Photofrin

DRUG DESCRIPTION

PHOTOFRIN (porfimer sodium) for Injection is a photosensitizing agent used in the photodynamic therapy (PDT) of tumors and of high-grade dysplasia (HGD) in Barrett's esophagus (BE). Following reconstitution of the freeze-dried product with 5% Dextrose Injection (USP) or 0.9% Sodium Chloride Injection (USP), it is injected intravenously. This is followed 4050 hours later by illumination of the tumor or the esophageal segment with HGD in BE with laser light (630 nm wavelength). PHOTOFRIN (porfimer sodium) is not a single chemical entity; it is a mixture of oligomers formed by ether and ester linkages of up to eight porphyrin units. It is a dark red to reddish brown cake or powder. Each vial of PHOTOFRIN contains 75 mg of porfimer sodium as a sterile freeze-dried cake or powder. Hydrochloric Acid and/or Sodium Hydroxide may be added during manufacture to adjust the pH to within 7.2-7.9. There are no preservatives or other additives. The structural formula below is representative of the components present in PHOTOFRIN (porfimer sodium) .

Figure 1 : Structure of Porfimer Sodium

PHOTOFRIN (porfimer sodium)  Structural Formula Illustration

What are the possible side effects of porfimer (Photofrin)?

If you experience any of the following serious side effects from porfimer, contact your doctor immediately:

  • an allergic reaction (including difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
  • shortness of breath or increased coughing;
  • chest pain;
  • bloody vomit or black, bloody, or tarry stools; or
  • a severe skin reaction to light such as blistering.

Other, less serious side effects may be more likely to occur. Talk to your doctor if...

Read All Potential Side Effects and See Pictures of Photofrin

What are the precautions when taking porfimer sodium (Photofrin)?

Consult your...

Read All Potential Precautions of Photofrin


Photofrin Consumer (continued)

SIDE EFFECTS: Consult your pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Consult your pharmacist.


Photofrin Patient Information Including Side Effects

Brand Names: Photofrin

Generic Name: porfimer (Pronunciation: POR fi mer)

  • What is porfimer (Photofrin)?
  • What are the possible side effects of porfimer (Photofrin)?
  • What is the most important information I should know about porfimer (Photofrin)?
  • What should I discuss with my healthcare provider before using porfimer (Photofrin)?
  • How should I use porfimer (Photofrin)?
  • What happens if I miss a dose (Photofrin)?
  • What happens if I overdose (Photofrin)?
  • What should I avoid while using porfimer (Photofrin)?
  • What other drugs will affect porfimer (Photofrin)?
  • Where can I get more information?

What is porfimer (Photofrin)?

Porfimer increases the sensitivity of tissues to the effects of light. Porfimer is used before the administration of laser light to cancerous tumors to decrease tumor size.

Porfimer is used in the treatment of some esophageal and lung cancers.

Porfimer may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of porfimer (Photofrin)?

If you experience any of the following serious side effects from porfimer, contact your doctor immediately:

  • an allergic reaction (including difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
  • shortness of breath or increased coughing;
  • chest pain;
  • bloody vomit or black, bloody, or tarry stools; or
  • a severe skin reaction to light such as blistering.

Other, less serious side effects may be more likely to occur. Talk to your doctor if you experience

  • mild constipation;
  • nausea;
  • mild to moderate skin reactions such as redness, swelling, itching, or burning sensations;
  • increased hair growth, skin discoloration, skin growths, increased wrinkles, or increased skin fragility of the area treated; or
  • eye sensitivity to sun, bright lights, or car headlights.

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. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about porfimer (Photofrin)?

Porfimer should only be administered under the supervision of a qualified healthcare provider experienced in the use of cancer chemotherapeutic agents.

After porfimer has been administered, exposure to sunlight or bright indoor light (examination lamps, dental lights, operating room lamps, tanning beds, or very close unshaded light bulbs) must be avoided for at least 30 days. Sensitivity may last for 90 days or more. Exposure to normal indoor light is good, as this helps the body to eliminate porfimer. Therefore, do not stay in darkened rooms. Before exposing any area of skin to direct sunlight or bright indoor light, test for sensitivity by exposing a small area of skin to sunlight for 10 minutes. If there is no reaction (such as redness, blistering or swelling) within 24 hours, you can gradually increase your sun exposure time. If a reaction does occur, wait another 2 weeks before testing again. Do not use the face or skin around the eyes as a test area. If you travel to a place that has more sunlight, you should retest with the 10 minute exposure procedure. Sun screens will not prevent a reaction. Sun screens stop UV (invisible) light, while porfimer makes the skin sensitive to visible light

Porfimer may increase the sensitivity of the eyes to sun, bright lights, or car headlights. Dark sunglasses which have an average white light transmittance of less than 4% should be worn when outdoors for 30 days following treatment with porfimer.

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