Are there any reasons why I should not receive Restylane Kysse?
Your doctor will ask about your medical history to determine if Restylane Kysse is right for you. Patients
with any of these conditions should not use Restylane Kysse:
• Highly allergic (for example: a history of severe allergic reaction or multiple severe allergies). Use
may result in an allergic reaction.
• If you have previous experience with allergic reactions to HA fillers. Use may result in an allergic
• Allergic to anesthetics, such as lidocaine. Use may result in an allergic reaction.
What precautions should my doctor discuss with me?
• The use of Restylane Kysse where skin sores, pimples, rashes, hives, cysts, or infections are
present should be postponed until healing is complete. Use of Restylane Kysse where these are
present could delay healing or make your skin problems worse.
• As with any injection procedure, you may have a higher risk of bruising or bleeding at the injection
site if you have a bleeding disorder.
• Tell your doctor if you are using St. John’s Wort, high doses of Vitamin E supplements, aspirin, and
other NSAIDs, such as ibuprofen, because these may increase bruising or bleeding at the injection
• Tell your doctor if you are planning other skin therapies such as laser, mechanical or chemical
peeling, microneedling and hair removal after treatment. The use of Restylane Kysse with these
skin therapies may lead to other side effects such as inflammation.
• After treatment with Restylane Kysse, you should minimize exposure to the sun and avoid being in
the heat and cold until any redness or swelling has disappeared. Exposure to any of these may
cause temporary redness, swelling, and/or itching at the injection site.
• Tell your doctor if you are pregnant or breastfeeding. The safety and effectiveness of Restylane
Kysse has not been established in pregnant women or nursing mothers.
• Tell your doctor if you are on a therapy to decrease the body’s immune response. Treatment may
result in an increased risk of infection.
• Tell your doctor if you have a history of thick, hard scars (excessive scarring). The safety and
effectiveness of Restylane Kysse in patients with a history of thick, hard scars has not been studied
and may result in additional scarring.
What side effects were seen in the clinical study?
In the study of Restylane Kysse, most side effects were mild or moderate in nature and their duration was
short lasting (7 days or less). The most common side effects included, but was not limited to, temporary
injection site responses such as:
What happens in the office before the injection?
Note that each doctor may have a unique process for treating patients.
The following is an example of what your doctor may do before the injection procedure.
• Talk to you about your medical history, including questions about prior procedures, surgeries,
illnesses and medications you have taken.
• Talk to you about your desired results for your procedure.
• Examine your face and discuss whether Restylane Kysse is the right treatment for you.
• Review what you should expect during and after the procedure.
• Let you know of any possible side effects that you may experience, and what to do if you
• Take photos of the area of your face that will be treated.
Your doctor may also have additional ways of evaluating patients and preparing them for a procedure.
What happens during the procedure?
Your doctor may do the following during your procedure:
• Your skin will be cleansed prior to treatment
• Use a cream or ointment called a topical anesthetic to numb the area where you will receive your
• Your doctor will begin the procedure by giving you the first injection, then pausing to allow the
anesthetic that is part of Restylane Kysse to continue to numb the area around your injection. The
anesthetic part of Restylane Kysse has been shown to significantly reduce the pain and discomfort
that may occur with a dermal filler gel injection.
• Your doctor will continue the injection of Restylane Kysse until the area being treated shows the
• After the injection is completed, your doctor may gently massage the area that was treated to
ensure the dermal filler gel is distributed evenly and looks natural.
What other treatments are available to me?
There are other dermal filler gels in the United States that are available to you for treatment. Additionally,
there are alternative treatments such as botulinum toxins, laser therapy and chemical peels for the
treatment of lines and wrinkles. You can discuss these treatments with your doctor to determine which
one is right for you.
When should I call my doctor?
You should call your doctor immediately if you have:
• Changes in your vision
• Signs of a stroke (including sudden difficulty speaking, numbness or weakness in your face, arms,
or legs, difficulty walking, face drooping, severe headache, dizziness, or confusion)
• White appearance of the skin
• Unusual pain during or shortly after treatment.
Be sure to call your doctor if you have:
• Persistent injection site reactions beyond 14 days, as most side effects such as bruising, swelling,
pain, tenderness, redness, and itching will usually go away within one to two weeks
• Blisters or skin sores that recur, which may signal the presence of a herpes infection
• Any signs of infection such as fever, redness that spreads to surrounding areas, drainage,
increasing tenderness or increasing pain that does not go away
• Significant pain away from the injection site
• Any side effect that occurs weeks or months after treatment
• Any other symptoms that cause you concern.
What if I experience a problem?
If you believe that you have experienced a serious problem related to Restylane Kysse you should call your
doctor. Your questions about Restylane Kysse can be personally answered by contacting the Galderma
Laboratories L.P. toll-free call center between 8:00 a.m. and 5:00 p.m. Central Daylight Time, Monday to
Restylane and Galderma are registered trademarks.