Dosing & Uses
Dosage Forms & Strengths
powder for injection
- 75mg/vial
Esophageal Cancer, Endobronchial NSCLC
Follow by corresponding spectrum of laser light 40-50 hours after injection, then again 96-120 hours after injection; separate repeat courses by 30 days; not to exceed 3 courses
Ablation of High-grade Dysplasia in Barrett's Esophagus
Follow by corresponding spectrum of laser light 40-50 hours after injection, then again 96-120 hours after injection Barrett's esophagus patients who do not undergo esophagectomy; separate repeat courses by 30 days; not to exceed 3 courses
Bladder Carcinoma (Orphan)
Photodynamic therapy of transitional cell carcinoma in situ of the urinary bladder
Orphan sponsor
- QLT Phototherapeutics, Inc, Lederle Laboratories; 401 North Middletown Road; Pearl River, NY 10965
Cholangiocarcinoma (Orphan)
Orphan sponsor
- Pinnacle Biologics, Inc; 2801 lakeside Drive, Suite 209; Bannockburn, IL 60015
Mesothelioma (Orphan)
Orphan designation for malignant pleural mesothelioma
Orphan sponsor
- Pinnacle Biologics, Inc; 2801 lakeside Drive, Suite 209; Bannockburn, IL 60015
Safety and efficacy not established
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (0)
Serious - Use Alternative (4)
- aminolevulinic acid oral
aminolevulinic acid oral, porfimer. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Avoid administering other phototoxic drugs with aminolevulinic acid oral for 24 hr during perioperative period.
- aminolevulinic acid topical
porfimer, aminolevulinic acid topical. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Each drug may increase the photosensitizing effect of the other.
- methyl aminolevulinate
porfimer, methyl aminolevulinate. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Each drug may increase the photosensitizing effect of the other.
- palifermin
palifermin increases toxicity of porfimer by Other (see comment). Avoid or Use Alternate Drug. Comment: Palifermin should not be administered within 24 hr before, during infusion of, or within 24 hr after administration of antineoplastic agents. Coadministration of palifermin within 24 hr of chemotherapy resulted in increased severity and duration of oral mucositis.
Monitor Closely (40)
- abciximab
abciximab decreases effects of porfimer by pharmacodynamic antagonism. Use Caution/Monitor.
- anagrelide
anagrelide decreases effects of porfimer by pharmacodynamic antagonism. Use Caution/Monitor.
- antithrombin III
antithrombin III decreases effects of porfimer by pharmacodynamic antagonism. Use Caution/Monitor.
- argatroban
argatroban decreases effects of porfimer by pharmacodynamic antagonism. Use Caution/Monitor.
- bivalirudin
bivalirudin decreases effects of porfimer by pharmacodynamic antagonism. Use Caution/Monitor.
- chlorothiazide
chlorothiazide, porfimer. Mechanism: pharmacodynamic synergism. Use Caution/Monitor. Enhanced photosensitivity.
- chlorpromazine
chlorpromazine, porfimer. Mechanism: pharmacodynamic synergism. Use Caution/Monitor. Enhanced photosensitivity.
- chlorthalidone
chlorthalidone, porfimer. Mechanism: pharmacodynamic synergism. Use Caution/Monitor. Enhanced photosensitivity.
- cholera vaccine
porfimer decreases effects of cholera vaccine by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs and corticosteroids (used in greater than physiologic doses), may reduce the immune response to cholera vaccine.
- cilostazol
cilostazol decreases effects of porfimer by pharmacodynamic antagonism. Use Caution/Monitor.
- clopidogrel
clopidogrel decreases effects of porfimer by pharmacodynamic antagonism. Use Caution/Monitor.
- dabigatran
dabigatran decreases effects of porfimer by pharmacodynamic antagonism. Use Caution/Monitor.
- dalteparin
dalteparin decreases effects of porfimer by pharmacodynamic antagonism. Use Caution/Monitor.
- demeclocycline
demeclocycline, porfimer. Mechanism: pharmacodynamic synergism. Use Caution/Monitor. Enhanced photosensitivity.
- dipyridamole
dipyridamole decreases effects of porfimer by pharmacodynamic antagonism. Use Caution/Monitor.
- doxycycline
doxycycline, porfimer. Mechanism: pharmacodynamic synergism. Use Caution/Monitor. Enhanced photosensitivity.
- enoxaparin
enoxaparin decreases effects of porfimer by pharmacodynamic antagonism. Use Caution/Monitor.
- eptifibatide
eptifibatide decreases effects of porfimer by pharmacodynamic antagonism. Use Caution/Monitor.
- fluphenazine
fluphenazine, porfimer. Mechanism: pharmacodynamic synergism. Use Caution/Monitor. Enhanced photosensitivity.
- fondaparinux
fondaparinux decreases effects of porfimer by pharmacodynamic antagonism. Use Caution/Monitor.
- griseofulvin
griseofulvin, porfimer. Mechanism: pharmacodynamic synergism. Use Caution/Monitor. Enhanced photosensitivity.
- heparin
heparin decreases effects of porfimer by pharmacodynamic antagonism. Use Caution/Monitor.
- hydrochlorothiazide
hydrochlorothiazide, porfimer. Mechanism: pharmacodynamic synergism. Use Caution/Monitor. Enhanced photosensitivity.
- indapamide
indapamide, porfimer. Mechanism: pharmacodynamic synergism. Use Caution/Monitor. Enhanced photosensitivity.
- metolazone
metolazone, porfimer. Mechanism: pharmacodynamic synergism. Use Caution/Monitor. Enhanced photosensitivity.
- minocycline
minocycline, porfimer. Mechanism: pharmacodynamic synergism. Use Caution/Monitor. Enhanced photosensitivity.
- perphenazine
perphenazine, porfimer. Mechanism: pharmacodynamic synergism. Use Caution/Monitor. Enhanced photosensitivity.
- prasugrel
prasugrel decreases effects of porfimer by pharmacodynamic antagonism. Use Caution/Monitor.
- prochlorperazine
prochlorperazine, porfimer. Mechanism: pharmacodynamic synergism. Use Caution/Monitor. Enhanced photosensitivity.
- promazine
promazine, porfimer. Mechanism: pharmacodynamic synergism. Use Caution/Monitor. Enhanced photosensitivity.
- promethazine
promethazine, porfimer. Mechanism: pharmacodynamic synergism. Use Caution/Monitor. Enhanced photosensitivity.
- siponimod
siponimod and porfimer both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution if coadministered because of additive immunosuppressive effects during such therapy and in the weeks following administration. When switching from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs to avoid unintended additive immunosuppressive effects.
- sulfadiazine
sulfadiazine, porfimer. Mechanism: pharmacodynamic synergism. Use Caution/Monitor. Enhanced photosensitivity.
- sulfamethoxazole
sulfamethoxazole, porfimer. Mechanism: pharmacodynamic synergism. Use Caution/Monitor. Enhanced photosensitivity.
- tetracycline
tetracycline, porfimer. Mechanism: pharmacodynamic synergism. Use Caution/Monitor. Enhanced photosensitivity.
- thioridazine
thioridazine, porfimer. Mechanism: pharmacodynamic synergism. Use Caution/Monitor. Enhanced photosensitivity.
- ticlopidine
ticlopidine decreases effects of porfimer by pharmacodynamic antagonism. Use Caution/Monitor.
- tirofiban
tirofiban decreases effects of porfimer by pharmacodynamic antagonism. Use Caution/Monitor.
- tretinoin topical
tretinoin topical will increase the level or effect of porfimer by pharmacodynamic synergism. Use Caution/Monitor. May enhance the photosensitizing effects of porfimer
- trifluoperazine
trifluoperazine, porfimer. Mechanism: pharmacodynamic synergism. Use Caution/Monitor. Enhanced photosensitivity.
Minor (17)
- amlodipine
amlodipine decreases levels of porfimer by unspecified interaction mechanism. Minor/Significance Unknown.
- clevidipine
clevidipine decreases levels of porfimer by unspecified interaction mechanism. Minor/Significance Unknown.
- cortisone
cortisone decreases levels of porfimer by unspecified interaction mechanism. Minor/Significance Unknown.
- dexamethasone
dexamethasone decreases levels of porfimer by unspecified interaction mechanism. Minor/Significance Unknown.
- ethanol
ethanol decreases levels of porfimer by increasing metabolism. Minor/Significance Unknown.
- felodipine
felodipine decreases levels of porfimer by unspecified interaction mechanism. Minor/Significance Unknown.
- hydrocortisone
hydrocortisone decreases levels of porfimer by unspecified interaction mechanism. Minor/Significance Unknown.
- isradipine
isradipine decreases levels of porfimer by unspecified interaction mechanism. Minor/Significance Unknown.
- methyclothiazide
methyclothiazide, porfimer. Mechanism: pharmacodynamic synergism. Minor/Significance Unknown. Enhanced photosensitivity.
- methylprednisolone
methylprednisolone decreases levels of porfimer by unspecified interaction mechanism. Minor/Significance Unknown.
- nicardipine
nicardipine decreases levels of porfimer by unspecified interaction mechanism. Minor/Significance Unknown.
- nifedipine
nifedipine decreases levels of porfimer by unspecified interaction mechanism. Minor/Significance Unknown.
- nisoldipine
nisoldipine decreases levels of porfimer by unspecified interaction mechanism. Minor/Significance Unknown.
- prednisolone
prednisolone decreases levels of porfimer by unspecified interaction mechanism. Minor/Significance Unknown.
- prednisone
prednisone decreases levels of porfimer by unspecified interaction mechanism. Minor/Significance Unknown.
- triamcinolone acetonide injectable suspension
triamcinolone acetonide injectable suspension decreases levels of porfimer by unspecified interaction mechanism. Minor/Significance Unknown.
- verapamil
verapamil decreases levels of porfimer by unspecified interaction mechanism. Minor/Significance Unknown.
Adverse Effects
>10%
Anemia (32%)
Fever (31%)
Pleural effusion (28%)
Constipation (24%)
Chest pain (22%)
Abd pain (20%)
Dyspnea (18%)
Pneumonia (16%)
Insomnia (14%)
Back pain (11%)
1-10%
Atrial-fib (10%)
Dysphagia (10%)
Pharyngitis (10%)
Resp distress (9%)
Decr wt (9%)
Hematemesis (8%)
Dehydration (7%)
Hypotension (7%)
Peripheral edema (7%)
Cardiac failure (7%)
Tachycardia (6%)
Asthenia (6%)
Hypertension (6%)
Cough (6%)
Diarrhea (5%)
Generalized edema (5%)
Postmarketing Reports
Infusion reactions including urticaria, bradycardia, hypotension, dizziness, and hypertension
Warnings
Contraindications
Hypersensitivity to porphyrins
Porphyria
Emergency treatment of severe acute respiratory distress when caused by endobronchial lesion
Esophageal or gastric varices
Esophageal ulcers
Tracheoesophageal or bronchoesophageal fistula; tumor erosion into major blood vessel
Cautions
Separate from radiotherapy by 2-4 wk
Avoid sunlight following injection
Esophageal stricture reported within 6 months of initiating treatment (usually within 6 months of treatment)
Inflammation resulting from treatment may obstruct airway (not for use in patients with esophageal tumors eroding into the trachea or bronchial tree
Potentially fatal gastrointestinal and esophageal necrosis and perforation may occur following treatment
May experience substernal chest pain from inflammatory responses within the treatment area
Ocular discomfort reported
Photosensitivity reactions reported in patients exposed to direct sunlight or bright indoor light
Thromboembolism reported, particularly in patients with other risk factors (eg, advanced cancer, postsurgery, prolonged immobilization, CV disease)
Hepatic or renal impairment will likely prolong the elimination of porfimer sodium leading to higher rates of toxicity; inform patients with severe renal impairment or mild to severe hepatic impairment that the period requiring precautionary measures for photosensitivity may be longer than 90 days
Risk of hemorrhage increased in patients esophageal varices or tumors eroding into pulmonary blood vessels; patients with large, centrally located tumors, cavitating tumors, or extensive tumors extrinsic to bronchus are at high risk for fatal massive hemoptysis; assess patients for tumors eroding into a pulmonary blood vessel and esophageal varices; do not administer light directly to an area with esophageal varices because of high risk of hemorrhage
Long-term effect of PDT on high grade dysplasia (HGD) in Barrett’s Esophagus (BE) is unknown; there is always a risk of cancer or abnormal epithelium that is invisible to endoscopist beneath the new squamous cell epithelium; these facts emphasize the risk of overlooking cancer in such patients and the need for rigorous continuing surveillance despite endoscopic appearance of complete squamous cell reepithelialization
Conduct endoscopic biopsy surveillance every 3 months, until 4 consecutive negative evaluations for HGD have been recorded; further follow-up may be scheduled every 6 to 12 months, as per judgment of healthcare providers; the follow-up period of randomized study at time of analysis was a minimum of 2 years (range 2 to 5.6 years)
If PDT is to be used before or after radiotherapy, allot sufficient time between the two therapies to ensure that the inflammatory response produced by the first treatment has subsided before commencing the second treatment
The inflammatory response from PDT will depend on tumor size and extent of surrounding normal tissue that receives light; allow 2-4 weeks after PDT before commencing radiotherapy; the acute inflammatory reaction from radiotherapy usually subsides within 4 weeks after completing radiotherapy; allow 4 weeks after completing radiotherapy before commencing PDT
Pregnancy & Lactation
Pregnancy
Based on animal studies, drug may cause embryo-fetal toxicity when administered to a pregnant woman; there are no available data on use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes
Verify pregnancy status in females of reproductive potential prior to initiation of therapy
Contraception
- Drug may cause fetal harm when administered to a pregnant woman
- Females: Advise females of reproductive potential to use effective contraception during treatment and for 5 months after final dose
- Males: Advise male patients with female partners of reproductive potential to use condoms during treatment and for 5 months following final dose
Animal data
- Intravenous administration of drug to pregnant rats and rabbits during period of organogenesis at dose levels approximately 0.64 times recommended human dose based on body surface area (BSA) resulted in increased fetal resorptions, decreased litter size, and reduced fetal weight, but did not cause fetal malformations
Lactation
There are no data on presence of drug in human or animal milk, effects on breastfed infant, or on milk production; because of potential for serious adverse reactions in breastfed infant, advise patients that breastfeeding is not recommended during treatment and for 5 months after last dose
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Cytotoxic activity dependent on light and oxygen; activated by laser light to produce oxygen free radicals and vascular necrosis via thromboxane A2 release
Pharmacokinetics
Half-Life: 17 days (first dose); 30 days (second dose); retained longest in tumors, skin, and reticuloendothelial organs
Peak Plasma Concentration: 15 mcg/mL
Protein Bound: 90%
Vd: 0.49 L/kg
Clearance: 0.051 mL/min/kg
Administration
IV Incompatibilities
Do not mix with other drugs in the same solution
IV Preparation
Reconstitute with 31.8 mL of either D5W or NS resulting in a final concentration of 2.5 mcg/mL & pH of 7-8
Shake well until dissolved
Protect the reconstituted product from bright light & use immediately
Reconstituted porfimer is an opaque solution in which detection of particulate matter by visual inspection is extremely difficult
IV Administration
Administer slow IVP over 3-5 min
Use of gloves & eye protection is recommended
Storage
Store intact vials at controlled room temp 20-25°C (68-77°F)
Images
Patient Handout
porfimer intravenous
NO MONOGRAPH AVAILABLE AT THIS TIME
USES: Consult your pharmacist.
HOW TO USE: Consult your pharmacist.
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 or at www.fda.gov/medwatch.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.
DRUG INTERACTIONS: Consult your pharmacist.Keep a list of all your medications with you, and share the list with your doctor and pharmacist.
OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
NOTES: No monograph available at this time.
MISSED DOSE: Consult your pharmacist.
STORAGE: Consult your pharmacist.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.
Information last revised July 2016. Copyright(c) 2022 First Databank, Inc.
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
Formulary
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