Do 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.
Help for your breakthrough cancer pain
Lazanda is a nasal spray containing fentanyl (a type of pain medicine called an opioid). It is used to manage breakthrough cancer pain (BTPc) in adults with cancer (18 years of age and older) who are already routinely taking other opioid pain medicines around the clock for their underlying cancer pain.
References: 1. Watts P, Smith A, Perelman M. Nasal delivery of fentanyl. Drug Deliv Transl Res. 2013;3:75-83. 2. Fisher A, Watling M, Smith A, Knight A. Pharmacokinetics and relative bioavailability of fentanyl pectin nasal spray 100–800 μg in healthy volunteers. Int J Clin Pharmacol Ther. 2010;48:860-867. 3. Lazanda nasal spray [prescribing information]. Northbrook, IL: West Therapeutic Development, LLC, 2018. 4. Portenoy RK, Burton AW, Gabrail N, Taylor D; on behalf of the Fentanyl Pectin Nasal Spray 043 Study Group. A multicenter, placebo-controlled, double-blind, multiple-crossover study of Fentanyl Pectin Nasal Spray (FPNS) in the treatment of breakthrough cancer pain. Pain. 2010;151:617-624. 5. Smith HS. Considerations in selecting rapid-onset opioids for the management of breakthrough pain. J Pain Res. 2013;6:189-200. 6. Castile J, Cheng Y-H, Simmons B, Perelman M, Smith A, Watts P. Development of in vitro models to demonstrate the ability of PecSys®, an in situ nasal gelling technology, to reduce nasal run-off and drip. Drug Dev Ind Pharm. 2013;39:816-824. 7. Radbruch L, Torres LM, Ellershaw JE, et al. Long-term tolerability, efficacy and acceptability of fentanyl pectin nasal spray for breakthrough cancer pain. Support Care Cancer. 2012;20:565-573. 8. Portenoy RK, Raffaeli W, Torres LM, et al; on behalf of the Fentanyl Nasal Spray Study 045 Investigators Group. Long-term safety, tolerability, and consistency of effect of fentanyl pectin nasal spray for breakthrough cancer pain in opioid-tolerant patients. J Opioid Manag. 2010;6:319-328. 9. Deandrea S, Corli O, Consonni D, Villani W, Greco MT, Apolone G. Prevalence of breakthrough cancer pain: a systematic review and a pooled analysis of published literature. J Pain Symptom Manage. 2014;47(1):57-76. 10. Zeppatella G. Breakthrough pain in cancer patients. Clin Oncol. 2011;23:393-398. 11. Mercadante, Sebastiano. Breakthrough pain in cancer patients: prevalence, mechanisms and treatment options. Current Opinion in Anesthesiology. 2015; 28(5):559-564. 12. Fallon M, Reale C, Davies A, Lux AE, Kumar K, Stachowiak A, Galvez R; Fentanyl Nasal Spray Study 044 Investigators Group. Efficacy and safety of fentanyl pectin nasal spray compared with immediate-release morphine sulfate tablets in the treatment of breakthrough cancer pain: a multicenter, randomized, controlled, double-blind, double-dummy multiple-crossover study. J Support Oncol. 2011 Nov-Dec;9(6):224-31.13. Actiq [prescribing information]. North Wales, PA: Cephalon, Inc., 2016. 14. Bellm LA, Cunningham G, Durnell L, et al. Defining clinically meaningful outcomes in the evaluation of new treatments for oral mucositis: oral mucositis patient provider advisory board. Cancer Invest. 2002;20:793-800. 15. Davies A, Sitte T, Elsner F, et al. Consistency of efficacy, patient acceptability, and nasal tolerability of fentanyl pectin nasal spray compared with immediate-release morphine sulfate in breakthrough cancer pain. J Pain Symptom Manage. 2011;41:358-366. 16. American Society of Clinical Oncology. Dry mouth or xerostomia. www.cancer.net/navigating-cancer-care/side-effects/dry-mouth-or-xerostomia. Accessed April 16, 2014. 17. Grassin-Delyle S, Buenestado A, Naline E, et al. Intranasal drug delivery: an efficient and non-invasive route for systemic administration focus on opioids. Pharmacol Ther. 2012;134:366-379. 18. European Oncology Nursing Society, Breakthrough pain cancer guidelines 2013: European Oncology Nursing Society guidelines. 2013:1-34.
LAZANDA® (Fentanyl) Nasal Spray CII
What is LAZANDA?
LAZANDA (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.
You should not use LAZANDA unless you are regularly using another opioid medicine around-the-clock and your body is used to these medicines (this means that you are opioid tolerant). You should ask your healthcare provider if you are opioid tolerant. You must continue to take your regular around-the-clock opioid medication while taking LAZANDA.
IMPORTANT SAFETY INFORMATION
Do not use LAZANDA unless you are regularly using another opioid pain medicine around-the-clock for your cancer pain.
Do not use for 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.
LAZANDA is only available through a restricted distribution program called the TIRF REMS ACCESS program.
To receive LAZANDA, you must:
- talk to your healthcare provider about LAZANDA
- understand the benefits and risks of LAZANDA
- agree to all of the instructions for using LAZANDA
- sign the Patient-Prescriber Agreement form which means that you understand all the risks and benefits of LAZANDA and how to use, safeguard, store, and dispose of LAZANDA
Keep Lazanda in a safe place away from children and from anyone for whom it has not been prescribed.
Get emergency 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.
HOW TO TAKE LAZANDA
Take Lazanda exactly as prescribed by your healthcare provider.
ALL patients start with one 100 mcg dose in one nostril. Talk to your healthcare provider if your dose of Lazanda does not relieve your breakthrough cancer pain. Always follow his or her instructions.
Do not change your dose of Lazanda unless your healthcare provider tells you to.
Your healthcare provider will determine the lowest effective dosage for your pain.
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 take Lazanda if:
- you are not opioid tolerant. Opioid tolerant means that you are already taking other opioid pain medicines around-the-clock, have been taking them for at least one week, and your body is used to these medicines.
- 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.
- you have severe asthma, trouble breathing or other lung problems.
- you have a bowel blockage or have narrowing of the stomach or intestines.
- you are allergic to fentanyl or any of the ingredients in Lazanda.
WARNINGS AND PRECAUTIONS
Life-Threatening Breathing Problems
LAZANDA can cause serious breathing problems that can be life-threatening and if not treated, can cause death. The risk is highest when you are being started on LAZANDA and when your dose is being increased. It is essential to follow the proper instructions for dosing and dose increase. If you overestimate the dose, it can cause a fatal overdose. LAZANDA can cause death if it is taken by someone for whom it has not been prescribed or if it is taken by someone who is not opioid tolerant. Accidentally taking or being exposed to even one dose of LAZANDA, especially by children, can cause life-threatening breathing problems and a fatal overdose.
High Risk of Overdose in Children
Death has occurred in children who accidentally took drugs containing fentanyl. You and your caregiver must know that LAZANDA contains fentanyl in an amount which can cause death in children. Always keep LAZANDA in a safe place away from children and anyone for whom it has not been prescribed.
Risk of Using or Discontinuing Certain Medications While Taking LAZANDA
Using or discontinuing certain medicines while taking LAZANDA may cause fatal respiratory depression. Do not take any other 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. Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins and herbal supplements. Sometimes, the doses of certain medicines and LAZANDA need to be changed if used together.
Risk of Medication Errors
The amount of fentanyl delivered by a dose of LAZANDA is not the same as in other medicines that contain fentanyl. DO NOT substitute any other fentanyl product instead of LAZANDA and DO NOT switch to any other fentanyl product in place of LAZANDA. Substitution of LAZANDA for any other fentanyl product can cause a fatal overdose. Your healthcare provider will start you on ONE 100 mcg spray.
Risk of Abuse or Addiction
LAZANDA contains fentanyl which is a Schedule II controlled substance. LAZANDA carries the risk of abuse, addiction and misuse. 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 illness. Tell your healthcare provider if you have a past or present drinking problem (alcoholism), or a family history of drinking problems. Tell your healthcare provider if you have a past or present problem with drug abuse or addiction, or a family history of drug abuse or addiction. Tell your healthcare provider if you have mental health problems such as depression, hallucinations or confusion.
Transmucosal Immediate Release Fentanyl (TIRF) Risk Evaluation and Mitigation Strategy (REMS) Access Program
Because of the risk of misuse, abuse, addiction and overdose, LAZANDA is only available through the TIRF REMS Access program. To receive LAZANDA you must talk to your healthcare provider, understand the benefits and risks of LAZANDA, agree to all of the instructions and sign the Patient-Prescriber Agreement form.
Risk to Your Newborn Baby
Prolonged use of LAZANDA during pregnancy can cause withdrawal effects in your newborn baby that could be life-threatening if not recognized and treated. Tell your healthcare provider if you are pregnant or planning to become pregnant.
Risk of Life-Threatening Breathing Problems in Patients with Asthma or Lung Problems or in Weakened Condition
LAZANDA can cause life-threatening breathing problems. Tell your healthcare provider if you have breathing or lung problems such as asthma, wheezing, shortness of breath or any other lung (pulmonary, respiratory) problems.
Risk of Serious or Life-Threatening Medical Problems if Taken with Medicines that Treat Psychiatric Disorders Like Depression
Some medicines may cause serious or life-threatening medical problems when taken with LAZANDA. Do not take any other 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 like anti-depressants, anti-anxiety medicines or tranquilizers. Tell your healthcare provider about all the medicines you take.
LAZANDA poses a risk of problems related to the adrenal glands which produce a variety of hormones that your body needs.
Risk of Severe Decreased Blood Pressure
LAZANDA can cause or increase severe low blood pressure that can make you feel dizzy or lightheaded if you get up too fast from sitting or lying down. Tell your doctor if you have low blood pressure.
Risk to Patients with a Head Injury or Brain Problem
LAZANDA poses risk to patients who have or have had a head injury or brain problem. Tell your healthcare provider if you have or have had a head injury, a brain tumor or other brain problems.
Risk to Patients with Bowel or Stomach Problems
LAZANDA poses a risk to patients with a bowel blockage or narrowing of the stomach or intestines.
Tell your doctor if you have any stomach or bowel problems.
Risk of Seizures in Patients with Seizure Disorders
LAZANDA may increase the incidence of seizures in patients with seizure disorders. Tell your healthcare provider if you have a history of seizures.
Risks of Driving and Operating Machinery
Do not drive, operate heavy machinery or do other dangerous activities if you feel sleepy or dizzy while taking LAZANDA. Ask your healthcare provider when it is okay to do these activities.
Risk to Patients with a Slow Heart Rate or other Heart Problems
Tell your healthcare provider if you have a slow heart rate or other heart problems.
POSSIBLE SIDE EFFECTS OF LAZANDA:
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.
Call your healthcare provider or get emergency help right away if you:
Have trouble breathing, shortness of breath with minimal exertion or at rest, fast heartbeat, chest pain, swelling of your face, tongue or throat, extreme drowsiness, light-headedness when changing positions, feeling faint, agitation, high body temperature, trouble walking, stiff muscles, or mental changes such as confusion, hallucinations, or extreme sleepiness.
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.
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.
For more information, ask your doctor or pharmacist or visit www.Lazanda.com for the Medication Guide and the complete full Prescribing Information for Lazanda, which includes a boxed warning.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Tell your health care provider if you have a history of:
- troubled breathing or lung problems such as asthma, wheezing or shortness of breath
- head injury, seizures
- slow heart rate or other heart problems
- low blood pressure
- abuse of street or prescription drugs, alcohol addiction or mental health problems
- mental problems [including major depression, confusion or hallucinations (seeing or hearing things that are not there)]
- liver, kidney or thyroid problems
- pancreas or gallbladder problems
Tell your healthcare provider if:
- You are pregnant or planning to become pregnant. Prolonged use of Lazanda during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.
- You are breastfeeding. Lazanda passes into breast milk and could harm your baby. Do not use Lazanda while breastfeeding.
- You are taking prescription, over-the-counter medicines, vitamins or herbal supplements. Taking Lazanda with certain other medicines can cause serious side effects that could lead to death.
DO NOT Drive or operate heavy machinery until you know how Lazanda affects you. Lazanda can make you sleepy, dizzy or lightheaded.
DO NOT Drink alcohol or use prescription or over-the-counter medicines that contain alcohol. Using products that contain alcohol during treatment with Lazanda may cause you to overdose and die.
DO NOT Switch from Lazanda to other medicines that contain fentanyl without talking to your healthcare provider. The amount of fentanyl in a dose of Lazanda is not the same as in other medicines that contain fentanyl. Your healthcare provider will prescribe a starting dose of Lazanda that may be different than other fentanyl containing medicines you may have been taking.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.