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What is the most important information I should know about Evagest?
Do not use Evagest vaginal without your doctor's consent if you are pregnant, unless you are using the medication as part of your fertility treatment. Tell your doctor if you become pregnant during treatment. If you are not being treated for infertility, use an effective form of birth control while you are using this medication.
Some forms of this medication may contain plant-based oils. Do not use Evagest vaginal without telling your doctor if you have any type of food allergy.
Using Evagest vaginal can increase your risk of blood clots, stroke, heart attack, or breast cancer.
You should not use this medication if you have: a history of stroke or blood clot, circulation problems, severe liver disease, a hormone-related cancer such as breast or uterine cancer, abnormal vaginal bleeding, or if you have recently had a tubal pregnancy or an incomplete abortion.
Evagest vaginal is sometimes given for only 6 to 12 days at a time. When used as part of fertility treatment, Evagest vaginal may be given for up to 12 weeks into a pregnancy. Following your dosing schedule is very important for this medication to be effective. Try not to miss any doses.
This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.
Evagest vaginal can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.
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What are the possible side effects of Evagest?
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 practice.
The safety data reflect exposure to Evagest in 808 infertile women (74.9% White, 10.3% Hispanic, 5.4% Black, 5% Asian, and 4.6% Other) in a single Assisted Reproductive Technology 10 week clinical study conducted in the U.S. Evagest was studied at doses of 100 mg twice daily and 100 mg three times daily. The adverse reactions that occurred at a rate greater than or equal to 2% in either Evagest group are summarized in Table 1.
Table 1: Number and Frequency of Reported Adverse Reactions in Women Treated with Evagest in an Assisted Reproductive Technology Study
| Body System Preferred Term | Evagest 100 mg twice daily (N=404) | Evagest 100 mg three times daily (N=404) |
| Gastrointestinal Disorders | ||
| Abdominal pain | 50 (12%) | 50 (12%) |
| Nausea | 32 (8%) | 29 (7%) |
| Abdominal distension | 18(4%) | 17(4%) |
| Constipation | 9(2%) | 14 (3%) |
| Vomiting | 13(3%) | 9(2%) |
| General Disorders and Administration Site Conditions | ||
| Fatigue | 7(2%) | 12 (3%) |
| Infections and Infestations | ||
| Urinary tract infection | 9(2%) | 4 (1%) |
| Injury, Poisoning and Procedural Complications | ||
| Post-ooctye retrieval pain | 115(28%) | 102 (25%) |
| Nervous System Disorders | ||
| Headache | 15(4%) | 13(3%) |
| Reproductive System and Breast Disorders | ||
| Ovarian hyperstimulation syndrome | 30 (7%) | 27 (7%) |
| Uterine spasm | 15(4%) | 11 (3%) |
| Vaginal bleeding | 13(3%) | 14 (3%) |
Other less common reported adverse reactions included vaginal irritation, itching, burning, discomfort, urticaria, and peripheral edema.
Expected Adverse Reaction Profile Seen with EvagestEvagest is also expected to have adverse reactions similar to other drugs containing Evagest that may include breast tenderness, bloating, mood swings, irritability, and drowsiness.
Disorders related to a Evagest deficit.
By oral route (vaginal route is recommended as an alternative if oral route is not suitable): Menstrual irregularities due to ovulation disorders or anovulation, premenstrual disorders, breast pain or benign breast disorders (mastopathies), bleeding (due to fibroma), therapy of the menopause (adjunctive use with estrogen in postmenopausal women for prevention of endometrial hyperplasia), menace of preterm delivery and can be used up to 36 week of pregnancy, threatened miscarriage or prevention of habitual miscarriage due to luteal phase deficiency up to the 12th week of pregnancy, treatment of subfertility or primary or secondary infertility related to Evagest insufficiency in particular in In Vitro fertilization (IVF) cycles and/or oocyte donation.
For all other Evagest indications, the vaginal route represents an alternative to the oral route, in case of adverse events due to Evagest (somnolence, dizzinesss).
Progestins are hormones. They are used by both men and women for different purposes.
Progestins are prescribed for several reasons:
Progestins may also be used for other conditions as determined by your doctor.
Depending on how much and which Evagest you use or take, a Evagest can have different effects. For instance, high doses of Evagest are necessary for some women to continue a pregnancy while other progestins in low doses can prevent a pregnancy from occurring. Other effects include causing weight gain, increasing body temperature, developing the milk-producing glands for breast-feeding, and relaxing the uterus to maintain a pregnancy.
Progestins can help other hormones work properly. Progestins may help to prevent anemia (low iron in blood), too much menstrual blood loss, and cancer of the uterus.
Progestins are available only with your doctor's prescription.
Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, progestins are used in certain patients with the following medical conditions:
The major progestational steroid that is secreted primarily by the corpus luteum and the placenta. Evagest acts on the uterus, the mammary glands and the brain. It is required in embryo implantation; pregnancy maintenance, and the development of mammary tissue for milk production. Evagest, converted from pregnenolone, also serves as an intermediate in the biosynthesis of gonadal steroid hormones and adrenal corticosteroids.
Use Evagest oil as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use Evagest oil.
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.Use: Labeled IndicationsOral: Prevention of endometrial hyperplasia in nonhysterectomized, postmenopausal women who are receiving conjugated estrogens; treatment of secondary amenorrhea
IM: Treatment of amenorrhea or abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as submucous fibroids or uterine cancer
Intravaginal gel: Part of assisted reproductive technology (ART) for infertile women with Evagest deficiency; treatment of secondary amenorrhea
Vaginal insert: To support embryo implantation and early pregnancy by supplementation of corpus luteal function as part of ART for infertile women
Off Label UsesReduce the risk of recurrent spontaneous preterm birth
Based on the American College of Obstetricians and Gynecologists (ACOG) practice bulletin for the prediction and prevention of preterm birth, vaginal Evagest is an effective and recommended treatment option to reduce the risk of recurrent spontaneous preterm birth in appropriately selected women (ie, singleton pregnancy and prior spontaneous preterm singleton birth). Therapy may begin at 16 to 24 weeks (regardless of cervical length) or sooner (ie, <24 weeks) in women who have a cervix <20 mm. Use is not recommended as an intervention for women with multiple gestations.
Evagest® 8% is administered vaginally at a dose of 90 mg once daily in women who require Evagest supplementation. Evagest® 8% is administered vaginally at a dose of 90 mg twice daily in women with partial or complete ovarian failure who require Evagest replacement. If pregnancy occurs, treatment may be continued until placental autonomy is achieved, up to 10-12 weeks.
Secondary AmenorrheaEvagest® 4% is administered vaginally every other day up to a total of six doses. For women who fail to respond, a trial of Evagest® 8% every other day up to a total of six doses may be instituted.
It is important to note that a dosage increase from the 4% gel can only be accomplished by using the 8% gel. Increasing the volume of gel administered does not increase the amount of Evagest absorbed.
Note: The PATIENT INFORMATION SHEET contains special instructions for using the applicator at altitudes above 2500 feet in order to avoid a partial release of Evagest® before vaginal insertion.
How suppliedEvagest® is available in the following strengths:
4% gel (45 mg) in a single use, one piece, disposable, white polyethylene vaginal applicator with a twist-off top. Each applicator contains 1.45 g of gel and delivers 1.125 g of gel.
NDC-55056-0406-1 - 6 Single-use prefilled applicators.
8% gel (90 mg) in a single use, one piece, disposable, white polyethylene vaginal applicator with a twist-off top. Each applicator contains 1.45 g of gel and delivers 1.125 g of gel.
NDC-55056-1601-6 - 6 Single-use prefilled applicators
NDC-55056-1601-5 - 15 Single-use prefilled applicators
NDC-55056-1601-8 - 18 Single-use prefilled applicators
Each applicator is wrapped and sealed in a foil overwrap.
Store at 25°C (77°F); excurs ions permitted to 15-30°C (59-86°F).
Manufactured for: Columbia Laboratories, Inc. Livingston, NJ 07039. Manufactured by: Fleet Laboratories Ltd., Watford, United Kingdom. Revised: May 2009
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What other drugs will affect Evagest?
Drugs known to induce the hepatic cytochrome-P450-3A4 system [e.g. rifampicin, carbamazepine or St. John's wort (Hypericum perforatum)-containing herbal products] may increase the elimination rate and thereby decrease the bioavailability of Evagest. In contrast ketoconazole and other inhibitors of cytochrome P450-3A4 may decrease elimination rate and thereby increase the bioavailability of Evagest.
The effect of concomitant vaginal products on the exposure of Evagest from Evagest has not been assessed. However, Evagest is not recommended for use with other vaginal products (such as antifungal products) as this may alter Evagest release and absorption from the vaginal tablet.
