Lazanda

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 (5.10)}.

As with all opioids, the safety of patients using such products is dependent on healthcare professionals prescribing them in strict conformity with their approved labeling with respect to patient selection, dosing, and proper conditions for use.

Open the child-resistant container just prior to product use and always replace the bottle in the child-resistant container between doses.

2.1 Dose Titration

The goal of dose titration is to find the individual patient's effective and tolerable dose. The dose of Lazanda is not predicted from the daily maintenance dose of opioid used to manage the persistent cancer pain and MUST be determined by dose titration.

Starting Dose: Individually titrate Lazanda to a dose that provides adequate analgesia with tolerable side effects. Begin treatment of all patients (including those switching from another fentanyl product) using ONE 100 mcg spray of Lazanda (1 spray in one nostril). Due to differences in pharmacokinetic properties and individual variability, do not switch patients on a mcg per mcg basis from any other fentanyl product to Lazanda as Lazanda is not equivalent with any other fentanyl product, nor is Lazanda a generic version of any other fentanyl product.

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.

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 Using 100 mcg 1 × 100 mcg spray 200 mcg 2 × 100 mcg spray (1 in each nostril) 400 mcg 1 × 400 mcg 800 mcg 2 × 400 mcg (1 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. There are no clinical data to support the use of a combination of dose strengths to treat an episode.

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.

2.2 Maintenance Treatment

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.

2.3 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.

2.4 Administration of Lazanda

Instruct patients on the proper use of Lazanda.

Prime the device before use by spraying into the pouch (4 sprays in total) following the instructions for use in the Medication Guide [17.3]. 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. 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.

2.5 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.

• do not take more than directed (see overdose warning)

adults and children 12 years and over

• take 2 caplets every 6 hours while symptoms last • do not take more than 6 caplets in 24 hours, unless directed by a doctor • do not use for more than 10 days unless directed by a doctor

children under 12 years

ask a doctor