Next Choice

Name: Next Choice

What is the most important information I should know about Next Choice (levonorgestrel emergency contraceptive)?

Do not use this medication if you are already pregnant. Levonorgestrel emergency contraceptive will not terminate a pregnancy that has already begun (the fertilized egg has attached to the uterus).

Levonorgestrel emergency contraceptive is not intended for use as a routine form of birth control and should not be used in this manner. Talk with your doctor about the many forms of birth control available.

Do not give this medication to anyone younger than 17 years old. Contact a doctor for medical advice.

Uses For Next Choice

Levonorgestrel is an emergency contraceptive that is used to prevent pregnancy after unprotected sex or after failure of another birth control method. It works by preventing a woman's egg from fully developing. It may also prevent the attachment of the woman's egg to the wall of the uterus (womb).

No contraceptive method is 100 percent effective. Birth control methods such as having surgery to become sterile or not having sex are more effective. This medicine should not be used as a regular method of birth control. Discuss your options for birth control with your doctor.

Plan B One-StepĀ® is available as an over-the-counter medicine for any woman of childbearing potential.

Dosage and administration

Take Next Choice One DoseTM tablet orally as soon as possible within 72 hours after unprotected intercourse or a known or suspected contraceptive failure. Efficacy is better if the tablet is taken as soon as possible after unprotected intercourse. Next Choice One DoseTM tablet can be used at any time during the menstrual cycle.

If vomiting occurs within two hours of taking the tablet, consideration should be given to repeating the dose.

Dosage forms and strengths

The Next Choice One DoseTM tablet is supplied as a peach, round tablet containing 1.5 mg of levonorgestrel and is embossed with 287 on one side and WATSON on the other side.

Contraindications

Next Choice One DoseTM is contraindicated for use in the case of known or suspected pregnancy.

Warnings and precautions

Ectopic Pregnancy

Ectopic pregnancies account for approximately 2% of all reported pregnancies. Up to 10% of pregnancies reported in clinical studies of routine use of progestin-only contraceptives are ectopic.

A history of ectopic pregnancy is not a contraindication to use of this emergency contraceptive method. Healthcare providers, however, should consider the possibility of an ectopic pregnancy in women who become pregnant or complain of lower abdominal pain after taking Next Choice One DoseTM. A follow-up physical or pelvic examination is recommended if there is any doubt concerning the general health or pregnancy status of any woman after taking Next Choice One DoseTM.

Existing Pregnancy

Next Choice One DoseTM is not effective in terminating an existing pregnancy.

Effect on Menses

Some women may experience spotting a few days after taking Next Choice One DoseTM. Menstrual bleeding patterns are often irregular among women using progestin-only oral contraceptives and women using levonorgestrel for postcoital and emergency contraception.

If there is a delay in the onset of expected menses beyond 1 week, consider the possibility of pregnancy.

STI/HIV

Next Choice One DoseTM does not protect against HIV infection (AIDS) or other sexually transmitted infections (STIs).

Physical Examination and Follow-up

A physical examination is not required prior to prescribing Next Choice One DoseTM. A follow-up physical or pelvic examination is recommended if there is any doubt concerning the general health or pregnancy status of any woman after taking Next Choice One DoseTM.

 Fertility Following Discontinuation

A rapid return of fertility is likely following treatment with Next Choice One DoseTM for emergency contraception; therefore, routine contraception should be continued or initiated as soon as possible following use of Next Choice One DoseTM to ensure ongoing prevention of pregnancy.

Presence of FD&C Yellow #6

Next Choice One DoseTM contains FD&C Yellow #6 as a color additive.

Adverse reactions

 Clinical Trial 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.

Levonorgestrel tablet was studied in a randomized, double-blinded multicenter clinical trial. In this study, all women who had received at least one dose of study medication were included in the safety analysis: 1,379 women in the levonorgestrel tablet group (1 dose of 1.5 mg levonorgestrel), and 1,377 women in the levonorgestrel tablets group (2 doses of 0.75 mg levonorgestrel taken 12 hours apart). The mean age of women given levonorgestrel tablet was 27 years. The racial demographic of those enrolled was 54% Chinese, 12% Other Asian or Black, and 34% were Caucasian in each treatment group. 1.6% of women in the levonorgestrel tablet group and 1.4% in levonorgestrel tablets group were lost to follow-up.

The most common adverse events (>10%) in the clinical trial for women receiving levonorgestrel tablet included heavier menstrual bleeding (30.9%), nausea (13.7%), lower abdominal pain (13.3%), fatigue (13.3%), and headache (10.3%). Table 1 lists those adverse events that were reported in > 4% of levonorgestrel tablet users.

Table 1: Adverse Events in > 4% of Women, by % Frequency
 Most Common Adverse Events
(MedDRA)
 Levonorgestrel
N=1359 (%)
 Heavier Menstrual Bleeding  30.9
 Nausea  13.7
 Lower abdominal pain  13.3
 Fatigue  13.3
 Headache  10.3
 Dizziness  9.6
 Breast tenderness  8.2
 Delay of menses (> 7 days)  4.5

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of levonorgestrel tablets (2 doses of 0.75 mg levonorgestrel taken 12 hours apart). 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.

Gastrointestinal Disorders
Abdominal Pain, Nausea, Vomiting

General Disorders and Administration Site Conditions
Fatigue

Nervous System Disorders
Dizziness, Headache

Reproductive System and Breast Disorders
Dysmenorrhea, Irregular Menstruation, Oligomenorrhea, Pelvic Pain

Nonclinical toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenicity: There is no evidence of increased risk of cancer with short-term use of progestins. There was no increase in tumorgenicity following administration of levonorgestrel to rats for 2 years at approximately 5 mcg/day, to dogs for 7 years at up to 0.125 mg/kg/day, or to rhesus monkeys for 10 years at up to 250 mcg/kg/day. In another 7 year dog study, administration of levonorgestrel at 0.5 mg/kg/day did increase the number of mammary adenomas in treated dogs compared to controls. There were no malignancies.

Genotoxicity: Levonorgestrel was not found to be mutagenic or genotoxic in the Ames Assay, in vitro mammalian culture assays utilizing mouse lymphoma cells and Chinese hamster ovary cells, and in an in vivo micronucleus assay in mice.

Fertility: There are no irreversible effects on fertility following cessation of exposures to levonorgestrel or progestins in general.

Clinical studies

A double-blind, randomized, multicenter, multinational study evaluated and compared the efficacy and safety of three different regimens for emergency contraception. Subjects were enrolled at 15 sites in 10 countries; the racial/ethnic characteristics of the study population overall were 54% Chinese, 34% Caucasian, and 12% Black or Asian (other than Chinese). 2,381 healthy women with a mean age of 27 years, who needed emergency contraception within 72 hours of unprotected intercourse were involved and randomly allocated into one of the two levonorgestrel groups. A single dose of 1.5 mg of levonorgestrel (levonorgestrel tablet) was administered to women allocated into group 1. Two doses of 0.75 mg levonorgestrel 12 hours apart (levonorgestrel tablets) were administered to women in group 2. In the levonorgestrel tablet group, 16 pregnancies occurred in 1,198 women and in the levonorgestrel tablets group, 20 pregnancies occurred in 1,183 women. The number of pregnancies expected in each group was calculated based on the timing of intercourse with regard to each woman’s menstrual cycle. Among women receiving levonorgestrel tablet, 84% of expected pregnancies were prevented and among those women taking levonorgestrel tablets, 79% of expected pregnancies were prevented. The expected pregnancy rate of 8% (with no contraceptive use) was reduced to approximately 1% with levonorgestrel tablet.

Emergency contraceptives are not as effective as routine contraception since their failure rate, while low based on a single use, would accumulate over time with repeated use [see INDICATIONS AND USAGE (1)].

In the clinical study, bleeding disturbances were the most common adverse event reported after taking the levonorgestrel-containing regimens. More than half of the women had menses within two days of the expected time; however, 31% of women experienced change in their bleeding pattern during the study period; 4.5% of women had menses more than 7 days after the expected time.

For Healthcare Professionals

Applies to levonorgestrel: intrauterine device, oral tablet, subcutaneous implant

General

The most commonly reported adverse effects are alterations of menstrual bleeding patterns, nausea, abdominal/pelvic pain, headache/migraine, dizziness, fatigue, amenorrhea, ovarian cysts, genital discharge, acne/seborrhea, breast tenderness, and vulvovaginitis.[Ref]

Genitourinary

Very common (10% or more): Irregular menstrual bleeding (67%), infrequent menstrual bleeding (up to 57%), ovarian cyst (31.2%), menstrual changes (up to 31.9%), decreased uterine bleeding (23.4%), prolonged menstrual bleeding (22%), vulvovaginitis (20.2%), amenorrhea (18.4%), genital discharge (up to 14.9%), heavier menstrual bleeding (13.8%),vaginal infections (13.6%), vulvovaginal infections (13.3%), lighter menstrual bleeding (12.5%), increased scheduled uterine bleeding (11.9%), breast tenderness (10.7%)
Common (1% to 10%): Dysmenorrhea, breast pain/discomfort, upper genital tract infection, genital tract bleeding, pelvic inflammatory disease, endometritis, dyspareunia, pelvic discomfort/pain, delay of menses more than 7 days, vaginal discharge, bleeding not related to menses
Uncommon (0.1% to 1%): Uterine spasm, cervicitis/Papanicolaou smear normal class II, change in vaginal secretion
Rare (less than 0.1%): Uterine perforation
Frequency not reported: Breast enlargement, vaginal candidiasis, changes in cervical erosion, changes in cervical secretion, ectopic pregnancy
Postmarketing reports: Oligomenorrhea, irregular menstruation[Ref]

Gastrointestinal

Very common (10% or more): Nausea (up to 23.1%), abdominal/pelvic pain (up to 22.6%)
Common (1% to 10%): Diarrhea, vomiting
Uncommon (0.1% to 1%): Abdominal distension
Frequency not reported: Bloating, abdominal cramps[Ref]

Other

Very common (10% or more): Fatigue (16.9%)
Common (1% to 10%): Partial/complete IUS expulsion, weight increased
Uncommon (0.1% to 1%): Edema, change in body weight
Very rare (less than 0.01%): Face edema
Frequency not reported: Decreased weight, sepsis, group A streptococcal sepsis
Postmarketing reports: IUS breakage, procedural bleeding[Ref]

Nervous system

Very common (10% or more): Headache (up to 16.8%), dizziness (11.2%)
Common (1% to 10%): Migraine
Postmarketing reports: Stroke, syncope, IUS insertion related vasovagal reaction or seizure[Ref]

Psychiatric

Common (1% to 10%): Depression/depressed mood, mood changes, mood swings, decreased libido, nervousness
Frequency not reported: Changes in libido[Ref]

Dermatologic

Very common (10% or more): Acne/seborrhea (15%)
Common (1% to 10%): Alopecia, hirsutism
Uncommon (0.1% to 1%): Pruritus, eczema, pigmentation changes/hyperpigmentation
Rare (less than 0.1%): Rash, urticaria
Frequency not reported: Chloasma, melasma
Postmarketing reports: Angioedema[Ref]

Cardiovascular

Postmarketing reports: Increased blood pressure, arterial/venous thrombotic events, pulmonary emboli, deep vein thrombosis, stroke[Ref]

Musculoskeletal

Common (1% to 10%): Back pain[Ref]

Oncologic

Frequency not reported: Benign/malignant liver tumors
Postmarketing reports: Breast cancer[Ref]

Ocular

Frequency not reported: Contact lens intolerance[Ref]

Metabolic

Frequency not reported: Diabetes mellitus[Ref]

Hypersensitivity

Frequency not reported: Allergic reaction
Postmarketing reports: Hypersensitivity reactions[Ref]

Some side effects of Next Choice may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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