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AbbVie Limited

Citywest Business Campus, Dublin 24, Ireland
Telephone: +353 1 428 7900
Fax: +353 1 428 7940
Summary of Product Characteristics last updated on medicines.ie: 15/12/2017
SPC Duodopa intestinal gel

When a pharmaceutical company changes an SPC or PIL, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 15/12/2017 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   07-Dec-2017
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company



Section 4.4   Special warnings and precautions for use

The following bullet point has been added:

Dopamine Dysregulation Syndrome (DDS) is an addictive disorder resulting in excessive use of the product seen in some patients treated with levodopa/carbidopa. Before initiation of treatment, patients and caregivers should be warned of the potential risk of developing DDS (see also section 4.8).

 

 Section 4.8 Undesirable effects

The adverse reaction Dopamine dysregulation syndromed  has been added been added to Table 1; MedDRA System Organ Class: Psychiatric disorders,  (Frequency Unknown Post-marketing) , followed by the inclusion of the following footnote:

d Dopamine Dysregulation Syndrome (DDS) is an addictive disorder seen in some patients treated with levodopa/ carbidopa. Affected patients show a compulsive pattern of dopaminergic drug misuse above doses adequate to control motor symptoms, which may in some cases result in severe dyskinesias (see also section 4.4).

 

Section 10 Date of Revision of text

Updated to December 2017

Updated on 20/10/2017 and displayed until 15/12/2017
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.4 - Special precautions for storage
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   10-Oct-2017
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company



Section 1

“Duodopa, 20 mg/ml + 5 mg/ml, intestinal gel”  has been amended to “Duodopa 20 mg/ml + 5 mg/ml intestinal gel”

Section 2

“For a full list of excipients, see section 6.1.”   revised to “For the full list of excipients, see section 6.1.

Section 4.1

Amended to read:

Treatment of advanced levodopa-responsive Parkinson’s disease with severe motor fluctuations and hyperkinesia / or dyskinesia when available combinations of Parkinson medicinal products have not given satisfactory results.

Section 4.2

The below section amended to read:

Dosage:

The total dose/day of Duodopa is composed of three individually adjusted doses: the morning bolus dose, the continuous maintenance dose and extra bolus doses administered over approximately 16 hours. In addition to daytime, if medically justified Duodopa may be administered during the night.

The drug  medicine cassettes are for single use only and should not be used for longer than 16 hours, even if some medicinal product remains. Do not reuse an opened cassette.

By the end of the storage time the gel might become slightly yellow. This does not influence the concentration of the drug medicine or the treatment.

The statement “If medically justified Duodopa may be administered during the night.” has been deleted lower down in the section.

Section 4.3

The following bullet has been amended to read:

       hypersensitivity to levodopa, carbidopa the active substances or to any of the excipients listed in section 6.1.

Section 4.4

The following bullet has been amended to read:

Epidemiological studies have shown that patients with Parkinson’s disease have a higher risk of developing melanoma than the general population. It is unclear whether the increased risk observed was due to Parkinson’s disease or other factors, such as drugs medicines used to treat Parkinson’s disease.

 

Section 4.8

Angle closure glaucoma has been added to Table 1 (uncommon).

 

Section 5.1

The below paragraph has been amended as follows:

Analyses of other secondary efficacy endpoints, in order of the hierarchical testing procedure, demonstrated statistically significant results for Duodopa compared to oral levodopa/-carbidopa for the Parkinson's Disease Questionnaire (PDQ-39) Summary Index (an index Parkinson’s disease-related quality of life), Clinical Global Impression (CGI-I) score, and Unified Parkinson's Disease Rating Scale (UPDRS) Part II score (ADL - Activities of Daily Living (ADL)). The PDQ-39 Summary Index showed a decrease from baseline of 10.9 points at week 12. Other secondary endpoints, UPDRS Part III score, EQ-5D Summary Index, and ZBI total score, did not meet statistical significance based on the hierarchical testing procedure

 

Section 6.4

“Store in a refrigerator (2°C-8°C).” has been amended to read  

“Store and transport refrigerated (2°C-8°C).”

 

Section 10

Date of Revision of text has been amended to October 2017.

Updated on 08/06/2016 and displayed until 20/10/2017
Reasons for adding or updating:
  • Change to section 9 - Date of renewal of authorisation
  • Correction of spelling/typing errors
Date of revision of text on the SPC:   25-May-2016
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

Section 9
Date of first authorisation corrected to 18 November 2005
Updated on 27/05/2016 and displayed until 08/06/2016
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
Date of revision of text on the SPC:   25-May-2016
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

Section 4.4 (Special warnings and precautions for use)
  • The following has been updated:

    From 

Reported complications in the clinical studies, include bezoar, ileus, implant site erosion/ulcer, intestinal haemorrhage, intestinal ischaemia, intestinal obstruction, intestinal perforation, pancreatitis, peritonitis, pneumoperitoneum and post-operative wound infection. Bezoars are retained concretions of undigested food material in the intestinal tract.  Most bezoars reside in the stomach but bezoars may be encountered elsewhere in the intestinal tract.  Abdominal pain may be a symptom of the above listed complications. Some events may result in serious outcomes, such as surgery and/or death. Patients should be advised to notify their physician if they experience any of the symptoms associated with the above events.

To

  •        Reported complications in the clinical studies, and seen Post-marketing, include bezoar, ileus, implant site erosion/ulcer, intestinal haemorrhage, intestinal ischaemia, intestinal obstruction, intestinal perforation, intussusception, pancreatitis, peritonitis, pneumoperitoneum and post-operative wound infection. Bezoars are retained concretions of   undigested food indigestible material (such as vegetable or fruit non-digestible fibers) in the intestinal tract.  Most bezoars reside in the stomach but bezoars may be encountered elsewhere in the intestinal tract. A bezoar around the tip of the jejunal tube may function as a lead point for intestinal obstruction or the formation of intussusception. Abdominal pain may be a symptom of the above listed complications. Some events may result in serious outcomes, such as surgery and/or death. Patients should be advised to notify their physician if they experience any of the symptoms associated with the above events.


    Section 4.8 (Undesirable effects)
    • Intussusception added to the list of Device and Procedure Related Adverse Reactions

Updated on 03/03/2016 and displayed until 27/05/2016
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   23-Feb-2016
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

Section 7

Address changed from

AbbVie Limited

Block B

Liffey Valley Office Campus

Quarryvale

Co. Dublin

to

AbbVie Limited

Citywest Business Park

Dublin 24

Ireland

Updated on 16/07/2015 and displayed until 03/03/2016
Reasons for adding or updating:
  • Change to section 4.7 - Effects on ability to drive and use machines
Date of revision of text on the SPC:   19-May-2015
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

Section 4.7
Correction of wording:



"Duodopa has a major influence on the ability to drive and use machines."   changed to "Duodopa can have a major influence on the ability to drive and use machines."
Updated on 25/05/2015 and displayed until 16/07/2015
Reasons for adding or updating:
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
Date of revision of text on the SPC:   19-May-2015
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company



Update  to the  contact details in section 4.8 of the SmPC (from IMB to HPRA) for the reporting of suspected adverse reactions.

Updated on 11/06/2014 and displayed until 25/05/2015
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
Date of revision of text on the SPC:   26-May-2014
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company



1) Section 4.1: Removal of the statement requiring the use of a nasoduodenal tube prior to insertion of permanent tube. This change is the consequence of change in Section 4.2.

2) Section 4.2:   Update the use of the nasoduodenal tube for the determination of patient response to Duodopa® prior to duodenal/jejunal tube placement from recommended to “based on physician judgement”.  Specify the pump model to be used with the cassettes. Include a dosing table, other dosing instructions and clarify tubing location.  Clarify the dosage recommendations in renally/hepatically impaired patients.

3) Section 4.3: Removing the contraindication severe liver and renal insufficiency. Non-selective MAO inhibitors and selective MAO type A inhibitors are contraindicated. Clarify that MAO Type B inhibitors may be administered concomitantly with Duodopa®.    Include a contraindication for use in patients with suspicious undiagnosed skin lesions or a history of melanoma.

4) Section 4.4:    Include the precaution that patients with Parkinson’s have a higher risk of developing melanoma than the general population. Removal of the specific precaution paragraph about bezoar and include it in a proposed precaution section about reported complications in the clinical studies that include bezoar, ileus, implant site erosion/ulcer, intestinal haemorrhage, intestinal ischemia, intestinal obstruction, intestinal perforation, pancreatitis, peritonitis, pneumoperitoneum and post-operative wound infection.

5) Section 4.5 this sentence is added:  The dose of levodopa may need to be reduced when an MAO inhibitor selective for type B is added.

6) Sections 4.6 and 4.7 are updated in line with the current QRD template.

7) Section 4.8    Include undesirable effects derived from clinical trials. Create a new table that includes ADRs derived from clinical trials and post-marketing. This table is divided in two sections; drug-related adverse reactions section, and device- and procedure-related adverse reactions section. Include a new table containing additional adverse reactions that have been observed with oral levodopa/carbidopa and could occur with Duodopa.

8) Section 5.1    Update the summary of pharmacodynamic to include the results of new studies using Duodopa® including a new Phase 1 study and a new Phase 3 study comparing Duodopa® to oral levodopa/carbidopa formulations.

9) Section 5.2    Update the summary of pharmacokinetic effects to include the results of new studies using Duodopa® including a new Phase 1 study and a new Phase 3 study comparing Duodopa® to oral levodopa/carbidopa formulations.

10) Section 5.3    Toxicity to reproduction is removed from the first paragraph.

Updated on 24/10/2013 and displayed until 11/06/2014
Reasons for adding or updating:
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   15-Oct-2013
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

Section 6.3 (Shelf Life)


The statement “Chemical and physical in-use stability has been demonstrated for 16 hours at 40°C.”  has been  by the proposed statement, “The product is to be used for up to 16 hours once it is out of the refrigerator.”

Section 6.4 (Special precautions for storage)

The following statement has been added:

"For storage conditions after first opening of the medicinal product, see section 6.3."
Updated on 11/04/2013 and displayed until 24/10/2013
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.4 - Special warnings and precautions for use
Date of revision of text on the SPC:   27-Mar-2013
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

Section 4.4 & 4.8 updated regarding regarding the risk of Impulse Control Disorders for levodopa, dopamine agonists and COMT-inhibitors.
Updated on 22/02/2013 and displayed until 11/04/2013
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
Date of revision of text on the SPC:   01-Feb-2013
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

Marketing Authorisation Holder has been changed to AbbVie
Updated on 27/11/2012 and displayed until 22/02/2013
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   24-Oct-2012
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

The following text was added to section4.4:

         Isolated reports have been received describing gastrostomy tube blockage and/or intestinal obstruction with bezoar formation, necessitating replacement of tubing and in rare cases surgery.  Early symptoms include aggravation of Parkinson’s symptoms, reduced efficacy, abdominal pain, nausea and vomiting.  In some cases, gastric and intestinal ulcerations have been found.  Bezoars are retained concretions of indigested food material in the intestinal tract.  Most bezoars are found in the stomach but bezoars may be encountered elsewhere in the intestinal tract.

The following text was added to section 4.8 :
There have been isolated reports of bezoar formation (see 4.4)

Updated on 19/04/2012 and displayed until 27/11/2012
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   16-Apr-2012
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

Section 4.2

Dosage:

The following statement was added: " The maximum recommended daily dose is 200 ml (see section 4.4)

Section 4.8

Undesirable effects:

The following statement was added below the MEDRA table:

"Other adverse reactions have been reported in association with levodopa/ carbidopa combinations including Duodopa:

Patients treated with dopamine agonists for treatment of Parkinson´s disease, including levodopa/ carbidopa, especially at high doses, have been reported as showing pathological gambling, increased libido and hypersexuality, generally reversible upon reduction of the dose or treatment discontinuation"

The following statement was removed:
"Patients treated with dopamine agonists for treatment of Parkinson´s disease, including levodopa/carbidopa, especially at high doses, have been reported as showing pathological gambling, increased libido and hypersexuality, generally reversible upon reduction of the dose or treatment discontinuation"

Updated on 05/10/2010 and displayed until 19/04/2012
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.3 - Preclinical safety data
  • Change to section 7 - Marketing authorisation holder
Date of revision of text on the SPC:   01-Oct-2010
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company



Section 4.2

 

From:

 

Morning bolus dose: 140 mg = 7 ml (including the volume to fill the intestinal tube)

 

To:

 

Morning bolus dose: 140 mg = 7 ml (excluding the volume to fill the intestinal tube)

 

 

Section 4.4

 

The following statement has been included;

 

Duodopa contains hydrazine, a degradation product of carbidopa that can be genotoxic and possibly carcinogenic. The average recommended daily dose of Duodopa is 100 ml, containing 2 g levodopa and 0.5 g carbidopa. The maximum recommended daily dose is 200 ml. This includes hydrazine at up to an average exposure of 4 mg/day, with a maximum of 8 mg/day. The clinical significance of this hydrazine exposure is not known.

 

 

Section 4.8

 

The frequency sub headings have been updated.

 

 

Section 5.3

 

The following statement has been included;

 

Hydrazine is a degradation product of Carbidopa. In animal studies, hydrazine showed notable systemic toxicity, particularly by inhalation exposure. These studies reported that hydrazine is hepatotoxic, has CNS toxicities (although not described after oral treatment), and is genotoxic as well as carcinogenic (see also section 4.4).

 

Section 7:

 

From:

 

Solvay Pharmaceuticals GmbH

Hans-Boeckler-Allee 20

D-30173 Hannover

Germany

 

 

To:

 

Abbott Products GmbH

Hans-Boeckler-Allee 20

D-30173 Hannover

Germany

 

 

 

Updated on 12/07/2010 and displayed until 05/10/2010
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.3 - Shelf life
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 9 - Date of renewal of authorisation
Date of revision of text on the SPC:   10-Jun-2010
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

Section 4.8:
Flare ups have been removed
The following has also changed from (changes in bold):

The device: Complications with the device are very common (>1/10), e.g. connector leakage, dislocation of the intestinal tube. Dislocation of the intestinal tube backwards into the stomach leads to reappearance of motor fluctuations (due to erratic gastric emptying of Duodopa into the small intestines). In general, relocation of the tube can be done using a guide-wire to steer the tube into the duodenum under fluoroscopy. Occlusion, kinks, or knots of the intestinal tube lead to high pressure signals from the pump. Occlusions are usually remedied by flushing the tube with tap water; kinking, knotting, or a tube replacement may need readjustment of the tubing. Should complete failure of the intestinal tube or pump occur the patient must be treated with oral levodopa/carbidopa until the problem is solved. The stoma usually heals without complications. However, abdominal pain, infection and leakage of gastric fluid may occur shortly after surgery; it is rarely a problem long-term. Reported complications include wound infection (the most common complication) and peritonitis. Local infections around the stoma are treated conservatively with a disinfectant. Treatment with antibiotics is rarely needed.

To:

The device: Complications with the device are very common (>1/10), e.g. connector leakage, dislocation of the intestinal tube. Dislocation of the intestinal tube backwards into the stomach leads to reappearance of motor fluctuations (due to erratic gastric emptying of Duodopa into the small intestines). In general, relocation of the tube can be done using a guide-wire to steer the tube into the duodenum under fluoroscopy. Occlusion, kinks, or knots of the intestinal tube lead to high pressure signals from the pump. Occlusions are usually remedied by flushing the tube with tap water; kinking, knotting, or a tube displacement may need readjustment of the tubing. Should complete failure of the intestinal tube or pump occur the patient must be treated with oral levodopa/carbidopa until the problem is solved. The stoma usually heals without complications. However, abdominal pain, infection and leakage of gastric fluid may occur shortly after surgery; it is rarely a problem long-term. Reported complications include perforation of adjacent anatomical structures especially during PEG placement and bleeding, wound infection (the most common complication) and peritonitis. Local infections around the stoma are treated conservatively with a disinfectant. Treatment with antibiotics is rarely needed.

Section 6.3:

From:
15 weeks.
Chemical and physical in-use stability has been demonstrated for 16 hours at 40°C.

To:
Unopened: 15 weeks.
Once opened: Use immediately. Discard any unused portion.
Chemical and physical in-use stability has been demonstrated for 16 hours at 40°C.

Section 6.6:

From:
Any unused product or waste material should be disposed of in accordance with local requirements.
Empty/used cassettes should be returned to the pharmacy for destruction.

To:
Cassettes are for single use only.
Do not re-use an opened cassette.
Any unused product or waste material should be disposed of in accordance with local requirements.
Empty/used cassettes should be returned to the pharmacy for destruction.


Section 9:

From:
21 January 2004

To:
Date of first authorisation: 18 November 2005
Date of last renewal: 21 January 2009

Updated on 27/08/2008 and displayed until 12/07/2010
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
   Levodopa
   Carbidopa Monohydrate