Monday, May 10, 2010

FDA Approves Four-Phasic Natazia

Speaking of the Pill's 50th anniversary, the FDA just approved a new combination oral contraceptive pill, Natazia (Qlaira in Europe), the first four-phase oral contraceptive marketed in the United States.

Three things you should know about Natazia:

1. Uses New Estrogen/Progestin combination.

Natazia is the first and only oral contraceptive that contains an estrogen called estradiol valerate and a progestin called dienogest. Estradiol valerate is a synthetic estrogen that is converted to estradiol in a woman’s body....

Until today, all marketed combination oral contraceptives (COCs) contained ethinyl estradiol. With the FDA approval of Natazia, Bayer HealthCare Pharmaceuticals becomes the first company to launch estradiol valerate together with the progestin, dienogest.

So, Natazia contains the estrogen estradiol valerate and the progestin dienogest; the other COCs contain the estrogen ethinyl estradiol and various progestins like, for example, levonorgestrel.

2. Dosing Is Four-phasic.

Four-phasic means the doses of estrogen and progestin vary four times throughout each 28-day dosing cycle, like so:

  • 2 dark yellow tablets each containing 3 mg estrogen
  • 5 medium red tablets each containing 2 mg estrogen and 2 mg progestin
  • 17 light yellow tablets each containing 2 mg estrogen and 3 mg progestin
  • 2 dark red tablets each containing 1 mg estrogen
  • 2 white placebo tablets (inert)

Two things to note. First, the placebo interval is reduced to only 2 days. Second, you have 4 days (2 at the beginning and 2 at the end of the active cycle) when you're only taking estrogen pills.

3. It's New.

So, will Natazia's 4-phasic dosage provide the solution to all your past Pill use woes? Eh, I wish, but most likely no. Natazia is just a different Pill brand, not necessarily better or worst than existing brands. How well you do on it will depend on your personal history. Although I haven't seen any data so far to that effect, my guess on what's behind this new dosage regimen is that Bayer will try to gear this brand to the menstrual disorders demographic.

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At 6:12 AM, Anonymous Anonymous said...

I have started on Natazia and would like to know how to skip my period. It's very difficult to find any information on how to do that with this new fourphasic pill! Any feedback would be great.

At 4:00 PM, Blogger ema said...

Ah, a very good question. With the proviso that there are no studies on a suppression regimen (and I have limited experience with the brand):

When you use a "skip period" regimen, the aim is to level the hormone fluctuations to avoid BTB. In other words, you want to take as many pills with the same amount of hormones in a row. That's a bit of a challenge with this brand.

Here's what I would do. Take the pill on the regular regimen for at least 3 months and chart the timing of the withdrawal bleeding to establish a pattern. Let's say you experience bleeding for 2-4 days at the end of a pack.

The first thing to try is to skip the last 2 pills, the placebo pills, and just start a new pack right away. Do this for at least 4 mo and, again, chart to keep track of bleeding, if any.

At 10:03 PM, Anonymous Anonymous said...

I am about to start natazia and I was wondering on what pill would I get my period.

At 2:39 AM, Anonymous Anonymous said...

I started natazia 4 months ago and ive missed every period. Is that normal? Am i taking the pills wrong?

At 2:59 AM, Anonymous Anonymous said...

Looks like I'm not the only one. I've been taking it for at least a year and still have not gotten my period. My doctor says it's normal but I'm starting to wonder...

At 9:03 AM, Anonymous Anonymous said...

My doctor just prescribed this to me and I am very scared to try it with all of the side effects. I was on birthcontrol once before and it worked good. It was a low dose estrogen pill. So now after being birthcontrol free this new doctor wants to start me on this and I myself am worried about the high estrogen since my mother has had cervical and breast cancer. Plus my periods are already moderate to light so I am not sure this product is right for me since I haven't had a heavy period in 5year. Is this the right product? Is it safe?

At 2:46 PM, Blogger Catherine said...

From what i just read there are 2 inavtive pills (28 and 27) and 2 estrogen (26,25). I have a vaykay coming up so i am taking pills 1-24, and then starting a new pk on day one. They say yiu can do this for 3 months at a time.


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