Fentanyl, Nasal

________________________________________________________________________

KEY POINTS

• This medicine is sprayed in the nose to treat breakthrough pain in adults with cancer. Use it exactly as directed. Narcotic pain medicine may be habit-forming and can put you at risk for addiction, abuse, and misuse that may lead to overdose and death.
• This medicine may cause serious or life-threatening breathing problems, or other unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Taking this medicine with alcohol or other medicines that make you sleepy or slow your breathing can cause coma or death. Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

________________________________________________________________________

What are other names for this medicine?

Type of medicine: narcotic (opioid) pain reliever

Generic and brand names: fentanyl, nasal; Lazanda

What is this medicine used for?

This medicine is a nasal spray used to treat breakthrough pain in adults with cancer. It is not to be used to treat short-term pain such as pain after surgery or from headaches, minor injuries, dental procedures, or other causes.

This medicine is prescribed only for people who already take other narcotic pain medicines on a regular schedule. You must not take this medicine if your body is not used to narcotic pain medicines.

You must be enrolled in a special program before you can receive this medicine. Only a few healthcare providers are allowed to prescribe this medicine. Also, only a few pharmacies are allowed to sell it. Your healthcare provider will explain the program.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before using this medicine, tell your healthcare provider if you have:

• An allergic reaction to any medicine
• A blockage in the intestines, Crohn's disease, ulcerative colitis, or severe constipation
• A stroke, head injury, or brain tumor
• Addison's disease
• Glaucoma
• Heart disease or irregular heartbeat
• Liver or kidney disease
• Low blood pressure
• Lung or breathing problems such as asthma, COPD, or sleep apnea
• Mental health problems such as depression or bipolar disorder
• Pancreas or gallbladder problems
• Problems with alcohol or drug abuse
• Seizures
• Thyroid problems
• Trouble urinating or an enlarged prostate gland

Tell your provider if you have never taken narcotic pain medicines before. This medicine is to be used only by those who regularly take narcotic pain medicines.

Females of childbearing age: Tell your healthcare provider if you are pregnant or breast-feeding. Long-term use of this medicine during pregnancy can cause withdrawal symptoms in your newborn baby. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I take it?

Read the Medication Guide that comes in the medicine package when you start taking this medicine and each time you get a refill.

Check the label on the medicine for directions about your specific dose. Use this medicine exactly as your healthcare provider prescribes. Your healthcare provider will adjust your dosage until the lowest effective dosage is determined. Taking the wrong dose could be life-threatening. Talk with your healthcare provider about this.

Check with your healthcare provider before using this medicine in children under age 18.

You must wait at least 2 hours between doses of this medicine. You must never use more than 2 sprays (1 spray in each nostril) for an episode of breakthrough pain. If you have breakthrough pain more than 4 times a day, talk with your healthcare provider. You may need to have your pain medicines adjusted to better control your pain.

The amount of fentanyl in the nasal spray is not the same as the amount of fentanyl in other medicines that contain fentanyl. Do not switch from this medicine to other medicines that contain fentanyl without talking with your healthcare provider. Ask your pharmacist about anything you do not understand.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: extreme drowsiness; pinpoint pupils; confusion; trouble breathing or breathing that stops, cold and clammy skin; muscle weakness; irregular or slow heartbeat; fainting; seizures; coma.

What should I watch out for?

Do not take other medicines unless you check with your healthcare provider first. Taking this medicine with alcohol or medicines that make you sleepy or slow your breathing can cause life-threatening side effects. Tell your healthcare if you take any kind of sleeping pill, pain medicine, muscle relaxant, nausea medicine, or medicine to treat anxiety, depression, or seizures. This medicine may cause a life-threatening problem called serotonin syndrome if you take it with certain other medicines, such as migraine medicines, some cough medicines, St. John’s wort, and others. Make sure that your healthcare providers know ALL of the medicines that you take.

This medicine may cause life-threatening or fatal breathing problems. Taking this medicine for a long time may also cause a rare but very serious adrenal gland problem or decreased sex hormone levels. Talk with your healthcare provider about this.

Narcotic pain medicine may be habit-forming and can put you at risk for addiction, abuse, and misuse that may lead to overdose and death. This medicine is a controlled substance. It is illegal for you to give it to anyone else. Keep this medicine away from children. Accidental use by a child can cause death.

This medicine may make you dizzy or drowsy. Do not drive or operate machinery unless you are fully alert. You may feel dizzy or faint when you get up quickly after sitting or lying down. Getting up slowly may lessen this effect.

This medicine may make you constipated. Drinking lots of water, exercising, and taking more fiber may help. You may need to take a laxative or stool softener while taking this medicine. Talk with healthcare provider or pharmacist about this.

Your mouth may get dry. Drinking plenty of water, chewing sugarless gum, or sucking on hard sugarless candy may help to relieve dry mouth symptoms.

Adults over the age of 65 may be at greater risk for side effects from this medicine. Talk with your healthcare provider about this.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives, itching, rash, tightness in your chest, trouble breathing).

Serious (Report these to your healthcare provider right away.): Trouble breathing; slow or shallow breathing; extreme sleepiness; confusion; seizures; hallucinations (seeing or hearing things that are not there); fast, slow, or irregular heartbeat; cold, clammy skin; blue lips, fingernails, or skin; severe dizziness or fainting; trembling; pinpoint pupils; blurred vision; drowsiness, nervousness, restlessness, or weakness.

Other: Dizziness, nausea, vomiting, blurred vision, headache, fever, flushing, sweating, constipation, dry mouth, change in sexual desire or ability, mouth sores, mouth pain.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

This medicine may interact with MANY other medicines and cause life-threatening side effects. This list does not include all possible medicines that may interact. Do not start or stop ANY medicine unless you check with your healthcare provider or pharmacist first. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Tell your healthcare provider all the products you take, for example:

• Alcohol
• Antianxiety medicines such as alprazolam (Xanax), buspirone, diazepam (Valium), lorazepam (Ativan), and others
• Antibiotics such as erythromycin (E.E.S., Ery-Tab, Erythrocin), levofloxacin (Levaquin), linezolid (Zyvox), rifampin (Rifadin), telithromycin (Ketek), and others
• Anticholinergic medicines such as atropine/diphenoxylate (Lomotil), benztropine (Cogentin), dicyclomine (Bentyl), hyoscyamine (HyoMax, Levbid, Levsin), and others
• Antidepressants such as amitriptyline, duloxetine (Cymbalta), fluoxetine (Prozac), mirtazapine (Remeron), nefazodone, trazodone, and others
• Antifungal medicines such as itraconazole (Sporanox), ketoconazole (Nizoral), terbinafine (Lamisil), voriconazole (Vfend), and others
• Antihistamines such as azelastine (Astelin, Astepro), chlorpheniramine (Chlor-Trimeton), diphenhydramine (Benadryl), meclizine (Dramamine), and others
• Antipsychotic medicines such as chlorpromazine, haloperidol (Haldol), olanzapine (Zyprexa), risperidone (Risperdal), ziprasidone (Geodon), and others
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), gabapentin (Neurontin), levetiracetam (Keppra), phenytoin (Dilantin, Phenytek), and others
• Barbiturates such as butabarbital (Butisol), pentobarbital (Nembutal), phenobarbital, secobarbital (Seconal), and others
• Bladder control medicines such as darifenacin (Enablex), oxybutynin (Ditropan XL, Oxytrol), solifenacin (VESIcare), and tolterodine (Detrol)
• Bupropion (Aplenzin, Forfivo, Wellbutrin, Buproban, Zyban)
• Cimetidine (Tagamet)
• Decongestants such as oxymetazoline (Afrin, Dristan), phenylephrine (Neo-Synephrine, Sudafed PE), pseudoephedrine (Sudafed), and others
• Dexamethasone
• Dextromethorphan/quinidine (Nuedexta)
• Doxepin (Silenor)
• Eluxadoline (Viberzi)
• Flibanserin (Addyi)
• Heart medicines such as digoxin (Lanoxin), dronedarone (Multaq), quinidine, and others
• HIV medicines such as atazanavir (Reyataz), indinavir (Crixivan), lopinavir/ritonavir (Kaletra), ritonavir (Norvir), and others
• Lorcaserin (Belviq)
• MAO inhibitors such as isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate) (Do not take this medicine and an MAO inhibitor within 14 days of each other.)
• Medicines that block or may partially block the effect of narcotic pain medicines such as buprenorphine/naloxone (Bunavil, Suboxone, Zubsolv), bupropion/naltrexone (Contrave), naltrexone (ReVia, Vivitrol), and others
• Medicines to treat breathing or lung problems such as aclidinium (Tudorza), ipratropium (Atrovent), tiotropium (Spiriva), and umeclidinium (Incruse Ellipta), and others
• Migraine medicines such as almotriptan (Axert), dihydroergotamine (D.H.E. 45, Migranal), naratriptan (Amerge), sumatriptan (Alsuma, Imitrex, Sumavel), and others
• Milnacipran (Savella)
• Muscle relaxants such as baclofen (Gablofen, Lioresal), carisoprodol (Soma), cyclobenzaprine (Amrix), tizanidine (Zanaflex), and others
• Natural remedies such as garlic, ginger, ginkgo, glucosamine, St. John's wort, tryptophan, and others
• Nausea medicines such as aprepitant (Emend), dolasetron (Anzemet), ondansetron (Zofran), promethazine, and others
• Pain medicines such as buprenorphine (Buprenex, Butrans), hydrocodone/acetaminophen (Norco, Vicodin), morphine (Kadian, MS Contin), oxycodone (OxyContin, Roxicodone), and others
• Parkinson's disease medicines such as levodopa/carbidopa (Duopa, Rytary, Sinemet), entacapone (Comtan), pramipexole (Mirapex), rasagiline (Azilect), and others
• Paroxetine (Brisdelle, Paxil, Pexeva)
• Products that contain methylene blue (Hyophen, Prosed DS, Urophen, Uta)
• Sleeping pills such as eszopiclone (Lunesta), triazolam (Halcion), zaleplon (Sonata), zolpidem (Ambien, Edluar, Intermezzo), and others
• Tedizolid (Sivextro)

Do not drink alcohol while you are taking this medicine.

Ask your healthcare provider or pharmacist if you need to avoid products that contain grapefruit, Seville oranges, and tangelos while you are taking this medicine. These fruits and juices can affect the way this medicine works and may increase your risk of serious side effects.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Keep the medicine in the sealed child-proof pouch until you are ready to use it. Store it at room temperature. Protect from heat, high humidity, and bright light.

Dispose of the medicine bottle and start a new one if:

• You have used 8 sprays from the bottle, or
• You have not used the medicine in 60 days or more.

  ---

This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.