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For the treatment of moderate to severe vasomotor symptoms (VMS) due to menopause1

Safety

Well-documented safety profile across 3 clinical trials
1

The safety of LYNKUET® was evaluated in 1420 women across OASIS 1, OASIS 2, and OASIS 3.1

In OASIS 1 and OASIS 2 combined, 793 women received LYNKUET or placebo for 12 weeks.1

In OASIS 1 and 2 combined, through the first 12 weeks, commonly reported adverse reactions in the LYNKUET group (≥2% and greater than in placebo) were headache, fatigue, gastroesophageal reflux disease, dizziness, nausea and somnolence.1


Similar adverse reactions were seen in OASIS 3.

Common adverse reactions reported in ≥2% in LYNKUET and greater than placebo, Weeks 1-52 (OASIS 3)
1

Adverse Reaction

LYNKUET (N=313) n (%)

Placebo (N=314) n (%)

Headache

30 (9.6) 

22 (7.0) 

Fatigue*

23 (7.3)

9 (2.9) 

Dizziness†

19 (6.1)

6 (1.9)

Somnolence‡

16 (5.1)

4 (1.3)

Abdominal pain§

14 (4.5)

8 (2.5)

Rash

13 (4.2)

5 (1.6)

Diarrhea

12 (3.8)

3 (1.0)

Muscle spasms#

10 (3.2)

2 (0.6)

*Includes asthenia.
†Includes balance disorder, presyncope, vertigo, vertigo CNS origin, vertigo positional, and vestibular neuronitis.
‡Includes lethargy.

§Includes abdominal discomfort, abdominal pain lower/upper.

Includes dermatitis, urticaria.
#Includes muscle tightness.


 

Adverse Reactions Leading to Discontinuation1:

In OASIS 3, adverse reactions leading to treatment discontinuation (≥1% in LYNKUET and greater than placebo) were abdominal pain (1.6%), fatigue (1.6%), depression (1.6%) and headache (1.3%). 

Photosensitivity1:

In the OASIS trials, mild to moderate events of photosensitivity occurred in 0.5% of patients receiving LYNKUET and 0.1% of patients receiving placebo. Onset of photosensitivity reactions ranged from day 1 to day 290. While discontinuation occurred in one patient, photosensitivity events in other patients resolved under continued treatment with LYNKUET.

Effects on Endometrium in Postmenopausal Women1:

One case of endometrial hyperplasia with atypia was identified in OASIS 1 and two cases of endometrial hyperplasia without atypia were seen in OASIS 3. Also, one case of endometrial glandular hyperplastic polyp was identified in OASIS 2. The rate of endometrial abnormalities was 0.8% (4 in 477) in patients who received LYNKUET, in line with the expected background rate. No endometrial malignancies were identified.


See the Prescribing Information for the full LYNKUET safety profile.

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