DIVIGEL Gel (2020)

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Vertical Pharmaceuticals, LLC

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1. Indications and Usage

Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause.

2. Dosage and Administration

Generally, when estrogen is prescribed for a postmenopausal woman with a uterus, consider addition of a progestin to reduce the risk of endometrial cancer. A woman who takes estrogen but does not have ...

3. Dosage Forms and Strengths

Divigel is available in five doses of 0.25, 0.5, 0.75, 1.0, and 1.25 grams for transdermal application (corresponding to 0.25, 0.5, 0.75, 1.0, and 1.25 mg estradiol, respectively). Divigel is a clear, ...

4. Contraindications

Divigel is contraindicated in women with any of the following conditions: Undiagnosed abnormal genital bleeding [see Warning and Precautions (5.2)] Breast cancer or history of breast cancer ...

5. Warnings and Precautions

5.1 Cardiovascular Disorders Increased risk of stroke and DVT are reported with estrogen-alone therapy. Increased risk of PE, DVT, stroke and MI are reported with estrogen plus progestin therapy. Immediately ...

6. Adverse Reactions

The following serious adverse reactions are discussed elsewhere in the labeling: Cardiovascular Disorders [see Boxed Warning, Warnings and Precautions (5.1)]. Malignant Neoplasms [see Boxed ...

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 ...

6.2. Postmarketing Experience

The following adverse reactions have been identified during post-approval use of Divigel. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible ...

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 ...

8.1. Pregnancy

Risk Summary Divigel is not indicated for use in pregnant women. There are no data with the use of Divigel in pregnant women; however, epidemiologic studies and meta-analyses have not found an increased ...

8.2. Lactation

Risk Summary Estrogens are present in human milk and can reduce milk production in breast-feeding women. This reduction can occur at any time but is less likely to occur once breast-feeding is well established. ...

8.4. Pediatric Use

Divigel is not indicated for use in pediatric patients. Clinical studies have not been conducted in the pediatric population.

8.5. Geriatric Use

There have not been sufficient numbers of geriatric women involved in studies utilizing Divigel to determine whether those over 65 years of age differ from younger subjects in their response to Divigel. ...

10. Overdosage

Overdosage of estrogen may cause nausea and vomiting, breast tenderness, abdominal pain, drowsiness and fatigue, and withdrawal bleeding in women. Treatment of overdose consists of discontinuation of Divigel ...

11. Description

Divigel (estradiol gel) 0.1 percent, is a clear, colorless gel, which is odorless when dry. It is designed to deliver sustained circulating concentrations of estradiol when applied once daily to the skin. ...

12.1. Mechanism of Action

Endogenous estrogens are largely responsible for the development and maintenance of the female reproductive system and secondary sexual characteristics. Although circulating estrogens exist in a dynamic ...

12.2. Pharmacodynamics

Generally, a serum estrogen concentration does not predict an individual womans therapeutic response to Divigel nor her risk for adverse outcomes. Likewise, exposure comparisons across different estrogen ...

12.3. Pharmacokinetics

Absorption Estradiol diffuses across intact skin and into the systemic circulation by a passive absorption process, with diffusion across the stratum corneum being the rate-limiting factor. In a 14-day, ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term continuous administration of natural and synthetic estrogens in certain animal species increases the frequency of carcinomas of the breast, uterus, cervix, vagina, testis and liver.

14. Clinical Studies

14.1 Effects on Vasomotor Symptoms in Postmenopausal Women A randomized, double-blind, placebo-controlled trial evaluated the efficacy of 12-week treatment with three different daily doses of Divigel for ...

15. References

1. Rossouw JE, et al. Postmenopausal Hormone Therapy and Risk of Cardiovascular Disease by Age and Years SinceMenopause. JAMA. 2007;297:1465–1477. 2. Hsia J, et al. Conjugated Equine Estrogens ...

16.1. How Supplied

Divigel (estradiol gel) 0.1% is a clear, colorless, smooth, opalescent gel supplied in single-dose foil packets of 0.25, 0.5, 0.75, 1.0, and 1.25 grams, corresponding to 0.25, 0.5, 0.75, 1.0, and 1.25 ...

16.2. Storage and Handling

Store at 20 to 25°C (68 to 77°F). Excursions permitted to 15 to 30°C (59 to 86°F) [See USP Controlled Room Temperature].

17. Patient Counseling Information

Advise the patient to read the FDA-Approved patient labeling (Patient Information and Instructions for Use). Vaginal Bleeding Inform women to report any vaginal bleeding to their healthcare provider as ...

BOXED WARNING SECTION

WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, PROBABLE DEMENTIA and BREAST CANCER Estrogen-Alone Therapy Endometrial Cancer There is an increased risk of endometrial cancer ...