Methoxsalen Oral capsule

What is this medicine?

METHOXSALEN (me THOK suh luhn) is a skin coloring and light sensitizing agent. This medicine is given before ultraviolet radiation. It is used to treat severe psoriasis and vitiligo. Some forms of this medicine are also used to treat the skin symptoms of cutaneous T-cell lymphoma.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• albinism

• eye problems like cataracts or aphakia

• heart disease

• liver disease

• lupus

• porphyria

• history of arsenic therapy

• history of x-ray therapy

• skin cancer

• skin photosensitivity problems

• xeroderma

• an unusual or allergic reaction to methoxsalen, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. If this medicine upsets your stomach, you may take it with low-fat food or milk, or you may divide your dose and take it in 2 portions (30 minutes apart). Follow your doctor's directions. Do not take it more often than directed.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

It is important not to miss your dose. Call your doctor or health care professional if you are unable to keep an appointment.

What may interact with this medicine?

• anthralin

• coal tar

• diuretics like hydrochlorothiazide

• griseofulvin

• medical dyes like methylene blue, toluidine blue, rose bengal, methyl orange

• medicines for seizures like ethotoin, fosphenytoin, phenytoin

• nalidixic acid

• phenothiazines like chlorpromazine, mesoridazine, prochlorperazine, thioridazine

• retinoids like bexarotene, tazarotene, tretinoin

• some antibiotics like ciprofloxacin, sulfamethoxazole, tetracycline

• some bacteriostatic soaps

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular check ups. See your eye doctor regularly. Report any changes in your vision right away.

This medicine may increase your chance of getting cancer. Talk to your doctor about your risk. See a doctor for regular cancer checks as directed.

This medicine can make you more sensitive to the sun. Keep out of the sun. If you cannot avoid being in the sun, wear protective clothing and use sunscreen. Do not use sun lamps or tanning beds/booths. Stay out of the sun for 24 hours before a UV treatment and at least 8 hours after taking this medicine, or as directed by your doctor.

For 24 hours after you take this medicine, wear wrap-around sunglasses that block all UV light whenever you can see any sunlight.

Do not switch between hard- and soft-gelatin capsules of this medicine. This may change the timing of your UV treatment.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• changes in vision

• depression

• swelling of feet or hands

• unusually weak or tired

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• dizziness

• headache

• increased sensitivity to the sun

• itching, dry skin

• leg cramps

• nausea

• nervous

• skin thinning or wrinkles

• trouble sleeping

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Protect from light. Keep container tightly closed. Throw away any unused medicine after the expiration date.

Methoxsalen Solution for injection

What is this medicine?

METHOXSALEN (me THOK suh luhn) is a skin coloring and light sensitizing agent. This medicine is given before ultraviolet radiation. It is used to treat the skin symptoms of cutaneous T-cell lymphoma.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• albinism

• eye problems like cataracts or aphakia

• heart disease

• liver disease

• lupus

• porphyria

• history of arsenic therapy

• history of x-ray therapy

• skin cancer

• skin photosensitivity problems

• xeroderma

• an unusual or allergic reaction to methoxsalen, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

This medicine is mixed with your collected white blood cells during a procedure. Then, the mixture is re-infused into your body. It is given by a health care professional in a hospital or clinic setting.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

It is important not to miss your dose. Call your doctor or health care professional if you are unable to keep an appointment.

What may interact with this medicine?

• anthralin

• coal tar

• diuretics like hydrochlorothiazide

• griseofulvin

• medical dyes like methylene blue, toluidine blue, rose bengal, methyl orange

• medicines for seizures like ethotoin, fosphenytoin, phenytoin

• nalidixic acid

• phenothiazines like chlorpromazine, mesoridazine, prochlorperazine, thioridazine

• retinoids like bexarotene, tazarotene, tretinoin

• some antibiotics like ciprofloxacin, sulfamethoxazole, tetracycline

• some bacteriostatic soaps

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular check ups. See your eye doctor regularly. Report any changes in your vision right away.

This medicine may increase your chance of getting cancer. Talk to your doctor about your risk. See a doctor for regular cancer checks as directed.

This medicine can make you more sensitive to the sun. Keep out of the sun. If you cannot avoid being in the sun, wear protective clothing and use sunscreen. Do not use sun lamps or tanning beds/booths. Stay out of the sun for 24 hours before a UV treatment and at least 8 hours after taking this medicine, or as directed by your doctor.

For 24 hours after you take this medicine, wear wrap-around sunglasses that block all UV light whenever you can see any sunlight.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• changes in vision

• fever, infection

• low blood pressure

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• dizziness

• headache

• itching, dry skin

• skin thinning, wrinkles

• skin sensitive to the sun

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

This drug is given in a hospital or clinic and will not be stored at home.

Methoxsalen Topical lotion

What is this medicine?

METHOXSALEN (me THOK suh luhn) is a skin coloring and light sensitizing agent. This medicine is combined with ultraviolet light or sunlight, in a therapy called PUVA. This therapy is used to treat vitiligo, a condition where skin color is missing.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• absence of the lens in the eye

• albinism

• cataracts

• heart disease

• porphyria

• skin cancer

• recent radiation therapy

• skin photosensitivity problems

• an unusual or allergic reaction to methoxsalen, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

This medicine is for external use on the skin only. Do not take by mouth. This medicine should only be applied by a physician to a well-defined area of skin before the area is exposed to ultraviolet A light.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

This medicine is only applied by a doctor or health care professional. For the treatment to be successful, light treatment must be done at the correct time after the lotion is applied.

What may interact with this medicine?

This medicine will make you sensitive to the sun. This effect may be increased by other medicines that also cause sensitivity to the sun such as:

• anthralin

• antibacterial soaps

• certain diuretics

• certain staining dyes (examples: methylene blue, toluidine blue, rose bengal, or methyl orange)

• coal tar

• griseofulvin

• medicines for infections including sulfa or tetracycline antibiotics

• medicines for depression, anxiety, or psychotic disturbances

• vitamin A and vitamin A-like medicines and creams

• vitamin E

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular checks on your progress. You may see an improvement in your condition after a few weeks. The full effect can take 6 to 9 months of treatment. This medicine and PUVA can increase your risk of getting skin cancer. Show your doctor or health care professional any unusual sores or blemishes that develop. If your skin gets very dry, ask your doctor or health care professional before you use any skin products.

This medicine can increase sensitivity of the skin to sun or UV light. This could lead to a serious burn. Keep out of the sun for at least 24 hours before and 48 hours after PUVA. Keep out of the sun for 12 to 48 hours after application of this medicine. If you must be outside, wear protective clothing and use a sunscreen (at least SPF 15). Do not apply sunscreen to areas of psoriasis until after light therapy. Do not use sun lamps, sun tanning beds or booths. Certain foods can increase your sensitivity to sunlight while using this medicine. Avoid eating limes, figs, parsley, parsnips, mustard, carrots, and celery while using this medicine.

You can get permanent premature aging of the skin if you use this medicine for a long time. This effect is similar to the result of too much sunbathing.

Recent treatment with radiation therapy or cancer medicines increases the chance of developing side effects from combined light treatment and this medicine.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• burning, blistering, or redness of the skin

• increased sensitivity to the sun and skin irritation

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• generalized itching, dry skin

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

This medicine will be applied in your doctor's office and will not be stored at home.