Theramex, in agreement with the MHRA, has issued guidance relating to prescribing of Zoely®, a combined oral contraceptive containing estradiol in combination with 2.5mg of the progestogen nomegestrol acetate (NOMAC).
The guidance is a response to evidence indicating an association between use of preparations containing nomegestrol acetate at higher doses than in Zoely (3.75mg-5mg) and increased risk of intracranial meningioma. There is not evidence relating directly to use of Zoely itself. The Theramex guidance is available here.
Guidance from FSRH CEU
In line with MHRA/EMA guidance, FSRH CEU advises that Zoely should not be used by individuals who have or have had meningioma.
Additionally, although this evidence does not relate directly to Zoely, but to preparations containing higher doses of NOMAC, FSRH CEU suggests that:-
- Providers should advise users of Zoely that it is possible that higher cumulative NOMAC exposure resulting from prolonged use could increase risk of intracranial meningioma - although absolute risk would remain small. Any associated increase in meningioma risk would be expected to reduce towards baseline after stopping Zoely (as it does after cessation of higher NOMAC doses).
- Providers should be vigilant for symptoms and signs of meningioma in users of Zoely.
- Although absolute risk of intracranial meningioma remains low amongst NOMAC users, providers may wish to consider offering alternative effective contraceptive options, bearing in mind also that incidence of meningioma increases markedly with age.
Suspected adverse drug reactions should be reported to the MHRA through the Yellow Card Scheme.
The full statement is available below to view and download.