Tyblume

Tyblume is an FDA-registered drug product whose active ingredient is LEVONORGESTREL AND ETHINYL ESTRADIOL. It is labelled by Exeltis USA, Inc. and marketed as a human prescription drug product. Identifiers on file: NDC 0642-7471, application NDA209405, label effective 20260827. It is one of 10 FDA drug label records sharing the active ingredient LEVONORGESTREL AND ETHINYL ESTRADIOL. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing LEVONORGESTREL AND ETHINYL ESTRADIOL are most often described in connection with: females reproductive, potential prevent, ethinyl estradiol, usage tyblume, tablets combination, levonorgestrel progestin, estrogen indicated. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

1 INDICATIONS AND USAGE TYBLUME is indicated for use by females of reproductive potential to prevent pregnancy. TYBLUME (levonorgestrel and ethinyl estradiol tablets) is a combination of levonorgestrel, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy. ( 1 )

2 DOSAGE AND ADMINISTRATION 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 water on an empty stomach. ( 2.1 ) Start on Day 1 and take each tablet at the same time every day in the order directed on the blister pack, or ( 2 ) Start on a Sunday and take each tablet at the same time every day in the order directed on the blister pack. ( 2 ) Take 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. ( 2 ) 2.1 Important Administration Instructions 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) ]. 2.2 Additional Administration Information 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 ). Table 1 Instructions for Administration of TYBLUME Starting TYBLUME in females with no current use of hormonal contraception (start on Day 1 or Sunday) Day 1 start Take first tablet without food (i.e. empty stomach) on the first day of menses Take subsequent tablets once daily at the same time each day Begin each subsequent 28-day pack on the same day of the week as the first cycle pack (i.e., on the day after taking the last tablet) Sunday start Take first tablet without food (i.e. empty stomach) on the first Sunday after the onset of menstrual period Take subsequent tablets once daily at the same time each day Use additional nonhormonal contraception for the first seven days of TYBLUME use Begin each subsequent 28-day pack on the same day of the week as the first cycle pack (i.e., on the day after taking the last tablet) Switching to TYBLUME from another contraceptive method Start TYBLUME: A combined oral contraceptive (COC) On the day when the new pack of the previous COC would have been started Transdermal system On the day when next application would have been scheduled Vaginal ring On the day when next insertion would have been scheduled Injection On the day when next injection would have been scheduled Intrauterine system On the day of removal Implant On the day of removal Complete instructions to facilitate patient counseling on proper tablet usage are located in the FDA-Approved Patient Labeling (Instructions for Use). 2.3 Missed Doses 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). Table 2 Instructions for Missed TYBLUME If one white active tablet is missed in Weeks 1, 2, or 3 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. If two white active tablets are missed in Week 1 or Week 2 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. If two white active tablets are missed in the third week or three or more active tablets are missed in a row in Weeks 1, 2, or 3 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. If one or more peach (inactive) tablets are missed in the fourth week 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. 2.4 Administration Recommendations after Vomiting or Acute Diarrhea 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) ].

4 CONTRAINDICATIONS 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) ] High risk of arterial or venous thrombotic diseases. ( 4 ) Breast cancer or other estrogen- or progestin-sensitive cancer. ( 4 ) Liver tumors, acute viral hepatitis or decompensated cirrhosis. ( 4 ) Undiagnosed abnormal uterine bleeding. ( 4 ) Use of Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir. ( 4 )

6 ADVERSE REACTIONS The following serious adverse reactions with the use of CHCs are discussed elsewhere in labeling: Serious cardiovascular events [see Boxed Warning and Warnings and Precautions (5.1 and 5.4) ] Vascular events [see Warnings and Precautions (5.1) ] Liver disease [see Warnings and Precautions (5.2) ] Hypertension [see Warnings and Precautions (5.3) ] Gallbladder disease [see Warnings and Precautions (5.5) ] Adverse carbohydrate and lipid metabolic effects [see Warnings and Precautions (5.6) ] Headache [see Warnings and Precautions (5.7) ] Bleeding irregularities and amenorrhea [see Warnings and Precautions (5.8) ] Depression [see Warnings and Precautions (5.9) ] Cervical cancer [see Warnings and Precautions (5.10) ] Effect on binding globulins [see Warnings and Precautions (5.11) ] Hereditary angioedema [see Warnings and Precautions (5.12) ] Chloasma [see Warnings and Precautions (5.13) ] Risk of liver enzyme elevations with concomitant hepatitis C treatment [see Warnings and Precautions (5.14) ] The following adverse reactions associated with the use of oral CHCs were identified in clinical studies or postmarketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Common adverse reactions associated with oral CHCs are headache, abdominal pain, nausea, metrorrhagia, vaginal moniliasis and pain, acne, and vaginitis. Additional adverse reactions that have been reported include the following: Eye disorder: intolerance to contact lenses, steepening of corneal curvature Gastrointestinal disorders: Abdominal bloating, vomiting General disorders and administration site condition: Edema, fluid retention Hepatobiliary disorders: Cholestatic jaundice Psychiatric disorders: Change in libido, mood changes Reproductive system and breast disorders: Amenorrhea, breast tenderness, breast pain, breast enlargement, increased cervical mucous, change in menstrual flow, unscheduled bleeding Skin and subcutaneous tissue disorders: Acne, melasma [see Warnings and Precautions (5.13) ] Vascular disorders: Budd-Chiari syndrome, aggravation of varicose veins Common adverse reactions are: headache, abdominal pain, nausea, metrorrhagia, vaginal moniliasis and pain, acne, and vaginitis. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Exeltis USA, Inc. at 1-877-324-9349 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

FDA lists 10 drug label records with LEVONORGESTREL AND ETHINYL ESTRADIOL as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

What is Tyblume used for?
1 INDICATIONS AND USAGE TYBLUME is indicated for use by females of reproductive potential to prevent pregnancy. TYBLUME (levonorgestrel and ethinyl estradiol tablets) is a combination of levonorgestrel, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy. ( 1 )

Who makes Tyblume?
Exeltis USA, Inc. is the labeler of record for Tyblume. 10 FDA label records share the active ingredient LEVONORGESTREL AND ETHINYL ESTRADIOL, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

Is Tyblume prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing LEVONORGESTREL AND ETHINYL ESTRADIOL?
Yes. 10 FDA drug label records list LEVONORGESTREL AND ETHINYL ESTRADIOL as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Tyblume been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.