Consumer medicine information

Picato gel 0.015%

Ingenol mebutate

BRAND INFORMATION

Brand name

Picato Gel

Active ingredient

Ingenol mebutate

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Picato gel 0.015%.

What is in this leaflet?

This leaflet answers some common questions about using the medicine Picato® gel, 0.015%. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you using Picato® gel against the benefits it is expected to have for you.

If you have any concerns about using Picato® gel talk to your doctor or pharmacist.

What Picato® gel, 0.015% is used for

Picato® gel, 0.015% is used as a topical treatment of solar keratoses (sun spots) on the face and scalp of adults.

Solar keratoses are thickened, scaly patches of skin caused by too much sun exposure. Solar keratoses are also known as actinic keratoses.

Picato® gel contains the active ingredient ingenol mebutate.

The ingenol mebutate in Picato® gel treats the lesions in the area where the gel is applied.

USE PICATO® GEL 0.015% ON YOUR FACE AND SCALP

IT IS NOT RECOMMENDED THAT PICATO® GEL, 0.015% IS USED ON OTHER PARTS OF YOUR BODY

Picato® gel is only available with a doctor’s prescription.

This medicine is not expected to affect your ability to drive a car or operate machinery.

This medicine is not addictive.

Before you use Picato® gel

When you must not use Picato® gel

Do not use Picato® gel, if you are allergic to ingenol mebutate or any of the other ingredients listed at the end of this leaflet (see Product description).

Some of the symptoms of an allergic reaction include shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue or other parts of the body; rash, itching or “hives” on the skin.

Do not use Picato® gel, on broken skin

Do not use Picato® gel

  • after the expiry date printed on the pack OR
  • if the packaging is torn, doesn’t look quite right or shows signs of tampering.

If any of these apply, return the medicine to your pharmacist for disposal.

If you are not sure whether you should start using Picato® gel, talk to your doctor.

Before you start to use Picato® gel

Tell your doctor if you have a known allergy to Picato® gel, ingenol mebutate or any of the ingredients listed at the end of this leaflet.

Tell your doctor if you

  • are pregnant or intend to become pregnant.
  • are taking any other medicines
  • currently have, or in the past have had, any other medical conditions.

Do not use Picato® gel on children. Solar keratoses is not a condition that normally affects children. Safety and effectiveness of Picato® gel in those below 18 years of age has not been established.

If you have not told your doctor about any of the above, tell him/her before you start using this medicine.

Other medicines

Tell your doctor or pharmacist if you are using any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food store.

Your doctor and pharmacist have more information on medicines you should be careful with or avoid whilst using Picato® gel.

How to use Picato® gel, 0.015%

Follow carefully all directions given to you by your doctor or pharmacist. They may differ from the information contained in this leaflet.

If you do not understand the instructions in this leaflet, ask your doctor or pharmacist for help.

How much Picato® gel, 0.015% to use

Each carton of Picato® gel, 0.015% contains 3 small tubes.

Each tube of Picato® gel, 0.015% contains a single dose. You should apply the contents of 1 tube to the area on your face or scalp containing the sun spot(s)/lesion(s).

Each tube of Picato® gel, 0.015% contains enough gel to cover an area of approximately 25cm2 (e.g. 5cm x 5cm). However, avoid getting Picato® gel close to the eye area, nostrils and mouth. If the lesion is near the eye area, nostrils or mouth you may need to apply Picato® gel to a smaller treatment area.

How to use Picato® gel, 0.015%

Apply Picato® gel, 0.015% only to treatment areas on the face or scalp.

Use Picato® gel, 0.015% as follows:

  • Squeeze the gel from the single use tube onto the fingertip and then spread it evenly over the treatment area
  • Allow treatment area to dry for 15 minutes. Do not touch during this time.
  • Wash your fingertip with soap and water immediately after application.
  • Do not wash the area of the body where Picato® gel, 0.015% was applied for at least 6 hours after application
  • After this period the treatment area may be washed using mild soap and water.
  • Picato® gel, 0.015% should not be applied immediately before or after taking a shower as the skin needs to be very dry before application
  • Picato® gel, 0.015% should not be applied less than 2 hours before bedtime
  • The area treated with Picato® gel, 0.015% should not be covered with occlusive bandages.

The full effects of Picato® gel, 0.015% are best assessed approximately 8 weeks after treatment.

How long to use Picato® gel

A treatment course lasts for 3 days.

Apply Picato® gel, 0.015% once a day for 3 days in a row.

If you forget to use Picato® gel

If you forget to apply the second or third tube of Picato® gel within 3 days of the last application, apply the second or third tube when you remember. If it has been more than 3 days since the last application, do not apply the remaining tube(s). If this happens you should contact your doctor.

If you are not sure what to do, ask your doctor or pharmacist.

If you use too much or use it other than directed (Overdose)

If you use too much or use it other than directed (Overdose) immediately telephone your doctor or the Poisons Information Centre (Telephone 13 11 26 in Australia or 0800 764 766 in New Zealand) for advice, or go to the Emergency Department at the nearest hospital, if you think that you or anyone else may have used too much or swallowed some of this medicine. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

While you are using Picato® gel

Things you must do

While you are using Picato® gel you should protect the treated skin areas from sunlight and ultraviolet (UV) rays. This can be done by wearing a hat and covering the treated area with clothing before going outside. Sunscreens and moisturisers (non-medicated, non-irritant) can be applied to the treated area once treatment is completed and if the skin is not broken.

If you are going to start any new medicine, tell your doctor and pharmacist that you are using Picato® gel.

If you become pregnant while using Picato® gel tell your doctor immediately.

If you experience an allergic reaction whilst you are using Picato® gel, stop using it, and immediately seek medical attention.

Monitor your skin and watch for any new scaly red patches, open sores, elevated or wart-like growths within the treatment area. If you notice any of these, tell your doctor immediately.

Keep all appointments with your doctor so that your progress can be checked.

Things you must not do

Do not give your medicine to anyone else, even if they have the same condition as you.

Do not use more than the recommended daily dose (see How to use Picato® gel, 0.015%).

DO NOT APPLY PICATO® GEL TO OR NEAR YOUR EYE AREA.

Avoid contact with, or accidental transfer to, the eye area during or after treatment. If it gets into your eyes or your eye area, flush with plenty of water then consult your doctor immediately.

Side effects

As with all medicines, Picato® gel can cause some side effects.

The most common effects are expected and show that the treatment is working.

The expected effects at the application site include:

  • Skin reddening
  • Skin flaking or scaling
  • Mild swelling
  • Crusting or Scabbing
  • Blistering

Swelling at the application site may extend to the eye area.

Side effects not listed above may also occur in some people. These less common side effects include:

  • Pain
  • Itching
  • Irritation
  • Ulceration of the treatment site.

All these effects usually clear within 2 weeks. If the effects continue for longer you should talk to your doctor.

Tell your doctor or pharmacist if you notice the following side effects:

  • Ulcers forming
  • Skin weeping
  • Swelling of the eye area
  • You think the application site has become infected.

You should also tell your doctor or pharmacist if you have any additional unpleasant effects while you are using Picato® gel.

After using Picato® gel

Keep Picato® gel in the box in the refrigerator until required.

Storage

STORE PICATO® GEL IN THE REFRIGERATOR AT 2-8°C.

Picato® gel can spend a short time outside of the refrigerator if the temperature is below 30°C. This will allow you time to get Picato® gel home from the pharmacy and into the refrigerator.

Periods of storage outside of the refrigerator may reduce the effectiveness of Picato® gel.

Store Picato® gel where children cannot reach it.

Disposal

Ask your pharmacist what to do with Picato® gel that is left over if:

  • your doctor tells you to stop using Picato® gel
    or
  • the expiry date has passed

Product description

What it looks like

Picato® gel is a clear, colourless gel.

Ingredients

Picato® gel contains the active ingredient ingenol mebutate.

It also contains:

  • isopropyl alcohol,
  • hydroxyethylcellulose,
  • citric acid monohydrate,
  • sodium citrate,
  • benzyl alcohol

The Australian Registration Number is AUST R 190122

This is not all the information available on Picato® gel, 0.015%. If you have any more questions or are unsure about anything, ask your doctor or pharmacist.

Supplier

Picato® gel is supplied in Australia by:

LEO Pharma Pty Ltd, Level 3, Tower 1, 25 Montpelier Road, Bowen Hills, QLD 4006, AUSTRALIA

Picato® gel is supplied in New Zealand by:

LEO Pharma Ltd, Level 31, Vero Centre, 48 Shortland St, Auckland, NEW ZEALAND.

Contact details:

Australia Toll free no: 1800 991 778
New Zealand Toll free no: 0800 497 456
Email: [email protected]

® Picato, LEO and LEO/lion device are registered trademarks of LEO Pharma A/S.

This leaflet was revised in February 2019.


Published by MIMS September 2019

BRAND INFORMATION

Brand name

Picato Gel

Active ingredient

Ingenol mebutate

Schedule

S4

 

1 Name of Medicine

Ingenol mebutate.

6.7 Physicochemical Properties

The chemical name for ingenol mebutate is 2-butenoic acid, 2-methyl-, (1aR,2S,5R,5aS,6S,8aS,9R,10aR)- 1a,2,5,5a,6,9,10,10a-octahydro- 5,5a-dihydroxy-4-(hydroxymethyl)- 1,1,7,9-tetramethyl-11-oxo-1H-2,8a- methanocyclopenta[a] cyclopropa[e]cyclodecen-6-yl ester, (2Z)- or (1aR,2S,5R,5aS,6S,8aS,9R,10aR)- 5,5a-dihydroxy-4-(hydroxymethyl)- 1,1,7,9-tetramethyl-11-oxo- 1a,2,5,5a,6,9,10,10a-octahydro-1H-2,8a- methanocyclopenta[a] cyclopropa[e]cyclodecen-6-yl (2Z)-2-methylbut-2-enoate.
The empirical formula is C25H34O6. The molecular weight is 430.53 g/mol.
Ingenol mebutate is a purified ingenol angelate extracted from the E. peplus plant and is a white to pale yellow crystalline powder.
The distribution coefficient between octanol and phosphate buffer is 4.1 at a pH of 7.4.
Ingenol mebutate is practically insoluble in water.

Chemical structure.


CAS number.

75567-37-2.

2 Qualitative and Quantitative Composition

Picato gel 0.015%.

Each gram of gel contains 150 micrograms of ingenol mebutate. Each tube contains 70 micrograms of ingenol mebutate in 0.47 g of gel.

Picato gel 0.05%.

Each gram of gel contains 500 micrograms of ingenol mebutate. Each tube contains 235 micrograms of ingenol mebutate in 0.47 g of gel.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Gel.
Picato gel is a clear colourless gel intended for topical administration.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

The mechanism of action of Picato gel in solar (actinic) keratoses remains to be fully characterised. In vivo and in vitro models have shown a dual mechanism of action for the effects of ingenol mebutate: 1) induction of local lesion cell death; and 2) promotion of an inflammatory response characterised by local production of proinflammatory cytokines and chemokines and infiltration of immunocompetent cells.

Pharmacodynamics.

Results from two clinical trials on biological effects of ingenol mebutate have shown that topical administration induced epidermal necrosis and a profound inflammatory response in both the epidermis and the upper dermis of the treated skin, dominated by infiltrating T cells, neutrophils and macrophages. Necrosis in the dermis was rarely observed.
Gene expression profiles of skin biopsies from the treated areas is suggestive of inflammatory responses and response to wounding, which is consistent with the histology assessments.
Noninvasive examination of the treated skin by reflectance confocal microscopy has shown that the skin changes induced by ingenol mebutate were reversible, with almost complete normalisation of all measured parameters on day 57 after treatment, which is supported also by clinical findings and studies in animals.

Clinical trials.

Solar (actinic) keratoses.

The efficacy and safety of Picato gel, 0.015%, applied to the face or scalp for 3 consecutive days, was studied in two double blind, vehicle controlled, clinical studies including 547 adult patients. Likewise the efficacy and safety of Picato gel 0.05%, administered on the body (trunk or extremities) for 2 consecutive days was studied in two double blind, vehicle controlled, clinical studies including 458 adult patients. Patients continued in the studies for an 8 week follow-up period during which they returned for clinical observations and safety monitoring. Efficacy, measured as complete and partial clearance rate, as well as median percent reduction, was assessed at day 57 (see Table 4).
Patients had 4 to 8 clinically typical, visible, nonhyperkeratotic, nonhypertrophic discrete solar keratosis lesions within a contiguous 25 cm2 treatment area on the face or scalp or on the body (trunk or extremities). On each scheduled dosing day, the study gel was applied to the entire treatment area. The compliance rate was high, with 98% of the patients completing these studies. Study patients ranged from 34 to 89 years of age (mean 64 and 66 years, respectively, for the two strengths) and 94% had Fitzpatrick skin type I, II, or III.
At day 57, patients treated with Picato gel had higher complete and partial clearance rates than patients treated with vehicle gel (p < 0.001). The median percent reduction in solar keratosis lesions was higher in the group treated with Picato gel compared to the vehicle group (see Table 4). These studies did not assess clearance by histology.
The safety of Picato gel, 0.015% treatment for 3 days or Picato gel 0.05% treatment for 2 days was assessed up to day 57. The results demonstrated that ingenol mebutate gel was well tolerated. All adverse drug reactions and local skin responses resolved without sequelae.
Statistically significant differences in patient reported outcomes were observed in favour of patients receiving Picato gel compared to those receiving vehicle gel. Higher mean patient global satisfaction scores, indicating a higher level of overall satisfaction, were seen in the Picato gel groups compared to the vehicle groups (p < 0.001) as measured by the Treatment Satisfaction Questionnaire for Medication (TSQM).

Long-term efficacy.

Three prospective, observational long-term 1 year follow-up studies were conducted to evaluate sustained efficacy by recurrence of solar keratosis lesions in the treatment field, and safety in patients who had received treatment with Picato gel. One study included patients treated with Picato gel, 0.015% on the face or scalp for 3 days and two studies included patients treated with Picato gel, 0.05% on the trunk or extremities for 2 days. Only those patients who achieved complete clearance in the treated area at the end of the phase 3 studies (day 57) were eligible for long-term follow-up. Patients were followed every 3 months for 12 months (see Table 5).

Progression to squamous cell carcinoma.

At end of study (day 57), the rate of squamous cell carcinoma (SCC) reported in the treatment area was comparable in patients treated with Picato gel (0.3%, 3 of 1165 patients) and in vehicle treated patients (0.3%, 2 of 632 patients), in the solar keratoses clinical studies.
SCC in the treatment area was reported in none of the 184 patients previously treated with Picato, in three prospective, observational long-term 1 year follow-up studies.

Experience with treatment of a larger area.

In a double blind, vehicle controlled study to evaluate systemic exposure, ingenol mebutate 0.05% gel, from 4 single dose tubes, was applied to a 100 cm2 contiguous treatment area daily for 2 consecutive days. Results demonstrated no systemic absorption.
Picato gel, 0.05% was well tolerated when applied to a contiguous treatment area of 100 cm2 on trunk and extremities.

Use in the elderly.

Of the 1165 subjects treated with Picato gel in the solar keratoses clinical studies, 656 subjects (56%) were 65 years and older and, 241 subjects (21%) were 75 years and older. No overall differences in safety or efficacy were observed between these subjects and younger subjects.

5.2 Pharmacokinetic Properties

The pharmacokinetic profile of ingenol mebutate and its metabolites has not been characterised in humans due to the absence of quantifiable blood levels following topical administration.
No systemic absorption was detected at or above the lower limit of detection (0.1 nanogram/mL) when Picato gel, 0.05% from 4 single dose tubes was applied to an area of 100 cm2 on the dorsal forearm in solar keratoses patients once daily for two consecutive days.
In vitro study results demonstrate that ingenol mebutate does not inhibit or induce human cytochrome P450 isoforms, at clinically relevant concentrations.

5.3 Preclinical Safety Data

Genotoxicity.

Ingenol mebutate was not mutagenic in an in vitro Ames test, mouse lymphoma assay, and in vivo rat micronucleus test, and gave a positive response in the Syrian hamster embryo cell in vitro transformation assay.

Carcinogenicity.

Carcinogenic evaluations of ingenol mebutate have not been conducted.

4 Clinical Particulars

4.1 Therapeutic Indications

Picato gel is indicated for the topical treatment of solar (actinic) keratoses in adults.

4.3 Contraindications

Any known hypersensitivity to ingenol mebutate or any constituent of Picato gel.

4.4 Special Warnings and Precautions for Use

For external use only; not for oral, ophthalmic, vaginal or anal use. Avoid eye area.

Ophthalmic adverse reactions.

Avoid treatment in the periocular area. Eye disorders, including severe eye pain, chemical conjunctivitis, corneal burn, eyelid oedema, eyelid ptosis, periorbital oedema can occur after exposure (see Section 4.8 Adverse Effects (Undesirable Effects)).

Eye exposure.

Avoid contact with, or inadvertent transfer to, the eyes and to the periocular area during treatment and for 6 hours after treatment with Picato gel.
To avoid transfer of the drug into the eyes and to the periocular area during and after application, patients should wash hands well after applying Picato gel (see Section 4.2 Dose and Method of Administration). If accidental exposure occurs to the eyes or periocular area, the eyes or periocular area should be flushed immediately with large amounts of water, and the patient should seek medical assistance as soon as possible.

Ingestion.

If you get Picato gel in your mouth, rinse well with water right away. Contact your healthcare provider or the Poisons Information Centre, phone 13 11 26.

Local skin responses.

Local skin responses such as erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation and erosion/ulceration can occur after topical application of Picato. These local skin responses have been shown to be associated with the clinical efficacy. Localised skin responses are transient and typically occur within 1 day of treatment initiation and peak in intensity up to 1 week following completion of treatment. Localised skin responses typically resolve within 2 weeks of treatment initiation when treating areas on the face and scalp and within 4 weeks of treatment initiation when treating areas on the trunk and extremities. A treatment effect may not be adequately assessed until resolution of local skin responses.
Administration of Picato gel is not recommended until the skin is healed from any treatment with a previous medicinal product, surgical treatment or from any open wounds.

Ultraviolet light exposure.

Studies have been conducted to assess the effects of UV irradiation on the skin following single and multiple applications of ingenol mebutate gel, 0.01%. Ingenol mebutate gel did not demonstrate any potential for photoirritation or photoallergic effects. However, due to the nature of the disease, excessive exposure to sunlight (including sunlamps and tanning beds) should be avoided or minimised.

Hypersensitivity reactions.

If anaphylactic or other clinically significant hypersensitivity reactions occur, discontinue Picato gel immediately and institute appropriate medical therapy.

Other.

Health care professionals should advise patients to be vigilant for any lesions developing within the treatment area and to seek medical advice should any occur. Lesions clinically atypical for actinic keratosis or suspicious for malignancy should be biopsied to determine appropriate treatment.

Use in the elderly.

No dosage adjustment is required (see Section 5.1 Pharmacodynamic Properties, Clinical trials).

Paediatric use.

Picato gel is not indicated for use in the paediatric population.

Effects on laboratory tests.

There are no data available on the effects of Picato on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

No interaction studies have been performed. Interactions with systemically absorbed medicinal products are considered unlikely as ingenol mebutate is not absorbed systemically.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No fertility studies have been performed with ingenol mebutate.
(Category B3)
There are no data from the use of ingenol mebutate in pregnant women. Animal studies are equivocal with respect to reproductive toxicity (see below). Risks to humans receiving topical treatment with Picato gel are considered unlikely as ingenol mebutate is not absorbed systemically. As a precautionary measure, it is preferable to avoid the use of Picato gel during pregnancy.
In rats, ingenol mebutate was not associated with foetal developmental effects at IV doses up to 5 microgram/kg/day (30 microgram/m2/day), however, there was a possible increase in early embryonic deaths. In rabbits there were no major abnormalities at IV doses up to 4 microgram/kg/day (48 microgram/m2/day). Minor foetal abnormalities or variants were observed in the foetuses of treated dams at doses ≥ 2 microgram/kg/day (24 microgram/m2/day). The foetal NOAEL was 1 microgram/kg/day (12 microgram/m2/day).
 No effects on the breastfed newborn/infants are anticipated as ingenol mebutate is not absorbed systemically. The nursing mother should be instructed that physical contact between her newborn/infant and the treated area should be avoided for a period of 6 hours after application of Picato gel.

4.8 Adverse Effects (Undesirable Effects)

Clinical trials.

The data described below reflect exposure to ingenol mebutate or vehicle in 1002 subjects with solar keratoses treated in four vehicle controlled phase 3 studies. Subjects received field treatment (area of 25 cm2) with Picato gel at concentrations of 0.015% or 0.05% or vehicle once daily for 3 or 2 consecutive days, respectively. Adverse reactions were generally mild to moderate in intensity (Table 1).
Other less common adverse reactions (less than 1% but more than 0.5%) were, in decreasing order: application site paraesthesia and eyelid oedema.
In the four vehicle controlled phase 3 studies, local skin responses (erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, erosion/ulceration) were assessed within the selected treatment area and graded by the investigator on a scale of 0 to 4. A grade of 0 represented no reaction present in the treated area, and a grade of 4 indicated a marked and discernable skin reaction that extended beyond the area treated (Tables 2 and 3).
For both treatment locations (face/scalp and trunk/extremities), erythema and flaking/scaling were the most common LSRs, followed by crusting and swelling in patients treated with Picato gel. The local skin responses are transient and typically occur within one day of treatment initiation and peak in intensity up to one week following completion of treatment. Local skin responses typically resolve within 2 weeks for areas treated on the face and scalp and within 4 weeks for areas treated on the body (trunk and extremities).
Swelling at the application site on the face or scalp may gravitate to the eye area.

Clinical trial experience - long-term safety follow-up.

Three prospective, observational long-term follow-up studies were conducted to evaluate recurrence of solar keratosis lesions and safety in subjects receiving treatment with Picato gel on the face, scalp or body (trunk or extremities). Only those subjects who achieved complete clearance in the treated area at the end of the phase 3 studies (day 57) were eligible for long-term follow-up. Subjects were followed every 3 months for up to 12 months.
A total of 198 subjects (184 treated with Picato gel and 14 treated with vehicle), enrolled in the long-term follow-up studies. Results from these studies did not change the safety profile for Picato gel (see Section 5.1 Pharmacodynamic Properties, Clinical trials).

Other adverse effects.

Ophthalmic adverse reactions.

Eye disorders, including severe eye pain, chemical conjunctivitis, corneal burn, eyelid oedema, eyelid ptosis, periorbital oedema can occur after exposure (see Section 4.4 Special Warnings and Precautions for Use).

Post-marketing experience.

In addition to the adverse reactions reported during clinical studies and listed above, the following adverse reactions have been identified from post-marketing experience.
Chemical conjunctivitis and corneal burn in connection with accidental eye exposure (see Section 4.4 Special Warnings and Precautions for Use), application site pigmentation changes, application site scarring, herpes zoster reactivation, hypersensitivity reactions (including anaphylaxis and allergic contact dermatitis) (see Section 4.4 Special Warnings and Precautions for Use), Stevens-Johnson syndrome.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency.

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 https://www.tga.gov.au/reporting-problems.

4.2 Dose and Method of Administration

Picato gel is indicated for topical use only. Picato gel is not for oral, ophthalmic, intravaginal or anal use.

Dose.

Adults.

For the treatment of solar (actinic) keratoses on the face and scalp.

Picato gel, 0.015% should be applied to the affected area once daily for 3 consecutive days.

For the treatment of solar (actinic) keratoses on the body.

Picato gel, 0.05% should be applied to the affected area once daily for 2 consecutive days.

Children.

There is no relevant use of Picato gel in the paediatric population.

Application instructions for the face and scalp and body.

Picato gel should be applied to the treatment area as defined by the treating physician. Each tube contains enough gel to cover an area of approximately 25 cm2 (e.g. 5 cm x 5 cm). Tubes should not be re-used once opened.
Patients should be instructed to squeeze the gel from the single use tube onto the fingertip and then spread it evenly over the area to be treated, avoiding touching the treatment area and allowing it to dry for 15 minutes.
Picato gel should not be applied immediately before or after taking a shower or less than 2 hours before bedtime.
Patients should be instructed to wash their hands with soap and water immediately after applying Picato gel.
If treating the hands, only the fingertip which is used for applying the gel should be washed.
Washing and touching the treated area should be avoided for a period of 6 hours after application of Picato gel. After this period, the treatment area may be washed using mild soap and water.
The treated area should not be covered with occlusive bandages after Picato gel is applied.
Optimal therapeutic effect can be assessed approximately 8 weeks after treatment.

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.

4.9 Overdose

There has been no experience of overdose in clinical studies with Picato gel.
In clinical study 4 single dose tubes of Picato gel, 0.05% was applied daily for 2 consecutive days to a 100 cm2 area of skin for the treatment of solar keratoses. The result demonstrated no change in the safety profile compared to the safety profile of Picato gel, 0.05% when 1 tube is applied to a 25 cm2 area for 2 consecutive days.
For information on the management of overdose, contact the Poison Information Centre on 13 11 26 (Australia).

7 Medicine Schedule (Poisons Standard)

S4.

6 Pharmaceutical Particulars

6.1 List of Excipients

Isopropyl alcohol, hyetellose, citric acid monohydrate, sodium citrate dihydrate, benzyl alcohol, purified water.

6.2 Incompatibilities

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

6.3 Shelf Life

24 months. 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.

6.4 Special Precautions for Storage

Picato gel should be stored in a refrigerator (2°C-8°C).

6.5 Nature and Contents of Container

The tube is a white laminate with aluminum functional layer, with a high-density polyethylene (HDPE) layer in contact with product and with an outside acrylic lacquer layer. The cap is a white HDPE.
Picato 0.015% is available in 3 single use tubes per carton.
Picato 0.05% is available in 2 single use tubes per carton.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

Summary Table of Changes