Description
Drug Info: ApoThera Drug Disease Clinical Support App.
Vaginal Administration
– Wash hands and remove ring from protective pouch (keep pouch for later ring disposal).
– Press sides of ring together between thumb and index finger and insert folded ring into vagina.
– An optional alternative is to insert using the ring applicator (available separately).
– Specific placement is not required for ring to be effective, but ring should be inserted far enough into the vagina as to be comfortable.
– To remove, hook index finger around rim and pull out. Vaginal ring cannot be disposed of in the toilet.
– New rings should be inserted at approximately the same time of day the ring was removed the previous week.
– If the ring accidentally falls out, it may be rinsed with cool or warm (not hot) water and replaced.
– However, it must be replaced within 3 hours. Refer to dosing if ring is out of place for >3 hours.
– Regularly check for the presence of the ring in the vagina (eg, before and after intercourse).
– Tampons do not interfere with the effectiveness of the ring; caution should be used when removing tampon not to remove ring.
– Certain female barrier methods (eg, diaphragm, female condom) may interfere with proper ring placement, and therefore, are not recommended for use as a back-up method of contraception
– Ensure proper vaginal placement of the ring to avoid inadvertent urinary bladder insertion.
Storage
– Prior to dispensing, store refrigerated at 2°C to 8°C (36°F to 46°F)
– After dispensing, can be stored for up to 4 months at 25°C (77°F)
– Excursions are permitted between 15°C and 30°C (59°F and 86°F)
– Avoid direct sunlight or temperatures above 30°C (86°F)
Monitor
– Assessment of pregnancy status (prior to therapy)
– Blood pressure (prior to therapy and yearly)
– Weight (optional; BMI at baseline may be helpful to monitor changes during therapy)
– Assess potential health status changes at routine visits
– If vaginal ring was out of the vagina >3 hours, or the ring free interval was extended for >1 week, and 1 menstrual period is missed, the possibility of pregnancy should be considered. If the ring was used as directed and 2 consecutive menstrual periods are missed, assess pregnancy status before a new dosing cycle is started. In addition, assess pregnancy status if ring was in place >4 weeks.
– Monitor patient for vision changes
– Blood pressure
– Signs and symptoms of thromboembolic disorders
– Signs or symptoms of depression
– Glycemic control in patients with diabetes
– Lipid profiles in patients being treated for hyperlipidemias
– Adequate diagnostic measures, including endometrial sampling, if indicated, should be performed to rule out malignancy in all cases of undiagnosed abnormal vaginal bleeding
– In patients with persistent urinary symptoms, assess for inadvertent urinary bladder insertion if ring is not otherwise located.
Related
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