Natazia

What is Natazia?

Natazia is a brand of combination birth control pills. This pill (which is already licensed in Europe under the brand name Qlaira) is the first four-phase oral contraceptive marketed in the United States. Natazia is unique in the sense that it is first and only oral contraceptive that contains an estrogen called estradiol valerate and a progestin called dienogest. With the exception of Natazia, all available combination birth control pills contain ethinyl estradiol.

Estradiol valerate, the synthetic estrogen found in Natazia, is converted to estradiol in a woman's body.

Natazia is different from traditional monophasic pills which are made up of a constant dose of both estrogen and progestin. Natazia delivers varying doses of hormones at four times throughout each 28-day treatment cycle. The pills contain varying doses of estradiol valerate, and estradiol valerate in combination with dienogest, for specific days of the 28-day cycle. The estradiol valerate decreases from 3 mg to 1 mg over the 28 days. Each blister pack of Natazia contains the following pills that must be taken in this specific order:

  • 2 dark yellow tablets, each containing 3 mg estradiol valerate.
  • 5 medium red tablets, each containing 2 mg estradiol valerate and 2 mg dienogest.
  • 17 light yellow tablets, each containing 2 mg estradiol valerate and 3 mg dienogest.
  • 2 dark red tablets, each containing 1 mg estradiol valerate.
  • 2 white placebo tablets (contains no hormones).

Estradiol valerate is not as potent as ethinyl estradiol. Because of this,  Natazia may be a good combination contraceptive for women who are sensitive to estrogen since this pill may be not trigger as many estrogen-related side effects.

Natazia Side Effects:

As with any type of hormonal contraceptive, you may experience some side effects (that usually go away after the first 3 months) if you use Natazia.

The most common reported side effects of this four-phasic pill are:

  • Breast discomfort/pain
  • Spotting or irregular bleeding
  • Weight gain
  • Headaches
  • Acne
  • Stomach pain
  • Nausea
  • Mood changes

Noncontraceptive Benefits of Natazia:

Natazia has been FDA-approved to help reduce bleeding in women who have heavy monthly periods (known as menorrhagia). Natazia's prescribing information also claims that "based on patient diaries, amenorrhea (having no period) occurs in approximately 16% of cycles in women using Natazia."

Research supports the effectiveness of Natazia for helping women who suffer from heavy periods. In a randomized study, researchers examined the bleeding patterns and cycle control in 804 women (ages 18-50). The women were either given Natazia or a monophasic pill with the hormones, ethinyl estradiol and levonorgestrel (like Seasonique and Amethyst). The women in the Natazia group reported significantly less bleeding and/or spotting days compared to the women in the monophasic pill group – median of 16 days vs. 21 days.

The researchers also found that during their withdrawal bleed (i.e., “period”), the women who used Natazia described their bleeding as being less intense and they bled for fewer days as compared to the monophasic group. Finally, the women using Natazia were also more likely to not have any bleeding at all.

Missing an Ortho Tri-Cyclen Lo Pill:

Because the hormone levels are different throughout the four-phases of these pills, you will need to follow different directions depending on where you are in your pack when you forget to take a pill(s). The following is a good rule of thumb to follow (but you should always check with the pill prescribing information that comes with each monthly pack). If you are less than 12 hours late taking your pill, take your pill as soon as you remember and take your next pill at your usual time (you do not need to use back-up contraception). When using Natazia, it you are more than 12 hours late and you forget to take:

  • ONE Pill During Days 1-17: Take the pill as soon as you remember, and take the next pill at your regular time (you may take two pills in one day); use back-up contraception for the next 9 days while continuing to take one pill at the same time for the rest of the pack.
  • TWO Pills (in a row) During Days 1-17: Do not take the missed pills.Rather, take the pill for the day on which you first noticed you had missed pills. You could become pregnant if you have sex in the 9 days after you miss these pills, so use a back-up birth control method for those 9 days. Continue taking one pill each day at the same time for the rest of your cycle.**NOTE: If you miss the pills for Days 17 and 18, follow the instructions for Days 17–25 instead.
  • ONE Pill During Days 18-24: Do not take any pills from your current blister pack - throw out the remainder of the pack and start a new pack of pills (Day 1) that same day. Use back-up contraception for the next 9 days while continuing to take one pill at the same time for the rest of the pack.
  • TWO Pills (in a row) During Days 17-25: Do not take any pills from your current blister pack - throw out the rest of the pack. Take Day 3 pill from a new pill pack, use back-up birth control for the next 9 days, and continue taking one pill from the new blister pack at the same time each day. **NOTE: If you miss the pills for Days 25 and 26, follow the instructions for Days 25-28 instead.
  • ONE Pill During Days 25-28: Take the pill as soon as you remember, and take the next pill at your regular time (you may take two pills in one day); No back-up contraception is needed but continue to take one pill at the same time for the rest of the pack.
  • TWO Pills (in a row) During Days 25-28: Do not take any pills from your current blister pack and just throw it away. Start a new pack on the same day or start a new pack on the day you usually start a new pack. You do not need a back-up method.

Natazia Effectiveness:

Combination birth control pills are a highly effective and convenient form of contraception. The pill is 92-99.7% effective. With typical use, 8 out of every 100 women will become pregnant during the first year of pill use. With perfect use, less than 1 will become pregnant. Regardless of the type/amount of hormones in the pill, all combination pills essentially work the same way to prevent pregnancy.

You may already be pregnant or could become pregnant if you had sex on the days after missing pills. The more pills that you missed and/or the closer you are to the end of the cycle, the higher your risk of a pregnancy.

Natazia may be less effective in women who are obese (which can apply to about 30% of all Americans). The efficacy of Natazia in women with a body mass index (BMI) of > 30 kg/m2 has not been evaluated.

Natazia Costs:

It appears that the price for Natazia is more expensive than other available oral contraceptives. Since Natazia is considered a branded medication or tier 3 drug under most health insurance plans, it may not be covered or may require a higher copay.

That being said, there is no generic alternative for Natazia. Bayer (it’s manufacturer) has exclusive rights to the production and sale of Natazia until 2016 -- when it’s patent expires. After that time, other drug companies may be able to make and sell generic Natazia. Because there is no generic version of Natazia, it may be covered with no out-of-pocket costs for all non-grandfathered insurance plans.

You can also save money on Natazia with the Bayer Savings Card. After activating this card (which doesn’t cost anything), you need to print it out and show it to your pharmacist:

  • If you have insurance, you will pay no more than $30 for each month’s Natazia prescription.
  • If you do not have insurance, you will receive up to $25 off your out-of-pocket expense for each month's supply.

Sources:

Ahrendt HJ, Makalova D, Parke S, Mellinger U, Mansour D. "Bleeding pattern and cycle control with an estradiol-based oral contraceptive: Seven-cycle, randomized comparative trial of estradiol valerate/dienogest and ethinyl estradiol/levonorgestrel." Contraception. 2009;80: 436–444. Full article accessed via private subscription.

"NATAZIA - estradiol valerate and estradiol valerate/dienogest kit." [Bayer HealthCare Pharmaceuticals Inc.]. Daily Med. Accessed: December 4, 2014.

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