ALDARA CREAM 5% [SIN10105P]

Product Info

ALDARA CREAM 5%

[SIN10105P]

Indication

INDICATIONS AND USAGE

Aldara 5% cream is indicated for:

• treatment of external genital and perianal warts /condyloma acuminata in adults.

• primary treatment of confirmed superficial basal cell carcinoma with a maximum tumour diameter of 2.0 cm, where surgery is considered inappropriate [see WARNINGS AND PRECAUTIONS and CLINICAL PHARMACOLOGY – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information, and

• treatment of clinically typical, nonhyperkeratotic, and nonhypertrophic solar (actinic) keratosis on the face and scalp [see WARNINGS AND PRECAUTIONS and CLINICAL PHARMACOLOGY – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information]

Dosing

DOSAGE AND ADMINISTRATION

Before applying Aldara, the patient should wash the treatment area with mild soap and water and allow the area to dry thoroughly. Aldara cream is to be applied to the affected area prior to normal sleeping hours, and left on the skin for 6–10 hours.
The cream should be rubbed in until it is no longer visible. Following the treatment period cream should be removed by washing the treated area with mild soap and water. During the 6–10 hours treatment period showering or bathing should be avoided. Hand washing before and after cream application is recommended.

Local skin reactions (erythema) at the treatment area are common. These reactions may be due to the pharmacological response of the body’s immune system to Aldara. In clinical studies in patients with sBCC the histological clearance following Aldara therapy was statistically (p<0.001) higher (91%) in patients with moderate to severe local skin reactions compared to those patients who experienced no or mild skin reactions (54%). Similarly there was a significant association between the intensity of local skin reactions (eg erythema) seen during the treatment period and complete clearance of solar (actinic) keratosis. A rest period of several days may be taken if required due to the patient’s discomfort or severity of the local skin reaction. These local skin reactions generally decrease in intensity or resolve after cessation of Aldara therapy. Treatment may resume once the reaction subsides. In patients requiring a rest period during treatment with Aldara it is not necessary to make up the missed doses or to prolong the duration of Aldara therapy.

Aldara is provided in a pump or in single use sachets. If you are using the Aldara pump remove the protective cap and prime several times until cream appears at the nozzle. Four actuations of the pump is equivalent to one 250 mg sachet of Aldara cream. The contents of the pump should be used within 4 weeks after opening and the pump discarded thereafter. Fewer than four full actuations of the pump may be sufficient cream for a single application. A new sachet should be opened for each treatment, and cream from a previously opened sachet should not be used.

For the Aldara pump the patient is to remove the protective cap and prime several times until cream appears at the nozzle.

The dosing frequency of Aldara for the treatment of sBCC is different to that for the treatment of solar keratosis and external genital warts.

External Genital/Perianal Warts:

Aldara is to be applied once per day three times per week. Examples of 3 times per week application schedules are: Monday, Wednesday, Friday; or Tuesday, Thursday, Saturday application prior to sleeping hours. Aldara treatment should continue until there is total clearance of the genital/perianal warts or for a maximum of 16 weeks. A thin layer of Aldara is to be applied to the wart area. Four actuations of the pump or each sachet contains sufficient cream to cover a wart area of up to 20cm²; use of excessive amounts of cream should be avoided. The application site is not to be occluded. Non-occlusive dressings such as cotton gauze or cotton underwear may be used in the management of skin reactions.

Solar (Actinic) Keratosis

Aldara is to be applied to a treatment area no larger than 25cm². The recommended dose per application is 4 actuations or one sachet.

Aldara may be applied 3 times per week (example: Monday, Wednesday and Friday) for four weeks prior to normal sleeping hours and left on the skin for approximately 8 hours. Sufficient cream should be applied to cover the treatment area. After a 4-week treatment-free period, clearance of SKs should be assessed. If any lesions persist, treatment should be repeated for another four weeks.

An interruption of dosing should be considered if intense local inflammatory reactions occur (see WARNINGS AND PRECAUTIONS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information) or if infection is observed at the treatment site. In this latter case, appropriate other measures should be taken. Each treatment period should not be extended beyond 4 weeks due to missed doses or rest periods.

If the treated lesion(s) show an incomplete response at the follow-up examination at 4–8 weeks after the second treatment period, a different therapy should be used (see WARNINGS AND PRECAUTIONS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Superficial Basal Cell Carcinoma

Aldara is to be applied once daily for 5 consecutive days per week and the treatment should continue for 6 weeks. Sufficient cream should be applied to cover the treatment area, including one centimetre of skin surrounding the tumour. The clinical outcome of therapy can be determined after regeneration of the treated skin, approximately 6 to 12 weeks after the end of treatment. At this time the skin may appear different from the non-affected surrounding skin that includes an increase in hypopigmentation and a decrease in the degree of rough/dry/scaly skin surface. These changes may be secondary to the appearance of the treated healing target tumour area, contrasting with the surrounding sun damaged skin.

Ten percent (19/185) of patients treated with 5x/week Aldara therapy for the treatment of sBCC received rest periods. The median time for rest periods was 4 weeks with a range of 1 to 6 weeks after the initiation of therapy. The average number of doses not received per patient due to rest periods was 7 doses with a range of 2 to 22 doses. There was higher histological clearance in patients treated with Aldara 5x/week for 6 weeks who had taken a rest period during treatment (89%) compared to those who did not take a rest period from dosing (81%). No statistically significant difference in the effect of rest periods was noted.

Contraindications

CONTRAINDICATIONS

Hypersensitivity to any ingredient