Xulane

Generic name: Ethinyl Estradiol And Norelgestromin
Dosage form: transdermal patch
Drug class: Contraceptives

Usage of Xulane

Xulane is a birth control patch you wear on your skin to stop you getting pregnant. Xulane contains two hormones - an estrogen and progestin - which are absorbed through the skin. It prevents pregnancy by stopping your ovaries from ovulating and releasing eggs.

Xulane is a generic version of a patch called Ortho Evra, which has been discontinued.

Xulane side effects

Hormones from Xulane get into the blood stream and are processed by the body differently than hormones from 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.

See “Important information” above.

Xulane may cause serious side effects, including:

blood clots. Like pregnancy, hormonal birth control methods increase the risk of serious blood clots (see following graph), especially in women who have other risk factors such as smoking, high blood pressure, high levels of fat in the blood, diabetes, obesity, a family history of blood clots, 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 provider 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)

To put the risk of developing a blood clot into perspective: If 10,000 women who are not pregnant and do not use hormonal birth control are followed for one year, between 1 and 5 of these women will develop a blood clot. The likelihood of developing a serious blood clot for women who use hormonal birth control is between 3 and 12, for pregnant women is between 5 and 20, and for women in the first 12 weeks after delivering a baby (postpartum) is between 40 and 65.

Call your healthcare provider 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 does not go away, check with your healthcare provider.

Less common side effects are:

acne

less sexual desire

bloating or fluid retention

blotchy darkening of your skin, especially your face

high blood sugar, especially in women with diabetes

high fat (cholesterol, triglycerides) levels in the blood

depression, especially if you have had depression in the past. Call your healthcare provider immediately if you have any thoughts of harming yourself.

problems tolerating contact lenses

weight gain

Tell your healthcare provider 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 provider or pharmacist.

Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Does hormonal birth control cause cancer?

It is not known if hormonal birth control causes breast cancer. Some studies, but not all, suggest that there could be a slight increase in the risk of breast cancer among current users with longer duration of use.

If you have breast cancer now, or have had it in the past, do not use hormonal birth control because some breast cancers are sensitive to hormones.

Women who use hormonal birth control methods may have a slightly higher chance of getting cervical cancer. However, this may be due to other reasons such as having more sexual partners.

Before taking Xulane

Xulane is not known to cause birth defects when used by accident during pregnancy.

Tell your doctor if you are breastfeeding or plan to breastfeed. Hormonal birth control methods that contain estrogen, like Xulane, may decrease the amount of milk you make. A small amount of hormones from the Xulane patch may pass into your breast milk. Consider another method of birth control until you are ready to stop breastfeeding.

Relate drugs

How to use Xulane

Xulane (is available in one strength of 150 mcg/day norelgestromin (NGMN) and 35 mcg/day ethinyl estradiol (EE).

Xulane is a 14 cm2 peach, transdermal system printed with “Xulane® (norelgestromin and ethinyl estradiol) 150/35 mcg per day” in brown ink. Each system contains 4.86 mg norelgestromin, USP and 0.53 mg ethinyl estradiol, USP.

Warnings

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.

Do not use Xulane if you have an increased risk for blood clots.

Do not use Xulane if your Body Mass Index (BMI) is 30 kg/m2 or more. Women with a BMI of 30 kg/m2 or more who use Xulane may be at a higher risk for developing blood clots compared to women with a BMI lower than 30 kg/m2.

Hormonal birth control methods help to lower the chances of becoming pregnant. They do not protect against HIV infection (AIDS) and other sexually transmitted infections.

What other drugs will affect Xulane

Tell your healthcare provider about all medicines and herbal products that you take.

Some medicines and herbal products may make hormonal birth control less effective, including, but not limited to:

certain seizure medicines (Carbamazepine, felbamate, oxcarbazepine, phenytoin, rufinamide, and topiramate)

aprepitant

barbiturates

bosentan

griseofulvin

certain combinations of HIV medicines (nelfinavir, ritonavir, ritonavir-boosted protease inhibitors)

certain non-nucleoside reverse transcriptase inhibitors (nevirapine)

rifampin and rifabutin

St. John’s wort

Use another birth control method (such as a condom and spermicide or diaphragm and spermicide) when you take medicines that may make the Xulane patch less effective.

Some medicines and grapefruit juice may increase your level of the hormone ethinyl estradiol if used together, including:

acetaminophen

ascorbic acid

medicines that affect how your liver breaks down other medicines (itraconazole, ketoconazole, voriconazole, and fluconazole)

certain HIV medicines (atazanavir, indinavir)

atorvastatin

rosuvastatin

etravirine

Hormonal birth control methods may interact with lamotrigine, an anti-seizure medicine used for epilepsy. This may increase the risk of seizures, so your healthcare provider may need to adjust the dose of lamotrigine.

Women on thyroid replacement therapy may need increased doses of thyroid hormone.

Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

Disclaimer

Every effort has been made to ensure that the information provided by Drugslib.com is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Drugslib.com information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Drugslib.com does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Drugslib.com's drug information does not endorse drugs, diagnose patients or recommend therapy. Drugslib.com's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Drugslib.com does not assume any responsibility for any aspect of healthcare administered with the aid of information Drugslib.com provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.