Lazanda

Fentanyl is a prescription medication used to treat breakthrough cancer pain. It can also be used as part of surgical anesthesia.

Fentanyl belongs to a group of drugs called opioid agonists or narcotic pain medications. These work by changing the way the brain and nervous system respond to pain.

This medication comes in nasal spray, sublingual spray, sublingual (buccal) tablet, lozenge, and transdermal patch forms. The dose and frequency of administration will vary with the indication and dosage form.

This medication is also available in an injectable form to be given directly into a vein (IV) or the muscle (IM) by a healthcare professional.

Common side effects of fentanyl include difficulty breathing, nausea, upset stomach, and difficulty urinating.

Fentanyl can also cause changes in vision, drowsiness, and dizziness. Do not drive or operate heavy machinery until you know how fentanyl affects you.

Lazanda is part of the drug class:

• Opioid anesthetics

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• Antihistamines
• Barbiturates such as phenobarbital (Luminal)
• Buprenorphine (Buprenex, Subutex, in Suboxone)
• Butorphanol (Stadol)
• Carbamazepine (Carbatrol, Epitol, Tegretol)
• Efavirenz (in Atripla, Sustiva)
• Modafinil (Provigil)
• Nalbuphine (Nubain)
• Nalmefene (Revex)
• Naloxone (Narcan)
• Nevirapine (Viramune)
• Oral steroids such as dexamethasone (Decadron, Dexpak), methylprednisolone (Medrol), and prednisone
• Oxcarbazepine (Trileptal)
• Other pain medications
• Pentazocine (Talwin)
• Phenytoin (Dilantin, Phenytek)
• Pioglitazone (Actos, in Actoplus Met, in Duetact)
• Rifabutin (Mycobutin)
• Rifampin (Rifadin, Rimactane, in Rifamate, in Rifater)
• Sedatives, sleeping pills, or tranquilizers

Also tell your doctor or pharmacist if you are taking any of the following medications or if you have stopped taking them within the past two weeks: monoamine oxidase (MAO) inhibitors including isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate).

This is not a complete list of fentanyl drug interactions. Ask your doctor or pharmacist for more information.

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

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Fentanyl falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

If you take too much fentanyl, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If fentanyl is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

Nasal Spray:

WARNING: RISK OF RESPIRATORY DEPRESSION, MEDICATION ERRORS, ABUSE POTENTIAL

See full prescribing information for complete boxed warning.

Due to the risk of fatal respiratory depression, Lazanda is contraindicated in opioid non-tolerant patients and in management of acute or postoperative pain, including headache/migraines.

Keep out of reach of children.

Use with CYP3A4 inhibitors may cause fatal respiratory depression.

When prescribing, do not convert patients on a mcg per mcg basis from any other oral transmucosal fentanyl product to Lazanda.

When dispensing, do not substitute with any other fentanyl products.

Contains fentanyl, a Schedule II controlled substance with abuse liability similar to other opioid analgesics.

Lazanda is available only through a restricted program called the TIRF REMS Access program. Outpatients, healthcare professionals who prescribe to outpatients, pharmacies, and distributors are required to enroll in the program.

Sublingual Spray:

WARNING: RISK OF RESPIRATORY DEPRESSION, MEDICATION ERRORS, ABUSE POTENTIAL

See full prescribing information for complete boxed warning.

Due to the risk of fatal respiratory depression, SUBSYS is contraindicated in opioid non-tolerant patients and in management of acute or postoperative pain, including headache/migraines.

Keep out of reach of children.

Use with CYP3A4 inhibitors may cause fatal respiratory depression.

When prescribing, do not convert patients on a mcg per mcg basis from any other oral transmucosal fentanyl product to SUBSYS.

When dispensing, do not substitute with any other fentanyl products.

Contains fentanyl, a Schedule II controlled substance with abuse liability similar to other opioid analgesics.

SUBSYS is available only through a restricted program called the TIRF REMS Access program. Outpatients, healthcare professionals who prescribe to outpatients, pharmacies, and distributors are required to enroll in the program.

Sublingual tablets:

WARNING: RISK OF RESPIRATORY DEPRESSION, MEDICATION ERRORS, ABUSE POTENTIAL

See full prescribing information for complete boxed warning.

Due to the risk of fatal respiratory depression, fentanyl sublingual (buccal) tablets are contraindicated in opioid non-tolerant patients and in management of acute or postoperative pain, including headache/migraines.

Keep out of reach of children.

Use with CYP3A4 inhibitors may cause fatal respiratory depression.

When prescribing, do not convert patients on a mcg per mcg basis from any other oral transmucosal fentanyl product to fentanyl sublingual tablets.

When dispensing, do not substitute with any other fentanyl products.

Contains fentanyl, a Schedule II controlled substance with abuse liability similar to other opioid analgesics.

Fentanyl sublingual tablets are available only through a restricted program called the TIRF REMS Access program. Outpatients, healthcare professionals who prescribe to outpatients, pharmacies, and distributors are required to enroll in the program.

Oral lozenges:

WARNING: RISK OF RESPIRATORY DEPRESSION, MEDICATION ERRORS, ABUSE POTENTIAL

See full prescribing information for complete boxed warning.

Due to the risk of fatal respiratory depression, fentanyl oral transmucosal lozenge is contraindicated in opioid non-tolerant patients and in management of acute or postoperative pain, including headache/migraines.

Keep out of reach of children.

Use with CYP3A4 inhibitors may cause fatal respiratory depression.

When prescribing, do not convert patients on a mcg per mcg basis from any other oral transmucosal fentanyl product to fentanyl oral transmucosal lozenge.

When dispensing, do not substitute with any other fentanyl products.

Contains fentanyl, a Schedule II controlled substance with abuse liability similar to other opioid analgesics.

Fentanyl oral transmucosal lozenge is available only through a restricted program called the TIRF REMS Access program. Outpatients, healthcare professionals who prescribe to outpatients, pharmacies, and distributors are required to enroll in the program.

Transdermal systems:

WARNING: ADDICTION, ABUSE, and MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL EXPOSURE; NEONATAL OPIOID WITHDRAWAL SYNDROME; CYTOCHROME P450 3A4 INTERACTION, and EXPOSURE TO HEAT

Fentanyl transdermal system exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient's risk before prescribing, and monitor regularly for development of these behaviors or conditions.

Serious, life-threatening, or fatal respiratory depression may occur. Monitor closely, especially upon initiation or following a dose increase.

Accidental exposure to fentanyl transdermal system, especially in children, can result in fatal overdose of fentanyl.

Prolonged use of fentanyl transdermal system during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.

Initiation of CYP 3A4 inhibitors (or discontinuation of CYP 3A4 inducers) can result in a fatal overdose of fentanyl from fentanyl transdermal system.

Avoid exposing the fentanyl transdermal system application site and surrounding area to direct external heat sources. Temperature dependent increases in fentanyl release from the system may result in overdose and death.

• It is used to ease pain.
• This medicine is not for mild pain or pain that only lasts a short time (like headaches, toothaches, or pain after surgery).

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Very bad dizziness or passing out.
• Feeling confused.
• Very upset stomach or throwing up.
• Very hard stools (constipation).
• Very bad belly pain.
• Feeling very tired or weak.
• Trouble breathing, slow breathing, or shallow breathing.
• Noisy breathing.
• Shortness of breath.
• Chest pain.
• Fast or slow heartbeat.
• Feeling very sleepy.
• Seizures.
• Very bad irritation where Lazanda (fentanyl nasal spray) is used.
• A very bad and sometimes deadly health problem called serotonin syndrome may happen if you take this medicine with drugs for depression, migraines, or certain other drugs. Call your doctor right away if you have agitation; change in balance; confusion; hallucinations; fever; fast or abnormal heartbeat; flushing; muscle twitching or stiffness; seizures; shivering or shaking; sweating a lot; very bad diarrhea, upset stomach, or throwing up; or very bad headache.
• Taking an opioid drug like Lazanda may lead to a rare but very bad adrenal gland problem. Call your doctor right away if you have very bad dizziness or passing out, very bad upset stomach or throwing up, or if you feel less hungry, very tired, or very weak.
• Long-term use of an opioid drug like this medicine may lead to lower sex hormone levels. This may lead to signs like change in sex ability in men, no menstrual period in women, lowered interest in sex, or fertility problems. Call your doctor if you have any of these signs.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Dizziness.
• Dry mouth.
• Upset stomach or throwing up.
• Hard stools (constipation).
• Loose stools (diarrhea).
• Headache.
• Feeling sleepy.
• Feeling tired or weak.
• Feeling cold.
• Not hungry.
• Not able to sleep.
• Sweating a lot.
• Belly pain.
• Irritation where Lazanda is used.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.