Dosage & Administration
By using PrescriberAI, you agree to the AI Terms of Use.
Nextstellis Prescribing Information
NEXTSTELLIS is contraindicated in females who are known to have or develop the following conditions:
- A history of, increased risk for, or current arterial or venous thrombotic/thromboembolic diseases. Examples include females who are known to:
- Smoke, if 35 years of age and older[see Boxed Warningand Warnings and Precautions (5.1)]- Have current or history of deep vein thrombosis or pulmonary embolism[see Warnings and Precautions (5.1)]- Have cerebrovascular disease[see Warnings and Precautions (5.1)]- Have coronary artery disease[see Warnings and Precautions (5.1)]- 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 (5.1)]- Have inherited or acquired hypercoagulopathies[see Warnings and Precautions (5.1)]- Have uncontrolled hypertension or hypertension with vascular disease[see Warnings and Precautions (5.1)]- Have diabetes mellitus with hypertension or end-organ damage; or diabetes mellitus of > 20 years duration[see Warnings and Precautions (5.9)]- Have migraine headaches with aura[see Warnings and Precautions (5.4)]
- Current diagnosis of, or history of, breast cancer, which may be hormone-sensitive [see Warnings and Precautions (5.5)]
- Hepatic adenoma, hepatocellular carcinoma, acute hepatitis, or severe (decompensated) cirrhosis[see Warnings and Precautions (5.6)]
- Use of hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations[see Warnings and Precautions (5.7)]
- Abnormal uterine bleeding that has an undiagnosed etiology[see Warnings and Precautions (5.5)]
- Renal Impairment[see Warnings and Precautions (5.2)]
- Adrenal insufficiency[see Warnings and Precautions (5.2)]
- A high risk of arterial or venous thrombotic diseases
- Breast cancer or history of breast cancer
- Hepatic adenoma, hepatocellular carcinoma, acute hepatitis or decompensated cirrhosis
- Co-administration with hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir
- Abnormal uterine bleeding that has an undiagnosed etiology
- Renal impairment
- Adrenal insufficiency
- Stop NEXTSTELLIS if an arterial or venous thrombotic/thromboembolic event occurs.
- Stop NEXTSTELLIS if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions and evaluate for retinal vein thrombosis immediately.
- Discontinue NEXTSTELLIS during prolonged immobilization.
- Start NEXTSTELLIS no earlier than four weeks after delivery in females who are not breast feeding. The risk of postpartum thromboembolism decreases after the third postpartum week, whereas the likelihood of ovulation increases after the third postpartum week.
Before starting NEXTSTELLIS, evaluate any past medical history or family history of thrombotic or thromboembolic disorders and consider whether the history suggests an inherited or acquired hypercoagulopathy. NEXTSTELLIS is contraindicated in females with a high risk of arterial or venous thrombotic/thromboembolic diseases
Use of CHCs increases the risk of cardiovascular events and cerebrovascular events, such as myocardial infarction and stroke. The risk is greater among females over age 40, smokers, and females with hypertension, dyslipidemia, diabetes, or obesity. The risk increases with age, particularly in females 35 years of age and older, and with the number of cigarettes smoked. In addition to cigarettes, use of other nicotine-containing products – including cigars, smokeless tobacco, hookah tobacco, e-cigarettes, and nicotine replacement therapy – may also increase the risk of serious cardiovascular events from CHC use.
Use of CHCs also increases the risk of venous thromboembolic events (VTEs), such as deep vein thrombosis and pulmonary embolism. The rate of VTE in females using COCs has been estimated to be
Risk factors for VTEs include smoking, obesity, family history of VTE, and prolonged immobilization in addition to other factors that contraindicate use of CHCs
The risk of VTE is increased during the first six weeks postpartum compared to the risk in non-pregnant, non-postpartum females. The risk is highest in the first three weeks postpartum
Figure 1 shows the risk of developing a VTE for females who are not pregnant and do not use COCs, for females who use COCs, for pregnant females, and for females in the postpartum period. To put the risk of developing a VTE into perspective: if 10,000 females who are not pregnant and do not use oral contraceptives are followed for one year, between 1 and 5 of these females will develop a VTE.
Two prospective studies of NEXTSTELLIS have been conducted, one in Europe/Russia (NCT02817828; C301) and one in North America (NCT02817841; C302) (N=3,632), for the prevention of pregnancy in females 16-50 years of age. There was one reported VTE in the Europe/Russia study
Warnings and Precautions (Breast Cancer NEXTSTELLIS is contraindicated in females who currently have or have had breast cancer because breast cancer may be hormonally sensitive [see Contraindications (4)]. Epidemiology studies have not found a consistent association between use of combined oral contraceptives (COCs) and breast cancer risk. Studies do not show an association between ever (current or past) use of COCs and risk of breast cancer. However, some studies report a small increase in the risk of breast cancer among current or recent users (<6 months since last use) and current users with longer duration of COC use [see Postmarketing Experience (6.2)]. Cervical Cancer A causal relationship between the use of CHCs and the development of cervical cancer and intraepithelial neoplasia has not been clearly established. In observational studies, the use of oral hormonal contraceptives in females for five years or more, compared to females who did not use oral hormonal contraceptives, was associated with an increased risk of cervical cancer and intraepithelial neoplasia. In these studies, the use of oral hormonal contraceptives in females for 10 years or more, compared to females who received oral hormonal contraceptives for 5-9 years, was associated with an increased risk of cervical cancer and intraepithelial neoplasia. Limitations in these epidemiologic studies include potential recall bias, differences in sexual behavior, and other factors such as establishing whether there were data on persistent high-risk Human Papilloma Virus (HPV) infection. | 04/2022 |
NEXTSTELLIS is indicated for use by females of reproductive potential to prevent pregnancy.
- Take one tablet by mouth at the same time every day. ()
2.1 Recommended Dosage and AdministrationStart NEXTSTELLIS using a Day 1 start. Take one tablet by mouth at the same time every day with or without food.
- Take tablets in the order directed on the blister pack. ()
2.1 Recommended Dosage and AdministrationStart NEXTSTELLIS using a Day 1 start. Take one tablet by mouth at the same time every day with or without food.
NEXTSTELLIS (drospirenone and estetrol tablets) is available in a blister card, with 28 6-mm round, bi-convex film-coated tablets in the following order:
- 24 pink active tablets containing 3 mg drospirenone and 14.2 mg estetrol embossed with a drop-shaped logo on one side.
- 4 white inert tablets embossed with a drop-shaped logo on one side.
- Pregnancy: Discontinue if pregnancy occurs. (8.1)
- Lactation: Advise postpartum females that NEXTSTELLIS can decrease milk production. ()
8.2 LactationRisk SummaryContraceptive hormones and/or metabolites are present in human milk. COCs can reduce milk production in breast-feeding females. This reduction can occur at any time but is less likely to occur once breast-feeding is well established. When possible, advise the nursing woman to use other methods of contraception until she discontinues breast-feeding
[see also Dosage and Administration (2.1)]. The developmental and health benefits of breast-feeding should be considered along with the mother's clinical need for NEXTSTELLIS and any potential adverse effects on the breast-fed child from NEXTSTELLIS or from the underlying maternal condition.After oral administration of DRSP 3 mg/EE 30 µg, about 0.02% of the DRSP dose was excreted into the breast milk of postpartum females within 24 hours. This results in a potential maximal daily dose of less than 1 µg DRSP in an infant.