Sublimaze

Fentanyl is a prescription medication used to treat breakthrough cancer pain. It can also be used as part of surgical anesthesia.

Fentanyl belongs to a group of drugs called opioid agonists or narcotic pain medications. These work by changing the way the brain and nervous system respond to pain.

This medication comes in nasal spray, sublingual spray, sublingual (buccal) tablet, lozenge, and transdermal patch forms. The dose and frequency of administration will vary with the indication and dosage form.

This medication is also available in an injectable form to be given directly into a vein (IV) or the muscle (IM) by a healthcare professional.

Common side effects of fentanyl include difficulty breathing, nausea, upset stomach, and difficulty urinating.

Fentanyl can also cause changes in vision, drowsiness, and dizziness. Do not drive or operate heavy machinery until you know how fentanyl affects you.

The oral, topical, and inhalational forms of fentanyl are prescription medications used to treat breakthrough cancer pain. Fentanyl injection may also be used as premedication prior to surgery, for anesthesia induction, as an adjunct to regional anesthesia, or for pain control in the post-operative setting.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• how you respond to this medication
• your weight
• your age

Nasal spray:

The recommended dose/dose range of (LAZANDA) fentanyl nasal spray for the treatment of breakthrough cancer pain is 100 mcg to 800 mcg. LAZANDA is only indicated for patients who are opioid tolerant, meaning they have been taking opioid pain medications for at least one week. The dose of LAZANDA is titrated based on your response to the medication. Each episode of pain can be treated with a single spray into one nostril or a single spray into each nostril. If adequate pain relief is not achieved, do not repeat the dose of LAZANDA. No more than 4 episodes of pain should be treated with LAZANDA in one day.

Sublingual spray:

The recommended dose/dose range of SUBSYS (fentanyl sublingual spray) for the treatment of breakthrough cancer pain is 100 mcg to 1600 mcg. SUBSYS is only indicated for patients who are opioid tolerant, meaning they have been taking opioid pain medications for at least one week. The dose of SUBSYS is titrated based on your response to the medication and the dose may be repeated in 30 minutes if additional pain relief is needed. No more than 2 doses should be taken for each episode of breakthrough pain; wait at least 4 hours before treating another episode of pain with SUBSYS.

Sublingual tablet:

The recommended dose/dose range of ABSTRAL (fentanyl sublingual tablet) for the treatment of breakthrough cancer pain is 100 mcg to 800 mcg. ABSTRAL is only indicated for patients who are opioid tolerant, meaning they have been taking opioid pain medications for at least one week. The dose of ABSTRAL is titrated based on your response to the medication and the dose may be repeated in 2 hours if additional pain relief is needed. No more than 2 doses should be taken for each episode of breakthrough pain and no more than 4 episodes of pain should be treated with ABSTRAL in one day.

Oral lozenge:

The recommended dose/dose range of ACTIQ (fentanyl) lozenge for the treatment of breakthrough cancer pain is 200 mcg to 1600 mcg. The lozenge should be consumed over 15 minutes. ACTIQ is only indicated for patients who are already taking around-the-clock opioid medications. The dose of ACTIQ is titrated based on your response to the medication and the dose may be repeated once in 30 minutes if additional pain relief is needed. Wait at least 4 hours before treating another episode of pain.

Transdermal system:

The recommended dose/dose range of fentanyl extended release transdermal systems for the treatment of pain is 12 to 100 mcg/hour. Fentanyl transdermal systems are only indicated for patients who are opioid tolerant, meaning they have been taking opioid pain medications for at least one week. The dose will be titrated based on your response to the medication.

Injection:

The dose/dose range of fentanyl injection is individualized on the basis of its indication for use. Fentanyl injection can be administered as premedication prior to surgery, for anesthesia induction, as an adjunct to regional anesthesia, or for pain control in the post-operative setting.

Nasal Spray:

WARNING: RISK OF RESPIRATORY DEPRESSION, MEDICATION ERRORS, ABUSE POTENTIAL

See full prescribing information for complete boxed warning.

Due to the risk of fatal respiratory depression, Lazanda is contraindicated in opioid non-tolerant patients and in management of acute or postoperative pain, including headache/migraines.

Keep out of reach of children.

Use with CYP3A4 inhibitors may cause fatal respiratory depression.

When prescribing, do not convert patients on a mcg per mcg basis from any other oral transmucosal fentanyl product to Lazanda.

When dispensing, do not substitute with any other fentanyl products.

Contains fentanyl, a Schedule II controlled substance with abuse liability similar to other opioid analgesics.

Lazanda is available only through a restricted program called the TIRF REMS Access program. Outpatients, healthcare professionals who prescribe to outpatients, pharmacies, and distributors are required to enroll in the program.

Sublingual Spray:

WARNING: RISK OF RESPIRATORY DEPRESSION, MEDICATION ERRORS, ABUSE POTENTIAL

See full prescribing information for complete boxed warning.

Due to the risk of fatal respiratory depression, SUBSYS is contraindicated in opioid non-tolerant patients and in management of acute or postoperative pain, including headache/migraines.

Keep out of reach of children.

Use with CYP3A4 inhibitors may cause fatal respiratory depression.

When prescribing, do not convert patients on a mcg per mcg basis from any other oral transmucosal fentanyl product to SUBSYS.

When dispensing, do not substitute with any other fentanyl products.

Contains fentanyl, a Schedule II controlled substance with abuse liability similar to other opioid analgesics.

SUBSYS is available only through a restricted program called the TIRF REMS Access program. Outpatients, healthcare professionals who prescribe to outpatients, pharmacies, and distributors are required to enroll in the program.

Sublingual tablets:

WARNING: RISK OF RESPIRATORY DEPRESSION, MEDICATION ERRORS, ABUSE POTENTIAL

See full prescribing information for complete boxed warning.

Due to the risk of fatal respiratory depression, fentanyl sublingual (buccal) tablets are contraindicated in opioid non-tolerant patients and in management of acute or postoperative pain, including headache/migraines.

Keep out of reach of children.

Use with CYP3A4 inhibitors may cause fatal respiratory depression.

When prescribing, do not convert patients on a mcg per mcg basis from any other oral transmucosal fentanyl product to fentanyl sublingual tablets.

When dispensing, do not substitute with any other fentanyl products.

Contains fentanyl, a Schedule II controlled substance with abuse liability similar to other opioid analgesics.

Fentanyl sublingual tablets are available only through a restricted program called the TIRF REMS Access program. Outpatients, healthcare professionals who prescribe to outpatients, pharmacies, and distributors are required to enroll in the program.

Oral lozenges:

WARNING: RISK OF RESPIRATORY DEPRESSION, MEDICATION ERRORS, ABUSE POTENTIAL

See full prescribing information for complete boxed warning.

Due to the risk of fatal respiratory depression, fentanyl oral transmucosal lozenge is contraindicated in opioid non-tolerant patients and in management of acute or postoperative pain, including headache/migraines.

Keep out of reach of children.

Use with CYP3A4 inhibitors may cause fatal respiratory depression.

When prescribing, do not convert patients on a mcg per mcg basis from any other oral transmucosal fentanyl product to fentanyl oral transmucosal lozenge.

When dispensing, do not substitute with any other fentanyl products.

Contains fentanyl, a Schedule II controlled substance with abuse liability similar to other opioid analgesics.

Fentanyl oral transmucosal lozenge is available only through a restricted program called the TIRF REMS Access program. Outpatients, healthcare professionals who prescribe to outpatients, pharmacies, and distributors are required to enroll in the program.

Transdermal systems:

WARNING: ADDICTION, ABUSE, and MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL EXPOSURE; NEONATAL OPIOID WITHDRAWAL SYNDROME; CYTOCHROME P450 3A4 INTERACTION, and EXPOSURE TO HEAT

Fentanyl transdermal system exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient's risk before prescribing, and monitor regularly for development of these behaviors or conditions.

Serious, life-threatening, or fatal respiratory depression may occur. Monitor closely, especially upon initiation or following a dose increase.

Accidental exposure to fentanyl transdermal system, especially in children, can result in fatal overdose of fentanyl.

Prolonged use of fentanyl transdermal system during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.

Initiation of CYP 3A4 inhibitors (or discontinuation of CYP 3A4 inducers) can result in a fatal overdose of fentanyl from fentanyl transdermal system.

Avoid exposing the fentanyl transdermal system application site and surrounding area to direct external heat sources. Temperature dependent increases in fentanyl release from the system may result in overdose and death.

Serious side effects have been reported with oral, topical, inhalational, and injectable forms of fentanyl, including the following:

• Changes in heart rate
• Seizures
• Slowed or shallow breathing
• Difficulty breathing or swallowing
• Extreme drowsiness
• Confusion
• Fainting

Fentanyl can cause drowsiness and vision changes. Do not drive or operate heavy machinery until you know how fentanyl affects you.

Do not take fentanyl if you are allergic to fentanyl or to any of its ingredients.

Serious side effects have been reported oral, topical, inhalational, and injectable forms of fentanyl. See the “Fentanyl Precautions” section.

Common side effects of fentanyl include the following:

• Drowsiness
• Nausea
• Stomach pain
• Vomiting
• Constipation
• Gas
• Heartburn
• Loss of appetite
• Weight loss
• Difficulty urinating
• Weakness
• Headache
• Vision changes
• Anxiety
• Depression
• Hallucinations
• Changes in thinking or dreams
• Dry mouth
• Difficulty sleeping
• Sweating
• Reddening of the face, neck, or chest
• Swelling of the extremities
• Hives, rash, and itching

Irritation at the site of application may also occur after administration of oral, topical, and inhalational forms of fentanyl.

This is not a complete list of fentanyl side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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

• Antihistamines
• Barbiturates such as phenobarbital (Luminal)
• Buprenorphine (Buprenex, Subutex, in Suboxone)
• Butorphanol (Stadol)
• Carbamazepine (Carbatrol, Epitol, Tegretol)
• Efavirenz (in Atripla, Sustiva)
• Modafinil (Provigil)
• Nalbuphine (Nubain)
• Nalmefene (Revex)
• Naloxone (Narcan)
• Nevirapine (Viramune)
• Oral steroids such as dexamethasone (Decadron, Dexpak), methylprednisolone (Medrol), and prednisone
• Oxcarbazepine (Trileptal)
• Other pain medications
• Pentazocine (Talwin)
• Phenytoin (Dilantin, Phenytek)
• Pioglitazone (Actos, in Actoplus Met, in Duetact)
• Rifabutin (Mycobutin)
• Rifampin (Rifadin, Rimactane, in Rifamate, in Rifater)
• Sedatives, sleeping pills, or tranquilizers

Also tell your doctor or pharmacist if you are taking any of the following medications or if you have stopped taking them within the past two weeks: monoamine oxidase (MAO) inhibitors including isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate).

This is not a complete list of fentanyl drug interactions. Ask your doctor or pharmacist for more information.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Fentanyl falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your doctor if you are breastfeeding or plan to breastfeed.

Fentanyl has been detected in human breast milk. Because of the possibility for adverse reactions in nursing infants from fentanyl, a choice should be made whether to stop nursing or to stop use of this medication. The importance of the drug to the mother should be considered.

• Fentanyl has the potential for abuse. Fentanyl should be used exactly as prescribed only by the person to whom it was prescribed.
• Fentanyl may cause life-threatening respiratory depression.
• Fentanyl should be prescribed only by physicians who have experience treating breakthrough cancer pain.