Overview: Natazia is a hormonal birth control medicine that is used to prevent pregnancy. Natazia prevents pregnancy by stopping the release of an egg from the ovaries. It also decreases menstrual bleeding by thinning the lining of the uterus. Common side effects include headache, nausea, and breast tenderness. Before taking Natazia, make sure to tell your health care provider about any health conditions you have or medicines you are taking. Get emergency help if you have trouble breathing, chest pain, vision changes, or trouble speaking.
Uses
What is Natazia used for?
Natazia (estradiol valerate and estradiol valerate/dienogest) is a combination birth control pill that is commonly used to prevent pregnancy. It can also be used to treat heavy menstrual bleeding in people who want to take a birth control pill to prevent pregnancy.
Natazia may also be used for other conditions as determined by your health care provider.
How does Natazia work (mechanism of action)?
Natazia contains two types of hormones, estradiol valerate (an estrogen) and dienogest (a progestin). Natazia prevents pregnancy by stopping the release of an egg from your ovaries. It also decreases menstrual bleeding by thinning the lining of the uterus.
How is Natazia supplied (dosage forms)?
28-Day Quadriphasic (Four Phases)
- Days 1-2: Estradiol valerate oral tablets (3 mg)
- Days 3-7: Estradiol valerate/dienogest oral tablets (2 mg/2 mg)
- Days 8-24: Estradiol valerate/dienogest oral tablets (2 mg/3 mg)
- Days 25-26: Estradiol valerate oral tablets (1 mg)
- Days 27-28: Inactive oral tablets
How should I store Natazia?
Natazia should be stored at room temperature, between 68 F and 77 F (20 C and 25 C). It can be exposed to temperatures between 59 F and 86 F (15 C and 30 C) for shorter periods of time, such as when transporting it. Store in a cool, dry place.
Only remove a tablet from the blister pack when you are ready to take it.
Side Effects
What are the most common side effects of Natazia?
The most common side effects of Natazia are listed below. Tell your health care provider if you have any of these side effects that bother you.
- Headache or migraine (see below)
- Breast tenderness or pain
- Changes in menstrual bleeding (see below)
- Nausea or vomiting
- Acne
- Changes in mood (see below)
- Weight gain
There may be other side effects of Natazia that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088). In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.
What are the serious side effects of Natazia?
While less common, the most serious side effects of Natazia are described below, along with what to do if they happen.
Severe Allergic Reactions. Natazia may cause allergic reactions, which can be serious. Stop taking Natazia and get help right away if you have any of the following symptoms of a serious allergic reaction.
- Breathing problems or wheezing
- Racing heart
- Fever or general ill feeling
- Swollen lymph nodes
- Swelling of the face, lips, mouth, tongue, or throat
- Trouble swallowing or throat tightness
- Itching, skin rash, or pale red bumps on the skin called hives
- Nausea or vomiting
- Dizziness, feeling lightheaded, or fainting
- Stomach cramps
- Joint pain
Blood Clots. Natazia may cause a blood clot in your arteries or veins and could cause a stroke, heart attack, or venous thromboembolism (VTE), including a blood clot in the lungs (pulmonary embolism), in the back of your eye (retinal vein occlusion), or in your legs or arms (deep venous thrombosis). Stop taking Natazia and get emergency help if you have any of the following signs of a blood clot.
- Chest pain or pressure
- Fast or abnormal heartbeat
- Trouble breathing
- Pain in your back, jaw, throat, or arm
- Sweating, upset stomach, vomiting, or dizziness
- Sudden weakness on one side of your body
- Sudden and severe headache
- Slurred speech or trouble understanding speech
- Pain, swelling, or tenderness in your arm or leg
- Vision loss
- Bulging eyes
- Double vision
Changes in Menstrual Bleeding. Natazia can cause irregular bleeding, spotting, or light bleeding between periods, especially during the first three months of use. For some people, periods may stop. Call your health care provider right away if you continue to have spotting or breakthrough bleeding between periods, or if you have spotting after having regular cycles while taking Natazia. If you do not have a period for two months, check to see if you may be pregnant.
Liver Problems. Natazia may cause changes to your liver function, including an increase in your liver enzymes or possibly liver tumors. Call your health care provider if you have any of the following symptoms of liver problems.
- Nausea or vomiting
- Stomach or belly pain
- Fever
- Weakness or unusual tiredness
- Itching
- Loss of appetite
- Light-colored poop
- Dark-colored urine (pee)
- Your skin or the whites of your eyes turning yellowish in color (also called jaundice)
Increased Blood Pressure (Hypertension). Natazia may increase your blood pressure or make it worse if you have a history of high blood pressure. Call your health care provider if your blood pressure increases while using this medicine.
If you measure your blood pressure and the top number (systolic) is 180 or higher or the bottom number (diastolic) is 120 or higher, get medical attention right away. Increases in blood pressure may not be noticeable, but tell your health care provider right away if you have any of the following symptoms of severely high blood pressure.
- Sudden severe headache
- Chest pain
- Dizziness or confusion
- Trouble breathing
- Nausea or vomiting
- Blurry or other changes to vision
- Anxiety
- Buzzing in the ears
- Nosebleed
- Feeling of skipped heartbeats
Gallbladder Problems. Taking Natazia may increase the risk of gallbladder problems, including cholecystitis and cholelithiasis (also known as gallstones). Call your health care provider right away if you have any of the following symptoms.
- Your skin or the whites of your eyes turning yellowish in color (also called jaundice)
- Fever
- Pain in your upper stomach area
- Stool (poop) that is clay-colored
Headache or Migraine. Natazia may cause headaches or migraine. Call your health care provider right away if you get new headaches or migraine attacks that keep coming back, do not go away, or cause you a lot of pain.
Changes in Mood. Natazia may cause changes in mood, including depression and mood swings. Call your health care provider right away if you have new or increased depression or other unusual changes in mood or behavior. If you are about to harm yourself, call 911 or call or text 988, the Suicide & Crisis Lifeline.
Cancer. Natazia is a combination birth control pill that contains two hormones. Certain cancers, including breast cancer and cervical cancer, may be sensitive to hormones. Make sure you keep all appointments with your health care provider.
Warnings & Precautions
Who should not use Natazia?
Allergies to Ingredients. People who are allergic to any of the following should not take Natazia.
- Dienogest
- Estradiol valerate
- Natazia
- Any of the ingredients in the specific product dispensed
Your pharmacist can tell you all of the ingredients in Natazia.
Smoking. Natazia should not be taken if you smoke and are over age 35, as this can increase your chances of having a heart attack, stroke, or blood clots.
Blood Clots. Natazia should not be used if you have or have had blood clots, including a blood clot in the lungs (pulmonary embolism) or deep vein thrombosis (DVT). This medicine should also not be used if you have a condition that makes your blood more prone to forming clots (thrombophilia). Natazia can increase the risk of developing a blood clot that could be dangerous or even deadly.
Heart Attack or Stroke. Natazia should not be used if you have had a stroke or heart attack. Natazia can increase the risk of having a heart attack or stroke, which could be dangerous or even deadly.
Blood Vessel Problems. Natazia should not be used if you have or have had a history of plaque buildup in your blood vessels (coronary artery disease) or if you have or have had a condition that affects blood flow to your brain (cerebrovascular disease). Natazia could increase your chances of having a heart attack, stroke, or blood clots.
Heart Problems. Natazia should not be used if you have heart rhythm problems (such as atrial fibrillation) or heart valve problems, as this may increase your chances of having a blood clot.
Increased Blood Pressure (Hypertension). Natazia should not be used if you have high blood pressure that is not managed or high blood pressure with a condition that affects your blood vessels (vascular disease). Natazia could increase your chances of having a heart attack, stroke, or blood clots.
Diabetes. Natazia should not be used if you have diabetes with kidney, eye, nerve, or blood vessel damage. This can increase your chance of having a heart attack, stroke, or blood clots.
Headaches or Migraine. Natazia should not be used if you have migraine with vision or hearing changes, muscle weakness, tingling, or trouble speaking (known as migraine with aura) or certain other types of headaches. This can increase your risk of having a stroke. Natazia also should not be used if you are over age 35 and have any type of migraine headaches (with or without aura).
Unusual Vaginal Bleeding. Natazia should not be used if you have bleeding from the uterus or vagina that is not part of your menstrual cycle or is abnormal. Any unusual uterine bleeding needs to be checked out by your health care provider.
Breast Cancer. Natazia should not be used if you have or have had breast cancer. Some breast cancers are sensitive to hormones and could get worse if you use Natazia.
Liver Problems. Natazia should not be taken if your liver is not working as well as it should be or if you have liver tumors. If there is a concern about the health of your liver, your health care provider may do tests to see if it is working well enough to take this medicine.
What should I know about Natazia before using it?
Do not take Natazia unless it has been prescribed to you by a health care provider. Take it as prescribed.
Do not share Natazia with other people, even if they have the same condition as you. It may harm them.
Keep Natazia out of the reach of children.
Natazia does not protect you from HIV, AIDS, or other sexually transmitted diseases (STDs).
Expect to start Natazia during a specific time of your menstrual period or within a certain number of weeks after having a baby or abortion. The timing will determine whether and for how long you need to use backup birth control (such as condoms or spermicide) after starting Natazia. Ask your health care provider if you are not sure how or when to start Natazia.
Take tablets in order (from left to right) at the same time every day until the pack is finished, and swallow the tablets whole. After taking the last tablet in the blister pack, start with the first tablet in a new blister pack.
Consider using a calendar or app to help you remember to take Natazia at the same time each day.
If you have vomiting or diarrhea within a few hours of taking Natazia, it may not work as well. If you vomit or have diarrhea within four hours after taking Natazia, this is considered a “missed tablet” because your body may not have fully absorbed the medicine. Take another pill of the same color from your extra blister pack.
Natazia may affect your blood sugar or cholesterol levels. Make sure to keep all follow-up appointments, including for blood tests and blood pressure checks, with your health care provider.
What should I tell my health care provider before using Natazia?
Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if Natazia is right for you.
In particular, make sure that you discuss any of the following.
Current and Past Health Conditions. Tell your health care provider if you have any of the following.
- Diabetes
- Gave birth within last month
- Recent abortion
- High blood pressure
- High cholesterol or triglycerides
- Headaches or migraine
- Gallbladder, kidney, or liver problems
- Personal or family history of heart disease, blood clots, or stroke
- Depression
- A condition called hereditary angioedema
Upcoming Surgery or Bed Rest. You may be at a higher risk for some side effects of Natazia if you do not move around normally for an extended period of time. Tell your health care provider if you have any upcoming surgeries or need to be on bed rest. Your health care provider can tell you if or when you need to stop Natazia.
Smoking. Smoking can increase your risk of getting heart disease, which increases your risk of having a heart attack, stroke, or blood clots. Tell your health care provider if you smoke before starting Natazia.
Skin Darkening. Talk to your health care provider if you have had a condition that led to dark patches of skin around your forehead, nose, cheeks, and around your mouth (chloasma) during pregnancy, as you may have an increased chance of having chloasma while taking Natazia. If you have had chloasma, avoid exposure to the sun and ultraviolet (UV) rays from tanning booths or sun lamps.
Other Medicines and Supplements. Natazia may interact with other medicines and supplements. Before taking Natazia, tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.
Pregnancy. Do not take Natazia and tell your health care provider if you are pregnant or plan to become pregnant. If you become pregnant, stop taking Natazia right away and contact your health care provider.
Breastfeeding. Natazia passes into breast milk. Tell your health care provider if you are breastfeeding or plan to breastfeed. Natazia may decrease the amount of breastmilk you make. Your health care provider will let you know if you should take Natazia while breastfeeding.
How can I get more information about Natazia?
For more information about Natazia, you can visit the drugmaker’s website at www.natazia.com or call them at 877-745-5855.
Interactions
Does Natazia interact with foods or drinks?
Eating grapefruit or drinking grapefruit juice while taking Natazia can increase the amount of medicine in your body and increase the risk of side effects. Talk to your health care provider if you eat grapefruit or drink grapefruit juice.
There are no known interactions between Natazia and alcohol.
Does Natazia interact with other medicines (drug interactions)?
Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.
In particular, make sure that you discuss if you are using any of the following before taking Natazia.
- St. John’s wort, which is a supplement that may be used to treat depression
- A barbiturate, such as butalbital, phenobarbital, or primidone, which is a medicine that may be used to treat insomnia, migraine, or seizures
- Any medicine that may be used to treat seizures, such as carbamazepine (Carbatrol, Tegretol, and others), felbamate, lamotrigine (Lamictal), oxcarbazepine (Oxtellar XR, Trileptal), phenytoin (Dilantin, Phenytek, and others), or topiramate (Topamax, Trokendi XR, Qudexy XR)
- Rifampin (Rifadin), which is a medicine commonly used to treat an infection called tuberculosis
- Clarithromycin or erythromycin (Ery-Tab and others), which are used for bacterial infections
- Bosentan, which is a medicine used to treat a condition called pulmonary arterial hypertension (PAH)
- Fluconazole (Diflucan), griseofulvin, itraconazole (Sporanox, Tolsura), ketoconazole, or voriconazole (Vfend), which are some medicines used for fungal infections
- Diltiazem (Cardizem CD and others), which is a medicine used for high blood pressure and other conditions
- A medicine for HIV, AIDS, or hepatitis C
Some other medicines may alter the blood levels of Natazia, and vice versa. Tell your health care provider about all medicines that you take or have recently taken.
This may not be a complete list of medicines that can interact with Natazia. Always check with your health care provider.
Overdose/Missed Dose
What should I do if I accidentally use too much Natazia?
If you or someone else has used too much Natazia, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.
What should I do if I miss a dose of Natazia?
Natazia may not work well if you miss tablets. Follow the Patient Labeling on how to take Natazia when you miss a dose, as this can change depending on how many tablets you have missed and which weeks they were missed on. In some cases, you may need to avoid sexual intercourse or use backup birth control (such as condoms or spermicide) for nine days.