Indicated for long term female contraception. Click here for Depo-Provera® (medroxyprogesterone acetate) Prescribing Information. Adverse event reporting information can be found at the bottom of the page.
What can women expect with Depo-Provera®?
To help manage their expectations, there are several important things to know.
Assessment of women prior to starting hormonal contraceptives (and at regular intervals thereafter) should include an individuals personal and family medical history.
Clinical trials studied the mean time to return to ovulation up to 15 months following the last dose of DMPA-IM:1
*Repeat injections are required every 12 weeks (± 5 days) to maintain and ensure efficacy1
Up to 30% of women will stop having 'periods' during the first 3 months and the percentage of women with amenorrhoea increases with time.1
*After the first injection, up to 33% of women may have prolonged episodes of bleeding; in 12% of women this may still be occurring after a year. Rarely, heavy prolonged bleeding may occur.
See below for a diagrammatic representation of the proportion of women who experienced amenorrhoea during 1-year treatment with DMPA-IM.1
If abnormal bleeding persists or is severe, appropriate investigation should take place to rule out the possibility of organic pathology and appropriate treatment should be instituted when necessary.
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 study to assess the BMD effects of DMPA-IM 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, Depo-Provera 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 Depo-Provera.
Significant risk factors for osteoporosis include:
Alcohol abuse and/or tobacco use
Chronic use of drugs that can reduce bone mass
Low body mass index or eating disorder
Previous low trauma fracture
Family history of osteoporosis
For further information on BMD changes in both adult and adolescent females, refer to the Depo-Provera Summary of Product Characteristics.
Some epidemiological studies suggest a small difference in risk of breast cancer in current and recent users. It showed:1
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.
As with any intramuscular injection, especially if not administered correctly, there is a risk of abscess formation at the site of injection, which may require medical and/or surgical intervention.
Should the patient experience pulmonary embolism, cerebrovascular disease or retinal thrombosis while receiving Depo-Provera, the drug should not be re-administered.
Reports of anaphylactic responses (anaphylactic reactions, anaphylactic shock, anaphylactoid reactions) have been received.
To read the full special warnings and precautions for use for Depo-Provera 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 Depo-Provera 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 Depo-Provera use should be discontinued.
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PP-PFE-GBR-2688. December 2020