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Lazanda Warnings and Precautions

Specific Precautions and Warnings With Lazanda

Some warnings and precautions to be aware of prior to using this drug include the following:
  • Because it has a high risk for abuse and overdose, this medication is only available through a special program called the Transmucosal Immediate-Release Fentanyl (TIRF) Risk Evaluation and Mitigation Strategy (REMS) program. You, your healthcare provider, and your pharmacy must be enrolled in the program before you can receive this medication. Your healthcare provider and pharmacy will help you enroll in the program. For inpatient use (such as within a hospital), only the pharmacy (not the prescriber or the patient) needs to be enrolled.


  • This medication should only be used in people who are already on scheduled, around-the-clock opioid treatment and are tolerant to opioid effects (which means the body has become accustomed to the opioid). People who are not opioid tolerant may experience life-threatening breathing problems from even small Lazanda doses. Your healthcare provider can tell you if you are opioid tolerant.
  • If you stop taking your regular, around-the-clock opioid, you must also stop using Lazanda. You may no longer be opioid tolerant and will be at risk for potentially serious Lazanda effects.
  • Do not drive or operate heavy machinery until you know how Lazanda affects you. This medicine can make you drowsy and may significantly alter your reflexes and reaction times.
  • The amount of fentanyl in Lazanda is not the same as the amount of fentanyl in other fentanyl-containing medicines. Your healthcare provider will determine your individual dose based on your pain and side effects, not the dose of other fentanyl medicines you may be taking.
  • Like other opioid narcotics, Lazanda can cause serious, and potentially life-threatening, breathing problems, including slow, irregular, or shallow breathing. These problems are more likely to occur in people who already have breathing problems, are older, have never taken an opioid medicine, or are taking other medicines that slow breathing. Seek immediate medical attention if you have difficulty breathing while using this medicine.
  • Lazanda is particularly dangerous, and may cause death, if used by children, people who are not currently taking opioids, or people for whom the medicine is not prescribed. Do not share this medicine with someone else, even if they seem to have the same symptoms as you.
  • It is important to keep Lazanda bottles in their child-resistant containers, in a safe place out of the reach of children. Each bottle contains medicine in an amount that could be life-threatening if ingested by a child. Follow the special disposal instructions to dispose of bottles that are empty or no longer needed (see Lazanda Storage and Disposal for more information).
  • Lazanda is a narcotic medication with a significant potential for abuse (see Lazanda Abuse). Do not use the drug more frequently, or at a higher dose, than prescribed. If you or someone you know may be developing a problem with Lazanda abuse, please seek help from a healthcare provider.
  • This medication may be particularly dangerous for people with high pressure around the brain, such as those with head injuries, or people with a low or irregular heart rate. It should be used with caution in people with these conditions.
  • This medication comes with a medication guide that describes the correct way to use it. Make sure to read this medication guide each time you get your prescription filled.
  • Lazanda passes through breast milk. Therefore, if you are breastfeeding or plan to start, discuss this with your healthcare provider prior to using the drug (see Lazanda and Breastfeeding).
  • Lazanda is a pregnancy Category C medication. This means that it may not be safe for use during pregnancy, although the full risks are currently unknown (see Lazanda and Pregnancy).
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