LAZANDA- fentanyl citrate spray

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

Fentanyl Citrate (UNII: MUN5LYG46H) (Fentanyl - UNII:UF599785JZ)

可用日期:

Archimedes Pharma US Inc.

INN（国际名称）:

Fentanyl Citrate

组成:

Fentanyl 100 ug

给药途径:

NASAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

Lazanda (fentanyl) nasal spray 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 opioid therapy for their underlying persistent cancer pain. Patients considered opioid tolerant are those who are taking at least: 60 mg of oral morphine/day, 25 mcg of transdermal fentanyl/hour, 30 mg oral oxycodone/day, 8 mg oral hydromorphone/day, 25 mg oral oxymorphone/day, or an equianalgesic dose of another opioid for a week or longer. Patients must remain on around-the-clock opioids when taking Lazanda. Lazanda is contraindicated for patients who are not already tolerant to opioids because life-threatening respiratory depression and death could occur in patients not taking chronic opioids. For this reason, Lazanda is contraindicated in the management of acute or postoperative pain, including headache/migraine, or dental pain. [4] Lazanda is intended to be prescribed only by healthcare professionals who are knowledgeable of and

產品總結:

Lazanda is supplied in glass bottles, containing 8 sprays of 100 mcL containing 100 mcg/100 mcL or 400 mcg/100 mcL concentration solution. Each bottle is supplied in a child-resistant container. The amount of fentanyl contained in Lazanda can be fatal to a child, individual for whom it is not prescribed or non-opioid tolerant adult. Patients and their caregivers must be instructed to keep Lazanda out of the reach of children [see Boxed Warning - Warning: Risk of Respiratory Depression, Medication Errors, Abuse Potential, Warnings and Precautions (5), and Patient Counseling Information (17.1) ]. 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 . Patients and caregivers must be instructed 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. The patient should be instructed 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. The patient and caregiver must be instructed to seal the pouch and place both it and the empty bottle into the child-resistant storage container. Hands must be washed 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: In the event that caregivers or patients require additional assistance with the disposal of Lazanda bottles, call the Archimedes Pharma toll-free number (1-866-435-6775). Lazanda is supplied in 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 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. The nasal spray delivers 8 full sprays. There are 2 product strengths and each 100 mcL spray contains either 100 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 or 4 bottles with instructions for use. Each carton contains one carbon-lined pouch per bottle for disposal of priming sprays, unwanted doses and residual fentanyl solution.

授权状态:

New Drug Application

资料单张

LAZANDA- FENTANYL CITRATE SPRAY
Archimedes Pharma US Inc.
----------
Medication Guide
Lazanda® (La-ZAN-da) CII
(fentanyl)
nasal spray
100 mcg, 400 mcg
IMPORTANT:
Do not use Lazanda unless you are regularly using another opioid pain
medicine around-the-clock for
your cancer pain and your body is used to these medicines (this means
that you are opioid tolerant). You
can ask your healthcare provider if you are opioid tolerant.
Keep Lazanda in a safe place away from children.
Get emergency medical help right away if:
•
a child takes Lazanda. Lazanda can cause an overdose and death in any
child who takes it
•
an adult who has not been prescribed Lazanda takes it
•
an adult who is not already taking opioids around-the-clock takes
Lazanda
These are medical emergencies that can cause death.
Read this Medication Guide completely before you start taking Lazanda
and each time you get a new
prescription. There may be new information. This Medication Guide does
not take the place of talking to
your healthcare provider about your medical condition or your
treatment. Be sure to share this important
information with members of your household and other caregivers.
What is the most important information I should know about Lazanda?
Lazanda can cause life-threatening breathing problems that can lead to
death:
1.
Do not take Lazanda if you are not opioid tolerant.
2.
If you stop taking your around-the-clock opioid pain medicine for your
cancer, you must stop
taking Lazanda. You may no longer be opioid tolerant. Talk to your
healthcare provider about how
to treat your pain.
3.
Take Lazanda exactly as prescribed by your healthcare provider.
•
You must not take more than 1 dose of Lazanda for each episode of
breakthrough cancer
pain.
•
You must wait two hours before treating a new episode of breakthrough
cancer pain with
Lazanda. See the Medication Guide section "How should I use Lazanda?"
and the
"Instructions for Use" section at the end of this Medication Guide for
detailed information
about how to use Lazanda the right wa

产品特点

LAZANDA- FENTANYL CITRATE SPRAY
ARCHIMEDES PHARMA US INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LAZANDA SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR LAZANDA
LAZANDA (FENTANYL) NASAL SPRAY CII
INITIAL U.S. APPROVAL: 1968
WARNING: RISK OF RESPIRATORY DEPRESSION, MEDICATION ERRORS, ABUSE
POTENTIAL
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_.
DUE TO THE RISK OF FATAL RESPIRATORY DEPRESSION, LAZANDA IS
CONTRAINDICATED IN OPIOID NON-TOLERANT
PATIENTS (1) AND IN MANAGEMENT OF ACUTE OR POSTOPERATIVE PAIN,
INCLUDING HEADACHE/MIGRAINES. (4)
KEEP OUT OF REACH OF CHILDREN. (5.3)
USE WITH CYP3A4 INHIBITORS MAY CAUSE FATAL RESPIRATORY DEPRESSION. (7)
WHEN PRESCRIBING, DO NOT CONVERT PATIENTS ON A MCG PER MCG BASIS FROM
ANY OTHER ORAL TRANSMUCOSAL
FENTANYL PRODUCT TO LAZANDA. (2.1, 5.2)
WHEN DISPENSING, DO NOT SUBSTITUTE WITH ANY OTHER FENTANYL PRODUCTS.
(5.2)
CONTAINS FENTANYL, A SCHEDULE II CONTROLLED SUBSTANCE WITH ABUSE
LIABILITY SIMILAR TO OTHER OPIOID
ANALGESICS. (9.1)
LAZANDA IS AVAILABLE ONLY THROUGH A RESTRICTED PROGRAM CALLED THE TIRF
REMS ACCESS PROGRAM.
OUTPATIENTS, HEALTHCARE PROFESSIONALS WHO PRESCRIBE TO OUTPATIENTS,
PHARMACIES, AND DISTRIBUTORS ARE
REQUIRED TO ENROLL IN THE PROGRAM. (5.10)
RECENT MAJOR CHANGES
Indications and Usage (1)
12/2011
Warnings and Precautions- TIRF REMS Access Program
(5.10)
12/2011
INDICATIONS AND USAGE
Lazanda is an opioid agonist 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 opioid therapy
for their underlying persistent cancer pain. [1]
Limitations of Use:
Lazanda may be dispensed only to patients enrolled in the TIRF REMS
Access program.
DOSAGE AND ADMINISTRATION
Patients must require and use around-the-clock opioids when taking
Lazanda. (1)
Initial dose of Lazanda for all patients is 100 mcg. [2.1]
Individually titrate to an effective dose, from 100 mcg to 200 mcg to
400 mcg