DEPO-PROVERA STERILE AQUEOUS SUSPENSION 50 MG/ML [SIN04540P]

Product Info

DEPO-PROVERA STERILE AQUEOUS SUSPENSION 50 MG/ML

[SIN04540P]

4.1 Therapeutic indication

Medroxyprogesterone acetate (MPA) injectable suspension is indicated for:

Contraception
Contraception (ovulation suppression).

Gynecology
Treatment of endometriosis.
Treatment of menopausal vasomotor symptoms.

Oncology
Adjunctive and/or palliative treatment of recurrent and/or metastatic endometrial or renal carcinoma.

Treatment of hormonally-dependent, recurrent breast cancer in post-menopausal women.

Long-term Use
Since loss of bone mineral density (BMD) may occur in pre-menopausal women who use MPA injection long-term (see Section 4.4 Special warnings and precautions for use - Additional Warnings and Precautions for Specific Use or Formulation, Contraception/Endometriosis - Injectable Formulations, Loss of Bone Mineral Density (BMD) and Section 5.1 Pharmacodynamic properties - Clinical Studies, BMD Studies – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information), a risk/benefit assessment, which also takes into consideration the decrease in BMD that occurs during pregnancy and/or lactation, should be considered.

Use in Children
MPA IM is not indicated before menarche.

Data are available in adolescent females (12–18 years) (see Section 5.1 Pharmacodynamic properties - Clinical Studies, BMD Changes in Adolescent Females (12–18 years) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). The safety and effectiveness of MPA IM are expected to be the same for post-menarcheal adolescent and adult females.

4.2 Posology and method of administration

Injectable suspensions should be shaken well before use.

Contraception
Contraception (Ovulation Suppression)
MPA intramuscular injectable suspension should be vigorously shaken just before use to ensure that the dose being administered represents a uniform suspension.

Intramuscular (IM)
The recommended dose is 150 mg of MPA injectable suspension every 12–13 weeks (3 months) administered by intramuscular injection in the gluteal or deltoid muscle.

First Injection
The initial IM injection should be given during the first 5 days after the onset of a normal menstrual period; within 5 days post-partum if not breast-feeding; or, if exclusively breast-feeding, at or after 6 weeks post-partum.

Second and Subsequent Injections
If the time interval between IM injections is greater than 13 weeks, pregnancy should be ruled out before administering the next IM injection.

Switching from Other Methods of Contraception
When switching from other contraceptive methods, (MPA IM) should be given in a manner that ensures continuous contraceptive coverage based upon the mechanism of action of both methods.

Gynecology
Use of combined estrogen/progestin therapy in post-menopausal women should be limited to the lowest effective dose and shortest duration consistent with treatment goals and risks for the individual woman, and should be periodically evaluated (see Section 4.4 Special warnings and precautions for use – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Periodic check-ups are recommended of a frequency and nature adapted to the individual woman (see Section 4.4 Special warnings and precautions for use – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Unless there is a previous diagnosis of endometriosis, it is not recommended to add a progestin in a woman without an intact uterus.

Endometriosis
Injectable MPA given intramuscularly 50 mg weekly or 100 mg every 2 weeks for at least 6 months.

Menopausal Vasomotor Symptoms
Injectable MPA given intramuscularly 150 mg every 12 weeks.

Oncology
Endometrial and Renal Carcinoma
Injectable MPA 400 mg to 1,000 mg intramuscularly per week is recommended initially. If improvement is noted within a few weeks or months and the disease appears stabilized, it may be possible to maintain improvement with as little as 400 mg per month.

Breast Cancer
Injectable MPA 500 mg/day intramuscularly for 28 days. The patient should then be placed on a maintenance schedule of 500 mg twice weekly as long as she responds to treatment.

Hepatic Insufficiency
No clinical studies have evaluated the effect of hepatic disease on the pharmacokinetics of MPA. However, MPA is almost exclusively eliminated by hepatic metabolism and steroid hormones may be poorly metabolized in patients with severe liver insufficiency (see Section 4.3 Contraindications).

Renal Insufficiency
No clinical studies have evaluated the effect of renal disease on the pharmacokinetics of MPA. However, since MPA is almost exclusively eliminated by hepatic metabolism, no dosage adjustment should be necessary in women with renal insufficiency.

4.3 Contraindications

MPA is contraindicated in patients with the following conditions:

• Known or suspected pregnancy

• Undiagnosed vaginal bleeding

• Severe liver dysfunction

• Known sensitivity to MPA or any component of the drug

Additional Contraindication(s) for Specific Use

Contraception/Gynecology: Known or suspected malignancy of the breast