Lazanda nasal spray contains fentanyl, an opioid pain medication. An opioid is sometimes called a narcotic.

Lazanda nasal spray is used to treat "breakthrough" cancer pain. It is used together with other non-fentanyl narcotic pain medicine that is used around the clock.

This medication is not for treating pain that isn't cancer-related, such as pain from surgery, dental work, or migraine headaches.

Unless given in a hospital, Lazanda is available use only under a special program. You must be registered in the program and understand the risks and benefits of using this medication.

Do not use Lazanda unless you are already being treated with a similar opioid pain medicine and your body is tolerant to it. Do not use Lazanda to replace any other form of fentanyl. If you switch from another form of fentanyl, you will not use the same dose.

Fentanyl can slow or stop your breathing, and may be habit-forming. Use only your prescribed dose. Never share this medicine with another person.

Lazanda is not for treating pain that isn't cancer-related, such as pain from surgery, dental work, or migraine headaches. MISUSE OF NARCOTIC PAIN MEDICATION CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription

Many other drugs can interact with fentanyl. Tell your doctor about all your medications and any you start or stop using during treatment with Lazanda.

Keep Lazanda out of the reach of children. The amount of fentanyl in each bottle of Lazanda can be fatal to a child.

Do not use Lazanda to replace any other form of fentanyl, such as Abstral, Actiq, Fentora, Onsolis, Duragesic, or generic brands of fentanyl (injection, skin patch, dissolving film, or "lollipop" device).

Fentanyl may be habit-forming, even at regular doses. Never share this medicine with another person. MISUSE OF NARCOTIC PAIN MEDICATION CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription. Selling or giving away Lazanda is against the law.

The usual starting dose of Lazanda is 1 single spray into 1 nostril. Your doctor may change your dose. Follow all directions on your prescription label. Fentanyl can slow or stop your breathing. Never use Lazanda in larger amounts, or for longer than prescribed. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

Keep using your around-the-clock narcotic pain medicine but never use Lazanda together with a second form of fentanyl.

If you switch to Lazanda from another form of fentanyl, you will not use the same dose. You must start with the lowest dose (100 micrograms).

Do not use more than one dose for each episode of breakthrough cancer pain.

Call your doctor if you still have pain within 30 minutes after using the nasal spray. Do not use the nasal spray more than 4 times in 24 hours. You must wait at least 2 hours after your last dose of Lazanda before you can treat a new pain episode.

Do not treat more than 4 pain episodes per day with Lazanda. Call your doctor if you have breakthrough pain more than 4 times in one day.

Do not stop using this medicine suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using this medicine.

Keep out of the reach of children. The amount of fentanyl in each bottle of Lazanda can be fatal to a child.

Do not use a bottle of Lazanda that has not been used for 5 days or longer. Once you have primed a spray bottle, throw it away after 14 days, even if there is still medicine left in it.

Store at room temperature, away from heat and moisture. Keep the bottle tightly closed and stored in the child-resistant container when not in use.

Keep track of your medicine. Fentanyl is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

Do not keep leftover opioid medication. Just one dose can cause death in someone using this medicine accidentally or improperly. Ask your pharmacist where to locate a drug take-back disposal program. If there is no take-back program, flush the unused medicine down the toilet.

Do not use Lazanda 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.

Tell your doctor if there are children living in the home where you will store this medicine. Keep out of the reach of children. The amount of fentanyl in Lazanda can be fatal to a child.

To make sure Lazanda is safe for you, tell your doctor if you have ever had:

• breathing problems, sleep apnea;

• a head injury, brain tumor, or seizures;

• drug or alcohol addiction, mental illness;

• urination problems;

• liver or kidney disease;

• a blockage in your stomach or intestines; or

• problems with your gallbladder, pancreas, or thyroid.

If you use Lazanda while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on habit-forming medicine may need medical treatment for several weeks. Tell your doctor if you are pregnant or plan to become pregnant.

Lazanda may also cause drowsiness, breathing problems, or withdrawal symptoms in a nursing infant. Do not breastfeed while you are using this medicine.

Do not give this medication to anyone under 18 years old.

Since Lazanda is used for pain, you are not likely to miss a dose. Skip any missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. A fentanyl overdose can be fatal, especially in a child or other person using the medicine without a prescription. Overdose symptoms may include extreme drowsiness, weak pulse, fainting, and slow breathing (breathing may stop).

Do not drink alcohol. Dangerous side effects or death could occur.

Fentanyl may impair your thinking or reactions. Avoid driving or operating machinery until you know how this medicine will affect you. Dizziness or severe drowsiness can cause falls or other accidents.

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

Get emergency medical help if you have signs of an allergic reaction to Lazanda: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Like other narcotic medicines, fentanyl can slow your breathing. Death may occur if breathing becomes too weak. A person caring for you should seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.

Call your doctor at once if you have:

• slow heart rate, sighing, shallow breathing, breathing that stops during sleep;

• confusion, extreme fear, unusual thoughts or behavior;

• dizziness, feeling like you might pass out; or

• worsening tiredness or weakness.

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Serious side effects may be more likely in older adults and those who are malnourished or debilitated.

Long-term use of opioid medication may affect fertility (ability to have children) in men or women. It is not known whether opioid effects on fertility are permanent.

Common Lazanda side effects may include:

• nausea, vomiting, constipation; or

• fever.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Some drugs can raise or lower your blood levels of fentanyl, which may cause side effects or make Lazanda less effective. Tell your doctor if you also use certain antibiotics, antifungal medications, heart or blood pressure medications, or medicines to treat HIV or AIDS.

Fentanyl can interact with many other drugs and cause dangerous side effects or death. Be sure your doctor knows if you also use:

• other narcotic medications - opioid pain medicine or prescription cough medicine;

• a sedative like Valium - diazepam, alprazolam, lorazepam, Ativan, Klonopin, Restoril, Tranxene, Versed, Xanax, and others;

• drugs that make you sleepy or slow your breathing - a sleeping pill, muscle relaxer, tranquilizer, antidepressant, or antipsychotic medicine;

• drugs that affect serotonin levels in your body - medicine for depression, Parkinson's disease, migraine headaches, serious infections, or prevention of nausea and vomiting.

This list is not complete. Other drugs may interact with fentanyl, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.