Kyleena (Page 6 of 10)

6.2 Postmarketing Experience

Adverse Reactions from Postmarketing Spontaneous Reports

The following adverse reactions have been identified during post-approval use of LNG-releasing IUSs. 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.

Arterial thrombotic and venous thromboembolic events, including cases of pulmonary embolism, deep vein thrombosis and stroke
Device breakage
Hypersensitivity (including rash, urticaria, and angioedema)
Increased blood pressure

Reported Adverse Reactions from Postmarketing Studies

Assessment of Perforation and Expulsion of Intrauterine Devices (APEX IUD) Study

APEX IUD was a large US retrospective cohort study to assess the impact of breastfeeding and timing of postpartum IUD insertion on uterine perforation and IUD expulsion. The analyses included a total of 326,658 insertions, 30% (97,824 insertions) of which were performed in women with a delivery in the previous 12 months. For insertions performed in women who had delivered ≤ 52 weeks before IUD insertion, the majority of postpartum insertions, 57.3% (56,047 insertions) occurred between 6 and 14 weeks postpartum. Breastfeeding data were available in 94,817 insertions performed in women 52 weeks or less after delivery.

The study results indicated that the risk of uterine perforation was highest in women with IUD insertion ≤ 6 weeks postpartum. Immediate postpartum insertion (0–3 days) findings are limited due to the relatively small number of insertions occurring within this time interval. Women who were breastfeeding at the time of insertion were at 33% higher risk of perforation (adjusted hazard ratio [HR]=1.33, 95% confidence interval [CI]: 1.07–1.64) compared to women who were not breastfeeding at the time of insertion. Progressively lower risk of uterine perforation was observed in postpartum time windows beyond 6 weeks, in both breastfeeding and not breastfeeding women. Table 5 presents the uterine perforation rates for LNG IUS stratified by breastfeeding status and postpartum interval.

Table 5: Uterine Perforation1 rates for LNG IUS, by Breastfeeding Status and Postpartum Interval

Breastfeeding at time of insertion

Not breastfeeding at time of insertion

Postpartum interval at time of insertion

Number of events/ insertions

Uterine perforation rate per 1,000 insertions

Number of events/ insertions

Uterine perforation rate per 1,000 insertions

0 to 3 days

8/1,896

4.22

0/277

0.00

4 days to ≤ 6 weeks

120/10,735

11.18

28/2,377

11.78

> 6 to ≤ 14 weeks

268/29,677

9.03

30/12,011

6.66

> 14 to ≤ 52 weeks

43/6,139

7.00

22/9,089

2.42

> 52 weeks or no delivery

no data available

243/184,733

1.32

1 Uterine perforation includes both complete and partial perforation

Risk of expulsion was variable over the postpartum intervals through 52 weeks. Women who were breastfeeding were at 28% lower risk of IUD expulsion (adjusted HR=0.72, 95% CI: 0.64-0.80) compared to women who were not breastfeeding at time of insertion. Table 6 presents the IUD expulsion rates for LNG IUS stratified by breastfeeding status and postpartum interval.

Table 6: Expulsion1 Rates for LNG IUS, by Breastfeeding Status and Postpartum Interval

Breastfeeding at time of insertion

Not breastfeeding at time of insertion

Postpartum interval at time of insertion

Number of events/ insertions

Expulsion rate per 1,000 insertions

Number of events/ insertions

Expulsion rate per 1,000 insertions

0 to 3 days

187/1,896

98.63

12/277

43.32

4 days to ≤ 6 weeks

185/10,735

17.23

52/2,377

21.88

> 6 to ≤ 14 weeks

421/29,677

14.19

306/12,011

25.48

> 14 to ≤ 52 weeks

120/6,139

19.55

273/9,089

30.04

> 52 weeks or no delivery

no data available

5,481/184,733

29.67

1 Expulsion includes both complete and partial expulsion

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