RALOVERA

What it is

RALOVERA contains medroxyprogesterone acetate (MPA) . It is supplied as a tablet .

Approved indications —

Palliative treatment of recurrent and/or metastatic breast cancer — Palliative treatment of recurrent and/or metastatic renal cell cancer — Palliative treatment of inoperable recurrent or metastatic endometrial carcinoma — Treatment of visually proven endometriosis (confirmed by laparoscopy) where the required end-point of treatment is pregnancy, or for the control of symptoms when surgery is contraindicated or has been unsuccessful — Long-term prevention of pregnancy in women when administered at 3-month intervals

Dosing overview

For inoperable, recurrent or metastatic endometrial and renal cell carcinoma: initially 600 mg to 1200 mg weekly, followed by 450 mg to 600 mg every 1 to 4 weeks for maintenance . For breast carcinoma: 500 mg daily for 4 weeks, then 500 mg to 1000 mg at weekly intervals for maintenance . For endometriosis: 50 mg weekly or 100 mg every 2 weeks for at least 6 months . For contraception: 150 mg every 3 months .

Key safety warnings

Loss of bone mineral density may occur in premenopausal women who use MPA long-term (greater than 2 years), and women should be assessed before starting treatment for contraception or endometriosis for the risk of osteoporosis . Meningiomas have been reported following long-term administration of progestins including MPA, and MPA should be discontinued if a meningioma is diagnosed . The physician should be alert to the earliest manifestations of thrombotic disorders (thrombophlebitis, cerebrovascular disorders, pulmonary embolism and retinal thrombosis), and should the drug should be discontinued immediately if any of these occur or are suspected . Most women receiving RALOVERA for contraception experience disruption of menstrual bleeding patterns, including irregular or unpredictable bleeding or spotting, or rarely heavy or continuous bleeding; if abnormal bleeding persists or is severe, appropriate investigations should be instituted to rule out organic pathology . Because this drug may cause some degree of fluid retention, conditions which might be influenced by this factor, such as epilepsy, migraine, asthma, or cardiac or renal dysfunction, require careful observation .

Contraindications

RALOVERA is contraindicated in patients with thrombophlebitis, thromboembolic disorders, cerebral apoplexy or a past history of these conditions; markedly impaired liver function; undiagnosed vaginal bleeding; undiagnosed urinary tract bleeding; undiagnosed breast pathology; missed abortion; known sensitivity to MPA or any of the excipients; known or suspected pregnancy; severe uncontrolled hypertension; and known or suspected malignancy of the breast (excluding use in oncology indications) .

PBS listing

The 10 mg tablet is listed on the PBS with 4 items at an ex-manufacturer price of A$6.39, with restrictions that vary between restricted and unrestricted . The 5 mg tablet is listed on the PBS with 2 items at an ex-manufacturer price of A$5.10, with restrictions that vary between unrestricted and restricted .

Regulatory history

RALOVERA was first approved on 2 August 1991 . The brand was registered on the ARTG with three tablet presentations (5 mg and 10 mg formulations) first listed on 14 October 1993 .