ELURYNG- etonogestrel and ethinyl estradiol ring

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

ETONOGESTREL (UNII: 304GTH6RNH) (ETONOGESTREL - UNII:304GTH6RNH), ETHINYL ESTRADIOL (UNII: 423D2T571U) (ETHINYL ESTRADIOL - UNII:423D2T571U)

Disponível em:

Amneal Pharmaceuticals LLC

Via de administração:

VAGINAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

FOR VAGINAL USE ONLY EluRyng™ is indicated for use by females of reproductive age to prevent pregnancy. EluRyng 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 (5.1) ] - Have deep vein thrombosis or pulmonary embolism, now or in the past [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 [see Warnings and Precautions (5.5)] - Have diabetes mellitus with vascular disease [see Warnings and Precautions (5.9)] - Have headaches with focal neurological symptoms or migraine headaches with aura [see Warnings and Precautions (5.10)] Women over age 35 with any migraine headaches [see Warnings and Precautions (5.10)] - Women over age 35 with any migraine headaches [see Warnings and Precautions (5.10)] - Liver tumors, benign or malignant or liver disease [see Warnings and Precautions (5.3)  and Use in Specific Populations (8.6) ] - Undiagnosed abnormal uterine bleeding [see Warnings and Precautions (5.11)] - Pregnancy, because there is no reason to use CHCs during pregnancy [see Use in Specific Populations (8.1) ] - Current diagnosis of, or history of, breast cancer, which may be hormone-sensitive [see Warnings and Precautions (5.14)] - Hypersensitivity reactions, including anaphylaxis and angioedema, to any of the components of EluRyng [see Warnings and Precautions (5.6)  and Adverse Reactions (6)] -   Use of Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to potential for ALT elevations [see Warnings and Precautions (5.4)] . Risk Summary EluRyng is contraindicated during pregnancy because there is no need for pregnancy prevention in a woman who is already pregnant. Epidemiologic studies and meta-analyses have not shown an increased risk of genital or non-genital birth defects (including cardiac anomalies and limb-reduction defects) following maternal exposure to low dose CHCs prior to conception or during early pregnancy. No adverse developmental outcomes were observed in pregnant rats and rabbits with the administration of etonogestrel during organogenesis at doses approximately 300 times the anticipated daily vaginal human dose (~0.002 mg/kg/day). No adverse developmental outcomes were observed in pregnant rats and rabbits with the co-administration of the combination desogestrel/ethinyl estradiol during organogenesis at desogestrel/ethinyl estradiol doses at least 2/5 times, respectively, the anticipated daily vaginal human dose (~0.002 desogestrel/0.00025 ethinyl estradiol mg/kg/day). Discontinue EluRyng use if pregnancy is confirmed. Data Animal Data In rats and rabbits at dosages up to 300 times the anticipated dose, etonogestrel is neither embryotoxic nor teratogenic. Co-administration of a maternally toxic dose of desogestrel/ethinyl estradiol to pregnant rats was associated with embryolethality and wavy ribs at a desogestrel/ethinyl estradiol dose that was 40/130 times, respectively, the anticipated vaginal human dose (0.002 desogestrel/0.00025 ethinyl estradiol mg/kg/day). No adverse embryofetal effects were observed when the combination was administered to pregnant rats at a desogestrel/ethinyl estradiol dose that was 4/13 times, respectively, the anticipated vaginal human dose. When desogestrel/ethinyl estradiol was given to pregnant rabbits, pre-implantation loss was observed at a desogestrel/ethinyl estradiol dose that was 3/10 times, respectively, the anticipated vaginal human dose. No adverse embryofetal effects were observed when the combination was administered to pregnant rabbits at a desogestrel/ethinyl estradiol dose that was 2/5 times the anticipated vaginal human dose. Risk Summary Small amounts of contraceptive steroids and/or metabolites, including etonogestrel and ethinyl estradiol are transferred to human milk. Harmful effects have not been observed in breastfed infants exposed to CHCs through breast milk. CHCs can reduce milk production in breastfeeding mothers. This is less likely to occur once breastfeeding is well-established; however, it can occur at any time in some women. When possible, advise the nursing mother to use non-estrogen-containing contraception until she has completely weaned her child. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for EluRyng and any potential adverse effects on the breastfed child from EluRyng or from the underlying maternal condition. Safety and efficacy of EluRyng 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. EluRyng has not been studied in postmenopausal women and is not indicated in this population. The effect of hepatic impairment on the pharmacokinetics of EluRyng has not been studied. Steroid hormones may be poorly metabolized in patients with impaired liver function. Acute or chronic disturbances of liver function may necessitate the discontinuation of CHC use until markers of liver function return to normal [see Contraindications (4)  and Warnings and Precautions (5.3) ]. The effect of renal impairment on the pharmacokinetics of EluRyng has not been studied. EluRyng ™ (el’ue ring) (etonogestrel and ethinyl estradiol vaginal ring) Read these Instructions for Use before you start using EluRyng and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your treatment. How should I start using EluRyng? If you are not currently using hormonal birth control, you have 2 ways to start using EluRyng. Choose the best way for you: - First Day Start: Insert EluRyng on the first day of your menstrual period. You will not need to use another birth control method since you are using EluRyng on the first day of your menstrual period. - Day 2 to Day 5 Cycle Start: You may choose to start EluRyng on days 2 to 5 of your menstrual period. Make sure you also use an extra method of birth control (barrier method), such as male condoms with spermicide for the first 7 days of EluRyng use in the first cycle. If you are changing from a birth control pill or patch to EluRyng: If you have been using your birth control method correctly and are certain that you are not pregnant, you can change to EluRyng any day. Do not start EluRyng any later than the day you would start your next birth control pill or apply your patch. If you are changing from a progestin-only birth control method, such as a minipill, implant or injection or from an intrauterine system (IUS): - You may switch from a minipill on any day. Start using EluRyng on the day that you would have taken your next minipill. - You should switch from an implant or the IUS and start using EluRyng on the day that you remove the implant or IUS. - You should switch from an injectable and start using EluRyng on the day when your next injection would be due. If you are changing from a minipill, implant or injection or from an intrauterine system (IUS), you should use an extra method of birth control, such as a male condom with spermicide during the first 7 days of using EluRyng. If you start using EluRyng after an abortion or miscarriage: - Following a first trimester abortion or miscarriage: You may start EluRyng within 5 days following a first trimester abortion or miscarriage (the first 12 weeks of pregnancy). You do not need to use an additional birth control method . - If you do not start EluRyng within 5 days after a first trimester abortion or miscarriage, use a non-hormonal birth control method, such as male condoms and spermicide, while you wait for your period to start. Begin EluRyng at the time of your next menstrual period. Count the first day of your menstrual period as “Day 1” and start EluRyng one of the following 2 ways below. - First Day Start: Insert EluRyng on the first day of your menstrual period. You will not need to use another birth control method since you are using EluRyng on the first day of your menstrual period. - Day 2 to Day 5 Cycle Start: You may choose to start EluRyng on Days 2 to 5 of your menstrual period. Make sure you also use an extra method of birth control (barrier method), such as male condoms with spermicide for the first 7 days of EluRyng use in the first cycle. - Following a second trimester abortion or miscarriage: You may start using EluRyng no sooner than 4 weeks (28 days) after a second trimester abortion (after the first 12 weeks of pregnancy). If you are starting EluRyng after childbirth: - You may start using EluRyng no sooner than 4 weeks (28 days) after having a baby if you are not breastfeeding. - If you have not gotten your menstrual period after childbirth, you should talk to your healthcare provider. You may need a pregnancy test to make sure you are not pregnant before you start using EluRyng. - Use another birth control method such as male condoms with spermicide for the first 7 days in addition to EluRyng. If you are breastfeeding you should not use  EluRyng. Use other birth control methods until you are no longer breastfeeding. Step 1. Choose a position for insertion of EluRyng. - Choose the position that is comfortable for you. For example, lying down, squatting, or standing with 1 leg up (See Figures A, B, and C) . Positions for EluRyng insertion                                                    Figure A                                                 Figure B                                         Figure C Step 2. Open the pouch to remove your EluRyng. - Each EluRyng comes in a re-sealable foil pouch. - Wash and dry your hands before removing EluRyng from the foil pouch. - Open the foil pouch at either notch near the top. - Keep the foil pouch so you can place your used EluRyng in it before you throw it away in your household trash. Step 3. Prepare EluRyng for insertion. - Hold EluRyng between your thumb and index finger and press the sides of the ring together (See Figures D and E) .                                                    Figure D                                                         Figure E Step 4. Insert EluRyng into your vagina. - Insert the folded EluRyng into your vagina and gently push it further up into your vagina using your index finger (See Figures F and G). - When you insert EluRyng it may be in different positions in your vagina, but EluRyng does not have to be in an exact position for it to work (See Figures H and I). - EluRyng may move around slightly within your vagina. This is normal. Although some women may be aware of EluRyng in the vagina, most women do not feel it when it is in place.   Figure F                                     Figure G                                             Figure H                                 Figure I Inserting EluRyng (Figure F, Figure G) and positioning EluRyng (Figure H, Figure I) Note: - If the EluRyng feels uncomfortable, you may not have pushed the ring into your vagina far enough. Use your finger to gently push the EluRyng as far as you can into your vagina. There is no danger of EluRyng being pushed too far up in the vagina or getting lost (See Figure G) . - Some women have accidentally inserted EluRyng into their bladder. If you have pain during or after insertion and you cannot find EluRyng in your vagina, call your healthcare provider right away. - Regularly check that EluRyng is in your vagina (for example, before and after intercourse) to ensure you are protected from pregnancy. Step 5. How do I remove EluRyng? - Wash and dry your hands. - Choose the position that is most comfortable for you (See Figures A, B, and C) . - Put your index finger into your vagina and hook it through the EluRyng. Gently pull downward and forward to remove the EluRyng and pull it out (See Figure J) .                        Figure J Step 6. Throw away the used EluRyng. - Place the used EluRyng in the re-sealable foil pouch and put it in a trash can out of the reach of children and pets. - Do not throw EluRyng in the toilet. What else should I know about using EluRyng? What if I leave EluRyng in too long? - If you leave EluRyng in your vagina for up to 4 weeks (28 days) you will still be getting pregnancy protection. Remove your old EluRyng for 1 week (7 days) and insert a new EluRyng 1 week (7 days) later (See Steps 1 through 4) . - If you leave EluRyng in your vagina longer than 4 weeks (28 days), remove the ring and check to make sure you are not pregnant. If you are not pregnant, insert a new EluRyng (See Steps 1 through 4). You must use another birth control method, such as male condoms with spermicide, until the new EluRyng has been used for 7 days in a row. What should I do if my EluRyng comes out of my vagina? EluRyng can slip or accidentally come out (expelled) of your vagina, for example, during sexual intercourse, bowel movements, use of tampons, or if it breaks. - EluRyng may break causing the ring to lose its shape. If the ring stays in your vagina this should not lower EluRyng’s effectiveness at preventing pregnancy. - If EluRyng breaks and slips out of your vagina, throw the broken ring in your household trash out of the reach of children and pets. - Insert a new EluRyng (See Steps 1 through 4) . - You should pay attention when removing a tampon to be sure that your EluRyng is not accidentally pulled out. Be sure to insert EluRyng before inserting a tampon. If you accidentally pull out your EluRyng while using tampons, rinse your EluRyng in cool to lukewarm (not hot) water and insert it again right away. - Be sure to insert EluRyng before inserting a tampon. - If you accidentally pull out your EluRyng while using tampons, rinse your EluRyng in cool to lukewarm (not hot) water and insert it again right away. - EluRyng can be pushed out of (expelled from) your vagina, for example, during sexual intercourse or during a bowel movement. If the expelled ring has been out of your vagina for less than 3 hours, rinse the expelled EluRyng in cool to lukewarm (not hot) water and insert it again right away. If the expelled EluRyng has been out of your vagina for more than 3 continuous hours: - If the expelled ring has been out of your vagina for less than 3 hours, rinse the expelled EluRyng in cool to lukewarm (not hot) water and insert it again right away. - If the expelled EluRyng has been out of your vagina for more than 3 continuous hours: - During Weeks 1 and 2, you may not be protected from pregnancy. Reinsert the ring as soon as you remember (See Steps 1 through 4) . Use another birth control method, such as male condoms with spermicide, until the ring has been in place for 7 days in a row. - During Week 3, do not reinsert the EluRyng that has been out of your vagina; but throw it away in your household trash away from children and pets. Use another birth control method, such as male condoms with spermicide, until the new EluRyng  has been used for 7 days in a row, following one of the two options below: -           Option 1. Insert a new ring right away to start your next 21 Day EluRyng use cycle. You may not have your regular period, but you may have spotting or vaginal bleeding. -           Option 2. Insert a new ring no later than 7 days from the time the previous ring was removed or expelled. During this time, you may have your period. Note: You should only choose to do option 2 if you used EluRyng for 7 days in a row, prior to the day that your previous EluRyng was accidentally removed or expelled. - If EluRyng was out of the vagina for an unknown amount of time, you may not be protected from pregnancy. Perform a pregnancy test prior to inserting a new ring and consult your healthcare provider. This Patient Information and Instructions for Use have been approved by the U.S. Food and Drug Administration. Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ  08807 Rev. 05-2022-03

Resumo do produto:

Each EluRyng (etonogestrel and ethinyl estradiol vaginal ring) is individually packaged in a reclosable aluminum laminate pouch consisting of four layers, from outside to inside: polyester, LDPE-EAA coex (low density polyethylene/ethylene acryclic acid copolymer coextrudate laminate), aluminum foil, and EAA-LLDPE coex (ethylene acryclic acid copolymer/ low low density polyethylene coextrudate laminate). The ring should be replaced in this reclosable pouch after use and discarded in a waste receptacle out of the reach of children and pets. It should not be flushed down the toilet. Carton of 3 pouches                 NDC 65162-469-35 Prior to dispensing to the user, store refrigerated 2° to 8°C (36° to 46°F). After dispensing to the user, EluRyng can be stored for up to 4 months at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Avoid storing EluRyng in direct sunlight or at temperatures above 30°C (86°F). For the Dispenser: When EluRyng is dispensed to the user, place an expiration date on the label. The date should not exceed either 4 months from the date of dispensing or the expiration date, whichever comes first.

Status de autorização:

Abbreviated New Drug Application

Características técnicas

ELURYNG- ETONOGESTREL AND ETHINYL ESTRADIOL RING
AMNEAL PHARMACEUTICALS LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ELURYNG SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ELURYNG. ELURYNG™ (ETONOGESTREL AND ETHINYL ESTRADIOL VAGINAL RING)
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 ELURYNG. (4)
CIGARETTE SMOKING INCREASES THE RISK OF SERIOUS CARDIOVASCULAR EVENTS
FROM
COMBINATION HORMONAL CONTRACEPTIVE (CHC) USE. (4)
RECENT MAJOR CHANGES
Warnings and Precautions (5.14) 04/2022
INDICATIONS AND USAGE
EluRyng is an estrogen/progestin combination hormonal contraceptive
(CHC) indicated for use by women
to prevent pregnancy. (1)
DOSAGE AND ADMINISTRATION
One EluRyng is inserted in the vagina. The ring must remain in place
continuously for three weeks, followed
by a one-week ring-free interval. (2)
DOSAGE FORMS AND STRENGTHS
EluRyng is a polymeric vaginal ring containing 11.7 mg etonogestrel
and 2.7 mg ethinyl estradiol, USP,
which releases on average 0.12 mg/day of etonogestrel and 0.015 mg/day
of ethinyl estradiol, USP. (3)
CONTRAINDICATIONS
A high risk of arterial or venous thrombotic diseases (4)
Breast cancer (4)
Liver tumors or liver disease (4)
Undiagnosed abnormal uterine bleeding (4)
Pregnancy (4)
Hypersensitivity, including anaphylaxis and angioedema, to any of the
components of Eluryng (4)
Co-administration with Hepatitis C drug combinations containing
ombitasvir/paritaprevir/ritonavir, with
or without dasabuvir (4)
WARNINGS AND PRECAUTIONS
Vascular risks: Stop EluRyng use if a thrombotic event occurs. Stop
EluRyng use at least 4 weeks before
and through 2 weeks after major surgery. Start no earlier than 4 weeks
after delivery, in women who are
not breastfeeding. (5.1)
Toxic Shock Syndrome (TSS): If patient exhibits signs or symptoms of
TSS, consider the possibility