TYBLUME- levonorgestrel and ethinyl estradiol
Exeltis USA, Inc.
Cigarette smoking increases the risk of serious cardiovascular events from combined hormonal contraceptive (CHC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, CHCs, including TYBLUME (levonorgestrel and ethinyl estradiol) tablets, are contraindicated in women who are over 35 years of age and smoke [ see Contraindications (4) and Warnings and Precautions (5.1)].
TYBLUME is indicated for use by females of reproductive potential to prevent pregnancy.
Take TYBLUME in one of two ways: (1) swallow whole on an empty stomach or (2) chew and then immediately swallow with a full glass of 240 mL of water on an empty stomach [see Dosage and Administration (2.2)].
To achieve maximum contraceptive effectiveness, take TYBLUME exactly as directed (one tablet orally at the same time every day) and at intervals not exceeding 24 hours. The failure rate may increase when tablets are missed or taken incorrectly. The recommended dosage of TYBLUME is one tablet daily for 28 consecutive days: one white active tablet daily during the first 21 consecutive days, followed by one peach inactive tablet daily during the 7 following days (see Table 1).
|Starting TYBLUME in females with no current use of hormonal contraception (start on Day 1 or Sunday)|
| Day 1 start |
| Sunday start |
|Switching to TYBLUME from another contraceptive method|
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|Complete instructions to facilitate patient counseling on proper tablet usage are located in the FDA-Approved Patient Labeling (Instructions for Use).|
Instruct patients about the handling of missed doses (e.g., to take a missed tablet as soon as possible) and to follow the dosing instructions provided in the FDA-approved patient labeling (Instructions for Use).
| ||Take the missed active tablet as soon as possible, even if two active tablets are taken in one day. Continue taking one tablet a day until the pack is finished.|
| ||Take two active tablets as soon as possible. Then, take two active tablets the next day. This means taking 4 tablets in 2 days. Continue taking one tablet a day until the pack is finished. Additional nonhormonal contraception (such as condoms and spermicide) should be used as back-up if the patient has sex within 7 days after missing tablets.|
| ||Day 1 start: Throw out the rest of the 28-day pack and start a new pack that same day. Sunday start: Continue taking one tablet a day until Sunday, then throw out the rest of the pack and start a new pack that same day. Additional nonhormonal contraception (such as condoms and spermicide) should be used as back-up if the patient has sex within 7 days after missing tablets.|
| ||Throw away the missed inactive tablets. Keep taking one tablet each day until the pack is empty. Back-up nonhormonal birth-control method is not needed but take the next pack on time.|
If vomiting or acute diarrhea occurs within 3 to 4 hours after taking an active tablet, take the new active tablet (scheduled for the next day) as soon as possible. If more than two active tablets are missed, see the recommendations in Table 2 [see Dosage and Administration (2.3)].
One pack of TYBLUME consists of 28 tablets:
- 21 active tablets are white, round, and debossed with 30 on one side and L2 on the other side. Each active tablet contains levonorgestrel 0.1 mg and ethinyl estradiol 0.02 mg.
- 7 inactive tablets (placebo) are peach-colored, round, and debossed with 1 on one side and L2 on the other side.
TYBLUME is contraindicated in females who are known to have the following conditions:
- A high risk of arterial or venous thrombotic diseases. Examples include females who are known to:
- Smoke, if over age 35 [see Boxed Warning and Warnings and Precautions (5.1)]
- Have current or history of deep vein thrombosis or pulmonary embolism [see Warnings and Precautions (5.1)]
- Have cerebrovascular disease [see Warnings and Precautions (5.1)]
- Have coronary artery disease [see Warnings and Precautions (5.1)]
- Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) [see Warnings and Precautions (5.1)]
- Have inherited or acquired hypercoagulopathies [see Warnings and Precautions (5.1)]
- Have uncontrolled hypertension or hypertension with vascular disease [see Warnings and Precautions (5.3)]
- Have diabetes mellitus and are over age 35, diabetes mellitus with hypertension or vascular disease or other end-organ damage, or diabetes mellitus of > 20 years duration [see Warnings and Precautions (5.6)]
- Have headaches with focal neurological symptoms, migraine headaches with aura, or over age 35 with any migraine headaches [see Warnings and Precautions (5.7)]
- Current or history of breast cancer or other estrogen- or progestin-sensitive cancer
- Liver tumors, acute viral hepatitis, or severe (decompensated) cirrhosis [see Warnings and Precautions (5.2)]
- Undiagnosed abnormal uterine bleeding [see Warnings and Precautions (5.8)]
- 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 (5.14)]
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