Duodopa fact sheet

APPROVAL WITH CONDITIONS OF
DUODOPA™ (levodopa/carbidopa intestinal gel) FOR USE IN THE
TREATMENT OF ADVANCED LEVODOPA-RESPONSIVE PARKINSON’S
DISEASE WHEN SATISFACTORY CONTROL OF SEVERE, DISABLING,
MOTOR FLUCTUATIONS AND HYPER-/DYSKINESIA CANNOT BE
ACHIEVED WITH AVAILABLE COMBINATIONS OF PARKINSON
MEDICINAL PRODUCTS
FACT SHEET
What is DUODOPA and what is it used for?
DUODOPA is a combination of levodopa and carbidopa in the form of a gel that is
administered directly into the small intestine through a surgically placed tube. This
treatment is for use in patients with advanced Parkinson’s disease who do not have
satisfactory control of severe, disabling motor symptoms when using available combinations
of other medications for Parkinson’s disease.

Health Canada has approved DUODOPA with conditions, under the Notice of Compliance
with Conditions (NOC/c) policy. This authorization reflects the promising nature of the
clinical evidence, which must be confirmed with further studies. Products approved under
Health Canada’s NOC/c policy, have demonstrated promising benefit, are of high quality
and possess an acceptable safety profile based on a benefit/risk assessment.
What is Parkinson’s Disease?
Parkinson’s disease is a progressive disease which results from the loss of cells in the brain
which produce dopamine. Dopamine is a substance that is naturally present in the brain and
spinal cord. Dopamine helps the nerve cells in the brain that control movement to function
properly. As levels of dopamine in the brain get lower, the symptoms of Parkinson’s disease
appear for example, tremor, muscle stiffness, slow movements and difficulty keeping one’s
balance.
How does DUODOPA work?
Levodopa is transformed in the body to dopamine. Treatment with levodopa increases the
amount of dopamine in the brain and reduces the symptoms of Parkinson’s disease.
Carbidopa is used in combination with levodopa to ensure that enough levodopa gets to the
brain where it is needed. This improves the effect and reduces the undesirable effects of
levodopa, such as upset stomach.
DUODOPA is a gel that is administered throughout the day with a pump via a tube, directly
into the upper small intestine. This means that the two active ingredients, levodopa and
carbidopa, are received continuously over the day. This allows the amount of drug in the
blood to be more constant and the risk of symptoms such as movement disorders is reduced.
What other treatments have been used to treat Parkinson’s disease?
As Parkinson’s disease progresses to more advanced stages, medicines used to treat the early
stages of Parkinson’s disease, such as dopamine receptor agonists, may no longer be able to
provide satisfactory control of motor symptoms. At this advanced stage there are limited
treatment options. The treatments offered will depend on your general health and may
include therapy with DUODOPA, brain surgery, or supportive care.
What are the advantages of DUODOPA over oral therapies?
By providing a continuous flow of medication directly to the intestines, where it is absorbed,
DUODOPA can help maintain a constant level of levodopa in the blood. Maintaining a
constant level of levodopa in the blood may decrease the number of times a patient alternates
between stiffness and uncontrolled movements.

Who can be treated with DUODOPA?
DUODOPA is for use in patients with advanced Parkinson’s disease, when treatment with
other medicines for Parkinson’s disease no longer provides adequate control of the severe,
disabling motor symptoms. The doctor will need to carefully examine your overall condition
to determine if DUODOPA treatment will be a suitable treatment for you.
Who should not be treated with DUODOPA?
If you cannot take levodopa/carbidopa (for example, as tablets), because you are
hypersensitive (allergic) to levodopa or carbidopa, or because you have certain other medical
conditions, DUODOPA should not be used.
If you have a history of complications or problems with your stomach and/or intestines (such
as swelling or obstruction), or with your pancreas that prevents placement of a PEG tube,
DUODOPA should not be used.
What are the side effects and how serious are they?
Side effects that can be caused by the drug
The side effects of DUODOPA are similar to the side effects experienced with tablets of
levodopa/carbidopa. The most common serious effects of levodopa include irregular
heartbeat and changes in mental condition. Rare cases of allergic reaction or inability to
urinate may occur and very rarely patients have been reported to fall asleep without warning.
If you experience any of the following, while using DUODOPA, you should notify your
doctor:
• Irregular heartbeat, feeling dizzy or faint when standing up • Changes in mental condition such as hallucinations or depression Side effects caused by the intestinal tubing
The long-term use of DUODOPA requires that a tube be surgically placed into your intestine.
Side effects related to the tube and the surgery include movement of the tube back into the
stomach, knots or blockages in the tube, infection of the surgical opening, leakage or swollen
flesh around the surgical opening, and stomach pain.
It is important to note that in very rare cases, serious complications may occur such as
bleeding and damage to the lining of the digestive tract, associated with the surgical
procedure. Leakage of fluids from the stomach through the surgical opening can result in
inflammation of the lining of the abdomen (peritonitis). Pneumonia may also occur.
One of the most important things for you to do to minimize the risks from side effects, while
being treated with DUODOPA, is to contact your doctor or nurse if you notice any symptom
that worries you, even if you think it is not connected with this treatment or is not described
in any of the information provided to you for DUODOPA.
What do patients need to know about taking DUODOPA?
DUODOPA should only be prescribed by a doctor who is experienced in treating patients
with Parkinson’s disease and who has completed the DUODOPA Education Program. The
DUODOPA Education Program provides training to doctors and nurses on how to use
DUODOPA and what information is necessary for you to use this treatment safely and
effectively. For patients who will be treated with DUODOPA or who have discussed
DUODOPA treatment with their doctor, detailed educational material about DUODOPA will
be provided for you and your caregiver.
Because DUODOPA may interact with other medications, including over-the-counter
medications, natural health products and multivitamins containing iron, you should inform
your doctors about all medications you are taking. You should also inform your doctor
about any medical problems you have or have had or if you are going to have an operation
that requires general anesthesia.
Because some patients treated with levodopa/carbidopa have been reported to fall asleep
without warning, special care should be taken when driving or operating machinery during
DUODOPA treatment.
You should not change the dosage or stop DUODOPA treatment without first talking to your
doctor. Abrupt interruption of treatment may result in complications.

How is DUODOPA taken?
DUODOPA is available in 100mL cassettes for use with the CADD-Legacy DUODOPA
pump. It is administered with the pump, through a tube directly into the upper intestine as
shown in the diagram below.
DUODOPA Infusion System
Gastric Port
Intestinal
Connection
cassette

Before you have surgery to insert a tube directly into the upper small intestine, your doctor
will usually first insert a temporary tube through the nose into the small intestine for at least
a few days, to see if you respond well to DUODOPA treatment and to adjust the dose.

The dose of DUODOPA is different for each patient. The doctor/nurse will determine the
best dosing regimen for you and program it into the pump. You will be able to make regular,
small adjustments to the dose, as required, to maintain the best control. If bigger dose
adjustments are required you should consult with your doctor/nurse.

Where can I learn more about DUODOPA?
For more information about DUODOPA please contact Abbott Products Inc. Medical
Information at: 1-800-268-4276.
™ Trade-mark NeoPharma AB, Licensed use by Abbott Products Inc. Markham ON L3R 0C9

Source: http://neurocommunity.org/wp-content/uploads/2013/12/Duodopa-fact-sheet.pdf