Abstral: Uses, Side Effects and Dosage

Serious Warnings and Precautions

• Serious adverse reactions, including death can occur if you take ABSTRAL without being opioid-tolerant, i.e. if you have not regularly used other opioid medicines for your cancer pain before you start taking ABSTRAL for your sudden flares of pain. ABSTRAL is not indicated for you if you use opioids only intermittently, on an as needed basis.
• When you take ABSTRAL sublingual tablets they must be allowed to completely dissolve under your tongue. Do not cut, break, crush, chew, suck, swallow or dissolve the tablet anywhere but under your tongue. This can be dangerous and can lead to death or seriously harm you.
• Even if you take ABSTRAL as prescribed you are at a risk for opioid addiction, abuse and misuse. This can lead to overdose and death.
• You may get life-threatening breathing problems while taking ABSTRAL. This is less likely to happen if you take it as prescribed by your doctor. Babies are at risk of life-threatening breathing problems if their mothers take opioids while pregnant or nursing.
• You should never give anyone your ABSTRAL, even if they have the same symptoms you have. They could die from taking it. If a person has not been prescribed ABSTRAL, taking even one dose can cause a fatal overdose. This is especially true for children.

• If you took ABSTRAL while you were pregnant, whether for short or long periods of time or in small or large doses, your baby can suffer life-threatening withdrawal symptoms after birth. This can occur in the days after birth and for up to 4 weeks after delivery. If your baby has any of the following symptoms:

  • has changes in their breathing (such as weak, difficult or fast breathing)

Serious Warnings and Precautions

• is unusually difficult to comfort
• has tremors (shakiness)
• has increased stools, sneezing, yawning, vomiting, or fever Seek immediate medical help for your baby.

• Taking ABSTRAL with other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death.

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

What is ABSTRAL used for?

ABSTRAL 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.

How does ABSTRAL work?

ABSTRAL is a prescription medicine that contains “fentanyl” which is a pain medication belonging to the class of drugs known as opioids. It relieves pain by acting on specific nerve cells of the spinal cord and brain.

ABSTRAL is a tablet that should be placed on the floor of the mouth under your tongue, where it will dissolve rapidly to deliver fentanyl quickly in your bloodstream. This convenient way gives you pain relief starting as early as 10 min after administration.

What are the ingredients in ABSTRAL?

Medicinal ingredient: Fentanyl

Non-medicinal ingredients: Croscarmellose sodium, mannitol, silicified microcrystalline cellulose and magnesium stearate.

ABSTRAL comes in the following dosage forms:

ABSTRAL comes as a small tablet that can easily be placed under your tongue. It is supplied in blister cards, divided into blister units that contain individual tablets.

ABSTRAL tablets come in a range of different strengths, shapes and packaging colours. Your doctor will prescribe the strength (shape) and number of tablets suitable for you. The different strengths and shapes are described below.

Do not use ABSTRAL:

• Unless you are using another opioid pain medication regularly (around-the-clock) for your background cancer pain, for at least a week, and your body is used to this medicine (opioid tolerant). If you have not been using these medicines you must not use ABSTRAL because it may increase the risk that breathing could become dangerously slow and/or shallow, or even stop.
• If you suffer from short-term pain other than breakthrough pain.
• For a condition for which it was not prescribed.
• If your doctor did not prescribe it for you.
• If you are allergic to fentanyl, other opioid-type pain medications, or any of the other ingredients in ABSTRAL tablets (see What are the ingredients in ABSTRAL?)
• If you can control your pain by the occasional use of other pain medications. This includes those available without a prescription.
• If you have severe asthma, trouble breathing, or other breathing problems.
• If you have any heart problems.
• If you have bowel blockage or narrowing of the stomach or intestines.
• If you have severe pain in your abdomen.
• If you have a head injury.
• If you are at risk for seizures.
• If you suffer from alcoholism.

• If you are taking or have taken within the past 2 weeks a Monoamine Oxidase inhibitor

  (MAOi) (such as phenelzine sulphate, tranylcypromine sulphate, moclobemide or selegiline).

• If you are going to have a planned surgery.
• If you are in labour.
• If you are breastfeeding.

Pediatrics: ABSTRAL is not indicated, and should not be used, in children under 18 years of age as safety and efficacy have not been established in patients below this age.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take ABSTRAL. Talk about any health conditions or problems you may have, including if you:

• (or a member of your family) have a history of illicit or prescription drug or alcohol abuse.
• have severe kidney, liver or lung disease.
• have a slow heart rate or other heart problems
• have low blood pressure,
• have past or current depression
• suffer from chronic or severe constipation,
• have trouble breathing or lung problems such as asthma, wheezing or being short of breath,
• have a head injury or brain problem,
• have or had seizures (convulsions or fits),
• have mouth wounds or mucositis (swelling and redness of the inside of the mouth),
• have problems with your thyroid, adrenal or prostate gland,
• have, or had in the past, hallucinations (seeing or hearing things that are not real) or other severe mental problems,
• suffer from migraines,
• are pregnant or planning to become pregnant.

Other warnings you should know about:

Opioid dependence and addiction: There are important differences between physical dependence and addiction. It is important that you talk to your doctor if you have questions or concerns about abuse, addiction or physical dependence.

Pregnancy, nursing, labour and delivery: Do not use ABSTRAL while nursing, during labour or delivery. Opioids can be transferred to your baby through breast milk, or while still in the womb. ABSTRAL can then cause life-threatening breathing problems in your unborn baby or nursing infant.

Your doctor will determine if the benefits of using ABSTRAL during pregnancy outweigh the risks to your unborn baby.

If you are pregnant and are taking ABSTRAL, it is important that you don’t stop taking your medication for your background cancer pain all of a sudden. If you do, it can cause a miscarriage or a still-birth. Your doctor will monitor and guide you on how to slowly stop taking your chronic opioid therapy for the treatment of your background cancer pain. This may help avoid serious harm to your unborn baby. If you do no longer experience breakthrough pain episodes, your doctor will take you off ABSTRAL immediately.

Driving and using machines: Before you do tasks which may require special attention, you should wait until you know how you react to ABSTRAL. ABSTRAL can cause:

• drowsiness
• dizziness or lightheadedness

This can usually occur after you take your first dose and when your dose is increased.

Disorder of the adrenal gland: You may develop a disorder of the adrenal gland called adrenal insufficiency. This means that your adrenal gland is not making enough of certain hormones. You may experience symptoms such as:

• nausea, vomiting
• feeling tired, weak or dizzy
• decreased appetite

You may be more likely to have problems with your adrenal gland if you have been taking opioids for longer than one month. Your doctor may do tests, give you another medication, and take you off ABSTRAL if you no longer experience breakthrough pain episodes.

Serotonin Syndrome: ABSTRAL can cause Serotonin Syndrome, a rare but potentially life-threatening condition. It can cause serious changes in how your brain, muscles and digestive system work. You may develop Serotonin Syndrome if you take ABSTRAL with certain anti-depressants or migraine medications.

Serotonin Syndrome symptoms include:

• fever, sweating, shivering, diarrhea, nausea, vomiting;
• muscle shakes, jerks, twitches or stiffness, overactive reflexes, loss of coordination;
• fast heartbeat, changes in blood pressure;
• confusion, agitation, restlessness, hallucinations, mood changes, unconsciousness, and coma.

Sexual Function/Reproduction: Long term use of opioids may lead to a decrease in sex hormone levels. It may also lead to low libido (desire to have sex), erectile dysfunction or being infertile.

Tell your doctor if you (or a family member) have ever abused or been dependent on alcohol, prescription medicines or street drugs.

Tell your doctor if you are:

• pregnant or planning to become pregnant. ABSTRAL may cause serious harm to your unborn baby.
• breast feeding. Fentanyl can pass through your body into breast milk and it could cause serious harm to your baby. Do not use ABSTRAL while breast feeding. You should not start breastfeeding until at least 5 days after the last dose of ABSTRAL.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

Do not start taking any medicine while using ABSTRAL until you have talked with your healthcare professional. Your healthcare professional will tell you if it is safe to take other medicines while you are using ABSTRAL.

Some other medications that you may be using can affect the level of ABSTRAL in your body and this may potentially cause respiratory problems and death.

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

The following may interact with ABSTRAL:

• Alcohol. This includes prescription and non-prescription medications that contain alcohol. Do not drink alcohol while you are taking ABSTRAL. It can lead to:

  • drowsiness
  • unusually slow or weak breathing
  • serious side effects or
  • a fatal overdose
• other sedative drugs which may enhance the drowsiness caused by ABSTRAL
• other opioid analgesics (drugs used to treat pain)
• certain types of strong pain killers called mixed agonist/antagonists (e.g., buprenorphine, nalbuphine, butorphanol, and pentazocine)
• general anesthetics (drugs used during surgery)
• benzodiazepines (drugs used to help you sleep or that help reduce anxiety)
• antidepressants (for depression and mood disorders) including selective serotonin reuptake inhibitors (SSRI) and serotonin/norepinephrine reuptake inhibitors (SNRI). Do not take ABSTRAL with MAO inhibitors (MAOi) or if you have taken MAOi’s in the last 14 days.
• drugs used to treat migraines (e.g. triptans)
• drugs used to treat serious mental or emotional disorders (such as schizophrenia)
• antihistamines (drugs used to treat allergies)
• anti-emetics (drugs used for the prevention of vomiting)
• drugs used to treat muscle spasms and back pain
• anti-retroviral drugs (used to treat viral infections)
• anti-fungal drugs (used to treat fungal infections)
• antibiotic drugs (used to treat bacterial infections)
• some heart medication (such as beta blockers)
• St. John’s Wort
• grapefruit juice

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

How to take ABSTRAL:

ABSTRAL must be placed on the floor of your mouth under your tongue as far back as you can place it. Let it dissolve completely. Do not suck, cut, break, crush, chew, dissolve outside of the mouth or swallow the tablet.

Do not take ABSTRAL if the tablet is broken or damaged.

Take ABSTRAL exactly as prescribed. Do not take ABSTRAL more often than prescribed.

You must already be taking another opioid medication before beginning to use ABSTRAL.

Do not use ABSTRAL in front of children.

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.
• You must not take more than one dose of ABSTRAL for each episode of breakthrough cancer pain.
• You must wait at least 2 hours before treating another episode of breakthrough cancer pain with ABSTRAL.
• Do not use ABSTRAL for more than four episodes of breakthrough cancer pain in one day.
• Do not stop taking ABSTRAL without talking to your doctor. If you do, you could become sick from withdrawal symptoms. Withdrawal symptoms include nausea, vomiting, diarrhea, anxiety, tremor, sweating and shivering.

Usual Adult Starting Dose:

All patients MUST begin treatment using one 100 mcg ABSTRAL tablet.

Your dose is tailored/personalized just for you. Be sure to follow your doctor’s dosing instructions exactly. Do not increase or decrease your dose without consulting your doctor.

Your doctor will prescribe the lowest dose that works to control your pain and determine the best dose for you to lower the risk of side effects and overdose. Higher doses can lead to more side effects and a greater chance of overdose.

Review your pain regularly with your doctor to determine if you still need ABSTRAL. Be sure to use ABSTRAL only for the condition for which it was prescribed.

If your pain increases or you develop any side effect as a result of taking ABSTRAL, tell your doctor immediately.

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.

The following is a step by step guide for safely increasing your dose of ABSTRAL that your doctor will explain to you:

• Your doctor will change the dose until you and your doctor find the right dose for you.

• You must not use more than one dose of ABSTRAL for each episode of breakthrough cancer pain:

  • Take 1 dose for an episode of breakthrough cancer pain.
  • If the pain does not get better 30 minutes after taking the first dose of ABSTRAL, you can take other rescue medication (but not ABSTRAL) as discussed with your doctor.
• You must wait at least 2 hours before treating a new episode of breakthrough cancer pain with ABSTRAL.

• Remember to keep taking your regular background opioid pain medicine while taking

  ABSTRAL.

Your doctor will monitor your reaction to the increases in ABSTRAL dose as well as any side effects that you may experience.

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

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 Abstral Tablet:

ABSTRAL tablets come in blister packages. Do not open the blister until ready to use.

Once opened, use ABSTRAL tablet right away.

The ABSTRAL tablet should be placed on the floor of the mouth under your tongue, where it will dissolve rapidly and be absorbed into your body through the lining of your mouth. Once absorbed, fentanyl starts to work to relieve pain.

Do not suck, cut, break, crush, chew, dissolve outside of the mouth or swallow the tablet(s).

Do not take ABSTRAL if the tablet is broken or damaged.

When you get an episode of breakthrough pain, take the dose advised by your doctor as follows:

• If your mouth is dry, take a sip of water to moisten it. Spit out or swallow the water. Dry your hands if they are wet before you handle ABSTRAL tablets.
• ABSTRAL comes in a blister package. Each blister unit contains an ABSTRAL tablet. It is important that the tablet stays sealed in the blister unit until you are ready to use it.

• When you are ready to take a tablet, pull apart one of the blister units from the blister card by tearing along the dotted lines (perforations). (see Figures 1 and 2)

  Figure 1

  Figure 2

• When the blister unit is fully separated, (see Figure 3)

• Peel back the foil starting at the unsealed area where indicated and gently remove the tablet.

  Do not try to push ABSTRAL tablets through the foil. This will damage the tablet. (see Figure 4)

  Figure 3 Figure 4

• As soon as you remove the tablet from the blister, place it on the floor of your mouth under your tongue, as far back as you can, (see Figures 5, 6 and 7) and let it dissolve completely. If more than one tablet is required, spread them around the floor of your mouth under your tongue. ABSTRAL will dissolve rapidly under the tongue and be absorbed in order to provide pain relief. It is therefore important that you do not suck, chew or swallow the tablet.

  Figure 5 Figure 6

  Figure 7

• You should not drink or eat anything until the tablet has completely dissolved under your tongue and you can no longer feel it in your mouth.
• Do not use more than 4 tablets simultaneously per dose.

Stopping your ABSTRAL Medication:

If you have been taking ABSTRAL for more than a few days and you no longer experience breakthrough pain episodes, your doctor will monitor and guide you on how to stop taking ABSTRAL. You must however continue to take your chronic opioid therapy used to treat your background cancer pain as advised by your doctor. When you stop taking ABSTRAL you could have uncomfortable symptoms such as:

• body aches
• diarrhea
• goosebumps
• loss of appetite
• nausea
• vomiting
• feeling nervous or restless
• runny nose
• sneezing
• tremors or shivering
• stomach cramps
• rapid heart rate (tachycardia)
• having trouble sleeping
• an unusual increase in sweating
• heart palpitations
• an unexplained fever
• weakness
• yawning

By reducing or stopping your opioid treatment, your body will become less used to opioids. If you start treatment again due to returning breakthrough pain episodes, you will need to start at the lowest dose. You may overdose if you restart at the last dose you took before you stopped taking ABSTRAL.

Refilling your Prescription for ABSTRAL:

A new written prescription is required from your doctor each time you need more ABSTRAL. Therefore, it is important that you contact your doctor before your current supply runs out.

Only obtain prescriptions for this medicine from the doctor in charge of your treatment. Do not seek prescriptions from other doctors unless you switch to another doctor for your pain management.

Overdose:

If you think you have taken too much ABSTRAL, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Fentanyl, like all other opioids, is a very strong narcotic pain medicine that can cause serious and life-threatening breathing problems because of an overdose or if the dose you are using is too high for you.

Signs of overdose may include:

• unusually slow or weak breathing (little chest movement with breathing),
• dizziness,
• confusion,
• extreme drowsiness,
• trouble breathing,
• problems with your heart especially a slow heartbeat
• cold, clammy skin
• feeling faint,
• inability to think, talk or walk normally,
• seizure and hallucinations.

If you have any of these symptoms, you or a family member should call your doctor or get emergency medical help immediately. These symptoms may lead to serious problems or death if not treated immediately. If you have any of these symptoms, do NOT take any more ABSTRAL until you have seen your doctor.

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

Missed Dose:

Take ABSTRAL when you need it for your sudden flares of pain (episode of breakthrough cancer pain). You must wait at least 2 hours before treating another episode of breakthrough cancer pain with ABSTRAL. You should also not take a double dose to make up for a previously untreated episode of breakthrough cancer pain.

What are possible side effects from using ABSTRAL?

These are not all the possible side effects you may feel when taking ABSTRAL. If you experience any side effects not listed here, contact your healthcare professional.

Side effects may include:

• Drowsiness
• Insomnia
• Dizziness
• Fainting
• Nausea, vomiting, or a poor appetite
• Dry mouth
• Headache
• Problems with vision
• Weakness, uncoordinated muscle movement
• Itching
• Sweating
• Constipation\
• Low sex drive, impotence (erectile dysfunction), infertility

Talk with your doctor or pharmacist about ways to prevent constipation when you start using ABSTRAL.

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.

Reporting Side Effects

We encourage you to report serious or unexpected side effects to Health Canada. The information is used to check for new safety concerns about health products. As a consumer, your report contributes to the safe use of health products for everyone.

3 ways to report:

• Online at MedEffect: https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada.html
• By calling 1-866-234-2345 (toll-free);

• By completing a Consumer Side Effect Reporting Form and sending it by:

  • Fax to 1-866-678-6789 (toll-free), or

  • Mail to: Canada Vigilance Program

    Health Canada, Postal Locator 1908C Ottawa, ON

    K1A 0K9

    Postage paid labels and the Consumer Side Effect Reporting Form are available at MedEffect. (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada.html).

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.

Storage:

• Keep unused or expired ABSTRAL in a secure place to prevent theft, misuse, abuse or accidental exposure.
• Store ABSTRAL tablets at room temperature between 15° and 30°C and in the original blister to protect from moisture until ready to use.
• Keep ABSTRAL under lock, out of sight and reach of children and pets. Accidental use by a child or pet is a medical emergency and may result in death. If a child or pet accidentally uses ABSTRAL, get emergency help right away.

• Never take medicine in front of small children as they will want to copy you.

  Accidental ingestion by a child is dangerous and may result in death. If a child accidentally takes ABSTRAL, get emergency help right away.

• Do not use if the blister package has been opened.
• The entire ABSTRAL tablet should be used immediately after opening the child-resistant package.

Disposal:

ABSTRAL should never be thrown into the household trash, where children and pets may find it. Broken, damaged, unused or expired tablets should be returned to a pharmacy for proper disposal.

If you want more information about ABSTRAL:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes this consumer medication information by visiting the Health Canada website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); by visiting http://www.paladin-labs.com, or by contacting the sponsor, Paladin Labs Inc., at: 1-888-867-7426.

Paladin Labs Inc.

St-Laurent, QC H4M 2P2

Last revised: March 8, 2018