Natazia

(Dienogest/Estradiol Valerate)

The active ingredients in Natazia are dienogest and estradiol valerate. Both hormones function together to prevent pregnancy by inhibiting ovulation (the release of an egg from the ovary), altering cervical mucus to hinder sperm motility, and making the uterine lining unsuitable for a fertilized egg by thinning it. This can also help lessen heavy menstrual bleeding.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using Natazia. However, the following is a synopsis of the general guidelines for the use of Natazia:

• Natazia comprises a mixture of dienogest and estradiol. Take one pill each day in the precise order indicated on the blister pack. Follow the arrows marked on each row of tablets in the pack.
• If you're switching from another birth control pill, begin taking Natazia on the first day of your period. If you were taking progestin-only tablets, begin taking Natazia on the same day you would have taken the next dose.
• If you are switching from a birth control implant, intrauterine device (IUD), vaginal ring, or skin patch, begin taking Natazia on the same day that the previous birth control device is removed. If you're switching from a birth control injection, start taking Natazia on the day you'd normally get your next injection.
• Inform your doctor if you experience severe breakthrough bleeding. You may also experience very little or no bleeding throughout your period.
• If you require surgery or medical testing, or if you will be on bed rest, you may need to discontinue using this medication for a brief period. Any doctor or surgeon who treats you should be aware that you are on Natazia.

The most common side effects of Natazia seen in clinical trials as compared to placebo include:

• Severe headaches.
• Weight gain.
• Breast tenderness.
• Mood changes.
• Irregular vaginal bleeding.
• Shortness of breath.

Some individuals may experience serious side effects while using Natazia. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Heart attack symptoms: chest pain, stomach discomfort, perspiration, nausea, and dizziness.
• Stroke symptoms: sudden numbness or weakness in the arm, leg, or face, confusion, vision problems, headaches, and difficulty walking.
• Deep vein thrombosis (blood clot in the leg): leg cramps, swelling, pain, and muscle tightness.
• Cough, chest pain, difficulty breathing, and a racing heart, which are symptoms of a pulmonary embolism (a blood clot in the lungs).
• Serious liver disorders: yellowing of the skin or whites of the eyes, fatigue, and abdominal pain.
• A ruptured ovarian cyst causes stomach pain, nausea, vomiting, fever, disorientation, and vaginal bleeding.
• Allergic reaction to the medication.

These are not all of the possible side effects of Natazia. You should always consult your healthcare provider for medical advice about your condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Natazia, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including:

• Untreated or uncontrollable high blood pressure (hypertension).
• Heart disease (coronary artery disease, uncontrolled heart valve condition, previous heart attack, stroke, or blood clot).
• A blood-clotting condition or circulatory issues.
• A history of hormonal cancer, such as breast or uterine cancer.
• Unusual uterine bleeding that has not been evaluated by a physician.
• Liver disease or cancer.
• If you smoke and are older than 35.
• High cholesterol or triglycerides, or being overweight.
• A history of depression.
• Underactive thyroid and gallbladder problems or gallbladder disease.
• Seizures.
• A history of jaundice from pregnancy or birth control medications.

Boxed Warning

Cigarette smoking raises the likelihood of significant cardiovascular side effects from combined hormonal contraception treatment. This risk increases with age (>35 years) and heavy smoking (15 cigarettes or more per day). Advise women using hormonal oral contraceptives not to smoke.

• Smoke and are over 35 years old.
• Currently have or have a history of DVT or PE.
• Coronary artery disease.
• Cerebrovascular disease (issues with blood flow to the brain).
• Certain cardiac valve or rhythm issues.
• Blood clotting issues.
• Unmanaged high blood pressure.
• Diabetes causes blood vessel issues.
• Specific sorts of headaches.
• Migraine with or without aura in those above the age of 35.
• Undiagnosed abnormal uterine haemorrhage.
• Have breast cancer or have had it in the past.
• Liver tumours or diseases.

Natazia is most commonly started by taking the first tablet in your pack on the first day of your menstrual cycle. You'll need to use a non-hormonal birth control (e.g., condom or spermicide) as a backup for the first 9 days to allow the medicine to take effect.

When Natazia is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• St. John’s Wort.
• Carbamazepine.
• Phenytoin.
• Ketoconazole.
• Oxcarbazepine.
• Lamotrigine.
• Rifampin.
• Topiramate.

Natazia comes in a 28-day bundle. There are 26 active tablets with varying doses of dienogest and ethinyl valerate. There are also two placebo tablets, which contain no active drugs.

Day 1–2: 3 mg estradiol valerate alone.

Day 3-7: 2 mg of dienogest and 2 mg ethinyl valerate.

Day 8–24: 3 mg of dienogest and 2 mg of ethinyl valerate.

Day 25-26: 1 mg estradiol valerate only.

Day 27-28: placebo tablets, no active medication.

The normal dose is one tablet taken orally at the same time each day. The tablets must be taken in the sequence indicated on the blister pack.

Store at room temperature and keep out of reach of children.

Bayer Pharmaceuticals Inc. is the manufacturer of Natazia.

There are no lower-cost generic versions available of Natazia.

It is not advised to stop taking hormonal contraceptives like Natazia without talking to your doctor first.

Do not use if you are pregnant. Stop taking Natazia and contact your doctor if you become pregnant or skip two menstrual cycles in a row. If you have just had a baby, you should wait at least 4 weeks before using this medication.

Talk to your doctor if you are already breastfeeding or if you have any plans to breastfeed. They will know or recommend what is best for you.