LYLLANA .025 mg/d
Estradiol · PATCH, EXTENDED RELEASE · Amneal Pharmaceuticals LLC
LYLLANA is a patch, extended release containing estradiol at .025 mg/d, taken transdermal. Manufactured by Amneal Pharmaceuticals LLC.
Key Facts
- Brand Name
- LYLLANA
- Generic Name
- Estradiol
- NDC Code (Product)
65162-126- Manufacturer
- Amneal Pharmaceuticals LLC
- Strength
- .025 mg/d
- Dosage Form
- PATCH, EXTENDED RELEASE
- Route
- TRANSDERMAL
- Marketing Status
- Application #
- ANDA211396
- Drug Class
- Estrogen [EPC]
- Marketing Start
- 09/30/2020
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE LYLLANA is indicated for: LYLLANA ® is an estrogen indicated for: Treatment of moderate to severe vasomotor symptoms due to menopause ( 1.1 ) Prevention of postmenopausal osteoporosis ( 1.2 ) Limitations of Use When prescribing solely for the treatment of postmenopausal osteoporosis, first consider the use of non-estrogen medications. Consider estrogen therapy only for women at significant risk of osteoporosis. 1.1 Treatment of Moderate to Severe Vasomotor Symptoms Due to Menopause 1.2 Prevention of Postmenopausal Osteoporosis Limitation of Use When prescribing solely for the prevention of postmenopausal osteoporosis, first consider the use of non-estrogen medications. Consider estrogen therapy only for women at significant risk of osteoporosis.
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Generally, when estrogen is prescribed for a postmenopausal woman with a uterus, consider addition of a progestogen to reduce the risk of endometrial cancer. Generally, a woman without a uterus, does not need to use a progestogen in addition to her estrogen therapy. In some cases, however, hysterectomized women who have a history of endometriosis may need a progestogen [see Warnings and Precautions (5.2, 5.14) ] . Use estrogen-alone, or in combination with a progestogen, at the lowest effective dose and for the shortest duration consistent with treatment goals and risks for the individual woman. Reevaluate postmenopausal women periodically as clinically appropriate to determine if treatment is still necessary. Start therapy with LYLLANA ® 0.0375 mg per day applied to the skin twice weekly for the treatment of moderate to severe vasomotor symptoms due to menopause. Dosage adjustment should be guided by the clinical response (2.1) Start therapy with LYLLANA 0.025 mg per day applied to the skin twice weekly for the prevention of postmenopausal osteoporosis. The dose may be adjusted as necessary (2.2) Place LYLLANA on a clean, dry area on the lower abdomen (…
Contraindications
4 CONTRAINDICATIONS LYLLANA is contraindicated in women with any of the following conditions: Undiagnosed abnormal genital bleeding [see Warnings and Precautions (5.2) ]. Breast cancer or a history of breast cancer [see Warnings and Precautions (5.2) ]. Estrogen-dependent neoplasia [see Warnings and Precautions (5.2 )]. Active DVT, PE, or a history of these conditions [see Warnings and Precautions (5.1) ]. Active arterial thromboembolic disease (for example, stroke or MI), or a history of these conditions [see Warnings and Precautions (5.1) ] . Known anaphylactic reaction, angioedema, or hypersensitivity to LYLLANA Hepatic impairment or disease Protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders Undiagnosed abnormal genital bleeding ( 4 , 5.2 ) Breast cancer or a history of breast cancer (4, 5.2 ) Estrogen-dependent neoplasia (4, 5.2 ) Active DVT, PE, or a history of these conditions (4, 5.1 ) Active arterial thromboembolic disease (for example, stroke or MI), or a history of these conditions (4, 5.1 ) Known anaphylactic reaction, angioedema, or hypersensitivity to LYLLANA (4) Hepatic impairment or disease (4, 5.10 ) Protein C, protein S, or ant…
Drug Interactions
7 DRUG INTERACTIONS In vitro and in vivo studies have shown that estrogens are metabolized partially by cytochrome P450 3A4 (CYP3A4). Therefore, inducers or inhibitors of CYP3A4 may affect estrogen drug metabolism. Inducers of CYP3A4 such as St. John’s wort ( Hypericum perforatum ) preparations, phenobarbital, carbamazepine and rifampin may reduce plasma concentrations of estrogens, possibly resulting in a decrease in therapeutic effects and/or changes in the uterine bleeding profile. Inhibitors of CYP3A4 such as erythromycin, clarithromycin, ketoconazole, itraconazole, ritonavir, and grapefruit juice may increase plasma concentrations of estrogens and may result in adverse reactions. Inducers and/or inhibitors of CYP3A4 may affect estrogen drug metabolism and decrease or increase the estrogen plasma concentration. ( 7 )
Adverse Reactions
6 ADVERSE REACTIONS The following serious adverse reactions are discussed elsewhere in labeling: Cardiovascular Disorders [see Boxed Warning , Warnings and Precautions (5.1) ] Malignant Neoplasms [see Boxed Warning , Warnings and Precautions (5.2) ] The most common adverse reactions (greater than or equal to 5 percent) with LYLLANA are: headache, breast tenderness, back pain, pain in limb, nasopharyngitis, dyspepsia, nausea, sinusitis, and intermenstrual bleeding ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. There were no clinical trials conducted with LYLLANA. LYLLANA is bioequivalent to Vivelle ® . The following adverse reactions are reported with Vivelle therapy: Table 1: Summary of Most Frequently Reported Adverse Reactions (Vivelle versus Placebo) Regardless of Relationship Reported at a Fr…
Frequently Asked Questions
What is LYLLANA used for?
LYLLANA contains Estradiol. It is a patch, extended release taken transdermal. Consult your doctor for specific uses.
Is LYLLANA a controlled substance?
LYLLANA is not classified as a controlled substance by the DEA.
What is the generic name for LYLLANA?
The generic name for LYLLANA is Estradiol. There are 12 other brand versions of Estradiol.
What is the NDC code for LYLLANA .025 mg/d?
The NDC (National Drug Code) for LYLLANA .025 mg/d is 65162-126, listed by Amneal Pharmaceuticals LLC.