Sayana-Press Managing Expectations

 

Prescribing 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:

  • Since loss of bone mineral density (BMD) may occur in females of all ages who use Sayana-Press long-term, a risk/benefit assessment, which also takes into consideration the decrease in BMD that occurs during pregnancy and/or lactation, should be considered. 
  • Patients should be appropriately counselled concerning the likelihood of menstrual disturbance and the potential delay in return to ovulation1.  
  • Patients should be re-evaluated periodically as clinically appropriate at least every year to determine if Sayana-Press is still the best option for them. 

1. 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.

2. 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


In addition to amenorrhea, altered bleeding patterns included intermenstrual bleeding, menorrhagia and metrorrhagia. If abnormal bleeding associated with DMPA subcutaneous injection persists or is severe, appropriate investigation and treatment should be instituted.

3. 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

 

4. Bone Mineral Density (BMD) changes
Use of depot medroxyprogesterone acetate subcutaneous (DMPA-SC) reduces serum estrogen levels and is associated with significant loss of BMD due to the known effect of estrogen deficiency on the bone remodeling system. Bone loss is greater with increasing duration of use; however BMD appears to increase after DMPA-SC 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-SC by younger women will reduce peak bone mass and increase the risk for fracture in later life i.e. after menopause. 

A study to assess the BMD effects of DMPA-IM* (Depo-Provera)1 in adolescent females showed that its use was associated with a statistically significant decline in BMD from baseline. After discontinuing DMPA-IM in adolescents, return of mean BMD to baseline values required 1.2 years at the lumbar spine, 4.6 years at the total hip and 4.6 years at the femoral neck. However in some participants, BMD did not fully return to baseline during follow-up and the long-term outcome is not known in this group. In adolescents, Sayana-Press may be used, but only after other methods of contraception have been discussed with the patients and considered to be unsuitable or unacceptable. 

A large observational study of predominantly adult female contraceptive users showed that use of DMPA- IM did not increase risk for bone fractures. Importantly, this study could not determine whether use of DMPA has an effect on fracture rate later in life.

In women of all ages, careful re-evaluation of the risks and benefits of treatment should be carried out in those who wish to continue use for more than 2 years. In particular, in women with significant lifestyle and/or medical risk factors for osteoporosis, other methods of contraception should be considered prior to use of Sayana-Press.

Significant risk factors for osteoporosis include:

• Alcohol abuse and/or tobacco use 
• Chronic use of drugs that can reduce bone mass, e.g., anticonvulsants or corticosteroids
• Low body mass index or eating disorder, e.g., anorexia nervosa or bulimia
• Previous low trauma fracture
• Family history of osteoporosis

For further information on BMD changes in both adult and adolescent females, refer to the Sayana-Press Summary of Product Characteristics. Adequate intake of calcium and Vitamin D, whether from the diet or from supplements, is important for bone health in women of all ages.

* - A study comparing changes in BMD in women using DMPA-SC with women using DMPA-IM showed similar BMD loss between the two groups after two years of treatment

5. Cancer risks
Long-term case-controlled surveillance of DMPA-IM 150 mg users found no overall increased risk of ovarian, liver, or cervical cancer and a prolonged, protective effect of reducing the risk of endometrial cancer in the population of users. 

Breast cancer is rare among women under 40 years of age whether or not they use hormonal contraceptives.

Results from some epidemiological studies suggest a small difference in the risk of having the disease in current and recent users compared with never-users. Any excess risk in current and recent DMPA users is small in relation to the overall risk of breast cancer, particularly in young women (see Sayana Press Summary of Product Characteristics), and is not apparent after 10 years since last use. Duration of use does not seem to be important.

 

6. 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

7. Thromboembolic disorders
Although MPA has not been causally associated with the induction of thrombotic or thromboembolic disorders, any patient who develops such an event, e.g. pulmonary embolism, cerebrovascular disease or retinal thrombosis or deep venous thrombosis, while undergoing therapy with Sayana-Press should not be readministered the drug. Women with a prior history of thromboembolic disorders have not been studied in clinical trials and no information is available that would support the safety of Sayana-Press use in this population.

8. Anaphylaxis / Anaphylactoid reaction 
If an anaphylactic reaction occurs appropriate therapy should be instituted. Serious anaphylactic reactions require emergency medical treatment.

9. Ocular disorders
Medication should not be re-administered pending examination if there is a sudden partial or complete loss of vision or if there is a sudden onset of proptosis, diplopia, or migraine. If examination reveals papilledema or retinal vascular lesions, medication should not be re-administered.

10. Psychiatric disorders
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.1

To read the full special warnings and precautions for use for Sayana-Press and see a full list of adverse events, refer to the Summary of Product Characteristics. The benefits of contraceptive options and their risks must be evaluated individually for each woman. If any of the conditions/risk factors mentioned is present, the benefits of Sayana-Press use should be weighed against the possible risks for each individual woman and discussed with the woman before she decides to start using it. In the event of aggravation, exacerbation or first appearance of any of these conditions or risk factors, the woman should contact her physician. The physician should then decide on whether Sayana-Press use should be discontinued.

References:

  1. Sayana-Press Summary of Product Characteristics. Available at: https://www.medicines.org.uk/emc/product/3148/smpc.  Last accessed September 2020.
  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.

 

Prescribing Information:

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

Depo-Provera (Medroxyprogesterone acetate): 
Legal Category: POM  Basic NHS Price : £6.01

PP-SAY-GBR-0185.  September 2020