INN monograph
Ethinyloestradiol / Desogestrel contraceptive
Therapeutic agent (verify pharmacological class) · POM
Verified · Updated 01 Aug 2026 · Source: Local active-ingredient clinical extract; Component monographs (multi-source pipeline); Professional class pharmacology (Therapeutic agent (verify pharmacological class))
Kenya market
Wholesale / list prices where loaded
Risk first
Contraindications
- [From component Desogestrel] CONTRAINDICATIONS 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).
Precautions
- [From component Desogestrel] WARNINGS 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.
- Case control studies provide a measure of the relative risk of a disease, namely, a ratio of the incidence of a disease among oral contraceptive users to that among non-users.
- The relative risk does not provide information on the actual clinical occurrence of a disease.
- Cohort studies provide a measure of attributable risk, which is the difference in the incidence of disease between oral contraceptive users and non-users.
Point of care
Dosing
Adult
Dosing is indication-, age-, weight- and organ-function-specific for this INN. Do not use class averages for high-risk patients. Confirm the exact regimen in the current SmPC and Kenya Standard Treatment Guidelines. Typical professional workflow: (1) confirm indication, (2) check renal/hepatic function, (3) screen interactions/allergies, (4) select dose/route/duration, (5) define monitoring.
Paediatric
Paediatric dosing is weight- and age-based; use a paediatric formulary / SmPC. Do not extrapolate adult tablets without calculation.
Renal
Review renal impairment dosing; many agents need CrCl/eGFR adjustment.
- CrCl 0–120: Confirm renal dosing in product SmPC / primary label.
Hepatic
Review hepatic impairment dosing; monitor LFTs if agent is hepatically cleared or hepatotoxic.
Safety
Drug interactions
- Professional use: confirm indication, dose, duration, monitoring and patient counselling points against current Kenya STG / EML and the product SmPC.
- Document allergy status and key interactions.
Safety
Adverse effects
- [From component Desogestrel] ADVERSE REACTIONS 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.
Use
Indications
- Therapeutic use is agent- and indication-specific within the class (Therapeutic agent (verify pharmacological class)).
- Use according to culture results, national guidelines (Kenya STG/EML where applicable) and the current product SmPC.
- Contraception
Pharmacology
Mode of action
Mechanism is agent-specific.
Full mechanism text
Mechanism is agent-specific. At receptor, enzyme, ion channel, transporter or microbial target level, the drug alters a physiological or pathological pathway to produce its therapeutic effect. Confirm precise molecular mechanism in current SmPC / pharmacology reference for this INN before high-stakes decisions.
ADME
Pharmacokinetics & PD
| Onset | Product-specific |
|---|---|
| Duration | Product-specific |
| Route | See product SmPC |
| Elimination | are product-specific. Consider food effects, protein binding, hepatic CYP/UGT |
| Half-life | when adjusting for organ impairment, age and drug interactions. Verify parameters in the current SmPC. |
Full PK/PD text
Absorption, distribution, metabolism and excretion are product-specific. Consider food effects, protein binding, hepatic CYP/UGT metabolism, renal clearance and half-life when adjusting for organ impairment, age and drug interactions. Verify parameters in the current SmPC.
Kenya
Brands & prices
| Brand | Company | Pack | KES |
|---|---|---|---|
| Ethinyloestradiol/Desogestrel, by Metro | Distributed by Metro Pharmaceuticals Limited | Standard Commercial Pack | — |
Special populations
Pregnancy & lactation
Pregnancy
[Ethinyloestradiol] [From component Norelgestromin] 8.1 Pregnancy There is little or no increased risk of birth defects in women who inadvertently use hormonal contraceptives during early pregnancy. Epidemiologic studies and meta-analyses have not found an increased risk of genital or non-genital birth defects (including cardiac anomalies and limb reduction defects) following exposure to low dose hormonal contraceptives prior to conception or during early pregnancy. The administration of hormonal contraceptives to induce withdrawal bleeding should not be used as a test for pregnancy. Hormonal contraceptives should not be used during pregnancy to treat threatened or habitual abortion. [Desogestrel contraceptive] Use only if potential benefit justifies potential risk; prefer agents with better reproductive data when alternatives exist.
Lactation
[Ethinyloestradiol] [From component Norelgestromin] 8.3 Nursing Mothers The effects of norelgestromin and ethinyl estradiol transdermal system in nursing mothers have not been evaluated and are unknown. When possible, advise the nursing mother to use other forms of contraception until she has completely weaned her child. Estrogen-containing CHCs can reduce milk production in breastfeeding mothers. This is less likely to occur once breastfeeding is well-established; however, it can occur at any time in some women. Small amounts of contraceptive steroids and/or metabolites are present in breast milk. [Desogestrel contraceptive] Assess infant risk vs benefit of maternal therapy; prefer agents with lactation data.
Diet
Food & alcohol
- Food
- Food
Trust
Sources & disclaimer
Source: Local active-ingredient clinical extract; Component monographs (multi-source pipeline); Professional class pharmacology (Therapeutic agent (verify pharmacological class))
Last reviewed: 01 Aug 2026
Decision support only — not a substitute for clinical judgment, product SmPC, or Kenya STG/EML.