porfimer (Rx)

Brand and Other Names:Photofrin
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

powder for injection

  • 75mg/vial

Esophageal Cancer, Endobronchial NSCLC

2 mg/kg IV over 3-5 minutes  

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

2 mg/kg IV over 3-5 minutes  

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

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Interactions

Interaction Checker

and porfimer

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            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

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            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

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            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.

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            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

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            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)

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            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.