Get your patient on Altavera - Levonorgestrel And Ethinyl Estradiol (Levonorgestrel And Ethinyl Estradiol)

Altavera is indicated for use by females of reproductive potential to prevent pregnancy.

Altavera (levonorgestrel and ethinyl estradiol tablets) is a combination oral contraceptive (COC) consisting of 21 peach active tablets, each containing 0.15 mg of levonorgestrel, a synthetic progestin and 30 mcg of ethinyl estradiol, an estrogen, and 7 white inert tablets (without hormones).

The structural formulas for the active components are:

Levonorgestrel C ₂₁ H ₂₈ O ₂ MW: 312.4

Ethinyl Estradiol C ₂₀ H ₂₄ O ₂ MW: 296.4

Ethinyl Estradiol is 19-nor-17α-pregna-1,3,5(10)-trien-20-yne-3, 17-diol.

Each peach active tablet contains the following inactive ingredients: lactose anhydrous, iron oxide black, iron oxide red, iron oxide yellow, magnesium stearate, polyethylene glycol, polyvinyl alcohol-part hydrolyzed, povidone, talc, titanium dioxide.

Each white inert tablet contains the following inactive ingredients: lactose anhydrous, magnesium stearate, polyethylene glycol, polyvinyl alcohol-part hydrolyzed, povidone, talc, titanium dioxide.

Combination oral contraceptives prevent pregnancy primarily by suppressing ovulation.

Altavera tablets (levonorgestrel and ethinyl estradiol, 0.15 mg/30 mcg) are available in a carton containing three blister cards, each containing 28 tablets:

Store at 20º to 25°C (68° to 77º F) [See USP Controlled Room Temperature].

ALTAVERA is a registered trademark of Xiromed Pharma España, S.L.

Manufactured by Laboratorios Leon Farma S.A., Spain

for Xiromed, LLC., Florham Park, NJ 07932

Product of Spain

PI-116-06
Rev. 02/2023

ALTAVERA [all-tuh-VAIR-uh]
(levonorgestrel 0.15 mg and ethinyl estradiol tablets 30 mcg)

Important Information about taking Altavera
• Take 1 pill every day at the same time. Take the pills in the order directed on your pill pack.
• Do not skip your pills, even if you do not have sex often. 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.
• If you have trouble remembering to take Altavera, talk to your healthcare provider.
• When you first start taking Altavera, spotting or light bleeding in between your periods may occur. Contact your healthcare provider if this does not go away after a few months.
• You may feel sick to your stomach (nauseous), especially during the first few months of taking Altavera. If you feel sick to your stomach, do not stop taking the pill. The problem will usually go away. If your nausea does not go away, call your healthcare provider.
• 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 (see What should I do if I miss any Altavera pills? below), you could also feel a little sick to your stomach.
• It is not uncommon to miss a period. However, if you miss a period and have not taken Altavera according to directions, or feel like you may be pregnant, call your healthcare provider. If you have a positive pregnancy test, you should stop taking Altavera.
• If you have vomiting or diarrhea within 3-4 hours of taking a light-orange pill, take another light-orange pill as soon as possible. Continue taking all your remaining pills in order. Start the first pill of your next pill pack the day after finishing your current pill pack. This will be 1 day earlier than originally scheduled. Continue on your new schedule.
• If you have vomiting or diarrhea for more than 1 day, your birth control pills may not work as well. Use an additional birth control method, like condoms or spermicide, until you check with your healthcare provider.
• Stop taking Altavera at least 4 weeks before you have major surgery and do not restart after the surgery without asking your healthcare provider. Be sure to use other forms of contraception (like condoms or spermicide) during this time period.

Before you start taking Altavera:
• Decide what time of day you want to take your pill. It is important to take it at the same time every day and in the order as directed on your pill pack.
• Look at your pill pack. Your pill pack consists of 1 card that holds 28 individually sealed pills. The 28 pills consist of 21 light-orange pills (3 rows of 7 pills) and 7 pink pills (1 row of 7 pills). See Figure A .

Figure A

• Also find:
o Where on the card to start taking pills (upper left corner) and
o In what order to take the pills (follow the weeks)
• Be sure you have ready at all times another kind of birth control (such as condoms or spermicide), to use as a back-up in case you miss pills.

When should I start taking Altavera?

If you start taking Altavera and you have not used a hormonal birth control method before:
• There are 2 ways to start taking your birth control pills. You can either start on a Sunday (Sunday Start) or on the first day (Day 1) of your natural menstrual period (Day 1 Start). Your healthcare provider should tell you when to start taking your birth control pill.
• If you use the Sunday Start, use non-hormonal back-up contraception such as condoms or spermicide for the first 7 days that you take Altavera. You do not need back-up contraception if you use the Day 1 Start.

If you start taking Altavera and you are switching from another birth control pill:
• Start your new Altavera pack on the same day that you would start the next pack of your previous birth control method.
• Do not continue taking the pills from your previous birth control pill pack.

If you start taking Altavera and previously used a vaginal ring:
• Start using Altavera on the day you would have started the next ring.

If you start taking Altavera and previously used a transdermal patch:
• Start using Altavera on the day you would have started a new cycle (first patch application).

If you start taking Altavera and you are switching from a progestin-only method such as an implant or injection:
• Start taking Altavera on the day of removal of your implant, or on the day when you would have had your next injection.

If you start taking Altavera and you are switching from an intrauterine device or system (IUD or IUS):
• Start taking Altavera on the day of removal of your IUD or IUS.
• You do not need back-up contraception if your IUD or IUS is removed on the first day (Day 1) of your period. If your IUD or IUS is removed on any other day, use non-hormonal back-up contraception such as condoms or spermicide for the first 7 days that you take Altavera.

Keep a calendar to track your period: If this is the first time you are taking birth control pills, read, “ When should I start taking Altavera? ” above. Follow these instructions for either a Sunday Start or a Day 1 Start .

Instructions for using your Altavera Pill Dispenser:

Sunday Start:
You will use a Sunday Start if your healthcare provider told you to take your first pill on a Sunday.
• Take pill 1 on the Sunday after your period starts . To remove your pill from the dispenser, press the pill through the hole in the bottom of the dispenser.
• If your period starts on a Sunday, take pill " 1 " that day and refer to Day 1 Start instructions below.
• Take 1 pill every day in the order on the pill dispenser at the same time each day for 28 days.
• After taking the last pill on Day 28 from the pill dispenser, start taking the first pill from a new pack, on the same day of the week as the first pack (Sunday). Take the first pill in the new pack whether or not you are having your period.
• Use non-hormonal back-up contraception such as condoms or spermicide for the first 7 days of the first cycle that you take Altavera.

Day 1 Start:
You will use a Day 1 Start if your doctor told you to take your first pill (Day 1) on the first day of your period.
• Take 1 pill every day in the order of the pill dispenser, at the same time each day, for 28 days. To remove your pill from the dispenser, press the pill through the hole in the bottom of the dispenser.
• After taking the last pill on Day 28 from the pill dispenser, start taking the first pill from a new pack, on the same day of the week as the first pack. Take the first pill in the new pack whether or not you are having your period.

What should I do if I miss any Altavera pills?

If you miss 1 pill in Weeks 1, 2, or 3, follow these steps:
• Take it as soon as you remember. Take the next pill at your regular time. This means you may take 2 pills in 1 day.
• Then continue taking 1 pill every day until you finish the pack.
• You do not need to use a back-up birth control method if you have sex.

If you miss 2 pills in Week 1 or Week 2 of your pack, follow these steps:
• Take the 2 missed pills as soon as possible and the next 2 pills the next day.
• Then continue to take 1 pill every day until you finish the pack.
• Use a non-hormonal birth control method (such as a condom or spermicide) as a back-up if you have sex during the first 7 days after missing your pills.

If you miss 2 pills in a row in Week 3, or you miss 3 or more pills in a row during Weeks 1, 2, or 3 of the pack, follow these steps: If you are a Day 1 Starter:
o Throw out the rest of the pill pack and start a new pack that same day.
o You may not have your period this month, but this is expected. However, if you miss your period 2 months in a row, call your healthcare provider because you might be pregnant.
o You could become pregnant if you have sex during the first 7 days after you restart your pills. You MUST use a non-hormonal birth control method (such as a condom or spermicide) as a back-up if you have sex during the first 7 days after you restart your pills.

If you are a Sunday Starter :
o Keep taking 1 pill every day until Sunday. On Sunday, throw out the rest of the pack and start a new pack of pills that same day.
o Use a non-hormonal birth control method (such as a condom or spermicide) as a back-up if you have sex during the first 7 days after you restart your pills.

If you have any questions or are unsure about the information in this leaflet, call your healthcare provider.

This Patient Information and Instructions for Use have been approved by the U.S. Food and Drug Administration.

ALTAVERA is a registered trademark of Xiromed Pharma España, S.L.

Manufactured by Laboratorios Leon Farma S.A., Spain

for Xiromed, LLC., Florham Park, NJ 07932

Product of Spain

PIL-116-05

Rev. 02/2023