Dosage & Administration
By using PrescriberAI, you agree to the AI Terms of Use.
Natazia Prescribing Information
Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptives (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs should not be used by women who are over 35 years of age and smoke. [See Contraindications .]
Oral Contraception
Natazia® is indicated for use by women to prevent pregnancy.
The efficacy of Natazia in women with a body mass index (BMI) of > 30 kg/m2 has not been evaluated.
Heavy Menstrual Bleeding
Natazia 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 ].
How to Take Natazia
To 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.
How to Start Natazia
Instruct the patient to begin taking Natazia on Day 1 of her menstrual cycle (that is, the first day of her menstrual bleeding). See FDA-Approved Patient Labeling. Instruct the patient to use a non-hormonal contraceptive as back-up during the first 9 days.
For postpartum women who do not breastfeed or after a second trimester abortion, start Natazia no earlier than 4 weeks postpartum due to the increased risk of thromboembolism. If the patient starts on Natazia postpartum and has not yet had a period, evaluate for possible pregnancy, and instruct her to use an additional method of contraception until she has taken Natazia for 9 consecutive days. The possibility of ovulation and conception prior to initiation of medication should also be considered.
If the patient is switching from a combination hormonal method such as:
- •
- Another pill
- •
- Vaginal ring
- •
- Patch
- •
- Instruct her to take the first dark yellow pill on the first day of her withdrawal bleed. She should not continue taking the pills from her previous birth control pack. If she does not have a withdrawal bleed, rule out pregnancy before starting Natazia.
- •
- If she previously used a vaginal ring or transdermal patch, she should start using Natazia on the day the ring or patch is removed.
- •
- Instruct the patient to use a non-hormonal back-up method such as a condom or spermicide for the first 9 days.
If the patient is switching from a progestin-only method such as a:
- •
- Progestin-only pill
- •
- Implant
- •
- Intrauterine system
- •
- Injection
- •
- Instruct her to take the first dark yellow pill on the day she would have taken her next progestin-only pill or on the day of removal of her implant or intrauterine system or on the day when she would have had her next injection.
- •
- Instruct the patient to use a non-hormonal back-up method such as a condom or spermicide for the first 9 days.
Advice in case of Gastrointestinal Disturbances
In case of severe vomiting or diarrhea, absorption may not be complete and additional contraceptive measures should be taken. If vomiting or diarrhea occurs within 3-4 hours after taking a colored tablet, this can be regarded as a missed tablet.
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
Pregnancy
Risk Summary
There is no reason to use COCs in pregnancy Discontinue Natazia if pregnancy occurs. Epidemiologic studies and meta-analyses have not found an increased risk of genital or non-genital birth defects (including cardiac anomalies and limb-reduction defects) following exposure to COCs prior to conception or during early pregnancy.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4 percent and 15 to 20 percent, respectively.
Lactation
Risk Summary
Contraceptive 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.
Pediatric Use
Safety and efficacy of Natazia have been established in women of reproductive age. Efficacy is expected to be the same for postpubertal adolescents under the age of 18 and for users 18 years and older. Use of this product before menarche is not indicated.
Geriatric Use
Natazia has not been studied in postmenopausal women and is not indicated in this population.
Patients with Renal Impairment
The pharmacokinetics of Natazia has not been studied in subjects with renal impairment, but an effect requiring dose adjustment is unlikely to be present [see Clinical Pharmacology ].
Patients with Hepatic Impairment
The pharmacokinetics of Natazia has not been studied in subjects with hepatic impairment. Steroid hormones may be poorly metabolized in patients with impaired liver function. Acute or chronic disturbances of liver function may necessitate the discontinuation of COC use until markers of liver function return to normal. [See Contraindications and Warnings and Precautions ].
Body Mass Index
The safety and efficacy of Natazia in women with a BMI of > 30 kg/m2 has not been evaluated.
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 ( 12.3])].