Mariprist200 mg+200 mcg

Approved Indications

Mariprist is a two-drug regimen combining a progesterone receptor antagonist (mifepristone) with a prostaglandin E1 analogue (misoprostol), used under strict medical supervision for:

• Medical termination of confirmed intrauterine pregnancy, up to the gestational age limit specified in the approved product labeling/local regulatory authority (commonly through the early first trimester, calculated from the first day of the last menstrual period and confirmed by clinical assessment and/or ultrasound before use).

Guideline-Supported / Additional Use

• Management of early pregnancy loss (missed miscarriage) — in some markets and clinical guidelines, Mariprist is used as a medical alternative to surgical uterine evacuation for confirmed non-viable early intrauterine pregnancy, at the treating physician's discretion.

Mariprist must only be used after an intrauterine pregnancy has been confirmed and an ectopic pregnancy has been excluded (see Contraindications), and requires a follow-up visit to confirm the pregnancy has been completely terminated.

Mifepristone + Misoprostol is supplied as a combination pack (kit) containing two active pharmaceutical ingredients taken in sequence:

• Mifepristone 200 mg — one tablet, taken orally.
• Misoprostol 200 mcg tablets (commonly supplied as four tablets, for a total dose of 800 mcg) — taken 24–48 hours after mifepristone, by the route specified in the approved regimen.

Pack sizes and exact tablet counts may vary slightly by manufacturer, but Mifepristone + Misoprostol kits are formulated to deliver this standard sequential regimen.

Mariprist is a combination regimen used for the medical termination of early intrauterine pregnancy, pairing an antiprogestin (mifepristone) that ends the pregnancy with a prostaglandin analogue (misoprostol) that induces uterine contractions to expel the pregnancy. It offers eligible women a non-surgical alternative to procedural (surgical) abortion, but it is not a simple over-the-counter product — Mariprist must be prescribed, dispensed, and used strictly under the supervision of a qualified physician, with confirmation of intrauterine pregnancy, gestational dating, and a scheduled follow-up visit to confirm complete termination.

Mariprist works in two sequential steps rather than as a single dose, and significant vaginal bleeding and cramping are an expected part of how it works.

Mariprist belongs to the therapeutic class of Progesterone Receptor Antagonists (Antiprogestins) combined with Prostaglandin E1 Analogues — a combination regimen used for medical termination of pregnancy / uterine evacuation.

Pharmacodynamics

Mifepristone + Misoprostol acts through two complementary mechanisms:

• Mifepristone is a synthetic steroid that competitively binds progesterone receptors, blocking the action of progesterone that is required to maintain pregnancy. This causes decidual breakdown, detachment of the trophoblast, cervical softening, and increased sensitivity of the myometrium to the contractile effects of prostaglandins. At higher exposures, mifepristone also has antiglucocorticoid activity.
• Misoprostol is a synthetic prostaglandin E1 analogue that directly stimulates myometrial contractions and promotes cervical ripening/dilation, leading to expulsion of the uterine contents.

Pharmacokinetics

Mifepristone is well absorbed orally, is highly (~98%) protein-bound, is metabolized mainly by hepatic CYP3A4, and has a prolonged terminal elimination profile due to slow release from plasma protein binding. Misoprostol is rapidly absorbed and de-esterified to its active free-acid form; it is quickly eliminated with a short elimination half-life of roughly 20–40 minutes, mainly via the kidneys. Because Mifepristone + Misoprostol is dosed as two sequential single-use steps rather than chronic therapy, steady-state kinetics are not clinically relevant.

The mifepristone tablet in Mariprist is swallowed whole with water, typically at a medical facility, under direct physician supervision. The misoprostol tablets are taken 24–48 hours later by the route directed by the prescribing physician — for example, held between the cheek and gum (buccal) for the specified time before swallowing any remainder, placed vaginally by trained staff, or held under the tongue, depending on the approved regimen. Patients should be given clear, physician-provided instructions on what bleeding/cramping to expect, when the second step should be taken, and when to seek urgent medical attention. Mariprist must be taken exactly as directed by the supervising physician, and the scheduled follow-up visit must not be missed.

Clinically Significant Drug Interactions

This list is not exhaustive. Patients should inform their physician about all prescription, over-the-counter, and herbal products being used before starting Mariprist.

Common / Expected Effects

• Vaginal bleeding — expected and part of how Mariprist works; can be heavier and longer than a normal menstrual period
• Abdominal pain and uterine cramping
• Nausea and vomiting
• Diarrhea
• Fever or chills (mainly related to the misoprostol component)
• Headache, dizziness, and weakness

Less Common but Clinically Important Effects

• Heavy or prolonged bleeding requiring medical intervention
• Incomplete termination of pregnancy, requiring further medical or surgical treatment

Rare but Serious Effects

• Serious infection, including rare cases of severe or fatal sepsis, which can occasionally occur without the typical signs of fever
• Severe allergic/hypersensitivity reactions

Patients should seek urgent medical attention for soaking through more than two sanitary pads per hour for two or more consecutive hours, severe or worsening abdominal pain, fever lasting more than 24 hours, or feeling generally unwell after taking Mariprist (see Precautions and Warnings).

Pregnancy

Mariprist is specifically indicated for the medical termination of a confirmed intrauterine pregnancy, and is used precisely because the intended outcome is ending that pregnancy; it must therefore never be used with the intention of continuing a pregnancy. Mariprist must only be administered after intrauterine pregnancy is confirmed (to exclude ectopic pregnancy) and gestational age is verified to be within the approved limit, under direct physician supervision, with a scheduled follow-up visit to confirm the pregnancy has been completely terminated. If treatment fails to fully terminate the pregnancy, there is a risk of birth defects from continued fetal exposure to these medicines, and the physician must discuss further management, which may include surgical completion.

Lactation

Small amounts of mifepristone and misoprostol pass into breast milk. Because clinical experience with breastfeeding immediately around Mariprist administration is limited, a physician should be consulted about the appropriate timing of breastfeeding relative to each dose; many current clinical protocols allow breastfeeding to continue, but the treating physician's guidance should be followed on an individual basis.

Medical Supervision and Follow-Up Are Required

Mariprist must be used only under the direct supervision of a qualified physician, with confirmed intrauterine pregnancy, verified gestational age, and access to emergency care if needed. A follow-up visit (typically 7–14 days after the mifepristone dose) is required to confirm the pregnancy has been completely terminated and to exclude an ongoing or previously unrecognized ectopic pregnancy; treatment is not considered complete without this follow-up.

Expected Bleeding vs. Warning Signs

Vaginal bleeding and cramping are an expected part of how Mariprist works and are not by themselves a reason for alarm. However, soaking through more than two sanitary pads per hour for two or more consecutive hours, prolonged heavy bleeding, severe abdominal pain, or fever lasting more than 24 hours require urgent medical evaluation, as these can indicate excessive blood loss, incomplete termination, or infection.

Rh(D) Sensitization

Rh(D)-negative women may require Rh immunoglobulin as per local clinical protocol when receiving Mariprist, as with any procedure involving termination of pregnancy.

Ectopic Pregnancy Must Be Excluded

Mariprist does not treat ectopic pregnancy. Persistent or worsening abdominal pain, especially if bleeding is minimal, should prompt urgent evaluation to rule out ectopic pregnancy even after Mariprist has been given (see Contraindications).

Treatment May Be Incomplete

Mariprist does not terminate every pregnancy successfully; a small proportion of patients will need additional medical or surgical treatment to complete the process. This possibility should be discussed with the patient before starting treatment.

There is limited clinical experience with overdose of Mariprist. Excessive doses may be expected to intensify uterine cramping, bleeding, gastrointestinal symptoms, and fever/chills. If overdose of Mariprist is suspected, or if bleeding, pain, or fever become severe, seek immediate medical attention or contact emergency services right away. Do not attempt to manage a suspected overdose or severe symptoms at home. There is no specific antidote; management in a medical facility is supportive, with monitoring of vital signs, bleeding, and, where indicated, surgical evacuation of the uterus. Keep Mariprist out of reach of children and other household members for whom it is not prescribed.

Store at room temperature (below 30°C), away from light and moisture. Keep out of reach of children.

Renal Impairment

Clinical data on the use of Mariprist in patients with significant renal impairment are limited; use with added caution and closer clinical monitoring under specialist supervision.

Hepatic Impairment

Clinical data on the use of Mariprist in patients with significant hepatic impairment are limited; because mifepristone is hepatically metabolized, use with caution and specialist supervision in these patients.

Adolescents

Mariprist may be used in pregnant adolescents of reproductive age under the same physician-supervised regimen as adults, with age-appropriate counselling and involvement of a guardian where required by local law/practice (see Pediatric Uses).

Breastfeeding Women

See Pregnancy and Lactation for guidance on breastfeeding around the time of Mariprist administration.

Mariprist is administered as a short, defined treatment episode rather than an ongoing/chronic therapy: mifepristone on day 1, followed by misoprostol 24–48 hours later, with a follow-up visit approximately 7–14 days after the first dose to confirm the pregnancy has been completely terminated. Mariprist is not repeated within the same treatment episode except on specific physician direction (for example, if further doses of misoprostol are needed to complete the process), and is not intended for repeated or long-term use.

Progesterone Receptor Antagonist (Antiprogestin) + Prostaglandin E1 Analogue — combination regimen for medical termination of pregnancy

Mifepristone + Misoprostol works through two sequential, complementary actions. First, the mifepristone component blocks progesterone receptors, removing the hormonal support that pregnancy depends on — this causes the lining of the uterus to break down, the placental attachment to loosen, the cervix to soften, and the uterine muscle to become more sensitive to prostaglandins. Then, the misoprostol component, a prostaglandin E1 analogue, directly stimulates the uterine muscle to contract and the cervix to open, leading to expulsion of the pregnancy. This two-step, complementary mechanism is why Mifepristone + Misoprostol is given as mifepristone followed by misoprostol, rather than either medicine alone, for medical termination of pregnancy.

Mariprist is intended for use only in pregnant individuals of reproductive age; it has no role in pre-menarchal children. In pregnant adolescents, Mariprist is given under the same physician-supervised regimen used in adults, with the treating physician providing age-appropriate counselling and involving a parent/guardian where required by local law or clinical practice. Formal pediatric-specific dose-ranging studies separate from the adult regimen have not established a different dose for adolescents; safety and efficacy in this subgroup are supported by the same clinical experience as in adult women when the standard regimen and medical supervision described above are followed.