esia 4 1
Injury, poisoning and procedural complications
Fall
Laceration
Skin abrasion
3
2
2
2
0
0
General disorders and administration site conditions
Chest discomfort 2 0
Investigations
Blood bilirubin increased
Red blood cell count decreased
2
2
0
0
Musculoskeletal and connective tissue disorders
Pain in extremity 2 1
Nervous system disorders
Headache 2 0
Psychiatric disorders
Insomnia 2 1
Vascular disorders
Orthostatic hypotension/blood pressure decreased 2 0
Adverse Reactions Leading to Discontinuation in Study 1
In Study 1, 6 of 114 patients (5%) in the INBRIJA 84 mg group and 3 of 112 patients (3%) in theplacebo group discontinued because of adverse reactions. The most common of these adverse reactions was cough, which lead to discontinuation in 2% of patients in the INBRIJA 84 mggroup and none in the placebo group.
7 DRUG INTERACTIONS
7.1 Monoamine Oxidase (MAO) Inhibitors
The use of nonselective MAO inhibitors with INBRIJA is contraindicated [seeContraindications (4)]. Discontinue use of any nonselective MAO inhibitors at least two weeksprior to initiating INBRIJA.
The use of selective MAO-B inhibitors with INBRIJA may be associated with orthostatichypotension. Monitor patients who are taking these drugs concurrently.
7.2 Dopamine D2 Receptor Antagonists and IsoniazidDopamine D2 receptor antagonists (e.g., phenothiazines, butyrophenones, risperidone,metoclopramide) and isoniazid may reduce the effectiveness of levodopa. Monitor patients forworsening Parkinson’s symptoms.
7.3 Iron Salts
Iron salts or multivitamins containing iron salts can form chelates with levodopa andconsequently reduce the bioavailability of levodopa.
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
There are no adequate data on the developmental risk associated with the use of INBRIJA inpregnant women. In animal studies, carbidopa/levodopa has been shown to be developmentallytoxic (including teratogenic effects) [see Data]. In the U.S. general population, the estimatedbackground risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. The background risk of major birth defects and miscarriage for theindicated population is unknown.
Data
Animal Data
When administered to pregnant rabbits throughout organogenesis, carbidopa/levodopa causedboth visceral and skeletal malformations in rabbits. No teratogenic effects were observed whencarbidopa/levodopa was administered to pregnant mice throughout organogenesis.
There was a decrease in the number of live pups delivered by rats receiving carbidopa/levodopaduring organogenesis.
8.2 Lactation
Risk Summary
The prolactin-lowering action of dopamine suggests that levodopa may interfere with lactation,although there are limited data on the effects of levodopa on milk production in lactating women.
Levodopa has been detected in human milk. There are no adequate data on the effects oflevodopa on the breastfed infant. The developmental and health benefits of breastfeeding shouldbe considered along with the mother’s clinical need for INBRIJA and any potential adverseeffects on the breastfed infant from INBRIJA or from the underlying maternal condition.
8.4 Pediatric Use
Safety and effectiveness in pediatric patients have not been established.
8.5 Geriatric Use
Of the Parkinson’s disease patients in Study 1 who to |
