New injectable – Sayana Press and Dianette VTE update

Posted on by BMJ

Sayana Press®

is a progestogen-only injectable contraceptive licensed for subcutaneous use. It contains 104mg of medroxyprogesterone acetate (MPA) in 0.65ml suspension and is bioequivalent to IM depot medroxyprogesterone acetate. It is administered at intervals of 13 weeks +/- 7 days via a new delivery system (Unijet) – a single dose pre-filled injector.

Sayana

Although ideal for self-administration it is not currently licensed for use in this way.  The April issue of the Journal included a commentary on SC MPA by Sharon Cameron from Edinburgh.

Further information for professionals including a step-by-step administration guide will be available via MedIsis website.

Dianette® and cyproterone acetate products: strengthening of warnings, new contraindications, and updated indication

In agreement with the MHRA and European Medicines Agency (EMA) Bayer has written to health professionals about Dianette®, co-cyprindiol and cyproterone acetate products. This follows the outcome of a review of the known risk of thromboembolic events by the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC). There are no new data, but there has been a “scare” in France which led to this and other so-called third generation products being removed from the market leaving very limited options for women.

The PRAC recommendations include:

  • Dianette® and other medicines containing cyproterone acetate 2mg/ethinylestradiol 35 mcg are indicated for the treatment of moderate to severe acne related to androgen-sensitivity (with or without seborrhea) and/or hirsutism, in women of reproductive age.
  • For the treatment of acne, Dianette® and other cyproterone acetate 2mg/ethinylestradiol 35 mcg products should only be used after topical therapy or systemic antibiotic treatment have failed.
  • Since Dianette® and all other cyproterone acetate 2mg/ethinylestradiol 35 mcg products are also a hormonal contraceptive, they should not be used in combination with other hormonal contraceptives.
  • To increase awareness of the risk and risk factors of thromboembolism in relation to the use of Dianette® and other cyproterone acetate 2mg/ethinylestradiol 35 mcg products (e.g. increasing age, smoking, immobility), the warnings and precautions regarding this risk have been strengthened.

 

 

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