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For more information about our extensive product offerings, please contact your Mylan Sales Representative, or visit Mylan.com. A comprehensive line of

Not actual patients Contraceptives available from Mylan

Click on the Mylan product name(s) for Full Prescribing Information, including Boxed WARNING(s).

• Risk of liver enzyme elevations with concomitant hepatitis sex hormone-binding globulin and cortisol-binding globulin. The MYLAN PRODUCT NAME ROUTE OF ADMINISTRATION/ MYLAN NDC/ STRENGTH C treatment: ALT elevations greater than 5 times the upper limit dose of replacement thyroid hormone or cortisol therapy may DOSAGE FORM PACK SIZE of normal (ULN), were significantly more frequent in women using need to be increased. (5.13) ethinyl estradiol medications. Discontinue Xulane prior to starting TRANSDERMAL CONTRACEPTIVE • Monitoring: A woman who is taking hormonal contraceptive therapy [(See Contraindication (4)]. Xulane can be restarted should have a yearly visit with her healthcare provider for a blood approximately 2 weeks after hepatitis C combination drug regimen BW Transdermal 0378-3340-53 150 mcg/35 mcg pressure check and for other indicated healthcare. (5.14) (norelgestromin/ethinyl estradiol Extended Release Film 3 systems per day ombitasvir/paritaprevir/ritonavir, with or without dasabuvir. (5.4)] • Hereditary Angioedema: In women with hereditary angioedema, transdermal system) • High blood pressure: Do not prescribe Xulane for women with exogenous estrogens may induce or exacerbate symptoms of uncontrolled hypertension or hypertension with vascular angioedema. (5.15) disease. (5.5) BW Boxed Warning – This drug has a boxed warning. • Chloasma: Chloasma may occasionally occur, especially in • Gallbladder Disease: Studies suggest a small increased relative women with a history of chloasma gravidarum. Women with a risk of developing gallbladder disease among CHC users. (5.6) INDICATION AND USAGE norelgestromin and ethinyl estradiol transdermal system tendency of chloasma should avoid exposure to the sun or compared with women using oral contraceptives containing 30 Xulane® is indicated for the prevention of pregnancy in women who • Carbohydrate and lipid metabolic effects: Monitor prediabetic ultraviolet radiation while using Xulane. (5.16) mcg to 35 mcg of EE. Increased estrogen exposure may increase and diabetic women taking Xulane. Consider an alternate elect to use a transdermal patch as a method of contraception. ADVERSE REACTIONS the risk of adverse events, including VTE. contraceptive method for women with uncontrolled Limitation of Use: Xulane may be less effective in preventing dyslipidemia. (5.7) The most frequent adverse reactions reported during clinical trials pregnancy in women at or above 198 lbs (90 kg). (≥ 5%) were breast symptoms, nausea/vomiting, headache, CONTRAINDICATIONS • Headache: Evaluate significant change in headaches and SELECTED IMPORTANT RISK HIGHLIGHTS OF PRESCRIBING application site disorder, abdominal pain, dysmenorrhea, vaginal Do not prescribe Xulane to women who are known to have the discontinue Xulane if indicated. (5.8) INFORMATION: These selected highlights do not include all the bleeding and menstrual disorders, and mood, affect and anxiety following conditions: information needed to use XULANE safely and effectively. See the • Uterine bleeding: Evaluate irregular bleeding or amenorrhea. (5.9) disorders. (6.1) full Prescribing Information for XULANE. • A high risk of arterial or venous thrombotic diseases. Examples • Hormonal Contraceptive Use Before or During Early DRUG INTERACTIONS include women who are known to: Pregnancy: Discontinue Xulane if pregnancy is confirmed. NUMBERS IN THE PARENTHESES INDICATE RESPECTIVE SECTIONS IN THE FULL Drugs or herbal products that induce certain enzymes (for example PRESCRIBING INFORMATION. o Smoke, if over age 35 Administration of CHCs should not be used as a test for o Have deep vein thrombosis or pulmonary embolism, CYP3A4) may decrease the effectiveness of CHCs or increase WARNING: CARDIOVASCULAR RISK ASSOCIATED WITH pregnancy. (5.10) now or in the past breakthrough bleeding. Counsel patients to use a back-up or SMOKING, RISK OF VENOUS THROMBOEMBOLISM, AND o Have inherited or acquired hypercoagulopathies • Depression: Carefully observe women with a history of depression alternative method of contraception when enzyme inducers are used PHARMACOKINETIC PROFILE OF ETHINYL ESTRADIOL o Have cerebrovascular disease and discontinue Xulane if depression recurs to a serious degree. with CHCs. (7.1) (5.11) Cigarette Smoking and Serious Cardiovascular Risks o Have coronary artery disease Do not co-administer Xulane with HCV drug combinations containing Cigarette smoking increases the risk of serious cardiovascular o Have thrombogenic valvular or thrombogenic rhythm diseases • Carcinoma of Breasts and Cervix: Xulane is contraindicated in ombitasvir/ paritaprevir/ritonavir, with or without dasabuvir, due to events from hormonal contraceptive use. This risk increases with of the heart (for example, subacute bacterial endocarditis with women who currently have or have had breast cancer because potential for ALT elevations. (7.3) age, particularly in women over 35 years of age, and with the valvular disease, or atrial fibrillation) breast cancer may be hormonally sensitive. (5.12) [See Use In Specific Populations number of cigarettes smoked. For this reason, hormonal o Have uncontrolled hypertension Contraindications (4)]. contraceptives, including Xulane, should not be used by women o Have diabetes mellitus with vascular disease • Nursing mothers: Not recommended; can decrease milk • Effect on Binding Globulins: The estrogen component of CHCs who are over 35 years of age and smoke. o Have headaches with focal neurological symptoms or have production. (8.3) migraine headaches with aura may raise the serum concentrations of thyroxine-binding globulin, Risk of Venous Thromboembolism • Women over age 35 with any migraine headaches The risk of venous thromboembolism (VTE) among women aged • Liver tumors, benign or malignant, or liver disease 15 to 44 who used the norelgestromin and ethinyl estradiol • Undiagnosed abnormal uterine bleeding transdermal system compared to women who used several • Pregnancy, because there is no reason to use hormonal different oral contraceptives was assessed in five U.S. contraceptives during pregnancy epidemiologic studies using electronic healthcare claims data. • Breast cancer or other estrogen- or progestin-sensitive cancer, The relative risk estimates ranged from 1.2 to 2.2; one of the now or in the past studies found a statistically significant increased relative risk of • Do not prescribe Xulane to women using Hepatitis C drug VTE for current users of norelgestromin and ethinyl estradiol combinations containing ombitasvir/paritaprevir/ritonavir, with or transdermal system. without dasabuvir, due to the potential for ALT elevations Pharmacokinetic (PK) Profile of Ethinyl Estradiol (EE) WARNINGS AND PRECAUTIONS The PK profile for norelgestromin and ethinyl estradiol transdermal system is different from the PK profile for oral • Vascular risks: Stop Xulane if a thrombotic event occurs. Stop at contraceptives in that it has a higher steady state concentration least 4 weeks before and through 2 weeks after major surgery. and a lower peak concentration. Area under the Start no earlier than 4 weeks after delivery, in women who are not time-concentration curve (AUC) and average concentration at breastfeeding. (5.1) steady state (C ) for EE are approximately 60% higher in women ss • PK Profile: AUC and average Css for EE are approximately 60% using norelgestromin and ethinyl estradiol transdermal system higher in women using norelgestromin and ethinyl estradiol compared with women using an oral contraceptive containing 35 transdermal system compared with women using an oral mcg of EE. In contrast, the peak concentration (C ) for EE is max contraceptive containing 35 mcg [See Boxed WARNING and approximately 25% lower in women using norelgestromin and Clinical Pharmacology (12.3) found in Full Prescribing Information.] ethinyl estradiol transdermal system. It is not known whether there are changes in the risk of serious adverse events based on • Liver Disease: Discontinue Xulane if jaundice occurs. (5.3) the differences in PK profiles of EE in women using

2 A comprehensive line of

Not actual patients Contraceptives available from Mylan

Important Safety Information (Cont’d)

• Risk of liver enzyme elevations with concomitant hepatitis sex hormone-binding globulin and cortisol-binding globulin. The C treatment: ALT elevations greater than 5 times the upper limit dose of replacement thyroid hormone or cortisol therapy may of normal (ULN), were significantly more frequent in women using need to be increased. (5.13) ethinyl estradiol medications. Discontinue Xulane prior to starting • Monitoring: A woman who is taking hormonal contraceptive therapy [(See Contraindication (4)]. Xulane can be restarted should have a yearly visit with her healthcare provider for a blood approximately 2 weeks after hepatitis C combination drug regimen pressure check and for other indicated healthcare. (5.14) ombitasvir/paritaprevir/ritonavir, with or without dasabuvir. (5.4)] • Hereditary Angioedema: In women with hereditary angioedema, • High blood pressure: Do not prescribe Xulane for women with exogenous estrogens may induce or exacerbate symptoms of uncontrolled hypertension or hypertension with vascular angioedema. (5.15) disease. (5.5) • Chloasma: Chloasma may occasionally occur, especially in • Gallbladder Disease: Studies suggest a small increased relative women with a history of chloasma gravidarum. Women with a risk of developing gallbladder disease among CHC users. (5.6) INDICATION AND USAGE norelgestromin and ethinyl estradiol transdermal system tendency of chloasma should avoid exposure to the sun or compared with women using oral contraceptives containing 30 Xulane® is indicated for the prevention of pregnancy in women who • Carbohydrate and lipid metabolic effects: Monitor prediabetic ultraviolet radiation while using Xulane. (5.16) mcg to 35 mcg of EE. Increased estrogen exposure may increase and diabetic women taking Xulane. Consider an alternate elect to use a transdermal patch as a method of contraception. ADVERSE REACTIONS the risk of adverse events, including VTE. contraceptive method for women with uncontrolled Limitation of Use: Xulane may be less effective in preventing dyslipidemia. (5.7) The most frequent adverse reactions reported during clinical trials pregnancy in women at or above 198 lbs (90 kg). (≥ 5%) were breast symptoms, nausea/vomiting, headache, CONTRAINDICATIONS • Headache: Evaluate significant change in headaches and SELECTED IMPORTANT RISK HIGHLIGHTS OF PRESCRIBING application site disorder, abdominal pain, dysmenorrhea, vaginal Do not prescribe Xulane to women who are known to have the discontinue Xulane if indicated. (5.8) INFORMATION: These selected highlights do not include all the bleeding and menstrual disorders, and mood, affect and anxiety following conditions: information needed to use XULANE safely and effectively. See the • Uterine bleeding: Evaluate irregular bleeding or amenorrhea. (5.9) disorders. (6.1) full Prescribing Information for XULANE. • A high risk of arterial or venous thrombotic diseases. Examples • Hormonal Contraceptive Use Before or During Early DRUG INTERACTIONS include women who are known to: Pregnancy: Discontinue Xulane if pregnancy is confirmed. NUMBERS IN THE PARENTHESES INDICATE RESPECTIVE SECTIONS IN THE FULL Drugs or herbal products that induce certain enzymes (for example PRESCRIBING INFORMATION. o Smoke, if over age 35 Administration of CHCs should not be used as a test for o Have deep vein thrombosis or pulmonary embolism, CYP3A4) may decrease the effectiveness of CHCs or increase WARNING: CARDIOVASCULAR RISK ASSOCIATED WITH pregnancy. (5.10) now or in the past breakthrough bleeding. Counsel patients to use a back-up or SMOKING, RISK OF VENOUS THROMBOEMBOLISM, AND o Have inherited or acquired hypercoagulopathies • Depression: Carefully observe women with a history of depression alternative method of contraception when enzyme inducers are used PHARMACOKINETIC PROFILE OF ETHINYL ESTRADIOL o Have cerebrovascular disease and discontinue Xulane if depression recurs to a serious degree. with CHCs. (7.1) (5.11) Cigarette Smoking and Serious Cardiovascular Risks o Have coronary artery disease Do not co-administer Xulane with HCV drug combinations containing Cigarette smoking increases the risk of serious cardiovascular o Have thrombogenic valvular or thrombogenic rhythm diseases • Carcinoma of Breasts and Cervix: Xulane is contraindicated in ombitasvir/ paritaprevir/ritonavir, with or without dasabuvir, due to events from hormonal contraceptive use. This risk increases with of the heart (for example, subacute bacterial endocarditis with women who currently have or have had breast cancer because potential for ALT elevations. (7.3) age, particularly in women over 35 years of age, and with the valvular disease, or atrial fibrillation) breast cancer may be hormonally sensitive. (5.12) [See Use In Specific Populations number of cigarettes smoked. For this reason, hormonal o Have uncontrolled hypertension Contraindications (4)]. contraceptives, including Xulane, should not be used by women o Have diabetes mellitus with vascular disease • Nursing mothers: Not recommended; can decrease milk • Effect on Binding Globulins: The estrogen component of CHCs who are over 35 years of age and smoke. o Have headaches with focal neurological symptoms or have production. (8.3) migraine headaches with aura may raise the serum concentrations of thyroxine-binding globulin, Risk of Venous Thromboembolism • Women over age 35 with any migraine headaches The risk of venous thromboembolism (VTE) among women aged • Liver tumors, benign or malignant, or liver disease 15 to 44 who used the norelgestromin and ethinyl estradiol • Undiagnosed abnormal uterine bleeding transdermal system compared to women who used several • Pregnancy, because there is no reason to use hormonal different oral contraceptives was assessed in five U.S. contraceptives during pregnancy epidemiologic studies using electronic healthcare claims data. • Breast cancer or other estrogen- or progestin-sensitive cancer, The relative risk estimates ranged from 1.2 to 2.2; one of the now or in the past studies found a statistically significant increased relative risk of • Do not prescribe Xulane to women using Hepatitis C drug VTE for current users of norelgestromin and ethinyl estradiol combinations containing ombitasvir/paritaprevir/ritonavir, with or transdermal system. without dasabuvir, due to the potential for ALT elevations Pharmacokinetic (PK) Profile of Ethinyl Estradiol (EE) WARNINGS AND PRECAUTIONS The PK profile for norelgestromin and ethinyl estradiol transdermal system is different from the PK profile for oral • Vascular risks: Stop Xulane if a thrombotic event occurs. Stop at contraceptives in that it has a higher steady state concentration least 4 weeks before and through 2 weeks after major surgery. and a lower peak concentration. Area under the Start no earlier than 4 weeks after delivery, in women who are not time-concentration curve (AUC) and average concentration at breastfeeding. (5.1) steady state (C ) for EE are approximately 60% higher in women ss • PK Profile: AUC and average Css for EE are approximately 60% using norelgestromin and ethinyl estradiol transdermal system higher in women using norelgestromin and ethinyl estradiol compared with women using an oral contraceptive containing 35 transdermal system compared with women using an oral mcg of EE. In contrast, the peak concentration (C ) for EE is max contraceptive containing 35 mcg [See Boxed WARNING and approximately 25% lower in women using norelgestromin and Clinical Pharmacology (12.3) found in Full Prescribing Information.] ethinyl estradiol transdermal system. It is not known whether there are changes in the risk of serious adverse events based on • Liver Disease: Discontinue Xulane if jaundice occurs. (5.3) the differences in PK profiles of EE in women using Not actual patients

3 A comprehensive line of

Not actual patients Contraceptives available from Mylan

Click on the Mylan product name(s) for Full Prescribing Information, including Boxed WARNING(s).

MYLAN PRODUCT NAME ROUTE OF ADMINISTRATION/ MYLAN NDC/ STRENGTH DOSAGE FORM PACK SIZE

INJECTABLE CONTRACEPTIVE

MedroxyPROGESTERone Acetate BW Injectable 67457-887-99 150 mg/mL Injectable Suspension, USP 1 × 1 mL vials Generic of Depo-Provera® 67457-887-01 150 mg/mL 25 × 1 mL vials

BW Boxed Warning – This drug has a boxed warning.

INDICATION Cancer Risks: Women who have or have had a history of breast cancer should not use hormonal contraceptives. Monitor women Medroxyprogesterone acetate injectable suspension is a progestin with a strong family history of breast cancer carefully. indicated only for the prevention of pregnancy. Ectopic Pregnancy: Consider ectopic pregnancy if a woman IMPORTANT SAFETY INFORMATION using medroxyprogesterone acetate injectable suspension WARNING: LOSS OF BONE MINERAL DENSITY becomes pregnant or complains of severe abdominal pain. See full prescribing information for complete Boxed Warning. Anaphylaxis and Anaphylactoid Reactions: Anaphylaxis and • Women who use medroxyprogesterone acetate contraceptive anaphylactoid reactions have been reported with the use of injection may lose significant bone mineral density. Bone loss is medroxyprogesterone acetate. greater with increasing duration of use and may not be Injection Site Reactions: Persistent injection site reactions may completely reversible. occur after administration of medroxyprogesterone acetate • It is unknown if use of medroxyprogesterone acetate injectable suspension due to inadvertent subcutaneous contraceptive injection during adolescence or early adulthood, administration or release of the drug into the subcutaneous a critical period of bone accretion, will reduce peak bone mass space while removing the needle. and increase the risk for osteoporotic fracture in later life. Liver Function: Discontinue medroxyprogesterone acetate • Medroxyprogesterone acetate contraceptive injection should injectable suspension if jaundice or disturbances of liver function not be used as a long-term birth control method (i.e., longer develop. than 2 years) unless other birth control methods are considered Convulsions: There have been a few reported cases of convulsions inadequate. in patients who were treated with medroxyprogesterone acetate injectable suspension. The use of medroxyprogesterone acetate is contraindicated in Depression: Monitor patients who have a history of depression the following conditions: and do not readminister medroxyprogesterone acetate injectable • Known or suspected pregnancy or as a diagnostic test for suspension if depression recurs. pregnancy. (4) Bleeding Irregularities: Rule out the possibility of organic • Active thrombophlebitis, or current or past history of pathology if abnormal bleeding persists or is severe, and institute thromboembolic disorders, or cerebral vascular disease. (5.2) appropriate treatment. • Known or suspected malignancy of breast. (5.3) Weight Gain: Women tend to gain weight while on therapy with medroxyprogesterone acetate injectable suspension. • Known hypersensitivity to medroxyprogesterone acetate injectable suspension (medroxyprogesterone acetate) or any of Carbohydrate Metabolism: Monitor diabetic patients carefully due its other ingredients. (5.5) to potential decrease in glucose tolerance. • Significant liver disease. (5.6) Lactation: Detectable amounts of drug have been identified in the milk of mothers. No adverse effects have been noted in • Undiagnosed vaginal bleeding. (5.9) neonates and infants exposed to medroxyprogesterone from Loss of Bone Minderal Density: Use of medroxyprogesterone breast milk. acetate injectable suspension is associated with significant loss Fluid Retention: Monitor patients with conditions that might be of bone mineral density. This loss is of particular concern during influenced by fluid retention, such as epilepsy, migraine, asthma, adolescence and early adulthood, a critical period of bone and cardiac or renal dysfunction. accretion and should not be used as a long-term birth control method unless other methods are considered inadequate. Return of Fertility: Return to ovulation and fertility is likely to be delayed after stopping use. Thromboembolic Disorders: Discontinue medroxyprogesterone acetate injectable suspension in patients who develop thrombosis unless that there are no other acceptable options for birth control.

4

Sexually Transmitted Diseases: Patients should be counseled Interference with Laboratory Tests: The use of that medroxyprogesterone acetate injectable suspension does medroxyprogesterone acetate injectable suspension may change not protect against HIV infection (AIDS) and other sexually the results of some laboratory tests. transmitted diseases. Most common adverse reactions (incidence > 5%) are: menstrual Pregnancy: Although medroxyprogesterone acetate injectable irregularities (bleeding or spotting) 57% at 12 months, 32% at 24 suspension should not be used during pregnancy, there appears months, amenorrhea 55% at 12 months, 68% at 24 months, to be little to no increased risk of birth defects in women who abdominal pain/discomfort 11%, weight gain > 10 lbs at 24 months have inadvertently been exposed to medroxyprogesterone 38%, dizziness 6%, headache 17%, nervousness 11%, decreased injections in early pregnancy. libido 6%. Monitoring: Women should have a yearly visit with their healthcare provider for blood pressure check and other indicated healthcare. INDICATION Cancer Risks: Women who have or have had a history of breast cancer should not use hormonal contraceptives. Monitor women Medroxyprogesterone acetate injectable suspension is a progestin with a strong family history of breast cancer carefully. indicated only for the prevention of pregnancy. Ectopic Pregnancy: Consider ectopic pregnancy if a woman IMPORTANT SAFETY INFORMATION using medroxyprogesterone acetate injectable suspension WARNING: LOSS OF BONE MINERAL DENSITY becomes pregnant or complains of severe abdominal pain. See full prescribing information for complete Boxed Warning. Anaphylaxis and Anaphylactoid Reactions: Anaphylaxis and • Women who use medroxyprogesterone acetate contraceptive anaphylactoid reactions have been reported with the use of injection may lose significant bone mineral density. Bone loss is medroxyprogesterone acetate. greater with increasing duration of use and may not be Injection Site Reactions: Persistent injection site reactions may completely reversible. occur after administration of medroxyprogesterone acetate • It is unknown if use of medroxyprogesterone acetate injectable suspension due to inadvertent subcutaneous contraceptive injection during adolescence or early adulthood, administration or release of the drug into the subcutaneous a critical period of bone accretion, will reduce peak bone mass space while removing the needle. and increase the risk for osteoporotic fracture in later life. Liver Function: Discontinue medroxyprogesterone acetate • Medroxyprogesterone acetate contraceptive injection should injectable suspension if jaundice or disturbances of liver function not be used as a long-term birth control method (i.e., longer develop. than 2 years) unless other birth control methods are considered Convulsions: There have been a few reported cases of convulsions inadequate. in patients who were treated with medroxyprogesterone acetate injectable suspension. The use of medroxyprogesterone acetate is contraindicated in Depression: Monitor patients who have a history of depression the following conditions: and do not readminister medroxyprogesterone acetate injectable • Known or suspected pregnancy or as a diagnostic test for suspension if depression recurs. pregnancy. (4) Bleeding Irregularities: Rule out the possibility of organic • Active thrombophlebitis, or current or past history of pathology if abnormal bleeding persists or is severe, and institute thromboembolic disorders, or cerebral vascular disease. (5.2) appropriate treatment. • Known or suspected malignancy of breast. (5.3) Weight Gain: Women tend to gain weight while on therapy with medroxyprogesterone acetate injectable suspension. • Known hypersensitivity to medroxyprogesterone acetate injectable suspension (medroxyprogesterone acetate) or any of Carbohydrate Metabolism: Monitor diabetic patients carefully due its other ingredients. (5.5) to potential decrease in glucose tolerance. • Significant liver disease. (5.6) Lactation: Detectable amounts of drug have been identified in the milk of mothers. No adverse effects have been noted in • Undiagnosed vaginal bleeding. (5.9) neonates and infants exposed to medroxyprogesterone from Loss of Bone Minderal Density: Use of medroxyprogesterone breast milk. acetate injectable suspension is associated with significant loss Fluid Retention: Monitor patients with conditions that might be of bone mineral density. This loss is of particular concern during influenced by fluid retention, such as epilepsy, migraine, asthma, adolescence and early adulthood, a critical period of bone and cardiac or renal dysfunction. accretion and should not be used as a long-term birth control method unless other methods are considered inadequate. Return of Fertility: Return to ovulation and fertility is likely to be delayed after stopping use. Thromboembolic Disorders: Discontinue medroxyprogesterone acetate injectable suspension in patients who develop thrombosis unless that there are no other acceptable options for birth control.

A comprehensive line of

Not actual patients Contraceptives available from Mylan

Important Safety Information (Cont’d) Sexually Transmitted Diseases: Patients should be counseled Interference with Laboratory Tests: The use of that medroxyprogesterone acetate injectable suspension does medroxyprogesterone acetate injectable suspension may change not protect against HIV infection (AIDS) and other sexually the results of some laboratory tests. transmitted diseases. Most common adverse reactions (incidence > 5%) are: menstrual Pregnancy: Although medroxyprogesterone acetate injectable irregularities (bleeding or spotting) 57% at 12 months, 32% at 24 suspension should not be used during pregnancy, there appears months, amenorrhea 55% at 12 months, 68% at 24 months, to be little to no increased risk of birth defects in women who abdominal pain/discomfort 11%, weight gain > 10 lbs at 24 months have inadvertently been exposed to medroxyprogesterone 38%, dizziness 6%, headache 17%, nervousness 11%, decreased injections in early pregnancy. libido 6%. Monitoring: Women should have a yearly visit with their healthcare provider for blood pressure check and other indicated healthcare.

Not actual patients

Contraceptive Patient Identification Choosing a contraceptive method may be a difficult decision, especially with so many options available. Given that no method of contraception is perfect, each woman, along with her healthcare provider, should balance the benefits of each method against the risks and side effects, and decide which method is appropriate for her. Mylan Offers a Broad Portfolio of Contraceptives Whether the 3-month injectable, or the weekly transdermal system, or daily combined and progestin-only oral contraceptives, Mylan offers a comprehensive line of contraceptive options for your appropriate patients.

Consider Mylan contraceptives when exploring her options.

5 A comprehensive line of

Not actual patients Contraceptives available from Mylan

Click on the Mylan product name(s) for Full Prescribing Information, including Boxed WARNING(s).

MYLAN PRODUCT NAME ROUTE OF ADMINISTRATION/ MYLAN NDC/ STRENGTH DOSAGE FORM PACK SIZE

ORAL CONTRACEPTIVES

PROGESTIN-ONLY PILLS

Norethindrone Tablets, USP Oral 0378-7272-53 0.35 mg Generic of Micronor® Tablet 3 x 28 tablets Norethindrone Tablets, USP Oral 0378-7292-53 0.35 mg Generic of Nor-QD® Tablet 3 x 28 tablets

MONOPHASIC PILLS

Norethindrone and Ethinyl Estradiol Tablets, USP BW Oral 0378-7297-53 0.4 mg/0.035 mg (Chewable) and Ferrous Fumarate Tablets (Chewable) Chewable Tablet 3 x 28 tablets 75 mg Fe* Generic of Femcon® FE

Norethindrone and Ethinyl Estradiol Tablets (Chewable), BW Oral 0378-7308-53 0.8 mg/0.025 mg and Ferrous Fumarate Tablets (Chewable) Chewable Tablet 3 x 28 tablets 75 mg Fe* Generic of Generess® FE

Levonorgestrel and ethinyl estradiol tablets, USP BW Oral 0378-7287-53 0.1 mg/0.02 mg Generic of Lutera® Tablet 3 x 28 tablets

Norethindrone Acetate and Ethinyl Estradiol BW Oral 0378-7280-53 1 mg/0.02 mg Tablets, USP Tablet 3 x 21 tablets Generic of Loestrin® 21 1/20

Norethindrone Acetate and Ethinyl Estradiol BW Oral 0378-7283-53 1 mg/0.02 mg Tablets, USP and Ferrous Fumarate Tablets Tablet 3 x 28 tablets 75 mg Fe* Generic of Loestrin® FE 1/20

Levonorgestrel and Ethinyl Estradiol Tablets, USP BW Oral 0378-6550-53 0.15 mg/0.03 mg Generic of Nordette® Tablet 3 x 28 tablets

Desogestrel and Ethinyl Estradiol Tablets, USP BW Oral 0378-7282-53 0.15 mg/0.03 mg Generic of Ortho-Cept® Tablet 3 x 28 tablets

Norgestimate and Ethinyl Estradiol Tablets, USP BW Oral 0378-7286-53 0.25 mg/0.035 mg Generic of Ortho-Cyclen® Tablet 3 x 28 tablets

Drospirenone and Ethinyl Estradiol Tablets, USP BW Oral 0378-7300-53 3 mg/0.03 mg Generic of Yasmin® Tablet 3 x 28 tablets

Drospirenone and Ethinyl Estradiol Tablets, USP BW Oral 0378-7299-53 3 mg/0.02 mg Generic of Yaz ® Tablet 3 x 28 tablets

Ethynodiol Diacetate and Ethinyl BW Oral 0378-7307-53 1 mg/0.035 mg Estradiol Tablets, USP Tablet 3 x 28 tablets Generic of Zovia® 1/35

Ethynodiol Diacetate and Ethinyl BW Oral 0378-7306-53 1 mg/0.050 mg Estradiol Tablets, USP Tablet 3 x 28 tablets Generic of Zovia® 1/50

*Fe: Ferrous fumarate Ferrous fumarate tablets are not USP for dissolution and assay. Strength of ferrous fumarate is noted in chart.

BW Boxed Warning – This drug has a boxed warning.

6 A comprehensive line of

Not actual patients Contraceptives available from Mylan

Click on the Mylan product name(s) for Full Prescribing Information, including Boxed WARNING(s).

MYLAN PRODUCT NAME ROUTE OF ADMINISTRATION/ MYLAN NDC/ STRENGTH DOSAGE FORM PACK SIZE

BIPHASIC PILLS

Desogestrel and Ethinyl Estradiol Tablets, BW Oral 0378-7296-53 0.15 mg/ USP and Ethinyl Estradiol Tablets, USP Tablet 3 x 28 tablets 0.02 mg + 0.01 mg Generic of Mircette®

TRIPHASIC PILLS

Norgestimate and Ethinyl Estradiol Tablets, USP BW Oral 0378-7293-53 0.18 mg/0.035 mg Generic of Ortho Tri-Cyclen® Tablet 3 x 28 tablets 0.215 mg/0.035 mg 0.25 mg/0.035 mg

EXTENDED-CYCLE PILLS

Levonorgestrel and Ethinyl Estradiol Tablets, BW Oral 0378-7284-90 0.1 mg/0.02 mg USP and Ethinyl Estradiol Tablets, USP Tablet 2 x 91 tablets and 0.01 mg Generic of LoSeasonique®

Levonorgestrel and Ethinyl Estradiol Tablets, USP BW Oral 0378-7281-53 0.15 mg/0.03 mg Generic of Seasonale® Tablet 3 x 91 tablets

Levonorgestrel and Ethinyl Estradiol Tablets, BW Oral 0378-7285-90 0.15 mg/0.01 mg USP and Ethinyl Estradiol Tablets, USP Tablet 2 x 91 tablets and 0.01 mg Generic of Seasonique®

Levonorgestrel and Ethinyl Estradiol tablets, BW Oral 0378-7316-85 0.15 mg/0.02 mg USP and Ethinyl Estradiol tablets, USP Tablet 1 x 91 tablets 0.15 mg/0.025 mg Generic of Quartette® 0.15 mg/0.03 mg and 0.01 mg

BW Boxed Warning – This drug has a boxed warning.

INDICATION • Renal impairment or adrenal insufficiency. Oral contraceptives are indicated for use by women to prevent • Undiagnosed abnormal uterine bleeding. pregnancy. The efficacy of some oral contraceptives in women with • Pregnancy, because there is no reason to use oral contraceptives a body mass index (BMI) of > 35 kg/m2 has not been evaluated. during pregnancy. Oral contraceptives do not protect against HIV infection (AIDS) and • Breast cancer or other estrogen- or progestin-sensitive cancer, now other sexually transmitted diseases. or in the past. IMPORTANT SAFETY INFORMATION: • Hypersensitivity to any component of the oral contraceptive product. WARNING: CIGARETTE SMOKING AND SERIOUS Serious adverse reactions associated with the use of oral CARDIOVASCULAR EVENTS contraceptives include thrombophlebitis; arterial thromboembolism; pulmonary embolism; myocardial infarction; cerebral haemorrhage; Cigarette smoking increases the risk of serious cerebral thrombosis; hypertension; gallbladder disease; hepatic cardiovascular events from oral contraceptive use. This risk adenomas or benign liver tumors; hyperkalemia; carbohydrate and increases with age, particularly in women over 35 years of lipid metabolic effects; ectopic pregnancy; delayed follicular age, and with the number of cigarettes smoked. For this atresia/ovarian cysts; carcinoma of the breast and reproductive reason, oral contraceptives should not be used by women organs; genital bleeding irregularities; and onset of or change in who are over 35 years of age and smoke. migraine/headache. Do not prescribe oral contraceptives to women who are known to Common adverse reactions reported for oral contraceptives include have the following conditions: menstrual irregularities or disorders, irregular uterine bleeding; • A high risk of arterial or venous thrombotic diseases. Examples nausea; vomiting; breast pain, tenderness or discomfort; headache; include women who are known to smoke, if over age 35, or women migraine; vaginal infection; genital discharge; weight changes who have: deep vein thrombosis or pulmonary embolism, now or in (increased or decreased ); abdominal pain, tenderness or discomfort; the past; cerebrovascular disease; coronary artery disease; anxiety symptoms; depression or mood changes or disorders ; acne; thrombogenic valvular or thrombogenic rhythm diseases of the fatigue; irritability; decreased libido; affect lability; flatulence, heart; inherited or acquired hypercoagulopathies; uncontrolled nervousness, and rash. hypertension; diabetes with vascular disease; or headaches with Before prescribing any contraceptive listed in this catalog, focal neurological symptoms or have migraine headaches with or please read the Full Prescribing Information, including without aura if over age 35. Boxed WARNING(s), by clicking on the Mylan product name. • Liver tumors, benign or malignant, or liver disease. 7 A comprehensive line of Menopausal

Not actual patient Hormone Therapy available from Mylan

Click on the Mylan product name(s) for Full Prescribing Information, including Boxed WARNING(s).

MYLAN PRODUCT NAME ROUTE OF ADMINISTRATION/ MYLAN NDC/ STRENGTH DOSAGE FORM PACK SIZE

BW Transdermal 0037-4801-70 0.06% (estradiol gel) for topical use Metered Gel 35 g x 2

ESTRADIOL Vaginal Cream, USP BW Vaginal 0378-8770-35 0.01% Generic of Estrace® Cream Cream 1.5 oz (42.5 g) tube

ESTRADIOL Transdermal System, USP BW Transdermal 0378-3349-99 0.025 mg per day Continuous Delivery (Once-Weekly) Extended Release Film 0378-3360-99 0.0375 mg per day Generic of Climara® 0378-3350-99 0.05 mg per day 0378-3361-99 0.06 mg per day 0378-3351-99 0.075 mg per day 0378-3352-99 0.1 mg per day 4 systems

ESTRADIOL Transdermal System, USP BW Transdermal 0378-4644-26 0.025 mg per day (Twice-Weekly) Extended Release Film 0378-4643-26 0.0375 mg per day Generic of Vivelle Dot® 0378-4642-26 0.05 mg per day 0378-4641-26 0.075 mg per day 0378-4640-26 0.1 mg per day 8 systems

ESTRADIOL Transdermal System, USP BW Transdermal 0378-4619-26 0.025 mg per day (Twice-Weekly) Extended Release Film 0378-4620-26 0.0375 mg per day Generic of Minivelle® 0378-4621-26 0.05 mg per day 0378-4622-26 0.075 mg per day 0378-4623-26 0.1 mg per day 8 systems

ESTRADIOL Tablets, USP BW Oral 0378-1452-01 0.05 mg Generic of Estrace® Tablet 0378-1454-01 0.1 mg 0378-1458-01 0.2 mg 100 Tablets

ESTRADIOL AND NORETHINDRONE BW Oral 0378-7294-53 0.1 mg ACETATE Tablets, USP Tablet 0378-7295-53 0.5 mg Generic of Activella® 3 x 28 tablets

BW Boxed Warning – This drug has a boxed warning. Boxed WARNING (continued) INDICATIONS • The Women's Health Initiative (WHI) estrogen-alone substudy Estrogens are used for the treatment of moderate to severe vasomotor reported increased risks of stroke and deep vein thrombosis (DVT) symptoms due to menopause. • The WHI Memory Study (WHIMS) estrogen-alone ancillary study of WHI reported an increased risk of probable dementia in Estradiol Vaginal Cream, USP, 0.01% is indicated in the treatment postmenopausal women 65 years of age and older of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause. Estrogen Plus Progestin Therapy IMPORTANT SAFETY INFORMATION • Estrogen plus progestin therapy should not be used for the prevention of cardiovascular disease or dementia WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR • The WHI estrogen plus progestin substudy reported increased risk DISORDERS, BREAST CANCER AND PROBABLE DEMENTIA of stroke, DVT, pulmonary embolism (PE), and myocardial Estrogen-Alone Therapy infarction (MI) • There is an increased risk of endometrial cancer in a woman with • The WHI estrogen plus progestin study reported increased risks a uterus who uses unopposed estrogens of invasive breast cancer • Estrogen-alone therapy should not be used for the prevention of • The WHIMS estrogen plus progestin ancillary study of WHI cardiovascular disease or dementia reported an increased risk of probable dementia in postmenopausal women 65 years of age and older

8

Estrogens should not be used in women with any of the Estrogens increase the risk of gallbladder disease. following conditions: Discontinue estrogen if severe hypercalcemia, loss of vision, severe • Undiagnosed abnormal genital bleeding. hypertriglyceridemia or cholestatic jaundice occurs. • Known, suspected, or history of breast cancer. Monitor thyroid function in women on thyroid replacement therapy. • Known or suspected estrogen-dependent neoplasia. In a placebo-controlled trial that included a total of 484 postmenopausal • Active DVT, PE, or history of these conditions. women, the most common adverse reactions (≥ 5 percent) are breast tenderness, metorrhagia, nasopharyngitis, and upper respiratory tract • Active arterial thromboembolic disease (for example, stroke and MI) infections. or a history of these conditions. Inducers and/or inhibitors of CYP3A4 may affect estrogen drug • Known anaphylactic reaction or angioedema to estrogens. metabolism. • Known liver impairment or disease. Before prescribing any estrogen therapy product listed in this • Known protein C, protein S, or antithrombin deficiency, or other catalog, please read the Full Prescribing Information, including known thrombophilic disorders. Boxed WARNING(s), by clicking on the Mylan product name. • Known or suspected pregnancy. INDICATIONS • The Women's Health Initiative (WHI) estrogen-alone substudy Estrogens are used for the treatment of moderate to severe vasomotor reported increased risks of stroke and deep vein thrombosis (DVT) symptoms due to menopause. • The WHI Memory Study (WHIMS) estrogen-alone ancillary study of WHI reported an increased risk of probable dementia in Estradiol Vaginal Cream, USP, 0.01% is indicated in the treatment postmenopausal women 65 years of age and older of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause. Estrogen Plus Progestin Therapy IMPORTANT SAFETY INFORMATION • Estrogen plus progestin therapy should not be used for the prevention of cardiovascular disease or dementia WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR • The WHI estrogen plus progestin substudy reported increased risk DISORDERS, BREAST CANCER AND PROBABLE DEMENTIA of stroke, DVT, pulmonary embolism (PE), and myocardial Estrogen-Alone Therapy infarction (MI) • There is an increased risk of endometrial cancer in a woman with • The WHI estrogen plus progestin study reported increased risks a uterus who uses unopposed estrogens of invasive breast cancer • Estrogen-alone therapy should not be used for the prevention of • The WHIMS estrogen plus progestin ancillary study of WHI cardiovascular disease or dementia reported an increased risk of probable dementia in postmenopausal women 65 years of age and older

A comprehensive line of Menopausal

Not actual patient Hormone Therapy available from Mylan

Important Safety Information (Cont’d) Estrogens should not be used in women with any of the Estrogens increase the risk of gallbladder disease. following conditions: Discontinue estrogen if severe hypercalcemia, loss of vision, severe • Undiagnosed abnormal genital bleeding. hypertriglyceridemia or cholestatic jaundice occurs. • Known, suspected, or history of breast cancer. Monitor thyroid function in women on thyroid replacement therapy. • Known or suspected estrogen-dependent neoplasia. In a placebo-controlled trial that included a total of 484 postmenopausal • Active DVT, PE, or history of these conditions. women, the most common adverse reactions (≥ 5 percent) are breast tenderness, metorrhagia, nasopharyngitis, and upper respiratory tract • Active arterial thromboembolic disease (for example, stroke and MI) infections. or a history of these conditions. Inducers and/or inhibitors of CYP3A4 may affect estrogen drug • Known anaphylactic reaction or angioedema to estrogens. metabolism. • Known liver impairment or disease. Before prescribing any estrogen therapy product listed in this • Known protein C, protein S, or antithrombin deficiency, or other catalog, please read the Full Prescribing Information, including known thrombophilic disorders. Boxed WARNING(s), by clicking on the Mylan product name. • Known or suspected pregnancy.

Not actual patients

We, at Mylan, are committed to innovation and access, so that every patient can find options for their health concerns. Moreover, we understand that a woman’s health often changes at various stages of her life and she needs care that is specially designed for her. That's why Mylan has created a broad portfolio of prescription branded and generic pharmaceuticals, as well as OTC consumer healthcare medicines. These are offered through a wide range of dosage forms and therapies, including contraceptives and treatments for menopause.

With its current spectrum of products and many offerings that are being developed to address women's unique health concerns, Mylan is focused on becoming an important contributor to women's healthcare through all the stages of her life.

9 Visit Mylan.com to learn more about our extensive portfolio of products.

MYLAN and the Mylan logos are registered trademarks of Mylan Inc. Xulane is a registered trademark of Mylan Pharmaceuticals Inc. Elestrin is a registered trademark of Meda Pharma S.A.R.L. LLC a Mylan company. The non-Mylan brand names listed are the trademarks of their respective owners, some of which may no longer be marketed. ©2019 Mylan Pharmaceuticals Inc. All rights reserved. MUL-2019-0082