Instructions for use
INFORM YOUR PATIENTS TO PLACE ONE VAGINAL INSERT USING THE DISPOSABLE APPLICATOR INTO THE VAGINA EACH NIGHT AT BEDTIME1
Here are the steps they can follow:
Step 1
1a. Remove 1 applicator from the package.
1b. Pull back on the plunger until it stops to activate the applicator. The applicator must be activated before use. Place the applicator on a clean surface.
Step 1
1a. Remove 1 applicator from the package.
1b. Pull back on the plunger until it stops to activate the applicator. The applicator must be activated before use. Place the applicator on a clean surface.
Step 2
Slowly pull the plastic tabs on the vaginal insert away from each other while keeping the vaginal insert still between your fingers. Carefully remove the vaginal insert from the plastic wrap. If a vaginal insert falls on an unsanitary
surface, replace it with a new one.
Step 2
Slowly pull the plastic tabs on the vaginal insert away from each other while keeping the vaginal insert still between your fingers. Carefully remove the vaginal insert from the plastic wrap. If a vaginal insert falls on an unsanitary
surface, replace it with a new one.
Step 3
Place the flat end of the vaginal insert into the open end of the activated applicator as shown. You are now ready to insert the vaginal insert into your vagina.
Step 3
Place the flat end of the vaginal insert into the open end of the activated applicator as shown. You are now ready to insert the vaginal insert into your vagina.
Step 4
Hold the applicator between your thumb and middle finger. Leave your index (pointer) finger free to press the applicator plunger after the applicator is inserted into your vagina.
Step 4
Hold the applicator between your thumb and middle finger. Leave your index (pointer) finger free to press the applicator plunger after the applicator is inserted into your vagina.
Step 5
Select the position for insertion of the vaginal insert that is most comfortable for you.
5a. Lying position
Step 5
Select the position for insertion of the vaginal insert that is most comfortable for you.
5a. Lying position
5b. Standing position
5b. Standing position
Step 6
Gently slide the vaginal insert end of the applicator into your vagina as far as it will comfortably go.
Do not use force.
Step 6
Gently slide the vaginal insert end of the applicator into your vagina as far as it will comfortably go.
Do not use force.
Step 7
Press the applicator plunger with your index (pointer) finger to release the vaginal insert. Remove the applicator and throw it away after use.
Step 7
Press the applicator plunger with your index (pointer) finger to release the vaginal insert. Remove the applicator and throw it away after use.
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Indication
INTRAROSA is a steroid indicated for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause.
Important Safety Information
INTRAROSA is contraindicated in women with undiagnosed abnormal genital bleeding.
Estrogen is a metabolite of prasterone. Use of exogenous estrogen is contraindicated in women with a known or suspected history of breast cancer. INTRAROSA has not been studied in women with a history of breast cancer.
In four 12-week randomized, placebo-controlled clinical trials, the most common adverse reaction with an incidence ≥2 percent was vaginal discharge. In one 52-week open-label clinical trial, the most common adverse reactions with an incidence ≥2 percent were vaginal discharge and abnormal Pap smear.
To report SUSPECTED ADVERSE REACTIONS, contact Millicent Pharma at 1-877-810-2101 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please see full Prescribing Information.
Reference: 1. Intrarosa [package insert]. East Hanover, NJ: Millicent Pharma Ltd; 2020.
