Instanyl: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

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

What the medication is used for:

Adults

INSTANYL™ 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

INSTANYL™ is intended for patients already treated with opioids for their usual pain.

What it does:

INSTANYL™ contains fentanyl which belongs to a group of strong painkillers called opioids. Opioids act by blocking the pain signals to the brain. INSTANYL™ acts very fast, giving you pain relief starting as early as 10 minutes after administration

When it should not be used:

• Do not use INSTANYL™ unless you are using another opioid pain medication regularly for your cancer pain and your body is used to this medicine (opioid tolerant).
• Do not use INSTANYL™ if you have severe problems with your breathing or your lungs.
• Do not use INSTANYL™ if you know you are allergic to fentanyl or any of the other ingredients of INSTANYL™ (See “What the medicinal ingredient is” and “What the non-medicinal ingredients are”)
• Do not use INSTANYL™ if you are currently taking monoamine-oxidase (MAO) inhibitors (used for severe depression) or have done so in the past 2 weeks.
• Do not use if you suffer from recurrent nose bleeding
• If you have damage to the nasal cavity from previous facial radiotherapy

Pediatrics:

INSTANYL™ is not indicated, and should not be used, in children under 18 years of age as safety and efficacy have not been established.

What the medicinal ingredient is:

Fentanyl

What the nonmedicinal ingredients are:

Disodium phosphate dihydrate, purified water, and sodium dihydrogen phosphate dihydrate.

What dosage forms it comes in:

INSTANYL™ is a nasal spray; each nasal spray unit contains one dose. It is supplied in a child-resistant blister package, colour coded by strength. INSTANYL™ comes in three strengths (per spray):

50 mcg: labelling is orange

100 mcg: labelling is purple

200 mcg: labelling is greenish-blue

WARNINGS AND PRECAUTIONS

Serious Warnings and Precautions

Serious adverse reactions, including death can occur if you take INSTANYL™ without being opioid-tolerant, i.e. if you have not regularly used other opioid medicine for your cancer pain before you start taking INSTANYL™ for your sudden flares of pain. INSTANYL™ 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 INSTANYL™. Your dose of INSTANYL™ 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 INSTANYL™.

You must begin treatment of INSTANYL™ at the lowest does of 50 mcg.

If your breakthrough cancer pain is not relieved after 10 minutes, you may use only ONE more puff of INSTANYL™ in that episode of breakthrough cancer pain. You must wait at least 4 hours before treating a new episode of breakthrough cancer pain with INSTANYL™.

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

Before you use INSTANYL™ 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 problems
• 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
  • You experience recurrent nose bleeding or nasal discomfort.
  • You have previously received facial radiotherapy

Tell your doctor if you are:

Pregnant or planning to become pregnant. INSTANYL™ may cause harm to your unborn baby.

Breast feeding. Fentanyl can pass into the breast milk and may cause side effects to the breast-fed child. You should not use INSTANYL™ while breast feeding.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, other nasal spray products, vitamins, and herbal supplements. Some medicines may cause serious or life-threatening medical problems when taken with INSTANYL™. Sometimes the doses of certain medicines and INSTANYL™ may need to be changed if used together.

• Do not start taking any medicine while using

  INSTANYL™ until you have talked with your doctor. Your doctor will tell you if it is safe to take other medicines while you are using INSTANYL™.

• 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 INSTANYL™ affects you as it can make you sleepy.

• Do not drink alcohol while using INSTANYL™ 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 INSTANYL™ and other drugs that use a system called CYP 3A4 in the body. Tell your doctor about all the medicines you are taking as your INSTANYL™ prescribed dose will have to be increased or decreased accordingly.

PROPER USE OF THIS MEDICATION

IMPORTANT:

• Always use INSTANYL™ exactly as your doctor has told

  you. You should check with your doctor or pharmacist if you are not sure about the treatment or if you have additional questions.

• INSTANYL™ is for nasal use

• When you first start using INSTANYL™, your doctor will

  work with you to find the dose that will relieve your breakthrough cancer pain.

• Do not change the dose of INSTANYL™ or your other

  pain medicines on your own. Change in dosage must be done together with your doctor.

• If your breakthrough cancer pain is not relieved after 10

  minutes, you may use only one more puff for this episode. DO NOT USE MORE THAN TWO PUFFS FOR EACH BREAKTHROUGH PAIN EPISODE

• You should wait four hours before treating the next episode

  of breakthrough cancer pain.

• Do not use INSTANYL™ for more than four episodes of

  breakthrough cancer pain per day.

Starting Dose

The initial dose is one puff of 50 mcg in one nostril. If your breakthrough cancer pain is not relieved after 10 minutes, you may use only one more puff for this episode.

Subsequent Doses

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

If the pain is not relieved adequately after the first dose, a second dose of INSTANYL™ may be taken after 10 minutes for that episode of breakthrough cancer pain. You should wait at least 4 hours before treating the next episode of breakthrough cancer pain.

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

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

If you experience more than four episodes of breakthrough cancer pain per day, you should contact your doctor as your usual cancer pain treatment may have to be changed.

How to Use your INSTANYL™ Nasal Spray

Each nasal spray is sealed in a child-resistant blister. Do not open the blister before you are ready to use the spray. If an INSTANYL™ nasal spray unit is dropped following removal from the blister packaging and the unit is damaged, the unit should not be used. The damaged unit should be disposed of. Each nasal spray contains only one dose of INSTANYL™. Do not test before use.

• To open cut with scissors along the perforated line on the blister. Hold the edge of the foil, peel the foil back and take the nasal spray out.
• Blow your nose if it feels blocked or you have a cold.
• Gently hold the nasal spray with your thumb supporting it at the plunger at the bottom and your index and middle finger on either side of the spray tip.
• Block one nostril by placing your other index finger against the side of your nose and insert the spray tip into the other nostril (approximately 1cm). It does not matter which nostril you use. If you have to take a second dose after 10 minutes to get sufficient pain relief, this dose should preferably be taken in the other nostril.
• Keep your head upright.
• Press the plunger upwards firmly to release the dose with your thumb while inhaling gently through the nose and then remove the nasal spray from the nose.
• You may not feel the dose in your nose, but you have received it when the plunger has been pressed.
• Your nasal spray is now empty.

Overdose:

If you accidentally take more than your prescribed dose of INSTANYL™, seek emergency medical help by calling 911 or going to a hospital emergency department immediately.

Overdose with an opioid medicine such as INSTANYL™ can cause serious problems, the most serious being trouble breathing, extreme drowsiness with slowed breathing, and slow shallow breathing. Other signs of INSTANYL™ 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 medicines, INSTANYL™ can cause side effects, although not everybody gets them.The most common side effects of INSTANYL™ are nausea, vertigo, vomiting,

drowsiness, dizziness, headache, sweating, throat irritation and hot flash.

INSTANYL™ can cause your blood pressure to drop. This can make you feel dizzy if you get up too fast from sitting or lying down.

INSTANYL™ can cause physical dependence if taken regularly. Do not stop taking INSTANYL™ 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 INSTANYL™. The chance is higher if you are or have previously been addicted to or abused other medications, street drugs, or alcohol, or if you have a history of mental health problems. Your doctor can advice you on these risks.

There have been a few reports of patients developing a hole in the septum of the nose – the structure, which separates the nostrils.

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

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 slowed breathing

• Slow, shallow breathing (little chest movement with

  breathing)

• Feel faint, dizzy or confused
• Inability to think, talk or walk normally
• Seizure and hallucination

These can be symptoms of an overdose of INSTANYL™. Your dose of INSTANYL™ 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 INSTANYL™.

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

HOW TO STORE IT

Keep INSTANYL™ in a safe place away from the sight and reach of children. The amount of fentanyl contained in INSTANYL™ can be fatal to a child. INSTANYL™ should be used immediately after opening the child-resistant package.

Store INSTANYL™ at room temperature (15 to 30°C). Do not use INSTANYL™ after the expiry date which is stated on the nasal spray as EXP.

How to dispose of any unused INSTANYL™

INSTANYL™ can be harmful to other people, especially children. Unused INSTANYL™ should not be disposed of via wastewater or household waste. Any unused nasal sprays should be returned in the child-resistant blister to the pharmacy. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

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:

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• 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 0701E Ottawa, Ontario K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect™ Canada 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.

Adverse events may be reported directly to Takeda Medical Information & Pharmacovigilance at: 1-866-295-4636.

MORE INFORMATION

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

http://www.takedacanada.com or by contacting the sponsor, Takeda Canada Inc., at:

1-866-295-4636.

Last revised: June 26, 2013.