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Warnings 

WARNING: ENDOMETRIAL CANCER AND
CARDIOVASCULAR DISORDERS

See full prescribing information for complete boxed warning.

OSPHENA is an estrogen agonist/antagonist with tissue selective effects. In the endometrium, OSPHENA has estrogen agonistic effects. There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens. Adding a progestin to estrogen therapy reduces the risk of endometrial hyperplasia, which may be a precursor to endometrial cancer.

Estrogen-alone therapy has an increased risk of stroke and deep vein thrombosis (DVT). OSPHENA 60 mg had cerebral thromboembolic and hemorrhagic stroke incidence rates of 0.72 and 1.45 per thousand women, respectively vs. 1.04 and 0 per thousand women, respectively in placebo. For deep vein thrombosis, the incidence rate for OSPHENA 60 mg is 1.45 per thousand women vs. 1.04 per thousand women in placebo.

See warnings and precautions below.

Description 

OSPHENA (ospemifene) tablets, for oral use
Initial U.S. Approval: 2013

OSPHENA is an estrogen agonist/antagonist.

Clinical pharmacology

Mechanism of Action:
OSPHENA is an estrogen agonist/antagonist with tissue selective effects. Its biological actions are mediated through binding to estrogen receptors. This binding results in activation of estrogenic pathways in some tissues (agonism) and blockade of estrogenic pathways in others (antagonism).

Indications and usage 

INDICATIONS AND USAGE:
OSPHENA is an estrogen agonist/antagonist indicated for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause.

Contraindications

  1.  Undiagnosed abnormal genital bleeding
  2. Known or suspected estrogen-dependent neoplasia
  3. Active DVT, pulmonary embolism (PE), or a history of these conditions
  4. Active arterial thromboembolic disease (for example, stroke and myocardial infarction [MI]), or a history of these conditions
  5. Known or suspected pregnancy

Precautions

WARNINGS AND PRECAUTIONS:

  1.  Venous Thromboembolism: Risk of DVT and pulmonary embolism
  2. Known, suspected, or history of breast cancer
  3. Severe Hepatic Impairment

Adverse reactions

ADVERSE REACTIONS
Adverse reactions (geq1 percent) include: hot flush, vaginal discharge, muscle spasms, genital discharge, hyperhidrosis.

To report SUSPECTED ADVERSE REACTIONS, contact Shionogi Inc. at 1-855-OSPHENA (1-855-677-4362) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS
Do not use estrogens or estrogen agonist/antagonist concomitantly with OSPHENA.

Do not use fluconazole concomitantly with OSPHENA. Fluconazole increases serum concentrations of OSPHENA.

Do not use rifampin concomitantly with OSPHENA. Rifampin decreases serum concentration of OSPHENA.

USE IN SPECIFIC POPULATIONS
Nursing Mothers: It is not known whether OSPHENA is excreted in human breast milk (8.3)

See PACKAGE INSERT for PATIENT COUNSELING INFORMATION and Medication Guide.

Dosage and administration 

DOSAGE AND ADMINISTRATION:
One tablet taken orally once daily with food .

How supplied

DOSAGE FORMS AND STRENGTHS

Tablet: 60 mg

Reference

Package insert data:   [Accessed: Jan 2014].

Manufactured for:
Shionogi Inc.
Florham Park, NJ 07932

Manufactured by:
Penn Pharmaceutical Services Ltd.
23-24 Tafarnauback Industrial Estate
Tredegar, Gwent, South Wales
NP22 3AA, United Kingdom

Made in UK

Approved: February 2013

Reference(s)

National Institutes of Health, U.S. National Library of Medicine, DailyMed Database.
Provides access to the latest drug monographs submitted to the Food and Drug Administration (FDA). Please review the latest applicable package insert for additional information and possible updates.  A local search option of this data can be found here.

Disclaimer

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