See coverage in your area

QULIPTA® Is Safe and
Well Tolerated1

Real QULIPTA® patient.

ESTABLISHED SAFETY PROFILE

Safe & well tolerated across 12 weeks1

Pooled adverse events from 1 chronic migraine and 2 episodic migraine studies

ADVERSE REACTIONS
≥2% FOR QULIPTA AND
GREATER THAN PLACEBO1*		 Placebo(n=663) QULIPTA
10 mg QD(n=314)		 QULIPTA
30 mg QD(n=411)		 QULIPTA
60 mg QD(n=678)
NAUSEA 3% 5% 6% 9%
CONSTIPATION 2% 6% 6% 8%
FATIGUE / SOMNOLENCE 4% 4% 4% 5%
DECREASED APPETITE <1% 2% 1% 3%
DIZZINESS 2% 2% 2% 3%

Discontinuation2: 3.1% of patients (21/663) on placebo discontinued due to adverse events vs patients on QULIPTA 10 mg 4.1% (13/314), QULIPTA 30 mg 3.6% (15/411), or QULIPTA 60 mg 3.1% (21/678).

*QULIPTA 10 mg and QULIPTA 30 mg data are specific to 2 EM trials; QULIPTA 60 mg data are pooled from 1 CM trial and 2 EM trials.

Studies included patients with a history of3:

  • Gastrointestinal disorders (31%)
  • Psychiatric disorders (41.7%)

In all studies, a decrease in weight was observed1:

The proportion of patients with a weight decrease of at least 7% at any point was 5.3% for QULIPTA 60 mg QD, 3.2% for QULIPTA 30 mg QD, 3.8% for QULIPTA 10 mg QD, and 2.5% for placebo.

study designs

OPEN-LABEL, LONG-TERM SAFETY STUDY FOR EM

52-WEEK WEIGHT SAFETY DATA

Well tolerated across 52 weeks6

ADVERSE EVENTS ≥5%6 QULIPTA 60 mg QD(n=543)
UPPER RESPIRATORY TRACT INFECTION 10%
CONSTIPATION 7%
NAUSEA 6%
URINARY TRACT INFECTION 5%

Patients experienced weight decrease at Week 52:

In the overall safety population (N=366), the mean weight decrease from baseline (177.6 lb) was -3.4 lb*

Discontinuation6: 5.7% of patients (31/543) discontinued QULIPTA 60 mg due to adverse events.

*Baseline weight measurements were converted from kilograms to pounds. In the overall safety population, baseline weight was 80.7 kg with a reduction of -1.5 kg.

Patients experienced ≥5% weight decrease at Week 528

  OVERALL SAFETY POPULATION(N=366)
PERCENTAGE of
patients with ≥5%
WEIGHT DECREASE
at Week 52		 26%
(94/366)
CHANGE IN WEIGHT (lb)
from baseline in
patients with ≥5%
WEIGHT DECREASE
at Week 52		 -17.2 lb
Baseline: 184.9 lb

NOTE: In the overall safety population, 10.4% of patients on QULIPTA experienced a ≥5% weight gain at Week 529

Baseline weight measurements were converted from kilograms to pounds. In the overall safety population, patients who experienced at least 5% weight decrease had a baseline weight of 83.8 kg with a reduction of -7.8 kg.8

LIMITATIONS: These are observations from the 52-week, open-label safety study. This open-label safety study was not blinded, not controlled, and included inherent self-selection bias for remaining in the trial. Results should be interpreted with these factors in mind.

study design

Get connected with a QULIPTA representative

request a rep

Baseline weight measurements were converted from kilograms to pounds. In the overall safety population, patients who experienced at least 5% weight decrease had a baseline weight of 83.8 kg with a reduction of -7.8 kg.8

CM=chronic migraine; EM=episodic migraine; mITT=modified intent-to-treat; QD=once daily.

PREVIOUS:
DAILY ACTIVITIES & HEAD-TO-HEAD DATA
NEXT:
HEAD-TO-HEAD SAFETY DATA