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What you need to know about starting birth control pills

When can women start using birth control pills? What are some of the risks involved?

Here are seven quick things you need to know before starting birth control pills!

Questions to ask your doctor about birth control pills

For many women, speaking to their doctor is the first step to finding a birth control option that’s right for them. While it can be easy to feel overwhelmed learning about different types of pregnancy prevention methods, consider writing a list of important questions you want to ask your doctor about birth control pills. Some examples include:

  • Are birth control pills a safe option for me?
  • What is the difference between combined oral contraceptives (COCs) and progestin-only pills (POPs, also known as the mini-pill)?
  • Based on my medical history and lifestyle, do I have a higher risk of blood clots or other cardiovascular issues?
  • What happens if I forget to take a pill one day?
  • How effective are oral contraceptives?
  • If I’m currently taking medication for another health issue, can I still take birth control pills?

 

Birth control pills can fit your needs and lifestyle

Long gone are the days when women had a limited selection of birth control pills to choose from. Innovations in the industry have led to new products that offer more flexibility and freedom. With Slynd®, we believe your birth control pill should fit your needs and your lifestyle, not the other way around!

An important distinction to make when it comes to oral contraceptives is COCs (combined oral contraceptives) versus POPs (progestin-only pills). COCs contain two types of hormones—estrogen and progestin—that prevent pregnancy. On the other hand, POPs only contain progestin and are safer for women who smoke and those who may be at risk of adverse side effects when taking a pill with estrogen.

For some women, such as those who are overweight or smoke, COCs may be less effective and may lead to increased risks of side effects. COCs contain a boxed warning regarding increased risk of blood clots in women over the age of 35 who smoke. POPs, which do not contain estrogen, do not have a boxed warning and are a safer option.

Who is at a higher risk of side effects?

When speaking to your doctor about starting birth control pills, they will ask about your medical history. Certain health conditions (i.e. liver cancer, serious cardiovascular risk such as heart attacks) and lifestyle choices may lead to a woman having a higher risk of side effects when taking birth control pills. These include:

  • Women who are smokers and are 35 years old or older
  • Women who have a history of breast cancer, heart disease, or stroke
  • Women with high blood pressure or have a history of blood clotting
  • Women who have had diabetes for more than 10 years
  • Women who suffer from migraine headaches

Teen talking to Doctor

When can teenage girls start birth control pills?

In addition to preventing pregnancy, some young women may also want to take oral contraceptives as a way to control their acne. Slynd® contains drospirenone, which is a more appropriate birth control hormone for those suffering from skin-related problems, like acne.

In addition to the list above about certain health conditions, girls who have unexplained vaginal bleeding or think they may be pregnant should not start or take oral contraceptives. Before prescribing oral contraceptives, doctors or registered nurses may also conduct a physical exam (including a pelvic exam).

The most common age for teenage girls to start birth control pills is 16 since, at this age, most will have an established menstrual cycle. We recommend speaking to your doctor to learn more about whether or not oral contraceptives are the best option for you.

One question younger women might be asked by their doctor is whether or not they can reliably take the pill at the same time every day. This is because a pill must be taken in a short window of time every day in order to be effective.

After getting your first pack of pills, when should you start them?

Consult with your doctor on when you should take your pills. In many cases, women will start taking their birth control pills as soon as they have them, even during their period. Visit our FAQ section to learn when to start taking Slynd® pills if:

  • You haven’t been taking any other form of hormonal birth control
  • You’re switching from another birth control pill
  • You’re switching from a vaginal ring or transdermal patch
  • You’re switching from a different progestin-only method, such as an implant or injection
  • Or you’re switching from an intrauterine device or system (IUD or IUS)

In general, for COCs (pills with estrogen), women can start taking the pill within five days after their period starts. This protects them from pregnancy immediately. For women who start COCs at other times, they must take the pill for at least seven days before they’re fully protected.

Most POPs provide protection against pregnancy after 48 hours. However, Slynd® is different because it offers protection immediately if women take it on day one of their period. If taken at any other time, women should use other forms of birth control for at least 48 hours (such as a condom).

 

How long should oral contraceptives be taken?

Healthy women can take the pill on an ongoing basis as long as they require birth control or until they experience menopause. For older women who haven’t had a menstrual cycle for at least a year, this signals that they have reached menopause. At this stage, the changing hormone levels within the body means the ovaries aren’t releasing any eggs so women can’t get pregnant naturally.

Women who are trying to get pregnant should speak to their doctors about stopping their oral contraceptives. This is also an opportunity to get a pre-pregnancy check-up to ensure you are in full health before getting pregnant.

For older women who haven’t had a menstrual cycle for at least a year, this signals that they have reached menopause. At this stage, the changing hormone levels within the body means the ovaries aren’t releasing any eggs so women can’t get pregnant naturally.

 

Taking your pill every day

Birth control pills are most effective when they’re taken at the same time every day so the important question to ask yourself is whether or not this is realistic based on your schedule and lifestyle. For progestin-only pills (POPs), until recently, all of them offer a short 3-hour missed pill window. Slynd® now offers a much more generous and flexible 24-hour missed pill window.

Maintaining a schedule to take the pill on time can be a breeze for some women, but may be difficult and stressful for other women. Talk to your doctor about ways you can help yourself remember to take the pill on time and whether it’s the right option for you.

Your pill, your way

It’s important to speak to your doctor about how birth control pills can support your health and lifestyle. While some of the terminologies can get confusing, don’t worry—we can help! Here are some educational resources to help get you started:

If any of these conditions happen while you are taking Slynd, stop taking Slynd right away and talk to your healthcare provider. Use non-hormonal contraception when you stop taking Slynd.

Click here to read more Important Risk Information and full prescribing information.

 

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What are “POPs”?

When considering oral contraceptives, two common options include combination oral contraceptives (COCs), which contain both estrogen and progestin, and progestin-only pills (POPs). In our What’s the difference between progestin and estrogen in birth control pills?, we looked at the major differences between these hormones and the benefits and drawbacks of COCs versus POPs.

Keep reading to learn more about progestin-only pills, how effective POPs are, potential side effects of this type of oral contraceptive, and women who may want to consider a POP over a pill that uses estrogen.

How do progestin-only pills work?

The key difference between POPs and COCs is that POPs do not contain estrogen. Instead, progestin is the primary hormone used to prevent pregnancy.

Progestin-only birth control pills prevent pregnancy by thickening the mucus of the cervix. This makes it harder for sperm to enter the uterus to fertilize an egg. As a synthetic form of progesterone (which is naturally produced in the body), progestin stops ovulation but this process is not always consistent.

Studies show that roughly four out of ten women who use progestin-only pills will still ovulate. Another way POPs prevent pregnancy is that it thins the lining of the uterus. This means any egg that is fertilized will have a harder time implanting itself to the wall of the uterus. Similar to other oral contraceptives, POPs do not prevent STDs (sexually transmitted diseases) or HIV. Because certain birth control methods do not provide skin-to-skin protection (oral contraceptives and IUDs), use a barrier method to protect against STDs, such as condoms.

POPs are taken orally and in order to be effective, must be taken once per day at the same time every day. Typical progestin-only pills come in a pack of 28 tablets, all of which contain active hormones with no placebo. However, Slynd®, a newer progestin-only pill, features 24 white active pills and four green inactive or placebo pills which helps to provide a scheduled withdrawal bleed that can be planned and anticipated.

Birth Control Pills

As with all medical products, read the patient package insert or ask your doctor to learn how to properly store your pills to ensure product stability and shelf-life.

How effective are progestin-only pills?

Clinical studies are performed to evaluate the effectiveness of POP products. These trials often look at both typical use and perfect use. When looking at typical use, approximately nine out of 100 women will become pregnant during the first year of using a POP. It’s important to keep in mind that these findings are based on other POPs that offer a 3-hour missed pill window. As the only POP with a more flexible 24-hour missed pill window, Slynd® has a Pearl Index of just 4.0 Pearl Index (2.3, 6.4; 95% CI).

Even if you’re taking your progestin-only birth control pills on schedule and ensure it’s safely stored, there are certain medications that may impact how effective the pill is in preventing pregnancy. Certain medications, such as Rifampin, some barbiturates, and griseofulvin, may make POPs less effective. Before taking birth control pills, inform your doctor of any other medication you may be taking.

The effectiveness of POPs may also be negatively impacted if you experience vomiting or diarrhea, resulting in your body not properly absorbing the pill. In this situation, women should use another method of birth control, such as a condom, for at least 48 hours.

Progestin products like Micronor® that use norethindrone offer a 3-hour window during which women must take the pill for it to be effective. Instead of using norethindrone, Slynd® uses drospirenone, another form of progestin. Slynd® is the only progestin-only pill that offers a 24-hour missed pill window. This means that you can be up to 24 hours late in taking your next Slynd® pill without compromising its effectiveness. However, it is still recommended that you take your pill at the same time every day for maximum effectiveness.

What are common side effects when taking progestin-only pills?

When using progestin-only pills, women may experience a lighter period with less blood flow and cramping. Certain women may also experience no periods at all when taking the pill. POPs have also been linked to a reduced risk of pelvic inflammatory infection, anemia, and endometrial cancer.

One adverse side effect when taking progestin-only pills, particularly those that use norethindrone, include erratic or unscheduled bleeding. Slynd®, unlike typical progestin-only pills, has a tolerable bleeding profile comparable to combined oral contraceptives. In clinical studies, there was as little as <1% (0.4%) discontinuation rate due to bleeding irregularities.

Other side effects of POPs may include headaches, acne, nausea, breast tenderness, lower sex drive, and weight gain.

group shot of 4 women with high BMI

 

Who should or shouldn’t take progestin-only pills?

Certain women who are more sensitive to estrogen may want to consider a progestin-only pill in order to avoid introducing additional hormones to their bodies.

Who should consider taking progestin-only pills?

Increased levels of estrogen may impact breast milk production during the postpartum period, so women who are breastfeeding will want to consider a POP instead of a combined pill.

Progestin-only pills are considered safe for older women (35 years old and older) who experience high blood pressure, blood clots, or migraine headaches with aura. Women who smoke should also avoid estrogen-based oral contraceptives, but POPs are a viable and safe alternative.

Who should not take any birth control pills, including progestin-only pills?

Women who have had breast cancer in the past or have a history of breast cancer in their family should not take a progestin-only pill. Additionally, those who experience severe cirrhosis, acute liver disease, abnormal uterine bleeding, or have benign or malignant liver tumors should not take POPs.

What are some common side effects of POP products?

With progestin-only pills, some of the common side effects include headaches, nausea, breast pain and tenderness, weight gain, decreased sexual drive, menstrual cramps, and acne. Speak to your doctor if side effects persist or worsen.

 

Choosing the progestin-only pill that’s right for you

When considering a progestin-only pill or combination birth control pill, always speak to a doctor to learn more about which product is right for you and your needs.

Do not take Slynd if you:

  • have kidney disease or kidney failure
  • have reduced adrenal gland function (adrenal insufficiency)
  • have or have had cervical cancer or any cancer that is sensitive to female hormones
  • have liver disease, including liver tumors
  • have unexplained vaginal bleeding
  • If any of these conditions happen while you are taking Slynd, stop taking Slynd right away and talk to your healthcare provider. Use non-hormonal contraception when you stop taking Slynd.

Click here to read more Important Risk Information and full prescribing information.

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What’s the difference between progestin and estrogen in birth control pills?

When considering which oral contraceptive is right for you, two medical terms you might come across are progestin (a synthetic form of progesterone) and estrogen. These refer to two female sex hormones that are used in birth control products. Outside of their use in contraceptives, estrogen and progesterone are naturally produced in the female body and play key roles in regulating certain body functions in women throughout puberty, pregnancy, and menopause.

As two common hormones found in oral contraceptives, understanding the differences between combination pills and progestin-only pills can help you select one that fits your needs and lifestyle. In this article, we will look at the major differences between progestin and  estrogen as it relates to birth control, and why the pill is not “one size fits all.”

What you need to know about progestin

Progestin is a synthetic form of progesterone, which is a female hormone found in a woman’s body. As a naturally occurring hormone, progesterone is released from the ovaries to prepare the body for pregnancy. Progesterone also plays an important role during pregnancy. It contributes to maternal breast tissue growth while also preventing lactation, and prepares the body for labor by strengthening the wall muscles around the pelvic area.

Some common uses for progestin in products outside of contraception include treating abnormal uterine bleeding, severe premenstrual syndrome (PMS), and postmenopausal hormone replacement therapy.

Do progestin products have any adverse side effects? When taking oral contraceptives that contain progestin, some women may experience side effects including ovarian cysts, breast tenderness, headaches, fatigue, nausea, and hair thinning.

Other studies analyzing other side effects, such as the impact on sex drive and development of mood disturbances, are limited in terms of evidence and may offer conflicting views.

If you’re experiencing any adverse side effects when taking oral contraceptives, make sure to talk to your doctor.

Woman speaking to a doctor

What you need to know about estrogen

Like progesterone, estrogen is a sex hormone naturally produced in the body and is responsible for developing female sexual characteristics. For example, during puberty, estrogen contributes to the development of mammary ducts. During pregnancy, it supports functions that secrete breast milk.

Estrogen is commonly found in birth control products, such as oral contraceptives and vaginal rings. It is also found in products that treat symptoms during menopause, such as hot flashes, vaginal dryness, and itching.

Some side effects of taking estrogen products include nausea, cramps, headaches, weight gain, and abnormal uterine bleeding.

If you’re experiencing any adverse side effects when taking oral contraceptives, make sure to talk to your doctor.

Combination birth control pills or progestin-only pills?

Combination Oral Contraceptives (COCs)

Combination birth control pills contain both estrogen and progestin. When used in birth control pills, progestin and estrogen thicken the mucus inside the cervix, making it harder for sperm to travel to the egg. They also work to thin the lining of the uterine wall so that if an egg is fertilized, it is more difficult to implant.

COCs are most effective when the pills are taken correctly according to the instructions. Most products on the market use a one-phase dosing cycle, or monophasic. In other words, tablets of one strength are taken for 21 days. A monophasic dosing cycle with 28 days will include seven inactive or placebo pills that are another color.

Other dosing schedules include biphasic (two-phase), triphasic (three-phase), and even quadriphasic (four-phase). The differences between these phases are the number of different colored pills formulated with different strengths. The benefit of a monophasic dosing cycle is that it’s much more straightforward and easier for patients to remember—they don’t have to remember what color pill corresponds to what formulation strength. Learn more about dosing schedules in this Mayo Clinic article.

Combined birth control pills typically have a tight 3-hour dosage window. They contain varying levels of estrogen and also in different forms (chewables, soft gels, tablets).

Chewables or soft gels have similar side effects as other traditional combined pills, including headaches, breakthrough bleeding, nausea, and weight gain. However, similar to other COC products, side effects may vary from person to person.

A benefit of chewable birth control is that it may be easier to swallow, especially for women who are experiencing nausea. While not chewable, soft gel capsules are more flexible and easier to swallow than traditional pills.

It is important to note that all combined oral contraceptives contain a boxed warning about the increased risk of heart and blood vessel problems as well as death from blood clots, heart attack, or stroke in females that smoke and are over 35, which increases with age and the number of cigarettes smoked and is therefore not recommended in this group.

Progestin Only Pills (POPs)

Progestin-only pills (POPs) only contain progestin (no estrogen) and typically have a lower dose of progestin compared to a combination pill with both progestin and estrogen. Progestin-only birth control pills also prevent pregnancy by thickening the mucus of the cervix and thinning the lining of the uterine wall.

For women who are breastfeeding and want to take oral contraception, doctors may recommend a progestin-only pill since estrogen may interfere with the production of breastmilk.

POPs are also a more suitable option for women who smoke and are over the age of 35 because they do not contain estrogen. Patients with a history of blood clots or high blood pressure are better off taking a POP due to the increased cardiovascular risk seen with combined oral contraceptives.

Doctors may not recommend POPs for women who have had breast cancer, have liver disease, serious cardiovascular risk, have had cardiovascular surgery or other issues, or take other drugs that may interfere with the effectiveness of the pill.

For a very long time, progestin-only pills only offered a tight 3-hour dosage window during which a woman must take her pill for maximum effectiveness in pregnancy prevention. However, that changed when Slynd® entered the market. Slynd® is the first and only POP with a 24-hour missed pill window, comparable to COCs.

Package of Slynd® Birth Control Pills

When deciding between a combination oral contractive or a progestin-only pill, consult your healthcare provider to learn more about which option best suits you.

Click here to learn more about how Slynd® may fit your needs.

Do not take Slynd if you:

  • have kidney disease or kidney failure
  • have reduced adrenal gland function (adrenal insufficiency)
  • have or have had cervical cancer or any cancer that is sensitive to female hormones
  • have liver disease, including liver tumors
  • have unexplained vaginal bleeding
  • If any of these conditions happen while you are taking Slynd, stop taking Slynd right away and talk to your healthcare provider. Use non-hormonal contraception when you stop taking Slynd.

Click here to read more Important Risk Information and full prescribing information.

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Two New Publications Support the Safety and Efficacy of Slynd™ (drospirenone) tablets, 4 mg

FLORHAM PARK, N.J. July 7, 2020 – Exeltis USA, Inc., a division of Insud Pharma, today communicated that 2 new articles published in Contraception and The European Journal of Contraception & Reproductive Health Care,  reviewed the US Phase III clinical study involving Slynd™ (drospirenone) tablets 4 mg, a novel estrogen-free oral contraceptive in a physician and patient communication letter.

The publications highlighted the safety and efficacy of drospirenone 4 mg, similarly to the FDA which approved the Slynd™ NDA in May 2019.The first in Contraception, “A one-year prospective, open-label, single arm, multicenter phase 3 trial of the contraceptive efficacy and safety of the oral progestin-only drospirenone 4 mg using a 24/4 daily regimen” (Kimble et al; February 21, 2020), indicated that drospirenone provides a contraceptive option for the majority of women regardless of blood pressure and BMI. The second, “Estrogen-free oral contraception with a 4 mg drospirenone-only pill: new data and review of the literature” (Palacios et al; April 21, 2020), published in The European Journal of Contraception & Reproductive Healthcare-, concluded that drospirenone 4mg has shown contraceptive effectiveness similar to that of currently available COCs (combined oral contraceptives), very low cardiovascular side effects and a favorable bleeding pattern.

“We are pleased to see the Slynd™ clinical study  results being reported in renowned journals,” said  Randi Rievman, Senior Director, Marketing and Sales Training for Exeltis. “The data validates what we have known for some time: Slynd™ is an attractive option for many women who want or need an estrogen-free oral contraceptive. It offers  the right balance of safety and efficacy to address the needs of many women, especially for those who may not be good candidates for other  currently available oral contraceptive options.”

In addition to these findings, Exeltis USA President Salustiano Perez added, “Slynd™ is further differentiated in the market because it is an estrogen-free oral contraceptive product that provides a 24 active plus 4 inactive tablet dosing regimen and allows a 24-hour missed pill window.”

Slynd™ is indicated to prevent pregnancy among females of reproductive potential. Slynd™ is contraindicated in females with conditions that predispose to hyperkalemia (e.g. renal impairment, hepatic impairment, and adrenal insufficiency). Other contraindications include presence or history of progestin sensitive cancers, liver tumors, benign or malignant, or undiagnosed abnormal uterine bleeding. Slynd™ may cause side effects including hyperkalemia, thromboembolism, bone loss, cervical cancer, liver problems, ectopic pregnancy, high blood sugar, changes in menstrual bleeding or depression. Discontinue Slynd™ if a thromboembolic event occurs or there are acute or chronic changes in liver function. For full important risk and use information about Slynd™ please see full  Slynd™ Prescribing Information.

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Slynd™ (Drospirenone) tablets, 4 mg Updated Website Launches for Patients and Physicians

FLORHAM PARK, N.J, June 23, 2020 – Exeltis USA, Inc, a division of Insud Pharma, today announced the launch of the updated slynd.com, the website for Slynd™ (drospirenone) tablets 4 mg, a novel estrogen-free oral contraceptive, in a physician and patient communication letter.

The updated Slynd™ website provides patients and healthcare professionals a rich array of information in a user-friendly format to familiarize visitors with this new progestin-only pill and educate them on Slynd™ safety and efficacy while pointing out the unique aspects that differentiate Slynd™ from other birth control options.

The website offers information about patients for whom Slynd™ is an option, with educational videos for each patient type. The website also includes video commentary from three well-respected obstetricians and gynecologists who, with their endorsement,  share their perspective on Slynd™ and why they perceive it as a meaningful contraceptive option for their patients.

Slynd™, a progestin-only pill (POP) is a novel estrogen-free oral contraceptive with a 24 active and 4 inactive tablet dosing regimen and also allows a 24-hour missed pill window.  This not only can mean favorable safety and efficacy but an improved bleeding profile and contraceptive efficacy for up to a 24-hour window in the event of a delayed or missed dose, which is particularly beneficial for breastfeeding mothers.

“We are excited to share the website with patients and physicians.  Slynd™ is an appealing option for women who can’t or don’t wish to take oral contracptives with estrogen,” said Salustiano Perez, president of Exeltis USA. “It is a good option for women who are breastfeeding, overweight, smokers or those who want estrogen-free oral contraceptive choices. It also has a less rigid dosing schedule than other progestin-only oral contraceptives on the market.”

Slynd™ is indicated to prevent pregnancy among females of reproductive potential. Slynd™ is contraindicated in females with conditions that predispose to hyperkalemia (e.g. renal impairment, hepatic impairment, and adrenal insufficiency). Other contraindications include presence or history of progestin sensitive cancers, liver tumors, benign or malignant, or undiagnosed abnormal uterine bleeding. Slynd™ may cause side effects including hyperkalemia, thromboembolism, bone loss, cervical cancer, liver problems, ectopic pregnancy, high blood sugar, changes in menstrual bleeding or depression. Discontinue Slynd™ if a thromboembolic event occurs or there are acute or chronic changes in liver function. For full important risk and use information about Slynd™ please see full Slynd™ Prescribing Information.

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Peer-Reviewed Publication Reinforces Safety and Efficacy of Slynd™ (Drospirenone) tablets, 4 mg

FLORHAM PARK, N.J., June 11, 2020 — Exeltis USA, Inc, a division of Insud Pharma, today released a physician and patient communication letter announcing a recent publication in Drugs of Today 2020 that highlights the Slynd™ safety data and the efficacy of drospirenone to inhibit ovulation, reinforcing the features and benefits of Slynd™ (drospirenone) tablets 4 mg, a novel estrogen-free oral contraceptive.

The published article, “Drospirenone: a novel progesterone used as an oral contraceptive without an estrogen component” (D.M. Paton, 56(5): 321-328) reviews two phase III clinical studies of Slynd. The paper concludes that “it was a logical development to determine the efficacy of a tablet that only included [drospirenone] DRSP as an oral contraceptive” which gained approval by the Food & Drug Administration in May, 2019.

“There is an important place in the market for this next generation progestin-only pill for prevention of pregnancy”, notes Randi Rievman, Senior Director, Marketing and Sales Training at Exeltis USA. “Slynd, which is proven safe and effective for contraception, is truly fitting a patient need in today’s environment. Using telemedicine service providers, it can be prescribed without an office visit.  It doesn’t require a blood pressure check before prescribing as the CDC guidance stipulates for other estrogen-containing oral contraceptives or need to be inserted like the IUDs.”

Exeltis, the license holder of Slynd™, has taken additional measures during the current COVID-19 environment to make the progestin-only pill easily available to women in need of an oral contraceptive. The company has made sampling delivery safe and convenient for physicians and patients by enabling physicians to order samples sent directly to their offices or direct shipments to patient homes to further facilitate their ability to start their patients on Slynd™.

“In the current COVID-19 environment, where there are many women physically distancing and unable to go to physician offices for visits, our program enables their doctors to help them access oral contraceptives without an office visit,” said Rievman.

Slynd™, a progestin-only pill (POP), is a novel estrogen-free oral contraceptive that has a 24 active with 4 inactive tablet dosing regimen and also allows a 24-hour missed pill window.  This not only can mean favorable safety and efficacy but an improved bleeding profile and contraceptive efficacy for up to a 24-hour window in the event of a delayed or missed dose, which is also very beneficial for breastfeeding mothers.

Slynd is indicated to prevent pregnancy among females of reproductive potential. Slynd is contraindicated in females with conditions that predispose to hyperkalemia (e.g. renal impairment, hepatic impairment, and adrenal insufficiency). Other contraindications include presence or history of progestin sensitive cancers, liver tumors, benign or malignant, or undiagnosed abnormal uterine bleeding. Slynd may cause side effects including hyperkalemia, thromboembolism, bone loss, cervical cancer, liver problems, ectopic pregnancy, high blood sugar, changes in menstrual bleeding or depression. Discontinue Slynd if a thromboembolic event occurs or there are acute or chronic changes in liver function. For full important risk and use information about Slynd please see full Slynd Prescribing Information.

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Exeltis USA, Inc. Announces the Launch of Slynd™(drospirenone) tablets, 4 mg, the First and Only Progestin-Only Pill Providing Pregnancy Prevention with a 24-hour missed pill window and 24/4 Dosing Regimen

FLORHAM PARK, N.J., Sept. 16, 2019 /PRNewswire/ — Exeltis USA, Inc. a division of Insud Pharma (headquartered in Madrid, Spain) today announced the commercial launch of its oral contraceptive tablet Slynd™ (drospirenone) tablets, 4 mg in the US market.

Slynd™, a progestin-only pill (POP), is a novel estrogen-free oral contraceptive product that provides a 24 active plus 4 inactive tablet dosing regimen and allows a 24-hour missed pill window.  This not only can mean favorable safety and efficacy, but an improved bleeding profile and contraceptive efficacy for up to a 24 hour window in the event of a delayed or missed dose.

Slynd™ contains the active ingredient drospirenone—a synthetic form of progesterone that has a similar pharmacological profile to the natural hormone progesterone.  In clinical trials, Slynd™ showed no instances of thromboembolic events which some women taking combined oral contraceptives (COCs) with estrogen experience.  In addition, the safety of Slynd™ is supported by its approval by the Food and Drug Administration (FDA) with no Boxed Warning unlike the COCs.

Slynd™ is indicated to prevent pregnancy among females of reproductive potential. Slynd™ is contraindicated in females with conditions that predispose to hyperkalemia (e.g. renal impairment, hepatic impairment, and adrenal insufficiency). Other contraindications include presence or history of progestin sensitive cancers, liver tumors, benign or malignant, or undiagnosed abnormal uterine bleeding.

“The Slynd™ safety profile was demonstrated for all patients, including higher-risk populations like smokers, older women, and women with a Body Mass Index (BMI) >30,” observed Enrico Colli, MD, Chief Scientific Officer.

In addition, Salustiano Perez, President of Exeltis USA, Inc. noted that “Slynd™ is a POP that may fit the lifestyle of more patient types, especially breastfeeding mothers seeking a safe and effective oral contraceptive without the risks of estrogen and some of the dosing challenges.”

The launch of Slynd™ will be backed by a strong sales and marketing effort directed toward healthcare professionals in the field of Obstetrics and Gynecology, the medical specialty most involved in contraceptive patient consultation and prescribing.

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Exeltis USA, Inc. Announces the Approval of Slynd™, the First and Only Progestin-Only Pill Providing Pregnancy Prevention with a 24/4 Dosing Regimen and 24-hour Missed Pill Window

FLORHAM PARK, N.J., June 6, 2019 /PRNewswire/ — Exeltis USA, Inc. a division of the global pharmaceutical group Insud Pharma, announced today that the US Food and Drug Administration (FDA) has approved the new drug application (NDA) for Slynd™ (pronounced “slind”) containing drospirenone 4 mg, an oral contraceptive tablet for pregnancy prevention.Slynd™, a progestin-only pill (POP) is a novel estrogen-free oral contraceptive that is intended as a 24 active with 4 inactive tablet dosing regimen and also allows a 24-hour missed pill window.  This not only can mean favorable safety and efficacy but an improved bleeding profile and contraceptive efficacy for up to 24 hours in the event of a delayed or missed dose.

In clinical trials, Slynd™ (a synthetic form of progesterone that has a similar pharmacological profile to the natural hormone progesterone) showed no instances of thromboembolic events experienced by some women taking COCs, which by definition contain estrogen.  In addition, the safety of Slynd™ is supported by its approval with no black box warning unlike other combined oral contraceptives.  But for females with conditions that predispose to hyperkalemia (e.g. renal impairment, hepatic impairment and adrenal insufficiency), Slynd™ is contraindicated due to its anti-mineralocorticoid activity.

“This safety profile was demonstrated for all patients, including higher-risk populations like smokers, older women, and subjects with a Body Mass Index (BMI) >30,” said Enrico Colli, MD, Chief Scientific Officer.

Salustiano Perez, President of Exeltis USA, Inc. observed “Slynd™ may be an excellent choice for women who need or want safe and effective oral contraception without the risks of estrogen. Slynd may be an ideal choice for a breastfeeding mother.”

Slynd™ is indicated to prevent pregnancy among females of reproductive potential. Contraindications include renal impairment, adrenal insufficiency, presence or history of progestin sensitive cancers, liver tumors, benign or malignant, or hepatic impairment, or undiagnosed abnormal uterine bleeding.

The commercial launch of Slynd™ is anticipated in early Fall 2019.