Etonogestrel (Nexplanon)

Trade Name : Nexplanon

Organon USA Inc.

IMPLANT

Strength 68 mg/1

ETONOGESTREL Progesterone Congeners [CS],Progestin [EPC]

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Etonogestrel (Nexplanon) which is also known as Nexplanon and Manufactured by Organon USA Inc.. It is available in strength of 68 mg/1 per ml. Read more

Etonogestrel (Nexplanon) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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NEXPLANON is indicated for use by women to prevent pregnancy.
NEXPLANON is a progestin indicated for use by women to prevent pregnancy. ()

The efficacy of NEXPLANON does not depend on daily, weekly or monthly administration.
All healthcare providers should receive instruction and training prior to performing insertion and/or removal of NEXPLANON.
A single NEXPLANON implant is inserted subdermally just under the skin at the inner side of the non-dominant upper arm. The insertion site is overlying the triceps muscle about 8-10 cm (3-4 inches) from the medial epicondyle of the humerus and 3-5 cm (1.25-2 inches) posterior to (below) the sulcus (groove) between the biceps and triceps muscles. This location is intended to avoid the large blood vessels and nerves lying within and surrounding the sulcus (See , and ). An implant inserted more deeply than subdermally (deep insertion) may not be palpable and the localization and/or removal can be difficult or impossible n
NEXPLANON must be inserted by the expiration date stated on the packaging. NEXPLANON is a long-acting (up to 3 years), reversible, hormonal contraceptive method. The implant must be removed by the end of the third year and may be replaced by a new implant at the time of removal, if continued contraceptive protection is desired.
Insert one NEXPLANON subdermally just under the skin at the inner side of the non-dominant upper arm. NEXPLANON must be removed no later than by the end of the third year. ()

Single, white/off-white, soft, radiopaque, flexible, ethylene vinyl acetate (EVA) copolymer implant, 4 cm in length and 2 mm in diameter containing 68 mg etonogestrel, 15 mg of barium sulfate and 0.1 mg of magnesium stearate.
NEXPLANON consists of a single, radiopaque, rod-shaped implant, containing 68 mg etonogestrel, pre-loaded in the needle of a disposable applicator. ()

NEXPLANON should not be used in women who have

Known or suspected pregnancy. ()
Current or past history of thrombosis or thromboembolic disorders. (, )
Liver tumors, benign or malignant, or active liver disease. (, )
Undiagnosed abnormal genital bleeding. (, )
Known or suspected breast cancer, personal history of breast cancer, or other progestin-sensitive cancer, now or in the past. (, )
Allergic reaction to any of the components of NEXPLANON. (, )

The following information is based on experience with the etonogestrel implants (IMPLANON and/or NEXPLANON), other progestin-only contraceptives, or experience with combination (estrogen plus progestin) oral contraceptives.

Insertion and removal complications: Pain, paresthesias, bleeding, hematoma, scarring or infection may occur. ()
Menstrual bleeding pattern: Counsel women regarding changes in bleeding frequency, intensity, or duration. ()
Ectopic pregnancies: Be alert to the possibility of an ectopic pregnancy in women using NEXPLANON who become pregnant or complain of lower abdominal pain. ()
Thrombotic and other vascular events: The NEXPLANON implant should be removed in the event of a thrombosis. ()
Liver disease: Remove the NEXPLANON implant if jaundice occurs. ()
Elevated blood pressure: The NEXPLANON implant should be removed if blood pressure rises significantly and becomes uncontrolled. ()
Carbohydrate and lipid metabolic effects: Monitor prediabetic and diabetic women using NEXPLANON. ()

The following adverse reactions reported with the use of hormonal contraception are discussed elsewhere in the labeling:
Most common (u226510%) adverse reactions reported in clinical trials were change in menstrual bleeding pattern, headache, vaginitis, weight increase, acne, breast pain, abdominal pain, and pharyngitis. ()
To report SUSPECTED ADVERSE REACTIONS, contact Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., at 1-877-888-4231 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Consult the labeling of concurrently-used drugs to obtain further information about interactions with hormonal contraceptives or the potential for enzyme alterations.
Drugs or herbal products that induce certain enzymes, such as CYP3A4, may decrease the effectiveness of progestin hormonal contraceptives or increase breakthrough bleeding. ()

No data

Pregnancy: Discontinue if maintaining a pregnancy. ()
Overweight women: NEXPLANON may become less effective in overweight women over time, especially in the presence of other factors that decrease etonogestrel concentrations, such as concomitant use of hepatic enzyme inducers. ()

Overdosage may result if more than one implant is inserted. In case of suspected overdose, the implant should be removed.

NEXPLANON is a radiopaque, progestin-only, soft, flexible implant preloaded in a sterile, disposable applicator for subdermal use. The implant is white/off-white, non-biodegradable and 4 cm in length with a diameter of 2 mm (see ). Each implant consists of an ethylene vinyl acetate (EVA) copolymer core, containing 68 mg of the synthetic progestin etonogestrel, barium sulfate (radiopaque ingredient), and may also contain magnesium stearate, surrounded by an EVA copolymer skin. Once inserted subdermally, the release rate is 60-70 mcg/day in week 5-6 and decreases to approximately 35-45 mcg/day at the end of the first year, to approximately 30-40 mcg/day at the end of the second year, and then to approximately 25-30 mcg/day at the end of the third year. NEXPLANON is a progestin-only contraceptive and does not contain estrogen. NEXPLANON does not contain latex.
Etonogestrel [13-Ethyl-17-hydroxy-11-methylene-18,19-dinor-17u03b1-pregn-4-en-20-yn-3-one], structurally derived from 19-nortestosterone, is the synthetic biologically active metabolite of the synthetic progestin desogestrel. It has a molecular weight of 324.46 and the following structural formula (Figure 20).

No data

In a 24-month carcinogenicity study in rats with subdermal implants releasing 10 and 20 mcg etonogestrel per day (equal to approximately 1.8-3.6 times the systemic steady state exposure in women using NEXPLANON), no drug-related carcinogenic potential was observed. Etonogestrel was not genotoxic in the Ames/Salmonella reverse mutation assay, the chromosomal aberration assay in Chinese hamster ovary cells or in the mouse micronucleus test. Fertility in rats returned after withdrawal from treatment.

No data

No data

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Manufactured for: Merck Sharp & Dohme Corp., a subsidiary ofn Whitehouse Station, NJ 08889, USA
Manufactured by: N.V. Organon, Oss, The Netherlands, a subsidiary of , Whitehouse Station, NJ 08889, USA
For patent information: www.merck.com/product/patent/home.html
Copyright u00a9 2011-2019 Merck Sharp & Dohme B.V., a subsidiary of n All rights reserved.
uspi-mk8415-iptx-1911r022

FDA-Approved Patient Labeling
NEXPLANON (etonogestrel implant) Radiopaque Subdermal Use Only
NEXPLANON does not protect against HIV infection (the virus that causes AIDS) or other sexually transmitted diseases.
Read this Patient Information leaflet carefully before you decide if NEXPLANON is right for you. This information does not take the place of talking with your healthcare provider. If you have any questions about NEXPLANON, ask your healthcare provider.
What is NEXPLANON?
NEXPLANON is a hormone-releasing birth control implant for use by women to prevent pregnancy for up to 3 years. The implant is a flexible plastic rod about the size of a matchstick that contains a progestin hormone called etonogestrel. It contains a small amount of barium sulfate so that the implant can be seen by X-ray, and may also contain magnesium stearate. Your healthcare provider will insert the implant just under the skin of the inner side of your upper arm. You can use a single NEXPLANON implant for up to 3 years. NEXPLANON does not contain estrogen.
What if I need birth control for more than 3 years?
The NEXPLANON implant must be removed after 3 years. Your healthcare provider can insert a new implant under your skin after taking out the old one if you choose to continue using NEXPLANON for birth control.
What if I change my mind about birth control and want to stop using NEXPLANON before 3 years?
Your healthcare provider can remove the implant at any time. You may become pregnant as early as the first week after removal of the implant. If you do not want to get pregnant after your healthcare provider removes the NEXPLANON implant, you should start another birth control method right away.
How does NEXPLANON work?
NEXPLANON prevents pregnancy in several ways. The most important way is by stopping the release of an egg from your ovary. NEXPLANON also thickens the mucus in your cervix and this change may keep sperm from reaching the egg. NEXPLANON also changes the lining of your uterus.
How well does NEXPLANON work?
When the NEXPLANON implant is placed correctly, your chance of getting pregnant is very low (less than 1 pregnancy per 100 women who use NEXPLANON for 1 year). It is not known if NEXPLANON is as effective in very overweight women because studies did not include many overweight women.
The following chart shows the chance of getting pregnant for women who use different methods of birth control. Each box on the chart contains a list of birth control methods that are similar in effectiveness. The most effective methods are at the top of the chart. The box on the bottom of the chart shows the chance of getting pregnant for women who do not use birth control and are trying to get pregnant.
Arrayn- Who should not use NEXPLANON?
Do not use NEXPLANON if you:
Tell your healthcare provider if you have or have had any of the conditions listed above. Your healthcare provider can suggest a different method of birth control.
In addition, talk to your healthcare provider about using NEXPLANON if you:
Arrayn- Interaction with Other Medicines
Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements. Certain medicines may make NEXPLANON less effective, including:
Ask your healthcare provider if you are not sure if your medicine is one listed above.
If you are taking medicines or herbal products that might make NEXPLANON less effective, you and your doctor may decide to leave NEXPLANON in place; in that case, an additional non-hormonal contraceptive should be used. Because the effect of another medicine on NEXPLANON may last up to 28 days after stopping the medicine, it is necessary to use the additional non-hormonal contraceptive for that long.
When you are using NEXPLANON, tell all of your healthcare providers that you have NEXPLANON in place in your arm.
Arrayn- How is the NEXPLANON implant placed and removed?
Your healthcare provider will place and remove the NEXPLANON implant in a minor surgical procedure in his or her office. The implant is placed just under the skin on the inner side of your non-dominant upper arm.
The timing of insertion is important. Your healthcare provider may:
Your healthcare provider will cover the site where NEXPLANON was placed with 2 bandages. Leave the top bandage on for 24 hours. Keep the smaller bandage clean, dry, and in place for 3 to 5 days.
Immediately after the NEXPLANON implant has been placed, you and your healthcare provider should check that the implant is in your arm by feeling for it.
If you cannot feel the implant immediately after insertion, the implant may not have been inserted, or it may have been inserted deeply. A deep insertion may cause problems with locating and removing the implant. Once the healthcare professional has located the implant, it should be removed.
If at any time you cannot feel the NEXPLANON implant, contact your healthcare provider immediately and use a non-hormonal birth control method (such as condoms) until your healthcare provider confirms that the implant is in place.
Depending on the exact position of the implant, removal may be difficult and may require surgery.
You will be asked to review and sign a consent form prior to inserting the NEXPLANON implant. You will also get a USER CARD to keep at home with your health records. Your healthcare provider will fill out the USER CARD with the date the implant was inserted and the date the implant is to be removed. Keep track of the date the implant is to be removed. Schedule an appointment with your healthcare provider to remove the implant on or before the removal date.
Be sure to have checkups as advised by your healthcare provider.
Arrayn- What are the most common side effects I can expect while using NEXPLANON?
u2022 n
The most common side effect of NEXPLANON is a change in your normal menstrual bleeding pattern. In studies, one out of ten women stopped using the implant because of an unfavorable change in their bleeding pattern. You may experience longer or shorter bleeding during your periods or have no bleeding at all. The time between periods may vary, and in between periods you may also have spotting.
Tell your healthcare provider right away if:
Besides changes in menstrual bleeding patterns, other frequent side effects that caused women to stop using the implant include:
Other common side effects include:
Implants have been reported to be found in a blood vessel, including a blood vessel in the lung which can be associated with shortness of breath, cough and/or the coughing up of blood or blood-stained mucus.
This is not a complete list of possible side effects. For more information, ask your healthcare provider for advice about any side effects that concern you. You may report side effects to the FDA at 1-800-FDA-1088.
Arrayn- What are the possible risks of using NEXPLANON?
u2022 n
The implant may not be placed in your arm at all due to a failed insertion. If this happens, you may become pregnant. Immediately after insertion, and with help from your healthcare provider, you should be able to feel the implant under your skin. If you can't feel the implant, tell your healthcare provider.
Location and removal of the implant may be difficult or impossible because the implant is not where it should be. Special procedures, including surgery in the hospital, may be needed to remove the implant. If the implant is not removed, then the effects of NEXPLANON will continue for a longer period of time.
Implants have been found in the pulmonary artery (a blood vessel in the lung). If the implant cannot be found in the arm, your healthcare professional may use x-rays or other imaging methods on the chest. If the implant is located in the chest, surgery may be needed.
Other problems related to insertion and removal are:
u2022 n
If you become pregnant while using NEXPLANON, you have a slightly higher chance that the pregnancy will be ectopic (occurring outside the womb) than do women who do not use birth control. Unusual vaginal bleeding or lower stomach (abdominal) pain may be a sign of ectopic pregnancy. Ectopic pregnancy is a medical emergency that often requires surgery. Ectopic pregnancies can cause serious internal bleeding, infertility, and even death. Call your healthcare provider right away if you think you are pregnant or have unexplained lower stomach (abdominal) pain.
u2022 n
Cysts may develop on the ovaries and usually go away without treatment but sometimes surgery is needed to remove them.
u2022 n
It is not known whether NEXPLANON use changes a woman's risk for breast cancer. If you have breast cancer now, or have had it in the past, do not use NEXPLANON because some breast cancers are sensitive to hormones.
u2022 n
NEXPLANON may increase your chance of serious blood clots, especially if you have other risk factors such as smoking. It is possible to die 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:
The risk of serious blood clots is increased in women who smoke. If you smoke and want to use NEXPLANON, you should quit. Your healthcare provider may be able to help.
Tell your healthcare provider at least 4 weeks before if you are going to have surgery or will need to be on bed rest. You have an increased chance of getting blood clots during surgery or bed rest.
u2022 n
A few women who use birth control that contains hormones may get:
u2022 n
If you feel that the implant may have broken or bent while in your arm, contact your healthcare provider.
Arrayn- When should I call my healthcare provider?
Call your healthcare provider right away if you have:
Arrayn- What if I become pregnant while using NEXPLANON?
You should see your healthcare provider right away if you think that you may be pregnant. It is important to remove the implant and make sure that the pregnancy is not ectopic (occurring outside the womb). Based on experience with other hormonal contraceptives, NEXPLANON is not likely to cause birth defects.
Arrayn- Can I use NEXPLANON when I am breastfeeding?
If you are breastfeeding your child, you may use NEXPLANON if 4 weeks have passed since you had your baby. A small amount of the hormone contained in NEXPLANON passes into your breast milk. The health of breast-fed children whose mothers were using the implant has been studied up to 3 years of age in a small number of children. No effects on the growth and development of the children were seen. If you are breastfeeding and want to use NEXPLANON, talk with your healthcare provider for more information.
Additional Information
This Patient Information leaflet contains important information about NEXPLANON. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider for information about NEXPLANON that is written for healthcare professionals. You may also call 1-800-622-4477 or visit www.NEXPLANON-USA.com.

Manufactured for: Merck Sharp & Dohme Corp., a subsidiary ofn Whitehouse Station, NJ 08889, USA
Manufactured by: N.V. Organon, Oss, The Netherlands, a subsidiary of, Whitehouse Station, NJ 08889, USA
For patent information: www.merck.com/product/patent/home.html
Copyright u00a9 2011-2019 Merck Sharp & Dohme B.V., a subsidiary of n All rights reserved.
Revised: 10/2019
usppi-mk8415-iptx-1910r020

NDC 0052-4330-011 applicator containing 1 subdermal implant
Nexplanonn (etonogestrel implant) 68 mg Radiopaque Subdermal Use Only
This product is intended to prevent pregnancy. It does not protect against HIV infection (AIDS) and other sexually transmitted diseases. Rx only

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Etonogestrel (Nexplanon)

Trade Name : Nexplanon

IMPLANT

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

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Etonogestrel (Nexplanon)

Trade Name : Nexplanon

IMPLANT

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

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