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Ingenol

Generic Name: ingenol (IN-je-nol)
Brand Name: Picato

Ingenol is used for:

Treating actinic keratoses. It may also be used for other conditions as determined by your doctor.

Ingenol treats actinic keratoses by causing cell death. Exactly how it causes cell death is not known.

Do NOT use ingenol if:

  • you are allergic to any ingredient in ingenol

Contact your doctor or health care provider right away if any of these apply to you.

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Before using ingenol:

Some medical conditions may interact with ingenol. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have other skin problems or a sunburn in the treatment area
  • if you are being treated or have been treated for actinic keratoses with other medicines or surgery. You should not use ingenol until your skin has healed from other treatments

Some MEDICINES MAY INTERACT with ingenol. Because little, if any, of ingenol is absorbed into the blood, the risk of it interacting with another medicine is low.

Ask your health care provider if ingenol may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use ingenol:

Use ingenol as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • An extra patient leaflet is available with ingenol. Talk to your pharmacist if you have questions about this information.
  • Ingenol is for external use only. Do not get it in your eyes, nose, vagina, or mouth. If you get ingenol in your eyes, flush them with large amounts of water and seek medical care as soon as possible.
  • Do not apply ingenol to any area of the body other than the affected area.
  • Do not apply ingenol right after taking a shower or less than 2 hours before bedtime.
  • Apply ingenol to the affected area once each day. Use a new tube for each day of treatment.
  • Squeeze ingenol onto a fingertip. Use only enough medicine to cover the affected area, as directed by your doctor.
  • Spread ingenol evenly over only the affected skin area and allow it to dry for 15 minutes.
  • Wash your hands immediately after using ingenol, unless your hands are part of the treated area.
  • Do not cover the treated area with bandages or other dressings after you have applied ingenol.
  • Avoid touching the treated area or doing activities that cause excessive sweating for 6 hours after applying ingenol. After 6 hours, you may wash the treatment area with mild soap and water.
  • Avoid transferring ingenol to other areas or to another person after it has been applied.
  • Only use a tube of ingenol one time. Throw away any unused medicine that is left in the tube after use. Do not keep a tube that has been used for use at a later time. Throw away any used tubes in a trash container, away from children and pets.
  • If you miss a dose of ingenol, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use ingenol.

Important safety information:

  • Eye problems, including severe eye pain, swelling or drooping eyelids, or swelling around the eyes, may occur if ingenol gets in your eyes. Do not touch your eyes while you are applying ingenol. Wash your hands well with soap and water after applying ingenol. Do not allow the medicine on the treated area to come into contact with your eyes. If you get it in your eyes, flush them with large amounts of water and seek medical care as soon as possible.
  • Skin reactions, such as mild redness, flaking or scaling, crusting, or swelling at the application site are common with the use of ingenol. Tell your doctor right away if you develop blisters, pus, sores, ulcers, or severe redness, flaking or scaling, crusting, or swelling at the application site.
  • Do NOT use for longer than prescribed without checking with your doctor.
  • Do not use more of ingenol than needed to cover the affected area. Using too much or using it too often or too long can increase your risk for a severe skin reaction or other side effects.
  • Do not use other medicines or products on the treated area without first checking with your doctor.
  • Ingenol may cause harm if it is swallowed. If you may have taken it by mouth, contact your poison control center or emergency room right away.
  • Ingenol should be used with extreme caution in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using ingenol while you are pregnant. It is not known if ingenol is found in breast milk after topical use. If you are or will be breast-feeding while you use ingenol, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of ingenol:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Headache; mild pain, itching, irritation, redness, flaking or scaling, crusting, or swelling at the application site; nose and throat irritation.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blisters, pus, sores, or ulcers at the application site; severe redness, flaking or scaling, crusting, or swelling at the application site.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of ingenol:

Store ingenol in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. Store away from heat, moisture, and light. Do not store in the bathroom. Keep ingenol out of the reach of children and away from pets.

General information:

  • If you have any questions about ingenol, please talk with your doctor, pharmacist, or other health care provider.
  • Ingenol is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take ingenol or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about ingenol. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to ingenol. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using ingenol.

Issue Date: November 5, 2014
Database Edition 14.4.1.002
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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