pharmacopeia
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Boxed warning

Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. This risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite marked in women over 35 years of age. Women who use oral contraceptives are strongly advised not to smoke.

Mechanism of action

Sourced from openFDA

Mechanism-of-action class: Progestational Hormone Receptor Agonists.

Progestational Hormone Receptor

Indications

Sourced from openFDA
  • Volnea™ (desogestrel and ethinyl estradiol and ethinyl estradiol) tablets are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. Oral contraceptives are highly effective.ICD-10: Z30.9

Contraindications

Sourced from openFDA
  • Volnea is contraindicated in females who are known to have or develop the following conditions: • Thrombophlebitis or thromboembolic disorders • A past history of deep vein thrombophlebitis or thromboembolic disorders • Cerebral vascular or coronary artery disease • Current diagnosis of, or history of, breast cancer, which may be hormone sensitive • Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia • Undiagnosed abnormal genital bleeding • Cholestatic jaundice of pregnancy or jaundice with prior pill use • Hepatic adenomas or carcinomas • Known or suspected pregnancy • Are receiving Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations (see Warnings, RISK OF LIVER ENZYME ELEVATIONS WITH CONCOMITANT HEPATITIS C TREATMENT).contraindicated

Dosage & administration

Sourced from openFDA

To achieve maximum contraceptive effectiveness, Volnea™ (desogestrel and ethinyl estradiol and ethinyl estradiol) tablets must be taken exactly as directed and at intervals not exceeding 24 hours Volnea ™ may be initiated using either a Sunday start or a Day 1 start. NOTE: Each blister card is preprinted with the days of the week, starting with Sunday, to facilitate a Sunday start regimen. Six different “day label strips” are provided with each blister card in order to accommodate a Day 1 start regimen. In this case, the patient should place the self-adhesive “day label strip” that corresponds to her starting day over the preprinted days. IMPORTANT: The possibility of ovulation and conception prior to initiation of use of Volnea ™ should be considered. The use of Volnea™ for contraception may be initiated 4 weeks postpartum in women who elect not to breast-feed. When the tablets are administered during the postpartum period, the increased risk of thromboembolic disease associated with the postpartum period must be considered (see CONTRAINDICATIONS and WARNINGS concerning thromboembolic disease. See also PRECAUTIONS for Nursing Mothers ). If the patient starts on Volnea™ postpartum, and has not yet had a period, she should be instructed to use another method of contraception until a white tablet has been taken daily for 7 days. SUNDAY START When initiating a Sunday start regimen, another method of contraception should be used until after the first 7 consecutive days of administration.

Warnings & precautions

Sourced from openFDA

Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. This risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite marked in women over 35 years of age. Women who use oral contraceptives should be strongly advised not to smoke. The use of oral contraceptives is associated with increased risks of several serious conditions including myocardial infarction, thromboembolism, stroke, hepatic neoplasia, and gallbladder disease, although the risk of serious morbidity or mortality is very small in healthy women without underlying risk factors. The risk of morbidity and mortality increases significantly in the presence of other underlying risk factors such as hypertension, hyperlipidemias, obesity, and diabetes. Practitioners prescribing oral contraceptives should be familiar with the following information relating to these risks. The information contained in this package insert is principally based on studies carried out in patients who used oral contraceptives with formulations of higher doses of estrogens and progestogens than those in common use today. The effect of long-term use of the oral contraceptives with formulations of lower doses of both estrogens and progestogens remains to be determined. Throughout this labeling, epidemiologic studies reported are of two types: retrospective or case control studies and prospective or cohort studies.

Adverse reactions

Sourced from openFDA

Post Marketing Experience Five studies that compared breast cancer risk between ever-users (current or past use) of COCs and never-users of COCs reported no association between ever use of COCs and breast cancer risk, with effect estimates ranging from 0.90 - 1.12 (Figure 1). Three studies compared breast cancer risk between current or recent COC users (<6 months since last use) and never users of COCs (Figure 1). One of these studies reported no association between breast cancer risk and COC use. The other two studies found an increased relative risk of 1.19 - 1.33 with current or recent use. Both of these studies found an increased risk of breast cancer with current use of longer duration, with relative risks ranging from 1.03 with less than one year of COC use to approximately 1.4 with more than 8- 10 years of COC use. Figure 1: Risk of Breast Cancer with Combined Oral Contraceptive Use RR = relative risk; OR = odds ratio; HR = hazard ratio. “ever COC” are females with current or past COC use; “never COC use” are females that never used COCs. For your reference, below are the studies reviewed by FDA to inform the breast cancer risk: References: 1. Marchbanks PA, McDonald JA, Wilson HG, et al. Oral contraceptives and the risk of breast cancer. N Engl J Med . 2002;346(26):2025-2032. 2. Dumeaux V, Fournier A, Lund E, Clavel-Chapelon F. Previous oral contraceptive use and breast cancer risk according to hormone replacement therapy use among postmenopausal women. Cancer Causes Control . 2005;16(5):537-544. 3. Dorjgochoo T, Shu XO, Li HL, et al.

Overdosage

Sourced from openFDA

Serious ill effects have not been reported following acute ingestion of large doses of oral contraceptives by young children. Overdosage may cause nausea, and withdrawal bleeding may occur in females.

Approval history

Sourced from openFDA
  • Aug 12, 1999ANDAANDA075256Duramed Pharms Barr
  • Apr 5, 2002ANDAANDA075863Barr
  • Feb 24, 2004ANDAANDA076455Duramed Pharms Barr
  • Apr 2, 2012ANDAANDA091346Glenmark Pharms Ltd
  • Mar 7, 2013ANDAANDA201887Lupin Ltd
  • Jul 12, 2013ANDAANDA091234Novast Labs
  • Aug 1, 2013ANDAANDA091247Novast Labs
  • Aug 30, 2013ANDAANDA202296Xiromed

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
3,968 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Pain98825%
  2. 2Fatigue96324%
  3. 3Rash95124%
  4. 4Lower Respiratory Tract Infection90723%
  5. 5Dyspnoea90223%
  6. 6Joint Swelling89523%
  7. 7Arthralgia88722%
  8. 8Drug Ineffective87822%
  9. 9Pruritus87322%
  10. 10Peripheral Swelling86722%
  11. 11Swelling84821%
  12. 12Confusional State84521%
  13. 13Sinusitis83421%
  14. 14Weight Increased83021%
  15. 15Folliculitis81320%

Literature

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Recent PubMed references pinned to Desogestrel as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 64 ClinicalTrials.gov registrations naming Desogestrel as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Desogestrel work?
Mechanism-of-action class: Progestational Hormone Receptor Agonists.
What is Desogestrel used for?
According to FDA labeling, Desogestrel carries indications including: Volnea™ (desogestrel and ethinyl estradiol and ethinyl estradiol) tablets are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. Oral contraceptives are highly effective.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Desogestrel?
Desogestrel is classified as Progestogens, Progestin, Progestational Hormone Receptor Agonists, Hypothalamic Endocrine Activity Alteration, Increased Blood Pressure.
What are the contraindications for Desogestrel?
Desogestrel labeling lists contraindications including: Volnea is contraindicated in females who are known to have or develop the following conditions: • Thrombophlebitis or thromboembolic disorders • A past history of deep vein thrombophlebitis or thromboembolic disorders • Cerebral vascular or coronary artery disease • Current diagnosis of, or history of, breast cancer, which may be hormone sensitive • Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia • Undiagnosed abnormal genital bleeding • Cholestatic jaundice of pregnancy or jaundice with prior pill use • Hepatic adenomas or carcinomas • Known or suspected pregnancy • Are receiving Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations (see Warnings, RISK OF LIVER ENZYME ELEVATIONS WITH CONCOMITANT HEPATITIS C TREATMENT).. Always consult the full prescribing information and a clinician.
Note. Data for desogestrel is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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