Scenesse

Scenesse is used in adults with erythropoietic protoporphyria to help increase the amount of time you can spend in sunlight or artificial light without pain.

Scenesse may also be used for other reasons that are not mentioned in this medication guide.

Tell your doctor if you are taking other medicines or have any other medical conditions or allergies.

You should not take Scenesse if you are allergic to it.

Inform your doctor if you are pregnant or breastfeeding.

Get emergency medical help if you have signs of an allergic reaction: hives, trouble breathing, swelling of your face, lips, tongue, or throat.

Scenesse may cause your skin to get darker, especially any moles or freckles you have. New moles or skin lesions might appear over time. Tell your doctor about any new moles or skin lesions.

Scenesse may cause serious side effects. Call your doctor right away if you have:

• severe pain, swelling, or bleeding where the implant was placed;
• new or worsening skin lesions;
• a mole that has changed in size or color; or
• if the implant sticks out of your skin or comes out by itself.

Common side effects of Scenesse may include:

• pain, itching, redness, swelling, bruising, or other irritation where the implant was placed;
• skin changes such as discoloration, scarring, or a hard lump where the implant was placed;
• skin irritation anywhere on your body;
• new moles or hair growth on the skin;
• cough, pain in your mouth or throat;
• dizziness, drowsiness, tiredness;
• nausea; or
• cold symptoms such as stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Scenesse is administered through a small implant inserted under the skin. You will receive the implant in a medical setting once every 2 months.

The implant is inserted using a special tool that pushes the implant into place under your skin. After injecting the implant, your doctor will feel the area to make sure your implant has been correctly placed.

You will be watched for a short time to make sure you do not have unwanted or dangerous side effects.

The skin where the implant was placed will be covered with a bandage. Leave the bandage in place for 24 hours.

You may be able to feel the implant through your skin, but it should not cause pain or discomfort. The implant will dissolve in your body over time.

Call your doctor if you think it has come out of place.

Store in the refrigerator, protect from light, and do not freeze.

Your will need a full-body skin examination every 6 months.

Call your doctor for instructions if you miss your appointment to receive your next implant, which is scheduled every 2 months.

Since the Scenesse implant has a set amount of the medicine, it is unlikely that you will experience an overdose.

Scenesse may make you more susceptible to sunburn. Avoid sunlight or tanning beds. Wear protective clothing and apply sunscreen (SPF 30 or higher) when you are outside.

Other drugs may affect Scenesse, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you are using.