THE REPRODUCTIVE HEALTH

DIALOGUE

Pioneering Autonomy
Charting the Course for Self-Injection and Contraceptive Excellence
Contents

❖ Advisory Board Objective

❖ The importance of self-care in family planning

❖ Overview of DMPA-SC

❖ DMPA-SC: Characteristics and administration

❖ DMPA-SC: Mechanism of Action

❖ DMPA-SC: Efficacy and Safety

❖ WHO Medical Eligibility Criteria for Contraceptive Use (MEC)

❖ DMPA-SC: Considerations for long-term use

❖ DMPA-SC: Self-injection

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The Reproductive Health Dialogue
Theme: Pioneering Autonomy: Charting the Course for Self-
Injection and Contraceptive Excellence
Product Focus: DMPA-SC (Depot Medroxyprogesterone Acetate, Subcutaneous)

Executive Summary
Pakistan faces a critical challenge in meeting its family planning targets, largely due to high
contraceptive discontinuation rates and significant access barriers.

Conventional provider-administered methods often fail to overcome these obstacles, particularly in

commercial and semi-urban settings.

Remington Pharma is introducing DMPA-SC, a modern injectable contraceptive, and proposing a

strategic focus on the self-injection (SI) model.

The National Challenge: Discontinuation and Access

Despite high awareness of contraception, Pakistan's Contraceptive Prevalence Rate (CPR) remains low,
and the unmet need for family planning is substantial (approx. 17%). The primary barriers to adoption
and continuation include:
● Access Constraints: Difficulty reaching healthcare facilities every three months due to distance,
time, or cost of transportation.
● Social & Familial Barriers: The need for covert use due to partner or in-law disapproval, making
mandatory clinic visits difficult.
● Service Quality: Inconsistent counseling quality and the perception of painful provider-
administered intramuscular injections.

Our Proposed Solution: Prioritizing the Self-Injection Model

Our strategy is to leverage DMPA-SC's unique features—its short needle and pre-filled system
(Uniject)—to make self-injection a viable, long-term option in the commercial market.

Primary Objective: To gain insights into current contraceptive landscape and develop clinical consensus
on self-injection method as a preferred choice through DMPA-SC

The self-injection model offers the potential to:

1. Enhance User Autonomy: Women control their injection schedule and location, increasing

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 discretion and removing reliance on clinic hours.
2. Improve Continuation: Global evidence suggests SI users have significantly higher continuation
rates than those relying on provider administration.
3. Optimize the Commercial Pathway: By shifting administration responsibility to the user, we
reduce recurring provider time, potentially optimizing the overall cost and convenience for the
consumer paying out-of-pocket.

The importance of self-care in family planning

“Self-care is the ability of individuals, families, and
communities to promote health, prevent disease,
maintain health, and cope with illness and disability
with or without the support of a health worker”

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Self-care is a vital component of contraception
• WHO recommends self-care interventions to improve women’s access to a range of
contraceptive options.
• Such self-care interventions include:
o Self-injectable contraception and over-the-counter availability of oral contraceptives.
o Home pregnancy tests.
o HIV and sexually transmitted infection self-testing.
o Pre-exposure prophylaxis (PrEP), condoms, and lubricants.
o Menstrual health products.

Self-injection is an important component of

contraceptive self-care
• Self-injection prioritizes a woman's autonomy in pregnancy prevention and is a globally endorsed
and nationally approved evidence-based practice that has been introduced and scaled up in
multiple countries.1,2
• Self-injection offers many benefits1-5:
o Increased autonomy and convenience:
▪ Feasible and accepted method of contraceptive delivery.
▪ Studies show higher rates of continuation with self-administration.
o Addresses some common barriers to contraception:
▪ Reduces the need for frequent clinic visits.
▪ Particularly beneficial in remote or underserved areas.
▪ Economically benefits health systems and women by
▪ reducing direct costs (e.g., transportation costs).
▪ Enhances accessibility to contraception.

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Overview of DMPA-SC
Composition:
DMPA-SC contains 104 mg/0.65 mL of medroxyprogesterone acetate, a lower dose than the
intramuscular formulation (150 mg/1.0 mL).
Administration:
Delivered via an all-in-one, auto-disable, prefilled BD Uniject injection system for subcutaneous
injection. Can be self-administered after proper informed-choice counseling and training.
Efficacy:
Over 99% effective at preventing pregnancy when used correctly. No pregnancies were reported in large
clinical trials.
Safety:
Well-tolerated, with a safety profile similar to that of DMPA-IM.
Eligibility:
Most adolescent girls and women of childbearing potential can use DMPA-SC, including those who are
breastfeeding. However, women should consult their health care provider before using DMPA-SC,
particularly if they have or are at risk of hypertension, diabetes, breast cancer, and/or osteoporosis.
Accessibility:
Approved in more than 70 countries, with self-injection authorized in more
than 60 countries.

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DMPA-SC: Indications and approval

What is the brand name What is DMPA-SC

Where is DMPA-SC
for indicated
approved?
DMPA-SC? for?
•The DMPA-SC product •DMPA-SC is approved for •DMPA-SC is indicated for
that is currently most use in female contraception and
widely available (Sayana® •>70 countries worldwide in most countries for the
Press) is delivered in a and for self-injection in management of
user-friendly single-dose >55, including countries endometriosis-associated
prefilled injection device across sub-Saharan pain.4-6
called the BD Uniject . Africa, Asia, Latin
•In the US, DMPA-SC is America, the United
provided as a prefilled Kingdom and several
glass syringe and needle European countries.3
(DEPO-SUBQ PROVERA
104®).
•Both products are
manufactured by Pfizer
Inc.1,2
•Generic versions of the
product may also become
available.

Pharmacology and Mechanism of Action

Formulation
● Active Ingredient: Medroxyprogesterone Acetate (MPA), a synthetic version of progesterone.

● Dose: 104 mg of MPA in 0.65 mL suspension. This is a lower dose compared to the intramuscular
formulation (DMPA-IM), which contains 150 mg.

● Device: Prefilled in the BD Uniject™ injection system. This is a single-use, auto-disable device with a
short (9.5mm) 23-gauge needle designed for subcutaneous injection.

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Mechanism of Action
DMPA-SC prevents pregnancy through three primary mechanisms:

1. Inhibition of Ovulation: The progestin inhibits the secretion of gonadotropins (LH and FSH) from
the anterior pituitary, preventing follicular maturation and the release of eggs.

2. Cervical Mucus Modification: It increases the viscosity and cellularity of cervical mucus while
decreasing water content. This creates a barrier that impairs sperm motility and penetration.

3. Endometrial Alteration: It causes decidualization of the stromal cells, creating a thin, atrophic
endometrium that is less receptive to embryo implantation.

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Pharmacokinetics
● Absorption: Relatively prompt after injection, with peak concentrations (C_max) reached in
approximately one week.

● Metabolism: Extensively metabolized in the liver.

● Half-life: Residual concentrations at the end of the dosing interval are low, with a half-life of
approximately 40 days.

Clinical Efficacy and Safety Profile

● Success Rate: Over 99% effective when used correctly. Large Phase 3 clinical trials reported zero
pregnancies among 2,042 women over one year of use.

● Injection Interval: One injection is effective for 3 months (13 weeks).

● Factors: Efficacy is not affected by body weight or injection site (abdomen vs. thigh).

Safety and Side Effects

● Common Side Effects: Headache, weight increase, injection site reactions (pain/dimpling), and
changes in menstrual bleeding (amenorrhea or irregular bleeding).

● Comparison to DMPA-IM: Generally, better tolerated. In a Nepal study, 48% of DMPA-SC users
reported no side effects compared to only 22% of DMPA-IM users.

● Bone Mineral Density (BMD): Long-term use is associated with a decrease in BMD due to lowered
estrogen levels. However, WHO states this should not prevent use or limit duration. The decrease
is generally reversible after discontinuation.

● Cancer Risk: A very small association with meningioma has been observed with prolonged high-
dose use, but the risk is minuscule (<0.1%) compared to the risks of unintended pregnancy.

Return to Fertility
● The contraceptive effect is reversible.

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 ● Timeline: The average time to conception is 10–12 months after the last injection. Some women
may conceive as early as 4 months after the last dose.

Administration and Usage

Preparation and Sites
● Storage: Room temperature (15°C to 30°C).

● Sites: Anterior thigh or abdomen (suitable for self-injection). The upper arm is also an approved
site but only for provider administration.

● Preparation: Shake the device vigorously for 30 seconds to mix the solution.

Administration Steps (The 4 Critical Steps)

1. Activate: Push the needle shield into the port until the gap is closed.

2. Pinch: Gently pinch the skin at the site to form a "tent".

3. Insert: Insert the needle at a downward angle into the subcutaneous fat.

4. Press: Squeeze the reservoir slowly (5–7 seconds) to inject the medication.

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Timing
● Initial Injection: Can be given at any time. If given within 5–7 days of the onset of menstruation, no
backup contraception is needed.

● Postpartum: WHO notes a theoretical risk to neonates in the first 6 weeks but acknowledges it may
be the only option in some settings; manufacturer labeling often permits use after 6 weeks.

Contraindications (WHO MEC)

DMPA-SC is generally contraindicated in women with:

▪ Active thrombophlebitis or history of thromboembolic disorders.

▪ Undiagnosed vaginal bleeding.

▪ Known or suspected breast cancer.

▪ Significant liver disease.

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DMPA-SC: Advantages over DMPA-IM

DMPA-SC: Considerations for long-term use

Effects on bone mineral density
WHO has determined that:
o The decrease in BMD associated with DMPA use should not prevent women of any age from
using DMPA.
o There is no need for women to limit the duration of DMPA use based on concerns about BMD.
o It is recommended that clients taking DMPA-SC ensure they consume enough calcium and
vitamin D, which helps to maintain bone strength.
Alternate methods of contraception should be considered for clients with other risk factors for
osteoporosis, including:
o Strong family history of osteoporosis.
o Long-term alcohol or tobacco use.
o Anorexia nervosa.
o Metabolic bone disease.
o Chronic use of other drugs that may reduce bone mass.

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DMPA-SC vs. DMPA-IM: Similar BMD decreases and recovery
o 534 women aged 18 to 35 were randomized to receive either DMPA-SC 104 mg or DMPA-IM 150
mg every three months for up to three years.
o Both groups showed modest decreases in hip and spine BMD over two years.
o Total hip (–3.3% and –3.6%, respectively)
o Lumbar spine (–4.3% and –5.0%, respectively)
o Decreases were slightly smaller with DMPA-SC than with DMPA-IM.
o Differences between groups were not statistically significant except for spine BMD at one year.
o Most bone loss occurred in the first two years, with little
o additional loss in year 3.
o In a small subgroup, there was evidence of BMD recovery after stopping DMPA

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DMPA-SC: Return to fertility after use
o The contraceptive effect of DMPA-SC is reversible and allows for future pregnancy planning.
o The length of time a woman has used DMPA does not affect the ability to later become
pregnant.
o On average, women can become pregnant 10 to 12 months after their last DMPA-SC injection if
no other family planning method is being used, although some women may become pregnant as
soon as 4 months after their last DMPA-SC injection, while a small percentage may take as long
as 18 months.
o After stopping contraception, DMPA users typically take four months longer to conceive
compared with users of other modern contraceptive methods.

DMPA-SC: Summary | Self-injection

▪ Easy to do: After informed-choice counseling and training, women can self-inject DMPA-SC,
which is feasible, acceptable, and safe.
▪ Improves continuation: Studies show higher contraceptive continuation rates with self-injection
compared with provider administration.
▪ Increases autonomy: Self-injection allows women to better manage their own reproductive
health with more privacy and convenience.
▪ Cost-effective: Self-injection can reduce costs for both women and health systems by decreasing
clinic visits.
▪ Widely approved: More than 55 countries have authorized DMPA-SC for self-injection.
▪ Requires training: Comprehensive education and training for both providers and clients is crucial
to ensure accurate information and proper use, and to address misconceptions.

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References

PATH. Evidence at-a-Glance: Spotlight on Self-Injection With DMPA-SC. December 2023. Accessed
December 16, 2024. [Link] 2. Ali G, et al. Front
Glob Womens Health. 2023; 4:1059408.
Curtis KM, et al. MMWR Morb Mortal Wkly Rep 2021;70(20):739–743. 4. Burke HM, et al. Lancet Glob
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Contraception 2019;99(2): 137–141. 7. Kohn JE, et al. Contraception 2018;97(3):198–204. 8. Sherpa LY,
et al. Contraception 2021;104(6):623–627. 9.
Burke, HM, et al. The case for investing in provider-administered subcutaneous DMPA: a costing study.
BMJ Global
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[Link] 4. Taylor DJ, et al. Contraception X.
2022;4:100072. 5. Injectables Access Collaborative. DMPA-SC key facts: Answering
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Sayana-Press® [prescribing information for UK]. July 2023. Accessed December 11, 2024.
[Link] 2. WHO. 2005. Accessed December 12, 2024.
[Link] 3. DEPO-SUBQ Provera 104 [prescribing
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[Link]
Jain J, et al. Contraception. 2004; 70:269–275.
WHO. 3 February 2015. Accessed February 17, 2025.
[Link] 2. Sayana-Press® [prescribing information
for UK]. July 2023. Accessed December 11, 2024. [Link]
DEPO-SUBQ Provera 104 [prescribing information for USA]. July 2024. Accessed December 11, 2024.
[Link] 2. Jain J, et al. Contraception.
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