If you think you may have heavy menstrual bleeding (HMB), there’s something you can do about it
Ask your doctor if Natazia® is right for you. Natazia is the first and only birth control pill FDA approved to treat HMB in women without organic pathology who choose an OC as their method of birth control
- Natazia is a birth control pill approved to prevent pregnancy
- Natazia can also be used for the treatment of HMB that is not caused by any diagnosed conditions of the uterus in women who decide to use the Pill for birth control
- Natazia has not been studied for pregnancy prevention in women who are obese (body mass index >30)
Ask your doctor if Natazia® is right for you. Natazia is the first and only birth control pill FDA approved to treat HMB in women without organic pathology who choose an OC as their method of birth control
- Natazia is a birth control pill approved to prevent pregnancy
- Natazia can also be used for the treatment of HMB that is not caused by any diagnosed conditions of the uterus in women who decide to use the Pill for birth control
- Natazia has not been studied for pregnancy prevention in women who are obese (body mass index >30)
All about preventing pregnancy and reducing HMB
When taken as directed, Natazia is highly effective at preventing pregnancy
Natazia is also highly effective at reducing heavy periods that are not caused by any diagnosed conditions of the uterus
About the clinical studies for HMB
- Two clinical studies compared Natazia with placebo (inactive hormone-free pill) in women experiencing irregular bleeding symptoms (heavy, frequent, and/or prolonged bleeding not caused by any diagnosed conditions of the uterus)
- The effectiveness of Natazia was evaluated during a 90-day assessment (efficacy phase)
- The studies looked at the number of women who were completely relieved of their HMB symptoms
Complete symptom relief results
For women taking Natazia during this 90-day phase, 29.2% in one study and 29.5% in the other reported “complete symptom relief” (defined as having no more irregular bleeding symptoms and who met up to 8 strictly defined criteria for success). In comparison, 2.9% and 1.2% of women who were given a placebo reported “complete symptom relief."
What are the most common side effects in Natazia clinical trials?
The most common side effects were headache/migraine, breast pain/discomfort/tenderness, menstrual disorders, nausea/vomiting, acne, mood changes, and weight gain.
Significantly reduced menstrual bleeding at cycle 7
In the same 2 clinical trials in women with HMB who were treated with Natazia, their menstrual bleeding was reduced by an average of 90% in one trial and 87% in the other at cycle 7. For women treated with placebo, their menstrual bleeding was reduced by an average of 14% and 32% in the 2 trials, respectively.
What are the most serious risks of taking birth control pills?
Like pregnancy, birth control pills increase the risk of serious blood clots, especially in women who have other risk factors, such as smoking, obesity, or age greater than 35. This increased risk is highest when you first start taking birth control pills and when you restart the same or different birth control pills after not using them for a month or more.
It is possible to die from a problem caused by a blood clot, such as a heart attack or a stroke. Some examples of serious blood clots are blood clots in the:
- Legs (deep vein thrombosis)
- Lungs (pulmonary embolus)
- Eyes (loss of eyesight)
- Heart (heart attack)
- Brain (stroke)
A few women who take birth control pills may get:
- High blood pressure
- Gallbladder problems
- Rare cancerous or noncancerous liver tumors
All of these events are uncommon in healthy women.
One pill, once a day
To achieve maximum contraceptive effectiveness, Natazia must be taken exactly as directed.
Take 1 tablet by mouth at the same time every day.
Tablets must be taken in the order directed on the blister pack.
Tablets should not be skipped or intake delayed by more than 12 hours.
- Take one pill every day at the same time. Take the pills in the order directed on the blister pack
- Do not skip pills or delay taking your pill by more than 12 hours. If you miss pills (including starting the pack late), you could get pregnant. The more pills you miss, the more likely you are to get pregnant
- If you have trouble remembering to take Natazia, talk to your healthcare provider about how to make pill-taking easier, or about using another method of birth control
- You may have spotting or light bleeding when you first take Natazia. Spotting or light bleeding is normal at first
- You may feel sick to your stomach (nauseous), especially during the first few months that you take Natazia. If you feel sick to your stomach, do not stop taking the pill. The problem will usually go away. If your nausea doesn't go away, call your healthcare provider
- If you vomit or have diarrhea within 4 hours of taking your pill, follow the instructions for “What Should I Do If I Miss Any Pills”
- Missing pills can also cause spotting or light bleeding, even when you take the missed pills later. On the days you take 2 pills to make up for missed pills, you could also feel a little sick to your stomach
Birth control pills prevent your ovaries from producing and releasing mature eggs. Natazia decreases menstrual bleeding by thinning the lining of the uterus.
An innovative dosing regimen
It is the only oral contraceptive (OC) with 4-phasic dosing that combines estrogen and progestin as part of a 28-day cycle.
Natazia contains an estrogen called estradiol valerate and a progestin called dienogest.
But what might this do for me?
Days 1-2
Help your body build up the lining of the uterus with a 3-mg dose of estradiol valerate
Days 3-7
Slow the lining growth with dienogest, while reducing estradiol valerate
Days 8-24
Stabilize the lining of the uterus by raising the dienogest level
Days 25-28
Promote a controlled period by ending with a short interval of further reduced estradiol valerate, followed by 2 days of no hormones
Missed your pill? No need to panic
In order to be sure your birth control pill is going to be most effective, remember to take your pill every day, as directed. It's important to take one pill every day at the same time in the order directed on the blister pack.
- Take your pill as soon as you remember
- Take the next pill at the usual time
- You do not need to use back-up contraception
- Take your missed pill immediately
- Take your next pill at the usual time (you may have to take two pills that day)
- Use back-up contraception for the next 9 days
- Continue taking one pill each day at the same time for the rest of your cycle
- Do not take any pills from your current blister pack and throw the pack away
- Take Day 1 pill from a new blister pack
- Use back-up contraception for the next 9 days
- Continue taking one pill from the new blister pack at the same time each day
- Take your missed pill immediately
- Take your next pill at the usual time (you may have to take two pills that day)
- No back-up contraception is needed
- Continue taking one pill each day at the same time for the rest of your cycle
(If you miss the pills for Days 17 and 18, follow the instructions for Days 17–25 instead)
- Do not take the missed pills. Instead, take the pill for the day on which you first noticed you had missed pills
- Use back-up contraception for the next 9 days
- Continue taking one pill each day at the same time for the rest of your cycle
(If you miss the pills for Days 25 and 26, follow the instructions for Days 25–28 instead)
- Do not take any pills from your current blister pack and throw the pack away
- Take Day 3 pill from a new blister pack
- Use back-up contraception for the next 9 days
- Continue taking one pill from the new blister pack at the same time each day
- Do not take any pills from your current blister pack and throw the pack away
- Start a new pack on the same day or start a new pack on the day you usually start a new pack
- No back-up contraception is needed
- Continue taking one pill from the new pack at the same time each day, for the rest of your cycle
You may already be pregnant or COULD BECOME PREGNANT if you had sex on the days after the pills were missed. The more pills missed and the closer they are to the end of the cycle, the higher the risk of a pregnancy. You should call your healthcare provider if you are unsure whether you are already pregnant.
If you are still not sure of what to do about the pills you have missed:
- Call your healthcare provider
- Use back-up contraception (such as condoms and spermicides) anytime you have sex and keep taking 1 pill each day
For more information about what to do if you miss a pill and about Natazia in general, please see the What Should I Do if I Miss Any Pills section of the FDA-approved Patient Guide for Using Natazia. This information is also included in each pack of Natazia you will receive.
Advice for taking Natazia
Whether you’re a first-time user or have been on the pill before, it’s important to remember that the pill is most effective when taken as directed. That means taking one pill consistently at the same time every day. You should never skip a pill or delay taking your daily pill for more than 12 hours.
For more information on starting Natazia, refer to the How Do I Take Natazia? section of the FDA-approved Patient Guide for Using Natazia.
