Dosage & Administration
By using PrescriberAI, you agree to the AI Terms of Use.
Natazia Prescribing Information
Natazia is contraindicated in females who are known to have or develop the following conditions:
• A high risk of arterial or venous thrombotic diseases. Examples include women who are known to:• Smoke, if over age 35[see Boxed Warning and Warnings and Precautions ]• Have deep vein thrombosis or pulmonary embolism, now or in the past[see Warnings and Precautions ]• Have cerebrovascular disease[see Warnings and Precautions ]• Have coronary artery disease[see Warnings and Precautions ]• Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation)[see Warnings and Precautions ]• Have inherited or acquired hypercoagulopathies[see Warnings and Precautions ]• Have uncontrolled hypertension[see Warnings and Precautions ]• Have diabetes mellitus with vascular disease[see Warnings and Precautions ]• Have headaches with focal neurological symptoms or have migraine headaches with or without aura if over age 35[see Warnings and Precautions ]
• Undiagnosed abnormal uterine bleeding[see Warnings and Precautions ]• Current diagnosis of, or history of, breast cancer, which may be hormone sensitive[see Warnings and Precautions ]• Liver tumors, benign or malignant, or liver disease[see Warnings and Precautions (5.3), Use in Specific Populations and Clinical Pharmacology• Undiagnosed abnormal uterine bleeding• Breast cancer• Liver tumors or liver disease
Contraindications, Pregnancy (4) Removed 6/2024
• Natazia is a combination of dienogest , a progestin, and estradiol valerate, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy. ()1 INDICATIONS AND USAGE• Natazia is a combination of dienogest , a progestin, and estradiol valerate, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy.• The efficacy of Natazia in females of reproductive potential with a body mass index (BMI) of
>30 kg/m2has not been evaluated.• Treatment of heavy menstrual bleeding in females of reproductive potential without organic pathology who choose to use an oral contraceptive as their method of contraception.
1.1 Oral ContraceptionNatazia®is indicated for use by women to prevent pregnancy.
The efficacy of Natazia in women with a body mass index (BMI) of > 30 kg/m2has not been evaluated.
1.2 Heavy Menstrual BleedingNatazia is also indicated for the treatment of heavy menstrual bleeding in women without organic pathology who choose to use an oral contraceptive as their method of contraception
[see Clinical Studies ].• The efficacy of Natazia in females of reproductive potential with a body mass index (BMI) of
>30 kg/m2 has not been evaluated. (,1 INDICATIONS AND USAGE• Natazia is a combination of dienogest , a progestin, and estradiol valerate, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy.• The efficacy of Natazia in females of reproductive potential with a body mass index (BMI) of
>30 kg/m2has not been evaluated.• Treatment of heavy menstrual bleeding in females of reproductive potential without organic pathology who choose to use an oral contraceptive as their method of contraception.
1.1 Oral ContraceptionNatazia®is indicated for use by women to prevent pregnancy.
The efficacy of Natazia in women with a body mass index (BMI) of > 30 kg/m2has not been evaluated.
1.2 Heavy Menstrual BleedingNatazia is also indicated for the treatment of heavy menstrual bleeding in women without organic pathology who choose to use an oral contraceptive as their method of contraception
[see Clinical Studies ].)8.8 Body Mass IndexThe safety and efficacy of Natazia in women with a BMI of > 30 kg/m2has not been evaluated.
• Treatment of heavy menstrual bleeding in females of reproductive potential without organic pathology who choose to use an oral contraceptive as their method of contraception. ()1.2 Heavy Menstrual BleedingNatazia is also indicated for the treatment of heavy menstrual bleeding in women without organic pathology who choose to use an oral contraceptive as their method of contraception
[see Clinical Studies ].
• Take one tablet daily by mouth at the same time every day. ()2.1 How to Take NataziaTo achieve maximum contraceptive effectiveness, Natazia must be taken exactly as directed. Take one 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. For patient instructions for missed pills, see FDA-Approved Patient Labeling.
• Tablets must be taken in the order directed on the blister pack. ()2.1 How to Take NataziaTo achieve maximum contraceptive effectiveness, Natazia must be taken exactly as directed. Take one 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. For patient instructions for missed pills, see FDA-Approved Patient Labeling.
• Do not skip or delay intake by more than 12 hours. ()2.1 How to Take NataziaTo achieve maximum contraceptive effectiveness, Natazia must be taken exactly as directed. Take one 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. For patient instructions for missed pills, see FDA-Approved Patient Labeling.
Natazia (estradiol valerate and estradiol valerate/dienogest) tablets are available in blister packs.
Each blister pack contains 28 round, biconvex, film-coated tablets in the following order:
• 2 dark yellow tablets, with an embossed “DD” in a regular hexagon on one side, each containing 3 mg estradiol valerate• 5 medium red tablets, with an embossed “DJ” in a regular hexagon on one side, each containing 2 mg estradiol valerate and 2 mg dienogest• 17 light yellow tablets, with an embossed “DH” in a regular hexagon on one side, each containing 2 mg estradiol valerate and 3 mg dienogest• 2 dark red tablets, with an embossed “DN” in a regular hexagon on one side, each containing 1 mg estradiol valerate• 2 white tablets (inert), with an embossed “DT” in a regular hexagon on one side
• Lactation: can decrease milk production. ()8.2 LactationRisk SummaryContraceptive hormones and/or metabolites are present in human milk. CHCs can reduce milk production in breastfeeding females. This reduction can occur at any time but is less likely to occur once breastfeeding is well-established. When possible, advise the nursing female to use other forms of contraception until she discontinues breastfeeding.
[See also Dosage and Administration ].The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Natazia and any potential adverse effects on the breast-fed child from Natazia or from the underlying maternal condition.• Body Mass Index: The safety and efficacy of Natazia in women with a body mass index (BMI) of >30 kg/m2 has not been evaluated. ()8.8 Body Mass IndexThe safety and efficacy of Natazia in women with a BMI of > 30 kg/m2has not been evaluated.