IMPORTANT SAFETY INFORMATIONLazanda (La-ZAN-da) (fentanyl) nasal spray is a prescription medicine used to manage breakthrough pain in adults with cancer (18 years of age and older) who are already routinely taking other opioid pain medicines around-the-clock for cancer pain.
Do not use Lazanda unless you are regularly using another opioid pain medicine around-the-clock for your cancer pain and your body is used to these medicines (this means that you are opioid tolerant). You can ask your healthcare provider if you are opioid tolerant.
Keep Lazanda in a safe place away from children.
Get emergency medical help right away if:
- a child takes Lazanda. Lazanda can cause an overdose and death in any child who takes it
- an adult who has not been prescribed Lazanda takes it
- an adult who is not already taking opioids around-the-clock takes Lazanda
These are medical emergencies that can cause death.
Lazanda can cause life-threatening breathing problems that can lead to death:
- Do not take Lazanda if you are not opioid tolerant. (Opioid tolerant means that you are already taking other opioid (narcotic) pain medicines around-the-clock for your cancer pain and your body is used to these medicines);.
- If you stop taking your around-the-clock opioid pain medicine for your cancer, you must stop taking Lazanda. You may no longer be opioid tolerant. Talk to your healthcare provider about how to treat your pain.
- Take Lazanda exactly as prescribed by your healthcare provider. You must not take more than 1 dose of Lazanda for each episode of breakthrough cancer pain. You must wait two hours before treating a new episode of breakthrough cancer pain with Lazanda.
- Do not switch from Lazanda to other medicines that contain fentanyl without talking with your healthcare provider. The amount of fentanyl in a dose of Lazanda is not the same as the amount of fentanyl in other medicines that contain fentanyl. Your healthcare provider will prescribe a starting dose of Lazanda that may be different than other fentanyl-containing medicine you may have been taking.
- Never give Lazanda to anyone else, even if they have the same symptoms you have. It may harm them or even cause death.
You should not take Lazanda
- if you are not opioid tolerant.
- if you have short-term pain that you would expect to go away in a few days, such as: pain after surgery, headache or migraine, or dental pain;
- if you are allergic to fentanyl or any of the ingredients in Lazanda.
Lazanda is available only through a program called the TIRF REMS ACCESS program. Talk to your healthcare provider for more information.
Before taking Lazanda, tell your healthcare provider if you:
- Do not take any medicine while using Lazanda until you have talked to your healthcare provider. Your healthcare provider will tell you if it is safe to take other medicines while you are using Lazanda.
- Be very careful about taking other medicines that may make you sleepy, such as other pain medicines, anti-depressants, sleeping pills, anti-anxiety medicines, anti-histamines, or tranquilizers.
- Do not drive, operate heavy machinery, or do other dangerous activities if you feel sleepy or dizzy while taking Lazanda.
- Do not drink alcohol or grapefruit juice while using Lazanda.
Possible side effects of Lazanda:
- Breathing problems that can become life-threatening.
Call your healthcare provider or get emergency medical help right away if you:
- have trouble breathing
- have drowsiness with slowed breathing
- have shallow breathing (little chest movement with breathing)
- feel faint, very dizzy, confused, or have other unusual symptoms
- Decreased blood pressure. This can make you feel dizzy or lightheaded if you get up too fast from sitting or lying down.
- Physical dependence. Do not stop taking Lazanda or any other opioid without talking to your healthcare provider. You could become sick with uncomfortable withdrawal symptoms because your body has become used to these medicines. Physical dependency is not the same as drug addiction.
- A chance of abuse or addiction. The chance is higher if you are or have ever been addicted to or abused other medicines, street drugs, or alcohol, or if you have a history of mental problems.
These symptoms can be a sign that you have taken too much Lazanda or the dose is too high for you. These symptoms may lead to serious problems or death if not treated right away. If you have any of these symptoms, do not take any more Lazanda until you have talked to your healthcare provider.
The most common side effects of Lazanda seen in clinical studies are:
Constipation (not often enough or hard bowel movements) is a very common side effect of pain medicines (opioids) including Lazanda and is unlikely to go away without treatment. Talk to your healthcare provider about dietary changes and the use of laxatives (medicines to treat constipation) and stool softeners to prevent or treat constipation while taking Lazanda.
These are not all the possible side effects of Lazanda.
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
This is only a brief summary of important information about Lazanda. For more information ask your doctor or pharmacist; or visit www.lazanda.com for the Medication Guide and the complete physician Prescribing Information for Lazanda, which includes a Boxed Warning on the potential for abuse and importance of proper patient selection.
Archimedes encourages the reporting of adverse experiences. Contact Archimedes Pharma (866-435-6775), or the FDA (visit www.fda.gov/medwatch; or call 1-800-FDA-1088).
Archimedes Pharma US Inc. • One Crossroads Drive • Bedminster NJ 07921
Lazanda® is a registered trademark of Archimedes Development Ltd.
© 2012 Archimedes Development Ltd.
All rights reserved.
V Jan 2012