Desogestrel

Desogestrel

Desogestrel structure

What is Desogestrel?

Desogestrel, sold under the brand name Marvelon among many others, is a progestin medication which is used in birth control pills for women. Its a synthetic progestogen structurally related to levonorgestrel.

Desogestrel molecule ball

What are the uses of this medicine?

Desogestrel is used in hormonal contraception in women, specifically in birth control pills. It is used alone in progestogen-only pills ("mini pills") and in combination with the estrogen ethinylestradiol in combined oral contraceptive pills. Along with norethisterone, it is one of the only progestins that is widely used as a progestogen-only "mini pill". It is also the only newer-generation progestin with reduced androgenic activity that is used in such formulations.

In addition to hormonal contraception, desogestrel has been used in combination with estrogens such as estradiol as a component of menopausal hormone therapy. The medication has also been used in the treatment of endometriosis.

How does this medicine work?

Combination oral contraceptives act by suppression of gonadotropins. Although the primary mechanism of this action is inhibition of ovulation, other alterations include changes in the cervical mucus (which increase the difficulty of sperm entry into the uterus) and the endometrium (which reduce the likelihood of implantation).

Who Should Not Use this medicine?

Contraindications of desogestrel include:

• Allergy to desogestrel or any other ingredients
• Active thrombosis (deep vein thrombosis or pulmonary embolism)
• Jaundice or severe liver disease
• Hormone-sensitive cancers (e.g., breast cancer)
• Unexplained vaginal bleeding
• Desogestrel is not indicated for use in pregnancy.

It is not contraindicated during lactation and breastfeeding

Is this medicine FDA approved?

Yes

How should this medicine be used?

• BE SURE TO READ THESE DIRECTIONS:

Before you start taking your pills.

Anytime you are not sure what to do.

• THE RIGHT WAY TO TAKE THE PILL IS TO TAKE ONE PILL EVERY DAY AT THE SAME TIME.

If you miss pills you could get pregnant. This includes starting the pack late.

The more pills you miss, the more likely you are to get pregnant.

• MANY WOMEN HAVE SPOTTING OR LIGHT BLEEDING, OR MAY FEEL SICK TO THEIR STOMACH DURING THE FIRST 1 TO 3 PACKS OF PILLS.

If you feel sick to your stomach, do not stop taking the pill. The problem will usually go away. If it doesn’t go away, check with your doctor or healthcare provider.

• MISSING PILLS CAN ALSO CAUSE SPOTTING OR LIGHT BLEEDING, even when you make up these missed pills.

On the days you take 2 pills to make up for missed pills, you could also feel a little sick to your stomach.

• IF YOU HAVE VOMITING OR DIARRHEA, for any reason, or IF YOU TAKE SOME MEDICINES, including some antibiotics, your pills may not work as well.

Use a back-up method (such as condoms, foam, or sponge) until you check with your doctor or healthcare provider.

• IF YOU HAVE TROUBLE REMEMBERING TO TAKE THE PILL, talk to your doctor or healthcare provider about how to make pill-taking easier or about using another method of birth control.

• IF YOU HAVE ANY QUESTIONS OR ARE UNSURE ABOUT THE INFORMATION IN THIS LEAFLET, call your doctor or healthcare provider.

What are the dosage forms and brand names of this medicine?

Desogestrel is available alone in the form of 75 μg oral tablets and at a dose of 150 μg in combination with 20 or 30 μg ethinylestradiol in oral tablets. These formulations are all indicated specifically for contraceptive purposes.

Kariva® (desogestrel/ethinyl estradiol and ethinyl estradiol tablets USP) contains 21 round, white, film-coated, biconvex tablets, 2 round, light-green tablets and 5 round, light-blue, film-coated, biconvex tablets in a blister card. Each white tablet (debossed with “dp” on one side and “021” on the other side) contains 0.15 mg desogestrel and 0.02 mg ethinyl estradiol, USP. Each light-green tablet (debossed with “dp” on one side and “331” on the other side) contains inert ingredients. Each light-blue tablet (debossed with “dp” on one side and “022” on the other side) contains 0.01 mg ethinyl estradiol, USP.

Box of 6 Blister Cards (NDC: 0555-9050-58)

What side effects can this medication cause?

Common side effects of desogestrel may include menstrual irregularities, amenorrhea, headaches, nausea, breast tenderness, and mood changes (e.g., depression), as well as weight gain, acne, and hirsutism.

Uncommon side effects of desogestrel may include vaginal infection, contact lens intolerance, vomiting, hair loss, dysmenorrhea, ovarian cysts, and fatigue, while rare side effects include rash, urticaria, and erythema nodosum.

Breast discharge, ectopic pregnancies, and aggravation of angioedema may also occur with desogestrel.

Serious side effects of combined oral contraceptives containing desogestrel may include venous thromboembolism, arterial thromboembolism, hormone-dependent tumors (e.g., liver tumors, breast cancer), and melasma.

What special precautions should I follow?

Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

• Lipid disorders

Women who are being treated for hyperlipidemias should be followed closely if they elect to use oral contraceptives. Some progestogens may elevate LDL levels and may render the control of hyperlipidemias more difficult.

• Liver function

If jaundice develops in any woman receiving such drugs, the medication should be discontinued. Steroid hormones may be poorly metabolized in patients with impaired liver function.

• Fluid retention

Oral contraceptives may cause some degree of fluid retention. They should be prescribed with caution, and only with careful monitoring, in patients with conditions which might be aggravated by fluid retention.

• Emotional disorders

Women with a history of depression should be carefully observed and the drug discontinued if depression recurs to a serious degree.

• Contact lenses

Contact lens wearers who develop visual changes or changes in lens tolerance should be assessed by an ophthalmologist.

• Drug interactions

Do not co-administer Kariva with HCV drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to potential for ALT elevations

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

Desogestrel is not indicated for use in pregnancy.

Teratogenic Effects : Pregnancy Category X

It is not contraindicated during lactation and breastfeeding. In addition, oral contraceptives given in the postpartum period may interfere with lactation by decreasing the quantity and quality of breast milk. If possible, the nursing mother should be advised not to use oral contraceptives but to use other forms of contraception until she has completely weaned her child.

Can this medicine be used in children?

Safety and efficacy of Kariva tablets have been established in women of reproductive age. Safety and efficacy are expected to be the same for postpubertal adolescents under the age of 16 and for users 16 years and older. Use of this product before menarche is not indicated.

What should I know about storage and disposal of this medication?

Store at 20° to 25°C (68° to 77°F)