apomorphine 4.9 mg/mL subcutaneous cartridge

Generic name:
Apomorphine - injection

Pronunciation
(A-poe-MOR-feen)

Brand name(s)
Onapgo

This medication is used to decrease the amount of "off" time in people with Parkinson's disease. It can help to decrease symptoms such as shakiness (tremor), stiffness, slowed movement, and unsteadiness. This medication is thought to work by helping to restore the balance of a certain natural substance (dopamine) in the brain.

Read the Patient Information Leaflet and Instructions for Use if available from your pharmacist before you start using apomorphine and each time you get a refill. Ask your health care professional how to prepare and use this medication. If you have any questions, ask your doctor or pharmacist.

This medication is usually given as a continuous infusion under the skin using an infusion pump as directed by your doctor. Do not inject this medication into a vein. The infusion is given in the abdomen (except for a 2-inch area around your belly button), thighs, or upper/lower back during waking hours. The dosage is based on your medical condition and response to treatment.

To reduce your risk of side effects, your doctor may direct you to start this medication at a low dose and gradually increase your dose. Nausea is very common with this medication. To decrease nausea, your doctor may direct you to use another medication (such as trimethobenzamide) to prevent or treat nausea. This medication may be started 3 days before you start treatment with apomorphine and should be taken as directed for up to 2 months.

Before using, check this product for particles or discoloration. If either is present, do not use the liquid. Clean the skin you are going to inject into (the injection site) with rubbing alcohol. Change the injection site every day to lessen injury under the skin. Do not inject into skin that is bruised, irritated, or has bumps. Learn how to store and discard medical supplies safely.

Do not stop using this medication without consulting your doctor. Some conditions may become worse when this medication is suddenly stopped. Your dose may need to be gradually decreased.

Rarely, abnormal drug-seeking behavior (drug abuse) is possible with this medication. Do not increase your dose or use it more often than prescribed. Properly stop the medication when so directed.

Tell your doctor if your condition does not get better or if it gets worse.

Redness/swelling/pain/itching/bruising at the injection site, nausea, vomiting, headache, dizziness, drowsiness, or trouble sleeping may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

• severe pain/swelling/warmth at the injection site
• mental/mood changes (such as confusion, agitation, hallucinations)
• uncontrolled movements
• muscle cramps/spasm
• unusual strong urges (such as increased gambling, increased sexual urges)
• unusual tiredness
• pale skin

Get medical help right away if you have any very serious side effects, including:

• chest pain
• shortness of breath
• fast/irregular heartbeat
• severe dizziness
• fainting
• trouble speaking
• vision changes
• weakness on one side of the body

Some people using apomorphine have fallen asleep suddenly during their usual daily activities (such as talking on the phone, driving). In some cases, sleep occurred without any feelings of drowsiness beforehand. This sleep effect may occur anytime during treatment with apomorphine even if you have used this medication for a long time. If you experience increased sleepiness or fall asleep during the day, do not drive or take part in other possibly dangerous activities until you have discussed this effect with your doctor. Your risk of this sleep effect is increased by using alcohol or other medications that can make you drowsy. See also Precautions section.

You may also develop a sudden drop in blood pressure that can cause dizziness, nausea, and fainting. This effect may also increase your risk of a fall. This drop in blood pressure is more likely when you are first starting the medication, when your dose is increased, or when you get up suddenly. To lower your risk, get up slowly from a sitting or lying position. Avoid alcohol.

Rarely, males may have a painful or prolonged erection lasting 4 or more hours. If this occurs, stop using this drug and get medical help right away, or permanent problems could occur.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using apomorphine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as sulfites), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• kidney problems
• liver problems
• low blood pressure
• sleep disorder (such as sleep apnea, narcolepsy)
• asthma
• heart problems (such as chest pain, heart attack)
• mental/mood disorders (such as hallucinations, psychosis, schizophrenia)
• stroke

Apomorphine may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.

The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using apomorphine, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions:

• certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG)
• family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death)

Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using apomorphine safely.

This drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis). See also Side Effects section.

Older adults may be more sensitive to the side effects of this drug, especially falls, mental/mood changes (such as confusion, hallucinations), and QT prolongation (see above).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug are:

• alosetron
• certain drugs for nausea (including metoclopramide, phenothiazines such as prochlorperazine, serotonin blockers such as ondansetron, granisetron)

Tell your doctor or pharmacist if you are taking other products that cause drowsiness such as opioid pain or cough relievers (such as codeine, hydrocodone), alcohol, marijuana (cannabis), drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or antihistamines (such as cetirizine, diphenhydramine).

Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Do not share this medication with others.

If your dose is interrupted or stopped, contact your doctor right away to establish a new dosing schedule.

Store at room temperature. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.