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Picato

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Picato

PATIENT INFORMATION

PICATO®
[Pih-KAY-toe]
(ingenol mebutate) gel 0.015%, 0.05%

Important: For use on the skin only (topical). Do not use Picato® gel in or on your eyes, mouth, or vagina.

Read the Patient Information leaflet that comes with Picato® gel before you start using it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your healthcare provider about your medical condition or treatment. If you do not understand the information, or have any questions about Picato® gel, talk with your healthcare provider or pharmacist.

What is Picato® gel?

Picato® gel, 0.015% is a prescription medicine used on the skin to treat actinic keratosis on the face and scalp.

Picato® gel, 0.05% is a prescription medicine used on the skin to treat actinic keratosis on the body, arms, and legs.

It is not known if Picato® gel is safe and effective for the treatment of actinic keratosis in children less than 18 years of age.

What should I tell my healthcare provider before using Picato® gel?

Before you use Picato ® gel, tell your healthcare provider if you:

  • are being treated or have been treated for actinic keratosis with other medicines or surgery. You should not use Picato® gel until your skin has healed from other treatments.
  • have other skin problems or sunburn in the treatment area.
  • have any other medical conditions.
  • are pregnant or plan to become pregnant. It is not known if Picato® gel can harm your unborn baby.

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements. It is not known if Picato® gel and other medicines can affect each other. Tell your healthcare provider if you have had other treatments for actinic keratosis. You should not use Picato® gel until your skin has healed from other treatments.

How should I use Picato® gel?

  • Use Picato® gel exactly as your healthcare provider tells you. Picato ® gel is for skin use only.
  • Your healthcare provider will tell you where to apply Picato® gel, and how often, and how long to apply it. Do not apply Picato® gel to other areas.
  • Do not use more Picato® gel than you need to cover the treatment area. Using too much Picato® gel, or using it too often, or too long can increase your chances for having a severe skin reaction or other side effects.
  • Do not get Picato® gel in your eyes . Do not touch your eyes while you are applying Picato® gel. Wash your hands well with soap and water after applying Picato® gel. After applying Picato® gel, be careful to keep Picato® gel on the treated area from coming into contact with your eyes. Irritation may happen if you get Picato® gel in your eyes. If you accidentally get Picato® gel in your eyes , flush them with large amounts of water and get medical care as soon as possible. Also see “What are the possible side effects of Picato® gel?”
  • Do not get Picato® gel in your mouth.
  • Only use a tube of Picato® gel 1 time. Throw away any open tube of Picato® gel after use even if there is medicine still left in it.
  • See the Instructions for Use that comes with your Picato® gel for information about the right way to apply it.

What should I avoid while using Picato® gel?

  • Do not cover the treated site with bandages or other closed dressings.

What are the possible side effects of Picato® gel?

PICATO ® gel may cause severe side effects including:

  • Eye problems can happen if Picato® gel gets in your eyes. Eye problems may include severe eye pain, swelling or drooping of your eyelids, or swelling around your eyes. If you accidentally get Picato ® gel in your eyes, flush them with large amounts of water and get medical care as soon as possible.
  • Local skin reactions. Skin reactions in the treatment area are common with Picato® gel. You may get a skin reaction such as mild redness, flaking or scaling, crusting, or swelling. Call your healthcare provider if you get skin redness, flaking or scaling, crusting, or swelling that is more severe, or if you get blisters, pus, ulcers or breakdown of your skin.

The most common side effects with Picato® gel include:

  • “local skin reactions,” see above
  • pain, itching, or skin irritation at the treatment area
  • infection at the treatment area
  • nose and throat irritation
  • headache

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the side effects of Picato® gel. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1800-FDA-1088.

You may also report side effects to LEO Pharma Inc. at 1-877-494-4536.

How do I store Picato® gel?

  • Store Picato® gel in a refrigerator at 36°F to 46°F (2°C to 8°C). Do not freeze.
  • Safely throw away used Picato® gel tubes in household trash.

Keep Picato® gel and all medicines out of the reach of children.

General information about Picato® gel.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Picato® gel for a condition for which it was not prescribed. Do not give Picato® gel to other people, even if they have the same symptoms you have. It may harm them.

This Patient Information leaflet summarizes the most important information about Picato® gel. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about Picato® gel that is written for healthcare professionals.

What are the ingredients in Picato® gel?

Active ingredient : ingenol mebutate.

Inactive ingredients : isopropyl alcohol, hydroxyethyl cellulose, citric acid monohydrate, sodium citrate, benzyl alcohol and purified water.

This Patient Information has been approved by the U.S. Food and Drug Administration.

Instructions for Use

PICATO®
[Pih-KAY-toe]
(ingenol mebutate) gel 0.015%

Be sure that you read, understand, and follow these Instructions for Use before you use Picato® gel for the first time. Also read the Patient Information leaflet that comes with Picato® gel.

Important:

  • Always use Picato® gel exactly as your healthcare provider tells you . Check with your healthcare provider or pharmacist if you are not sure.
  • Only use Picato® gel, 0.015% to treat actinic keratosis on your face and scalp.
  • Apply Picato® gel, 0.015% to the skin area to be treated 1 time each day for 3 days in a row. Use a new tube for each day of treatment.
  • Avoid touching the treatment area or doing activities that cause a lot of sweating for 6 hours after applying Picato® gel. After 6 hours you may wash the treatment area with a mild soap and water.

Do not :

  • apply right after taking a shower or less than 2 hours before bedtime.
  • cover the treated area with bandages or other dressings after you have applied Picato® gel.
  • get Picato® gel in your eyes . Do not touch your eyes while you are applying Picato® gel. Wash your hands well with soap and water after applying it. After applying Picato® gel, be careful to keep Picato® gel on the treated area from coming into contact with your eyes. Irritation may happen if you get Picato® gel in your eyes. If you accidentally get Picato® gel in your eyes , flush them with large amounts of water and get medical care as soon as possible. Also see the section of Patient Information leaflet section called “What are the possible side effects of Picato® gel?”

Applying Picato® gel.

Step 1 . Open a new tube each time you use Picato® gel.

Step 2. Remove cap from tube just before use. (See Figure A.)

Figure A

Remove cap - Illustration

Step 3. Squeeze the gel from the tube onto a fingertip. (See Figure B.) Only use enough gel needed to cover the affected area, as directed by your healthcare provider. One tube contains enough gel to cover a skin area of about 2 inches by 2 inches.

Figure B

Squeeze the gel from the tube onto a fingertip - Illustration

Step 4 . Spread the gel evenly over only the skin area to be treated. Allow the treated area to dry for 15 minutes. (See Figure C.)

Figure C

Spread the gel evenly over only the skin area to be treated - Illustration

Step 5 . Wash your hands right away after applying Picato® gel. (See Figure D.)

Figure D

Wash your hands right away - Illustration

Step 6 . Safely throw away (dispose of) the tube after use.

Repeat the above steps for each day of treatment.

How should I store Picato ® gel?

  • Store Picato® gel in a refrigerator at 36°F to 46°F (2°C to 8°C). Do not freeze.
  • Picato® gel has an expiration date (exp) marked on the end of the tube. Do not use the gel after this date.
  • Safely throw away used Picato® gel tubes in household trash.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Instructions for Use

PICATO®
[Pih-KAY-toe]
(ingenol mebutate) gel 0.05%

Be sure that you read, understand, and follow these Instructions for Use before you use Picato® gel for the first time. Also read the Patient Information leaflet that comes with Picato® gel.

Important :

  • Always use Picato® gel exactly as your healthcare provider tells you. Check with your healthcare provider or pharmacist if you are not sure.
  • Only use Picato® gel, 0.05% to treat actinic keratosis on your body, arms, hands and legs .
  • Apply Picato® gel, 0.05% to the skin area to be treated 1 time each day for 2 days in a row. Use a new tube for each day of treatment.
  • Avoid touching the treatment area or doing activities that cause a lot of sweating for 6 hours after applying Picato® gel. After 6 hours you may wash the treatment area with a mild soap and water.

Do not:

  • apply right after taking a shower or less than 2 hours before bedtime.
  • cover the treated area with bandages or other dressings after you have applied Picato® gel.
  • get Picato® gel in your eyes . Do not touch your eyes while you are applying Picato® gel. Wash your hands well with soap and water after applying it. After applying Picato® gel, be careful to keep Picato® gel on treated area from coming into contact with your eyes. Irritation may happen if you get Picato® gel in your eyes. If you accidentally get Picato® gel in your eyes , flush them with large amounts of water and get medical care as soon as possible. Also see the section of Patient Information leaflet section called “What are the possible side effects of Picato® gel?”

Applying Picato® gel.

Step 1 . Open a new tube each time you use Picato® gel.

Step 2. Remove cap from tube just before use. (See Figure A.)

Figure A

Remove cap - Illustration

Step 3. Squeeze the gel from the tube onto a fingertip. (See Figure B.) Only use enough gel needed to cover the affected area, as directed by your healthcare provider. One tube contains enough gel to cover a skin area of about 2 inches by 2 inches.

Figure B

Squeeze the gel from the tube onto a fingertip - Illustration

Step 4 . Spread the gel evenly over only the skin area to be treated. Allow the treated area to dry for 15 minutes. (See Figure C.)

Figure C

Spread the gel evenly - Illustration

Step 5 . Wash your hands right away after applying Picato® gel. (See Figure D.) If you are treating your hands you should only wash the fingertip which you used for a

Figure D

Wash your hands right away - Illustration

Step 6 . Safely throw away (dispose of) the tube after use.

Repeat the above steps for each day of treatment.

How should I store Picato® gel?

  • Store Picato® gel in a refrigerator at 36°F to 46°F (2°C to 8°C). Do not freeze.
  • Picato® gel has an expiration date (exp) marked on the end of the tube. Do not use the gel after this date.
  • Safely throw away used Picato® gel tubes in household trash.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Last reviewed on RxList: 2/6/2012
This monograph has been modified to include the generic and brand name in many instances.

A A A

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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