Ospemifene

What is Ospemifene?

• Ospemifene (OSPHENA) is an estrogen agonist/antagonist used for the treatment of dyspareunia.

What are the uses of this medicine?

This medicine is used after menopause for women with or without a uterus to treat:

• Moderate to severe pain during sexual intercourse due to changes in and around your vagina.
• Moderate to severe vaginal dryness due to changes in and around your vagina.

How does this medicine work?

• Ospemifene has estrogen-like effects (agonism) on vaginal epithelium, but antiestrogen activity (antagonism) on breast tissue.
• This differential activity is keyed to achieving the beneficial effects of estrogens on vaginal secretions and epithelial integrity, while avoiding the potential harmful effects of estrogen stimulation of breast tissue.
• In several large clinical trials, ospemifene was shown to decrease symptoms of dyspareunia (vaginal dryness and discharge and pain on intercourse) without stimulating breast and uterine growth.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• have unusual vaginal bleeding. Vaginal bleeding after menopause may be a warning sign of cancer of the lining of the uterus (womb). Your healthcare provider should check any unusual vaginal bleeding to find out the cause.
• currently have or have had certain cancers. If you have or have had cancer, talk with your healthcare provider about whether you should take OSPHENA.
• currently have or have had blood clots.
• had a stroke or heart attack.
• are allergic to ospemifene or any of the ingredients in OSPHENA. Allergic reaction to OSPHENA can include swelling of the face or tongue (angioedema), hives (urticaria), rash, and itching (pruritus). See the end of this Patient Information leaflet for a complete list of ingredients in OSPHENA.
• are pregnant or plan to become pregnant. OSPHENA is not for pregnant women.

What drug interactions can this medicine cause?

• 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.

Is this medicine FDA approved?

• FDA approved this drug in the year of 2013.

How should this medicine be used?

Recommended Dosage: 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.

Treatment of Moderate to Severe Vaginal Dryness, a Symptom of Vulvar and Vaginal Atrophy, Due to Menopause

• Take one 60 mg tablet with food once daily.

Administration

• Take OSPHENA exactly how your healthcare provider tells you to take it.
• Take 1 OSPHENA tablet by mouth each day with food.
• You and your healthcare provider should talk regularly about the dose of OSPHENA you are taking and whether or not you still need treatment with OSPHENA.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Tablet: 60 mg

This medicine is available in fallowing brand namesː

• OSPHENA

What side effects can this medication cause?

The most common side effects of this medicine include:

• hot flushes (also known as hot flashes)
• vaginal discharge
• muscle spasms
• headache
• excessive sweating (hyperhidrosis)
• heavy vaginal bleeding (vaginal hemorrhage)
• night sweats

OSPHENA may cause serious side effects, including:

• stroke
• blood clots
• cancer of the lining of the uterus (womb)

What special precautions should I follow?

• In the clinical trials for OSPHENA (duration of treatment up to 15 months), the incidence rates of thromboembolic and hemorrhagic stroke.
• OSPHENA should not be used in women with severe hepatic impairment.
• Inform postmenopausal women who have had hypersensitivity reactions to OSPHENA, such as angioedema, urticaria, rash, and pruritus, that they should not take OSPHENA.
• Inform postmenopausal women of the importance of reporting unusual vaginal bleeding to their healthcare providers as soon as possible.
• OSPHENA may initiate or increase the occurrence of hot flashes in some women.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• OSPHENA is contraindicated in women who are or may become pregnant.

Can this medicine be used in children?

• OSPHENA is not indicated in children. Clinical studies have not been conducted in the pediatric population.

What are the active and inactive ingredients in this medicine?

• Active Ingredient: ospemifene.
• Inactive Ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, mannitol, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, titanium dioxide, and triacetin.

Who manufactures and distributes this medicine?

Distributed by: Shionogi Inc. Florham Park, NJ Marketed by: Duchesnay USA, Inc. Bryn Mawr, PA Made in UK

What should I know about storage and disposal of this medication?

• Store OSPHENA at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep OSPHENA and all medicines out of the reach of children.

• Dailymed label info on Ospemifene
• FDA Ospemifene

Ospemifene Resources
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