Duodopa

Package Leaflet: Information for the User

Duodopa, 20 mg/ml + 5 mg/ml, Intestinal Gel

Levodopa/Carbidopa

Read the Package Leaflet Carefully Before Using the Medication, as it Contains Important Information for the Patient.

• Keep this package leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medication has been prescribed for a specific person. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this package leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Duodopa and What is it Used For
• 2. Important Information Before Using Duodopa
• 3. How to Use Duodopa
• 4. Possible Side Effects
• 5. How to Store Duodopa
• 6. Contents of the Package and Other Information

1. What is Duodopa and What is it Used For

Duodopa belongs to a group of medications used to treat Parkinson's disease.
Duodopa is a gel that is administered through a pump into the small intestine.
The gel contains two active substances:

• Levodopa,
• Carbidopa.

How Duodopa Works

• In the body, levodopa is converted into a substance called dopamine, which supplements the dopamine present in the brain and spinal cord. Dopamine facilitates the transmission of impulses between nerve cells.
• A lack of dopamine causes the symptoms of Parkinson's disease, such as tremors, stiffness, slow movement, and balance problems.
• Treatment with levodopa increases the amount of dopamine in the body and thus reduces the severity of symptoms.
• Carbidopa enhances the therapeutic effect of levodopa and also reduces its side effects.

2. Important Information Before Using Duodopa

When Not to Use Duodopa

• If the patient is allergic to levodopa, carbidopa, or any of the other ingredients of this medication (listed in section 6),
• If the patient has an eye disease called narrow-angle glaucoma,
• If the patient has severe heart problems,
• If the patient has irregular heartbeat (severe arrhythmia),
• If the patient has had a severe stroke,
• If the patient is taking medications for depression, called selective MAO-A inhibitors and non-selective MAO inhibitors, such as moclobemide or phenelzine,
• If the patient has a tumor of the adrenal gland (pheochromocytoma),
• If the patient has hormonal disorders, such as excessive production of cortisol (Cushing's syndrome) or high levels of thyroid hormones (hyperthyroidism),
• If the patient has had skin cancer or has unusual moles (skin lesions) or skin changes that have not been examined by a doctor.

Do not use Duodopa if any of the above points apply to the patient. If in doubt, consult a doctor before starting treatment with Duodopa.

Warnings and Precautions

Before starting treatment with Duodopa, discuss with your doctor if:

• The patient has had a heart attack, blocked blood vessels in the heart, or other heart problems, including arrhythmias,
• The patient has lung disease, such as asthma,
• The patient has had hormonal disorders,
• The patient has had depression with suicidal thoughts or other mental disorders,
• The patient has had eye disease called open-angle glaucoma,
• The patient has had stomach ulcers,
• The patient has had seizures (convulsions),
• The patient has had surgery in the upper abdomen,
• Patient's treated with intestinal gel containing levodopa and carbidopa have experienced progressive weakness, pain, numbness, or loss of sensation in the fingers or toes (peripheral neuropathy). Before starting treatment with intestinal gel containing levodopa and carbidopa, the doctor will examine if the patient has had symptoms of neuropathy and will perform periodic examinations. Consult a doctor if the patient already has neuropathy or conditions related to neuropathy.

If any of the above apply to the patient (or the patient is unsure), tell the doctor before using Duodopa.

Pay Attention to the Following Side Effects

Malignant Neuroleptic Syndrome

Do not stop using or reduce the dose of Duodopa unless advised by a doctor.
Sudden stopping or rapid reduction of the dose of Duodopa may cause a severe disorder called malignant neuroleptic syndrome (see section 4 "Severe Side Effects").

Feeling of Drowsiness or Dizziness

If the patient suddenly falls asleep (sleep attacks) or feels excessive drowsiness, or a feeling of emptiness in the head, or dizziness

• Should not drive vehicles, use tools, or operate machines until fully awake or the feeling of emptiness in the head or dizziness has passed (see section 2 "Driving and Operating Machines").

Skin Changes

Tell the doctor, pharmacist, or nurse if the patient notices the appearance of unusual changes or moles (skin lesions) on the skin or their worsening (see section 4 "Other Side Effects").

Impulse Control Disorders – Changes in Patient Behavior

Tell the doctor if the patient, their family, or caregiver notices the appearance of impulses or irresistible desires to engage in behaviors that are unusual for the patient or the patient is unable to resist the impulsive desire, impulse, or temptation to perform certain actions that may be harmful to themselves or others. Such behaviors are called impulse control disorders and include:

• Pathological gambling,
• Excessive eating or spending,
• Increased sexual drive or intense sexual thoughts or feelings.

It may be necessary to re-evaluate the treatment used by the doctor. The doctor will discuss with the patient ways to cope with these symptoms or reduce their severity (see section 4 "Impulse Control Disorders – Changes in Patient Behavior").

Dopamine Dysregulation Syndrome

If the patient or their family (caregiver) notices the occurrence of symptoms similar to addiction, leading to the desire to take large doses of Duodopa and other medications used to treat Parkinson's disease, tell the doctor.

Problems with Pump or Catheter

Problems may occur with the use of the pump and catheter:

• The patient starts having difficulty operating the pump and catheter, symptoms of Parkinson's disease worsen, or there is a deterioration in the ability to perform movements (bradykinesia) - the pump and catheter may not be working properly.
• The patient experiences abdominal pain, nausea, and vomiting - immediately inform the doctor (see section 4 "Severe Side Effects").
• Other side effects may also occur in the intestine and at the catheter insertion site (see section 4 "Side Effects Related to the Use of the Pump or Catheter").

Duodopa and Cancer

In the body, carbidopa (an active substance in Duodopa) breaks down into a substance called hydrazine. There is a possibility that hydrazine can damage genetic material, which may lead to cancer. However, it is not known whether the amount of hydrazine produced during the use of Duodopa can cause this.

Lab Tests

During treatment with Duodopa, the doctor may order certain blood tests.

Surgical Procedures

Before surgery (including dental surgery), inform the doctor (or dentist) that you are using Duodopa.

Children and Adolescents

Duodopa should not be used in children and adolescents under 18 years of age.

Duodopa and Other Medications

Tell the doctor or pharmacist about all medications you are currently taking or have recently taken, as well as any medications you plan to take. This includes medications available without a prescription and herbal remedies.
Do not use Duodopa if:

• You are taking medications for depression called selective MAO-A inhibitors and non-selective MAO inhibitors, such as moclobemide or phenelzine.

Before starting treatment with Duodopa, inform your doctor or pharmacist if you are taking medications for:

• Anemia - such as iron preparations,
• Tuberculosis - such as isoniazid,
• Anxiety - such as benzodiazepine derivatives,
• Nausea - such as metoclopramide,
• Hypertension - such as antihypertensive medications,
• Vasospasm - such as papaverine,
• Seizures (convulsions) or epilepsy - such as phenytoin,
• Parkinson's disease - such as tolcapone, entacapone, amantadine,
• Psychiatric disorders - such as antipsychotic medications, including phenothiazine derivatives, butyrophenone derivatives, and risperidone,
• Severe allergic reactions, asthma, chronic bronchitis, heart disease, and low blood pressure - such as anticholinergic medications and sympathomimetics,
• If you are taking a medication that may cause low blood pressure. This can cause a disorder called orthostatic hypotension - which causes dizziness when standing up from a chair or bed. Duodopa may worsen this. Always change positions slowly.

Duodopa with Food and Drink

In some patients, Duodopa may not work effectively if taken with food high in protein or soon after its consumption (such as meat, fish, dairy products, grains, and nuts). Tell the doctor if you suspect this may apply to you.

Pregnancy and Breastfeeding

• If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor before using Duodopa.
• Do not use Duodopa during breastfeeding.

Driving and Operating Machines

Do not drive vehicles, use tools, or operate machines until you know how Duodopa affects you.

• Duodopa may cause significant drowsiness or sudden sleepiness (sleep attacks).
• Duodopa may lower blood pressure, which can cause a feeling of emptiness in the head or dizziness. Do not drive vehicles, use tools, or operate machines until fully awake or the feeling of emptiness in the head or dizziness has passed.

3. How to Use Duodopa

Always use this medication exactly as your doctor, pharmacist, or nurse has told you. If you are not sure, ask your doctor or pharmacist.

Information About Duodopa Gel and Pump

• Duodopa is a gel that is administered through a pump into the small intestine.
• The gel is placed in a plastic cassette. The cassette is connected to the pump.
• The pump is connected to the catheter inserted into the small intestine.
• The patient is given a small dose of the medication through the pump throughout the day. This maintains a constant level of the medication in the blood, which reduces some of the movement-related side effects.

How Much to Use

• The doctor decides what dose of Duodopa to use and for how long.
• Usually, a larger morning dose (called a "bolus dose") is given to quickly achieve the desired level of the medication in the blood. After this dose, a constant maintenance dose is given.
• If necessary, additional doses can be given. The doctor will decide this.

Using More Than the Recommended Dose of Duodopa

In case of using more than the recommended dose of Duodopa, immediately contact a doctor or go to the hospital. Take the medication packaging with you. The following symptoms may occur:

• Difficulty opening the eyes,
• Uncontrolled muscle contractions of the eyes, head, neck, and body (dystonia),
• Unintentional movements (dyskinesia),
• Abnormal heartbeat (arrhythmia).

Missing a Dose of Duodopa

• Start the pump as soon as possible and take the next scheduled dose.
• Do not increase the dose to make up for the missed dose.

Stopping or Reducing the Dose of Duodopa

Do not stop using or reduce the dose of Duodopa unless advised by a doctor.
Sudden stopping or reduction of the dose of Duodopa may cause a severe disorder called malignant neuroleptic syndrome. The occurrence of this disorder is more likely if the patient is also taking a medication called an antipsychotic (see section 4 "Severe Side Effects").
If you have any further questions about the use of this medication, ask your doctor, pharmacist, or nurse.

4. Possible Side Effects

Like all medications, Duodopa can cause side effects, although not everybody gets them.

Severe Side Effects of Duodopa

If you experience any of the following side effects, stop using Duodopa and inform your doctor immediately. You may need urgent medical attention:

• Sudden severe eye pain, headache, blurred vision, nausea, and vomiting. These may be symptoms of acute angle-closure glaucoma. Not very common: may affect up to 1 in 100 people.
• Fever, sore throat or mouth sores or urinary problems. These may be symptoms of a blood disorder called agranulocytosis. The doctor will take a blood sample to check this. Rare: may affect up to 1 in 10,000 people.
• Swelling of the face, tongue, or throat, which may cause difficulty swallowing or breathing, or a skin rash like hives. These may be symptoms of a severe allergic reaction (anaphylaxis). Frequency not known: cannot be estimated from the available data.

Immediately inform your doctor if you experience any of the following severe side effects:

• Malignant neuroleptic syndrome - symptoms may include:
• rapid heartbeat, blood pressure changes, increased sweating, and then fever,
• rapid breathing, muscle stiffness, decreased consciousness, and coma,
• increased levels of an enzyme called creatine phosphokinase in the blood, which the doctor will assess with a test. Rare: may affect up to 1 in 1,000 people. For more information on malignant neuroleptic syndrome, see section 3 "Stopping or Reducing the Dose of Duodopa".

Other Side Effects of Duodopa

If you experience any of the following side effects, inform your doctor, pharmacist, or nurse immediately.
Very Common:may affect more than 1 in 10 people

• Nausea (nausea),
• Weight loss,
• Constipation,
• Anxiety, depression, insomnia (insomnia),
• Involuntary movements (dyskinesia), worsening of Parkinson's disease symptoms,
• Dizziness when standing up or changing position (orthostatic hypotension) due to low blood pressure. Always change positions slowly - do not get up too quickly,
• Urinary tract infections.

Common:may affect up to 1 in 10 people

• Weight gain,
• Irregular heartbeat,
• Lack of appetite,
• Feeling tired, weak,
• High or low blood pressure,
• Anemia - low iron levels in the blood,
• Pain, neck pain, muscle spasms, muscle weakness,
• Sudden sleepiness (sleep attacks), excessive drowsiness, sleep disturbances,
• Increased levels of amino acids or homocysteine in the blood, vitamin B and B deficiency,
• Dizziness or feeling of impending fainting or fainting,
• Difficulty swallowing or dry mouth, taste disturbances (bitter taste),
• Headaches,
• Progressive weakness, pain, numbness, or loss of sensation in the fingers or toes (peripheral neuropathy),
• Rashes, itching, increased sweating, swelling due to fluid retention,
• Urinary retention (urinary retention) or inability to control urination (urinary incontinence),
• Hallucinations, confusion, abnormal dreams, feeling of excitement, impulsive behavior, psychotic disorder,
• Abdominal distension, diarrhea, bloating with gas, dyspeptic symptoms (dyspepsia), vomiting,
• Sudden return of Parkinson's disease symptoms - called "ON/OFF" phenomenon,
• Decreased sensation, uncontrolled muscle contractions of the eyes, head, neck, and body (dystonia), tremors.

Impulse Control Disorders – Changes in Patient Behavior.

Common (may affect up to 1 in 10 people)
Some people are unable to resist the impulse to perform actions that may be harmful to themselves or others. These include:

• Strong impulse to pathological gambling, despite serious consequences for the patient or their family,
• Change or increase in sexual thoughts and behaviors, which may be very disturbing for the patient or others, such as increased sexual drive,
• Uncontrolled excessive shopping or spending,
• Binge eating - consuming large amounts of food in a short time or compulsive overeating - eating more food than normal and more than the body needs.

Tell the doctor if the patient, their family, or caregiver notices any of these behaviors. It may be necessary to re-evaluate the treatment used by the doctor. The doctor will discuss with the patient ways to cope with these symptoms or reduce their severity.
Uncommon:may affect up to 1 in 100 people

• Dark urine,
• Hoarseness, chest pain,
• Hair loss, skin redness, hives,
• Increased saliva production,
• Vein inflammation (phlebitis),
• Change in gait,
• Suicidal thoughts - suicide,
• Feeling tired or general malaise,
• Rapid or irregular heartbeat (palpitations),
• Low white blood cell count or changes in blood cell count that may cause bleeding,
• Disorientation, elevated mood (euphoria), increased interest in sex, nightmares, confusion, feeling of anxiety,
• Difficulty controlling movements and performing involuntary movements, uncontrolled muscle contractions of the eyes, head, neck, and body (dystonia),
• Difficulty opening the eyes, double vision, blurred vision, damage to the optic nerve (ischemic optic neuropathy).

Rare:may affect up to 1 in 1,000 people

• Abnormal thinking,
• Irregular breathing rate and depth,
• Painful erection that does not subside,
• Appearance of unusual changes or moles (skin lesions) on the skin or their worsening or skin cancer (malignant melanoma),
• Darkening of saliva or sweat, burning sensation of the tongue, teeth grinding, hiccups.

Frequency Not Known:cannot be estimated from the available data

• Dopamine dysregulation syndrome - characterized by the desire to take large doses of Duodopa, more than necessary to control motor symptoms. In some patients, after taking large doses of Duodopa, severe disorders may occur, such as involuntary movements (dyskinesia), mood swings, or other side effects.

If you experience any of the above side effects, inform your doctor, pharmacist, or nurse.

Side Effects Related to the Use of the Pump or Catheter

The following side effects have been reported in relation to the use of the pump and catheter (system for administering the medication). If you experience any of these side effects, inform your doctor or nurse.

• If the patient starts having difficulty operating the pump and catheter, symptoms of Parkinson's disease worsen, or there is a deterioration in the ability to perform movements (bradykinesia) - the pump and catheter may not be working properly.
• If the patient experiences abdominal pain, nausea, and vomiting - immediately inform the doctor - this may be a problem with the pump or catheter.

Very Common:may affect more than 1 in 10 people

• Abdominal pain,
• Infection at the site where the catheter was inserted into the abdomen - may be caused by surgery,
• Thick scarring at the site where the catheter was inserted into the abdomen,
• Complications related to the insertion of the catheter - pain or swelling of the mouth and/or throat, difficulty swallowing, discomfort in the abdomen, pain or swelling,
• Complications at the site where the catheter was inserted into the abdomen - redness or skin irritation, pressure sores, discharge, pain or irritation.

Common:may affect up to 1 in 10 people

• Infection at the surgical site, postoperative infection after catheter insertion,
• Inflammation of the abdominal wall,
• Infection in the intestine or at the catheter insertion site,
• Catheter migration in the intestine or catheter blockage - which may cause less medication to be absorbed,
• Pain when breathing, shortness of breath, lower respiratory tract infections (pneumonia, including aspiration pneumonia).

Uncommon:may affect up to 1 in 100 people

• Colitis,
• Pancreatitis,
• Perforation of the intestinal wall by the catheter,
• Intestinal obstruction, bleeding, or ulcer,
• Intussusception (part of the intestine slipping into an adjacent part),
• Catheter blockage by food,
• Abscess (infection) - may occur after catheter insertion into the abdomen.

Frequency Not Known:cannot be estimated from the available data

• Reduced blood flow to the small intestine,
• Perforation of the stomach or small intestine by the catheter,
• Blood infection (sepsis).

Side Effects of Oral Medications Containing Levodopa and Carbidopa

The following side effects have been reported in relation to the use of oral medications containing levodopa and carbidopa (the same active substances as in Duodopa). These side effects may also occur with the use of Duodopa.
Rare:may affect up to 1 in 1,000 people

• Anemia - low iron levels in the blood,
• An eye disorder called "Horner's syndrome",
• Inability to fully open the mouth (trismus),
• A red or purple rash that looks like small bruises (Henoch-Schönlein purpura),
• Malignant neuroleptic syndrome (see section 4 "Severe Side Effects"),
• Prolonged pupil dilation, reduced eye movements.

Very Rare:may affect up to 1 in 10,000 people

• Changes in blood test results.

Reporting Side Effects

If you experience any side effects, including those not listed in this package leaflet, inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Medicinal Product Monitoring, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, PL-02 222 Warszawa, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medication.

5. How to Store Duodopa

• Keep the medication out of the sight and reach of children.
• Do not use this medication after the expiry date stated on the carton after "EXP".
• Store and transport in a cool place (2°C - 8°C). Keep the cassette in the outer packaging to protect from light.
• The cassette with the gel should be used within 24 hours of removal from the refrigerator.
• The cassettes with the medication are for single use only. The cassette should not be used for more than 24 hours, even if there is still gel left in it.
• Do not reuse opened cassettes.
• The gel may turn yellow - this does not affect the medication.
• Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medications no longer required. This will help protect the environment. Used cassettes should not be reused but should be returned to the nearest pharmacy.

6. Contents of the Package and Other Information

What Duodopa Contains

• The active substances of Duodopa are levodopa and carbidopa (as monohydrate). 1 ml of the gel contains 20 mg of levodopa and 5 mg of carbidopa (as monohydrate).
• The other excipients are sodium carmellose and purified water.

What Duodopa Looks Like and Contents of the Package

Duodopa is available in cassettes (a plastic bag with a PVC bag in a hard plastic cassette) containing 100 ml of the gel, in packs of 7 cassettes. The gel is white to yellowish in color.

Marketing Authorization Holder

AbbVie Sp. z o.o., ul. Postępu 21B, 02-676 Warszawa

Manufacturer

HP Halden Pharma AS, Svinesundsveien 80, NO-1788 Halden, Norway; AbbVie Logistics B.V., Zuiderzeelaan 53, 8017 JV Zwolle, Netherlands

For More Information

For more detailed information, consult your doctor or pharmacist, or contact the marketing authorization holder: AbbVie Sp. z o.o., ul. Postępu 21B, 02-676 Warszawa, tel. +48 22 372 78 00

This Medicinal Product is Authorized in the Member States of the European Economic Area Under the Following Names:

Duodopa

Date of Last Revision of the Package Leaflet: 05/2024

Other Sources of Information

Detailed information about this medication is available on the website of the Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych: http://urpl.gov.pl