Description
Fentanyl nasal spray is used to treat severe pain in cancer patients. It is used for breakthrough cancer pain, which are flares of pain that “break through” after a routine pain medicine has been used. Fentanyl belongs to the group of medicines called opioid analgesics. It is only used in patients who are already taking opioid analgesics.
Fentanyl acts in the central nervous system (CNS) to relieve pain. Some of its side effects are also caused by actions in the CNS. When an opioid is used for a long time, it may become habit-forming (causing mental or physical dependence). However, under the close supervision of a healthcare provider, people who have continuing pain should not let the fear of dependence keep them from using opioids to relieve their pain. Mental dependence (addiction) is less likely to occur when opioids are used for this purpose. Physical dependence may lead to withdrawal symptoms if treatment is stopped suddenly. However, severe withdrawal symptoms can usually be prevented by reducing the dose gradually over a period of time before treatment is stopped completely. Your doctor will take this into consideration when deciding on the amount of nasal fentanyl you should receive.
This medicine is available only under a restricted distribution program called TIRF (Transmucosal Immediate Release Fentanyl) REMS Program.
This product is available in the following dosage forms:
- Spray
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of nasal fentanyl in the pediatric population. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of nasal fentanyl in the elderly. However, elderly patients may be more sensitive to the effects of opioid analgesics than younger adults and are more likely to have age-related kidney disease, which may require caution and an adjustment in the dose for patients receiving nasal fentanyl.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Levoketoconazole
- Mifepristone
- Naltrexone
- Safinamide
- Samidorphan
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Abametapir
- Acepromazine
- Aclidinium
- Alefacept
- Alfentanil
- Almotriptan
- Alprazolam
- Amantadine
- Amifampridine
- Amiloride
- Amineptine
- Amiodarone
- Amitriptyline
- Amitriptylinoxide
- Amobarbital
- Amoxapine
- Amphetamine
- Amprenavir
- Anileridine
- Apalutamide
- Aprepitant
- Aripiprazole
- Aripiprazole Lauroxil
- Armodafinil
- Asciminib
- Asenapine
- Atazanavir
- Atropine
- Avacopan
- Baclofen
- Belladonna
- Belzutifan
- Bemetizide
- Bendroflumethiazide
- Benperidol
- Bentazepam
- Benzhydrocodone
- Benzphetamine
- Benzthiazide
- Benztropine
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
- Ethanol
- Grapefruit Juice
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Adrenal problems or
- Alcohol use disorder, or history of or
- Brain problems (including tumors, increased intracranial pressure) or
- Cor pulmonale (serious heart problem) or
- Drug dependence, especially opioid use disorder, history of or
- Head injuries, history of or
- Lung or breathing problems (eg, COPD, hypoxia, sleep apnea) or
- Mental health problems, history of—Use with caution. May cause side effects to become worse.
- Asthma, acute or severe or
- Short-term pain (eg, pain after surgery, headache, migraine, dental pain) or
- Stomach or bowel blockage (including paralytic ileus), known or suspected—Should not be used in patients with these conditions.
- Bradyarrhythmia (slow heart rhythm) or
- Gallbladder disease or
- Hypotension (low blood pressure) or
- Pancreatitis (inflammation of the pancreas), acute—Use with caution. May make these conditions worse.
- Kidney disease or
- Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
Proper Use
Use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered.
Fentanyl nasal sprays are for use in opioid-tolerant patients only. If you are not sure whether or not you are opioid-tolerant, check with your doctor before using this medicine.
It is very important that you understand the rules of the TIRF REMS program to prevent addiction, abuse, and misuse of fentanyl. This medicine should also come with a Medication Guide and patient instructions. Read and follow these instructions carefully. Read it again each time you refill your prescription in case there is new information. Ask your doctor if you have any questions.
This medicine is for use only in the nose. Do not get any of it in your eyes or on your skin. If it does get on these areas, rinse it off with water right away.
Fentanyl nasal spray works differently than other fentanyl products, even at the same dose. Do not substitute or convert it to other products containing fentanyl.
To use the nasal spray:
- Keep the spray in the child-resistant container until ready to use.
- If you are using the nasal spray for the first time, you must prime the spray. Press on the grips and then release. You will hear a "click" and you will see 1 wide red bar in the counting window. Keep pressing and releasing the grip 3 more times. Each time, the red bar will become smaller until you see a green bar in the counting window. Prime the spray if it has not been used for more than 5 days. Re-prime by spraying 1 time into the pouch.
- Gently blow your nose before using the spray. Sit up with your head upright and insert the tip of the nose piece into your nostril, and point the tip toward the bridge of your nose.
- Close the opposite nostril with a finger. Firmly press down on the finger grips until you hear a "click".
- Breathe in gently through your nose and out through your mouth one time after spraying. Do not sniff. Avoid blowing your nose for at least 30 minutes. Sit down for at least 1 minute.
- Throw this medicine away after 8 sprays.
If another dose is needed, wait at least 2 hours before treating another episode of breakthrough pain.
Do not eat grapefruit or drink grapefruit juice while you are using this medicine.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For nasal dosage form (spray):
- For cancer pain:
- Adults—At first, 100 micrograms (mcg) or 1 spray in one nostril during an episode of breakthrough cancer pain. Your doctor may increase your dose as needed and tolerated. The dose is usually not more than 4 sprays per episode of pain.
- Children—Use and dose must be determined by your doctor.
- For cancer pain:
Storage
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Ask your pharmacist about the best way to dispose of medicine that you do not use. Throw away the spray bottle and start using a new one if you have used 8 sprays or if it has been 60 days or more since it has been used. Dispose any used, partially used, or unneeded spray bottles by emptying and spraying the remaining solution into the pouch. The sealed pouch and the empty bottle should be placed in a child-resistant container before discarding it in the trash can. Wash your hands with soap and water right away after handling the pouch.
Precautions
It is very important that your doctor check your progress at regular visits. This will allow your doctor to make sure that this medicine is working properly and to check you for any problems or unwanted effects that may be caused by this medicine.
Do not use this medicine if you have used an MAO inhibitor (MAOI) (eg, isocarboxazid [Marplan®], linezolid [Zyvox®], phenelzine [Nardil®], selegiline [Eldepryl®], tranylcypromine [Parnate®]) within the past 14 days.
This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.
This medicine may cause sleep-related breathing problems (eg, sleep apnea, sleep-related hypoxemia). Your doctor may decrease your dose if you have sleep apnea (stop breathing for short periods during sleep) while using this medicine.
Using too much nasal fentanyl, or taking too much of another opioid while using nasal fentanyl, may cause an overdose. If this occurs, get emergency help right away. Your healthcare provider may prescribe naloxone to treat an overdose. Naloxone is a medicine that can temporarily reverse the effects of an overdose. If you have been prescribed naloxone, or purchased it over-the-counter, make sure your household members know how to use it in the event of an overdose. Emergency help is still needed after naloxone is used because the reversal effects are only temporary. Symptoms of an overdose include: drowsiness, extreme dizziness or weakness, irregular, fast or slow, or shallow breathing, pale or blue lips, fingernails, or skin, pinpoint pupils, relaxed and calm, slow heartbeat or breathing, seizures, sleepiness, trouble breathing, or cold, clammy skin. Tell your doctor right away if you notice these symptoms. Your doctor may also give naloxone to treat an overdose.
Using this medicine while you are pregnant may cause neonatal withdrawal syndrome in your newborn baby. Tell your doctor right away if your baby has an abnormal sleep pattern, diarrhea, a high-pitched cry, irritability, shakiness or tremors, weight loss, vomiting, or fails to gain weight.
Fentanyl is a medicine that can harm or cause death to a child. Patients and caregivers should keep this medicine out of the reach of children. Carefully dispose of any partially used units or unused medicine properly.
This medicine will add to the effects of alcohol and other central nervous system (CNS) depressants. This effect may last for a few days after you stop using this medicine. CNS depressants are medicines that slow down the nervous system, which may cause drowsiness or make you less alert. Some examples of CNS depressants are antihistamines or medicine for hay fever, allergies, or colds, sedatives, tranquilizers, benzodiazepines, sleeping medicines, other prescription pain medicine or opioids, barbiturates or seizure medicine, muscle relaxants, or anesthetics (numbing medicines), including some dental anesthetics. Check with your doctor before taking any of the other medicines listed above while you are using this medicine.
Check with your doctor right away if you have anxiety, restlessness, a fast heartbeat, fever, sweating, muscle spasms, twitching, nausea, vomiting, diarrhea, or see or hear things that are not there. These may be symptoms of a serious condition called serotonin syndrome. Your risk may be higher if you also take certain other medicines that affect serotonin levels in your body.
Check with your doctor right away if you have darkening of the skin, diarrhea, dizziness, fainting, loss of appetite, mental depression, nausea, skin rash, unusual tiredness or weakness, or vomiting. These may be symptoms of adrenal gland problems.
Dizziness, lightheadedness, or fainting may occur when you get up suddenly from a lying or sitting position. Getting up slowly may help lessen this problem. Also, lying down for a while may relieve the dizziness or lightheadedness.
Fentanyl may cause some people to become drowsy, dizzy, or lightheaded, or to feel a false sense of well-being. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert and clearheaded.
This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Call your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.
Using opioids for a long time may cause severe constipation. To prevent this, your doctor may tell you to take laxatives, drink a lot of fluids, or increase the amount of fiber in your diet. Be sure to follow the directions carefully, because continuing constipation can lead to more serious problems.
Using too much of this medicine may cause reduced infertility (unable to have children). Talk with your doctor before using this medicine if you plan to have children.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
More common
- Fever
Less common
- Anxiety
- black, tarry stools
- bladder pain
- bloating or swelling of the face, arms, hands, lower legs, or feet
- bloody nose
- bloody or cloudy urine
- blurred vision
- body aches or pain
- chest pain or tightness
- chills
- clay-colored stools
- confusion
- cough
- cough producing mucus
- dark urine
- decreased urination
- decreased weight
- difficult or labored breathing
- difficult, burning, or painful urination
- difficulty with breathing
- dizziness or lightheadedness
- dry mouth
- ear congestion
- fainting
- frequent urge to urinate
- headache
- hives
- hoarseness
- increase in heart rate
- increased sweating
- irritation
- itching
- joint pain, stiffness, or swelling
- loss of appetite
- loss of voice
- lower back or side pain
- nausea
- nervousness
- pain, redness, or swelling in the arm or leg
- pale skin
- pounding in the ears
- rapid breathing
- rapid weight gain
- rash
- redness of the skin
- runny or stuffy nose
- slow or fast heartbeat
- sneezing
- sore throat
- stomach pain
- sunken eyes
- swelling of the eyelids, face, lips, hands, or feet
- thirst
- tingling of the hands or feet
- trouble breathing or swallowing
- ulcers, sores, or white spots in the mouth
- unpleasant breath odor
- unusual bleeding or bruising
- unusual tiredness or weakness
- unusual weight gain or loss
- vomiting of blood
- wrinkled skin
- yellow eyes or skin
Incidence not known
- Irregular, fast or slow, or shallow breathing
- pale or blue lips, fingernails, or skin
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Difficulty having a bowel movement (stool)
- sleepiness or unusual drowsiness
- vomiting
Less common
- Acid or sour stomach
- arm or leg pain
- back pain
- belching
- burning feeling in the chest or stomach
- change in taste
- confusion about identity, place, and time
- decreased appetite
- depression
- diarrhea
- difficulty with moving
- drooping upper eyelids
- dry eyes
- flushed, dry skin
- fruit-like breath odor
- heartburn
- hyperventilation
- increased hunger
- increased thirst
- increased urination
- indigestion
- irregular heartbeats
- irritability
- irritation or soreness of the mouth
- lack or loss of strength
- loss of taste
- muscle aches
- muscle pain or stiffness
- pain in the rectum
- restlessness
- shaking
- sleeplessness
- stomach discomfort or upset
- stomach bloating
- sweating
- tenderness in the stomach area
- trouble with sleeping
- unable to sleep
- unexplained weight loss
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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