
Eat and drink slowly; chew
food well for better digestion
Avoid milk and milk products
if they make diarrhea worse
Avoid odors such as cooking
smells, smoke, or perfume
Eat low-fiber foods, such as
white bread; white rice or
noodles; creamed cereals;
ripe bananas; canned or
cooked fruit without skins;
eggs; mashed or baked
potatoes without the skin;
pureed vegetables; and fish,
chicken, or turkey without
the skin
Eat foods cold or at room
temperature so as not to be
affected by strong smells
Avoid high-fiber foods,
which can lead to diarrhea
and cramping; these include
whole-grain breads and
cereals, raw vegetables,
beans, nuts, seeds, popcorn,
and fruit (fresh and dried)
For morning nausea, eat dry
foods, such as cereal, toast,
or crackers before getting
up (not in the case
of stomatitis)
Suck on ice cubes or mints
Rest in a chair after eating;
avoid lying flat for at least
2 hours after finishing meals
Wear loose-fitting clothes
Breathe deeply and slowly
when feeling nauseated
In clinical trials, most cases of diarrhea were of
mild to moderate intensity and occurred within
the first 3 months of treatment1
In clinical trials, most cases of nausea and
vomiting were of mild to moderate intensity1