FDA Drug Safety Communication:
- As part of its ongoing efforts to address the nation's opioid crisis, FDA is requiring several updates to the prescribing information of opioid pain medicines. The changes are being made to provide additional guidance for safe use of these drugs while also recognizing the important benefits when used appropriately. The changes apply to both immediate-release (IR) and extended-release/long-acting preparations (ER/LA).
- Updates to the IR opioids state that these drugs should not be used for an extended period unless the pain remains severe enough to require an opioid pain medicine and alternative treatment options are insufficient, and that many acute pain conditions treated in the outpatient setting require no more than a few days of an opioid pain medicine.
- Updates to the ER/LA opioids recommend that these drugs be reserved for severe and persistent pain requiring an extended period of treatment with a daily opioid pain medicine and for which alternative treatment options are inadequate.
- A new warning is being added about opioid-induced hyperalgesia (OIH) for both IR and ER/LA opioid pain medicines. This includes information describing the symptoms that differentiate OIH from opioid tolerance and withdrawal.
- Information in the boxed warning for all IR and ER/LA opioid pain medicines will be updated and reordered to elevate the importance of warnings concerning life-threatening respiratory depression, and risks associated with using opioid pain medicines in conjunction with benzodiazepines or other medicines that depress the central nervous system (CNS).
- Other changes will also be required in various other sections of the prescribing information to educate clinicians, patients, and caregivers about the risks of these drugs.
Fentanyl nasal spray may be habit forming, especially with prolonged use. Use fentanyl nasal spray exactly as directed. Do not use a larger dose of fentanyl nasal spray, use the medication more often, or use it for a longer period of time than prescribed by your doctor. While using fentanyl nasal spray, discuss with your healthcare provider your pain treatment goals, length of treatment, and other ways to manage your pain. Tell your doctor if you or anyone in your family drinks or has ever drunk large amounts of alcohol, uses or has ever used street drugs, or has overused prescription medications, or has had an overdose, or if you have or have ever had depression or another mental illness. There is a greater risk that you will overuse fentanyl nasal spray if you have or have ever had any of these conditions. Talk to your healthcare provider immediately and ask for guidance if you think that you have an opioid addiction or call the U.S. Substance Abuse and Mental Health Services Administration (SAMHSA) National Helpline at 1-800-662-HELP.
Fentanyl nasal spray may cause serious breathing problems or death, especially if it is used by people who have not been treated with other narcotic medications or who are not tolerant (used to the effects of the medication) to narcotic medications. Fentanyl nasal spray should only be prescribed by doctors who are experienced in treating pain in cancer patients. It should be used only to treat breakthrough cancer pain (sudden episodes of pain that occur despite around-the-clock treatment with pain medication) in cancer patients at least 18 years of age who are taking regularly scheduled doses of another narcotic (opiate) pain medication, and who are tolerant (used to the effects of the medication) to narcotic pain medications. This medication should not be used to treat pain other than chronic cancer pain, especially short-term pain such as migraines or other headaches, pain from an injury, or pain after a medical or dental procedure.
Fentanyl nasal spray may cause serious harm or death if used accidentally by a child or by an adult who has not been prescribed the medication. Partially used fentanyl nasal spray bottles contain enough medication to cause serious harm or death to children or other adults. Always keep fentanyl nasal spray in its child-resistant container and out of the reach of children. If fentanyl nasal spray is used by a child or an adult who has not been prescribed the medication, get emergency medical help.
Fentanyl nasal spray should be used along with your other pain medication(s). If you stop taking your other pain medication(s) you will need to stop using fentanyl nasal spray.
You must wait at least 2 hours after using fentanyl nasal spray before using another dose, even if you still have pain. Tell your doctor if you still have pain 30 minutes after using fentanyl nasal spray.
Taking certain medications during your treatment with fentanyl nasal spray may increase the risk that you will develop serious or life-threatening breathing problems, sedation, or coma. Tell your doctor if you are taking any of the following medications: amiodarone (Nexterone, Pacerone); certain antibiotics such as clarithromycin (Biaxin, in PrevPac), benzodiazepines such as alprazolam (Xanax), chlordiazepoxide (Librium), clonazepam (Klonopin), diazepam (Diastat, Valium), estazolam, flurazepam, lorazepam (Ativan), oxazepam, temazepam (Restoril), and triazolam (Halcion); erythromycin (Erythocin, Eryc, Erythrocin, others), and telithromycin (Ketek); certain antifungals such as fluconazole (Diflucan), itraconazole (Onmel, Sporanox), and ketoconazole (Nizoral); aprepitant (Emend); cimetidine (Tagamet); diltiazem (Cardizem, Taztia, Tiazac, others); certain medications for human immunodeficiency virus (HIV) such as amprenavir (no longer available in the U.S.; Agenerase), fosamprenavir (Lexiva), indinavir (Crixivan), nelfinavir (Viracept), ritonavir (Norvir, in Kaletra), and saquinavir (Invirase); medications for mental illness and nausea; muscle relaxants; nefazodone; sedatives; sleeping pills; tranquilizers; or verapamil (Calan, Covera, Verelan, in Tarka). Your doctor may need to change the dosages of your medications and will monitor you carefully. If you use fentanyl with any of these medications and you develop any of the following symptoms, call your doctor immediately or seek emergency medical care: unusual dizziness, lightheadedness, extreme sleepiness, slowed or difficult breathing, or unresponsiveness. Be sure that your caregiver or family members know which symptoms may be serious so they can call the doctor or emergency medical care if you are unable to seek treatment on your own.
Drinking alcohol, taking prescription or nonprescription medications that contain alcohol, or using street drugs during your treatment with fentanyl increases the risk that you will experience these serious, life-threatening side effects. Do not drink alcohol, take prescription or nonprescription medications that contain alcohol, or use street drugs during your treatment.
Fentanyl comes as several different products. The medication in each product is absorbed differently by the body, so one product cannot be substituted for any other fentanyl product. If you are switching from one product to another, your doctor will prescribe a dose that is best for you.
A program has been set up to decrease the risk of using fentanyl nasal spray. Your doctor will need to enroll in the program in order to prescribe fentanyl nasal spray and you will need to have your prescription filled at a pharmacy that is enrolled in the program. As part of the program, your doctor will talk with you about the risks and benefits of using fentanyl nasal spray and about how to safely use, store, and dispose of the medication. After you talk with your doctor, you will sign a form acknowledging that you understand the risks of using fentanyl nasal spray and that you will follow your doctor's instructions to use the medication safely. Your doctor will give you more information about the program and how to get your medication and will answer any questions you have about the program and your treatment with fentanyl nasal spray.
Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with fentanyl nasal spray and each time you get more medication. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/drugs/drugsafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.
Talk to your doctor about the risks of using this medication.
Why is this medication prescribed?
Fentanyl nasal spray is used to treat breakthrough pain (sudden episodes of pain that occur despite round the clock treatment with pain medication) in cancer patients 18 years of age or older who are taking regularly scheduled doses of another narcotic (opiate) pain medication, and who are tolerant (used to the effects of the medication) to narcotic pain medications. Fentanyl is in a class of medications called narcotic (opiate) analgesics. It works by changing the way the brain and nervous system respond to pain.
How should this medicine be used?
Fentanyl nasal spray comes as a solution (liquid) to spray in the nose. It is used as needed to treat breakthrough pain but not more often than four times per day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand.
Your doctor will start you on a low dose of fentanyl nasal spray and gradually increase your dose until you find the dose that will relieve your breakthrough pain. Talk to your doctor about how well the medication is working and whether you are experiencing any side effects so that your doctor can decide whether your dose should be adjusted. If you still have pain 30 minutes after using fentanyl nasal spray, your doctor may tell you to use another pain medication to relieve that pain, and may increase your dose of fentanyl nasal spray to treat your next episode of pain. Do not increase your dose of fentanyl nasal spray unless your doctor tells you that you should.
Do not use fentanyl nasal spray more than four times a day. Call your doctor if you experience more than four episodes of breakthrough pain per day. Your doctor may need to adjust the dose of your other pain medication(s) to better control your pain.
Do not stop using fentanyl nasal spray without talking to your doctor. If you suddenly stop using fentanyl nasal spray, you may experience unpleasant withdrawal symptoms.
To use fentanyl nasal spray, follow these steps:
- Blow your nose, if you have a runny nose.
- Remove the cap from the child-resistant container and take the bottle of fentanyl nasal spray out. Remove the protective cap from the bottle tip. Hold the bottle so that the nozzle is between your first and second fingers and your thumb is on the bottom.
- If you are using a new bottle, you must prime the bottle before use. Prime the bottle by spraying 4 sprays into the pouch following the manufacturer's instructions in the Medication Guide.
- Sit upright and insert the tip of the bottle approximately 1/2 inch (1 cm) 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 1, 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 steps 4 through 6, using your other nostril.
- When the number in the counting window is an ''8'', do not try to use any more sprays from the bottle. There will still be some liquid in the bottle that will need to be sprayed in the pouch following the manufacturer's instructions in the Medication Guide.
- 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.
- Replace the protective cap on the bottle and put the bottle back in the child-resistant container, out of reach of children.
Other uses for this medicine
This medication should not be prescribed for other uses; ask your doctor or pharmacist for more information.
What special precautions should I follow?
Before using fentanyl nasal spray,
- tell your doctor and pharmacist if you are allergic to fentanyl patches, injection, nasal spray, tablets, lozenges, or films; any other medications; or any of the ingredients in fentanyl nasal spray. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
- tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, and nutritional supplements you are taking or plan to take. Be sure to mention the medications listed in the IMPORTANT WARNING section and any of the following medications: antihistamines; barbiturates such as phenobarbital; buprenorphine (Buprenex, Subutex, in Suboxone); butorphanol; carbamazepine (Carbatrol, Epitol, Tegretol, Teril); cyclobenzaprine (Amrix); dextromethorphan (found in many cough medications; in Nuedexta); efavirenz (in Atripla, Sustiva); lithium (Lithobid); medications for migraine headaches such as almotriptan (Axert), eletriptan (Relpax), frovatriptan (Frova), naratriptan (Amerge), rizatriptan (Maxalt), sumatriptan (Alsuma, Imitrex, in Treximet), and zolmitriptan (Zomig); mirtazapine (Remeron); modafinil (Provigil); nalbuphine; naloxone (Evzio, Narcan); nasal decongestants such as oxymetazoline (Afrin, Neo-Synephrine, Vicks Sinex, others); nevirapine (Viramune); oxcarbazepine (Trileptal); pentazocine (Talwin); phenytoin (Dilantin, Phenytek); pioglitazone (Actos, in Actoplus Met, in Duetact, others); rifabutin (Mycobutin); rifampin (Rifadin, Rimactane, in Rifamate, in Rifater); 5HT3 serotonin blockers such as alosetron (Lotronex), dolasetron (Anzemet), granisetron (Kytril), ondansetron (Zofran, Zuplenz), or palonosetron (Aloxi); selective serotonin-reuptake inhibitors such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem, in Symbyax), fluvoxamine (Luvox), paroxetine (Brisdelle, Prozac, Pexeva), and sertraline (Zoloft); serotonin and norepinephrine reuptake inhibitors such as desvenlafaxine (Khedezla, Pristiq), duloxetine (Cymbalta), milnacipran (Savella), and venlafaxine (Effexor); oral steroids such as dexamethasone, methylprednisolone (Medrol), and prednisone (Rayos); trazodone (Oleptro); and tricyclic antidepressants ('mood elevators') such as amitriptyline, clomipramine (Anafranil), desipramine (Norpramin), doxepin (Silenor), imipramine (Tofranil), nortriptyline (Pamelor), protriptyline (Vivactil), and trimipramine (Surmontil). Also tell your doctor or pharmacist if you are taking or receiving any of the following medications or if you have stopped taking them within the past two weeks: monoamine oxidase (MAO) inhibitors including isocarboxazid (Marplan), linezolid (Zyvox), methylene blue, phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate). Many other medications may also interact with fentanyl, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- tell your doctor what herbal products you are taking, especially St. John's wort and tryptophan.
- tell your doctor if you or anyone in your family drinks or has ever drunk large amounts of alcohol or uses or has ever used street drugs or excessive amounts of prescription medications. Also tell your doctor if you have a runny nose or have or have ever had a head injury, a brain tumor, a stroke, or any other condition that caused high pressure inside your skull; seizures; slowed heartbeat or other heart problems; low blood pressure; difficulty urinating; mental problems such as depression, schizophrenia (a mental illness that causes disturbed or unusual thinking, loss of interest in life, and strong or inappropriate emotions), or hallucinations (seeing things or hearing voices that do not exist); breathing problems such as asthma and chronic obstructive pulmonary disease (COPD; a group of lung diseases that includes chronic bronchitis and emphysema); or kidney or liver disease.
- tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while using fentanyl nasal spray, call your doctor.
- you should know that this medication may decrease fertility in men and women. Talk to your doctor about the risks of using fentanyl nasal spray.
- if you are having surgery, including dental surgery, tell the doctor or dentist that you are using fentanyl nasal spray.
- you should know that fentanyl nasal spray may make you drowsy or dizzy. Do not drive a car or operate machinery until you know how this medication affects you.
- you should know that fentanyl nasal spray may cause dizziness, lightheadedness, and fainting when you get up too quickly from a lying position. To avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up.
- you should know that fentanyl nasal spray may cause constipation. Talk to your doctor about changing your diet and using other medications to treat or prevent constipation.
What special dietary instructions should I follow?
Do not eat grapefruit or drink grapefruit juice while using this medication.
What should I do if I forget a dose?
This medication is usually used as needed according to directions.
What side effects can this medication cause?
Fentanyl nasal spray may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
Some side effects can be serious. If you experience this symptom, call your doctor immediately:
- slow heartbeat
- agitation, hallucinations (seeing things or hearing voices that do not exist), fever, sweating, confusion, fast heartbeat, shivering, severe muscle stiffness or twitching, loss of coordination, nausea, vomiting, or diarrhea
- nausea, vomiting, loss of appetite, weakness, or dizziness
- inability to get or keep an erection
- irregular menstruation
- decreased sexual desire
If you experience any of these symptoms, stop using fentanyl nasal spray and call your doctor immediately or get emergency medical treatment:
- slow, shallow breathing
- decreased urge to breathe
- difficulty breathing or swallowing
- extreme drowsiness
Fentanyl nasal spray may cause other side effects. Call your doctor if you have any unusual problems while using this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).
What should I know about storage and disposal of this medication?
Store fentanyl nasal spray in its child-resistant container, tightly closed, and out of reach of children. Store the child-resistant container and pouch in the cardboard box it came in when not in use. Store fentanyl nasal spray in a safe place so that no one else can use it accidentally or on purpose. Keep track of how many sprays in each bottle are left so you will know if any are missing. Store it at room temperature and away from light, excess heat and moisture (not in the bathroom). Do not freeze fentanyl nasal spray.
Dispose of fentanyl nasal spray as soon as it becomes outdated or is no longer needed. Dispose of any bottle of fentanyl nasal spray if 5 days have passed since you last used it or if 14 days have passed since you prepared the bottle for its first use. You can safely dispose of fentanyl nasal spray by spraying remaining liquid into the pouch provided with the medication, as described in the Medication Guide. The sealed pouch and empty bottle should then be placed in the child-resistant container before putting it in the trash. Wash your hands with soap and water right away after handling the pouch. Call your pharmacist or the manufacturer if you have questions, need help disposing of unneeded medication, or do not have a pouch available.
It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org
In case of emergency/overdose
In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.
While using fentanyl nasal spray, you should talk to your doctor about having a rescue medication called naloxone readily available (e.g., home, office). Naloxone is used to reverse the life-threatening effects of an overdose It works by blocking the effects of opiates to relieve dangerous symptoms caused by high levels of opiates in the blood. Your doctor may also prescribe you naloxone if you are living in a household where there are small children or someone who has abused street or prescription drugs. You should make sure that you and your family members, caregivers, or the people who spend time with you know how to recognize an overdose, how to use naloxone, and what to do until emergency medical help arrives. Your doctor or pharmacist will show you and your family members how to use the medication. Ask your pharmacist for the instructions or visit the manufacturer's website to get the instructions. If symptoms of an overdose occur, a friend or family member should give the first dose of naloxone, call 911 immediately, and stay with you and watch you closely until emergency medical help arrives. Your symptoms may return within a few minutes after you receive naloxone. If your symptoms return, the person should give you another dose of naloxone. Additional doses may be given every 2 to 3 minutes, if symptoms return before medical help arrives.
Symptoms of overdose may include the following:
- difficulty breathing or slow or shallow breathing
- unable to respond or wake up
- smaller pupils (black circles in the middle of the eyes)
What other information should I know?
Keep all appointments with your doctor and laboratory. Your doctor will order certain lab tests to check your body's response to fentanyl.
Before having any laboratory test (especially those that involve methylene blue), tell your doctor and the laboratory personnel that you are using fentanyl.
Do not let anyone else use your medication, even if he or she has the same symptoms that you have. Selling or giving away this medication may cause severe harm or death to others and is against the law.
This prescription is not refillable. Be sure to schedule appointments with your doctor on a regular basis so that you do not run out of medication.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.