How does this medication work? What will it do for me?

This is a combination product containing two medications in the form of a gel: levodopa and carbidopa. It is used to treat Parkinson's disease in people who are responsive to levodopa treatment, have tried other types of Parkinson's disease medication combinations but continue to have symptoms. Levodopa - carbidopa intestinal gel is given using a small portable pump and tube that connects directly into the gut. The medication is given throughout the day, which allows a constant amount of medication to be in the blood and decrease the Parkinson's symptoms.

Levodopa helps to control the symptoms of Parkinson's disease by correcting the chemical imbalance in the brain that produces symptoms. The addition of carbidopa lowers the amount of levodopa that is required and may reduce some of the side effects of levodopa, such as nausea and vomiting.

Although levodopa helps relieve symptoms of Parkinson's disease, it does not slow down the progression of the disease.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

What form(s) does this medication come in?

This medication is available as a ready-to-use intestinal gel contained in a reservoir bag inside a hard plastic cassette. Each cassette contains 100 mL of this medication.

Each mL of white to slightly yellow coloured intestinal gel contains 20 mg levodopa and 5 mg carbidopa. Nonmedcinal ingredients: carmellose sodium and purified water.

How should I use this medication?

Levodopia - carbidopa intestinal gel is given by a small portable pump and tube (called percutaneous endoscopic gastrostomy jejunal tube or PEG-J tube) that connects directly into your gut. The medication itself is contained in hard plastic cassettes. Instructions on how to use the pump as well as how to attach the cassettes to the pump are provided at the end of this section. Your doctor will teach you how to properly use this device and medication.

A minor surgery is needed to place the medication tube into your gut. Before this surgery, your doctor will first give you a trial of the medication by placing a temporary tube through your nose into your gut to see how well you respond to the medication and to adjust the dose. Follow the instructions given by your doctor on how to maintain this tube. If you are also using an extension tube, the extension tube should be removed, capped and placed in the refrigerator each night.

The usual dose for levodopa - carbidopa intestinal gel is different for each person and you may need regular small adjustments to reach the best dose for your symptoms. Your dose is programmed into your pump by your doctor or nurse and should only be adjusted by a healthcare professional. Once your pump has been programmed, you will learn how to take your various doses throughout the day (up to 16 hours). This medication is not for use in people under 18 years of age.

Usually, a larger dose in the morning is given to quickly reach the correct amount of medication needed in the blood. Afterward, a lower dose is given throughout the day until bedtime. Your doctor may recommend extra doses throughout the day, if needed. If needed, you may give yourself extra doses throughout the day as recommended by your doctor. It is normal that some gel may remain in your cassette at the end of the day or after a 16-hour period. You should never reuse any leftover gel after the 16-hour period. At bedtime, the tube should be disconnected from the pump and flushed daily with room temperature tap water to prevent it from becoming blocked.

Do not suddenly stop or reduce the dose of this medication on your own, as it can result in serious life-threatening problems.

Using the pump: Before using the pump, carefully inspect the tubing and connections for any kinks or blockages that may result in too little or no medication being pumped. Before attaching the cassette to the pump, inspect the cassette tube to ensure that its contents appear milky white, or slightly yellow. Do not use the medication if the contents are not milky white, or slightly yellow, or the container is leaking.

Attaching the cassette to the pump:

  1. Insert the cassette hooks into the hinge pins on the pump.
  2. Place the pump and cassette upright on a firm, flat surface. Press down so the cassette fits tightly against the pump.
  3. Insert a coin into the latch, push in, and turn counterclockwise until the line on the latch lines up with the arrow on the side of the pump. You should be able to hear and/or feel the latch click into place.
  4. Gently twist, push and pull on the cassette to make sure it is firmly attached. You may need to repeat the procedure if the cassette is not secure.

To attach the cassette to the PEG-J tube:

  1. Remove the red protective cap from the cassette tube and open any tube clamps.
  2. Connect the cassette tube to the intestinal port of the PEG-J tube. Make sure to twist the cassette tube and not the PEG-J tube.

Cleaning the pump: To clean the pump and accessories, dampen a soft, lint free cloth with soapy water and wipe the exterior surface of the pump. Wipe the surface dry with another soft, lint-free cloth. Allow the pump to dry completely before using it again. Do not immerse the pump in water or cleaning fluid or use any acetone, solvents or abrasive cleaners.

Cleaning the tubes: Clean the external PEG-J tubing and connectors on a regular basis using warm, soapy water. The intestinal tube should be flushed with tap water every night to prevent blockages.

It is important to only use the PEG-J tube for this medication. Do not use your PEG-J tube to take any substances other than this medication without speaking with your doctor.

During treatment with this medication, the internal and external tubing will periodically require replacement. Your doctor should regularly check to see that it is working properly.

This medication should be stored in a refrigerator and protected from light (i.e. keep the carton of this medication carefully closed).

It is important to take this medication exactly as prescribed by your doctor. Do not change the dose or stop treatment without talking to your doctor. If your symptoms suddenly or slowly become worse, it is possible that a part of the tube is blocked, disconnected or has moved. If this happens, call your doctor right away.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Who should NOT take this medication?

Levodopa - carbidopa intestinal gel should not be taken by anyone who:

  • is allergic to levodopa, carbidopa, or to any of the ingredients of the medication
  • cannot take sympathomimetic amines (e.g., epinephrine, norepinephrine)
  • has a history of stomach or pancreas problems such as swelling or obstruction that prevents placement of a PEG tube (a type of tube that connects to the gut in order to use this medication)
  • has an active infection of the abdominal space
  • has active uncontrolled or severe heart disease, blood related diseases, endocrine disease, liver disease, lung disease, or kidney disease
  • has narrow-angle glaucoma
  • has suspicious undiagnosed skin lesions or a history of melanoma
  • has or has had a stroke in the last 6 months
  • has used an MAO inhibitor (e.g., phenelzine, tranylcypromine) within the past 2 weeks. As an exception, selegiline (a specific MAO inhibitor) can be used safely at the recommended dose with levidopa - carbidopa intestinal gel

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent. The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

As this medication is delivered using a pump-tube delivery system, complications can occur from the surgical procedure required to create the small opening in the stomach wall for the intestinal tube and with long-term use of the intestinal tube. This risk should be discussed with your doctor to determine if this medication is a good choice for your treatment.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

Although most of these side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

  • anxiety
  • cold, burning, tingling, prickling sensations in the hands, feet, arms or legs
  • constipation
  • depression
  • diarrhea
  • dizziness
  • falls, feeling lightheaded or faint after standing
  • hallucinations
  • increased sweating
  • involuntary movements, muscle cramps
  • loss of appetite
  • surgical procedure-related problems (e.g., abdominal pain, redness or swelling around the surgical wound, infection around the tube, air or gas in the abdomen etc.)
  • upset stomach
  • vomiting
  • weight loss

Check with your doctor as soon as possible if any of the following side effects occur:

  • changes in mental conditions such as hallucinations, depression or worsening of depression
  • a sudden return of your Parkinson's disease symptoms
  • irregular heartbeat, feeling dizzy or faint when standing up, fainting.
  • signs of skin cancer, irregular or new skin lesions
  • abnormal thinking- developing urges to gamble, increased sexual urges, excessive eating or spending, and/or other intense urges that could harm yourself or others
  • falling asleep without warning

The following side effects may be caused from the tubing as you should check you with your doctor as soon as possible if any occurs:

  • tube blockages
  • dislocation of the tube
  • inflammation or infection around the tube leading to swelling or leakage
  • stomach pain, nausea, vomiting
  • worsening movement (or slow movement)

Seek immediate medical attention if any of the following occur:

  • severe abdominal pain which may be associated with fever, vomiting, abdominal tenderness, or swelling of the abdomen
  • signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, redness, itching, or swelling of the skin, face and throat)
  • vomiting of blood or noticing blood in your stools
  • with reduced dosing or stopping the medication resulting in a high fever, muscle rigidity, involuntary movements, altered consciousness, mental status changes such as more frequent breathing, sweating or dizziness

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Activities requiring alertness: There have been reports of sudden onset of sleep by individuals taking levodopa and carbidopa combination. The doctor should be informed immediately if any episodes of suddenly falling asleep occur.

Behavior and mood: There have been reports of behavior and mood changes in people taking these types of medication. Your doctor should be informed immediately if you notice any behavior or mood changes.

Blood pressure and heart: This medication can cause blood pressure changes. If you have an existing heart condition, you should discuss with your doctor about how your condition may affect your medication dosage, or how your dosage may affect your medical condition.

Device-related complications: A sudden decrease in treatment response with increased symptoms of Parkinson's disease may be due to problems with the tubing or pump device, including tube blockages or dislocations. The doctor should be informed immediately if this occurs.

Diet: Protein rich diets such as diets that contain a lot of meat, poultry or fish) may reduce the beneficial effects of levodopa.Your doctor should be informed about your diet patterns prior to taking this medication.

Eye: People with chronic wide-angle glaucoma should use this medication with caution, as it may increase pressure inside the eye.

Medical conditions: People with epilepsy, peptic ulcer or previous surgery in the upper part of the abdomen, heart disease, lung disease (e.g. asthma), liver disease, kidney disease, hormonal disturbances, depression, suicidal tendencies, impulse control disorders and/or any mental disorder should be frequently monitored by their doctor while taking this medication.

Skin cancer: People with Parkinson's have shown to have 2 to 6 fold higher risk of developing skin cancer than the general population. It is unknown if this is caused by the medication or due to the Parkinson's disease. You should discus with your doctor regarding regular monitoring of your skin.

Surgeries: Except in emergencies, levodopa-carbidopa intestinal gel should be stopped 2-3 hours before any surgeries that require general anesthesia. Use of anesthesia and this medication together may cause changes in blood pressure or abnormal heart rhythms. Levodopa-carbidopa intestinal gel can be restarted after surgery as soon as the doctor allows you to drink fluids normally.

Pregnancy: The safety and effectiveness of using this medication have not been established for pregnant women. Levodopa-carbidopa intestinal gel should not be used during pregnancy unless the benefits outweigh the risks.

Breast-feeding: Levodopa-carbidopa intestinal gel should not used by breast-feeding mothers.

Children: The safety and effectiveness of levodopa-carbidopa intestinal gel have not been established for use by people under 18 years of age.

What other drugs could interact with this medication?

There may be an interaction between levodopa - carbidopa intestinal gel and any of the following:

  • amisulpride
  • anesthetics
  • iron salts (e.g., ferrous sulfate, multivitamins that contain iron)
  • MAO inhibitors (e.g., phenelzine, tranylcypromine)
  • medications that lower blood pressure
  • medications that treat heart disease
  • medications that treat nausea and vomiting (e.g., metoclopramide)
  • medications that treat schizophrenia
  • medications that treat seizures (e.g., benzodiazepines)
  • medications to treat severe allergic reactions, asthma, chronic bronchitis such as sympathomimetic medications (e.g., isproterenol, epinephrine, cough and cold medications)
  • medications that treat spasms in the blood vessels such as papaverine
  • medications that treat tuberculosis (e.g., isoniazid)
  • methionine
  • pyridoxine
  • sulpiride
  • tricyclic antidepressants (e.g., amitriptyline, desipramine)

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.