Nextstellis Contraindications

As no epidemiological data are yet available for estetrol-containing CHCs, the contraindications for ethinylestradiol-containing CHCs are considered applicable to the use of Nextstellis. CHCs should not be used in the following conditions. Should any of the conditions appear for the first time during Nextstellis use, the medicinal product should be stopped immediately.
Presence or risk of venous thromboembolism (VTE): VTE: current VTE (on anticoagulants) or history of VTE (e.g., deep venous thrombosis [DVT] or pulmonary embolism [PE]).
Known hereditary or acquired predisposition for venous thromboembolism, such as activated protein C (APC)-resistance (including factor V Leiden), antithrombin-III-deficiency, protein C deficiency, protein S deficiency.
Major surgery with prolonged immobilisation (see Precautions).
A high risk of venous thromboembolism due to the presence of multiple risk factors (see Precautions).
Presence or risk of arterial thromboembolism (ATE): ATE: current ATE, history of ATE (e.g., myocardial infarction [MI]) or prodromal condition (e.g., angina pectoris).
Cerebrovascular disease: current stroke, history of stroke or prodromal condition (e.g., transient ischaemic attack [TIA]).
Known hereditary or acquired predisposition for arterial thromboembolism, such as hyperhomocysteinaemia and antiphospholipid-antibodies (anticardiolipin-antibodies, lupus anticoagulant).
History of migraine with focal neurological symptoms.
A high risk of arterial thromboembolism due to multiple risk factors (see Precautions) or to the presence of one serious risk factor such as: diabetes mellitus with vascular symptoms; severe hypertension; severe dyslipoproteinaemia.
Presence or history of severe hepatic disease as long as liver function values have not returned to normal.
Severe renal insufficiency or acute renal failure.
Presence or history of liver tumours (benign or malignant).
Known or suspected sex steroid-influenced malignancies (e.g., of the genital organs or the breasts).
Undiagnosed vaginal bleeding.
Hypersensitivity to the active substances or to any of the excipients listed in Description.