Description
Foscarbidopa and foslevodopa combination injection is used to treat advanced Parkinson's disease. Parkinson's disease is a disorder of the central nervous system (brain and spinal cord).
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Solution
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of foscarbidopa and foslevodopa combination injection in the pediatric population. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of foscarbidopa and foslevodopa combination injection in the elderly. However, elderly patients are more likely to have age-related kidney, liver, or heart problems, which may require caution and an adjustment in the dose for patients receiving this medicine.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Isocarboxazid
- Methylene Blue
- Phenelzine
- Tranylcypromine
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Alfentanil
- Alprazolam
- Amobarbital
- Anileridine
- Aripiprazole
- Aripiprazole Lauroxil
- Asenapine
- Baclofen
- Benperidol
- Benzhydrocodone
- Bromazepam
- Bromperidol
- Buprenorphine
- Buspirone
- Butabarbital
- Butorphanol
- Calcium Oxybate
- Cannabidiol
- Cannabis
- Carbinoxamine
- Carisoprodol
- Carphenazine
- Cetirizine
- Chloral Hydrate
- Chlordiazepoxide
- Chlorpromazine
- Chlorzoxazone
- Clobazam
- Clonazepam
- Clorazepate
- Clozapine
- Codeine
- Cyclobenzaprine
- Daridorexant
- Dexmedetomidine
- Diacetylmorphine
- Diazepam
- Dichloralphenazone
- Difenoxin
- Dihydrocodeine
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
- Ethanol
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Dyskinesia (abnormal muscle movements) or
- Glaucoma or
- Heart attack, history of or
- Heart or blood vessel disease or
- Heart rhythm problems, history of or
- Hypertension (high blood pressure) or
- Mental health problems (eg, hallucinations) or
- Sleep disorder—Use with caution. May make these conditions worse.
Proper Use
A nurse or other trained health professional will teach you or a caregiver how to give this medicine. It is given as an infusion that is placed directly under your skin.
Your doctor or nurse will teach you how to prepare the medicine and how to use the pump for the infusion. You will be given detailed instructions on how to use and care for your pump and accessories. Make sure you understand all of the instructions before giving yourself an infusion.
This medicine should come with a Medication Guide and patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions.
You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. This will help prevent skin problems. Do not inject into skin areas that are tender, red, bruised, or hard.
Allow the medicine to warm to room temperature for 30 minutes. Do not warm using heat sources (eg, microwave, hot water).
Check the liquid in the vial. It should be colorless to light yellow and brown (possibly purple or red tint). Do not use if it is cloudy or has flakes or particles in it. Do not shake.
Do not add any other liquid or fill the syringe with anything other than this medicine.
You can stop using this medicine for short periods of time, including taking a shower or a short medical procedure. Change your infusion set and rotate to a different injection site if you stop the infusion for more than 1 hour.
If you stop using this medicine for more than 3 hours, you should give yourself a loading dose.
Keep a supply of oral backup medicine that contains levodopa and carbidopa with you at all times, in case your treatment with this medicine is stopped for 1 hour or more.
Do not drink alcohol while you are using this medicine.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For injectable dosage form (solution):
- For Parkinson's disease:
- Adults—Dose is based on the total levodopa dosage and must be determined by your doctor.
- Children—Use and dose must be determined by your doctor.
- For Parkinson's disease:
Missed Dose
Call your doctor or pharmacist for instructions.
Storage
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Store in the refrigerator. Do not freeze.
You may store the medicine at room temperature for up to 28 days. Do not put it back in the refrigerator once kept in room temperature. Throw away unused medicine if not used within 28 days.
Do not use this medicine if it has been in the syringe for more than 24 hours.
Throw away used needles in a hard, closed container where the needles cannot poke through. Keep this container away from children and pets.
Precautions
It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.
Do not use this medicine together with a non-selective MAO inhibitor (eg, phenelzine, tranylcypromine, Nardil®, Parnate®) in the past 14 days.
This medicine may make you dizzy or drowsy, or even cause you to fall asleep without warning. This could happen while you are driving, eating, or talking. Tell your doctor right away if this happens. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
If you develop any unusual or strange thoughts and behavior while receiving this medicine, be sure to discuss it with your doctor. Other changes might be confusion, worsening of depression, visual hallucinations (seeing things that are not there), suicidal thoughts, and unusual excitement, nervousness, or irritability.
This medicine may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. Also tell your doctor if you have sudden or strong feelings, including feeling nervous, angry, restless, violent, or scared. If you or your caregiver notice any of these adverse effects, tell your doctor right away.
Some people who have used this medicine had unusual changes in their behavior. Talk with your doctor right away if you start having unusual urges, including gambling, binge or compulsive eating, compulsive shopping, or an increased interest in sex while using this medicine.
This medicine may cause infusion site reactions and infections. Check with your doctor right away if you have collection of blood under the skin, deep, dark purple bruise, itching, pain, redness, or swelling at the infusion site.
Do not stop using this medicine without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping completely.
This medicine may cause withdrawal symptoms (eg, withdrawal-emergent fever and confusion). Check with your doctor right away if you are having difficulty with breathing, a fast heartbeat, a high fever, high or low blood pressure, increased sweating, loss of bladder control, seizures, severe muscle stiffness, unusually pale skin, or tiredness.
Check with your doctor before taking any of these medicines while you are using this medicine. The use of alcohol or other medicines that affect the CNS may worsen the side effects of this medicine, such as dizziness, poor concentration, drowsiness, unusual dreams, and trouble with sleeping. Some examples of CNS depressants are antihistamines or medicine for hay fever, allergies, or colds, sedatives, tranquilizers, or sleeping medicines, prescription pain medicine or narcotics, medicine for attention deficit and hyperactivity disorder, medicine for seizures or barbiturates, muscle relaxants, or anesthetics (numbing medicines), including some dental anesthetics. This effect may last for a few days after you stop using this medicine.
This medicine may cause uncontrolled sudden movements (dyskinesia) or make such movements you already have worse or more frequent. Tell your doctor if this happens.
This medicine may cause heart problems (eg, heart attack, arrhythmia). Check with your doctor right away if you have chest pain or discomfort, dizziness, fainting, fast, slow, or irregular heartbeat, nausea, pain or discomfort in the arms, jaw, back, or neck, sweating, trouble breathing, or vomiting.
Check with your doctor right away if you have blurred vision, change in vision, or loss of vision. These may be symptoms of increased pressure in the eye.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
More common
- Bloating or swelling of the face, arms, hands, lower legs, or feet
- difficulty swallowing
- dry, red, hot, or irritated skin
- loss of balance control
- mask-like face
- rapid weight gain
- seeing, hearing, or feeling things that are not there
- shuffling walk
- slowed movements
- slurred speech
- stiffness of the arms and legs
- tic-like (jerky) movements of the head, face, mouth, and neck
- tingling of hands or feet
- trembling and shaking of the fingers and hands
- twitching, twisting, uncontrolled repetitive movements of the tongue, lips, face, arms, or legs
- unusual weight gain or loss
Less common
- Anxiety
- delusions of persecution, mistrust, suspiciousness, or combativeness
- dry mouth
- false beliefs that cannot be changed by facts
- hyperventilation
- irritability
- nervousness
- restlessness
- shaking
- trouble breathing
- trouble sleeping
Incidence not known
- Blindness
- blurred vision
- cough or hoarseness
- decreased vision
- dizziness
- eye pain
- fainting
- fast, slow, or irregular heartbeat
- fever or chills
- high or low blood pressure
- loss of bladder control
- lower back or side pain
- nausea or vomiting
- painful or difficult urination
- seizures
- severe muscle stiffness
- tearing
- unusually pale skin
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Constipation
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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