Transmucosal fentanyl: the advantages of nasal delivery
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Important Safety Information
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.
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.
Always keep Lazanda in a safe place away from children and from anyone for whom it has not been prescribed.
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.
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.
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:
- have trouble breathing or lung problems such as asthma, wheezing, or shortness of breath
- have or had a head injury or brain problem
- have liver or kidney problems
- have seizures
- have a slow heart rate or other heart problems
- have low blood pressure
- have mental health problems including major depression, schizophrenia, or hallucinations (seeing or hearing things that are not there)
- have a past or present drinking problem (alcoholism), or a family history of drinking problems
- have a past or present drug abuse problem or addiction problem, or a family history of a drug abuse problem or addiction problem
- have any other medical conditions
- are pregnant or planning to become pregnant. Lazanda may cause serious harm to your unborn baby
- are breastfeeding or plan to breastfeed. Lazanda can pass into your breast milk. It can cause serious harm to your baby. Do not use Lazanda while breastfeeding.
Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Some medicines may cause serious or life-threatening medical problems when taken with Lazanda. Sometimes, the doses of certain medicines and Lazanda need to be changed if used together.
- 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. Ask your healthcare provider when it is okay to do these activities.
- Do not drink alcohol while using Lazanda. It can increase your chances of getting dangerous side effects.
- Do not drink 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
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.
- 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.
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.
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. You can also report side effects to Depomed by calling 1-866-458-6389.
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*Co-pay Help Terms and Conditions
The Lazanda Signature Support program is available to help patients with any issues they may have in obtaining Lazanda, including prior authorizations from their insurance companies as well as how to save on their out-of-pocket costs for Lazanda.†
Here is how the program works:
- For new patients, you will receive up to 10 FREE bottles of Lazanda (equal to 80 sprays of medication) for a $0 co-pay. This offer is good for up to 5 bottles per fill, and up to 3 refills during the first month of treatment
- For existing patients and for new patients with an initial prescription of over 5 bottles and for subsequent fills after the first month, you will pay no more than $5 for your prescription (up to $625 off)
- There is a limit of 1 day between fills
- You can use the card an unlimited number of times up through and including June 30, 2015, after which the offer expires
- This program can be redeemed at a retail or specialty pharmacy
- The card is accepted at most pharmacies in the United States. If your pharmacy does not accept the card, call 1‑855‑859‑2970
- Your doctor may ask you to fill your prescription for Lazanda directly through the Signature Support program or through a specialty pharmacy. As a new patient, you will still receive your first month (up to 10 bottles) of Lazanda for a $0 co-pay (up to 3 fills during the first month) and $5 for each additional month (up to $625 off)
- Once you download your card, you do not need to do anything to activate it. Simply present the co-pay savings card and a valid prescription for Lazanda at your pharmacy
Terms and Conditions
- Patients who are cash paying or are covered by Medicare, Medicaid, or any other state- or federally-funded benefit program are excluded
- Patients must be 18 years of age or older
- This program cannot be combined with any other programs, offers, or discounts
- Offer expires June 30, 2015
Click here to download your co-pay savings card. You can also obtain a card at your physician’s office. If you have questions about using the co-pay savings card, please call 1‑855‑859‑2970. For benefit verification or help with prior authorization, please call Signature Support at 1‑855‑775‑2762 toll-free or email SignatureSupport@Depomed.com.
Patient instructions: Redeem this co-pay savings card ONLY when it is accompanied by a valid prescription for Lazanda. This offer is not valid for cash-paying patients or prescriptions covered by or submitted for reimbursement under Medicaid, Medicare, or similar federal or state programs. Please see specific eligibility requirements above.
If you are a new patient with a prescription for 5 bottles or less, please present your co-pay card for a $0 co-pay that is good for up to 3 refills during the first month of treatment, for a total of up to 10 bottles. If your prescription is for over 5 bottles of Lazanda, you pay $5 (up to a maximum benefit of $625) for the first and each additional month.
Pharmacist instructions for a patient with an eligible third party ($0 co-pay): Submit the claim to the primary third-party payer first, then submit the balance due to Therapy First Plus as a secondary payer as co-pay using a valid Other Coverage Code: use 8 to reduce the co-pay expense, or 3 if primary has denied coverage. The patient can receive up to 10 bottles at no more than 5 bottles per fill, at a $0 co-pay for the first 30 days, good for up to 3 fills. If the patient’s insurance requires prior authorization, please initiate the prior authorization process by calling, or instructing the patient to call, the Signature Support line at 1-855-775-2762; this will help the patient to gain access to Lazanda and to save on additional prescriptions. Reimbursement will be received from Therapy First Plus. For any questions regarding Therapy First Plus online processing, please call the Help Desk at 1‑800‑422‑5604.
Eligibility: This offer is valid for commercially insured patients who are 18 years of age or older. Offer expires on June 30, 2015. This program cannot be combined with any other programs, offers, or discounts. Program managed by PSKW, LLC on behalf of Depomed, Inc. Void where taxed, restricted, or prohibited by law. Product dispensed pursuant to program rules and federal and state laws. The parties reserve the right to amend or end this program at any time without notice.
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- †Available to commercially insured patients only. Cash-paying patients and patients covered by Medicare, Medicaid, or any other state- or federally-funded benefit program are excluded. Patients must be 18 years of age or older. This promotion cannot be combined with any other programs, offers, or discounts. Depomed reserves the right to rescind, revoke, or amend this offer without further notice.
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References: 1. American Cancer Society. Types of pain. http://www.cancer.org/treatment/treatmentsandsideeffects/physicalsideeffects/pain/paindiary/pain-control-types-of-pain. Accessed May 2, 2014. 2. 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. 3. Data on file. Depomed Inc., 2014. 4. Watts P, Smith A, Perelman M. Nasal delivery of fentanyl. Drug Deliv Transl Res. 2013;3:75-83.