Onsolis

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.

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.

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.

Grapefruit and grapefruit juice may interact with fentanyl and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

Before taking fentanyl, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to fentanyl or to any of its ingredients
• are taking herbal supplements, especially St. John’s Wort
• drink large amounts of alcohol or use illegal drugs
• have had a head injury, brain tumor, stroke, or seizures
• have liver problems
• have kidney problems
• have heart problems, especially problems with your heart rate
• have low blood pressure
• have mental illness, such as depression, schizophrenia, or hallucinations
• have breathing disorders, such as asthma or chronic obstructive pulmonary disorder
• are pregnant or breastfeeding

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

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.

Take fentanyl exactly as prescribed.

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

Instructions for use of nasal spray:

To use fentanyl nasal spray, begin by blowing your nose, if you have a runny nose. Remove the protective cap from the bottle tip and hold the bottle so that the nozzle is between your first and second fingers and your thumb is on the bottom. Sit upright and insert the tip of the bottle approximately 1/2 inch into one nostril, pointing the tip toward the bridge of your nose. Close your other nostril with your finger. Press down firmly on the finger grips until you hear a ''click'' sound. You may not feel the spray go into your nose, but as long as the number in the counting window increases by one, the spray has been given. Breathe in gently through your nose and out through your mouth one time after spraying. Do not sniff after spraying the medication into your nose. If your doctor wants you to use two sprays, repeat the adminsitration, using your other nostril. Stay sitting down for at least 1 minute after using fentanyl nasal spray. Do not blow your nose for at least 30 minutes after using fentanyl nasal spray.

Instructions for use of sublingual spray:

To use the sublingual spray, first remove the fentanyl sublingual spray unit from the blister package by cutting along the dashed line with a pair of scissors. Swallow any saliva in your mouth. Hold the fentanyl sublingual spray unit upright using your index and middle fingers and thumb. Point the nozzle into your mouth and under your tongue. Squeeze your fingers and thumb together to spray the medication under your tongue. Hold the medication under your tongue for 30 to 60 seconds. Do not spit out the medication or rinse your mouth. The fentanyl sublingual spray is a one-time use unit and will remain locked after use.

Instructions for use of sublingual tablets:

Place ABSTRAL (fentanyl) sublingual tablets on the floor of the mouth directly under the tongue immediately after removal from the blister pack. Do not chew, suck, or swallow ABSTRAL tablets. Allow ABSTRAL tablets to completely dissolve in the sublingual cavity. Do not eat or drink anything until the tablet is completely dissolved. If you have a dry mouth, use water to moisten the buccal mucosa before taking ABSTRAL.

Instructions for use of lozenges:

Place ACTIQ in your mouth between your cheeks and gums and actively suck on the medicine. Move the lozenge around in your mouth, especially along the inside of your cheeks. Twirl the handle often. Finish the ACTIQ unit completely in 15 minutes to get the most relief. If you finish ACTIQ too quickly, you will swallow more of the medicine and get less relief. Do not bite or chew ACTIQ. You will get less relief for your breakthrough cancer pain.

Instructions for use of transdermal patches:

A fentanyl transdermal system may be applied to the chest, back, flank, or upper arm in a place where there is no hair. Patches should not be placed on skin that is oily, burned, cut, irritated, or damaged. Avoid areas that are sensitive or that move around a lot. Do not shave the area where the patch will be placed.

A patch may be applied at any time of the day, but you should change the patch around the same time every 3 days. Do not wear more than one patch at a time, unless directed by your doctor. Before applying the patch, clean the skin and pat the area dry. Open the patch’s protective pouch and peel the plastic backing away from the patch. Take care not to touch the sticky side of the patch. Press the patch to the skin with the palm of your hand for at least 30 seconds. Make sure it sticks well, especially at the edges. Wash your hands after applying the patch. After 3 days, remove the patch and apply a new one in a different spot. If the patch falls off before 3 days, do not replace it with a new patch; wait until 3 days after you put it on to apply a new patch.

Injection:

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.

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.

If you take too much fentanyl, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If fentanyl is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Store fentanyl at room temperature.
• Keep this and all medicines out of the reach of children.
• Special instructions for discarding used and unused fentanyl doses are provided in the medication guide you will receive with your medication. Follow these instructions carefully and ask your pharmacist for more information or if you are unclear how to dispose of fentanyl products safely.

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.