DUOPA- carbidopa and levodopa suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Levodopa (UNII: 46627O600J) (Levodopa - UNII:46627O600J), Carbidopa (UNII: MNX7R8C5VO) (Carbidopa Anhydrous - UNII:KR87B45RGH)

Available from:

AbbVie Inc.

INN (International Name):

Levodopa

Composition:

Levodopa 20 mg in 1 mL

Administration route:

ENTERAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

DUOPA® is indicated for the treatment of motor fluctuations in patients with advanced Parkinson’s disease. DUOPA is contraindicated in patients who are currently taking a nonselective monoamine oxidase (MAO) inhibitor (e.g., phenelzine and tranylcypromine) or have recently (within 2 weeks) taken a nonselective MAO inhibitor. Hypertension can occur if these drugs are used concurrently [see Drug Interactions ( 7.1 and 7.2 )] . Risk Summary There are no adequate data on the developmental risk associated with the use of DUOPA in pregnant women. In animal studies, carbidopa-levodopa has been shown to be developmentally toxic (including teratogenic effects) at clinically relevant doses (see Data) . The estimated background risk of major birth defects and miscarriage in the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data When administ

Product summary:

Single-use cassettes containing 4.63 mg carbidopa (as 5 mg of the monohydrate) and 20 mg levodopa per mL of enteral suspension. Each cassette contains approximately 100 mL of suspension. Carton of 7 DUOPA cassettes: NDC 0074-3012-07 Store in freezer at -20o C (-4o F). Thaw in refrigerator at 2o C to 8o C (36o F to 46o F) prior to dispensing. Cassettes should be protected from light and kept in the carton prior to use. Thawing instructions for pharmacies

Authorization status:

New Drug Application

Patient Information leaflet

AbbVie Inc.
----------
MEDICATION GUIDE
DUOPA (Do-oh-pa)
(carbidopa and levodopa) enteral suspension
Read this Medication Guide before you start using DUOPA and each time
you get a refill. There may be new
information. This information does not take the place of talking to
your healthcare provider about your
medical condition or treatment.
What is the most important information I should know about DUOPA?
DUOPA can cause serious side effects, including:
•
Stomach and intestine (gastrointestinal) problems and problems from
the procedure you will need to
have to receive DUOPA (gastrointestinal procedure-related problems).
Some of these problems may require surgery and may lead to death.
○ a blockage of your stomach or intestines (bezoar)
○ stopping movement through intestines (ileus)
○ drainage, redness, swelling, pain, feeling of warmth around the
small hole in your stomach wall
(stoma)
○ bleeding from stomach ulcers or your intestines
○ inflammation of your pancreas (pancreatitis)
○ infection in your lungs (pneumonia)
○ air or gas in your abdominal cavity
○ skin infection around the intestinal tube, pocket of infection
(abscess), infection in your blood
(sepsis) or abdominal cavity may occur, after surgery
○ stomach pain, nausea or vomiting
•
Tell your healthcare provider right away if you have any of the
following symptoms of stomach and
intestine problems and gastrointestinal procedure-related problems:
○ stomach (abdominal) pain
○ constipation that does not go away
○ nausea or vomiting
○ fever
○ blood in your stool or a dark tarry stool (melanotic stool)
You will need to have a procedure to make a small hole (called a
“stoma”) in your stomach wall to place a
gastro-jejunostomy tube (called a PEG-J tube) in an area of your small
intestine called the jejunum. DUOPA
is delivered directly to your small intestine through this tube. Your
healthcare provider will talk to you about
the stoma procedure. Before the stoma procedure, tell your healthcare
provider if you have ever had a s

Summary of Product characteristics

DUOPA- CARBIDOPA AND LEVODOPA SUSPENSION
ABBVIE INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DUOPA SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR DUOPA.
DUOPA (CARBIDOPA AND LEVODOPA) ENTERAL SUSPENSION
INITIAL U.S. APPROVAL: 1975
INDICATIONS AND USAGE
DUOPA is a combination of carbidopa (an aromatic amino acid
decarboxylation inhibitor) and levodopa (an
aromatic amino acid) indicated for the treatment of motor fluctuations
in patients with advanced
Parkinson’s disease (1)
DOSAGE AND ADMINISTRATION
The maximum recommended daily dose of DUOPA is 2000 mg of levodopa
(i.e., one cassette per day)
administered over 16 hours (2.1)
Prior to initiating DUOPA, convert patients from all forms of levodopa
to oral immediate-release
carbidopa-levodopa tablets (1:4 ratio) (2.2)
Titrate total daily dose based on clinical response for the patient
(2.2)
Administer DUOPA into the jejunum through a percutaneous endoscopic
gastrostomy with jejunal tube
(PEG-J) with the CADD®-Legacy 1400 portable infusion pump (2.3)
DOSAGE FORMS AND STRENGTHS
Enteral Suspension: 4.63 mg carbidopa and 20 mg levodopa per mL (3)
CONTRAINDICATIONS
DUOPA is contraindicated in patients taking nonselective monoamine
oxidase (MAO) inhibitors (4)
WARNINGS AND PRECAUTIONS
Gastrointestinal procedure-related complications may result in serious
outcomes, such as need for
surgery or death (5.1)
May cause falling asleep during activities of daily living (5.2)
Monitor patients for orthostatic hypotension, especially after
starting DUOPA or increasing the dose
(5.3)
Hallucinations/Psychosis/Confusion: May respond to dose reduction in
levodopa (5.4)
Impulse Control Disorders: Consider dose reductions or stopping DUOPA
(5.5)
Monitor patients for depression and suicidality (5.6)
Avoid sudden discontinuation or rapid dose reduction to reduce the
risk of withdrawal-emergent
hyperpyrexia and confusion (5.7)
May cause or exacerbate dyskinesia: Consider dose reduction (5.8)
Monitor pa