KYLEENA SIDE EFFECTS
- Generic Name: levonorgestrel
- Brand Name: Kyleena
- Drug Class: Progestins
SIDE EFFECTS
The following serious or otherwise important adverse reactions are discussed elsewhere in the labeling:
- Ectopic Pregnancy
- Intrauterine Pregnancy
- Group A Streptococcal Sepsis (GAS)
- Pelvic Inflammatory Disease
- Perforation
- Expulsion
- Ovarian Cysts
- Bleeding Pattern Alterations
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
The data described below reflect exposure of 1,697 healthy 18 to 41-year-old women (mean age 27.8 ± 5.2 years) to Kyleena. These data come from two multi-center contraceptive trials: A phase 2 study with a 3-year duration was conducted in Europe, enrolling generally healthy, 21 to 41-year old women; 217 subjects were exposed to Kyleena for one year and 174 completed three years. The data in this trial cover approximately 8,000 cycles of exposure. A phase 3 study with a 3-year duration and an optional extension of Kyleena use up to 5 years was conducted in the United States (US), Canada, Europe, and Latin America. The population was generally healthy, 18 to 35-year old women. A total of 1,208 subjects were exposed to Kyleena for at least one year; 707 women entered the optional extension phase after 3 years and 550 completed five years. The data in this trial cover approximately 60,000 cycles.
In total for both studies, 1,425 subjects were exposed for at least 1 year, and 550 subjects completed 5 years of use. Of the total of 1,697 subjects exposed to Kyleena, 563 were from the US and 1,134 were from Europe, Canada and Latin America; 623 (37%) were nulliparous (mean age 24.6 ± 4.5 years) and 1,074 (63%) were parous (mean age 29.7 ± 4.7 years). Most women who received Kyleena were Caucasian (83%) or Black/African American (4.4%); 9.4% of women were of Hispanic ethnicity. The clinical trials had no upper or lower weight or body mass index (BMI) limit. Mean BMI of Kyleena subjects was 25.2 kg/m² (range 15.2 – 57.6 kg/m²); 16% had a BMI ≥ 30 kg/m², and 2.0% had a BMI ≥ 40 kg/m². The frequencies of reported adverse drug reactions represent crude incidences.
The most common adverse reactions (occurring in ≥ 5% users) were vulvovaginitis (24%), ovarian cyst (22%), abdominal pain/pelvic pain (21%), headache/migraine (15%), acne/seborrhea (15%), dysmenorrhea/uterine spasm (10%), breast pain/breast discomfort (10%), and increased bleeding (8%).
In the combined studies, 22% discontinued prematurely due to an adverse reaction. The most common adverse reactions (>1%) leading to discontinuation were increased bleeding (4.5%), abdominal pain/pelvic pain (4.2%), device expulsion (3.1%), acne/seborrhea (2.3%), and dysmenorrhea/uterine spasm (1.3%).
Common adverse reactions (occurring in ≥1% users) are summarized in Table 1 (presented as crude incidences).
Table 1: Adverse reactions that occurred in at least 1% of Kyleena users in clinical trials by System Organ Class (SOC)
| System Organ Class | Adverse Reaction | Incidence (%) (N=1,697) |
| Reproductive System and Breast Disorders | Vulvovaginitis | 24.3 |
| Ovarian cysta | 22.2 | |
| Dysmenorrhea/uterine spasm | 8.0/2.4 | |
| Increased bleedingb | 7.9 | |
| Breast pain/discomfort | 7.1/3.5 | |
| Genital discharge | 4.5 | |
| Device expulsion (complete and partial) | 3.5 | |
| Upper genital tract infection | 1.5 | |
| Gastrointestinal Disorders | Abdominal pain/pelvic pain | 13.3/8.2 |
| Nausea | 4.7 | |
| Skin and Subcutaneous Tissue Disorders | Acne/Seborrhea | 14.1/1.8 |
| Alopecia | 1.0 | |
| Nervous System Disorders | Headache/Migraine | 12.9/3.3 |
| Psychiatric Disorders | Depression/ Depressed mood | 4.4/0.2 |
| a Ovarian cysts were reported as adverse events if they were abnormal, non-functional cysts and/or had a diameter >3 cm on ultrasound examination b Not all bleeding alterations were captured as adverse reactions. |
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In the clinical trials, serious adverse reactions occurring in more than a single subject included: ectopic pregnancy/ruptured ectopic pregnancy (10 subjects); pelvic inflammatory disease (6 subjects); missed abortion/incomplete spontaneous abortion/spontaneous abortion (4 subjects); ovarian cyst (3 subjects); abdominal pain (4 subjects); depression/affective disorder (4 subjects); and uterine perforation/embedded device (myometrial perforation) (3 subjects).
Postmarketing Experience
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
SRC: NLM .