NIKKI- drospirenone and ethinyl estradiol kit

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

ETHINYL ESTRADIOL (UNII: 423D2T571U) (ETHINYL ESTRADIOL - UNII:423D2T571U), DROSPIRENONE (UNII: N295J34A25) (DROSPIRENONE - UNII:N295J34A25)

Disponível em:

Lupin Pharmaceuticals, Inc.

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

Nikki™ (drospirenone and ethinyl estradiol tablets USP), 3 mg/0.02 mg is indicated for use by females of reproductive potential  to prevent pregnancy. Nikki (drospirenone and ethinyl estradiol tablets USP), 3 mg/0.02 mg is also indicated for the treatment of symptoms of premenstrual dysphoric disorder (PMDD) in females of reproductive potential who choose to use an oral contraceptive as their method of contraception. The effectiveness of Nikki (drospirenone and ethinyl estradiol tablets USP), 3 mg/0.02 mg for PMDD when used for more than three menstrual cycles has not been evaluated. The essential features of PMDD according to the Diagnostic and Statistical Manual-4th edition (DSM-IV) include markedly depressed mood, anxiety or tension, affective lability, and persistent anger or irritability. Other features include decreased interest in usual activities, difficulty concentrating, lack of energy, change in appetite or sleep, and feeling out of control. Physical symptoms associated with PMDD include breast tenderness, headache, joint and muscle pain, bloating and weight gain. In this disorder, these symptoms occur regularly during the luteal phase and remit within a few days following onset of menses; the disturbance markedly interferes with work or school, or with usual social activities and relationships with others. Diagnosis is made by healthcare providers according to DSM-IV criteria, with symptomatology assessed prospectively over at least two menstrual cycles. In making the diagnosis, care should be taken to rule out other cyclical mood disorders. Nikki (drospirenone and ethinyl estradiol tablets USP), 3 mg/0.02 mg has not been evaluated for the treatment of premenstrual syndrome (PMS). Nikki (drospirenone and ethinyl estradiol tablets USP), 3 mg/0.02 mg is indicated for the treatment of moderate acne vulgaris in women at least 14 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. Nikki (drospirenone and ethinyl estradiol tablets USP), 3 mg/0.02 mg should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control. Nikki is contraindicated in females who are known to have or develop the following conditions: - Renal impairment - Adrenal insufficiency - A high risk of arterial or venous thrombotic diseases. Examples include women who are known to:           о Smoke, if over age 35 [see Boxed Warning and Warnings and Precautions (5.1)]           о Have deep vein thrombosis or pulmonary embolism, now or in the past [see Warnings and Precautions (5.1)]           о Have cerebrovascular disease [see Warnings and Precautions (5.1)]           о Have coronary artery disease [see Warnings and Precautions (5.1)]           о 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)]           о Have inherited or acquired hypercoagulopathies [see Warnings and Precautions (5.1)]           о Have uncontrolled hypertension [see Warnings and Precautions (5.6)]           о Have diabetes mellitus with vascular disease [see Warnings and Precautions (5.8)]           о Have headaches with focal neurological symptoms or have migraine headaches with or without aura if over age 35 [see Warnings and Precautions (5.9)] - Undiagnosed abnormal uterine bleeding [see Warnings and Precautions (5.10)] - Current diagnosis of, or history of, breast cancer, which maybe hormone sensitive [see Warnings and Precautions (5.3)] - Liver tumors, benign or malignant, or liver disease [see Warnings and Precautions (5.4) and Use In Specific Populations (8.7)] - 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 (5.5) and Drug Interactions (7.3)]. Risk Summary There is no use for contraception in pregnancy; therefore, Nikki should be discontinued during pregnancy. 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 CHCs before 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. Data Human Data A retrospective database study of women in Norway, that included 44,734 pregnancies of which 368 were women who inadvertently took DRSP/EE during the first trimester of a pregnancy, found there were no adverse effects on pre-term birth, small for gestational age, or birth weight Z-scores. Post-marketing adverse event data on the use of Nikki in pregnant women suggest that frequencies of miscarriage and congenital anomalies were not higher than the estimated background risk in the general population. Risk Summary DRSP is present in human milk. After a single oral administration of 3 mg DRSP/0.03 mg EE tablets, DRSP concentration in breast milk over the 24-h period ranged from 1.4 to 7.0 ng/mL, with a mean ± standard deviation value of 3.7 ± 1.9 ng/mL. The estimated mean infant dose was 0.003 mg/day, which is about 0.1% of maternal dose (see Data). There is limited information on the effects of Nikki on the breast-fed infant. CHCs 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 female to use other methods of contraception until she discontinues breast-feeding [see also Dosage and Administration (2.2)]. The developmental and health benefits of breast-feeding should be considered along with the mother's clinical need for Nikki and any potential adverse effects on the breast-fed child from Nikki or from the underlying maternal condition. Data Human  Data An open-label study evaluated the degree of DRSP transfer into milk within 72 hours following a single oral administration of 3 mg DRSP/0.03 mg EE tablets to 6 healthy lactating women who were 1 week to 3 months post-partum. DRSP was present in breast milk with a mean Cmax of 13.5 ng/mL, while the mean Cmax in serum of lactating women was 30.8 ng/mL. The DRSP concentration in breast milk over the 24-hour period following dosing ranged from 1.4 to 7.0 ng/mL, with a mean ± standard deviation value of 3.7 ± 1.9 ng/mL. Based on single dose data, the maximal daily infant dose of DRSP was calculated to be 0.003 mg/day, which represented a mean of 0.1% of the maternal dose. Safety and efficacy of Nikki 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. Nikki has not been studied in postmenopausal women and is not indicated in this population. Nikki is contraindicated in patients with renal impairment [see Contraindications (4) and Warning and Precautions (5.2)]. In subjects with creatinine clearance (CLcr) of 50 to 79 mL/min, serum DRSP levels were comparable to those in a control group with CLcr ≥80 mL/min. In subjects with CLcr of 30 to 49 mL/min, serum DRSP concentrations were on average 37% higher than those in the control group. In addition, there is a potential to develop hyperkalemia in subjects with renal impairment whose serum potassium is in the upper reference range, and who are concomitantly using potassium sparing drugs [see Clinical Pharmacology (12.3)]. Nikki is contraindicated in patients with hepatic disease [see Contraindications (4) and Warning and Precautions (5.4)]. The mean exposure to DRSP in women with moderate liver impairment is approximately three times higher than the exposure in women with normal liver function. Nikki has not been studied in women with severe hepatic impairment. No clinically significant difference was observed between the pharmacokinetics of DRSP or EE in Japanese versus Caucasian women [see Clinical Pharmacology (12.3)].

Resumo do produto:

Nikki (drospirenone and ethinyl estradiol tablets USP), 3 mg/0.02 mg is available in a blister (NDC 68180-886-71) packed in a pouch (NDC 68180-886-71). Such three pouches are packaged in a carton (NDC 68180-886-73). Each blister pack (28 film-coated tablets) contains in the following order: Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [See USP Controlled Room Temperature].

Status de autorização:

Abbreviated New Drug Application

Características técnicas

NIKKI - DROSPIRENONE AND ETHINYL ESTRADIOL
LUPIN PHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
NIKKI SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR NIKKI.
NIKKI™ (DROSPIRENONE / ETHINYL ESTRADIOL) TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2001
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
WOMEN OVER 35 YEARS OLD WHO SMOKE SHOULD NOT USE NIKKI (4).
CIGARETTE SMOKING INCREASES THE RISK OF SERIOUS CARDIOVASCULAR EVENTS
FROM
COMBINATION ORAL CONTRACEPTIVE (COC) USE. (4)
RECENT MAJOR CHANGES
Dosage and Administration (2.3) 5/2023
Contraindications, Pregnancy (4) Removed 5/2023
Warnings and Precautions (5.11) Removed 5/2023
INDICATIONS AND USAGE
Nikki (drospirenone and ethinyl estradiol tablets USP) is a
combination of drospirenone, a progestin, and
ethinyl estradiol, an estrogen, indicated for use by females of
reproductive potential to:
Prevent pregnancy. (1.1)
Treat symptoms of premenstrual dysphoric disorder (PMDD) for females
of reproductive potential who
choose to use an oral contraceptive for contraception. (1.2)
Treat moderate acne for women at least 14 years old only if the
patient desires an oral contraceptive
for birth control. (1.3)
DOSAGE AND ADMINISTRATION
Take one tablet daily by mouth at the same time every day. (2.1)
Tablets must be taken in the order directed on the blister pack. (2.1)
DOSAGE FORMS AND STRENGTHS
Nikki (drospirenone and ethinyl estradiol tablets USP), 3 mg/0.02 mg
consists of 28 film-coated, biconvex
tablets in the following order (3):
24 pink tablets, each containing 3 mg drospirenone (DRSP) and 0.02 mg
ethinyl estradiol (EE) as
betadex clathrate
4 white inert tablets
CONTRAINDICATIONS
Renal impairment (4)
Adrenal insufficiency (4)
A high risk of arterial or venous thrombotic diseases (4)
Undiagnosed abnormal uterine bleeding (4)
Breast cancer (4)
Liver tumors or liver disease (4)
Co-administrati