Kyleena (Page 5 of 10)

5.9 Breast Cancer

Women who currently have or have had breast cancer, or have a suspicion of breast cancer, should not use hormonal contraception, including Kyleena, because some breast cancers are hormone-sensitive [see Contraindications (4)].

Spontaneous reports of breast cancer have been received during postmarketing experience with a LNG-releasing IUS. Observational studies of the risk of breast cancer with use of a LNG-releasing IUS do not provide conclusive evidence of increased risk.

5.10 Clinical Considerations for Use and Removal

Use Kyleena with caution after careful assessment if any of the following conditions exist, and consider removal of the system if any of them arise during use:

Coagulopathy or use of anticoagulants
Migraine, focal migraine with asymmetrical visual loss or other symptoms indicating transient cerebral ischemia
Exceptionally severe headache
Marked increase of blood pressure
Severe arterial disease such as stroke or myocardial infarction

In addition, consider removing Kyleena if any of the following conditions arise during use:

Uterine or cervical malignancy
Jaundice

If the threads are not visible or are significantly shortened, they may have broken or retracted into the cervical canal or uterus. Consider the possibility that the system may have been displaced (for example, expelled or perforated the uterus) [see Warnings and Precautions (5.5, 5.6)]. Exclude pregnancy and verify the location of Kyleena, for example, by sonography, X-ray, or by gentle exploration of the cervical canal with a suitable instrument. If Kyleena is displaced, remove it. A new Kyleena may be inserted at that time or during the next menses if it is certain that conception has not occurred. If Kyleena is in place with no evidence of perforation, no intervention is indicated.

5.11 Magnetic Resonance Imaging (MRI) Information

MRI

Non-clinical testing has demonstrated that Kyleena is MR Conditional. A patient with Kyleena can be safely scanned in an MR system meeting the following conditions:

Static magnetic field of 3.0 T or less
Maximum spatial field gradient of 36,000 gauss/cm (360 T/m)
Maximum MR system reported, whole body averaged specific absorption rate (SAR) of 4W/kg (First Level Controlled Operating Mode)

Under the scan conditions defined above, the Kyleena IUS is expected to produce a maximum temperature rise of less than 2°C after 15 minutes of continuous scanning.

In non-clinical testing, the image artifact caused by the IUS extended up to 5 mm from the IUS when imaged with a gradient echo pulse sequence and a 3.0 T MRI system.

6 ADVERSE REACTIONS

The following serious or otherwise important adverse reactions are discussed elsewhere in the labeling:

Ectopic Pregnancy [see Warnings and Precautions (5.1)]
Intrauterine Pregnancy [see Warnings and Precautions (5.2)]
Group A Streptococcal Sepsis (GAS) [see Warnings and Precautions (5.3)]
Pelvic Inflammatory Disease [see Warnings and Precautions (5.4)]
Perforation [see Warnings and Precautions (5.5)]
Expulsion [see Warnings and Precautions (5.6]
Ovarian Cysts [see Warnings and Precautions (5.7)]
Bleeding Pattern Alterations [see Warnings and Precautions (5.8)]

6.1 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 4 (presented as crude incidences).

Table 4: 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 [see Warnings and Precautions (5.8)].

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).

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