Proven clinical safety profile

Review the demonstrated safety profile for VYALEV and see the breakdown of when adverse events occurred during the clinical trial.

OVERALL DOUBLE-BLIND PERIOD OVERALL DOUBLE-BLIND PERIOD
WHEN DID ADVERSE EVENTS OCCUR? WHEN DID ADVERSE EVENTS OCCUR?

Adverse reactions1

Adverse reactions that occurred in ≥3% of patients who received VYALEV with a difference >2% between the VYALEV and oral IR CD/LD groups

Adverse Reaction
  
VYALEV (%) (n=74)
  
Oral IR CD/LD (%) (n=67)
Infusion/catheter site reaction*   62   8
Infusion/catheter site infection†   28   3
Hallucination   12   2
Dyskinesia   11   6
“On” and “Off” phenomenon   8   0
Balance disorder   5   0
Constipation   5   0
Peripheral swelling   5   0
Agitation   4   2
Insomnia   4   2
Psychotic disorder‡   4   2
Dyspnea   4   0

Falls were reported in 18% of patients in the oral IR CD/LD group (n=12) and 8% of patients in the VYALEV group (n=6).2

*Infusion/catheter site reaction includes multiple related terms.1

†Infusion/catheter site infection includes multiple related terms.1

‡Psychotic disorder includes psychotic disorder, delusion, and paranoia.1

Adverse events2

Adverse events that occurred in the VYALEV Optimization Phase (baseline through week 4) and Maintenance Phase (weeks 5 through 12)

Adverse Event
  
VYALEV Optimization
Phase (%)
(Baseline through week 4; n=74)
  
VYALEV Maintenance
Phase (%)
(Weeks 5 through 12; n=56)
Infusion/catheter site reaction*   54.1   37.5
Infusion/catheter site infection†   13.5   21.4
Hallucination   8.1   8.9
Dyskinesia   10.8   0
“On” and “Off” phenomenon   6.8   1.8
Balance disorder   5.4   0
Constipation   4.1   1.8
Peripheral swelling   4.1   1.8
Agitation   1.4   3.6
Insomnia   2.7   1.8
Psychotic disorder‡   2.7   1.8
Dyspnea   1.4   3.6

There is an increased risk for hallucinations and psychosis in patients taking VYALEV. Hallucinations associated with levodopa may present shortly after the initiation of therapy and may be responsive to dose reduction of VYALEV or other concomitantly administered medications. Patients with a major psychotic disorder should not be treated with VYALEV.1§

*Infusion/catheter site reaction includes multiple related terms.1

†Infusion/catheter site infection includes multiple related terms.1

‡Psychotic disorder includes psychotic disorder, delusion, and paranoia.1

§In the VYALEV group, 1 patient discontinued treatment due to hallucinations.1

98% of infusion site reactions and 96% of infusion site infections in the VYALEV group were mild to moderate in severity1,3-5

Infusion site reactions
in the VYALEV group

2% Severe (n=1), 98% mild or moderate (n=56).

8% of VYALEV patients (6/74) discontinued due to infusion site reactions||

Infusion site infections
in the VYALEV group

4% severe (n=1), 96% mild or moderate (n=23).

5% of VYALEV patients (4/74) discontinued due to infusion site infections

Additional Information

  • VYALEV can cause infusion site reactions and infections
  • The majority of infusion site events resolved with or without treatment#
  • Of the 21 patients with reported infections, 10 received treatment with an antibiotic; all antibiotics were oral**

The most frequent infusion site infection was cellulitis. In the VYALEV group, 1 patient with a severe infusion site infection and 1 patient with a moderate infusion site infection required hospitalization and were treated with antibiotics. If an infection is suspected at the infusion site, the cannula should be removed. Either a new cannula should be placed at a new infusion site or, in the event of a prolonged interruption, prescribe oral CD/LD until the patient is able to resume VYALEV.

||No patient who received placebo subcutaneous infusion withdrew from treatment because of an infusion site reaction.1

Of the patients who received placebo subcutaneous infusion, 2% (n=1/67) withdrew from treatment because of an infusion site infection.1

#Documentation of resolution was not required; 60% of infections and 71% of reactions had documented end dates.3

**Antibiotic treatment was initiated within 3 days of infusion site infection onset.

Data are from the phase 3, randomized, double-blind, active-controlled study. Mild: Transient and easily tolerated; Moderate: Causes discomfort and interrupts the patient’s usual activities; Severe: Causes considerable interference with the patient’s usual activities and may be incapacitating or life threatening.

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CD=carbidopa; IR=immediate release; LD=levodopa.