Ospemifene: Difference between revisions

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{{DrugProjectFormSinglePage
{{DrugProjectFormSinglePage
|authorTag=<!--Overview-->{{RB}}
|authorTag=<!--Overview-->{{RB}}
|aOrAn=a Selective Estrogen Receptor Modulator
|genericName=Ospemifene
|aOrAn=a
|drugClass= Selective Estrogen Receptor Modulator
|indicationType=treatment
|indication=moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause
|hasBlackBoxWarning=Yes
|hasBlackBoxWarning=Yes
|adverseReactions=<!--Black Box Warning-->
|adverseReactions=hot flush, vaginal discharge, muscle spasms, genital discharge, hyperhidrosis.
 
<!--Black Box Warning-->
|blackBoxWarningTitle=<span style="color:#FF0000;">ConditionName: </span>
|blackBoxWarningTitle=<span style="color:#FF0000;">ConditionName: </span>
|blackBoxWarningBody=<i><span style="color:#FF0000;">ConditionName: </span></i>
|blackBoxWarningBody=<i><span style="color:#FF0000;">ConditionName: </span></i>


* Content
* WARNING: ENDOMETRIAL CANCER AND CARDIOVASCULAR DISORDERS


<!--Adult Indications and Dosage-->
Endometrial Cancer


<!--FDA-Labeled Indications and Dosage (Adult)-->
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. Adequate diagnostic measures, including directed and random endometrial sampling when indicated, should be undertaken to rule out malignancy in postmenopausal women with undiagnosed persistent or recurring abnormal genital bleeding [see Warnings and Precautions (5.2)].
|fdaLIADAdult======Condition1=====


* Dosing Information
Cardiovascular Disorders


:* Dosage
There is a reported increased risk of stroke and deep vein thrombosis (DVT) in postmenopausal women (50 to 79 years of age) who received daily oral conjugated estrogens (CE) [0.625 mg]-alone therapy over 7.1 years as part of the Women's Health Initiative (WHI) [see Warnings and Precautions (5.1)].


=====Condition2=====
In the clinical trials for OSPHENA (duration of treatment up to 15 months), the incidence rates of thromboembolic and hemorrhagic stroke were 0.72 and 1.45 per thousand women, respectively in OSPHENA 60 mg treatment group and 1.04 and 0 in placebo [see Warnings and Precautions (5.1)]. The incidence of DVT was 1.45 per thousand women in OSPHENA 60 mg treatment group and 1.04 per thousand women in placebo [see Warnings and Precautions (5.1)]. OSPHENA should be prescribed for the shortest duration consistent with treatment goals and risks for the individual woman.


* Dosing Information
<!--Adult Indications and Dosage-->


:* Dosage
<!--FDA-Labeled Indications and Dosage (Adult)-->
|fdaLIADAdult=====Indications====
* OSPHENA is indicated for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause.


=====Condition3=====
====Dosage====
* OSPHENA is an estrogen agonist/antagonist which has agonistic effects on the endometrium. Generally, when a product with estrogen agonistic effects on the endometrium is prescribed for a postmenopausal woman with a uterus, a progestin should be considered to reduce the risk of endometrial cancer. A woman without a uterus does not need a progestin [see Warnings and Precautions (5.2)].


* Dosing Information
Use of OSPHENA should be for the shortest duration consistent with treatment goals and risks for the individual woman. Postmenopausal women should be re-evaluated periodically as clinically appropriate to determine if treatment is still necessary.


:* Dosage
2.1 Treatment of Moderate to Severe Dyspareunia, a Symptom of Vulvar and Vaginal Atrophy, due to Menopause


=====Condition4=====
Take one 60 mg tablet with food once daily.


* Dosing Information
====DOSAGE FORMS AND STRENGTHS====


:* Dosage
OSPHENA tablets are white to off-white, oval, biconvex, film coated tablets containing 60 mg of ospemifene and engraved with "60" on one side.
 
<!--Off-Label Use and Dosage (Adult)-->
 
<!--Guideline-Supported Use (Adult)-->
|offLabelAdultGuideSupport======Condition1=====
|offLabelAdultGuideSupport======Condition1=====


Line 110: Line 114:


<!--Contraindications-->
<!--Contraindications-->
|contraindications=* Condition1
|contraindications=* OSPHENA is contraindicated in women with any of the following conditions:
 
    Undiagnosed abnormal genital bleeding
    Known or suspected estrogen-dependent neoplasia
    Active DVT, pulmonary embolism (PE), or a history of these conditions
    Active arterial thromboembolic disease [for example, stroke and myocardial infarctions (MI)], or a history of these conditions
    OSPHENA is contraindicated in women who are or may become pregnant. OSPHENA may cause fetal harm when administered to a pregnant woman. Ospemifene was embryo-fetal lethal with labor difficulties and increased pup deaths in rats at doses below clinical exposures, and embryo-fetal lethal in rabbits at 10 times the clinical exposure based on mg/m2. If this drug is used during pregnancy, or if a woman becomes pregnant while taking this drug, she should be apprised of the potential hazard to a fetus.
 


<!--Warnings-->
<!--Warnings-->

Revision as of 17:47, 4 February 2015

Ospemifene
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Rabin Bista, M.B.B.S. [2]

Disclaimer

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Black Box Warning

ConditionName:
See full prescribing information for complete Boxed Warning.
ConditionName:
  • WARNING: ENDOMETRIAL CANCER AND CARDIOVASCULAR DISORDERS

Endometrial Cancer

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. Adequate diagnostic measures, including directed and random endometrial sampling when indicated, should be undertaken to rule out malignancy in postmenopausal women with undiagnosed persistent or recurring abnormal genital bleeding [see Warnings and Precautions (5.2)].

Cardiovascular Disorders

There is a reported increased risk of stroke and deep vein thrombosis (DVT) in postmenopausal women (50 to 79 years of age) who received daily oral conjugated estrogens (CE) [0.625 mg]-alone therapy over 7.1 years as part of the Women's Health Initiative (WHI) [see Warnings and Precautions (5.1)].

In the clinical trials for OSPHENA (duration of treatment up to 15 months), the incidence rates of thromboembolic and hemorrhagic stroke were 0.72 and 1.45 per thousand women, respectively in OSPHENA 60 mg treatment group and 1.04 and 0 in placebo [see Warnings and Precautions (5.1)]. The incidence of DVT was 1.45 per thousand women in OSPHENA 60 mg treatment group and 1.04 per thousand women in placebo [see Warnings and Precautions (5.1)]. OSPHENA should be prescribed for the shortest duration consistent with treatment goals and risks for the individual woman.

Overview

Ospemifene is a Selective Estrogen Receptor Modulator that is FDA approved for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause. There is a Black Box Warning for this drug as shown here. Common adverse reactions include hot flush, vaginal discharge, muscle spasms, genital discharge, hyperhidrosis..

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

  • OSPHENA is indicated for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause.

Dosage

  • OSPHENA is an estrogen agonist/antagonist which has agonistic effects on the endometrium. Generally, when a product with estrogen agonistic effects on the endometrium is prescribed for a postmenopausal woman with a uterus, a progestin should be considered to reduce the risk of endometrial cancer. A woman without a uterus does not need a progestin [see Warnings and Precautions (5.2)].

Use of OSPHENA should be for the shortest duration consistent with treatment goals and risks for the individual woman. Postmenopausal women should be re-evaluated periodically as clinically appropriate to determine if treatment is still necessary.

2.1 Treatment of Moderate to Severe Dyspareunia, a Symptom of Vulvar and Vaginal Atrophy, due to Menopause

Take one 60 mg tablet with food once daily.

DOSAGE FORMS AND STRENGTHS

OSPHENA tablets are white to off-white, oval, biconvex, film coated tablets containing 60 mg of ospemifene and engraved with "60" on one side.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Condition1
  • Developed by:
  • Class of Recommendation:
  • Strength of Evidence:
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Ospemifene in adult patients.

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Ospemifene in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Condition1
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding FDA-Labeled Use of Ospemifene in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Condition1
  • Developed by:
  • Class of Recommendation:
  • Strength of Evidence:
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Ospemifene in pediatric patients.

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Ospemifene in pediatric patients.

Contraindications

  • OSPHENA is contraindicated in women with any of the following conditions:
   Undiagnosed abnormal genital bleeding
   Known or suspected estrogen-dependent neoplasia
   Active DVT, pulmonary embolism (PE), or a history of these conditions
   Active arterial thromboembolic disease [for example, stroke and myocardial infarctions (MI)], or a history of these conditions
   OSPHENA is contraindicated in women who are or may become pregnant. OSPHENA may cause fetal harm when administered to a pregnant woman. Ospemifene was embryo-fetal lethal with labor difficulties and increased pup deaths in rats at doses below clinical exposures, and embryo-fetal lethal in rabbits at 10 times the clinical exposure based on mg/m2. If this drug is used during pregnancy, or if a woman becomes pregnant while taking this drug, she should be apprised of the potential hazard to a fetus.

Warnings

ConditionName:
See full prescribing information for complete Boxed Warning.
ConditionName:
  • WARNING: ENDOMETRIAL CANCER AND CARDIOVASCULAR DISORDERS

Endometrial Cancer

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. Adequate diagnostic measures, including directed and random endometrial sampling when indicated, should be undertaken to rule out malignancy in postmenopausal women with undiagnosed persistent or recurring abnormal genital bleeding [see Warnings and Precautions (5.2)].

Cardiovascular Disorders

There is a reported increased risk of stroke and deep vein thrombosis (DVT) in postmenopausal women (50 to 79 years of age) who received daily oral conjugated estrogens (CE) [0.625 mg]-alone therapy over 7.1 years as part of the Women's Health Initiative (WHI) [see Warnings and Precautions (5.1)].

In the clinical trials for OSPHENA (duration of treatment up to 15 months), the incidence rates of thromboembolic and hemorrhagic stroke were 0.72 and 1.45 per thousand women, respectively in OSPHENA 60 mg treatment group and 1.04 and 0 in placebo [see Warnings and Precautions (5.1)]. The incidence of DVT was 1.45 per thousand women in OSPHENA 60 mg treatment group and 1.04 per thousand women in placebo [see Warnings and Precautions (5.1)]. OSPHENA should be prescribed for the shortest duration consistent with treatment goals and risks for the individual woman.
  • Description

Precautions

  • Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Ospemifene in the drug label.

Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Ospemifene in the drug label.

Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous

Drug Interactions

  • Drug
  • Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

  • Pregnancy Category


Pregnancy Category (AUS):

  • Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Ospemifene in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Ospemifene during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Ospemifene with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Ospemifene with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Ospemifene with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Ospemifene with respect to specific gender populations.

Race

There is no FDA guidance on the use of Ospemifene with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Ospemifene in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Ospemifene in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Ospemifene in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Ospemifene in patients who are immunocompromised.

Administration and Monitoring

Administration

  • Oral
  • Intravenous

Monitoring

There is limited information regarding Monitoring of Ospemifene in the drug label.

  • Description

IV Compatibility

There is limited information regarding IV Compatibility of Ospemifene in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

  • Description

Management

  • Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Ospemifene in the drug label.

Pharmacology

There is limited information regarding Ospemifene Pharmacology in the drug label.

Mechanism of Action

Structure

File:Ospemifene01.png
This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Ospemifene in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Ospemifene in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Ospemifene in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Ospemifene in the drug label.

How Supplied

Storage

There is limited information regarding Ospemifene Storage in the drug label.

Images

Drug Images

{{#ask: Page Name::Ospemifene |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}

Package and Label Display Panel

{{#ask: Label Page::Ospemifene |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

Patient Counseling Information

There is limited information regarding Patient Counseling Information of Ospemifene in the drug label.

Precautions with Alcohol

  • Alcohol-Ospemifene interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

Look-Alike Drug Names

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

  1. ↑ Empty citation (help)
  2. ↑ "http://www.ismp.org". External link in |title= (help)

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Retrieved from "https://www.wikidoc.org/index.php?title=Ospemifene&oldid=1063338"