Mylan Among CDC Partners in Zika Fight

Xulane Patch helps mitigate Zika

September 23, 2015


The CDC Foundation recently invited Mylan to be a partner in the ongoing fight against the Zika virus that has been linked to causing pregnancy complications and birth defects. Through this collaboration, Mylan’s Xulane® (norelgestromin/ethinyl estradiol transdermal system) birth control patches will be provided for free to women in Puerto Rico. While Xulane is not indicated as a treatment for Zika, it can be used to help prevent pregnancy in women choosing to use birth control.

Women who smoke and are over 35 years old should not use Xulane. Women who use Xulane will be exposed to about 60% more estrogen than a typical birth control pill. In general, increased estrogen may increase the risk of side effects, including blood clots. Please see the Boxed Warning and additional Important Safety Information about Xulane below.

The CDC Foundation, an independent nonprofit organization that supports the CDC’s mission of improving health, is coordinating the Zika Contraception Access Network (Z-CAN). According to the CDC Foundation, more than 65% of pregnancies in Puerto Rico are unplanned. In conjunction with healthcare services for women, Z-CAN is providing contraceptive options on the same day to women who want to delay or prevent pregnancies due to risks for birth defects caused by Zika virus. After determining Xulane is an appropriate choice to meet a woman's birth control needs, Mylan's Xulane will be given at no cost. Mylan has agreed to donate more than 20,000 patches for more than 1,500 women as part of the program.

In Puerto Rico, which has become one of the regions hardest hit by Zika, access to contraceptives is limited by high costs, insurance barriers, a lack of knowledge and other factors. Playing a part in providing women the help they need in preventing or delaying pregnancy due to the serious threats posed by the Zika virus is another way Mylan remains committed to its mission of providing the world’s 7 billion people access to high quality medicine.

Click here to learn more about Xulane.

Boxed WARNING

What is the most important information I should know about Xulane?

Do not use Xulane if you smoke cigarettes and are over 35 years old. Smoking increases your risk of serious cardiovascular side effects from hormonal birth control methods, including death from heart attack, blood clots or stroke. This risk increases with age and the number of cigarettes you smoke.

Women 15 to 44 years of age who use Xulane may have an increased risk of blood clots compared to women who use certain birth control pills.

You will be exposed to about 60% more estrogen if you use Xulane than if you use a typical birth control pill containing 35 micrograms of estrogen. In general, increased estrogen may increase the risk of side effects, including blood clots.

See full Prescribing Information for complete Boxed WARNING.

What is Xulane?

Xulane is a birth control patch available by prescription only. It contains two female hormones, an estrogen called ethinyl estradiol, and a progestin called norelgestromin.

Xulane may not be as effective in women who weigh more than 198 lbs. (90 kg.) Hormonal birth control methods help lower the chances of becoming pregnant. They do not protect against HIV infection (AIDS) and other sexually transmitted infections.

IMPORTANT SAFETY INFORMATION

Who should not use Xulane?

Do not use Xulane if you:

  • Smoke and are over 35 years old
  • Have or have had blood clots in your arms, legs, eyes or lungs
  • Have an inherited problem that makes your blood clot more than normal
  • Have had a stroke
  • Have had a heart attack
  • Have certain heart valve problems or heart rhythm problems that can cause blood clots to form in the heart
  • Have high blood pressure that medicine cannot control
  • Have diabetes with kidney, eye, nerve, or blood vessel damage
  • Have had certain kinds of severe migraine headaches with aura, numbness, weakness or changes in vision, or have any migraine headaches if you are over age 35
  • Have liver disease, including liver tumors (benign or cancerous)
  • Have unexplained vaginal bleeding
  • Are pregnant or think you may be pregnant. However, Xulane is not known to cause birth defects when used by accident during pregnancy.
  • Have had breast cancer or any cancer that is sensitive to female hormones

Hormonal birth control methods may not be a good choice for you if you have ever had jaundice (yellowing of the skin or eyes) caused by pregnancy or related to previous use of hormonal birth control.

Tell your healthcare professional if you have ever had any of the above conditions. Your healthcare professional may recommend another method of birth control.

What are the possible side effects of Xulane?

Xulane may cause serious side effects, including:

  • Blood clots. Like pregnancy, hormonal birth control methods increase the risk of serious blood clots, especially in women who have other risk factors, such as smoking, obesity, or age greater than 35. This increased risk is highest when you first start using hormonal birth control and when you restart the same or different hormonal birth control after not using it for a month or more. Some studies have reported that women who use norelgestromin and ethinyl estradiol transdermal system have a higher risk of getting a blood clot. Talk with your healthcare professional about your risk of getting a blood clot before using Xulane or deciding which type of birth control is right for you.

It is possible to die or be permanently disabled from a problem caused by a blood clot, such as a heart attack or a stroke. Some examples of serious blood clots are blood clots in the:

  • legs (deep vein thrombosis)
  • lungs (pulmonary embolus)
  • eyes (loss of eyesight)
  • heart (heart attack)
  • brain (stroke)

Call your healthcare professional right away if you have:

  • leg pain that will not go away
  • sudden shortness of breath
  • sudden blindness, partial or complete
  • severe pain or pressure in your chest
  • sudden, severe headache unlike your usual headaches
  • weakness or numbness in an arm or leg, or trouble speaking
  • yellowing of the skin or eyeballs

Other serious risks include:

  • liver problems including liver tumors
  • gallbladder disease
  • high blood pressure

The most common side effects of Xulane are:

  • breast symptoms (discomfort, swelling, or pain)
  • nausea
  • headache
  • skin irritation, redness, pain, swelling, itching or rash at the patch application site
  • stomach pain
  • pain during menstruation
  • vaginal bleeding and menstrual disorders, such as spotting or bleeding between periods
  • mood, affect and anxiety disorders

Some women have spotting or light bleeding, breast tenderness, or feel sick to their stomach during norelgestromin and ethinyl estradiol transdermal system use. If these symptoms occur, do not stop using the Xulane patch. The problem will usually go away. If it doesn't go away, check with your healthcare professional.

Tell your healthcare professional about any side effect that bothers you or that does not go away.

These are not all the possible side effects of Xulane. For more information, ask your healthcare professional or pharmacist.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

This is not all of the information you should read prior to using Xulane. Please click here to see Patient Information and full Prescribing Information.