facebook
Subscribe50$/product give away!


Submit an Article to Pharmacy HQ     
Please include the author's name, title, and citations.     

BELBUCA- buprenorphine hydrochloride film, soluble


  1. Patient Information
  2. Instruct Patients How To Properly Use Belbuca, Including The Following:
  3. Belbuca Is:
  4. Important Information About Belbuca:
  5. Do Not Use Belbuca If You Have:
  6. Before Applying Belbuca, Tell Your Healthcare Provider If You Have A History Of:
  7. Tell Your Healthcare Provider If You Are:
  8. When Taking Belbuca:
  9. While Using Belbuca Do Not:
  10. The Possible Side Effects Of Belbuca Are:
  11. Get Emergency Medical Help If You Have:

Patient Information 

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Storage and Disposal

Because of the risks associated with accidental ingestion, misuse, and abuse, advise patients to store BELBUCA securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home[seeWarnings and Precautions (5.1,5.3),Drug Abuse and Dependence (9.2)]. Inform patients that leaving BELBUCA unsecured can pose a deadly risk to others in the home.

Advise patients and caregivers that when medicines are no longer needed, they should be disposed of promptly. Expired, unwanted, or unused BELBUCA should be disposed of by removing the BELBUCA film from the foil packaging and flushing the unused medication down the toilet (if a drug take-back option is not readily available). Inform patients that they can visit www.fda.gov/drugdisposal for a complete list of medicines recommended for disposal by flushing, as well as additional information on disposal of unused medicines.

Addiction, Abuse, and Misuse

Inform patients that the use of BELBUCA, even when taken as recommended, can result in addiction, abuse, and misuse, which could lead to overdose and death[seeWarnings and Precautions (5.1)]. Instruct patients not to share BELBUCA with others and to take steps to protect BELBUCA from theft or misuse.

Life-Threatening Respiratory Depression

Inform patients of the risk of life-threatening respiratory depression, including information that the risk is greatest when starting BELBUCA or when the dosage is increased, and that it can occur even at recommended doses[seeWarnings and Precautions (5.3)]. Advise patients how to recognize respiratory depression and to seek medical attention if breathing difficulties develop.

Accidental Exposure

Inform patients that accidental exposure, especially in children, may result in respiratory depression or death[seeWarnings and Precautions (5.3)].

Interactions with Benzodiazepines and Other CNS Depressants

Inform patients and caregivers that potentially fatal additive effects may occur if BELBUCA is used with benzodiazepines or other CNS depressants, including alcohol, and not to use these concomitantly unless supervised by a healthcare provider[seeWarnings and Precautions (5.5),Drug Interactions (7)].

Serotonin Syndrome

Inform patients that BELBUCA could cause a rare but potentially life-threatening condition resulting from concomitant administration of serotonergic drugs. Warn patients of the symptoms of serotonin syndrome and to seek medical attention right away if symptoms develop. Instruct patients to inform their physicians if they are taking, or plan to take, serotonergic medications[seeDrug Interactions (7)].

Adrenal Insufficiency

Inform patients that BELBUCA could cause adrenal insufficiency, a potentially life-threatening condition. Adrenal insufficiency may present with non-specific symptoms and signs such as nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood pressure. Advise patients to seek medical attention if they experience a constellation of these symptoms[seeWarnings and Precautions (5.7)].

Interaction with Benzodiazepines

Warn patients that it is extremely dangerous to self-administer benzodiazepines while taking BELBUCA, and warn patients to use benzodiazepines concurrently with BELBUCA only as directed by their physician[seeDrug Interactions (7)].

Important Administration Instructions

Instruct Patients How To Properly Use Belbuca, Including The Following: 

  • To carefully follow instructions for the application of BELBUCA and to avoid eating or drinking until it dissolves.
  • To apply BELBUCA once daily, or every twelve (12) hours at the same time or times each day.
  • To avoid applying BELBUCA to areas of the mouth with any open sores or lesions.
  • To not use BELBUCA if the pouch seal is broken or the buccal film is cut, damaged, or changed in any way.

Important Discontinuation Instructions

In order to avoid developing withdrawal symptoms, instruct patients not to discontinue BELBUCA without first discussing a tapering plan with the prescriber[seeDosage and Administration (2.4)].

Hypotension

Inform patients that BELBUCA may cause orthostatic hypotension and syncope. Instruct patients how to recognize symptoms of low blood pressure and how to reduce the risk of serious consequences should hypotension occur (e.g., sit or lie down, carefully rise from a sitting or lying position)[seeWarnings and Precautions (5.9)].

Anaphylaxis

Inform patients that anaphylaxis has been reported with ingredients contained in BELBUCA. Advise patients how to recognize such a reaction and when to seek medical attention[seeWarnings and Precautions (5.13)].

Pregnancy

Neonatal Opioid Withdrawal Syndrome

Inform female patients of reproductive potential that prolonged use of BELBUCA during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated[seeWarnings and Precautions (5.4),Use in Specific Populations (8.1)].

Embryofetal Toxicity

Advise female patients that BELBUCA can cause fetal harm and to inform their healthcare provider of a known or suspected pregnancy[seeUse in Specific Populations (8.1)].

Lactation

Advise patients that breastfeeding is not recommended during treatment with BELBUCA[seeUse in Specific Populations (8.2)].

Constipation

Advise patients of the potential for severe constipation, including management instructions and when to seek medical attention[seeAdverse Reactions (6),Clinical Pharmacology (12.2)].

Driving or Operating Heavy Machinery

Inform patients that BELBUCA may impair the ability to perform potentially hazardous activities such as driving a car or operating heavy machinery. Advise patients not to perform such tasks until they know how they will react to the medication[seeWarnings and Precautions (5.18)].

Healthcare professionals can telephone BioDelivery Sciences International, Inc. at 1-800-469-0261 or access www.BELBUCA.com for information on this product.

Distributed by:
BioDelivery Sciences International, Inc.
Raleigh, NC 27612 USA

BELBUCA is a trademark of BioDelivery Sciences International, Inc.

2019 BioDelivery Sciences International, Inc. All rights reserved.

BEL-001-PI-OCT2019

This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised October 2019
Medication Guide
BELBUCA(bel-BUE-kuh)
(buprenorphine buccal film), CIII

Belbuca Is: 

  • A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage pain severe enough to require daily around-the-clock, long-term treatment with an opioid, when other pain treatments such as non-opioid pain medicines or immediate-release opioid medicines do not treat your pain well enough or you cannot tolerate them.
  • A long-acting opioid pain medicine that can put you at risk for overdose and death. Even if you take your dose correctly as prescribed, you are at risk for opioid addiction, abuse, and misuse that can lead to death.
  • Not for use to treat pain that is not around-the-clock.

Important Information About Belbuca: 

  • Get emergency help right away if you take too much BELBUCA (overdose).When you first start taking BELBUCA, when your dose is changed, or if you take too much (overdose), serious or life-threatening breathing problems that can lead to death may occur.
  • Taking BELBUCA with other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death.
  • Never give anyone else your BELBUCA. They could die from taking it. Selling or giving away BELBUCA is against the law.
  • Store BELBUCA securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home.

Do Not Use Belbuca If You Have: 

  • severe asthma, trouble breathing, or other lung problems.
  • a bowel blockage or have narrowing of the stomach or intestines.

Before Applying Belbuca, Tell Your Healthcare Provider If You Have A History Of: 

  • head injury, seizures
  • liver, kidney, thyroid problems
  • problems urinating
  • heart rhythm problems (long QT syndrome)
  • pancreas or gallbladder problems
  • abuse of street or prescription drugs, alcohol addiction, or mental health problems

Tell Your Healthcare Provider If You Are: 

  • pregnant or planning to become pregnant.Prolonged use of BELBUCA during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.
  • breastfeeding.Not recommended during treatment with BELBUCA. It may harm your baby.
  • taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking BELBUCA with certain other medicines can cause serious side effects and could lead to death.

When Taking Belbuca: 

  • Do not change your dose. Apply BELBUCA exactly as prescribed by your healthcare provider. Use the lowest effective dose possible for the shortest time needed.
  • See the detailedInstructions for Usefor information about how to apply BELBUCA.
  • Do not apply BELBUCA if the package seal is broken or the film is cut, damaged, or changed in any way.
  • After the film has adhered to your cheek, avoid eating or drinking until the film has completely dissolved, usually within 30 minutes.
  • Avoid touching or moving the buccal film with your tongue or fingers.
  • Do not chew, swallow, snort or inject BELBUCA. This will result in uncontrolled delivery of buprenorphine and may cause you to overdose and die.
  • Call your healthcare provider if the dose you are using does not control your pain.
  • Do not stop using BELBUCA without talking to your healthcare provider.
  • Dispose of expired, unwanted, or unused BELBUCA by removing the BELBUCA film from the foil packaging, and promptly flushing down the toilet (if a drug takeback option is not readily available). Visit www.fda.gov/drugdisposal for additional information on disposal of unused medicines.

While Using Belbuca Do Not: 

  • Drive or operate heavy machinery, until you know how BELBUCA affects you. BELBUCA can make you sleepy, dizzy, or lightheaded.
  • Drink alcohol or use prescription or over-the-counter medicines containing alcohol. Using products containing alcohol during treatment with BELBUCA may cause you to overdose and die.

The Possible Side Effects Of Belbuca Are: 

  • nausea, constipation, headache, vomiting, dizziness, and sleepiness. Call your healthcare provider if you have any of these symptoms and they are severe.

Get Emergency Medical Help If You Have: 

  • trouble breathing, shortness of breath, fast heartbeat, chest pain, swelling of your face, tongue or throat, extreme drowsiness, light-headedness when changing positions, feeling faint, agitation, high body temperature, trouble walking, stiff muscles, or mental changes such as confusion.
These are not all the possible side effects of BELBUCA. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.For more information go to dailymed.nlm.nih.gov
Manufactured for: BioDelivery Sciences International, Inc., Raleigh, NC 27612, www.BELBUCA.com or call 1-800-469-0261.



Your use of this website constitutes your agreement to the terms and conditions linked below:
Terms and Conditions | Resources
2017 © Copyright PharmacyHQ.com. Questions?
Please contact: pharmacyhq.mail@gmail.com