Sayana® Press Managing Expectations

Product Information and a link to the SPC is available at the bottom of this page.

What can women expect from Sayana® Press? To help manage their expectations, there are several important things they should know.

Patients should be appropriately counselled concerning the likelihood of menstrual disturbance and the potential delay in return to ovulation1.

Return to Fertility

A study, comprising 39 women, estimated the cumulative rate of return to ovulation, following a single dose of Depot-medroxyprogesterone acetate (DMPA-SC), by 1-year after administration.1

  • Median time to ovulation was 30 weeks.1
  • The cumulative rate of return to ovulation, as measured by plasma progesterone, was 97.4% (38/39 patients).1

* Return to fertility (ovulation) may be delayed for up to one year.

 

Menstrual changes

Amenorrhoea data were analysed from three Phase III contraception studies of 1-year treatment with DMPA-SC.1,2,3

  • Results showed that the overall incidence of amenorrhoea increased with treatment duration.1
  • Over the course of 1-year of exposure, the overall incidence of irregular bleeding decreased.1

Potential weight changes

Weight changes are common but unpredictable1.

Results were pooled from three Phase III contraception studies on weight changes that occurred during 1-year treatment with DMPA-SC.4

  • 50.3% of women remained within 2.2kg (4.9lbs) of their initial body weight.4
  • 11.9% of women lost more than 2.2kg (4.9lbs) weight.4
  • 37.7% of women gained more than 2.3kg (5.1lbs) weight.4

Use of depot MPA subcutaneous injection reduces serum estrogen levels and is associated with significant loss of BMD due to the known effect of estrogen deficiency on the bone remodelling system. Bone loss is greater with increasing duration of use, however BMD appears to increase after DMPA subcutaneous injection is discontinued and ovarian estrogen production increases.

This loss of BMD is of particular concern during adolescence and early adulthood, a critical period of bone accretion. It is unknown if use of DMPA subcutaneous injection by younger women will reduce peak bone mass and increase the risk for fracture in later life.

A randomised, evaluator-blinded, Phase III, 2-year study found DMPA-SC to have a comparable BMD side effect profile to DMPA-IM.3

  • DMPA-SC changes in BMD are reversible after stopping treatment.1
  • Concerns regarding BMD must be considered against the potential contraceptive benefits of DMPA-SC for each individual user, and treatment must be re-evaluated every 2-years.1
  • As adolescence is an important time of bone accretion, DMPA-SC may be used, but only after other methods of contraception have been discussed with the patient and considered unsuitable or unacceptable.1

Consider baseline risk factors for osteoporosis before prescribing DMPA-SC.1

  • Alcohol abuse
  • Smoking
  • Chronic use of medicines that can reduce bone mass
  • Osteoporosis family history
  • Low trauma fracture
  • Low body mass index or an eating disorder

Cancer Risks

  • Studies of women who have used contraception with the same active ingredient as Sayana® Press (DMPA-IM 150mg) found that they had no overall increased risk of developing cancer of the ovary, womb, cervix or liver.1
  • Sayana® Press may slightly increase the risk of breast cancer compared with women who have never used it. The risk varies with age.1

Injection Site Reactions

  • In the clinical trials involving DMPA-SC (n=2053), 6.1% of women experienced an injection site reaction and these reactions included1:
    • Injection site reaction, injection site persistent atrophy / indentation / dimpling, injection site nodule/lump, injection site pain/ tenderness1
  • In one of the three Phase III clinical trials, the efficacy and effects on bone mineral density of DMPA-SC (n=266) were compared to DMPA-IM (n=268). The investigators found that:
    • More injection site reactions (which were all mild to moderate in severity) were observed in the DMPA-SC group than the DMPA-IM group)3

HIV

Women should be counselled that Sayana® Press does not protect against sexually transmitted infections (STIs) including HIV infection (AIDS) but equally will not expose them to sexually transmitted infections. Safer sex practices including correct and consistent use of condoms reduce the transmission of STIs through sexual contact, including HIV. 

HIV: Human Immunodeficiency Virus
AIDS: Acquired Immunodeficiency syndrome

Depressed mood and depression are well-known undesirable effects of hormonal contraceptive use. Depression can be serious and is a well-known risk factor for suicidal behaviour and suicide. Women should be advised to contact their physician in case of mood changes and depressive symptoms, including shortly after initiating the treatment.5

 

References:

  1.  Sayana Press Summary of Product Characteristics. Available at: https://www.medicines.org.uk/emc/ Last accessed February 2019.
  2. Jain J, et al. Contraceptive efficacy and safety of DMPA-SC. Contraception 2004;70:269-75.
  3. Kaunitz AM, et al. Subcutaneous DMPA vs. intramuscular DMPA: a 2-year randomized study of contraceptive efficacy and bone mineral density. Contraception 2009; 80: 7-17.
  4. Pfizer Data on File, 2013. Analysis of weight changes from three Phase III contraception studies on DMPA-SC.
  5. https://www.medicines.org.uk/emc/product/3148/smpc

 

Summary of Product Characteristics:

Sayana® Press:
Legal Category: POM  Basic NHS Price : £6.90

Depo-Provera®
Legal Category: POM  Basic NHS Price : £6.01

PP-SAY-GBR-0183.  May 2020