Levonorgestrel/ethinyl Estradiol And Ethinyl Estradiol (Rivelsa)

Trade Name : Rivelsa

Teva Pharmaceuticals USA, Inc.

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Levonorgestrel/ethinyl Estradiol And Ethinyl Estradiol (Rivelsa) which is also known as Rivelsa and Manufactured by Teva Pharmaceuticals USA, Inc.. It is available in strength of per ml. Read more

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Contraindications ()t 9/2017
Warnings and Precautions ()t 9/2017

Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptives (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs should not be used by women who are over 35 years of age and smoke. n
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 RIVELSA. ()
Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. ()

RIVELSA is indicated for use by females of reproductive age to prevent pregnancy.
RIVELSA is an estrogen/progestin COC indicated for use by women to prevent pregnancy. ()

No data

Take one tablet daily by mouth at the same time every day for 91 days ()
Take tablets in the order directed on the Extended-Cycle Tablet Dispenser ()

RIVELSA (levonorgestrel/ethinyl estradiol and ethinyl estradiol) tablets are available as round, film-coated, biconvex tablets debossed with TV on one side, packaged in Extended-Cycle Tablet Dispensers, each containing a 13-week supply of tablets in the following order:
RIVELSA consists of 91 tablets in the following order ():

42 light pink tablets containing 0.15 mg levonorgestrel and 0.02 mg ethinyl estradiol,
21 pink tablets containing 0.15 mg of levonorgestrel and 0.025 mg ethinyl estradiol, and
21 purple tablets containing 0.15 mg of levonorgestrel and 0.03 mg ethinyl estradiol, and
7 yellow tablets containing 0.01 mg of ethinyl estradiol. ()

Do not prescribe RIVELSA to women who are known to have the following conditions:

A high risk of arterial or venous thrombotic diseases ()
Undiagnosed abnormal uterine bleeding ()
Breast cancer or other estrogen- or progestin-sensitive cancer ()
Liver tumors or liver disease ()
Pregnancy ()
Co-administration with Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir ()

No data

Vascular risks: Stop RIVELSA if a thrombotic event occurs. Stop RIVELSA at least 4 weeks before and through 2 weeks after major surgery. Start RIVELSA no earlier than 4 weeks after delivery, in women who are not breastfeeding. ()
Liver disease: Discontinue RIVELSA if jaundice occurs. ()
High blood pressure: Do not prescribe RIVELSA for women with uncontrolled hypertension or hypertension with vascular disease. ()
Carbohydrate and lipid metabolic effects: Monitor prediabetic and diabetic women taking RIVELSA. Consider an alternate contraceptive method for women with uncontrolled dyslipidemias. ()
Headache: Evaluate significant change in headaches and discontinue RIVELSA if indicated. (n
Uterine bleeding: Evaluate irregular bleeding or amenorrhea. ()

The following serious adverse reactions with the use of COCs are discussed elsewhere in the labeling:
Adverse reactions commonly reported by COC users are:
The most common adverse reactions (u22652%) in clinical trials for RIVELSA were headaches, heavy/irregular vaginal bleeding, nausea/vomiting, acne, dysmenorrhea, weight increased, mood changes, anxiety/panic attack, breast pain and migraines. ()
To report SUSPECTED ADVERSE REACTIONS, contact Teva Pharmaceuticals at 1-888-483-8279 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Consult the labeling of concurrently-used drugs to obtain further information about interactions with hormonal contraceptives or the potential for enzyme alterations.
No drug-drug interaction studies were conducted with RIVELSA.
Drugs or herbal products that induce certain enzymes, including CYP3A4, may decrease the effectiveness of COCs or increase breakthrough bleeding. Counsel patients to use a back-up or alternative method of contraception when enzyme inducers are used with COCs. ()

Nursing Mothers: Not recommended for nursing mothers; can decrease milk production. ()

There have been no reports of serious ill effects from overdose of oral contraceptives, including ingestion by children. Overdosage may cause withdrawal bleeding in females and nausea.

RIVELSA (levonorgestrel/ethinyl estradiol and ethinyl estradiol) tablets is an extended-cycle oral contraceptive. RIVELSA consists of 42 light pink tablets containing 0.15 mg levonorgestrel and 0.02 mg ethinyl estradiol, 21 pink tablets containing 0.15 mg levonorgestrel and 0.025 mg ethinyl estradiol, and 21 purple tablets containing 0.15 mg levonorgestrel and 0.03 mg ethinyl estradiol, and 7 yellow tablets containing 0.01 mg ethinyl estradiol. Levonorgestrel is a progestin and ethinyl estradiol is an estrogen.
The structural formulas, molecular formulas, molecular weights, and chemical names for the active components are shown below:
Levonorgestrel
CHO MW: 312.4
Levonorgestrel is chemically 18,19-Dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-(17u03b1)-(-)-.
Ethinyl Estradiol
CHO MW: 296.4
Ethinyl Estradiol is 19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17u03b1)-.
Each light pink tablet contains the following inactive ingredients:
anhydrous lactose, D&C Red no. 27/phloxine aluminum lake, FD&C Blue no. 2/Indigo Carmine aluminum lake, FD&C Yellow no. 6/Sunset Yellow FCF aluminum lake, hypromellose, lactose monohydrate, microcrystalline cellulose, magnesium stearate, polyethylene glycol/macrogol, titanium dioxide, and triacetin.
Each pink tablet contains the following inactive ingredients:
anhydrous lactose, D&C Red no. 27/phloxine aluminum lake, FD&C Blue no. 2/Indigo Carmine aluminum lake, hypromellose, lactose monohydrate, microcrystalline cellulose, magnesium stearate, polyethylene glycol/macrogol, titanium dioxide and triacetin.
Each purple tablet contains the following inactive ingredients:
anhydrous lactose, D&C Red no. 27/phloxine aluminum lake, FD&C Blue no. 1/Brilliant blue FCF aluminum lake, hypromellose, lactose monohydrate, microcrystalline cellulose, magnesium stearate, polyethylene glycol/macrogol, titanium dioxide and triacetin.
Each yellow tablet contains the following inactive ingredients:
anhydrous lactose, D&C yellow no. 10 aluminum lake, FD&C Yellow no. 6/Sunset Yellow FCF aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polacrilin potassium, polyethylene glycol/macrogol, polysorbate 80 and titanium dioxide.

No data

[See Warnings and Precautions (, ) and Use in Specific Populations ()].

In a 12-month, multicenter, open-label, single-arm clinical trial conducted in the US, 3,667 women, 18-40 years old, were enrolled and 3,565 were treated for up to four 91-day cycles, which equates to thirteen 28-day cycles, to assess the safety and efficacy of RIVELSA, completing the equivalent of 33,895 28-day cycles of exposure. The racial demographic of those treated was: Caucasian (64%), African-American (19%), Hispanic (11%), Asian (2%), and Other (3%). There were no exclusions for body mass index (BMI) or weight. The weight range of those women treated was 83 to 402 lbs., with a mean weight of 162.5 lbs. Among the women in the trial, 44% were current hormonal contraceptive users, 39% were prior users (who had used hormonal contraceptives in the past), and 17% were new starters. Of treated women, 13.2% were lost to follow-up, 12.8% discontinued due to an adverse event, and 6.1% discontinued by withdrawing their consent.
The pregnancy rate (Pearl Index [PI]) in women aged 18-35 years was 3.19 pregnancies per 100 woman-years of use (95% confidence interval 2.49, 4.03), based on 70 pregnancies that occurred after the onset of treatment and up to and including 7 days after the last pill. Cycles in which conception did not occur, but which included the use of backup contraception, were not included in the calculation of the PI. The PI includes patients who did not take the drug correctly.

No data

Counsel patients on the following information:
Manufactured by:
Teva Women's Health, Inc.
Subsidiary of Teva Pharmaceuticals USA, Inc.
North Wales, PA 19454
RIV-002
Rev. 9/2017

Guide for Using RIVELSA (levonorgestrel/ethinyl estradiol and ethinyl estradiol)
Birth control pills help to lower the chances of becoming pregnant. They do not protect against HIV infection (AIDS) and other sexually transmitted infections.
What Is RIVELSA?
RIVELSA is a birth control pill. It contains two female hormones, an estrogen called ethinyl estradiol, and a progestin called levonorgestrel.
How Well Does RIVELSA Work?
Your chance of getting pregnant depends on how well you follow the directions for taking your birth control pills. The more carefully you follow the directions, the less chance you have of getting pregnant.
Based on the results of a single clinical study lasting 12u00a0months, 2 to 4 women out of 100 women may get pregnant during the first year they use RIVELSA.
The following chart shows the chance of getting pregnant for women who use different methods of birth control. Each box on the chart contains a list of birth control methods that are similar in effectiveness. The most effective methods are at the top of the chart. The box on the bottom of the chart shows the chance of getting pregnant for women who do not use birth control and are trying to get pregnant.
How Do I Take RIVELSA?
1.u00a0 Take one pill every day at the same time. Take pills in the order directed on the Extended-Cycle Tablet Dispenser.u00a0n
Do not skip pills or delay taking your pills. If you miss pills (including starting the pack late), you could get pregnant. The more pills you miss, the more likely you are to get pregnant.
2. You may have spotting or light bleeding, or feel sick to your stomach during the first few months of taking RIVELSA. If you feel sick to your stomach, dou00a0 u00a0 u00a0not stop taking the pill. The problem will usually go away. If it doesn't go away, check with your healthcare provider.
If you vomit or have diarrhea within 4 hours after taking your pill, follow the instructions in u201cn
3.u00a0 Missing pills can also cause spotting or light bleeding, even when you take the missed pills later. On the days you take 2 pills to make up for missed pills,u00a0 u00a0 u00a0you could also feel a little sick to your stomach.
If you have trouble remembering to take RIVELSA, talk to your healthcare provider about how to make pill-taking easier or about using another method of birth control.
Arrayn- Before
Tray 1 contains 4 rows of 7 light pink pills.
Tray 2 contains 2 rows of 7 light pink pills (a total of 14 light pink pills) followed by 2 rows of 7 pink pills (a total of 14 pink pills).
Tray 3 contains 1 row of 7 pink pills, followed by three rows of 7 purple pills (a total of 21 purple pills), followed by the last row, which contains 7 yellow pills.
3. Also find:
4. Be sure you have another kind of birth control (such as condoms and spermicides) ready at all times, to use as a back-up in case you miss pills.
When to Start RIVELSA
How to Take RIVELSA
What To Do If You Miss Pills
If you light pink, pink or purple pill:
If you light pink, pink or purple pills in a row:
If you light pink, pink or purple pills in a row:
If you of the 7 yellow pills:
Finally, if you are still not sure what to do about the pills you have missed
Who Should Not Take RIVELSA?
Your healthcare provider will not give you RIVELSA if you have:
Also, do not take birth control pills if you:
Birth control pills may not be a good choice for you if you have ever had jaundice (yellowing of the skin or eyes) caused by pregnancy.
Tell your healthcare provider if you have ever had any of the above conditions (your healthcare provider may recommend another method of birth control).
What Else Should I Know About Taking RIVELSA?
Birth control pills do protect you against any sexually transmitted infection, including HIV, the virus that causes AIDS.
Do not skip any pills, even if you do not have sex often.
Birth control pills should not be taken during pregnancy. However, birth control pills taken by accident during pregnancy are not known to cause birth defects.
You should stop RIVELSA at least four weeks before you have major surgery and not restart it for at least two weeks after the surgery, due to an increased risk of blood clots.
If you are breastfeeding, consider another birth control method until you are ready to stop breastfeeding. Birth control pills that contain estrogen, like RIVELSA, may decrease the amount of milk you make. A small amount of the pill's hormones pass into breast milk.
Tell your healthcare provider about all medicines and herbal products that you take. Some medicines and herbal products may make birth control pills less effective, including:
Use a back-up or alternative birth control method when you take medicines that may make birth control pills less effective.
If you have vomiting or diarrhea, your birth control pills may not work as well. Use another birth control method, like condoms and spermicide, until you check with your healthcare provider.
Birth control pills may interact with lamotrigine, an anticonvulsant used for epilepsy. This may increase the risk of seizures, so your healthcare provider may need to adjust the dose of lamotrigine.
Women on thyroid hormone replacement therapy may need increased doses of thyroid hormone.
What Are The Most Serious Risks Of Taking Birth Control Pills?
Like pregnancy, birth control pills increase the risk of serious blood clots, especially in women who have other risk factors, such as smoking, obesity, or age greater than 35. This increased risk is highest when you first start taking birth control pills and when you restart the same or different birth control pills after not using them for a month or more.
It is possible to die from a problem caused by a blood clot, such as a heart attack or a stroke. Some examples of serious blood clots are blood clots in the:
Women who take birth control pills may get:
All of these events are uncommon in healthy women.
Call your healthcare provider right away if you have:
What Are Common Side Effects Of Birth Control Pills?
The most common side effects of birth control pills are:
These side effects are usually mild and usually disappear with time.
Less common side effects are:
This is not a complete list of possible side effects. Talk to your healthcare provider if you develop any side effects that concern you. You may report side effects to the FDA at 1-800-FDA-1088.
No serious problems have been reported from a birth control pill overdose, even when accidentally taken by children.
Do Birth Control Pills Cause Cancer?
Birth control pills do not appear to cause breast cancer. However, if you have breast cancer now, or have had it in the past, do not use birth control pills because some breast cancers are sensitive to hormones.
Women who use birth control pills may have a slightly higher chance of getting cervical cancer. However, this may be due to other reasons such as having more sexual partners.
What Should I Know About My Period When Taking RIVELSA?
When you take RIVELSA, which has a 91-day extended dosing cycle, you should expect to have 4 scheduled periods per year (bleeding when you are taking the 7 yellow pills). Each period is likely to last about 3-4 days. However, you will probably have more bleeding or spotting between your scheduled periods than if you were using a birth control pill with a 28-day dosing cycle. This bleeding or spotting tends to decrease with each additional cycle. Do not stop taking RIVELSA because of this bleeding or spotting. If the spotting continues for more than 7 consecutive days or if the bleeding is heavy, call your healthcare provider.
What If I Miss My Scheduled Period When Taking RIVELSA?
You should consider the possibility that you are pregnant if you miss your scheduled period (no bleeding on the days that you are taking yellow pills). Because scheduled periods are less frequent when you are taking RIVELSA, notify your healthcare provider that you have missed your period and that you are taking RIVELSA. Also notify your healthcare provider if you have symptoms of pregnancy such as morning sickness or unusual breast tenderness. It is important that your healthcare provider evaluates you to determine if you are pregnant. Stop taking RIVELSA if it is determined that you are pregnant.
What If I Want To Become Pregnant?
You may stop taking the pill whenever you wish. Consider a visit with your healthcare provider for a pre-pregnancy checkup before you stop taking the pill.
General Advice About RIVELSA
Your healthcare provider prescribed RIVELSA for you. Do not share RIVELSA with anyone else. Keep RIVELSA out of the reach of children.
If you have concerns or questions, ask your healthcare provider. You may also ask your healthcare provider for a more detailed label written for medical professionals.
Manufactured by:
Teva Women's Health, Inc.
Subsidiary of Teva Pharmaceuticals USA, Inc.
North Wales, PA 19454
RIVPL-002
Revised: September 2017

NDCn- 6031
2 Extended-Cycle Tablet Dispensers,
91 Tablets Each
RIVELSAu2122
(levonorgestrel/ethinyl estradiol) tablets
0.15 mg/0.02 mg, 0.15 mg/0.025 mg,
0.15 mg/0.03 mg
(ethinyl estradiol) tablets
0.01 mg
Usual Dosage:
One tablet daily for 91 consecutive days in the following order: 42 light pink tablets each
containing 0.15 mg levonorgestrel and 0.02 mg ethinyl estradiol, 21 pink tablets each
containing 0.15 mg of levonorgestrel and 0.025 mg ethinyl estradiol, and 21 purple
tablets each containing 0.15 mg of levonorgestrel and 0.03 mg ethinyl estradiol, and
7 yellow tablets each containing 0.01 mg of ethinyl estradiol.
Pharmacist:
Rx only
SHAPING
WOMENu2019S Healthu00ae
TEVA

NDCn- 6031
2 Extended-Cycle Tablet Dispensers,
91 Tablets Each
RIVELSAu2122
(levonorgestrel/ethinyl estradiol) tablets
0.15 mg/0.02 mg, 0.15 mg/0.025 mg,
0.15 mg/0.03 mg
(ethinyl estradiol) tablets
0.01 mg
Usual Dosage:
One tablet daily for 91 consecutive days in the following order: 42 light pink tablets each
containing 0.15 mg levonorgestrel and 0.02 mg ethinyl estradiol, 21 pink tablets each
containing 0.15 mg of levonorgestrel and 0.025 mg ethinyl estradiol, and 21 purple
tablets each containing 0.15 mg of levonorgestrel and 0.03 mg ethinyl estradiol, and
7 yellow tablets each containing 0.01 mg of ethinyl estradiol.
Pharmacist:
Rx only
SHAPINGu00a0n- WOMENu2019S Healthu00ae
TEVA

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Levonorgestrel/ethinyl Estradiol And Ethinyl Estradiol (Rivelsa)

Trade Name : Rivelsa

KIT

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

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Levonorgestrel/ethinyl Estradiol And Ethinyl Estradiol (Rivelsa)

Trade Name : Rivelsa

KIT

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

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