What is Lazanda (fentanyl) nasal spray, and how does it work?
Generic drug: fentanyl
Brand name: Lazanda
- A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage breakthrough pain in adults (18 years of age and older) with cancer who are already routinely taking other opioid pain medicines around-the-clock for cancer pain. Lazanda is started only after you have been taking other opioid pain medicines and your body has become used to them (you are opioid tolerant). Do not use Lazanda if you are not opioid tolerant.
- A nasal spray. You use Lazanda by placing the nozzle attached to the bottle in your nostril and spraying.
- An opioid pain medicine that can put you at risk for overdose and death. Even if you take your dose correctly as prescribed you are at risk for opioid addiction, abuse, and misuse that can lead to death.
What are the side effects of Lazanda?
The possible side effects of Lazanda may include:
- abdominal pain,
- trouble sleeping,
- low red blood cell count,
- swelling of the arms, hands, legs and feet.
- Call your healthcare provider if you have any of these symptoms and they are severe.
- Decreased blood pressure. This can make you feel dizzy or lightheaded if you get up too fast from sitting or lying down.
LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL EXPOSURE; CYTOCHROME P450 3A4 INTERACTION; CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS; RISK OF MEDICATION ERRORS; ADDICTION, ABUSE, AND MISUSE; REMS; and NEONATAL OPIOID WITHDRAWAL SYNDROME
Life-Threatening Respiratory Depression
- Serious, life-threatening, and/or fatal respiratory depression has occurred in
patients treated with Lazanda, including following use in opioid non-tolerant
patients and improper dosing.
- Monitor for respiratory depression, especially
during initiation of Lazanda or following a dose increase.
- The substitution of Lazanda for any other fentanyl product may result in fatal overdose.
to the risk of respiratory depression, Lazanda is contraindicated in the
management of acute or postoperative pain including headache/migraine and in
opioid non-tolerant patients.
exposure of even one dose of Lazanda, especially in children, can result in a
fatal overdose of fentanyl.
- Death has been reported in children who have
accidentally ingested transmucosal immediate-release fentanyl products.
must be kept out of reach of children.
Cytochrome P450 3A4 Interaction
- The concomitant use of Lazanda with all cytochrome P450 3A4 inhibitors may
result in an increase in fentanyl plasma concentrations, which could increase or
prolong adverse reactions and may cause potentially fatal respiratory
- In addition, discontinuation of a concomitantly used cytochrome P450
3A4 inducer may result in an increase in fentanyl plasma concentration.
patients receiving Lazanda and any CYP3A4 inhibitor or inducer.
Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants
- Reserve concomitant prescribing of
Lazanda and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate.
- Limit dosages and durations to the minimum required.
- Follow patients for signs and symptoms of respiratory depression and sedation.
Risk of Medication Errors
Substantial differences exist in the pharmacokinetic profile of Lazanda compared
to other fentanyl products that result in clinically important differences in
the extent of absorption of fentanyl that could result in fatal overdose.
- When prescribing, do not convert patients on a mcg per mcg basis from any other fentanyl products to
- When dispensing, do not substitute a Lazanda prescription for other fentanyl products.
Addiction, Abuse, and Misuse
- Lazanda exposes patients and other users to the risks of opioid addiction,
abuse, and misuse, which can lead to overdose and death.
- Assess each patient’s
risk prior to prescribing Lazanda, and monitor all patients regularly for the
development of these behaviors and conditions.
Risk Evaluation and Mitigation Strategy (REMS) Access Program
- Because of the risk for misuse, abuse, addiction, and overdose,
available only through a restricted program required by the Food and Drug
Administration, called a Risk Evaluation and Mitigation Strategy (REMS).
the Transmucosal Immediate Release Fentanyl (TIRF) REMS Access program,
outpatients, healthcare professionals who prescribe to outpatients, pharmacies,
and distributors must enroll in the program.
- Further information is available at www.TIRFREMSaccess.com or by calling 1-866-822-1483.
Neonatal Opioid Withdrawal Syndrome
- Prolonged use of Lazanda during pregnancy can result in neonatal opioid
withdrawal syndrome, which may be life-threatening if not recognized and
treated, and requires management according to protocols developed by neonatology
- If opioid use is required for a prolonged period in a pregnant woman,
advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure
that appropriate treatment will be available.
What drugs interact with Lazanda?
Table 3 includes clinically significant drug interactions with Lazanda.
Inhibitors of CYP3A4Clinical Impact:The concomitant use of
Table 3: Clinically Significant Drug Interactions with Lazanda
Lazanda and CYP3A4 inhibitors can increase the plasma concentration of fentanyl, resulting in increased or prolonged opioid effects, particularly when an inhibitor is added after a stable dose of
Lazanda is achieved.After stopping a CYP3A4 inhibitor, as
the effects of the inhibitor decline, the fentanyl plasma concentration
will decrease, resulting in decreased opioid efficacy or a withdrawal syndrome in patients who had developed physical dependence to fentanyl.Intervention:If concomitant use is necessary, consider dosage reduction of
Lazanda until stable drug effects are achieved. Monitor patients for respiratory depression and sedation at frequent intervals.If a CYP3A4 inhibitor is discontinued, consider increasing the
Lazanda dosage until stable drug effects are achieved. Monitor for signs of opioid withdrawal.ExamplesMacrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g., ketoconazole), protease inhibitors (e.g., ritonavir), grapefruit juiceCYP3A4 InducersClinical Impact:The concomitant use of
Lazanda and CYP3A4 inducers can decrease the plasma concentration of
fentanyl, resulting in decreased efficacy or onset of a withdrawal syndrome
in patients who have developed physical dependence to fentanyl.After stopping a CYP3A4 inducer, as the effects of the inducer decline,
the fentanyl plasma concentration will increase, which could increase or prolong both the therapeutic effects and adverse reactions, and may cause serious respiratory depression.Intervention:If concomitant use is necessary, consider increasing the
Lazanda dosage until stable drug effects are achieved. Monitor for signs of opioid withdrawal. If a CYP3A4 inducer is discontinued, consider
Lazanda dosage reduction and monitor for signs of respiratory depression.ExamplesRifampin, carbamazepine, phenytoinBenzodiazepines and Other Central Nervous System (CNS) DepressantsClinical Impact:Due to additive pharmacologic effect, the concomitant use of benzodiazepines and other CNS depressants, including alcohol, can increase the risk of hypotension, respiratory depression, profound sedation, coma, and death.Intervention:Reserve concomitant prescribing of these drugs for use in patients for whom
alternative treatment options are inadequate. Limit dosages and durations to
the minimum required. Follow patients closely for signs of respiratory
depression and sedation.Examples:Benzodiazepines and other sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, other opioids, alcohol.Serotonergic DrugsClinical Impact:The concomitant use of opioids with other drugs that affect the serotonergic
neurotransmitter system has resulted in serotonin syndrome.Intervention:If concomitant use is warranted, carefully observe the patient, particularly during treatment initiation and dose adjustment. Discontinue
Lazanda if serotonin syndrome is suspected.Examples:Selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), triptans, 5-HT3 receptor antagonists, drugs that effect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e., cyclobenzaprine, metaxalone), monoamine oxidase (MAO) inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue).Monoamine Oxidase Inhibitors (MAOIs)Clinical Impact:MAOI interactions with opioids may manifest as serotonin syndrome or opioid
toxicity (e.g., respiratory depression, coma).Intervention:The use of
Lazanda is not recommended for patients taking MAOIs or within 14 days of stopping such treatment.Examples:phenelzine, tranylcypromine, linezolidMixed Agonist/Antagonist and Partial Agonist Opioid AnalgesicsClinical Impact:May reduce the analgesic effect of
Lazanda and/or precipitate withdrawal symptoms.Intervention:Avoid concomitant use.Examples:butorphanol, nalbuphine, pentazocine, buprenorphineMuscle RelaxantsClinical Impact:Fentanyl may enhance the neuromuscular blocking action of skeletal muscle relaxants and produce an increased degree of respiratory depression.Intervention:Monitor patients for signs of respiratory depression that may be greater than otherwise expected and decrease the dosage of
Lazanda and/or the muscle relaxant as necessary.DiureticsClinical Impact:Opioids can reduce the efficacy of diuretics by inducing the release of antidiuretic hormone.Intervention:Monitor patients for signs of diminished diuresis and/or effects on blood pressure and increase the dosage of the diuretic as needed.Anticholinergic DrugsClinical Impact:The concomitant use of anticholinergic drugs may increase risk of urinary retention and/or severe constipation, which may lead to paralytic ileus.Intervention:Monitor patients for signs of urinary retention or reduced gastric motility when
Lazanda is used concomitantly with anticholinergic drugs.Agents used to treat Allergic RhinitisClinical Impact:The presence of allergic rhinitis is not expected to affect
Lazanda absorption. However, co-administration of a vasoconstrictive nasal decongestant such as oxymetazoline to treat allergic rhinitis leads to lower peak plasma concentrations and a delayed Tmax of fentanyl that may cause
Lazanda to be less effective in patients with allergic rhinitis who use such
decongestants, thus potentially impairing pain management. Additionally, in
view of the possibility that the titration of a patient while they are
experiencing an acute episode of rhinitis could lead to incorrect dose
identification (particularly if they are using a vasoconstrictive
decongestant), titration under these circumstances must be avoided.Intervention:Avoid using
Lazanda in patients with allergic rhinitis and consider other products with a different route of administration.
Does Lazanda cause addiction or withdrawal symptoms?
Drug Abuse And Dependence
Lazanda contains fentanyl, a Schedule II controlled substance.
- Lazanda contains fentanyl, a substance with a high potential for abuse similar to other opioids including hydrocodone, hydromorphone, methadone, morphine, oxycodone, oxymorphone, and tapentadol.
- Lazanda can be abused and is subject to misuse, addiction, and criminal
- All patients treated with opioids require careful monitoring for signs of abuse and addiction, since use of opioid analgesic products carries the risk of addiction even under appropriate medical use.
- Prescription drug abuse is the intentional non-therapeutic use of a prescription drug, even once, for its rewarding psychological or physiological effects.
- Drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that develop after repeated substance use and includes: a strong desire to take the drug, difficulties in controlling its use, persisting in its use despite harmful consequences, a higher priority given to drug use than to other activities and obligations, increased tolerance, and sometimes a physical withdrawal.
- “Drug-seeking” behavior is very common in persons with substance use disorders.
- Drug-seeking tactics include emergency calls or visits near the end of office hours, refusal to undergo appropriate examination, testing, or referral, repeated “loss” of prescriptions, tampering with prescriptions, and reluctance to provide prior medical records or contact information for other treating health care provider(s).
- “Doctor shopping” (visiting multiple prescribers to obtain additional prescriptions) is common among drug abusers and people suffering from untreated addiction. Preoccupation with achieving adequate pain relief can be appropriate behavior in a patient with poor pain control.
- Abuse and addiction are separate and distinct from physical dependence and tolerance. Healthcare providers should be aware that addiction may not be accompanied by concurrent tolerance and symptoms of physical dependence in all addicts. In addition, abuse of opioids can occur in the absence of true addiction.
- Lazanda, like other opioids, can be diverted for non-medical use into illicit channels of distribution.
- Careful record-keeping of prescribing information, including quantity, frequency, and renewal requests, as required by state and federal law, is strongly advised.
- Proper assessment of the patient, proper prescribing practices, periodic re-evaluation of therapy, and proper dispensing and storage are appropriate measures that help to limit abuse of opioid drugs.
Risks Specific to the Abuse of Lazanda
- Lazanda is for intranasal transmucosal use only.
- Abuse of Lazanda poses a risk of overdose and death.
- The risk is increased with concurrent abuse of Lazanda with alcohol and other central nervous system depressants.
- Both tolerance and physical dependence can develop during chronic opioid therapy.
- Tolerance is the need for increasing doses of opioids to maintain a defined effect such as analgesia (in the absence of disease progression or other external factors).
- Tolerance may occur to both the desired and undesired effects of drugs, and may develop at different rates for different effects.
- Physical dependence results in withdrawal symptoms after abrupt discontinuation or a significant dosage reduction of a drug.
- Withdrawal also may be precipitated through the administration of drugs with opioid antagonist activity (e.g., naloxone, nalmefene), mixed agonist/antagonist analgesics (e.g., pentazocine, butorphanol, nalbuphine), or partial agonists (e.g., buprenorphine).
- Physical dependence may not occur to a clinically significant degree until after several days to weeks of continued opioid usage.
- Infants born to mothers physically dependent on opioids will also be
physically dependent and may exhibit respiratory difficulties and withdrawal
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Is Lazanda safe to use while pregnant or breastfeeding?
- Prolonged use of opioid analgesics during pregnancy may cause neonatal opioid withdrawal syndrome.
- Available data with Lazanda in pregnant women are insufficient to inform a drug-associated risk for major birth defects and miscarriage.
- Fentanyl is present in breast milk.
- One published lactation study reports a relative infant dose of fentanyl of 0.024%. However, there is insufficient information to determine the effects of fentanyl on the breastfed infant and the effects of fentanyl on milk production.
- Because of the potential for serious adverse reactions, including excess sedation and respiratory depression in a breastfed infant, advise patients that breastfeeding is not recommended during treatment with