Do not take SUBSYS if you:

• had an allergic reaction to dronabinol. Signs and symptoms of an allergic reaction to dronabinol include: swelling of the lips, hives, a rash over your whole body, mouth sores, skin burning, flushing, and throat tightness.
• had an allergic reaction to alcohol.
• are using a medicine that contains disulfiram (Antabuse) or metronidazole (Pylera, Flagyl, Flagyl ER, Nuvessa, Vandazole) or have taken or received a medicine that contains disulfiram or metronidazole in the last 14 days.

Before taking SUBSYS, tell your doctor about all of your medical conditions, including if you:

• have or had heart problems.
• have or had problems with drug abuse or dependence.
• have or had problems with alcohol abuse or dependence.
• have or had mental health problems including mania, depression or schizophrenia.
• have had a seizure or have a medical condition that may increase your risk of having a seizure.
• are pregnant or plan to become pregnant. SUBSYS may harm your unborn baby. Avoid the use of SUBSYS if you are pregnant.
• are breastfeeding or plan to breastfeed. The Centers for Disease Control and Prevention recommends that mothers with HIV not breastfeed because they can pass the HIV through their breast milk to the baby. It is not known if SUBSYS passes into your breast milk. Talk to your doctor about the best way to feed your baby if you take SUBSYS. Do not breastfeed while taking SUBSYS and for 9 days after your last dose of SUBSYS if you are being treated for nausea and vomiting caused by anti-cancer medicine.

TELL YOUR DOCTOR ABOUT ALL THE MEDICINES YOU TAKE OR HAVE TAKEN IN THE LAST 14 DAYS, INCLUDING PRESCRIPTION AND OVER-THE-COUNTER MEDICINES, VITAMINS, AND HERBAL SUPPLEMENTS. SUBSYS AND CERTAIN OTHER MEDICINES CAN AFFECT EACH OTHER, CAUSING SERIOUS SIDE EFFECTS.

How should I take SUBSYS?

• See the “Instructions for Use” at the end of the Patient Information for detailed instructions about the right way to take SUBSYS.
• Always use the oral syringe that comes with your SUBSYS oral solution to measure your prescribed dose. Ask your doctor or pharmacist to show you how to measure your prescribed dose.
• Take SUBSYS exactly as your doctor tells you to. Your doctor may change your dose after seeing how it affects you. Do not change your dose unless your doctor tells you to change it.
• Drink a full glass of water (6 to 8 ounces) right after you take your prescribed dose of SUBSYS oral solution.
• If you are an adult with AIDS with loss of appetite and weight loss:
  • SUBSYS is usually taken 2 times each day, 1 hour before lunch and 1 hour before dinner. If you are elderly, or unable to tolerate this dose of SUBSYS, your doctor may prescribe SUBSYS to be taken 1 time each day, 1 hour before dinner or bedtime.
• If you are an adult with nausea and vomiting caused by anti-cancer medicine:
  • SUBSYS is usually taken 1 to 3 hours before your chemotherapy treatment and then every 2 to 4 hours after chemotherapy for up to 4 to 6 doses each day. If you are elderly, your doctor may prescribe SUBSYS to be taken 1 to 3 hours before your chemotherapy, 1 time each day.
  • Take your first dose of SUBSYS on an empty stomach at least 30 minutes before eating. After your first dose of SUBSYS, you can take SUBSYS with or without food.
  • After your doctor has decided the dose of SUBSYS that is right for you, take SUBSYS exactly at the same time before or after meals during future chemotherapy treatment.
• If you take too much SUBSYS, call your Poison Control Center at 1-800-222-1222 right away or go to the nearest emergency room.

What should I avoid while taking SUBSYS?

• Do not drive, operate machinery, or do other dangerous activities until you know how SUBSYS affects you. SUBSYS taken with medicines that cause dizziness, confusion, and sleepiness may make these symptoms worse.

What is the most important information I should know about SUBSYS?

SUBSYS can cause serious side effects, including:

• Worsening mental (psychiatric) symptoms. Psychiatric symptoms can worsen in adults who have mania, depression, or schizophrenia and who take SUBSYS. SUBSYS taken with medicines that cause psychiatric symptoms can worsen psychiatric symptoms. Elderly people who take SUBSYS may have a greater risk of having psychiatric symptoms. Tell your doctor if you have new or worsening mood symptoms, including symptoms of mania, depression, or schizophrenia.
• Problems thinking clearly. Tell your doctor if you have trouble remembering things, concentrating, have increased sleepiness, or confusion. Elderly people may have a greater risk of having problems thinking clearly.
• Changes in your blood pressure. SUBSYS may increase or decrease your blood pressure, especially when you start taking SUBSYS or when your dose is changed. Tell your doctor if you have signs or symptoms of changes in your blood pressure including: headaches, vision problems, dizziness, feeling lightheaded, fainting, or a fast heartbeat. Elderly people, especially those with dementia, and people with heart problems may have an increased risk of changes in blood pressure and an increased risk of falls.
• Interactions with disulfiram or metronidazole. SUBSYS contains alcohol, which can cause you to have a reaction to medicines that contain disulfiram or metronidazole. You should not use any medicine that contains disulfiram (Antabuse) or metronidazole (Pylera, Flagyl, Flagyl ER, Nuvessa, Vandazole) if you take SUBSYS. You should not use a medicine that contains disulfiram or metronidazole for at least 14 days before you start taking SUBSYS and within 7 days after your last dose of SUBSYS. Tell your doctor if you have signs or symptoms of a reaction to disulfiram or metronidazole including: stomach-area (abdominal) cramping, nausea, vomiting, headache, and flushing.

What are the possible side effects of SUBSYS?

SUBSYS may cause serious side effects, including:

• See “What is the most important information I should know about SUBSYS?”
• Seizures. SUBSYS may increase your risk of seizures. Stop taking SUBSYS and call your doctor and get medical care right away if you have a seizure during treatment with SUBSYS.
• Drug and alcohol abuse. You may have an increased risk of abusing SUBSYS if you have a history of drug or alcohol abuse or dependence, including marijuana. Tell your doctor if you develop abuse behaviors such as increased irritability, nervousness, restlessness or want more or higher doses of SUBSYS during your treatment.
• Nausea, vomiting, or stomach-area (abdominal) pain. Tell your doctor if you have nausea, vomiting, or abdominal pain or if your nausea, vomiting, or abdominal pain gets worse during treatment with SUBSYS.

THE MOST COMMON SIDE EFFECTS OF SUBSYS INCLUDE:

• stomach-area (abdominal) pain
• dizziness
• feeling extremely happy (euphoria)
• nausea
• overly suspicious or feeling people want to harm you (paranoid reaction)
• sleepiness
• abnormal thoughts
• vomiting

THESE ARE NOT ALL THE POSSIBLE SIDE EFFECTS OF SUBSYS. TELL YOUR DOCTOR IF YOU HAVE ANY SIDE EFFECT THAT BOTHERS YOU OR DOES NOT GO AWAY. CALL YOUR DOCTOR FOR MEDICAL ADVICE ABOUT SIDE EFFECTS. YOU MAY REPORT SIDE EFFECTS TO FDA AT 1-800-FDA-1088.

General information about the safe and effective use of SUBSYS

MEDICINES ARE SOMETIMES PRESCRIBED FOR PURPOSES OTHER THAN THOSE LISTED IN A PATIENT INFORMATION LEAFLET. DO NOT USE SUBSYS FOR A CONDITION FOR WHICH IT WAS NOT PRESCRIBED. DO NOT GIVE SUBSYS TO OTHER PEOPLE, EVEN IF THEY HAVE THE SAME SYMPTOMS THAT YOU HAVE. IT MAY HARM THEM. YOU CAN ASK YOUR DOCTOR OR PHARMACIST FOR INFORMATION ABOUT SUBSYS THAT IS WRITTEN FOR HEALTH PROFESSIONALS.

What are the ingredients in SUBSYS?

ACTIVE INGREDIENT: DRONABINOL INACTIVE INGREDIENTS: DEHYDRATED ALCOHOL, POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL, SUCRALOSE, METHYL PARABEN, PROPYL PARABEN, BUTYLATED HYDROXYANISOLE, AND WATER