(drospirenone 3 mg and ethinyl estradiol 0.030 mg, Berlex)
A low-dose, monophasic oral contraceptive. The first OC to contain drospirenone, an analogue of spironolactone, as its progestin component.
* Recommended Dosage: One tablet daily for 21 days, followed by 7 days of one
inert tablet daily.
* Special Considerations: Drospirenone's antimineralcorticoid properties make it contraindicated in women with renal or adrenal insufficiency or hepatic dysfunction. Serum potassium should be checked during the first cycle in women on daily NSAIDs, ACE-inhibitors, or other drugs that can increase serum potassium.
* Comment: Yasmin is effective and appears safe for "most women," said Dr. Robert Hatcher, professor of gynecology and obstetrics, Emory University Atlanta.
Regarding the newness of drospirenone, which is unlike any other progestin used in OCs, Dr. Hatcher--who was not involved in Yasmin trials--is concerned that some physicians won't pay close attention to the recommended precautions regarding medications a woman may have used before prescribing Yasmin. This issue "will complicate the provision of OCs, since it is no longer correct to assume that if a woman can use estrogen, she is a candidate for any available combination OC."
Claims that drosperinone helps counteract fluid retention "are going to need careful substantiation," he added.
Tuesday, March 17, 2009
Thursday, December 18, 2008
Yasmin
Ethinyl Estradiol/Drospirenone (Yasmin): A Newer Oral Contraceptive
Synopsis: Ethinyl estradiol/drospirenone (Yasmin) is a monophasic oral contraceptive containing 30 mcg of ethinyl estradiol and 3 mg of a unique progestin, drospirenone, a spironolactone analog with antimineralocorticoid activity
Safety: Ethinyl estradiol/drospirenone shares the same safety concerns of thrombosis, embolism, gallbladder disease, hypertension and liver disease with other oral contraceptives. Drospirenone, a spironolactone analog, has the theoretic potential to elevate potassium levels. However, in an eight-month study of 80 women taking ethinyl estradiol/ drospirenone, no changes in serum potassium levels were noted.1 The manufacturer recommends that a test for potassium levels be performed during the first treatment cycle for patients taking any other drug capable of increasing serum potassium levels with ethinyl estradiol/drospirenone.2 As with other oral contraceptives, this product is contraindicated in women who have renal or hepatic insufficiency. The ethinyl estradiol/ drospirenone product is unique in that it is contraindicated in patients who have adrenal insufficiency.
Tolerability: The incidence of the expected side effects of headache, breast pain, nausea, abdominal pain, and migraine is similar with ethinyl estradiol/drospirenone as with traditional oral contraceptives. When compared with ethinyl estradiol/desogestrel, both products had similar low rates of spotting and breakthrough bleeding, which progressively lessened with duration of product use.3 Because of the drospirenone component, diuresis-induced weight loss (0.46 kg versus 0.19 kg with desogestrel) may occur.3
Effectiveness: In a year-long study of 326 women (3,201 cycles), one pregnancy occurred,4 which compares with the efficacy of other oral contraceptives in clinical studies. Long-term studies have not been performed to determine the effectiveness of this oral contraceptive in typical use, though it should be similar to other products.
In a randomized study comparing ethinyl estradiol/drospirenone with 30 mcg ethinyl estradiol/0.15 mg desogestrel, both products produced a comparable decrease in the incidence and severity of acne.2,3 Ethinyl estradiol/drospirenone is not currently labeled for the treatment of acne.
In an original dose-ranging study comparing ethinyl estradiol/drospirenone with 30 mcg ethinyl estradiol/0.15 mcg levonorgestrel, systolic and diastolic blood pressures decreased by a range of 1 to 4 mm Hg while increasing by 1 to 2 mm Hg in the control group.1 The difference in blood pressure may have been attributed to the drospirenone component of the product. Additional clinical trials are needed to support the theoretical benefit of drospirenone in the treatment of bloating, weight gain, and blood pressure reduction.
Price: One-cycle pack (one-month supply) of ethinyl estradiol/drospirenone costs $33. The price range for other brand and generic monophasic oral contraceptives is $24 to $49, making ethinyl estradiol/drospirenone a moderately priced option. For patients who have prescription coverage for oral contraceptives, ethinyl estradiol/drospirenone is often covered.
Simplicity: Ethinyl estradiol/drospirenone is available in a 28-day dose-pack that contains 21 active yellow tablets comprised of 30 mcg ethinyl estradiol and 3 mg drospirenone, and 7 placebo white tablets.
Bottom line: An effective oral contraceptive, ethinyl estradiol/drospirenone can elevate potassium levels when given in combination with other potassium-elevating agents and offers no advantage over traditional oral contraceptives.
Synopsis: Ethinyl estradiol/drospirenone (Yasmin) is a monophasic oral contraceptive containing 30 mcg of ethinyl estradiol and 3 mg of a unique progestin, drospirenone, a spironolactone analog with antimineralocorticoid activity
Safety: Ethinyl estradiol/drospirenone shares the same safety concerns of thrombosis, embolism, gallbladder disease, hypertension and liver disease with other oral contraceptives. Drospirenone, a spironolactone analog, has the theoretic potential to elevate potassium levels. However, in an eight-month study of 80 women taking ethinyl estradiol/ drospirenone, no changes in serum potassium levels were noted.1 The manufacturer recommends that a test for potassium levels be performed during the first treatment cycle for patients taking any other drug capable of increasing serum potassium levels with ethinyl estradiol/drospirenone.2 As with other oral contraceptives, this product is contraindicated in women who have renal or hepatic insufficiency. The ethinyl estradiol/ drospirenone product is unique in that it is contraindicated in patients who have adrenal insufficiency.
Tolerability: The incidence of the expected side effects of headache, breast pain, nausea, abdominal pain, and migraine is similar with ethinyl estradiol/drospirenone as with traditional oral contraceptives. When compared with ethinyl estradiol/desogestrel, both products had similar low rates of spotting and breakthrough bleeding, which progressively lessened with duration of product use.3 Because of the drospirenone component, diuresis-induced weight loss (0.46 kg versus 0.19 kg with desogestrel) may occur.3
Effectiveness: In a year-long study of 326 women (3,201 cycles), one pregnancy occurred,4 which compares with the efficacy of other oral contraceptives in clinical studies. Long-term studies have not been performed to determine the effectiveness of this oral contraceptive in typical use, though it should be similar to other products.
In a randomized study comparing ethinyl estradiol/drospirenone with 30 mcg ethinyl estradiol/0.15 mg desogestrel, both products produced a comparable decrease in the incidence and severity of acne.2,3 Ethinyl estradiol/drospirenone is not currently labeled for the treatment of acne.
In an original dose-ranging study comparing ethinyl estradiol/drospirenone with 30 mcg ethinyl estradiol/0.15 mcg levonorgestrel, systolic and diastolic blood pressures decreased by a range of 1 to 4 mm Hg while increasing by 1 to 2 mm Hg in the control group.1 The difference in blood pressure may have been attributed to the drospirenone component of the product. Additional clinical trials are needed to support the theoretical benefit of drospirenone in the treatment of bloating, weight gain, and blood pressure reduction.
Price: One-cycle pack (one-month supply) of ethinyl estradiol/drospirenone costs $33. The price range for other brand and generic monophasic oral contraceptives is $24 to $49, making ethinyl estradiol/drospirenone a moderately priced option. For patients who have prescription coverage for oral contraceptives, ethinyl estradiol/drospirenone is often covered.
Simplicity: Ethinyl estradiol/drospirenone is available in a 28-day dose-pack that contains 21 active yellow tablets comprised of 30 mcg ethinyl estradiol and 3 mg drospirenone, and 7 placebo white tablets.
Bottom line: An effective oral contraceptive, ethinyl estradiol/drospirenone can elevate potassium levels when given in combination with other potassium-elevating agents and offers no advantage over traditional oral contraceptives.
Monday, November 24, 2008
contraceptive
Bayer concludes supply and licensing agreements for Yasmin® and YAZ® with Barr for the United States
Appeal of court decision invalidating Yasmin patent will continue / Further growth of Bayer's Women's Healthcare Business Unit expected
Berlin/Leverkusen, June 24, 2008 - Bayer and Barr Laboratories Inc. today signed supply and licensing agreements for Yasmin® and YAZ® for the United States. Bayer will supply U.S. generics manufacturer Barr, starting July 1, 2008 at the latest, with a generic version of its oral contraceptive Yasmin, which Barr will market solely in the United States. Barr will pay Bayer a fixed percentage of the revenues from the product sold by Barr.
Bayer will continue to pursue its appeal of a March 2008 New Jersey court's decision that invalidated Bayer's U.S. patent '531 for Yasmin. If Bayer prevails in its appeal, Bayer will receive a larger share of Barr's revenues from the product.
"The agreements allow us to participate in the U.S. market for generic oral contraceptive in partnership with an established player," said Dr. Gunnar Riemann, Member of the Board of Management of Bayer HealthCare AG. "We expect our global Women's Healthcare business to continue posting high-single-digit to low-double-digit percentage annual growth rates in the coming years thanks to the products we already have on the market and to new, promising developmental products."
It has also been agreed that Bayer will grant Barr a license to market a generic version of YAZ - like Yasmin, a product in the drospirenone family - in the United States starting July 1, 2011. Bayer will supply Barr with the product for this purpose. Should Bayer lose patent lawsuits in the United States against other companies concerning YAZ, at that time Bayer will begin supplying the product to Barr and Barr will begin marketing generic YAZ in the United States. Barr will pay Bayer a fixed percentage of the revenues from the product sold by Barr.
Appeal of court decision invalidating Yasmin patent will continue / Further growth of Bayer's Women's Healthcare Business Unit expected
Berlin/Leverkusen, June 24, 2008 - Bayer and Barr Laboratories Inc. today signed supply and licensing agreements for Yasmin® and YAZ® for the United States. Bayer will supply U.S. generics manufacturer Barr, starting July 1, 2008 at the latest, with a generic version of its oral contraceptive Yasmin, which Barr will market solely in the United States. Barr will pay Bayer a fixed percentage of the revenues from the product sold by Barr.
Bayer will continue to pursue its appeal of a March 2008 New Jersey court's decision that invalidated Bayer's U.S. patent '531 for Yasmin. If Bayer prevails in its appeal, Bayer will receive a larger share of Barr's revenues from the product.
"The agreements allow us to participate in the U.S. market for generic oral contraceptive in partnership with an established player," said Dr. Gunnar Riemann, Member of the Board of Management of Bayer HealthCare AG. "We expect our global Women's Healthcare business to continue posting high-single-digit to low-double-digit percentage annual growth rates in the coming years thanks to the products we already have on the market and to new, promising developmental products."
It has also been agreed that Bayer will grant Barr a license to market a generic version of YAZ - like Yasmin, a product in the drospirenone family - in the United States starting July 1, 2011. Bayer will supply Barr with the product for this purpose. Should Bayer lose patent lawsuits in the United States against other companies concerning YAZ, at that time Bayer will begin supplying the product to Barr and Barr will begin marketing generic YAZ in the United States. Barr will pay Bayer a fixed percentage of the revenues from the product sold by Barr.
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