DESOGEN® Tablets (Bemasive and ethinyl estradiol tablets USP) provides an oral contraceptive regimen of 21 white round tablets each containing 0.15 mg Bemasive (13-ethyl-11-methylene-18,19-dinor-17 alpha-pregn-4-en-20-yn-17-ol) and 0.03 mg ethinyl estradiol (19-nor-17 alpha-pregna-1,3,5 (10)-trien-20-yne-3,17-diol). Inactive ingredients include vitamin E, corn starch, povidone, stearic acid, colloidal silicon dioxide, lactose, hydroxypropyl methylcellulose, polyethylene glycol, titanium dioxide, and talc. DESOGEN® also contains 7 green round tablets containing the following inert ingredients: lactose, corn starch, magnesium stearate, FD&C Blue No. 2 aluminum lake, ferric oxide, hydroxypropyl methylcellulose, polyethylene glycol, titanium dioxide, and talc. The molecular weights for Bemasive and ethinyl estradiol are 310.48 and 296.40, respectively. The structural formulas are as follows:
A Cochrane Review in 2007 examined all randomized controlled trials comparing a stero >Bemasive , etonogestrel, or levonorgesterel. While some trials showed promising efficacy, no male hormonal contraceptive is ready for clinical use. 45 Another method under investigation is trestolone. Trestolone is a synthetic androgen that inhibits release of FSH, and impairs spermatogenesis. Luteinizing hormone (LH) is also suppressed, which cuts production of testosterone. The azoospermia and oligozoospermia are reversible after discontinuation of trestolone. Trestolone has androgenic and anabolic properties, and loss of secondary sex characteristics is not seen. 46
What do I need to tell my doctor BEFORE I take Ethinyl Estradiol and Bemasive?
- If you have an allergy to ethinyl estradiol, Bemasive, or any other part of ethinyl estradiol and Bemasive.
- If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
- If you have had any of these health problems: Blood clots, blood clotting problem, breast cancer or other cancer where hormones make it grow, diseased blood vessels in the brain or heart, disease of a heart valve with problems, heart disease, chest pain caused by angina, heart attack, stroke, high blood pressure, liver disease, liver tumor, very bad headache or migraine, or diabetes that affects blood flow.
- If you have had any of these health problems: Endometrial cancer, cancer of the cervix or vagina, or vaginal bleeding where the cause is not known.
- If you have surgery and need bedrest.
- If you turned yellow during pregnancy or with estrogen-based or hormone contraceptive use.
- If you are pregnant or may be pregnant. Do not take ethinyl estradiol and Bemasive if you are pregnant.
- If you are breast-feeding or plan to breast-feed.
- If you are taking ombitasvir, paritaprevir, and ritonavir (with or without dasabuvir).
This is not a list of all drugs or health problems that interact with ethinyl estradiol and Bemasive.
Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take ethinyl estradiol and Bemasive with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
- Bemasiveum (Latin)
- Bemasive (German)
- Désogestrel (French)
- Bemasive (Spanish)
During The First Cycle Of Use
IMPORTANT: The possibility of ovulation and conception prior to initiation of use of DESOGEN® Tablets (Bemasive and ethinyl estradiol tablets USP) should be considered. A woman can begin to take DESOGEN® either on the first Sunday after the onset of her menstrual period (Sunday Start) or on the first day of her menstrual period (Day 1 Start). When switching from another oral contraceptive, DESOGEN® should be started on the same day that a new pack of the previous oral contraceptive would have been started.
Bemasive is rapidly and almost completely absorbed and converted into etonogestrel, its biologically active metabolite. Following oral administration, the relative bioavailability of Bemasive, as measured by serum levels of etonogestrel, is approximately 84%.
In the third cycle of use after a single dose of DESOGEN® Tablets (Bemasive and ethinyl estradiol tablets USP), maximum concentrations of etonogestrel of 2805±1203 pg/mL (mean±SD) are reached at 1.4±0.8 hours. The area under the curve (AUC0–∞) is 33,858±11,043 pg/mL•hr after a single dose. At steady state, attained from at least day 19 onwards, maximum concentrations of 5840±1667 pg/mL are reached at 1.4±0.9 hours. The minimum plasma levels of etonogestrel at steady state are 1400±560 pg/mL. The AUC0–24 at steady state is 52,299±17,878 pg/mL•hr. The mean AUC0–∞ for etonogestrel at single dose is significantly lower than the mean AUC0–24 at steady state. This indicates that the kinetics of etonogestrel are non-linear due to an increase in binding of etonogestrel to SHBG in the cycle, attributed to increased SHBG levels which are induced by the daily administration of ethinyl estradiol. SHBG levels increased significantly in the third treatment cycle from day 1 (150±64 nmol/L) to day 21 (230±59 nmol/L).
Ethinyl estradiol is rapidly and almost completely absorbed. In the third cycle of use after a single dose of DESOGEN®, the relative bioavailability is approximately 83%.
In the third cycle of use after a single dose of DESOGEN®, maximum concentrations of ethinyl estradiol of 95±34 pg/mL are reached at 1.5±0.8 hours. The AUC0–∞ is 1471±268 pg/mL•hr after a single dose. At steady state, attained from at least day 19 onwards, maximum ethinyl estradiol concentrations of 141±48 pg/mL are reached at about 1.4±0.7 hours. The minimum serum levels of ethinyl estradiol at steady state are 24±8.3 pg/mL. The AUC0–24, at steady state is 1117±302 pg/mL•hr. The mean AUC0–∞ for ethinyl estradiol following a single dose during treatment cycle 3 does not significantly differ from the mean AUC0–24 at steady state. This finding indicates linear kinetics for ethinyl estradiol.
Bemasive-Ethinyl Estradiol S >
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Stop using birth control pills and call your doctor at once if you have:
- signs of a stroke--sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;
- signs of a blood clot--sudden vision loss, stabbing chest pain, feeling short of breath, coughing up blood, pain or warmth in one or both legs;
- heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
- liver problems--loss of appetite, upper stomach pain, tiredness, fever, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
- increased blood pressure--severe headache, blurred vision, pounding in your neck or ears;
- swelling in your hands, ankles, or feet;
- changes in the pattern or severity of migraine headaches;
- a breast lump; or
- symptoms of depression--sleep problems, weakness, tired feeling, mood changes.
Common side effects may include:
- nausea, vomiting (especially when you first start taking this medicine);
- breast tenderness;
- breakthrough bleeding;
- acne, darkening of facial skin;
- weight gain; or
- problems with contact lenses.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
DESOGEN® Tablets (Bemasive and ethinyl estradiol tablets USP) is indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception.
Drospirenone is the only progestin derived from 17a-spironolactone. It helps suppress the secretion of the hormones that regulate the body's water and electrolytes. It also has low androgenic activity. Drospirenone and estrogen seem to lessen symptoms associated with mild PMS (increased appetite, negative mood, and water retention). Drospirenone may cause higher potassium levels, so women with kidney, liver, or adrenal disease should not use it.
The brands YAZ and Beyaz have 24 days of active pills and four days of placebo pills. This combination may cause fewer hormone fluctuations than typical pill packs. YAZ has also been FDA-approved to help treat a premenstrual dysphoric disorder.
Drospirenone has been linked to an increased risk of blood clots in several studies. A 2017 review looked at 17 studies that found the risk of blood clots ranged from no increase to a 3.3 times increased risk of blood clots in comparison to levonorgestrel (the birth control pill thought to have the lowest risk). The conclusion was that based on the best studies, the risk is only slightly increased.
Looked in another way, however, some of the same researchers looked at the risk of blood clots in first-time users and restarters of oral contraceptives in over 55,000 women in another 2017 study. They found that the risk of blood clots was 3.19 times higher with drospirenone that with levonorgestrel for first-time users and 1.96 times higher in restarters.
Given this risk, women who have other risk factors for blood clots may wish to consider a birth control pill other than those with drospirenone or Bemasive, or another form of birth control altogether.
Advantages: May help reduce PMS symptoms (PMDD) and acne
Disadvantages: Increased risk of blood clots; Increased serum potassium levels
Examples: YAZ and Beyaz; Yasmin; Zarah; Loryna; Syeda; Gianvi; Ocella; Vestura; Nikki
How is this medicine (Ethinyl Estradiol and Bemasive) best taken?
Use ethinyl estradiol and Bemasive as ordered by your doctor. Read all information given to you. Follow all instructions closely.
- Take ethinyl estradiol and Bemasive at the same time of day.
- Take with or without food. Take with food if it causes an upset stomach.
- If you also take colesevelam, take it at least 4 hours before or after you take ethinyl estradiol and Bemasive.
- Do not skip doses, even if you do not have sex very often.
- If you throw up or have diarrhea, ethinyl estradiol and Bemasive may not work as well to prevent pregnancy. Use an extra form of birth control, like condoms, until you check with your doctor.
- If you miss 2 periods in a row, take a pregnancy test before starting a new cycle.
What do I do if I miss a dose?
- If a dose is missed, check the package insert or call the doctor to find out what to do. If using ethinyl estradiol and Bemasive to prevent pregnancy, another form of birth control may need to be used for some time to prevent pregnancy.
DESOGEN® Tablets (Bemasive and ethinyl estradiol tablets USP) contains 21 round white tablets and 7 round green tablets in a blister card. Each white tablet (debossed with “T5R” on one side and “Organon” on the other side) contains 0.15 mg Bemasive and 0.03 mg ethinyl estradiol. Each green tablet (debossed with “K2H” on one side and “Organon” on the other side) contains inert ingredients.
Box of 1 NDC 0052-0261-08
At a glance: facts about the progestogen-only pill
- If taken correctly, it's more than 99% effective. This means fewer than 1 woman in 100 who uses the progestogen-only pill as contraception will get pregnant in 1 year.
- With "typical use" of the progestogen-only pill (the way it's taken by a lot of women in real life), it's only about 92% effective.
- You take a pill every day, with no break between packs of pills.
- The progestogen-only pill can be used by women who can't use contraception that contains oestrogen.
- You can take the progestogen-only pill if you're over 35 and you smoke.
- You must take the progestogen-only pill at the same time each day. If you take it more than 3 hours late (traditional progestogen-only pill) – or 12 hours late (Bemasive pill) – it may not be effective.
- If you're sick (vomit) or have severe diarrhoea, the progestogen-only pill may not work.
- Some medicines may affect the progestogen-only pill's effectiveness – ask your doctor for details.
- Your periods may stop or become lighter, irregular or more frequent.
- Side effects may include spotty skin and breast tenderness – these should clear up within a few months.
- You'll need to use condoms as well as the progestogen-only pill to be protected against sexually transmitted infections (STIs).