Implanon NXT

Implanon NXT Adverse Reactions

etonogestrel

Manufacturer:

Organon

Distributor:

Zuellig
/
Agencia Lei Va Hong
Full Prescribing Info
Adverse Reactions
During the use of Implanon NXT, women are likely to have changes in their menstrual bleeding pattern which are unpredictable beforehand. These may include the occurrence of an irregular bleeding pattern (absent, less frequent, more frequent or continuous), and changes in bleeding intensity (reduced or increased) or duration. Amenorrhoea was reported in about 1 of 5 women while another 1 of 5 women reported frequent and/or prolonged bleeding. Occasionally, heavy bleeding has been reported. In clinical trials, bleeding changes were the most common reason for stopping treatment (about 11%). The bleeding pattern experienced during the first three months is broadly predictive of future bleeding patterns for many women.
Possibly related undesirable effects reported in clinical trials have been listed in the following table: See table.

Click on icon to see table/diagram/image

During postmarketing surveillance, a clinically relevant rise in blood pressure has been observed in rare cases. Seborrhoea has also been reported. Anaphylactic reactions, urticaria, angioedema, aggravation of angioedema and/or aggravation of hereditary angioedema may occur.
The following undesirable effects have been reported in connection with the insertion or removal procedure of the implant: Insertion or removal of the implant may cause some bruising, including haematoma in some cases, slight local irritation, pain or itching. Insertion of the implant may cause vasovagal reactions (such as hypotension, dizziness, or syncope).
Fibrosis at the implant site may occur, a scar may be formed or an abscess may develop. Paraesthesia or paraesthesia-like events may occur. Expulsion or migration of the implant have been reported, including rarely to the chest wall. In rare cases, implants have been found within the vasculature including the pulmonary artery. Some cases of implants found within the pulmonary artery reported chest pain and/or respiratory disorders (such as dyspnoea, cough, haemoptysis); others have been reported as asymptomatic (see Precautions). If instructions are not followed (see Dosage & Administration), incorrect insertions, difficult localisations and difficult removals of the implant may occur. Surgical intervention might be necessary when removing the implant.
On rare occasions, ectopic pregnancies have been reported (see Precautions).
In women using (combined oral) contraceptives a number of (serious) undesirable effects have been reported. These include venous thromboembolic disorders, arterial thromboembolic disorders, hormone-dependent tumours (e.g. liver tumours, breast cancer) and chloasma, some of which are discussed in more detail in Precautions.
Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions.
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