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(fentanyl) for Intranasal Transmucosal Administration
RISK OF RESPIRATORY DEPRESSION, MEDICATION ERRORS, ABUSE POTENTIAL
Fatal respiratory depression has occurred in patients treated with immediate-release transmucosal fentanyl, including following use in opioid non-tolerant patients and improper dosing. The substitution of Lazanda for any other fentanyl product may result in fatal overdose.
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]
The concomitant use of Lazanda with CYP3A4 inhibitors may result in an increase in fentanyl plasma concentrations, and may cause potentially fatal respiratory depression [see DRUG INTERACTIONS].
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 Lazanda.
- When dispensing, do not substitute a Lazanda prescription for other fentanyl products.
Lazanda contains fentanyl, an opioid agonist and a Schedule II controlled substance, with an abuse liability similar to other opioid analgesics. Lazanda can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing Lazanda in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse or diversion.
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.
Lazanda (fentanyl) nasal spray is a liquid formulation of fentanyl citrate 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 or 400 mcg fentanyl base, respectively. This enables doses of 100 mcg or 400 mcg to be administered using a single spray into one nostril (1 spray) and 200 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 is available in 2 strengths of nasal spray: 100 mcg fentanyl (yellow 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
Last reviewed on RxList: 3/10/2016
This monograph has been modified to include the generic and brand name in many instances.
Additional Lazanda Information
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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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