*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.
Other Clinically Important Adverse Reactions
1
:
Seizure was reported in one patient (<0.1%) with a history of seizures in the clinical trials of LYNKUET.
Adverse Reactions Leading to Discontinuation
1
:
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%).
Photosensitivity
1
:
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.
Postmarketing Experience
1
:
The following adverse reactions have been identified during post-approval use of LYNKUET. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Postmarketing cases of seizure have been reported in patients treated with LYNKUET.
Effects on Endometrium in Postmenopausal Women
1
:
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.
