April 28, 2017
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Lazanda

"By Roxanne Nelson

Another study showing an increased risk for cancer with drinking alcohol, even with just one or two drinks a day, has prompted renewed warnings on the health risks associated with alcohol consumption.

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Lazanda

LAZANDA®
(fentanyl) Nasal Spray




WARNING

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 [see WARNINGS AND PRECAUTIONS].

Due 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. [see CONTRAINDICATIONS]

Accidental Exposure

Accidental exposure of even one dose of LAZANDA, especially in children, can result in a fatal overdose of fentanyl [see WARNINGS AND PRECAUTIONS]. Death has been reported in children who have accidentally ingested transmucosal immediate-release fentanyl products. LAZANDA must be kept out of reach of children [see WARNINGS AND PRECAUTIONS].

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 depression. In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in fentanyl plasma concentration. Monitor patients receiving LAZANDA and any CYP3A4 inhibitor or inducer [see WARNINGS AND PRECAUTIONS, DRUG INTERACTIONS, CLINICAL PHARMACOLOGY].

Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants

Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death [see WARNINGS AND PRECAUTIONS, DRUG INTERACTIONS].

  • 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 [see DOSAGE AND ADMINISTRATION, WARNINGS AND PRECAUTIONS].

  • When prescribing, do not convert patients on a mcg per mcg basis from any other fentanyl products to LAZANDA.
  • 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 [see WARNINGS AND PRECAUTIONS].

Risk Evaluation and Mitigation Strategy (REMS) Access Program

Because of the risk for misuse, abuse, addiction, and overdose, LAZANDA is available only through a restricted program required by the Food and Drug Administration, called a Risk Evaluation and Mitigation Strategy (REMS). Under the Transmucosal Immediate Release Fentanyl (TIRF) REMS Access program, outpatients, healthcare professionals who prescribe to outpatients, pharmacies, and distributors must enroll in the program. [see WARNINGS AND PRECAUTIONS] 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 experts. 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 [see WARNINGS AND PRECAUTIONS]

DRUG DESCRIPTION

LAZANDA (fentanyl) nasal spray is a liquid formulation of fentanyl citrate, an opioid agonist, intended for intranasal transmucosal administration. The product consists of a practically clear to clear, colorless, aqueous solution of fentanyl citrate in a glass multidose container to which is attached a metered-dose nasal spray pump with a visual and audible spray counter. Each actuation is designed to deliver a spray of 100 mcL of solution containing 100 mcg, 300 mcg or 400 mcg fentanyl base, respectively. This enables doses of 100 mcg , 300 mcg or 400 mcg to be administered using a single spray into one nostril (1 spray) and 200 mcg, 600 mcg or 800 mcg to be administered using a single spray into both nostrils (2 sprays).

Active ingredient: Fentanyl citrate, USP is N-(l-phenethyl-4-piperidyl) propionanilide citrate (1:1). Fentanyl is a highly lipophilic compound (octanol-water partition coefficient at pH 7.4 is 816:1). Fentanyl citrate is sparingly soluble in water (1:40). The molecular weight of the free base and citrate salt are 336.5 and 528.6, respectively. The pKa is 8.4. The compound has the following structural formula:

LAZANDA® (Fentanyl) Structural Formula Illustration

LAZANDA is available in 3 strengths of nasal spray: 100 mcg fentanyl (yellow label), 300 mcg fentanyl (blue label) and 400 mcg fentanyl (violet label). The strength is expressed as the amount of fentanyl free base per spray, e.g., the 100 mcg strength provides 100 mcg of fentanyl free base per 100 mcL spray.

Inactive ingredients: mannitol, pectin, phenylethyl alcohol, propylparaben, sucrose, water. Sodium hydroxide and/or hydrochloric acid are added if required for pH adjustment.

What are the possible side effects of fentanyl nasal (Lazanda)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using fentanyl and call your doctor at once if you have a serious side effect such as:

  • slow heart rate, weak or shallow breathing, sighing;
  • confusion, extreme fear, unusual thoughts or behavior; or
  • feeling like you might pass out.

Less serious side effects may include:

  • nausea, vomiting, constipation;
  • dizziness, drowsiness, tired feeling; or
  • white...

Read All Potential Side Effects and See Pictures of Lazanda »

Last reviewed on RxList: 3/31/2017
This monograph has been modified to include the generic and brand name in many instances.

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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