BDSI remains committed to the chronic pain community during the COVID-19 pandemic. For
more
information on access to our products, please call our
customer service line at 1-800-469-0261.
BDSI offers a diverse portfolio of solutions for the treatment of chronic pain and other serious and debilitating chronic conditions.
BELBUCA® (buprenorphine) is a medication administered to help manage chronic pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. It is administered using BioErodible MucoAdhesive (BEMA®) technology.
ContraindicationsFor more information on BELBUCA® visit www.belbuca.com
Medication Guide Full Prescribing InformationMedication Guide
BELBUCA (bel-BUE-kuh) (buprenorphine buccal film), CIII
BELBUCA is:
Important information about BELBUCA:
WARNING: ADDICTION, ABUSE, AND MISUSE: RISK EVALUATION AND MITIGATION STRATEGY (REMS); LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL EXPOSURE; NEONATAL OPIOID WITHDRAWAL SYNDROME; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES AND OTHER CNS DEPRESSANTS
See full prescribing information for complete boxed warning.
Do not use BELBUCA if you have:
Before applying BELBUCA, tell your healthcare provider if you have a history of:
Tell your healthcare provider if you are:
While using BELBUCA:
While using BELBUCA DO NOT:
The possible side effects of BELBUCA are:
Get emergency medical help if you have:
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.
Symproic® (naldemedine) is an opioid antagonist indicated for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (eg, weekly) opioid dosage escalation.
ContraindicationsFor more information on Symproic® visit www.symproic.com
Medication Guide Full Prescribing InformationMEDICATION GUIDE
What is the most important information I should know about SYMPROIC?
SYMPROIC may cause serious side effects, including:
What is SYMPROIC?
SYMPROIC is a prescription medicine used to treat constipation that is caused by prescription pain medicines called opioids, in adults with long-lasting (chronic) pain that is not caused by active cancer.
It is not known if SYMPROIC is safe and effective in children.
Do not take SYMPROIC if you:
Before you take SYMPROIC, tell your healthcare provider about all of your medical conditions, including if you:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Other medicines may affect the way SYMPROIC works.
How should I take SYMPROIC?
What are the possible side effects of SYMPROIC?
See “What is the most important information I should know about SYMPROIC?”
The most common side effects of SYMPROIC include stomach (abdomen) pain, diarrhea, nausea and vomiting (gastroenteritis).
Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of SYMPROIC. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store SYMPROIC?
Keep SYMPROIC and all medicines out of the reach of children.
General information about the safe and effective use of SYMPROIC.
Medicines are sometimes prescribed for purposes other than those in a Medication Guide. Do not take SYMPROIC for a condition for which it was not prescribed. Do not give SYMPROIC to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about SYMPROIC that is written for health professionals.
What are the ingredients in SYMPROIC?
Active Ingredient: naldemedine tosylate
Inactive ingredients: D-mannitol, croscarmellose sodium, magnesium stearate, hypromellose, talc, and yellow ferric oxide.
Manufactured for: BioDelivery Sciences International, Inc. Raleigh, NC 27612
Please see Full Prescribing Information and Medication Guide for SYMPROIC.
To report SUSPECTED ADVERSE REACTIONS, contact BioDelivery Sciences International, Inc. at 1-800-469-0261 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
BELBUCA®, BDSI®, and BEMA® are registered trademarks of BioDelivery Sciences International, Inc. All other trademarks and trade names are the property of their respective owners.
Oral Presentation of Data from Phase I Safety Study & Secondary Respiratory Outcomes Comparing BELBUCA ® to Oxycodone on January 16 from 1:10pm – 2:10pm CT RALEIGH, N.C. , Jan. 15, 2021 (GLOBE NEWSWIRE) -- BioDelivery Sciences International , Inc. (NASDAQ: BDSI), a rapidly growing specialty
Read moreRALEIGH, N.C. , Nov. 20, 2020 (GLOBE NEWSWIRE) -- BioDelivery Sciences International , Inc. (NASDAQ: BDSI), a rapidly growing specialty pharmaceutical company dedicated to patients living with serious and complex chronic conditions, today announced that Jeff Bailey , Chief Executive Officer, and
Read moreRALEIGH, N.C. , Nov. 11, 2020 (GLOBE NEWSWIRE) -- BioDelivery Sciences International, Inc. (NASDAQ: BDSI), a rapidly growing specialty pharmaceutical company dedicated to patients living with serious and complex chronic conditions, today announced that Jeffrey Bailey , Chief Executive Officer, and
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