XULANE (Page 4 of 11)

Amenorrhea and Oligomenorrhea

In the event of amenorrhea, consider the possibility of pregnancy. If the patient has not adhered to the prescribed dosing schedule (missed one patch or started the patch on a day later than she should have), consider the possibility of pregnancy at the time of the first missed period and take appropriate diagnostic measures. If the patient has adhered to the prescribed regimen and misses two consecutive periods, rule out pregnancy.

Some women may encounter amenorrhea or oligomenorrhea after discontinuation of hormonal contraceptive use, especially when such a condition was pre-existent.

5.10 Hormonal Contraceptive Use Before or During Early Pregnancy

Extensive epidemiological studies have revealed no increased risk of birth defects in women who have used oral contraceptives prior to pregnancy. Studies also do not suggest a teratogenic effect, particularly in so far as cardiac anomalies and limb reduction defects are concerned, when oral contraceptives are taken inadvertently during early pregnancy. Discontinue Xulane use if pregnancy is confirmed.

Administration of CHCs should not be used as a test for pregnancy [see Use in Specific Populations (8.1)].

5.11 Depression

Carefully observe women with a history of depression and discontinue Xulane if depression recurs to a serious degree.

5.12 Carcinoma of Breasts and Cervix

Xulane is contraindicated in women who currently have or have had breast cancer because breast cancer may be hormonally sensitive [see Contraindications (4)].

There is substantial evidence that CHCs do not increase the incidence of breast cancer. Although some past studies have suggested that CHCs might increase the incidence of breast cancer, more recent studies have not confirmed such findings.

Some studies suggest that combination oral contraceptive use has been associated with an increase in the risk of cervical cancer or intraepithelial neoplasia. However, there continues to be controversy about the extent to which such findings may be due to differences in sexual behavior and other factors.

5.13 Effect on Binding Globulins

The estrogen component of CHCs may raise the serum concentrations of thyroxine-binding globulin, sex hormone-binding globulin and cortisol-binding globulin. The dose of replacement thyroid hormone or cortisol therapy may need to be increased.

5.14 Monitoring

A woman who is taking hormonal contraceptive should have a yearly visit with her healthcare provider for a blood pressure check and for other indicated healthcare.

5.15 Hereditary Angioedema

In women with hereditary angioedema, exogenous estrogens may induce or exacerbate symptoms of angioedema.

5.16 Chloasma

Chloasma may occasionally occur, especially in women with a history of chloasma gravidarum. Women with a tendency to chloasma should avoid exposure to the sun or ultraviolet radiation while using Xulane.

6 ADVERSE REACTIONS

The following serious adverse reactions with the use of combination hormonal contraceptives, including Xulane, are discussed elsewhere in the labeling:

Serious cardiovascular events and stroke [see Boxed Warning and Warnings and Precautions (5.1)]
Vascular events, including venous and arterial thromboembolic events [see Warnings and Precautions (5.1)]
Liver disease [see Warnings and Precautions (5.3)]

Adverse reactions commonly reported by users of combination hormonal contraceptives are:

Irregular uterine bleeding
Nausea
Breast tenderness
Headache

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 to norelgestromin and ethinyl estradiol transdermal system in 3330 sexually active women (3322 of whom had safety data) who participated in three Phase 3 clinical trials designed to evaluate contraceptive efficacy and safety. These subjects received six or 13 cycles of contraception (norelgestromin and ethinyl estradiol transdermal system or an oral contraceptive comparator in 2 of the trials). The women ranged in age from 18 to 45 years and were predominantly white (91%).

The most common adverse reactions (≥ 5%) reported during clinical trials were breast symptoms, nausea/vomiting, headache, application site disorder, abdominal pain, dysmenorrhea, vaginal bleeding and menstrual disorders, and mood, affect and anxiety disorders. The most common events leading to discontinuation were application site reaction, breast symptoms (including breast discomfort, engorgement and pain), nausea and/or vomiting, headache and emotional lability.

Adverse drug reactions reported by ≥ 2.5% of norelgestromin and ethinyl estradiol transdermal system-treated subjects in these trials are shown in Table 3.

Table 3: Adverse Drug Reactions Reported by ≥ 2.5% of Norelgestromin and Ethinyl Estradiol Transdermal System-treated Subjects in Three Phase 3 Clinical Trials
*
MedDRA version 10.0
Represents a bundle of similar terms

System/Organ Class *

Adverse reaction

Norelgestromin and Ethinyl Estradiol Transdermal System

(n = 3322)

Reproductive system and breast disorders

Breast symptoms

22.4%

Dysmenorrhea

7.8%

Vaginal bleeding and menstrual disorders

6.4%

Gastrointestinal disorders

Nausea

16.6%

Abdominal pain

8.1%

Vomiting

5.1%

Diarrhea

4.2%

Nervous system disorders

Headache

21.0%

Dizziness

3.3%

Migraine

2.7%

General disorders and administration site conditions

Application site disorder

17.1%

Fatigue

2.6%

Psychiatric disorders

Mood, affect and anxiety disorders

6.3%

Skin and subcutaneous tissue disorders

Acne

2.9%

Pruritus

2.5%

Infections and infestations

Vaginal yeast infection

3.9%

Investigations

Weight increased

2.7%

Additional adverse drug reactions that occurred in < 2.5% of norelgestromin and ethinyl estradiol transdermal system-treated subjects in the above clinical trials datasets are:

Gastrointestinal disorders: Abdominal distension
General disorders and administration site conditions: Fluid retention1 , malaise
Hepatobiliary disorders: Cholecystitis
Investigations: Blood pressure increased, lipid disorders1
Musculoskeletal and connective tissue disorders: Muscle spasms
Psychiatric disorders: Insomnia, libido decreased, libido increased
Reproductive system and breast disorders: Galactorrhea, genital discharge, premenstrual syndrome, uterine spasm, vaginal discharge, vulvovaginal dryness
Respiratory, thoracic and mediastinal disorders: Pulmonary embolism
Skin and subcutaneous tissue disorders: Chloasma, dermatitis contact, erythema, skin irritation

1 Represents a bundle of similar terms

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