United States - English - NLM (National Library of Medicine)

amneal pharmaceuticals ny llc - norelgestromin (unii: r0tay3x631) (norelgestromin - unii:r0tay3x631), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - norelgestromin and ethinyl estradiol transdermal system is indicated for the prevention of pregnancy in women with a body mass index (bmi) < 30 kg/m2 for whom a combined hormonal contraceptive is appropriate. limitations of use : norelgestromin and ethinyl estradiol transdermal system may be less effective in preventing pregnancy in women who weigh 198 lbs (90 kg) or more. norelgestromin and ethinyl estradiol transdermal system is contraindicated for use in women with bmi ≥ 30 kg/m2 [see contraindications (4), warnings and precautions (5.1)  and clinical studies (14)] . norelgestromin and ethinyl estradiol transdermal system is contraindicated in females who are known to have or develop the following conditions: - at high risk of arterial or venous thromboembolic events. examples include women who: - 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 inherited or acquired hypercoagulopathies [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 uncontrolled hypertension [see warnings and precautions (5.5)] - have diabetes mellitus with vascular disease [see warnings and precautions (5.7)] - have headaches with focal neurological symptoms or have migraine headaches with aura - women over age 35 with any migraine headaches [see warnings and precautions (5.8)] -   body mass index ≥ 30 kg/m2  [see warnings and precautions (5.1)] - liver tumors, benign or malignant, or liver disease [see warnings and precautions (5.3), use in specific populations (8.6)  and clinical pharmacology (12.3)] - undiagnosed abnormal uterine bleeding [see warnings and precautions (5.9)] - pregnancy, because there is no reason to use hormonal contraceptives during pregnancy [see warnings and precautions (5.10)  and use in specific populations (8.1)] - current diagnosis of, or history of, breast cancer, which may be hormone-sensitive [see warnings and precautions (5.12)] - 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 (5.4)] there is little or no increased risk of birth defects in women who inadvertently use hormonal contraceptives during early 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 low dose hormonal contraceptives prior to conception or during early pregnancy. the administration of hormonal contraceptives to induce withdrawal bleeding should not be used as a test for pregnancy. hormonal contraceptives should not be used during pregnancy to treat threatened or habitual abortion. the effects of norelgestromin and ethinyl estradiol in nursing mothers have not been evaluated and are unknown. when possible, advise the nursing mother to use other forms of contraception until she has completely weaned her child. estrogen-containing 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. small amounts of contraceptive steroids and/or metabolites are present in breast milk. safety and efficacy of norelgestromin and ethinyl estradiol have been established in women of reproductive age. efficacy is expected to be the same for post-pubertal adolescents under the age of 18 and for users 18 years and older. use of this product before menarche is not indicated. norelgestromin and ethinyl estradiol has not been studied in postmenopausal women and is not indicated in this population. no studies with norelgestromin and ethinyl estradiol have been conducted in women with hepatic impairment. however, steroid hormones may be poorly metabolized in patients with impaired liver function. acute or chronic disturbances of liver function may necessitate the discontinuation of combined hormonal contraceptive use until markers of liver function return to normal and combined hormonal contraceptive causation has been excluded [see contraindications (4)  and warnings and precautions (5.3)] . no studies with norelgestromin and ethinyl estradiol have been conducted in women with renal impairment. norelgestromin and ethinyl estradiol transdermal system is contraindicated in women with a bmi ≥ 30 kg/m2 because of the potential increased risk of vte [see contraindications (4)  and warnings and precautions (5.1)] . norelgestromin and ethinyl estradiol may be less effective in preventing pregnancy in women who weigh 198 lbs or more [see clinical studies (14)] . norelgestromin and ethinyl estradiol transdermal system norelgestromin and ethinyl estradiol transdermal system is for skin use only. do not cut, damage, or alter the norelgestromin and ethinyl estradiol transdermal patch in any way. how to start using your norelgestromin and ethinyl estradiol transdermal patch: figure a - if you are not currently using hormonal birth control, you have 2 ways to begin using your norelgestromin and ethinyl estradiol transdermal patch. choose the way that is best for you: - first day start: apply your first norelgestromin and ethinyl estradiol transdermal patch during the first 24 hours of your menstrual period. - sunday start: apply your first norelgestromin and ethinyl estradiol transdermal patch on the first sunday after your menstrual period begins. use a non-hormonal contraceptive method of birth control, such as a condom and spermicide or diaphragm and spermicide, for the first 7 days of your first cycle only. if your period starts on sunday, apply your first norelgestromin and ethinyl estradiol transdermal patch that day, and no back-up birth control is needed. - if you are changing from oral hormone birth control pills, a vaginal contraceptive ring or another contraceptive transdermal patch to the norelgestromin and ethinyl estradiol transdermal patch: - complete your current oral hormone birth control pill cycle, vaginal ring cycle or contraceptive transdermal patch cycle. apply your first norelgestromin and ethinyl estradiol transdermal patch on the day you would normally start your next oral birth control pill, patch or insert your next vaginal ring. - if you do not get your period within 1 week after taking your last active pill, removing your last vaginal ring or contraceptive transdermal patch, check with your healthcare provider to make sure you are not pregnant. you may still go ahead and start norelgestromin and ethinyl estradiol transdermal patch for contraception. - if you apply your norelgestromin and ethinyl estradiol transdermal patch more than 1 week after taking your last active oral hormone birth control pill, removing your last vaginal ring or contraceptive transdermal patch, use a non-hormonal contraceptive method, such as a condom and spermicide or diaphragm and spermicide, with the norelgestromin and ethinyl estradiol transdermal patch for the first 7 days of patch use. - if you are starting norelgestromin and ethinyl estradiol transdermal system after childbirth: - if you are not breastfeeding, wait 4 weeks before using norelgestromin and ethinyl estradiol transdermal system and use a non-hormonal contraceptive method of birth control, such as a condom and spermicide or diaphragm and spermicide, for the first 7 days of your first cycle only. if you have had sex since your baby was born, wait for your first period, or see your healthcare provider to make sure you are not pregnant before starting norelgestromin and ethinyl estradiol transdermal system. - if you are starting norelgestromin and ethinyl estradiol transdermal system after a miscarriage or abortion: - you may start norelgestromin and ethinyl estradiol transdermal system immediately after a miscarriage or abortion that occurs in the first 12 weeks (first trimester) of pregnancy. you do not need to use another contraceptive method. - if you do not start norelgestromin and ethinyl estradiol transdermal system within 5 days after a first trimester miscarriage or abortion, use a non-hormonal contraceptive method of birth control, such as a condom and spermicide or diaphragm and spermicide, while you wait for your period to start. you have 2 ways to begin using your norelgestromin and ethinyl estradiol transdermal patch. choose the way that is best for you: - first day start: apply your first norelgestromin and ethinyl estradiol transdermal patch during the first 24 hours of your menstrual period. - sunday start: apply your first norelgestromin and ethinyl estradiol transdermal patch on the first sunday after your menstrual period begins. use a non-hormonal contraceptive method of birth control, such as a condom and spermicide or diaphragm and spermicide, for the first 7 days of your first cycle only. if your period starts on sunday, apply your first norelgestromin and ethinyl estradiol transdermal patch that day, and no back-up birth control is needed. - if you are starting norelgestromin and ethinyl estradiol transdermal system after a miscarriage or abortion that occurs after the first 12 weeks of pregnancy (second trimester), wait 4 weeks before using norelgestromin and ethinyl estradiol transdermal system and use a non-hormonal contraceptive method of birth control, such as a condom and spermicide or diaphragm and spermicide, for the first 7 days of your first cycle only. if you have had sex since your miscarriage or abortion, wait for your first period, or see your healthcare provider to make sure you are not pregnant before starting norelgestromin and ethinyl estradiol transdermal system. figure b is a picture of the norelgestromin and ethinyl estradiol transdermal patch. figure b step 1. choose a place on your body for your norelgestromin and ethinyl estradiol transdermal patch - the norelgestromin and ethinyl estradiol transdermal patch may be placed on your upper outer arm, abdomen, buttock or back in a place where it will not be rubbed by tight clothing. avoid the waistline because clothing and belts may cause your patch to be rubbed off. - do not apply the patch to your breasts. - apply the norelgestromin and ethinyl estradiol transdermal patch only to skin that is clean, dry, and free of any powder, make-up, cream, oil, or lotion. - do not apply the norelgestromin and ethinyl estradiol transdermal patch to cut or irritated skin, or in the same location as the previous norelgestromin and ethinyl estradiol transdermal patch. step 2: apply your norelgestromin and ethinyl estradiol transdermal patch - tear open the pouch at the top edge. peel open the foil pouch that contains the norelgestromin and ethinyl estradiol transdermal patch and its clear plastic cover. gently remove the norelgestromin and ethinyl estradiol transdermal patch and its plastic cover together from the pouch, being careful not to separate the patch from the clear plastic cover.  - using a fingernail, peel away half of the clear plastic. avoid touching the sticky surface with your fingers.  - apply the sticky side of the norelgestromin and ethinyl estradiol transdermal patch to clean, dry skin. remove the other half of the clear plastic and apply the entire patch to your skin.  - press firmly on the norelgestromin and ethinyl estradiol transdermal patch with the palm of your hand for 10 seconds, making sure that the whole patch sticks to your skin. - run your fingers over the entire surface area to smooth out any “wrinkles” around the outer edges of the norelgestromin and ethinyl estradiol transdermal patch. - check your norelgestromin and ethinyl estradiol transdermal patch every day to make sure all edges are sticking correctly.  step 3: throwing away your norelgestromin and ethinyl estradiol transdermal patch - to throw away the norelgestromin and ethinyl estradiol transdermal patch, fold the sticky side of the patch together, place it in a sturdy child-proof container, and place the container in the trash. - used norelgestromin and ethinyl estradiol transdermal patches should not be flushed in the toilet. important notes: - your norelgestromin and ethinyl estradiol transdermal patch must stick securely to your skin to work properly. - do not try to reapply a norelgestromin and ethinyl estradiol transdermal patch if it is no longer sticky, if it has become stuck to itself or another surface, or if it has other material stuck to it. do not tape or wrap the patch to your skin or reapply a patch that is partially adhered to clothing. - if your norelgestromin and ethinyl estradiol transdermal patch edge lifts up: - press down firmly on the patch with the palm of your hand for 10 seconds, making sure that the whole patch sticks to your skin. run your fingers over the entire surface area to smooth out any “wrinkles” around the edges of the norelgestromin and ethinyl estradiol transdermal patch. - if your norelgestromin and ethinyl estradiol transdermal patch does not stick completely, remove it and apply a replacement norelgestromin and ethinyl estradiol transdermal patch. - do not tape or wrap the norelgestromin and ethinyl estradiol transdermal patch to your skin or reapply a norelgestromin and ethinyl estradiol transdermal patch that is partially stuck to clothing. - if your norelgestromin and ethinyl estradiol transdermal patch has been off or partially off: - for less than 1 day, try to reapply it. if the norelgestromin and ethinyl estradiol transdermal patch does not stick completely, apply a new norelgestromin and ethinyl estradiol transdermal patch immediately. no back-up contraception is needed and your "patch change day" will stay the same. - for more than 1 day or if you are not sure for how long, you could become pregnant. to reduce this chance, apply a new norelgestromin and ethinyl estradiol transdermal patch and start a new 4 week cycle. you will now have a new "patch change day." use a non-hormonal back-up contraception method such as a condom and spermicide or diaphragm and spermicide for the first week of your new 4 week norelgestromin and ethinyl estradiol transdermal system cycle. - talk to your healthcare provider about a replacement norelgestromin and ethinyl estradiol transdermal patch prescription so you will always have an extra norelgestromin and ethinyl estradiol transdermal patch available if needed. - if you want to move your "patch change day" to a different day of the week, finish your current cycle. remove your third norelgestromin and ethinyl estradiol transdermal patch on the correct day. - during week 4, the "patch free week" (day 22 through day 28), you may choose an earlier "patch change day" by applying a new patch on the day you prefer. you now have a new day 1 and a new "patch change day." - if your norelgestromin and ethinyl estradiol transdermal patch becomes uncomfortable or your application site is red, painful or swollen, change your norelgestromin and ethinyl estradiol transdermal patch. remove your norelgestromin and ethinyl estradiol transdermal patch and apply a new patch to a new location until your next "patch change day." - if you forget to change or remove your norelgestromin and ethinyl estradiol transdermal patch: - at the start of any patch cycle (week 1, day 1): - you could become pregnant. you must use a back-up contraception method for 7 days. apply the first norelgestromin and ethinyl estradiol transdermal patch of your new cycle as soon as you remember. you now have a new "patch change day" and a new day 1. - in the middle of your patch cycle (week 2 or week 3): - if you forget to change your norelgestromin and ethinyl estradiol transdermal patch for 1 or 2 days, apply a new norelgestromin and ethinyl estradiol transdermal patch as soon as you remember. apply your next patch on your normal "patch change day." no back-up contraception method is needed. - if you forget to change your norelgestromin and ethinyl estradiol transdermal patch for more than 2 days, you could become pregnant. start a new 4 week cycle as soon as you remember by putting on a new norelgestromin and ethinyl estradiol transdermal patch. you now have a different "patch change day" and a new day 1. you must use a back-up contraception method for the first 7 days of your new cycle. - at the end of your patch cycle (week 4): - if you forget to remove your norelgestromin and ethinyl estradiol transdermal patch, take it off as soon as you remember. start your next cycle on your normal "patch change day," the day after day 28. no back-up contraception method is needed. - if you forget to apply your norelgestromin and ethinyl estradiol transdermal patch at the start of your next patch cycle, you could become pregnant. apply the first norelgestromin and ethinyl estradiol transdermal patch of your new cycle as soon as you remember. you now have a new "patch change day" and a new day 1. use a non-hormonal back-up contraception method such as a condom and spermicide or diaphragm and spermicide for the first 7 days of your new 4 week norelgestromin and ethinyl estradiol transdermal system cycle. - if you have trouble remembering to change your norelgestromin and ethinyl estradiol transdermal patch, talk to your healthcare provider about how to make patch changing easier or about using another method of contraception. - if you are not sure how to use your norelgestromin and ethinyl estradiol transdermal patch: - use a back-up contraception method such as a condom and spermicide or diaphragm and spermicide anytime you have sex. make sure to have 1 of these non-hormonal contraception methods ready at all times. - talk to your healthcare provider for instructions on using your norelgestromin and ethinyl estradiol transdermal patch. 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. 03-2022-02

United States - English - NLM (National Library of Medicine)

zydus pharmaceuticals usa inc. - norelgestromin (unii: r0tay3x631) (norelgestromin - unii:r0tay3x631), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - norelgestromin and ethinyl estradiol transdermal system is indicated for the prevention of pregnancy in women with a body mass index (bmi) < 30 kg/m2 for whom a combined hormonal contraceptive is appropriate. limitations of use: norelgestromin and ethinyl estradiol transdermal system may be less effective in preventing pregnancy in women who weigh 198 lbs (90 kg) or more. norelgestromin and ethinyl estradiol transdermal system is contraindicated for use in women with bmi ≥ 30 kg/m2 [see contraindications (4), warnings and precautions (5.1) and clinical studies (14) ]. norelgestromin and ethinyl estradiol transdermal system is contraindicated in females who are known to have or develop the following conditions: ●    at high risk of arterial or venous thromboembolic events. examples include women who: ○ 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 inherited or acqui

United States - English - NLM (National Library of Medicine)

mylan pharmaceuticals inc. - norelgestromin (unii: r0tay3x631) (norelgestromin - unii:r0tay3x631), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - norelgestromin 150 ug in 1 d - xulane is indicated for the prevention of pregnancy in women with a body mass index (bmi) < 30  kg/m2 for whom a combined hormonal contraceptive is appropriate. limitations of use: xulane may be less effective in preventing pregnancy in women who weigh 198 lbs. (90 kg) or more. xulane is contraindicated for use in women with bmi ≥ 30 kg/m2  [see contraindications (4), warnings and precautions (5.1) and clinical studies (14)] . xulane is contraindicated in females who are known to have or develop the following conditions: there is little or no increased risk of birth defects in women who inadvertently use hormonal contraceptives during early 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 low dose hormonal contraceptives prior to conception or during early pregnancy. the administration of hormonal contraceptives to induce withdrawal bleeding should not be u

United States - English - NLM (National Library of Medicine)

a-s medication solutions - norelgestromin (unii: r0tay3x631) (norelgestromin - unii:r0tay3x631), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - norelgestromin 150 ug in 1 d - xulane is indicated for the prevention of pregnancy in women with a body mass index (bmi) < 30  kg/m2 for whom a combined hormonal contraceptive is appropriate. limitations of use: xulane may be less effective in preventing pregnancy in women who weigh 198 lbs. (90 kg) or more. xulane is contraindicated for use in women with bmi ≥ 30 kg/m2  [see contraindications (4), warnings and precautions (5.1) and clinical studies (14)] . xulane is contraindicated in females who are known to have or develop the following conditions: there is little or no increased risk of birth defects in women who inadvertently use hormonal contraceptives during early 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 low dose hormonal contraceptives prior to conception or during early pregnancy. the administration of hormonal contraceptives to induce withdrawal bleeding should not be used as a test for pregnancy. hormonal contraceptives should not be used during pregnancy to treat threatened or habitual abortion. the effects of xulane in nursing mothers have not been evaluated and are unknown. when possible, advise the nursing mother to use other forms of contraception until she has completely weaned her child. estrogen-containing 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. small amounts of contraceptive steroids and/or metabolites are present in breast milk. safety and efficacy of norelgestromin and ethinyl estradiol transdermal system have been established in women of reproductive age. efficacy is expected to be the same for post-pubertal adolescents under the age of 18 and for users 18 years and older. use of this product before menarche is not indicated. xulane has not been studied in postmenopausal women and is not indicated in this population. no studies with xulane have been conducted in women with hepatic impairment. however, steroid hormones may be poorly metabolized in patients with impaired liver function. acute or chronic disturbances of liver function may necessitate the discontinuation of combined hormonal contraceptive use until markers of liver function return to normal and combined hormonal contraceptive causation has been excluded. [see contraindications (4) and warnings and precautions (5.3).] no studies with xulane have been conducted in women with renal impairment. xulane is contraindicated in women with a bmi ≥ 30 kg/m2 because of the potential increased risk of vte [see contraindications (4) and warnings and precautions (5.1)]. xulane may be less effective in preventing pregnancy in women who weigh 198 lbs. or more [see clinical studies (14)].

United States - English - NLM (National Library of Medicine)

janssen pharmaceutical, inc. - norelgestromin (unii: r0tay3x631) (norelgestromin - unii:r0tay3x631) - norelgestromin 150 ug in 1 d

Israel - English - Ministry of Health

trima israel pharmaceutical products maabarot ltd - ethinylestradiol; norelgestromin - patches - norelgestromin 6 mg; ethinylestradiol 0.6 mg - norelgestromin and estrogen - norelgestromin and estrogen - female contraception. evra is intended for women of fertile age.

Canada - English - Health Canada

janssen inc - norelgestromin; ethinyl estradiol - patch (extended release) - 6mg; 0.75mg - norelgestromin 6mg; ethinyl estradiol 0.75mg - contraceptives

United States - English - NLM (National Library of Medicine)

amneal pharmaceuticals llc - norelgestromin (unii: r0tay3x631) (norelgestromin - unii:r0tay3x631), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - zafemy® is indicated for the prevention of pregnancy in women with a body mass index (bmi) < 30 kg/m2 for whom a combined hormonal contraceptive is appropriate. limitations of use: zafemy may be less effective in preventing pregnancy in women who weigh 198 lbs (90 kg) or more. zafemy is contraindicated for use in women with bmi ≥ 30 kg/m2  [see contraindications (4), warnings and precautions (5.1) and clinical studies (14)]. zafemy is contraindicated in females who are known to have or develop the following conditions: - at high risk of arterial or venous thromboembolic events. examples include women who: - 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 inherited or acquired hypercoagulopathies [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)]

European Union - English - EMA (European Medicines Agency)

gedeon richter plc. - norelgestromin, ethinyl estradiol - contraception - sex hormones and modulators of the genital system, - female contraception.evra is intended for women of fertile age. the safety and efficacy has been established in women aged 18 to 45 years.

United States - English - NLM (National Library of Medicine)

zydus lifesciences limited - norelgestromin (unii: r0tay3x631) (norelgestromin - unii:r0tay3x631), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) -