Description
Porfimer injection is used together with a special laser light to treat cancer of the esophagus (the part of the digestive tract that carries food to the stomach) and to treat a form of lung cancer. This medicine may also treat changes in the esophagus that might lead to cancer, such as a condition called Barrett's esophagus. Porfimer belongs to the group of medicines known as antineoplastics.
This medicine is to be given only by or under the direct supervision of a doctor.
Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, porfimer is used in certain patients with the following medical conditions:
- Cancer of the biliary tract (cholangiocarcinoma), unresectable, after double stenting.
This product is available in the following dosage forms:
- Powder for Solution
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of porfimer injection in the pediatric population. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of porfimer injection in the elderly.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Acetazolamide
- Acetohexamide
- Bendroflumethiazide
- Benzthiazide
- Chlorothiazide
- Chlorpromazine
- Chlorpropamide
- Chlortetracycline
- Ciprofloxacin
- Delafloxacin
- Demeclocycline
- Dixyrazine
- Doxycycline
- Enoxacin
- Eravacycline
- Fluphenazine
- Gatifloxacin
- Gemifloxacin
- Gliclazide
- Glimepiride
- Glipizide
- Gliquidone
- Glyburide
- Grepafloxacin
- Griseofulvin
- Hydrochlorothiazide
- Hydroflumethiazide
- Levofloxacin
- Lomefloxacin
- Lymecycline
- Meclocycline
- Methacycline
- Methdilazine
- Methotrimeprazine
- Methyclothiazide
- Metopimazine
- Minocycline
- Moxifloxacin
- Norfloxacin
- Ofloxacin
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Cancer, other types of or
- Heart or blood vessel disease or
- Prolonged immobilization (cannot move for a long time) or
- Surgery, recent—May increase risk for more serious side effects.
- Esophageal ulcers or
- Porphyria (a problem with enzymes in your body) or
- Tracheoesophageal or bronchoesophageal fistula (opening between the esophagus and breathing airways) or
- Tumors or lesions that obstruct blood vessels or breathing airways or
- Varices (swollen veins) in the esophagus or stomach—Should not be used in patients with these conditions.
- Kidney disease or
- Liver disease—Use with caution. The effects may be increased because of slower removal of this medicine from the body.
- Radiation therapy—You will need to wait 2 to 4 weeks between phototherapy and radiation therapy.
- Sensitivity of the skin or eyes to sunlight or bright lights—Use with caution. May make this condition worse.
Proper Use
A nurse or other trained health professional will give you this medicine. This medicine is given through a needle placed in one of your veins.
Treatment with porfimer and laser light occurs in three steps. First, the porfimer is injected into your body. Second, about 2 days later, a laser light is directed at the cancer. Then, about 2 or 3 days after the light is applied, your doctor will remove the cancer cells that have been destroyed.
Precautions
It is very important that your doctor check you at regular visits for any problems or unwanted effects that may be caused by this medicine.
Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant during treatment and for at least 5 months after your last dose. Males who are receiving this medicine, with female partners who can become pregnant must use effective birth control during and for at least 5 months after the last dose of this medicine. If you think you have become pregnant while using the medicine, tell your doctor right away.
For at least 30 days after you receive an injection of porfimer, your eyes will be extra sensitive to light, including sunlight, bright indoor lights, and vehicle headlights. Certain types of sunglasses can help protect your eyes during this time. Check with your doctor about which sunglasses to use.
For at least 30 days after you receive an injection of porfimer, your skin will be extra sensitive to sunlight and to very bright indoor lights, such as lamps with unshaded light bulbs and lights in dental offices or operating rooms. Do not expose your skin to direct sunlight or to bright indoor lights during this time. Sunscreens will not protect your skin from a severe reaction to light (blistering, burning, and swelling of the skin). However, exposure to normal amounts of indoor light (eg, daylight or light from lamps with shades) will help use up the porfimer remaining in your skin. Therefore, do not protect your skin from normal amounts of indoor light. If you have any questions about whether the light in your home is too bright, check with your doctor or nurse. Also, ask your doctor or nurse ahead of time about what you should do if a severe reaction to light occurs.
Thirty days after receiving an injection of porfimer, test a small portion of your skin by exposing it to sunlight for 10 minutes. (Do not test skin on your face.) If the exposed part of your skin does not become blistered, red, or swollen during the next 24 hours, you can slowly increase your exposure to sunlight and bright indoor lights. If a reaction does occur, wait another 2 weeks, then test your sensitivity to sunlight again.
Even after your skin and eyes are no longer sensitive to the lights in your home or the amount of sunlight in the area where you live, you may still be sensitive to brighter levels of light. If you travel to an area where the sunlight is stronger than at home, test yourself again before exposing your skin to the stronger light.
You might have pain around your chest after your treatment. If you have pain, talk with your doctor about the best way to treat it.
If you are using this medicine to treat Barrett's esophagus, your chance of having narrowing of the esophagus may be increased. Check with your doctor right away if you start to have trouble with swallowing after you have received this medicine.
Blood clotting problems may occur in patients after receiving this medicine. Check with your doctor if you have pain in the chest, groin, or legs, especially the calves, difficulty with breathing, severe, sudden headache, slurred speech, sudden, unexplained shortness of breath, sudden loss of coordination, sudden, severe weakness or numbness in the arm or leg, or vision changes.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur:
More common
- Bladder pain
- bloody or cloudy urine
- blurred vision
- body aches or pain
- chest pain or discomfort
- confusion
- congestion
- cough
- coughing or spitting up blood
- difficult or troubled breathing
- difficult, burning, or painful urination
- difficulty with swallowing
- dilated neck veins
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- dryness or soreness of the throat
- extreme fatigue
- fast, pounding, or irregular heartbeat or pulse
- fever or chills
- frequent urge to urinate
- headache
- hoarseness
- increased sensitivity of the skin to sunlight
- irregular, fast or slow, or shallow breathing
- itching or skin rash
- lower back or side pain
- nervousness
- pale or blue lips, fingernails, or skin
- pale skin
- pounding in the ears
- redness or other discoloration of the skin
- runny nose
- severe pain in the chest
- severe sunburn
- slow or fast heartbeat
- sneezing
- sore throat
- sudden onset of severe breathing difficulty
- sweating
- swelling of the face, fingers, feet, or lower legs
- tender, swollen glands in the neck
- tightness in the chest
- unusual bleeding or bruising
- unusual tiredness or weakness
- voice changes
- vomiting of blood or material that looks like coffee grounds
- weight gain
- white patches in the mouth or throat or on the tongue
- white patches with diaper rash
Less common
- Bloody, black, or tarry stools
- decrease in the amount of urine
- decreased urination
- dry mouth
- fainting
- heartburn
- increase in heart rate
- noisy, rattling breathing
- pain or burning in the throat
- rapid breathing
- sores, ulcers, or white spots on the lips or tongue or inside the mouth
- sunken eyes
- thirst
- troubled breathing at rest
- vomiting
- wrinkled skin
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Acid or sour stomach
- back pain
- belching
- constipation
- diarrhea
- fear or nervousness
- indigestion
- lack or loss of strength
- loss of appetite
- nausea
- pain
- stomach discomfort, upset, or pain
- trouble sleeping
- weight loss
Less common
- Bloated or full feeling
- change in the color of treated skin
- excess air or gas in the stomach
- increased hair growth
- small lumps under the skin
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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