Cryselle (Page 3 of 5)

5. Interference with Laboratory Tests

The use of contraceptive steroids may influence the results of certain laboratory tests, such as coagulation factors, lipids, glucose tolerance, and binding proteins.

6. Carcinogenesis

See WARNINGS Sections 2 and 9.

7. Pregnancy

There is little or no increased risk of birth defects in women who inadvertently use COCs during early pregnancy. Epidemiologic studies and meta-analyses have not found an increased risk of genital or nongenital birth defects (including cardiac anomalies and limb reduction defects) following exposure to low dose COCs prior to conception or during early pregnancy.

Discontinue Cryselle use if pregnancy is confirmed.

Do not administer COCs to induce withdrawal bleeding as a test for pregnancy. Do not use COCs during pregnancy to treat threatened or habitual abortion.

8. Nursing Mothers

Advise the nursing mother to use other forms of contraception, when possible, until she has weaned her child. COCs can reduce milk production in breastfeeding mothers. This is less likely to occur once breastfeeding is well-established; however, it can occur at any time in some women. Small amounts of oral contraceptive steroids and/or metabolites are present in breast milk.

9. Pediatric Use

Safety and efficacy of Cryselle tablets have been established in women of reproductive age. Efficacy is expected to be the same for post-pubertal adolescents under the age of 16 and for users 16 years and older. Use of Cryselle before menarche is not indicated.

10. Geriatric Use

Cryselle has not been studied in postmenopausal women and is not indicated in this population.

11. Information for the Patient

See FDA-approved patient labeling (Patient Information and Instructions for Use). Counsel patients about the following information:

Cigarette smoking increases the risk of serious cardiovascular events from COC use, and that women who are over 35 years old and smoke should not use COCs [see Boxed Warning].
Increased risk of VTE compared to non-users of COCs is greatest after initially starting a COC or restarting (following a 4-week or greater pill-free interval) the same or a different COC.
Cryselle does not protect against HIV infection and other sexually transmitted infections.
Cryselle is not to be used during pregnancy; if pregnancy occurs during use of Cryselle, instruct the patient to stop further use.
Take one tablet daily by mouth at the same time every day. Instruct patients what to do in the event tablets are missed.
Use a back-up or alternative method of contraception when enzyme inducers are used with Cryselle.
COCs may reduce breast milk production; this is less likely to occur if breastfeeding is well established.
Women who start COCs postpartum, and who have not yet had a period, should use an additional method of contraception until they have taken an active tablet for 7 consecutive days.
Amenorrhea may occur. Consider pregnancy in the event of amenorrhea at the time of the first missed period. Rule out pregnancy in the event of amenorrhea in two or more consecutive cycles.

ADVERSE REACTIONS

An increased risk of the following serious adverse reactions (see Warnings section for additional information) has been associated with the use of oral contraceptives:

Serious cardiovascular events and stroke [see Boxed Warning]
Vascular events
Liver disease

Adverse reactions commonly reported by COC users are:

Irregular uterine bleeding
Nausea
Breast tenderness
Headache

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 safety of Cryselle was evaluated in 1,343 healthy women of child-bearing potential who participated in 9 clinical trials and received at least one dose of Cryselle for contraception. Subjects were exposed for a total of 11,085 cycles, with 429 women completing one year of exposure. Subjects ranged in age from 15 to 40 years. Demographics were 69% Caucasian, 28% Black, and 3% other.

Common Adverse Reactions (≥ 2% of women):

Weight increase (11%)
Cervical erosion (9%)
Weight decrease (6%)
Acne (4%)
Dysmenorrhea (4%)
Vaginal discharge (4%)
Abdominal pain, cramps, and bloating (3%)
Appetite increase (3%)
Depression (3%)
Nervousness (3%)
Chloasma/melasma (2%)
Fatigue (2%)
Varicose veins, aggravation of (2%)

A total of 8% of subjects discontinued the trials prematurely due to an adverse reaction, most commonly due to unscheduled bleeding, spotting, headache (including migraine), nausea, acne, changes in menstrual flow, weight increase, nervousness, high blood pressure, and depression.

Postmarketing Experience

Five studies that compared breast cancer risk between ever-users (current or past use) of COCs and never-users of COCs reported no association between ever use of COCs and breast cancer risk, with effect estimates ranging from 0.90 to 1.12 (Figure 1).

Three studies compared breast cancer risk between current or recent COC users (<6 months since last use) and never users of COCs (Figure 1). One of these studies reported no association between breast cancer risk and COC use. The other two studies found an increased relative risk of 1.19 to 1.33 with current or recent use. Both of these studies found an increased risk of breast cancer with current use of longer duration, with relative risks ranging from 1.03 with less than one year of COC use to approximately 1.4 with more than 8-10 years of COC use.

Figure 1: Relevant Studies of Risk of Breast Cancer with Combined Oral Contraceptives

1
(click image for full-size original)

RR = relative risk; OR = odds ratio; HR = hazard ratio. “ever COC” are females with current or past COC use; “never COC use” are females that never used COCs.

The following additional adverse drug reactions have been reported from worldwide postmarketing experience with Cryselle. 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 Events: Arterial thromboembolism, Myocardial infarction, Cerebral hemorrhage

Eye Disorder: Optic neuritis, which may lead to partial or complete loss of vision, Intolerance to contact lenses, Change (steepening) in corneal curvature

Gastrointestinal Disorders: Colitis, Nausea, Pancreatitis

Hepatobiliary Disorders: Gallbladder disease, Cholestatic jaundice, Budd-Chiari syndrome

Immune System Disorders: Anaphylactic/anaphylactoid reactions, including urticaria, angioedema, and severe reactions with respiratory and circulatory symptoms

Metabolism and Nutrition Disorders: Carbohydrate and lipid effects, Porphyria, exacerbation of Porphyria

Neoplasms, Benign, Malignant, and Unspecified: Carcinoma of the reproductive organs and breasts, Hepatic neoplasia (including hepatic adenomas or benign liver tumors)

Psychiatric Disorders: Mood changes

Reproductive System and Breast Disorders: Temporary infertility after discontinuation of treatment, Changes in libido, Vaginitis, including candidiasis; Breast secretion

Skin and Subcutaneous Tissue Disorders: Melasma/chloasma, which may persist; Erythema multiforme, Erythema nodosum, Hemorrhagic eruption, Hirsutism

Vascular Events: Venous thrombosis, Pulmonary embolism, Cerebral thrombosis, Mesenteric thrombosis, Retinal vascular thrombosis

OVERDOSAGE

There have been no reports of serious ill effects from overdosage of oral contraceptives, including ingestion by children. Overdosage may cause withdrawal bleeding in females and nausea.

DOSAGE AND ADMINISTRATION

To achieve maximum contraceptive effectiveness, Cryselle (norgestrel and ethinyl estradiol tablets) must be taken exactly as directed and at intervals not exceeding 24 hours. The dosage of Cryselle is one white tablet daily for 21 consecutive days, followed by one light-green colored inert tablet daily for 7 consecutive days, according to prescribed schedule. It is recommended that Cryselle tablets be taken by mouth at the same time each day.

How to Start Cryselle

Consider the possibility of ovulation and conception prior to initiation of medication.

Instruct the patient to begin taking Cryselle on the first Sunday after the onset of menstruation. If menstruation begins on a Sunday, the first tablet (white) is taken that day. The patient should take one white tablet daily for 21 consecutive days followed by one light-green colored inert tablet daily for 7 consecutive days. Withdrawal bleeding will usually occur within 3 days following discontinuation of white tablets and may not have finished before the next pack is started. During the first cycle, the patient should not rely on Cryselle for contraception until a white tablet has been taken daily for 7 consecutive days and she should use a non-hormonal back-up method of birth control during those 7 days.

After the first cycle of use

The patient is to begin her next and all subsequent 28-day courses of tablets on the same day of the week (Sunday) on which she began her first course, following the same schedule: 21 days of white tablets, followed by 7 days of light-green colored inert tablets. If in any cycle the patient starts tablets later than the proper day, instruct her to protect herself against pregnancy by using a non-hormonal back-up method of birth control until she has taken a white tablet daily for 7 consecutive days.

Switching from another hormonal method of contraception

When the patient is switching from a 21-day regimen of tablets, instruct her to wait 7 days after her last tablet before she starts Cryselle. She will probably experience withdrawal bleeding during that week. Instruct her not to let more than 7 days pass after her previous 21-day regimen before she starts Cryselle.
When the patient is switching from a 28-day regimen of tablets, instruct her to start her first pack of Cryselle on the day after her last tablet. She should not wait any days between packs.
The patient may switch any day from a progestin-only pill and should begin Cryselle the next day. If switching from an implant or injection, instruct the patient to start Cryselle on the day of implant removal or the day the next injection would be due. If switching from a contraceptive vaginal ring or transdermal patch instruct the patient to start Cryselle on the day they would have inserted the next ring or applied the next patch. If switching from an Intrauterine Device (IUD) or Intrauterine System (IUS), instruct the patient to start Cryselle on the day of IUD/IUS removal. If the IUD/IUS is not removed on the first day of the patient’s menstrual cycle, instruct her to use a non-hormonal back-up method of birth control for the first 7 days of tablet-taking.

Use after pregnancy, abortion, or miscarriage

Initiate Cryselle no earlier than day 28 postpartum in the nonlactating mother or after a second-trimester abortion due to the increased risk for thromboembolism (see Contraindications, Warnings and Precautions concerning thromboembolic disease). Advise the patient to use a non-hormonal back-up method for the first 7 days of tablet-taking.
Cryselle may be initiated immediately after a first-trimester abortion or miscarriage. If the patient starts Cryselle immediately, back-up contraception is not needed.

If spotting or breakthrough bleeding occurs

If spotting or breakthrough bleeding occurs, instruct the patient to continue on the same regimen. This type of bleeding is usually transient and without significance; however, advise the patient to consult her healthcare provider if the bleeding is persistent or prolonged.

Missed Tablets

The possibility of ovulation and pregnancy increases with each successive day that scheduled white tablets are missed. If withdrawal bleeding does not occur, the possibility of pregnancy must be considered. If the patient has not adhered to the prescribed schedule (if she missed one or more tablets or started taking them on a day later than she should have), consider the probability 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.

For additional patient instructions regarding missed tablets, see the WHAT TO DO IF YOU MISS PILLS section in FDA-Approved Patient Labeling below.

Advice in Case of Gastrointestinal Disturbances

In case of severe vomiting or diarrhea, absorption may not be complete and additional contraceptive measures should be taken. If vomiting or diarrhea occurs within 3 to 4 hours after taking an active tablet, handle this as a missed tablet [see FDA-Approved Patient Labeling].

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