Description
Apomorphine injection is used alone or together with other medicines to treat hypomobility, “off” episodes (“end-of-dose wearing off” and unpredictable “on/off” episodes) in patients with advanced Parkinson's disease, sometimes referred to as "shaking palsy." By improving muscle control and reducing stiffness, this medicine allows more normal movements of the body as the disease symptoms are reduced.
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 apomorphine 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 apomorphine injection in the elderly. However, elderly patients are more likely to have age-related heart, kidney, or liver problems and serious unwanted effects (eg, confusion, hallucination, heart or blood vessel problems, falls, stomach or bowel problems, lung or breathing problems), which may require caution in 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.
- Alosetron
- Bepridil
- Cisapride
- Dolasetron
- Dronedarone
- Granisetron
- Levoketoconazole
- Mesoridazine
- Ondansetron
- Palonosetron
- Piperaquine
- Saquinavir
- Sparfloxacin
- Sulpiride
- Terfenadine
- Thioridazine
- Ziprasidone
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.
- Adagrasib
- Alfuzosin
- Alizapride
- Amiodarone
- Amisulpride
- Amitriptyline
- Amoxapine
- Anagrelide
- Aripiprazole
- Aripiprazole Lauroxil
- Arsenic Trioxide
- Asenapine
- Astemizole
- Atazanavir
- Azithromycin
- Bedaquiline
- Benperidol
- Bromopride
- Bromperidol
- Buprenorphine
- Buserelin
- Ceritinib
- Chloroquine
- Chlorpromazine
- Chlorprothixene
- Ciprofloxacin
- Citalopram
- Clarithromycin
- Clofazimine
- Clomipramine
- Clothiapine
- Clozapine
- Crizotinib
- Cyclobenzaprine
- Dabrafenib
- Dasatinib
- Degarelix
- Delamanid
- Desflurane
- Desipramine
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Nitroglycerin
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:
- Bradycardia (slow heartbeat) or
- Hypokalemia (low potassium level in the blood) or
- Hypomagnesemia (low magnesium level in the blood)—Use with caution. May increase risk for more side effects.
- Dyskinesia (trouble controlling movements) or
- Heart or blood vessel disease or
- Heart rhythm problems (eg, QT prolongation, torsades de pointes) or
- Hypotension (low blood pressure) or
- Mental illness (eg, psychosis) or
- Trouble sleeping—Use with caution. May make these conditions worse.
- Kidney disease, mild to moderate or
- Liver disease, mild to moderate—Use with caution. The effects may be increased because of the slower removal of the medicine from the body.
- Kidney disease, severe or
- Liver disease, severe—Use with caution. The effects may be increased because of the slower removal of the medicine from the body.
Proper Use
A nurse or other trained health professional will give you this medicine. It is given as a shot under your skin. You or your caregiver may be trained to prepare and inject the medicine at home. Be sure that you understand how to use the medicine.
Onapgo™: 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.
If you use this medicine at home, 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 from the injections. Do not inject into skin areas that are bruised, irritated, or has bumps or nodules.
This medicine comes with a patient information leaflet and patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.
Check the liquid in the pen or cartridge. It should be clear or colorless. Do not use the medicine if it is cloudy, discolored, or has particles in it.
Do not get the liquid in the cartridge on your skin or into your eyes. Rinse it off with water right away if it does get in these areas.
You must prime the pen before using it. To prime:
- Set the dose knob of the pen to 0.1 milliliter (mL) to get rid of any air bubbles.
- Remove the inner needle shield. Do not let the needle touch anything.
- Point the needle up and firmly push the injection button. Hold it for at least 5 seconds. A small stream of medicine must come out of the end of the needle. If there is none, repeat the steps until medicine comes out of the needle.
- This medicine can stain fabric and other surfaces. Be careful where you prime it.
Use a new needle each time you inject your medicine.
Your doctor may give you other medicines (eg, trimethobenzamide 300 milligrams [mg] 3 times a day) 3 days before starting this medicine and for up to 2 months to prevent nausea and vomiting. Your doctor may also start this medicine at a lower dose to help prevent nausea and vomiting.
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 injection dosage form (solution):
- For hypomobility or "off episodes":
- Adults—At first, 0.1 milliliter (mL) (1 milligram [mg]) to 0.2 mL (2 mg) injected under the skin. Your doctor may adjust your dose as needed and tolerated. However, the dose is usually not more than 0.6 mL (6 mg) injected under the skin per day.
- Children—Use and dose must be determined by your doctor.
- For off episodes:
- Adults—At first, 1 milligram (mg) per hour injected under the skin as an infusion. Your doctor may adjust your dose as needed and tolerated. However, the dose is usually not more than 98 mg injected under the skin per day.
- Children—Use and dose must be determined by your doctor.
- For hypomobility or "off episodes":
Missed Dose
Call your doctor or pharmacist for instructions.
Apokyn®: Do not inject another dose of this medicine less than 2 hours after the last dose.
Onapgo™: Do not inject more than 3 extra doses per day over 16 hours with at least 3 hours between extra doses.
Storage
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
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.
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 take this medicine together with alosetron (Lotronex®), dolasetron (Anzemet®), granisetron (Kytril®, Sancuso®), ondansetron (Ondisolv®, Zofran®), or palonosetron (Aloxi®).
Do not change your dose or stop using this medicine without first checking with your doctor. Your doctor will need to slowly decrease your dose before you stop it completely.
Call your doctor if your symptoms do not improve or if they get worse.
This medicine may make you dizzy or drowsy, or cause trouble with controlling body movements, which may lead to falls. It may also 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. Standing up slowly from a sitting or lying position can help prevent getting dizzy.
This medicine may cause dyskinesia (a movement disorder). Check with your doctor right away if you have twitching, twisting, or uncontrolled repetitive movements of the tongue, lips, face, arms, or legs.
Check with your doctor right away if you have back, leg, or stomach pains, bleeding gums, chills, dark urine, difficulty breathing, fever, general body swelling, headache, loss of appetite, nausea or vomiting, nosebleeds, pale skin, sore throat, unusual tiredness or weakness, or yellowing of the eyes or skin. These may be symptoms of a blood problem called hemolytic anemia.
This medicine may cause infusion site reactions and infection. Check with your doctor right away if you have itching, pain, redness, or swelling at the infusion site, bleeding gums, collection of blood under skin, coughing up blood, deep, dark purple bruise, difficulty in breathing or swallowing, dizziness, dry, red, hot, or irritated skin, hard lump, headache, increased menstrual flow or vaginal bleeding, nosebleeds, paralysis, prolonged bleeding from cuts, red or dark brown urine, or red or black, tarry stools.
Some people who have used this medicine had unusual changes in their mood or behavior. Talk with your doctor right away if you start seeing, hearing, or feeling things that are not there, or start having unusual urges, such as gambling urges, binge or compulsive eating, compulsive shopping, or sexual urges while using this medicine.
This medicine may also increase your risk of having serious heart and blood vessel problems such as chest pain or heart attack. Check with your doctor right away if you start having chest pain or discomfort, pain or discomfort in the arms, jaw, back or neck, trouble breathing, nausea, sweating, or vomiting.
Contact your doctor right away if you have any changes to your heart rhythm. You might feel dizzy or faint, or you might have a fast, pounding, or uneven heartbeat. Make sure your doctor knows if you had a heart rhythm problem, such as QT prolongation.
This medicine may increase your risk for fibrotic complications (tissue changes in the pelvis, lungs, and heart valves). Check with your doctor right away if you have fever, general feeling of illness, loss of appetite, lower stomach or back pain, cough, or trouble breathing.
If you experience a prolonged or painful erection of the penis for more than 4 hours, check with your doctor right away.
Check with your doctor before using this medicine with alcohol or other medicines that affect the central nervous system (CNS). The use of alcohol or other medicines that affect the CNS with apomorphine may worsen the side effects of this medicine, such as dizziness, poor concentration, drowsiness, unusual dreams, and trouble with sleeping. Some examples of medicines that affect the CNS are antihistamines or medicine for allergies or colds, sedatives, tranquilizers, or sleeping medicines, medicine for depression, medicine for anxiety, prescription pain medicine or narcotics, medicine for attention deficit and hyperactivity disorder, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics.
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
- Anxiety
- bladder pain
- bloody or cloudy urine
- blurred vision
- chest pain, pressure, or tightness
- chills
- confusion
- cough
- decreased urination
- difficult, burning, or painful urination
- dilated neck veins
- discouragement
- dizziness
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- dry mouth extreme
- fainting
- falls
- feeling sad or empty
- fever
- frequent urge to urinate
- increase in heart rate
- irregular breathing or heartbeat
- irritability
- lack of appetite
- lightheadedness
- loss of interest or pleasure
- lower back or side pain
- nausea
- rapid breathing
- seeing, hearing, or feeling things that are not there
- sleepiness or unusual drowsiness
- sneezing
- sore throat
- sunken eyes
- sweating
- swelling of face, fingers, feet, or lower legs
- thirst
- trouble breathing
- trouble concentrating
- trouble sleeping
- twitching, twisting, uncontrolled repetitive movements of the tongue, lips, face, arms, or legs
- unusual tiredness or weakness
- vomiting
- weight gain
- wrinkled skin
Incidence not known
- Back, leg, or stomach pains
- bleeding gums
- collection of blood under the skin
- coughing up blood
- dark urine
- deep, dark purple bruise
- dry, red, hot, or irritated skin
- fast heartbeat
- general body swelling
- headache
- hives, itching, skin rash
- increased menstrual flow or vaginal bleeding
- joint pain, stiffness, or swelling
- loss of appetite
- nosebleeds
- pale skin
- paralysis
- prolonged bleeding from cuts
- red or dark brown urine
- red or black, tarry stools
- swelling of the eyelids, face, lips, hands, or feet
- yellowing of the eyes or 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
- Arm pain
- bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
- bruising
- constipation
- diarrhea
- difficulty in moving
- headache
- increased sweating
- joint pain
- lack or loss of strength
- large, flat, blue or purplish patches in the skin
- muscle pain or stiffness
- runny nose
- yawning
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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