Patient Medication Information: uses, side effects, how to take - Onsolis

ABOUT THIS MEDICATION

IMPORTANT

ONSOLIS can cause serious breathing problems that can progress to death. Read this information carefully before you take ONSOLIS and every time you get a new prescription.

What the medication is used for:

Adults

ONSOLIS is a strong prescription pain medicine that is used to relieve the sudden flares of pain that can occur unexpectedly, while you are taking regular doses of opioid pain killers for your constant cancer pain.

Those sudden flares of pain are described as “breakthrough pain” because they happen or break through your regularly taken opioid pain killers for your constant cancer pain, and usually last for a short while.

What it does:

ONSOLIS contains “fentanyl” which belongs to a class of medicines called “opioids”. Opioids are the strongest pain medicines available. ONSOLIS comes in a small film which attaches to the inside of your cheek to deliver fentanyl quickly in your bloodstream. This convenient way gives you pain relief starting as early as 15 minutes after administration. (see Proper Use of this Medication section)

When it should not be used:

Do not use ONSOLIS unless you are using another opioid pain medicine regularly for your cancer pain and your body is used to this medicine (opioid tolerant).
Do not use ONSOLIS if you have severe problems with your breathing or your lungs.
Do not use ONSOLIS if you are allergic to any of the ingredients (see the following two sections)
Do not use ONSOLIS if you are currently taking monoamine-oxidase (MAO) inhibitors (used for severe depression) or have done so in the past 2 weeks.

Pediatrics :

ONSOLIS is not indicated, and should not be used, in pediatric patients under 18 years of age as safety and efficacy have not been established in this patient population.

What the medicinal ingredient is:

Fentanyl

What the nonmedicinal ingredients are:

citric acid, ferric oxide, hydroxyethylcellulose,

hydroxypropylcellulose, methylparaben, monobasic sodium phosphate, peppermint oil, polycarbophil, propylene glycol,

propylparaben, saccharin sodium, sodium benzoate, sodium carboxymethylcellulose, sodium hydroxide, titanium dioxide, tribasic sodium phosphate, vitamin E acetate, and water.

What dosage forms it comes in:

ONSOLIS comes as a small thin film. It fits easily on the inside of your cheek. Each film has a white side and a pink side. The pink side quickly sticks to the inside of your cheek and the white side reduces fentanyl release into the saliva. (see Proper Use of this Medication section).

ONSOLIS films are supplied in individually-sealed child-resistant foil packages, color coded by strength:

200 mcg - Blue

400 mcg - Red

600 mcg - Green

800 mcg - Orange

1200 mcg - Purple

Each unit is a rectangle with rounded corners, pink on one side and white on the other side.

200 mcg/unit Each unit has a “2” mark debossed and visible

on the white side. 400 mcg/unit Each unit has a “4” mark debossed and visible

on the white side. 600 mcg/unit Each unit has a “6” mark debossed and visible

on the white side. 800 mcg/unit Each unit has a “8” mark debossed and visible

on the white side. 1200 mcg/unit Each unit has a “12” mark debossed and visible

on the white side.

WARNINGS AND PRECAUTIONS

Serious Warnings and Precautions

Serious adverse reactions, including death can occur if you take ONSOLIS without being opioid-tolerant, i.e. if you have not regularly used other opioid medicine for your cancer pain before you start taking ONSOLIS for your sudden flares of pain. ONSOLIS is not indicated for you if you use opioids only intermittently, on an as needed basis.
You or a family member should call your doctor or get emergency medical help immediately if you have trouble breathing, drowsiness with slow breathing, slow shallow breathing (little chest movement with breathing) or feel faint, dizzy, confused, or have other unusual symptoms. These can be symptoms of an overdose with ONSOLIS. Your dose of ONSOLIS may be too high for you. These symptoms may lead to serious problems or death if not treated immediately. If you have any of the above symptoms, do not take another dose of ONSOLIS.
You must begin treatment with ONSOLIS at the lowest dose of 200 mcg.
If your pain is not adequately relieved by a single dose of Onsolis, you should wait for 4 hours before taking another dose.
ONSOLIS contains a medicine that can be fatal to children, to any other adult for whom it is not prescribed, and to those who are not regularly taking opioid medicine for their cancer pain.
Tell your doctor about all the medicines you take and consult with your doctor before taking any new medications while taking ONSOLIS. Some other medications that you may be using can affect the level of ONSOLIS in your body and this may potentially cause respiratory problems and death.

BEFORE you use ONSOLIS talk to your doctor or pharmacist about all of your medical and mental health problems, especially if you have:

Trouble breathing or lung problems such as asthma, wheezing
or being short of breath
A head injury or brain problem
Liver or kidney problems
Seizures (convulsions or fits)
Slow heart rate or other heart problems
Low blood pressure
Mental health problems such as major depression or
hallucinations (seeing or hearing things that are not real)
Past or present drinking problem or alcoholism for you or a
family member
Past or present drug abuse or addiction problems for you or a
family member

Tell your doctor if you are:

Pregnant or planning to become pregnant. ONSOLIS may
harm your unborn baby.
Breast feeding. ONSOLIS passes through your breast milk. It
can cause serious harm to your baby. You should not use ONSOLIS while breast feeding.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Some medicines may cause serious or life-threatening medical problems when taken with ONSOLIS.

Sometimes the doses of certain medicines and ONSOLIS may need to be changed if used together.

Do not start taking any medicine while using ONSOLIS
until you have talked with your doctor. Your doctor will tell you if it is safe to take other medicines while you are using ONSOLIS.
Be very careful about taking other medicines that make
you sleepy, such as other pain medicines or some depression medicines (antidepressants that make you sleepy), sleeping pills, anxiety medicines, tranquilizer medicines, or some allergy medicines (antihistamines that make you sleepy).
Do not drive or operate machinery or do other dangerous
activities until you know how ONSOLIS affects you as it can make you sleepy.
Do not drink alcohol while using ONSOLIS as it can
increase your chance of having dangerous side effects

Know the medicines you take. Keep a list of your medicines to show your doctor and pharmacist.

INTERACTIONS WITH THIS MEDICATION

Interactions can occur between ONSOLIS and other drugs that use a system called CYP 3A4 in the body. Before taking ONSOLIS, tell your doctor about any other medications that you are using

including certain antidepressants (selective serotonin reuptake inhibitors (SSRI) and serotonin/norepinephrine reuptake inhibitors (SNRI)). Your prescribed dose will have to be increased or decreased accordingly.

PROPER USE OF THIS MEDICATION

Use ONSOLIS as prescribed by your doctor.

IMPORTANT:

Follow the instructions of your doctor carefully, as he will adjust your dose gradually until you have satisfactory pain relief.
Do not skip ahead to a higher dose.
Do not take more than one dose for one episode of breakthrough pain.
Do not use ONSOLIS for more than four episodes of breakthrough cancer pain in one day.
You must wait for 4 hours between doses.

STARTING DOSE

All patients MUST begin treatment using one 200 mcg ONSOLIS film.

SUBSEQUENT DOSES

To find the right dose for you, your doctor will instruct you on how to safely increase your dose until you have reached a dose, which provides you with adequate pain relief within 30 minutes, and if there are side effects that they are acceptable to you.

Following is a step by step guide for safely increasing your dose of ONSOLIS. Your doctor will explain to you:

1. Start with 200 mcg as prescribed by your physician. Do not take more than one dose for the first breakthrough pain episode.
2. If the pain is not relieved adequately after the first dose of 200 mcg, wait at least 4 hours and use two of the 200 mcg ONSOLIS films for the next breakthrough pain episode.
3. Increase the dose by 200 mcg for each subsequent pain episode until the dose administrated provides adequate relief with tolerable side effects. Always wait at least 4 hours between doses. When multiple 200 mcg ONSOLIS films are used, they should not be placed on top of each other and they should be placed on both sides of the mouth.
4. If the pain was adequately relieved with one or up to 4 films of 200 mcg, please call your doctor and indicate the number of films that provided appropriate pain relief. The doctor will prescribe to you the identified effective dose.
5. If 4 doses of 200 mcg ONSOLIS films do not provide adequate relief, call your doctor who may prescribe you a higher strength.

Your doctor will provide you with a prescription to treat up to four breakthrough pain episodes per day by using the identified dose.

Your doctor will monitor your reaction to the increases in

ONSOLIS dose as well as any side effects that you may experience.

If you have more than four episodes of breakthrough pain in one day talk to your doctor as your regular opioid medicine for your constant cancer pain may need to be changed.

HOW TO USE YOUR ONSOLIS BUCCAL FILM

ONSOLIS comes in a foil package. Do not open the package until ready to use. Do not cut or tear the ONSOLIS film.

Once opened, use ONSOLIS film right away.

To open an ONSOLIS package:

1.
With the back side of the foil package facing you:
- Fold along dotted lines.
- While folded, tear in direction of arrows

c)
Cut on the arrows with scissors and then tear.
1. 2. Repeat to open the other side of the package.
2. 3. Separate the layers of the foil package and remove the ONSOLIS film.

Take ONSOLIS as instructed by your healthcare professional.

Read and follow the instructions carefully.

Do not chew or swallow ONSOLIS. If you do, you will likely get less relief for your breakthrough cancer pain.

Use your tongue to wet the inside of your cheek or, if needed, rinse your mouth with water to wet the area in your mouth where you will place ONSOLIS.
With dry hands, take the ONSOLIS film between your forefinger and thumb with the pink side facing up (Figure 1)
Carefully place the ONSOLIS film inside your mouth with the pink side against the inside of your moistened cheek. The pink side quickly sticks to the inside of your cheek. It delivers fentanyl across the lining of your cheek into your bloodstream.
With your finger, press the ONSOLIS film against your cheek.
Hold it there for 5 seconds. The white side reduces fentanyl release into the saliva and helps ONSOLIS stay in place long enough to deliver fentanyl and usually dissolves within 15 to 30 minutes after application.
Take your finger away from the ONSOLIS film. It will stick to the inside of your cheek.
Leave the film in place until it dissolves
You may drink liquids after 5 minutes, do not eat any food

until after the film has dissolved.

Avoid touching or moving the film while it dissolves.

Overdose:

If you accidentally take more than your prescribed dose of ONSOLIS, seek emergency medical help by contacting your regional poison control centre or by calling 911 immediately. In cases of possible overdose try to remove Onsolis film or any parts of it still remaining in the mouth.

Overdose with an opioid medicine such as ONSOLIS can cause serious problems, the most serious being trouble breathing, extreme drowsiness with slowed breathing, and slow shallow breathing. Other signs of ONSOLIS overdose may include tiredness, extreme sleepiness or sedation; inability to think, talk or walk normally; and feeling faint, dizzy or confused, seizure and hallucination.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Like all medications, ONSOLIS may cause unwanted effects.

The most common side effects of ONSOLIS are nausea, vomiting, dizziness, constipation, drowsiness, tiredness, sedation, after taste, confusional state, headache, dry mouth, mouth sores, itchy skin, hot flash, and sweating.

ONSOLIS can cause your blood pressure to drop. This can
make you feel dizzy if you get up too fast from sitting or lying down.
ONSOLIS can cause physical dependence if taken
regularly. Do not stop taking ONSOLIS or any other opioid without talking to your doctor. You could become sick with uncomfortable withdrawal symptoms because your body has become used to these medicines. Physical dependency is not the same as drug addiction.
There is a chance of abuse or addiction with ONSOLIS.
The chance is higher if you have ever been addicted to or abused other medicines, street drugs, or alcohol, or have a history of mental health problems.

Talk with your doctor about any side effects that bother you or do not go away. These are not all the side effects of ONSOLIS. For more information, ask your doctor or pharmacist.

SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN

AND WHAT TO DO ABOUT THEM

You or a family member should call your doctor or get emergency medical help immediately if you have any of the symptoms below:

Trouble breathing
Extreme drowsiness with slow breathing
Slow, shallow breathing (little chest movement with
breathing)
- Feeling faint, dizzy or confused
- Inability to think, talk or walk normally
- Seizure and hallucination

These can be symptoms of an overdose of ONSOLIS. Your dose of ONSOLIS may be too high for you. These symptoms may lead to serious problems or death if not treated immediately. Do not take another dose of ONSOLIS.

In cases of possible overdose try to remove Onsolis film or any parts of it still remaining in the mouth.

This is not a complete list of side effects. For any unexpected effects while taking ONSOLIS, contact your doctor or pharmacist.

HOW TO STORE ONSOLIS

Keep ONSOLIS film in a safe place away from children.

Store between 15-30ºC (59-86ºF) until ready to use.
Protect ONSOLIS from freezing and moisture.
Do not use if the foil package has been opened.

The amount of fentanyl contained in a ONSOLIS film can be fatal to a child. The entire ONSOLIS film should be used immediately after opening the child-resistant package. Patients and their caregivers must be instructed to keep ONSOLIS out of the reach of children

How to dispose of ONSOLIS films when no longer needed

Bring all unused ONSOLIS films to your pharmacist for proper disposal

Or

Dispose of unopened ONSOLIS films as soon as you no longer need them by flushing them down the toilet:

1. Remove the ONSOLIS film from its foil package.
2. Drop the ONSOLIS film into the toilet.
3. Repeat steps 1 and 2 for each ONSOLIS film. Flush the toilet after all unneeded films have been put into the toilet.
• Do not flush the ONSOLIS foil packages or cartons down the toilet.

General Information

Medicines are sometimes prescribed for conditions other than those described in patient information leaflets. Do not use ONSOLIS for a condition for which it was not prescribed. Do not give ONSOLIS to other people, even if they have the same symptoms you have. It may harm them. The leaflet summarizes the most important information about ONSOLIS. If you would like more information, talk with your healthcare provider. You can also call MEDA VALEANT PHARMA CANADA INC. at:

1-800-361-4261

REPORTING SUSPECTED SIDE EFFECTS

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

Report online at www.healthcanada.gc.ca/medeffect
Call toll free at 1-866-234-2345
Complete a Canada Vigilance Reporting form and:
- Fax toll free to 1-866-678-6789, or
- Mail to:

Canada Vigilance Program

Health Canada

Postal Locator 0701D

Ottawa, Ontario

K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect^TMCanada Web site at www.healthcanada.gc.ca/medeffect.

NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals can be found at:

http://webprod.hc-sc.gc.ca/dpd-bdpp/index-eng.jsp

by contacting Meda Valeant Pharma Canada Inc. at: 1-800-361-4261

MEDA AB,

Pipers väg 2A

Box 906, S-170 09

Solna, Sweden

Manufactured at:

Aveva Drug Delivery Systems, Miramar, FL 33025

Imported by:

Valeant Canada LP

Montreal, Canada

H4R 2P9

Onsolis: Uses, Side Effects and Dosage