Disprin Extra Strength And Disprin Regular Strength 300 mg

ERANFU 250 is indicated for the treatment of oestrogen receptor positive, locally advanced or metastatic breast cancer in postmenopausal women not previously treated with endocrine therapy or with disease relapse on or after adjuvant anti-oestrogen therapy, or disease progression on therapy with an anti-oestrogen.

Posology

Adult females (including the elderly): The recommended dose is 500 mg intramuscularly at intervals of 1 month with an additional 500 mg dose given two weeks after the initial dose.

Special populations

Renal impairment: No dosage adjustments are recommended for patients with mild to moderate renal impairment (i.e. patients having a creatinine clearance greater than 30 ml/min). Safety and efficacy have not been evaluated in patients with severe renal impairment (creatinine clearance < 30 ml/min), and, therefore, caution is recommended in these patients (see Section 4.4).

Hepatic impairment: No dose adjustments are recommended for patients with mild to moderate hepatic impairment. However, as fulvestrant exposure may be increased, ERANFU 250 should be used with caution in these patients. Safety and efficacy have not been evaluated in patients with severe hepatic impairment (see Sections 4.3, 4.4 and 5.2).

Elderly: No dose adjustment is required for elderly patients.

Interactions requiring dose adjustment:

There are no known drug-drug interactions requiring dose adjustment.

Children: ERANFU 250 is not recommended for use in children or adolescents, as safety and efficacy have not been established in this age group.

Method of administration

ERANFU 250 should be administered as two consecutive 5 ml injections by slow intramuscular injection (1 to 2 minutes/injection), one in each buttock (gluteal area). Caution should be taken if injecting ERANFU 250 at the dorso-gluteal site due to the proximity of the underlying sciatic nerve. Refer to the end of the leaflet. For detailed instructions on administration, see Section 6.6.

• Hypersensitivity to the active substance (fulvestrant) or to any of the excipients (see Section 6.1).
• Patients with severe hepatic impairment (see Sections 4.4 and 5.2).
• Pregnancy and lactation (see Section 4.6).

• ERANFU 250 should be used with caution in patients with mild to moderate hepatic impairment (see Sections 4.2, 4.3 and 5.2).
• ERANFU 250 should be used with caution before treating patients with severe renal impairment (creatinine clearance less than 30 ml/min) (see Sections 4.2 and 5.2).
• Due to the intramuscular route of administration, caution should be used if treating patients with bleeding diatheses or thrombocytopenia or patients taking anticoagulants.
• Thromboembolic events are commonly observed in women with advanced breast cancer and have been observed in clinical trials with fulvestrant (see Section 4.8). This should be taken into consideration when prescribing ERANFU 250 to patients at risk.
• Injection site related events including sciatica, neuralgia, neuropathic pain and peripheral neuropathy have been reported with fulvestrant. Caution should be taken while administering ERANFU 250 at the dorso-gluteal injection site due to the proximity of the underlying sciatic nerve (see Sections 4.2 and 4.8).
• There are no long-term data on the effect of fulvestrant on bone. Due to the mechanism of action of fulvestrant, there is a potential risk of osteoporosis.
• The efficacy and safety of fulvestrant has not been studied in patients with critical visceral disease.
• Hypersensitivity reactions such as angioedema and urticaria have been commonly reported with fulvestrant (incidence of 1 to 10 %) and may be serious (see Section 4.8).
• Interference with estradiol antibody assays: Due to the structural similarity of fulvestrant and estradiol, fulvestrant may interfere with antibody based-estradiol assays and may result in falsely increased levels of estradiol (see Section 4.5).
• Ethanol: ERANFU 250 contains 10 % w/v ethanol (alcohol) as an excipient, i.e. up to 500 mg per injection, equivalent to 10 ml beer or 4 ml wine. This may be harmful for those suffering from alcoholism and should be taken into account in high risk groups such as patients with liver disease and epilepsy.
• Benzyl alcohol: ERANFU 250 contains benzyl alcohol as an excipient which may cause allergic reactions.
• Paediatric population: ERANFU 250 is not recommended for use in children and adolescents as safety and efficacy have not been established in this group of patients.

A clinical interaction study with midazolam (substrate of CYP3A4) demonstrated that fulvestrant does not inhibit CYP3A4. Clinical interaction studies with rifampicin (inducer of CYP3A4) and ketoconazole (inhibitor of CYP3A4) showed no clinically relevant change in fulvestrant clearance. Dose adjustment is therefore not necessary in patients who are receiving fulvestrant and CYP3A4 inhibitors or inducers concomitantly. Due to the structural similarity of fulvestrant and estradiol, fulvestrant may interfere with antibody based-estradiol assays and may result in falsely increased levels of estradiol (see Section 4.4).

Women of childbearing potential / Contraception in males and females

Women of child-bearing potential should be advised to use highly effective contraception while on treatment with ERANFU 250 and for two years after last dose.

Pregnancy

ERANFU 250 is contraindicated in pregnancy (see Section 4.3). Fulvestrant has been shown to cross the placenta after single intramuscular doses in rat and rabbit. Studies in animals have shown reproductive toxicity, including an increased incidence of foetal abnormalities and deaths. If pregnancy occurs while taking ERANFU 250, the patient must be informed of the potential hazard to the foetus and potential risk for loss of pregnancy.

Lactation

Breastfeeding must be discontinued during treatment with ERANFU 250. Fulvestrant is excreted in ratu2019s milk. It is not known if fulvestrant is excreted in human milk. Considering the potential for serious adverse reactions due to fulvestrant in breastfed infants, ERANFU 250 is contraindicated during lactation (See Section 4.3).

Fertility

The effects of fulvestrant on fertility in humans has not been studied.

ERANFU 250 has no or negligible influence on the ability to drive or operate machinery. However, since asthenia has been reported during treatment with fulvestrant, caution should be observed by those patients who experience this adverse reaction when driving or operating machinery (see Section 4.8).

Summary of the safety profile

This section provides information based on all adverse reactions from clinical studies, post-marketing studies or spontaneous reports. In the pooled dataset of fulvestrant monotherapy, the most frequently reported adverse reactions were injection site reactions, asthenia, nausea, and increased hepatic enzymes (ALT, AST, ALP).

Table 1: Adverse reactions by system organ class and frequency

In the FALCON study, of the 65 patients in the fulvestrant arm who reported joint and musculoskeletal pain, 40 % (26/65) of patients reported joint and musculoskeletal pain within the first month of treatment, and 66,2 % (43/65) of patients within the first 3 months of treatment. No patients reported events that were CTCAE Grade u2265 3 or that required a dose reduction, dose interruption, or discontinued treatment due to these adverse reactions.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Health care providers are asked to report any suspected adverse reactions to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on SAHPRA website. For any information about this medicine, please contact the local representative of the Holder of Certificate of Registration: Dr. Reddyu2019s Laboratories (Pty) Ltd. Tel: +27 11 324 2100

There is no experience of overdose in humans. Animal studies suggest that no effects other than those related directly or indirectly to anti-oestrogenic activity were evident with higher doses of fulvestrant. Should overdose occur, symptomatic supportive treatment is recommended.