What you need to know
about using Picato®
For topical treatment of actinic keratosis (AK), Picato® is here to help.
Once-daily dosing in 5 steps
1
2
OPEN
a new tube each time
you use Picato® gel.
3
SQUEEZE
the gel from the tube
onto your fingertip.
Only use enough gel
needed to cover the
affected area, as
directed by your
health care provider.
Important:
• One tube will cover an area of about 2 x 2 inches
• Keep out of the reach of children
4
SPREAD
the gel evenly over
only the skin area to
be treated.
WASH
your hands right
away after applying
gel. If treating your
hands, wash only the
fingertip you used
to apply the gel.
5
Allow for the
treated area to DRY
for 15 minutes.
• Avoid touching the treatment area for 6 hours after applying Picato®
• Do not use Picato® gel in, around, or near your eyes, mouth, lips, or vagina
Once-daily dosing for 3 days
Once-daily dosing for 2 days
BODY, ARMS, OR LEGS
FACE OR SCALP
0.05% GEL
0.015% GEL
Not actual size.
PAY AS LITTLE
AS $25*
RxBIN:
RxPCN:
RxGRP:
Issuer:
ID:
610524
Loyalty
50776440
(80840)
XXXXXXXXX
* For patients with private health
insurance, this card will cover up to
$250 off your co-pay.
Not actual size.
If eligible, you may pay as little as $25 for the first prescription
and $0 for all refills with the Co-pay Card
• Call the activation number on the front of your card prior to visiting the pharmacy
(1-855-242-6936)
Keep Picato® 0.015% and 0.05% refrigerated (36°F-46°F [2°C-8°C]).
Do not freeze.
LEO® Quality CareTM
Connect with helpful support professionals who can answer questions about your treatment. Contact live support
at 1-855-CARE-LEO (1-855-227-3536) to enroll.
To report SUSPECTED ADVERSE REACTIONS, contact LEO Pharma Inc. at 1-877-494-4536 or FDA at 1-800-FDA-1088
or fda.gov/medwatch.
Indications and Usage
Picato® (ingenol mebutate) gel, 0.015%, 0.05% is prescription medicine used on the skin to treat actinic keratosis.
Important Safety Information
Do not use Picato® gel if you are allergic to ingenol mebutate or any of the ingredients in Picato® gel.
There have been reports of serious allergic reactions (hives, itching, flushing and swelling of the lips
or tongue, trouble breathing or wheezing, chest tightness and dizziness or passing out) in patients
using Picato®. The frequency of these events or their relationship, if any, to treatment with Picato®
is unknown. If you experience any such symptoms, discontinue Picato® immediately and seek
emergency medical help.
Please see additional Important Safety Information on reverse and accompanying
full Prescribing Information.
What to expect following
Picato® application
After treating the affected area
Severe skin reactions may occur, such as redness, flaking or scaling, crusting, swelling, blisters, pus,
ulcers, or breakdown of your skin.
With Picato® on the face and scalp, skin reactions usually go away within 2 weeks
Here are some examples of the types of skin reactions, from mild to severe, experienced by real patients after starting
Picato® for AK on the face and scalp.
BEFORE TREATMENT
4 DAYS AFTER START
15 DAYS AFTER START
57 DAYS AFTER START
In clinical trials, treatment
results were reviewed 57 days
after initial application.
MILD
Skin reactions for the face
and scalp included erythema
(94%), flaking/scaling (85%),
crusting (80%), swelling (79%),
vesiculation/pustulation (56%),
and erosion/ulceration (32%).
Grade 4 reactions were
erythema (24%), flaking/
scaling (9%), crusting (6%),
swelling (5%), vesiculation/
pustulation (5%), and
erosion/ulceration (0%).
SEVERE
Individual results may vary.
With Picato® on the body, arms, and legs, skin reactions usually go away within 4 weeks.
Important Safety Information (cont’d)
For use on the skin only. Picato® can be applied to a contiguous
skin area of approximately 25cm2 (5 cm x 5 cm). Do not use Picato®
in, around, or near your eyes, mouth, lips, or vagina. Eye problems,
including severe eye pain, swelling or drooping of your eyelids,
corneal burn, redness, swelling and irritation inside the eye, or
swelling around your eyes can happen if Picato® gel gets in your
eyes. To avoid getting any of the Picato® into or around the eyes, it
is important that you wash your hands well with soap and water
after applying Picato® gel and be careful to keep Picato® gel on the
treated area from coming into contact with your eyes. If you
accidentally get Picato® gel in your eyes, flush them with large
amounts of water and get medical care as soon as possible.
Reports of hypersensitivity reactions (anaphylaxis and allergic
contact dermatitis) and herpes zoster (shingles) have been received
during post approval use of Picato®.
Severe skin reactions in the treated areas on the face/scalp and
body/arms/legs, including redness, flaking or scaling, crusting,
swelling, blisters, pus, ulcers or breakdown of your skin can happen
after applying Picato®. You should not use Picato® gel until
your skin has healed from other treatments or surgeries. The most
common side effects with Picato® gel on the face and
scalp (≥2%) include skin reactions in the treatment area (94%), pain
at the treatment area (15%), itching at the treatment area (8%),
infection at the treatment area (3%), swelling around your eyelids
(3%), and headache (2%). The most common side effects with
Picato® gel on the body, arms and legs (≥2%) include skin reactions
in the treatment area (92%), itching at the treatment area (8%),
skin irritation at the treatment area (4%), nose and throat irritation
(2%), and pain at the treatment area (2%).
Tell your healthcare provider if you are pregnant or plan to become
pregnant. It is not known if Picato® gel can harm your unborn baby.
It is also not known if Picato® is safe and effective for the treatment
of actinic keratosis in children less than 18 years of age.
You are encouraged to report negative side effects of prescription
drugs to the FDA at www.fda.gov/medwatch or 1-800-FDA-1088,
or LEO Pharma Inc. at 1-877-494-4536, and select option 1.
Please see Indications and Usage on reverse and accompanying
full Prescribing Information.
Picato is a registered trademark of LEO Laboratories Limited.
LEO and the LEO Lion Design are registered trademarks of LEO Pharma A/S.
QualityCare is a trademark of LEO Pharma A/S.
©2016 LEO Pharma Inc. MAT-01605 All rights reserved. Jan. 2016 Printed in USA.