"I love DUOPA™ (carbidopa/levodopa) | Official HCP Site"

2022-10-17 16:57:19

Important Safety Information Prescribing Information & Patient Information Prescribing Information Medication Guide Instructions for Use FOR PATIENTS HOME TELEMEDICINE RESOURCES For Patients @media (min-width: 985px) { #background-container-391721467 .abbv-background-container-display { background-image : url("/content/dam/duopahcp/images/HCP%20Campaign%20Visual%20-%20Setup%20View.jpg"); } } @media (min-width: 601px) and (max-width: 984px) { #background-container-391721467 .abbv-background-container-display{ background-image : url("/content/dam/duopahcp/images/HCP%20Campaign%20Visual%20-%20Setup%20View.jpg"); }} @media (max-width: 600px) { #background-container-391721467 .abbv-background-container-display { background-image : url("/content/dam/duopahcp/images/HCP%20Campaign%20Visual%20-%20Setup%20View.m.jpg"); } } @media (min-width: 985px) { #background-container-1646334822 .abbv-background-container-display { background-image : url("/content/dam/duopahcp/images/HCP%20Campaign%20Visual%20-%20Resolve%20View.jpg"); } } @media (min-width: 601px) and (max-width: 984px) { #background-container-1646334822 .abbv-background-container-display{ background-image : url("/content/dam/duopahcp/images/HCP%20Campaign%20Visual%20-%20Resolve%20View.jpg"); }} @media (max-width: 600px) { #background-container-1646334822 .abbv-background-container-display { background-image : url("/content/dam/duopahcp/images/HCP%20Campaign%20Visual%20-%20Resolve%20View.m.jpg"); } } IT’S TIME TO CHANGE COURSE. Transcript TELEMEDICINE BRINGS NEW MEANING TO “HOUSE CALL” TELEMEDICINE BRINGS NEWMEANING TO “HOUSE CALL” Listen to a Discussion Among Your PeersThis video explores how telemedicine can help healthcare professionals (HCPs) care for their patients with Parkinson’s who are not able to make an office visit. It features 2 HCPs discussing the benefits and challenges of using telemedicine to deliver personalized care to their patients who are taking Duopa. Transcript LEARN MORE AT PEER-LED PRESENTATIONS Please join us for virtual AbbVie educational presentations about Duopa. Register today to reserve your space. VIEW CALENDAR PATIENT RESOURCES FOR DISCUSSING DUOPA A range of resources are available to assist you in virtual discussions with patients and care partners. GET TELEMEDICINE RESOURCES WE’RE HERE TO HELP WE’RE HERE TO HELP Support and information are available for your patients at1-844-386-4968. GO TO DUOCONNECT COMPLETE PATIENT START FORMS DUOPA™ (carbidopa/levodopa) | Official HCP Site Access the DuoConnect Start Form, which includes the Duopa prescription form.  Download Here Get the annotated versions here PATIENT START FORMS Access the DuoConnect Start Form, which includes the Duopa prescription form.  Download Here Get the annotated versions here USING TELEMEDICINE? FIND RESOURCES IMPORTANT SAFETY INFORMATION AND INDICATIONIndication1DUOPA (carbidopa and levodopa) enteral suspension is indicated for the treatment of motor fluctuations in patients with advanced Parkinson’s disease. Important Safety Information1-3DUOPA is contraindicated in patients who are currently taking or have taken (within 2 weeks) a nonselective monoamine oxidase (MAO) inhibitor, as concurrent use can cause hypertension. A percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) is contraindicated with lack of transillumination/positive needle aspiration test; intestinal obstruction; sepsis; peritonitis; serious coagulation disorders; ascites; and neoplastic, inflammatory, and infiltrative diseases of the gastric and abdominal walls.Because DUOPA is administered using a PEG-J or naso-jejunal tube, gastrointestinal complications can occur, including abscess; bezoar; ileus; implant site erosion/ulcer; intestinal hemorrhage, ischemia, obstruction, or perforation; intussusception; pancreatitis; peritonitis; pneumonia (including aspiration pneumonia); pneumoperitoneum; post-operative wound infection; and sepsis, any of which may require surgery or be fatal. Instruct patients to immediately report abdominal pain, prolonged constipation, nausea, vomiting, fever, or melanotic stool.Patients treated with levodopa (a component of DUOPA) have reported falling asleep while engaged in activities of daily living, including the operation of motor vehicles, which sometimes resulted in accidents. Although many of these patients reported somnolence while on levodopa, some perceived that they had no warning signs (sleep attack), such as excessive drowsiness, and believed they were alert immediately prior to the event. For this reason, prescribers should reassess DUOPA-treated patients for drowsiness or sleepiness, especially since some of the events occur well after the start of treatment. Advise patients about the potential to develop drowsiness with DUOPA and ask about factors that may increase risk of somnolence. Consider discontinuing DUOPA in patients who report significant daytime sleepiness or episodes of falling asleep during activities that require active participation. For these patients, if a decision is made to continue DUOPA, advise them to avoid driving and other potentially dangerous activities that might result in harm if the patients become somnolent.Monitor patients for orthostatic hypotension, especially after starting DUOPA or increasing the dose.There is an increased risk for hallucinations, psychosis, and confusion in patients taking DUOPA. Hallucinations associated with levodopa may present shortly after the initiation of therapy and may be responsive to dose reduction of levodopa. Patients with a major psychotic disorder should not be treated with DUOPA.Patients may experience intense urges while on DUOPA. Because patients may not recognize these behaviors as abnormal, it is important for prescribers to ask patients or their caregivers specifically about the development of new or increased gambling urges, sexual urges, uncontrolled spending, binge or compulsive eating, or other urges while on DUOPA. Consider reducing the dose or discontinuing DUOPA if a patient develops such urges.Depression has been reported in patients treated with DUOPA. Monitor patients for depression and concomitant suicidal tendencies.Withdrawal-emergent hyperpyrexia and confusion, a symptom complex that resembles neuroleptic malignant syndrome (characterized by elevated temperature, muscular rigidity, altered consciousness, and autonomic instability), with no other obvious etiology, has been reported in association with rapid dose reduction, withdrawal, or change in dopaminergic therapy. Avoid sudden discontinuation or rapid dose reduction of DUOPA.DUOPA may cause or exacerbate dyskinesias, which may require a dose reduction of DUOPA or other Parkinson’s disease medications.Generalized polyneuropathy has been reported in patients receiving DUOPA. Assess patients for the signs and symptoms of peripheral neuropathy before and periodically after starting DUOPA, especially patients with pre-existing neuropathy, patients taking medications, or those who have medical conditions associated with neuropathy.Myocardial infarction and arrhythmia were reported in patients taking carbidopa-levodopa. Ask patients about symptoms of ischemic heart disease and arrhythmia, especially those with a history of myocardial infarction or cardiac arrhythmias.DUOPA may increase the risk for elevated blood urea nitrogen (BUN) and creatine phosphokinase (CPK). Patients taking levodopa may have increased levels of catecholamines and their metabolites in plasma and urine, giving false positive results that suggest the diagnosis of pheochromocytoma.Monitor patients with glaucoma after starting DUOPA, as it may cause increased intraocular pressure.Drug Interactions: Monitor patients taking selective MAO-B inhibitors and carbidopa-levodopa for orthostatic hypotension. Concurrent administration with antihypertensives may result in postural hypotension, necessitating a dose reduction of the antihypertensive. Co-administration with dopamine D2 antagonists, isoniazid, or iron salts may reduce effectiveness of DUOPA.The most common adverse events for DUOPA, with an incidence at least 7% greater than oral carbidopa-levodopa immediate release (CLIR), were (DUOPA vs CLIR): complication of device insertion (57% vs 44%), nausea (30% vs 21%), depression (11% vs 3%), peripheral edema (8% vs 0%), hypertension (8% vs 0%), upper respiratory tract infection (8% vs 0%), oropharyngeal pain (8% vs 0%), atelectasis (8% vs 0%), and incision site erythema (19% vs 12%).US-DUOP-200202 Please see full Prescribing Information. References: 1. DUOPA [package insert]. North Chicago, IL: AbbVie Inc. 2. AbbVie J Intestinal Tube 9 FR for PEG 15 and 20 FR [instructions for use].North Chicago, IL: AbbVie Inc. 3. AbbVie PEG Percutaneous Endoscopic Gastrostomy Kit [instructions for use]. North Chicago, IL: AbbVie Inc. IMPORTANT SAFETY INFORMATION FULL PRESCRIBING INFORMATION INSTRUCTIONS FOR USE CONTACT US PRIVACY POLICY TERMS OF USE ABBVIE ADVERTISING CHOICES COOKIES SETTINGS ©2021 AbbVie Inc. North Chicago, IL 60064. If you have any questions about this website that have not been answered, click here. This website and the information contained herein is intended for use by US physicians only and is provided for informational purposes only.©2021 AbbVie Inc. North Chicago, IL 60064If you have any questions about this AbbVie Inc. website that have not been answered, contact us. US-DUOP-210130 LEAVING DUOPAHCP.COM You are leaving this AbbVie Web site and connecting to a site that is not under the control of AbbVie. AbbVie is not responsible for the contents of any such site or any further links from such site. AbbVie is providing these links to you only as a convenience and the inclusion of any link does not imply the endorsement of the linked site by AbbVie. You should also be aware that the linked site may be governed by its own set of terms and conditions and privacy policy for which AbbVie has no responsibility.Conversely, the presence of this link does not imply the linked site's endorsement of DuopaHCP.com or AbbVie.Do you wish to leave this site? Yes No US-DUOP-200023 IMPORTANT SAFETY INFORMATION AND INDICATIONIndication1DUOPA (carbidopa and levodopa) enteral suspension is indicated for the treatment of motor fluctuations in patients with advanced Parkinson’s disease. Important Safety Information1-3DUOPA is contraindicated in patients who are currently taking or have taken (within 2 weeks) a nonselective monoamine oxidase (MAO) inhibitor, as concurrent use can cause hypertension. A percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) is contraindicated with lack of transillumination/positive needle aspiration test; intestinal obstruction; sepsis; peritonitis; serious coagulation disorders; ascites; and neoplastic, inflammatory, and infiltrative diseases of the gastric and abdominal walls.Because DUOPA is administered using a PEG-J or naso-jejunal tube, gastrointestinal complications can occur, including abscess; bezoar; ileus; implant site erosion/ulcer; intestinal hemorrhage, ischemia, obstruction, or perforation; intussusception; pancreatitis; peritonitis; pneumonia (including aspiration pneumonia); pneumoperitoneum; post-operative wound infection; and sepsis, any of which may require surgery or be fatal. Instruct patients to immediately report abdominal pain, prolonged constipation, nausea, vomiting, fever, or melanotic stool.Patients treated with levodopa (a component of DUOPA) have reported falling asleep while engaged in activities of daily living, including the operation of motor vehicles, which sometimes resulted in accidents. Although many of these patients reported somnolence while on levodopa, some perceived that they had no warning signs (sleep attack), such as excessive drowsiness, and believed they were alert immediately prior to the event. For this reason, prescribers should reassess DUOPA-treated patients for drowsiness or sleepiness, especially since some of the events occur well after the start of treatment. Advise patients about the potential to develop drowsiness with DUOPA and ask about factors that may increase risk of somnolence. Consider discontinuing DUOPA in patients who report significant daytime sleepiness or episodes of falling asleep during activities that require active participation. For these patients, if a decision is made to continue DUOPA, advise them to avoid driving and other potentially dangerous activities that might result in harm if the patients become somnolent.Monitor patients for orthostatic hypotension, especially after starting DUOPA or increasing the dose.There is an increased risk for hallucinations, psychosis, and confusion in patients taking DUOPA. Hallucinations associated with levodopa may present shortly after the initiation of therapy and may be responsive to dose reduction of levodopa. Patients with a major psychotic disorder should not be treated with DUOPA.Patients may experience intense urges while on DUOPA. Because patients may not recognize these behaviors as abnormal, it is important for prescribers to ask patients or their caregivers specifically about the development of new or increased gambling urges, sexual urges, uncontrolled spending, binge or compulsive eating, or other urges while on DUOPA. Consider reducing the dose or discontinuing DUOPA if a patient develops such urges.Depression has been reported in patients treated with DUOPA. Monitor patients for depression and concomitant suicidal tendencies.Withdrawal-emergent hyperpyrexia and confusion, a symptom complex that resembles neuroleptic malignant syndrome (characterized by elevated temperature, muscular rigidity, altered consciousness, and autonomic instability), with no other obvious etiology, has been reported in association with rapid dose reduction, withdrawal, or change in dopaminergic therapy. Avoid sudden discontinuation or rapid dose reduction of DUOPA.DUOPA may cause or exacerbate dyskinesias, which may require a dose reduction of DUOPA or other Parkinson’s disease medications.Generalized polyneuropathy has been reported in patients receiving DUOPA. Assess patients for the signs and symptoms of peripheral neuropathy before and periodically after starting DUOPA, especially patients with pre-existing neuropathy, patients taking medications, or those who have medical conditions associated with neuropathy.Myocardial infarction and arrhythmia were reported in patients taking carbidopa-levodopa. Ask patients about symptoms of ischemic heart disease and arrhythmia, especially those with a history of myocardial infarction or cardiac arrhythmias.DUOPA may increase the risk for elevated blood urea nitrogen (BUN) and creatine phosphokinase (CPK). Patients taking levodopa may have increased levels of catecholamines and their metabolites in plasma and urine, giving false positive results that suggest the diagnosis of pheochromocytoma.Monitor patients with glaucoma after starting DUOPA, as it may cause increased intraocular pressure.Drug Interactions: Monitor patients taking selective MAO-B inhibitors and carbidopa-levodopa for orthostatic hypotension. Concurrent administration with antihypertensives may result in postural hypotension, necessitating a dose reduction of the antihypertensive. Co-administration with dopamine D2 antagonists, isoniazid, or iron salts may reduce effectiveness of DUOPA.The most common adverse events for DUOPA, with an incidence at least 7% greater than oral carbidopa-levodopa immediate release (CLIR), were (DUOPA vs CLIR): complication of device insertion (57% vs 44%), nausea (30% vs 21%), depression (11% vs 3%), peripheral edema (8% vs 0%), hypertension (8% vs 0%), upper respiratory tract infection (8% vs 0%), oropharyngeal pain (8% vs 0%), atelectasis (8% vs 0%), and incision site erythema (19% vs 12%).US-DUOP-200202 YOU ARE ABOUT TO ENTER A SITE THAT IS FOR US HEALTHCARE PROFESSIONALS ONLY. By clicking Yes, I certify that I am a licensed US healthcare professional and wish to proceed with registering for this educational event.Do you wish to leave this site? Yes No US-DUOP-210130 Indication1DUOPA (carbidopa and levodopa) enteral suspension is indicated for the treatment of motor fluctuations in patients with advanced Parkinson’s disease.Important Safety Information1-3DUOPA is contraindicated in patients who are currently taking or have taken (within 2 weeks) a nonselective monoamine oxidase (MAO) inhibitor, as concurrent use can cause hypertension. A percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) is contraindicated with lack of transillumination/positive needle aspiration test; intestinal obstruction; sepsis; peritonitis; serious coagulation disorders; ascites; and neoplastic, inflammatory, and infiltrative diseases of the gastric and abdominal walls.Important Safety Information1-3DUOPA is contraindicated in patients who are currently taking or have taken (within 2 weeks) a nonselective monoamine oxidase (MAO) inhibitor, as concurrent use can causeIndication1DUOPA (carbidopa and levodopa) enteral suspension is indicated for the treatment of motor fluctuations in patients with advanced Parkinson’s disease.Important Safety Information1-3DUOPA is contraindicated in patients who are currently taking or have taken (within 2 weeks) a nonselective monoamine oxidase (MAO) inhibitor, as concurrent use can cause hypertension. A percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) is contraindicated with lack of transillumination/positive needle aspiration test; intestinal obstruction; sepsis; peritonitis; serious coagulation disorders; ascites; and neoplastic, inflammatory, and infiltrative diseases of the gastric and abdominal walls.Important Safety Information1-3DUOPA is contraindicated in patients who are currently taking or have taken (within 2 weeks) a nonselective monoamine oxidase (MAO) inhibitor, as concurrent use can cause IMPORTANT SAFETY INFORMATION AND INDICATIONIndication1DUOPA (carbidopa and levodopa) enteral suspension is indicated for the treatment of motor fluctuations in patients with advanced Parkinson’s disease. Important Safety Information1-3DUOPA is contraindicated in patients who are currently taking or have taken (within 2 weeks) a nonselective monoamine oxidase (MAO) inhibitor, as concurrent use can cause hypertension. A percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) is contraindicated with lack of transillumination/positive needle aspiration test; intestinal obstruction; sepsis; peritonitis; serious coagulation disorders; ascites; and neoplastic, inflammatory, and infiltrative diseases of the gastric and abdominal walls.Because DUOPA is administered using a PEG-J or naso-jejunal tube, gastrointestinal complications can occur, including abscess; bezoar; ileus; implant site erosion/ulcer; intestinal hemorrhage, ischemia, obstruction, or perforation; intussusception; pancreatitis; peritonitis; pneumonia (including aspiration pneumonia); pneumoperitoneum; post-operative wound infection; and sepsis, any of which may require surgery or be fatal. Instruct patients to immediately report abdominal pain, prolonged constipation, nausea, vomiting, fever, or melanotic stool.Patients treated with levodopa (a component of DUOPA) have reported falling asleep while engaged in activities of daily living, including the operation of motor vehicles, which sometimes resulted in accidents. Although many of these patients reported somnolence while on levodopa, some perceived that they had no warning signs (sleep attack), such as excessive drowsiness, and believed they were alert immediately prior to the event. For this reason, prescribers should reassess DUOPA-treated patients for drowsiness or sleepiness, especially since some of the events occur well after the start of treatment. Advise patients about the potential to develop drowsiness with DUOPA and ask about factors that may increase risk of somnolence. Consider discontinuing DUOPA in patients who report significant daytime sleepiness or episodes of falling asleep during activities that require active participation. For these patients, if a decision is made to continue DUOPA, advise them to avoid driving and other potentially dangerous activities that might result in harm if the patients become somnolent.Monitor patients for orthostatic hypotension, especially after starting DUOPA or increasing the dose.There is an increased risk for hallucinations, psychosis, and confusion in patients taking DUOPA. Hallucinations associated with levodopa may present shortly after the initiation of therapy and may be responsive to dose reduction of levodopa. Patients with a major psychotic disorder should not be treated with DUOPA.Patients may experience intense urges while on DUOPA. Because patients may not recognize these behaviors as abnormal, it is important for prescribers to ask patients or their caregivers specifically about the development of new or increased gambling urges, sexual urges, uncontrolled spending, binge or compulsive eating, or other urges while on DUOPA. Consider reducing the dose or discontinuing DUOPA if a patient develops such urges.Depression has been reported in patients treated with DUOPA. Monitor patients for depression and concomitant suicidal tendencies.Withdrawal-emergent hyperpyrexia and confusion, a symptom complex that resembles neuroleptic malignant syndrome (characterized by elevated temperature, muscular rigidity, altered consciousness, and autonomic instability), with no other obvious etiology, has been reported in association with rapid dose reduction, withdrawal, or change in dopaminergic therapy. Avoid sudden discontinuation or rapid dose reduction of DUOPA.DUOPA may cause or exacerbate dyskinesias, which may require a dose reduction of DUOPA or other Parkinson’s disease medications.Generalized polyneuropathy has been reported in patients receiving DUOPA. Assess patients for the signs and symptoms of peripheral neuropathy before and periodically after starting DUOPA, especially patients with pre-existing neuropathy, patients taking medications, or those who have medical conditions associated with neuropathy.Myocardial infarction and arrhythmia were reported in patients taking carbidopa-levodopa. Ask patients about symptoms of ischemic heart disease and arrhythmia, especially those with a history of myocardial infarction or cardiac arrhythmias.DUOPA may increase the risk for elevated blood urea nitrogen (BUN) and creatine phosphokinase (CPK). Patients taking levodopa may have increased levels of catecholamines and their metabolites in plasma and urine, giving false positive results that suggest the diagnosis of pheochromocytoma.Monitor patients with glaucoma after starting DUOPA, as it may cause increased intraocular pressure.Drug Interactions: Monitor patients taking selective MAO-B inhibitors and carbidopa-levodopa for orthostatic hypotension. Concurrent administration with antihypertensives may result in postural hypotension, necessitating a dose reduction of the antihypertensive. Co-administration with dopamine D2 antagonists, isoniazid, or iron salts may reduce effectiveness of DUOPA.The most common adverse events for DUOPA, with an incidence at least 7% greater than oral carbidopa-levodopa immediate release (CLIR), were (DUOPA vs CLIR): complication of device insertion (57% vs 44%), nausea (30% vs 21%), depression (11% vs 3%), peripheral edema (8% vs 0%), hypertension (8% vs 0%), upper respiratory tract infection (8% vs 0%), oropharyngeal pain (8% vs 0%), atelectasis (8% vs 0%), and incision site erythema (19% vs 12%).US-DUOP-200202