April 23, 2017
Recommended Topic Related To:

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.

The n"...

A A A

Lazanda




Indications
Dosage
How Supplied

INDICATIONS

LAZANDA is indicated for the management of breakthrough pain in cancer patients 18 years of age and older who are already receiving and who are tolerant to around-the-clock opioid therapy for their underlying persistent cancer pain.

Patients considered opioid tolerant are those who are taking, for one week or longer, around-the-clock medicine consisting of at least: 60 mg of oral morphine per day, 25 mcg of transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, or at least 25 mg oral oxymorphone per day, or at least 60mg oral hydrocodone per day, or an equianalgesic dose of another opioid for a week or longer. Patients must remain on around-the-clock opioids when taking LAZANDA.

Limitations Of Use

  • Not for use in opioid non-tolerant patients.
  • Not for use in the management of acute or postoperative pain, including headache/migraine, dental pain, or in the emergency department [see CONTRAINDICATIONS].
  • As a part of the TIRF REMS Access program, LAZANDA may be dispensed only to outpatients enrolled in the program. [see WARNINGS AND PRECAUTIONS]. For inpatient administration of LAZANDA (e.g. hospitals, hospices, and long-term care facilities that prescribe for inpatient use), patient enrollment is not required.

DOSAGE AND ADMINISTRATION

Important Dosage And Administration Instructions

  • Healthcare professionals who prescribe LAZANDA on an outpatient basis must enroll in the TIRF REMS Access program and comply with the requirements of the REMS to ensure safe use of LAZANDA [see WARNINGS AND PRECAUTIONS].
  • Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals.
  • It is important to minimize the number of strengths available to patients at any time to prevent confusion and possible overdose.
  • Initiate the dosing regimen for each patient individually, taking into account the patient's severity of pain, patient response, prior analgesic treatment experience, and risk factors for addiction, abuse, and misuse.
  • Monitor patients closely for respiratory depression, especially within the first 24-72 hours of initiating therapy and following dosage increases with LAZANDA and adjust the dosage accordingly [see WARNINGS AND PRECAUTIONS].
  • Instruct patients and caregivers to take steps to store LAZANDA securely and to properly dispose of unused LAZANDA as soon as no longer needed [see WARNINGS AND PRECAUTIONS, PATIENT INFORMATION].
  • LAZANDA is not bioequivalent with other fentanyl products. Do not convert patients on a mcg per mcg basis from other fentanyl products. There are no conversion directions available for patients on any other fentanyl products. (Note: This includes oral, transdermal, or parenteral formulations of fentanyl.) [see WARNINGS AND PRECAUTIONS].
  • LAZANDA is NOT a generic version of any other oral transmucosal fentanyl product [see WARNINGS AND PRECAUTIONS].

Initial Dosage

Initiate treatment with LAZANDA for all patients (including those switching from another fentanyl product) using ONE 100 mcg spray of LAZANDA (1 spray in one nostril).

Repeat Dosing
  • If adequate analgesia is obtained within 30 minutes of administration of the 100 mcg single spray, treat subsequent episodes of breakthrough pain with this dose.
  • If adequate analgesia is not achieved with the first 100 mcg dose, dose escalate in a step-wise manner over consecutive episodes of breakthrough pain until adequate analgesia with tolerable side effects is achieved.
  • Patients MUST wait at least 2 hours before treating another episode of breakthrough cancer pain with LAZANDA.

Titration And Maintenance Of Therapy

Titration

The objective of dose titration is to identify an effective and tolerable maintenance dose for ongoing management of breakthrough cancer pain episodes. The effective and tolerable dose of LAZANDA will be determined by dose titration in individual patients.

Titration steps: If adequate analgesia is not achieved with the first 100 mcg dose, dose escalate in a step-wise manner over consecutive episodes of breakthrough pain until adequate analgesia with tolerable side effects is achieved.

Patients MUST wait at least 2 hours before treating another episode of breakthrough cancer pain with LAZANDA.

The titration steps should be:

LAZANDA Dose How to administer the dose
100 mcg Using the 100 mcg dose; one spray in one nostril
200 mcg Using the 100 mcg dose; a total of two sprays, as one spray in each nostril
300 mcg Using the 100 mcg dose; a total of three sprays, alternating one spray in right nostril, second spray in left nostril, third spray in right nostril
400 mcg Using the 100 mcg dose, a total of four sprays, alternating one spray in right nostril, second spray in left nostril, third spray in right nostril, and fourth spray in left nostril OR Using the 400 mcg dose; one spray in one nostril
600 mcg Using the 300 mcg dose; total of two sprays, as one spray in each nostril
800 mcg Using the 400 mcg dose; total of two sprays, as one spray in each nostril

Patients should confirm the dose of LAZANDA that works for them with a second episode of breakthrough pain and review their experience with their physicians to determine if that dose is appropriate, or whether a further adjustment is warranted.

The safety and efficacy of doses higher than 800 mcg have not been evaluated in clinical studies. Avoid the use of a combination of dose strengths to treat an episode as this may cause confusion and dosing errors.

LAZANDA TITRATION PROCESS

LAZANDA TITRATION PROCESS - Illustration

In order to minimize the risk of LAZANDA-related adverse reactions and to identify the appropriate dose, it is imperative that patients be supervised closely by health professionals during the titration process.

Maintenance Therapy

Once an appropriate dose has been established, instruct patients to use that dose for each subsequent breakthrough cancer pain episode. Limit LAZANDA use to four or fewer doses per day.

Patients MUST wait at least 2 hours before treating another episode of breakthrough cancer pain with LAZANDA.

During any episode of breakthrough cancer pain, if there is inadequate pain relief after 30 minutes following LAZANDA dosing or if a separate episode of breakthrough cancer pain occurs before the next dose of LAZANDA is permitted (i.e. within 2 hours), the patients may use a rescue medication as directed by their healthcare provider.

Dose Re-Adjustment

If the response (analgesia or adverse reactions) to the titrated LAZANDA dose markedly changes, an adjustment of dose may be necessary to ensure that an appropriate dose is maintained.

If more than four episodes of breakthrough pain are experienced per day, re-evaluate the dose of the long-acting opioid used for persistent underlying cancer pain. If the long-acting opioid or dose of long-acting opioid is changed, re-evaluate and re-titrate the LAZANDA dose as necessary to ensure the patient is on an appropriate dose.

Limit the use of LAZANDA to treat four or fewer episodes of breakthrough pain per day.

It is imperative that any dose re-titration is monitored carefully by a healthcare professional.

Administration Of LAZANDA

Instruct patients on the proper use of LAZANDA.

  1. Prime the device before use by spraying into the pouch (4 sprays in total). If the product has not been used for 5 days, re-prime by spraying once. For priming, follow the instructions provided [See Medication Guide].
  2. Insert the nozzle of the LAZANDA bottle a short distance (about ½ inch or 1 cm) into the nose and point towards the bridge of the nose, tilting the bottle slightly.
  3. Press down firmly on the finger grips until they hear a “click” and the number in the counting window advances by one.

Advise patients that the fine mist spray is not always felt on the nasal mucosal membrane and to rely on the audible click and the advancement of the dose counter to confirm a spray has been administered.

Discontinuation Of Therapy

For patients no longer requiring opioid therapy, consider discontinuing LAZANDA along with a gradual downward titration of other opioids to minimize possible withdrawal effects. In patients who continue to take their chronic opioid therapy for persistent pain but no longer require treatment for breakthrough pain, LAZANDA therapy can usually be discontinued immediately [see Drug Abuse and Dependence].

Disposal Of LAZANDA

Instruct patients and caregivers to properly dispose of all unused, partially used and used LAZANDA bottles. The remaining liquid in all bottles must be sprayed into the pouch, provided in the pack, for safe disposal as soon as possible.

Instruct the patient how to do this correctly. If there are any unwanted therapeutic sprays remaining in the bottle, instruct the patient to spray these into the pouch until the number “8” appears in the counting window and there are no more full therapeutic sprays obtainable from the bottle. After the counter has advanced to “8”, the patient should continue to push down on the finger grips a total of four times in order to expel any residual medicine from the bottle. After the 8 therapeutic sprays have been emitted, the patient will not hear a click and the counter will not advance beyond “8”; further sprays emitted will not be full sprays and should always be trapped in the pouch, not used therapeutically.

Instruct the patient and caregiver to seal the pouch and place both it and the empty bottle into the child-resistant storage container. Patients must wash their hands with soap and water immediately after handling the pouch. The patient must discard the child-resistant container containing the pouch and the bottle in the trash.

The patient or caregiver must continue to store the LAZANDA bottle in the specially provided child-resistant container and the pouch out of the reach of children until proper disposal, as described above, is possible.

Instruct the patient to dispose of the LAZANDA bottle and start a new one if it has been 60 days or more since they first used the bottle of LAZANDA.

In the event that caregivers or patients require additional assistance with the disposal of LAZANDA bottles, call the Depomed, Inc. toll-free number (1-866-458-6389).

HOW SUPPLIED

Dosage Forms And Strengths

Nasal Spray, LAZANDA is formulated to deliver a spray of 100 mcL of solution containing 100 mcg, 300 mcg or 400 mcg fentanyl base.

Storage And Handling

LAZANDA is available as a 5.3 mL capacity clear glass bottle with an attached metered-dose nasal spray pump incorporating a visual and audible spray counter, and a protective dust cover. Each glass bottle, contains 8 sprays of 100 mcL available in three different concentrations: 100 mcg/100 mcL, 300 mcg/100 mcL or 400 mcg/100 mcL concentration solution. Each bottle contains a net fill weight of 1.57 grams and, after priming, delivers 8 sprays.

The pump will remain primed for up to 5 days after priming or use. If the product has not been used for 5 days, re-prime by spraying once. The nasal spray delivers 8 full sprays. There are 3 product strengths and each 100 mcL spray contains either 100 mcg, 300 mcg or 400 mcg of fentanyl. Each bottle is supplied in a child-resistant container.

Bottles in their child-resistant containers are supplied in cartons containing 1 bottle with instructions for use. Each carton contains one carbon-lined pouch per bottle for disposal of priming sprays, unwanted doses and residual fentanyl solution.

Lazanda Dosage Strength (fentanyl base) Number of Bottles per Carton NDC Number
100 mcg 1 13913-009-01
300 mcg 1 13913-013-01
400 mcg 1 13913-010-01

Store at up to 25°C. Do not freeze.

Return the bottle to the child-resistant container after each use. Put the bottle in its child-resistant container and the pouch in the cardboard carton and store securely out of the reach of children and protect from light.

Note: Carton and bottle label colors are a secondary aid in product identification. Confirm the printed dosage before dispensing.

Distributed by Depomed, Inc. Newark, CA 94560. Revised: Mar 2017

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 3/31/2017

Indications
Dosage
How Supplied

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.


Cancer

Get the latest treatment options.