NuvaRing

• Organon Pharmaceuticals USA

Serious side effects have been reported with NuvaRing including the following:

• blood clots. Like pregnancy, combination 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 a combination hormonal birth control method or when you restart the same or different combination hormonal birth control method after not using it for a month or more. Talk with your healthcare provider about your risk of getting a blood clot before using NuvaRing or before 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 heart attack or stroke. Some examples of serious blood clots are blood clots in the:
  • legs (deep vein thrombosis)
  • lungs (pulmonary embolism)
  • eyes (loss of eyesight)
  • heart (heart attack)
  • brain (stroke)
• Call your healthcare provider right away if you have:
  • leg pain that does 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:

• Toxic Shock Syndrome (TSS). Some of the symptoms are much the same as the flu, but they can become serious very quickly. Call your healthcare provider or get emergency treatment right away if you have the following symptoms:
  • sudden high fever
  • vomiting
  • diarrhea
  • a sunburn-like rash
  • muscle aches
  • dizziness
  • fainting or feeling faint when standing up
• liver problems, including liver tumors
• high blood pressure
• gallbladder problems
• accidental insertion into bladder
• symptoms of a problem called angioedema if you already have a family history of angioedema

Do not use NuvaRing 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 with your blood that makes it 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 can't control
• have diabetes with kidney, eye, nerve, or blood vessel damage
• have 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
• have unexplained vaginal bleeding
• are pregnant or think you may be pregnant. NuvaRing is not for pregnant women
• have or have had breast cancer or any cancer that is sensitive to female hormones
• are allergic to etonogestrel, ethinyl estradiol or any of the ingredients in NuvaRing

Grapefruit and grapefruit juice may interact with NuvaRing and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

NuvaRing falls into category X. It has been shown that women using NuvaRing during pregnancy may have babies born with problems. There are no situations where the benefits of the medication for the mother outweigh the risks of harm to the baby. These medicines should never be used by pregnant women.

In the U.S.

• NuvaRing

Available Dosage Forms:

• Insert, Extended Release

Therapeutic Class: Contraceptive

Pharmacologic Class: Progestin

• It is used to prevent pregnancy.
• It may be given to you for other reasons. Talk with the doctor.

• If you have an allergy to ethinyl estradiol, etonogestrel, or any other part of NuvaRing.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have had any of these health problems: Blood clots, blood clotting problem, breast cancer, diseased arteries in the brain, disease of a heart valve with problems, heart disease, chest pain caused by angina, heart attack, stroke, high blood pressure, high cholesterol, a pancreas problem (pancreatitis) due to high blood triglycerides, liver disease, liver tumor, very bad headache or migraine, diabetes that affects blood flow, or tumor where estrogen makes it grow.
• If you have unexplained vaginal bleeding.
• If you turned yellow during pregnancy or with estrogen-based or hormone contraceptive use.
• If you are pregnant or may be pregnant. Do not take this medicine if you are pregnant.
• If you are breast-feeding or plan to breast-feed.
• If you are taking ombitasvir, paritaprevir, and ritonavir (with or without dasabuvir).

This is not a list of all drugs or health problems that interact with NuvaRing.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

FOR VAGINAL USE ONLY

NuvaRing® is indicated for use by females of reproductive age to prevent pregnancy.

Do not prescribe NuvaRing to women who are known to have or use the following:

• A high risk of arterial or venous thrombotic diseases. Examples include women who are known to:
  • Smoke, if over age 35 [see Boxed Warning and Warnings and Precautions (5.1)]
  • Have deep vein thrombosis or pulmonary embolism, now or in the past [see Warnings and Precautions (5.1)]
  • Have cerebrovascular disease [see Warnings and Precautions (5.1)]
  • Have coronary artery disease [see Warnings and Precautions (5.1)]
  • Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) [see Warnings and Precautions (5.1)]
  • Have inherited or acquired hypercoagulopathies [see Warnings and Precautions (5.1)]
  • Have uncontrolled hypertension [see Warnings and Precautions (5.5)]
  • Have diabetes mellitus with vascular disease [see Warnings and Precautions (5.8)]
  • Have headaches with focal neurological symptoms or migraine headaches with aura [see Warnings and Precautions (5.9)]
    • Women over age 35 with any migraine headaches [see Warnings and Precautions (5.9)]
• Liver tumors, benign or malignant or liver disease [see Warnings and Precautions (5.3) and Use in Specific Populations (8.6)]
• Undiagnosed abnormal uterine bleeding [see Warnings and Precautions (5.10)]
• Pregnancy, because there is no reason to use CHCs during pregnancy [see Use in Specific Populations (8.1)]
• Breast cancer or other estrogen- or progestin-sensitive cancer, now or in the past [see Warnings and Precautions (5.13)]
• Hypersensitivity to any of the components of NuvaRing [see Adverse Reactions (6)]
• Use of Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to potential for ALT elevations [see Warnings and Precautions (5.4)].

1. Dinger, J et. al., Cardiovascular risk associated with the use of an etonogestrel-containing vaginal ring. Obstetrics & Gynecology 2013; 122(4): 800-808.
2. Sidney, S. et. al., Recent combined hormonal contraceptives (CHCs) and the risk of thromboembolism and other cardiovascular events in new users. Contraception 2013; 87: 93–100.
3. Combined hormonal contraceptives (CHCs) and the risk of cardiovascular endpoints. Sidney, S. (primary author) http://www.fda.gov/downloads/Drugs/DrugSafety/UCM277384.pdf, accessed 23-Aug-2013.

Applicator for NuvaRing® (NEW-vah-ring)

For optional use to help insert NuvaRing.

NuvaRing is not included with the applicator.

Important:

• The applicator is designed for use with NuvaRing.
• Do not reuse the applicator; it is designed for one time use.
• Do not share the applicator with others.
• If you accidently drop the applicator, wash it with cool to lukewarm water. Do not use hot water to wash the applicator.
• Throw the applicator away in the trash immediately after use.
• Do not flush the applicator down the toilet.

The applicator is not made with natural rubber latex.

Store the applicators between 41°F to 86°F (5°C to 30°C).

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Manufactured for: Merck Sharp & Dohme Corp., a subsidiary of
MERCK & CO., INC., Whitehouse Station, NJ 08889, USA

Manufactured by: Sonoco Plastics B.V., Berkel en Rodenrijs, The Netherlands

For patent information: www.merck.com/product/patent/home.html

Copyright © 2016 Merck Sharp & Dohme B.V., a subsidiary of Merck & Co., Inc.
All rights reserved.

Revised: 09/2016

usifu-mkd920-1609r000

PRINCIPAL DISPLAY PANEL - 3 Ring Carton

For the Dispenser: Store refrigerated 2-8°C (36- 46°F).

NDC 0052-0273-03

NuvaRing®
(etonogestrel/ethinyl estradiol vaginal ring)
delivers 0.120 mg/0.015 mg per day

For Vaginal Use

Keep out of the reach of children.

This product is intended to prevent
pregnancy. It does not protect against
HIV infection (AIDS) and other sexually
transmitted diseases.

Rx only

Contains 3 Rings