Sayana 104 mg/0,65 mL Suspension for injection
PDF Leaflet Revision Date: 10 October 2025
Clinical Summary
Quick overview from the medicine insert
Indication
Contraception and management of endometriosis-associated pain.
Dosage (summary)
104 mg subcutaneously every 3 months; first injection within 5 days of menstrual period or 6 weeks postpartum if breastfeeding.
Special Populations
- Hepatic insufficiency
- Renal insufficiency
- Paediatric population
Pregnancy & Breastfeeding
Contraindicated in pregnancy; safety in breastfeeding not established.
Key Drug Interactions
- Aminoglutethimide may depress bioavailability
- CYP3A4 inducers/inhibitors may affect kinetics
Contraindications
- Hypersensitivity to medroxyprogesterone acetate
- Pregnancy
- Undiagnosed vaginal bleeding
- Severe liver dysfunction
- Known malignancy of the breast
- Thrombophlebitis
- Meningioma
Common side effects
- Headache
- Metrorrhagia
- Increased weight
- Amenorrhea
- Injection site reactions
Counselling Points
- Counsel on potential menstrual disturbances
- Monitor for signs of depression
- Ensure adequate calcium and vitamin D intake
- Does not protect against STIs
Serious warnings
- Loss of bone mineral density
- Thromboembolic disorders
- Anaphylactic reactions
- Fluid retention
- Depression
Important Disclaimer
The Sayana 104 mg/0,65 mL Suspension for injection professional information leaflet below is the property of Pfizer Laboratories and is provided on Medinsert exactly as issued, with no.. alterations or editorial changes. We make every effort to keep content current by updating documents as soon as new versions become available. Medinsert serves as a trusted access point for healthcare professionals, but does not replace official sources or clinical judgement. For more details, please read our full disclaimer. read more>>
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