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 OSPHENA™ (ospemifene) tablets, for oral use

DESCRIPTION CLINICAL PHARMACOLOGY INDICATIONS AND USAGE
CONTRAINDICATIONS PRECAUTIONS ADVERSE REACTIONS
DOSAGE AND ADMINISTRATION HOW SUPPLIED WARNINGS
PRESCRIBING HIGHLIGHTS:  Please see package insert for additional information and possible updates to ensure safe and effective use of this medication. The authors make no claims of the accuracy of the information contained herein; and these suggested doses are not a substitute for clinical judgment. Neither GlobalRPh Inc. nor any other party involved in the preparation of this program shall be liable for any special, consequential, or exemplary damages resulting in whole or part from any user's use of or reliance upon this material. Please read the disclaimer carefully BEFORE accessing or using this site. BY ACCESSING OR USING THIS SITE, YOU AGREE TO BE BOUND BY THE TERMS AND CONDITIONS SET FORTH IN THE DISCLAIMER.  
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Drug Updates:  OSPHENA ® (ospemifene) tablets, for oral use
[Drug information  /  PDF]  
Dosing:  Click (+) next to Dosage and Administration section (drug info link)

Initial U.S. Approval:  2013

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).


WARNINGS  top of page

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  top of page

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

OSPHENA is an estrogen agonist/antagonist.

CLINICAL PHARMACOLOGY: top of page

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  top of page

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 top of page

  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 top of page

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 top of page

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  top of page

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

HOW SUPPLIED top of page

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
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