Mayne Pharma 5FU

MIMS Revision Date: 01 February 2026

1 Name of Medicine

Fluorouracil.

2 Qualitative and Quantitative Composition

Mayne Pharma 5FU is a cream containing fluorouracil 5% w/w.
Contains hydroxybenzoates.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

White, smooth and homogenous vanishing cream.

4 Clinical Particulars

4.1 Therapeutic Indications

Solar and senile keratoses, Bowen's disease.

4.2 Dose and Method of Administration

Mayne Pharma 5FU should only be used under medical supervision.
Mayne Pharma 5FU is well tolerated. The healthy skin surrounding the area being treated may occasionally become reddened, but soon resumes its normal colour on cessation of treatment.
In cases of senile and solar keratoses a thin layer of the cream is applied to the affected areas once or twice daily, generally without a dressing. In the treatment of other conditions (including keratosis palmaris) a fresh occlusive dressing should be applied daily. Treatment should be continued up to the erosion stage. Duration of therapy is usually 3-4 weeks, but it may prove necessary to exceed this on occasion. When Mayne Pharma 5FU is applied to the skin, the following usually happens: a redness of the affected area (generally within 3 to 5 days) followed by blistering, peeling, and cracking (within 11 to 14 days) with occasional open sores and some discomfort. Although the skin seems to be worse, it is a sign that the medication is working. The treated skin will flake away. Some redness of the skin will continue for some time after the drug is stopped.
Limitation of treatment area. The total area of skin being treated with Mayne Pharma 5FU at any time should not exceed 500 sq cm (approx. 23 x 23 cm). Larger areas should be treated a section at a time.

4.3 Contraindications

Mayne Pharma 5FU is contraindicated in women who are or may become pregnant during therapy (see Section 4.6 Fertility, Pregnancy and Lactation).
Known hypersensitivity to fluorouracil or any of its excipients.
Mayne Pharma 5FU should not be used in patients with dihydropyrimidine dehydrogenase (DPD) enzyme deficiency. A large percentage of fluorouracil is catabolised by the enzyme dihydropyrimidine dehydrogenase. DPD enzyme deficiency can result in shunting of fluorouracil to the anabolic pathway, leading to cytotoxic activity and potential toxicities.
Rarely, life-threatening toxicities such as stomatitis, diarrhoea, neutropenia, and neurotoxicity have been reported with intravenous administration of fluorouracil in patients with DPD enzyme deficiency.
A case of life-threatening systemic toxicity has been reported with the topical use of fluorouracil 5% in a patient with DPD enzyme deficiency. Symptoms included severe abdominal pain, bloody diarrhoea, vomiting, fever, and chills. Physical examination revealed stomatitis, erythematous skin rash, neutropenia, thrombocytopenia, inflammation of the oesophagus, stomach, and small bowel. Although this case was observed with 5% fluorouracil cream, it is unknown whether patients with profound DPD enzyme deficiency would develop systemic toxicity with lower concentrations of topically applied fluorouracil.

4.4 Special Warnings and Precautions for Use

Identified precautions. The normal pattern of response includes: early and severe inflammatory phases (typically characterised by erythema, which may become intense and blotchy), a necrotic phase (characterised by skin erosion) and finally healing (when epithelialisation occurs). The clinical manifestation of response usually occurs in the second week of Mayne Pharma 5FU treatment. However, these treatment effects sometimes are more severe and include pain, blistering and ulceration.
Mayne Pharma 5FU is highly irritant, and so should not be allowed to come in contact with mucous membranes (eyes, nose or mouth) due to the possibility of irritation, local inflammation and ulceration. There is a possibility of increased absorption through ulcerated or inflamed skin.
Treatment of perioral area or nasolabial fold should be avoided, or treated carefully. Because of its irritant nature, care should be taken to ensure that Mayne Pharma 5FU does not come into contact with normal skin. Mayne Pharma 5FU should be applied with a non-metal applicator or rubber glove. Should a glove not be worn and the hands come in contact with Mayne Pharma 5FU during application they should be washed thoroughly after applying Mayne Pharma 5FU.
Exposure to UV radiation, (e.g. natural sunlight or tanning salon) should be avoided. Mayne Pharma 5FU therapy is not advisable in persons who work outdoors for prolonged periods in the sun. Excessive sun exposure may produce a diffuse phototoxic response in the areas of application; therefore, exposure should be minimised during and immediately following treatment with Mayne Pharma 5FU because the intensity of the reaction may be increased.
While treatment is in progress, avoid cosmetics on treated areas and other topical medication applied to the same area, unless otherwise directed.
Occlusion of the skin with resultant hydration has been shown to increase percutaneous penetration of several topical preparations. If any occlusive dressing is to be used, there may be an increase in the severity of inflammatory reactions in the adjacent normal skin. A porous gauze dressing may be applied for cosmetic reasons without increase in reaction.
The excipients stearyl alcohol, cetyl alcohol and propylene glycol may cause local skin irritations (e.g. contact dermatitis); the excipients methyl hydroxybenzoate and propyl hydroxybenzoate may cause allergic reactions (possibly delayed).
Information for patients. Fluorouracil, including Mayne Pharma 5FU may be fatal if ingested by pets. Avoid allowing pets to contact the Mayne Pharma 5FU container or the skin where Mayne Pharma 5FU has been applied. Store Mayne Pharma 5FU out of reach of pets. Safely discard or clean any cloth or applicator that may retain Mayne Pharma 5FU and avoid leaving any residues of Mayne Pharma 5FU on your hands, clothing, carpeting or furniture.
Use in the elderly. No data available.
Paediatric use. Safety and effectiveness in children have not been established.
Effects on laboratory tests. No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Although no significant medicine interactions with Mayne Pharma 5FU have been reported, potential medicine interactions are possible, caution should be taken with medicines that may have an effect on the DPD enzyme.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility. No data available.
Use in pregnancy. (Category D)
Drugs which have caused, are suspected to have caused, or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.
Studies in animals have shown that fluorouracil is teratogenic. The potential risk for humans is unknown, hence Mayne Pharma 5FU is contraindicated in pregnancy or where pregnancy cannot be excluded (see Section 4.3 Contraindications).
Use in lactation. It is not known whether fluorouracil is excreted in human milk. Because there is some systemic absorption of fluorouracil after topical administration, because many medicines are excreted in human milk, and because of the potential for serious adverse reactions in nursing infants, Mayne Pharma 5FU use should be avoided in nursing mothers.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration. However, adverse effects of Mayne Pharma 5FU include dizziness which could affect the ability to drive or use machines (see Section 4.8 Adverse Effects (Undesirable Effects)).

4.8 Adverse Effects (Undesirable Effects)

The most frequently encountered reactions are often related to an extension of the pharmacological activity of the medicine. These include pain, pruritus, hyperpigmentation, burning, crusting, allergic contact dermatitis, erosions, erythema, hyperpigmentation, irritation, photosensitivity, scarring, rash, soreness and ulceration at the site of application. Leukocytosis is the most frequent haematological adverse effect.
Application site haemorrhage has also been reported (frequency unknown).
The patient should be advised of the temporary unsightly appearance and local discomfort to be expected during treatment with this drug (see Section 4.4 Special Warnings and Precautions for Use). Patients with chloasma and rosacea and other inflammatory dermatoses may encounter accentuation of their condition and should first be treated with appropriate therapy before using the medication. While absorption of Mayne Pharma 5FU through healthy skin is negligible, absorption is considerably increased when it is applied to diseased skin.
Although a causal relationship is remote, other adverse reactions which have been reported infrequently are:
Nervous system disorders. Dizziness, emotional upset, insomnia, irritability, headache.
Gastrointestinal disorders. Nausea.
Skin and subcutaneous tissue disorders. Alopecia, blistering, bullous pemphigoid, discomfort, ichthyosis, scaling, suppuration, swelling, telangiectasia, tenderness, urticarial, skin rash.
Special senses. Conjunctival reaction, corneal reaction, lacrimation, nasal irritation.
Miscellaneous. Herpes simplex.
Reporting suspected adverse effects. Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems.

4.9 Overdose

If Mayne Pharma 5FU is accidentally ingested, signs of fluorouracil overdosage may include nausea, vomiting and diarrhoea. Stomatitis and blood dyscrasias may occur in severe cases. Appropriate measures should be taken for the prevention of systemic infection and daily white cell counts should be performed.
For information on the management of overdose, contact the Poison Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action. When the preparation is applied to keratotic and preneoplastic lesions it produces the following pattern of response: first erythema, then, usually, vesiculation, erosion, ulceration, necrosis and epithelialisation.
Clinical trials. In a double-blind, placebo-controlled, three treatment parallel study, patients with solar (actinic) keratosis were randomized to be treated on the face with Mayne Pharma 5FU test cream, Efudix reference cream or a vehicle (placebo) cream, twice daily for 2 weeks.
The primary endpoint was the percent of patients with complete clearing of solar keratosis lesions at week 6. That is, 4 weeks after the 2 weeks treatment. The secondary objective was the statistical superiority of Mayne Pharma 5FU and reference cream to the vehicle. The safety objective was the severity of irritation (as evidenced by erythema, redness, and dermatitis) and incidence of adverse events in treated patients in the three treatment groups.
Three hundred and eighteen patients were enrolled in the study: 141 in the Mayne Pharma 5FU treatment group, 142 in the reference treatment group and 35 in the vehicle group. All 318 patients were included in the safety population. Three hundred and thirteen patients were included in the intent-to-treat population; 138 in the test treatment group, 142 in the reference treatment group and 33 in the vehicle group. Two hundred and ninety-seven patients were included in the per-protocol population: 130 in the Mayne Pharma 5FU treatment group, 135 in the reference treatment group and 32 in the vehicle group.
In the per-protocol population 87% of patients in the Mayne Pharma 5FU treatment group and 88% of patients in the reference treatment group cleared. The difference in active treatment success rates demonstrated the bioequivalence of the two active treatments. Irritation profiles between the active treatment groups were similar.

5.2 Pharmacokinetic Properties

While absorption of Mayne Pharma 5FU through healthy skin is negligible, absorption is considerably increased when it is applied to diseased skin.

5.3 Preclinical Safety Data

Genotoxicity. No data available.
Carcinogenicity. No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

Cetyl alcohol, methyl hydroxybenzoate, polysorbate 60, propylene glycol, propyl hydroxybenzoate, purified water, stearyl alcohol, white soft paraffin.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.
Discard 4 weeks after opening the tube.

6.4 Special Precautions for Storage

Store below 25°C.

6.5 Nature and Contents of Container

Tube, aluminium: 20 g.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

Chemical structure.

CAS number. 51-21-8.

7 Medicine Schedule (Poisons Standard)

Schedule 4 - Prescription Only Medicine.

Date of First Approval

06 March 2024