Fentanyl Buccal Tablet

FENTORA is indicated for the management of breakthrough pain in cancer patients 18 years of age and older who are already receiving and who are tolerant to around-the-clock opioid therapy for their underlying persistent cancer pain. Patients considered opioid tolerant are those who are taking around-the-clock medicine consisting of at least 60 mg of oral morphine daily, at least 25 mcg/hr of transdermal fentanyl, at least 30 mg of oral oxycodone daily, at least 8 mg of oral hydromorphone daily, at least 25 mg oral oxymorphone daily, or an equianalgesic dose of another opioid daily for a week or longer. Patients must remain on around-the-clock opioids while taking FENTORA.

This product must not be used in opioid non-tolerant patients because life-threatening hypoventilation and death could occur at any dose in patients not on a chronic regimen of opioids. For this reason, FENTORA is contraindicated in the management of acute or postoperative pain.

FENTORA is intended to be used only in the care of opioid tolerant cancer patients and only by healthcare professionals who are knowledgeable of and skilled in the use of Schedule II opioids to treat cancer pain.

Limitations of Use

As a part of the TIRF REMS Access program, FENTORA may be dispensed only to outpatients enrolled in the program [see WARNINGS AND PRECAUTIONS]. For inpatient administration of FENTORA (e.g., hospitals, hospices, and long-term care facilities that prescribe for inpatient use), patient and prescriber enrollment is not required.

Clinical Studies Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety of FENTORA has been evaluated in 304 opioid-tolerant cancer patients with breakthrough pain. The average duration of therapy was 76 days with some patients being treated for over 12 months.

The most commonly observed adverse events seen with FENTORA are typical of opioid side effects. Opioid side effects should be expected and managed accordingly.

The clinical trials of FENTORA were designed to evaluate safety and efficacy in treating patients with cancer and breakthrough pain; all patients were taking concomitant opioids, such as sustained-release morphine, sustained-release oxycodone or transdermal fentanyl, for their persistent pain.

The adverse event data presented here reflect the actual percentage of patients experiencing each adverse effect among patients who received FENTORA for breakthrough pain along with a concomitant opioid for persistent pain. There has been no attempt to correct for concomitant use of other opioids, duration of FENTORA therapy or cancer-related symptoms.

Table 2 lists, by maximum dose received, adverse events with an overall frequency of 5% or greater within the total population that occurred during titration. The ability to assign a dose-response relationship to these adverse events is limited by the titration schemes used in these studies.

Table 2: Adverse Events Which Occurred During Titration at a Frequency of ≥ 5%

Table 3 lists, by successful dose, adverse events with an overall frequency of ≥ 5% within the total population that occurred after a successful dose had been determined.

Table 3: Adverse Events Which Occurred During Long-Term Treatment at a Frequency of ≥ 5%

In addition, a small number of patients (n=11) with Grade 1 mucositis were included in clinical trials designed to support the safety of FENTORA. There was no evidence of excess toxicity in this subset of patients.

The duration of exposure to FENTORA varied greatly, and included open-label and double-blind studies. The frequencies listed below represent the ≥ 1% of patients (and not listed in Tables 2 and 3 above) from three clinical trials (titration and post-titration periods combined) who experienced that event while receiving FENTORA. Events are classified by system organ class.

Blood and Lymphatic System Disorders: Thrombocytopenia, Leukopenia

Cardiac Disorders: Tachycardia

Gastrointestinal Disorders: Stomatitis, Dry Mouth, Dyspepsia, Upper Abdominal Pain, Abdominal Distension, Dysphagia, Gingival Pain, Stomach Discomfort, Gastroesophageal Reflux Disease, Glossodynia, Mouth Ulceration

General Disorders and Administration Site Conditions: Pyrexia, Application Site Pain, Application Site Ulcer, Chest Pain, Chills, Application Site Irritation, Edema, Mucosal Inflammation, Pain

Hepatobiliary Disorders: Jaundice

Infections and Infestations: Oral Candidiasis, Urinary Tract Infection, Cellulitis, Nasopharyngitis, Sinusitis, Upper Respiratory Tract Infection, Influenza, Tooth Abscess

Injury, Poisoning and Procedural Complications: Fall, Spinal Compression Fracture

Investigations: Decreased Hemoglobin, Increased Blood Glucose, Decreased Hematocrit, Decreased Platelet Count

Metabolism and Nutrition Disorders: Decreased Appetite, Hypoalbuminemia, Hypercalcemia, Hypomagnesemia, Hyponatremia, Reduced Oral Intake

Musculoskeletal and Connective Tissue Disorders: Pain in Extremity, Myalgia, Chest Wall Pain, Muscle Spasms, Neck Pain, Shoulder Pain

Nervous System Disorders: Hypoesthesia, Dysgeusia, Lethargy, Peripheral Neuropathy, Paresthesia, Balance Disorder, Migraine, Neuropathy

Psychiatric Disorders: Anxiety, Disorientation, Euphoric Mood, Hallucination, Nervousness

Renal and Urinary Disorders: Renal Failure

Respiratory, Thoracic and Mediastinal Disorders: Pharyngolaryngeal Pain, Exertional Dyspnea, Pleural Effusion, Decreased Breathing Sounds, Wheezing

Skin and Subcutaneous Tissue Disorders: Pruritus, Rash, Hyperhidrosis, Cold Sweat

Vascular Disorders: Hypertension, Hypotension, Pallor, Deep Vein Thrombosis

Fentanyl is a narcotic (opioid) pain medicine.

Fentanyl buccal is used to treat "breakthrough" cancer pain that is not controlled by other medicines. Fentanyl buccal is taken together with other non-fentanyl narcotic pain medicine that is used around the clock. This medication is not for treating pain that is not cancer-related, such as general headaches or back pain.

Fentanyl buccal may also be used for purposes not listed in this medication guide.

Fentanyl buccal is available only under special programs called Fentora REMS or the FOCUS Program. You must be registered in the program and sign documents stating that you understand the risks and benefits of taking this medication.

Do not use fentanyl unless you are already being treated with a similar opioid pain medicine and your body is tolerant to it. Talk with your doctor if you are not sure you are opioid-tolerant.

Fentanyl buccal tablets are used to treat "breakthrough" cancer pain. This medication is not for treating pain that is not cancer-related, such as general headaches or back pain.

Do not use fentanyl buccal if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days.

Before using fentanyl buccal, tell your doctor if you have a breathing disorder, a head injury or brain tumor, seizures, mental illness, a heart rhythm disorder, low blood pressure, liver or kidney disease, or a history of drug or alcohol addiction.

Keep this medicine out of the reach of children or pets. The amount of fentanyl in each fentanyl buccal tablet can be fatal to a child or pet who accidentally sucks on or swallows it. Seek emergency medical attention if this happens.

Fentanyl may be habit-forming and should be used only by the person it was prescribed for. Never share fentanyl with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it.

Do not use fentanyl with any other narcotic pain medications, sedatives, tranquilizers, sleeping pills, muscle relaxers, or other medicines that can make you sleepy or slow your breathing. Dangerous side effects may result.

This medication may impair your thinking or reactions. Avoid driving or operating machinery until you know how fentanyl will affect you.

Do not drink alcohol. It can increase drowsiness or breathing problems caused by fentanyl.

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

• Tell all of your health care providers that you take fentanyl buccal tablet. This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how this medicine affects you.
• To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down stairs.
• Do not stop taking fentanyl buccal tablet all of a sudden without calling your doctor. You may have a greater risk of signs of withdrawal. If you need to stop this medicine, you will want to slowly stop it as ordered by your doctor.
• Do not take more than what your doctor told you to take. Taking more than you are told may raise your chance of very bad side effects.
• Do not take fentanyl buccal tablet with other strong pain drugs or if you are using a pain patch without talking to your doctor first.
• Avoid grapefruit and grapefruit juice.
• This medicine may raise the chance of seizures in some people, including people who have had seizures in the past. Talk to your doctor to see if you have a greater chance of seizures while taking this medicine.
• If you are 65 or older, use fentanyl buccal tablet with care. You could have more side effects.
• This medicine may cause harm to the unborn baby if you take it while you are pregnant. If you are pregnant or you get pregnant while taking this medicine, call your doctor right away.

Fentanyl can interact with other medications, vitamins, or herbs you may be taking. An interaction is when a substance changes the way a drug works. This can be harmful or prevent the drug from working well.

To help avoid interactions, your doctor should manage all of your medications carefully. Be sure to tell your doctor about all medications, vitamins, or herbs you’re taking. To find out how this drug might interact with something else you’re taking, talk to your doctor or pharmacist.

Alcohol interaction

The use of drinks that contain alcohol can increase your risk of serious side effects from fentanyl. It may even result in coma or death. You should not drink alcohol while taking fentanyl.

Medications that might interact with this drug

• Do not take these drugs with fentanyl. Taking fentanyl with these drugs can cause dangerous effects in your body. Examples of these drugs include:
  • Buprenorphine
    • Taking this drug with fentanyl may lower the effect of fentanyl or cause withdrawal symptoms or both.
  • Depression drugs such as monoamine oxidase inhibitors (MAOIs)
    • Taking these drugs with fentanyl may cause anxiety, confusion, slowed breathing, or coma. Do not take fentanyl if you’re taking MAOIs or have taken MAOIs within the last 14 days.

• Taking fentanyl with certain medications may result in an increase in adverse effects. Examples of these drugs include:
  • Muscle relaxants, such as baclofen, cyclobenzaprine, and methocarbamol.
    • You may experience increased breathing problems.

• Benzodiazepines, such as lorazepam, diazepam, temazepam, and estazolam.
  • you may experience increased breathing problems, low blood pressure, extreme drowsiness, coma, or death. Your doctor may prescribe a lower dose for you.
• Anticholinergic drugs, such as atropine, scopolamine, and benztropine.
  • You may experience increased problems urinating or severe constipation, which could lead to more serious bowel problems.
• Voriconazole, ketoconazole.
  • These drugs may increase fentanyl levels in your body, which may increase your risk of side effects. Your doctor may monitor you more frequently and adjust your dose as necessary.
• Erythromycin.
  • This medication may increase fentanyl levels in your body, which may increase your risk of side effects. Your doctor may monitor you more frequently and adjust your dose as necessary.
• Ritonavir.
  • This medication may increase fentanyl levels in your body, which may increase your risk of side effects. Your doctor may monitor you more frequently and adjust your dose as necessary.
• Serotonergic drugs, such as selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), and monoamine oxidase inhibitors (MAOIs)
  • Taking these drugs with fentanyl may cause serotonin syndrome, which can be fatal. Symptoms can include agitation, sweating, muscle twitches, and confusion.

• When fentanyl is used with certain drugs, it may not work as well to treat your condition. This is because the amount of fentanyl in your body may be decreased from the interaction with these drugs. Examples of these drugs include:

• Rifampin.
  • This drug may decrease fentanyl levels in your body, making the fentanyl less effective in relieving your pain. Your doctor may monitor you more frequently and adjust your dose as necessary.
• Carbamazepine, phenobarbital and phenytoin.
  • These drugs may decrease fentanyl levels in your body, making the fentanyl less effective in relieving your pain. Your doctor may monitor you more frequently and adjust your dose as necessary.

People with breathing problems

Fentanyl may decrease your breathing rate. Use this medication with extreme caution if you’ve been diagnosed with a breathing problem, such as chronic obstructive pulmonary disease (COPD). Do not use fentanyl if you have asthma.

People with intestinal blockage and constipation

Fentanyl can cause you to not notice symptoms of these conditions. This can make it difficult for doctors to diagnose or find the cause of these conditions.

People with head injury or seizures

Fentanyl may cause increased pressure in your brain and cause breathing problems.

People with liver disease

If you have liver disease, your body may process drugs more slowly. As a result, more of a drug stays in your body for a longer time. This increases your risk of side effects. Your doctor may start you on a lower dose. This can help keep levels of this drug from building up too much in your body.

People with kidney disease

If you have kidney disease or a history of kidney disease, you may not be able to clear this drug from your body well. This may increase the levels of fentanyl in your body and cause more side effects.

People with adrenal insufficiency

Taking this drug can reduce the amount of hormones your adrenal glands release. If you have this adrenal insufficiency, taking this drug can make it worse.

People with pancreas and gallbladder problems

Taking this drug can cause spasms that can make symptoms of conditions such as biliary tract disease and pancreatitis worse.

People with urination problems

Taking this drug can cause your body to retain urine. If you already have difficulty urinating, your doctor may prescribe a lowered dose.

People with slow heart rate

Taking this drug can slow your heart rate. If you already have a slow heart rate (bradycardia), this drug can make it worse. Use fentanyl with caution. Your doctor may prescribe a lowered dose and monitor you more closely for side effects.

Pregnant women

Fentanyl is a category C pregnancy drug. That means two things:

1. Research in animals has shown adverse effects to the fetus when the mother takes the drug.
2. There haven’t been enough studies done in humans to be certain how the drug might affect the fetus.

Talk to your doctor if you’re pregnant or planning to become pregnant. This drug should be used only if the potential benefit justifies the potential risk to the fetus.

Using fentanyl for a long time during pregnancy can lead to neonatal withdrawal syndrome in your newborn child. Symptoms include irritability, overactive behaviors, abnormal sleep pattern, high-pitched crying, tremors, vomiting, diarrhea, and failure to gain weight.

Women who are breast-feeding

Fentanyl does pass into breast milk and causes side effects in a child who is breast-fed.

Talk to your doctor if you breast-feed your baby. You may need to decide whether to stop breast-feeding or stop taking this medication.

For children

The safety and effectiveness of this form of fentanyl hasn’t been established in people younger than 18 years.

When to call the doctor

Call your doctor if you feel as though your pain remains uncontrolled. Your doctor may want to change the dose of your medicine.

Allergies

Fentanyl can cause a severe allergic reaction. Symptoms can include:

• trouble breathing
• swelling of your throat or tongue

If you have an allergic reaction, call your doctor or local poison control center right away. If your symptoms are severe, call 9-1-1 or go to the nearest emergency room.

Don’t take this drug again if you’ve ever had an allergic reaction to it. Taking it again could be fatal (cause death).

All possible dosages and drug forms may not be included here. Your dosage, drug form, and how often you take the drug will depend on:

• your age
• the condition being treated
• how severe your condition is
• other medical conditions you have
• how you react to the first dose

What are you taking this medication for?

Brand: Fentora

• The starting dose is usually 100 micrograms. Your doctor will prescribe the least amount of fentanyl to control your pain, with the least amount of side effects.
• Your doctor may increase your dose based on your level of pain. If you don’t feel relief 30 minutes after finishing your first tablet, you may take one more tablet of the same strength. You must wait at least 4 hours between doses.
• To take the tablet, place it under your tongue or near your rear molar, between your upper cheek and gum. Do not suck, chew, or swallow the tablet. Leave the tablet there for 14–25 minutes. After 30 mins, if there’s some medicine left over, you may swallow it with a glass of water. You should use the other side of your mouth for the next dose.

The safety and effectiveness of this form of fentanyl hasn’t been established in people younger than 18 years.

The kidneys of older adults may not work as well as they used to. This can cause your body to process drugs more slowly. As a result, more of a drug stays in your body for a longer time. This increases your risk of side effects.

Your doctor may start you on a lowered dose or a different medication schedule. This can help keep levels of this drug from building up too much in your body.

Do not eat or drink at the same time that you’re taking fentanyl

Do not cut or crush the tablet

Store this drug carefully

A prescription for this medication is not refillable

Travel

Clinical monitoring

Your diet

Not every pharmacy stocks this drug

Insurance

Are there any alternatives?