Lazanda is a narcotic analgesic used to relieve severe breakthrough cancer. This drug acts in the central nervous system or brain to relieve pain. Dependence and withdrawal symptoms have been associated with the use of this drug.
This drug is available only under a restricted distribution program called LazandaВ® REMS Program.
Before taking Lazanda, the risks and benefits for your body should be discussed with your healthcare provider.
Inform your healthcare provider for any allergic reactions to these drugs or any other drugs, foods, dyes, preservatives, or animals.
Carefully read the label of non-prescription drugs for any possible allergic reaction or contraindications.
Studies in children below 18 years of age regarding the correlation of age to the effects of fentanyl injection have not been performed while safety and efficacy have not been established.
Studies in the elderly have not demonstrated any geriatric-specific problems that would limit the utility of Fentanyl injection.
Adverse effects have been reported in animal studies but studies in pregnant women and animals are still inadequate.
Infant risk is still undetermined when using this drug during breastfeeding. Discuss with your healthcare professional about potential risks and benefits of taking this drug while breastfeeding.
Drugs should not be taken together to prevent any interactions but in necessary cases inquire your healthcare provider regarding the adjustments in dosage or any other necessary precautions to prevent any unwanted side effects.
Inform your healthcare professional if you are taking any other drugs such as moderate or strong CYP3A4 inhibitors, MAOI, other CNS depressants such as opioids, sedatives/hypnotics, or general anesthetics, CYP3A4 inducers such as barbiturates, carbamazepine, or efavirenz, drugs that depress respiration.
Intake of specific food or using alcohol or tobacco with this drug is associated with an increased risk of certain side effects. Your healthcare professional can give you special instructions about the use of food, alcohol, or tobacco.
Inform your healthcare provider for any other medical problems such as:
To use Lazanda properly, you must follow all instructions given by your doctor.
This drug is indicated for use in opioid-tolerant patients only. It is very important that you understand the requirements of the LazandaВ® REMS program.
Consult with your healthcare professional before start treatment with this drug. This drug is for use only in the nose. Do not get any of it in your eyes or on your skin. If it does get on these areas, rinse it off with water immediately. Fentanyl nasal spray works differently than other Fentanyl products, even at the same dose.
Do not substitute or convert it to other products containing Fentanyl. Keep the spray in the child-resistant container until ready to use. If you are using the nasal spray for the first time, you will need to prime the spray. To do this, you should release four sprays into the pouch. Gently blow your nose to clear the nostrils before using this drug. Insert the tip of the LazandaВ® bottle into the nose. Point towards the bridge of the nose and tilt the bottle slightly. Press down firmly on the finger grips until you hear a "click" sound and the number in the dose counter window adds up. This confirms a spray has been taken. Return the spray bottle to the child-resistant container after each use.
The dose of this drug will be variable for different patients. The directions on the label or the prescription by your healthcare professional should be followed. The dosage of this drug you take depends on the medical problem for which you are using this drug.
Adults with cancer pain are initially given 100 micrograms or 1 spray in one nostril during an episode of breakthrough cancer pain. Your healthcare professional may increase your dose as needed and tolerated, up to a maximum of 800 mcg or 1 spray containing 400 mcg of Fentanyl in each nostril. The dose must not exceed 4 doses per 24 hours. Wait at least 2 hours before treating another episode of breakthrough cancer pain. If pain relief is not achieved within 30 minutes, a rescue drug may be used as directed by your healthcare professional.
Patients should record their use over several episodes of breakthrough cancer pain and review their experience with their healthcare professional to determine if a dosage adjustment is warranted.
Use and dose in children must be determined by your healthcare professional.
Store the drug in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing. Keep out of the reach of children. Do not keep outdated drug or drug no longer needed.
Ask your healthcare professional how you should dispose of any drug you do not use. Throw away any unused spray bottle and start using a new one after 5 days or more since it has been used or 14 days or more since it has been primed.
Dispose any used, partially used, or unneeded spray bottles by emptying and spraying the remaining solution into the pouch. The sealed pouch and the empty bottle should be placed in a child-resistant container before discarding it in the trash can. Wash your hands with soap and water immediately after handling the pouch.
If additional assistance is required, call 1-866-435-6775.
4 Precautions to Take
Before using Lazanda, there are some precautions you must take.
Regular visits should be made to your healthcare provider to track your progress and to monitor the effectiveness and unwanted effects of the drug.
Do not use LazandaВ® if you need pain drug for just a short time, such as during a headache or migraine attack, tooth pain, or when recovering from surgery or an injury. After you have been using this drug for awhile, "breakthrough" pain may occur more often than usual, and it may not be relieved by your regular dose of drug. If this occurs, do not increase the amount of nasal Fentanyl or other narcotic that you are using without first checking with your healthcare professional.
Using too much nasal Fentanyl, or taking too much of another narcotic while using nasal Fentanyl, may cause an overdose. If this occurs, get emergency help immediately. An overdose can cause severe breathing problems, unconsciousness, and death. Serious signs of an overdose include very slow breathing and drowsiness that is so severe that you are not able to answer when spoken to or, if asleep, cannot be awakened. Other signs of an overdose may include cold, clammy skin, low blood pressure, pinpoint pupils of the eyes, and slow heartbeat.
It may be best to have a family member or a friend check on you several times a day when you start using a narcotic regularly, and whenever your dose is increased, so that he or she can get help for you if you cannot do so yourself.
LazandaВ® contains an amount of Fentanyl which can be fatal to a child. Patients and their caregivers should keep this drug out of the reach of children, and discard used and unused bottle sprays in its child-resistant container properly.
This drug will add to the effects of alcohol and other CNS depressants such as antihistamines or drug for allergies or colds, sedatives, tranquilizers, or sleeping drug, other prescription pain drug or narcotics, drug for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics.
Check with your healthcare professional before taking any of the other drugs listed above while you are using this drug. Fentanyl may cause some people to become drowsy, dizzy, or lightheaded, or to feel a false sense of well-being.
Make sure you know how you react to this drug before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert and clearheaded. These effects usually go away after a few days of treatment, when your body gets used to the drug. However, check with your healthcare professional if drowsiness that is severe enough to interfere with your activities continues for more than a few days.
This drug may be habit-forming. If you feel that the drug is not working as well, do not use more than your prescribed dose. Call your healthcare professional for instructions. Using narcotics for a long time may cause severe constipation. To prevent this, your healthcare professional may inform you to take laxatives, drink a lot of fluids, or increase the amount of fiber in your diet. Be sure to follow the directions carefully, because continuing constipation can lead to more serious problems.
For pregnant women: Do not use this drug during labor and delivery (including caesarean section).
Do not use this drug if you have taken a monoamine oxidase (MAOI) inhibitor in the previous 2 weeks.
Some examples of MAO inhibitors are isocarboxazid (MarplanВ®), phenelzine (NardilВ®), selegiline (EldeprylВ®), or tranylcypromine (ParnateВ®).
If you use the 2 drugs close together it may cause serious side effects like confusion, agitation, restlessness, stomach or intestinal symptoms, a sudden high temperature, an extremely high blood pressure, or severe convulsions.
Do not eat grapefruit or drink grapefruit juice while you are using this drug. Grapefruit and grapefruit juice may change the amount of this drug that is absorbed in the body.
Consult with your healthcare professional before taking any other prescription or non-prescription drugs, and herbal or vitamin supplements.
As with many medications, there are several potential side effects associated with Lazanda.
Side effects may vary for each individual and prompt medical attention should be given if they occur. Seek advice from your healthcare professional immediately if you experience any unusual symptoms such as:
wrinkled skin, yellow eyes or skin, irregular, fast or slow, or shallow breathing, pale or blue lips, fingernails, or skin. Some side effects may occur that usually do not need medical attention. As your body adjusts to the medicine, the side effects will slowly disappear.
Ask your healthcare professional about ways to prevent or reduce some of these side effects. If any of the following side effects persists, or are inconvenient, or if you notice any other effects, or if you have any questions about them, consult with your health care professional.
Report any side effects to the FDA hotline at 1-800-FDA-1088.
Fentanyl is a highly potent drug. It is significantly more powerful than morphine, and it is also stronger than heroin. Taking fentanyl can simply lead to an overdose and death. Taking just the slightest bit more than your prescribed dose can kill you. If you do not have instructions from a doctor, stay away from this drug.
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