Drug Interaction:
.
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
Indication:
OSPHENA® (ospemifene) tablets, for oral use
Initial U.S. Approval: 2013
WARNING: ENDOMETRIAL CANCER AND CARDIOVASCULAR DISORDERS
See full prescribing information for complete boxed warning.
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
RECENT MAJOR CHANGES
Contraindications (4) 02/2015
Drug Name- Osphena
Active Ingredient - Ospemifene
To treat women experiencing moderate to severe dyspareunia
(pain during sexual intercourse ) a symptom of vulvar and vaginal atrophy
due to menopause
Indication-
To treat Dyspareunia (pain during sexual intercource) a symptom of vulvar
and vaginal atrophy due to menopause
Approved by FDA on 26-2--2013 (Ref- FDA approved List- 2013)
Adverse Reaction:
Adverse reactions (.1 percent) include: hot flush, vaginal discharge,
muscle spasms, genital discharge, hyperhidrosis.
Contra-Indications:
CONTRAINDICATIONS
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
infarction [MI]), or a history of these conditions
.
Hypersensitivity (for example, angioedema, urticaria, rash, pruritus) to OSPHENA
or any ingredients
.
Known or suspected pregnancy
WARNINGS AND PRECAUTIONS
Venous Thromboembolism: Risk of DVT and pulmonary embolism
Known, suspected, or history of breast cancer
Severe Hepatic Impairment
Dosages/ Overdosage Etc:
Approved by FDA on 26-2--2013 (Ref- FDA approved List- 2013)
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
DOSAGE AND ADMINISTRATION
One tablet taken orally once daily with food
DOSAGE FORMS AND STRENGTHS
Tablet:60 mg
Patient Information:
PATIENT COUNSELING INFORMATION
See FDA-approved patient labeling (Patient Information)
1. Hypersensitivity Reactions
Inform postmenopausal women who have had hypersensitivity reactions to
OSPHENA, such as angioedema, urticaria, rash, pruritis, that they should
not take OSPHENA
2. Vaginal Bleeding
Inform postmenopausal women of the importance of reporting unusual vaginal
bleeding to their healthcare providers as soon as possible
3 Hot Flashes or Flushes
OSPHENA may initiate or increase the occurrence of hot flashes in some women
Pharmacology/ Pharmacokinetics:
CLINICAL PHARMACOLOGY
1.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).
2. Pharmacokinetics
Absorption
Following a single oral administration of OSPHENA 60 mg tablet in postmenopausa
l women under fasted condition, peak median serum concentrations was reached
at approximately 2 hours (range: 1 to 8 hours) post-dose
Pregnancy and lactation:
USE IN SPECIFIC POPULATIONS
1. Pregnancy
Teratogenic effects:
Pregnancy Category X
Risk Summary
Based on animal data, OSPHENA is likely to increase the risk of adverse outcomes
during pregnancy and labor. Therefore,caution should be taken and to be used only
if necessary.
2. Nursing Mothers
It is not known whether OSPHENA is excreted in human breast milk.In a nonclinical
study, ospemifene was excreted in rat milk and detected at concentrations higher
than that in maternal plasma.
3. Pediatric Use
OSPHENA is not indicated in children. Clinical studies have not been conducted
in the pediatric population.
4. Geriatric Use
Of the 1892 OSPHENA-treated women enrolled in the nine phase 2/3 trials of
OSPHENA, >19 percent were 65 years of age or older. No clinically meaningful
differences in safety or effectiveness were observed between these women
and younger women less than 65 years of age.
Manufacturer Details