Alyssa contains estrogen and progestin and has strict contraindications. Some patients are at higher risk due to underlying diseases or physiological conditions and should not use it or need special caution.
I. Absolute contraindications
1. Allergy and malignant tumor‑related contraindications
(1) Contraindicated in patients with a history of allergy to any component of the estetrol‑drospirenone combination tablet.
(2) Contraindicated in patients with confirmed or suspected estrogen‑dependent malignant tumors (e.g., breast cancer, endometrial cancer, cervical cancer) and in those with undiagnosed abnormal genital bleeding, because estrogen may stimulate tumor growth or mask signs of malignancy.
2. Thromboembolic disorders and hypercoagulable states
(1) Contraindicated in patients with a history or current diagnosis of thrombophlebitis, pulmonary embolism, cerebrovascular disorders, or coronary artery disease.
(2) This product may enhance blood coagulability and worsen the above conditions.
(3) In addition, antiphospholipid antibody syndrome, hereditary thrombotic tendency, diabetes with vascular complications, uncontrolled hypertension, and dyslipidemia are also contraindicated.
3. Severe hepatic or renal impairment and specific medical history
(1) Contraindicated in patients with severe hepatic dysfunction or liver tumors.
(2) Contraindicated in patients with severe renal insufficiency or acute kidney injury, because drospirenone's anti‑aldosterone effect may further elevate serum potassium.
(3) Contraindicated in patients who experienced jaundice, persistent pruritus, or gestational herpes during pregnancy, as recurrence may occur upon re‑use.
4. Lifestyle and age‑related contraindications
(1) Contraindicated in patients aged 35 years or older who smoke 15 or more cigarettes per day, due to a synergistic increase in myocardial infarction risk.
(2) Contraindicated in patients with migraine with aura, due to higher cerebrovascular event risk.
(3) Contraindicated in patients with open epiphyses, as it may affect bone growth.
II. Comorbidities and at‑risk populations requiring careful evaluation
1. Cardiovascular and metabolic risks
(1) In women over 40 years of age (excluding smokers), the risk of cardiovascular events increases with use of this product, and a strict benefit‑risk assessment is required.
(2) Patients with mild hypertension should also be vigilant about elevated blood pressure and thrombotic risk. In obese individuals and those with a family history of thrombosis, the likelihood of thromboembolic events during treatment is increased; enhanced monitoring and weight control are recommended.
2. Breast and reproductive system disorders
(1) Patients with a past history of breast cancer should not use this product because estrogen may cause recurrence.
(2) Patients with a family history of breast cancer or breast nodules should undergo regular breast specialist examinations and decide on medication under strict medical supervision.
(3) In patients with uterine fibroids, the fibroids may enlarge during treatment, and regular imaging follow‑up is required.
3. Migraine and mood disorders
(1) Patients with migraine without aura also need caution, as it may increase stroke risk.
(2) If headache worsens or neurological symptoms appear after taking the drug, the drug should be stopped immediately and medical attention sought.
III. Recommendations for special physiological states
1. Pregnant and breastfeeding women
(1) Absolute contraindication in pregnant women or those who may become pregnant.
(2) Use during breastfeeding is not recommended; similar drugs are excreted in breast milk and may cause neonatal jaundice or breast enlargement.
2. Preconception and timing of discontinuation
(1) Women planning pregnancy should stop using this product in advance and wait for natural menstrual cycles to resume before attempting conception.
(2) It is not recommended to attempt pregnancy immediately after stopping the drug, as cycle disruption may interfere with conception timing.
3. Patients with different degrees of renal impairment
In addition to the contraindication in severe and acute renal impairment, patients with mild‑to‑moderate renal insufficiency should also use with caution because of the potential risk of elevated serum potassium; electrolytes should be monitored regularly during treatment.
4. Children and adolescents
This product has not been studied for efficacy and safety in pediatric populations. It is not recommended for minors with open epiphyses, as it may affect bone growth.
