Usual Adult Dose for Melanoma - Metastatic

Initial Dose:

• Up to 4 mL at a concentration of 10(6) [1 million] plaque-forming units (PFU) per mL by intralesional injection.
• Largest lesion(s) should be injected first.
• Remaining lesion(s) should be prioritized for injection based on lesion size.

Second Dose:

• Up to 4 mL at a concentration of 10(8) [100 million] PFU per mL by intralesional injection 3 weeks after initial treatment.
• New lesions that developed since initial treatment should be injected first.
• Remaining lesion(s) should be prioritized for injection based on lesion size.

All Subsequent Treatments (including Reinitiation):

• Up to 4 mL at a concentration of 10(8) [100 million] PFU per mL by intralesional injection 2 weeks after previous treatment.
• New lesions that developed since previous treatment should be injected first.
• Remaining lesion(s) should be prioritized for injection based on lesion size.

Maximum Dose: The total injection volume for each treatment visit should not exceed 4 mL for all injected lesions combined.

Duration of Therapy:

• At each treatment visit: Lesions should be injected until maximum injection volume is reached or until all injectable lesion(s) have been treated.
• Full treatment course: At least 6 months unless other treatment is required or until there are no injectable lesions to treat.

Comments:
The injection volume should be based on lesion size (lesions clustered together should be treated as a single lesion):

• Greater than 5 cm: Up to 4 mL
• Greater than 2.5 cm to 5 cm: Up to 2 mL
• Greater than 1.5 cm to 2.5 cm: Up to 1 mL
• Greater than 0.5 cm to 1.5 cm: Up to 0.5 mL
• 0.5 cm or less: Up to 0.1 mL

Use: Local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma recurrent after initial surgery.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Precautions

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration Advice:

• This drug should be injected into cutaneous, subcutaneous, and/or nodal lesions that are visible, palpable, or detectable by ultrasound guidance.
• Previously injected and/or uninjected lesion(s) may be injected at subsequent treatment visits.
• It may not be possible to inject all lesions at each treatment visit or over the full course of treatment.
• This drug should only be administered by intralesional injection; IV administration should not be used.
• The manufacturer product information should be consulted for administration technique instructions.

Storage Requirements:

• This drug should be stored and transported at -90 to -70 degrees Celsius (-130 to -94 Fahrenheit).
• Thawed drug should be protected from light and stored in its original vial and carton in a refrigerator at 2 to 8 degrees Celsius (36 to 46 Fahrenheit) for no longer than 12 hours for the 10(6) [1 million] PFU per mL vial, and no longer than 48 hours for the 10(8) [100 million] PFU per mL vial.
• Vials left in the refrigerator longer than the specified times should be discarded.

Preparation/Handling Techniques:

• This drug should be thawed immediately prior to administration; the manufacturer product information should be consulted for thawing instructions.
• Healthcare providers who are immunocompromised or pregnant should not handle, prepare, or administer this drug, and should not come into direct contact with injection sites, dressings, or body fluids of treated patients.
• Personal protective equipment (gown or lab coat, safety glasses or face shield, gloves) should be worn while preparing or administering this drug.
• Accidental drug exposure (especially contact with skin, eyes, mucous membranes) should be avoided and exposed wounds should be covered before handling.
• If accidental occupational exposure occurs, the affected area should be flushed with clean water for at least 15 minutes.
• If exposure to broken skin or needle stick occurs, the affected area should be cleaned thoroughly with soap and water and/or a disinfectant.
• All drug spills should be treated with a virucidal agent (e.g., 1% sodium hypochlorite) and blotted with absorbent materials.
• All materials that come in contact with this drug should be disposed of in accordance with universal biohazard precautions.

General:

• Treatment with this drug should be reinitiated if new unresectable cutaneous, subcutaneous, or nodal lesions appear after a complete response.
• This drug has not been shown to improve overall survival or have an effect on visceral metastases.
• There is no clinical overdose experience with this drug; suspected overdoses should be treated symptomatically with supportive measures instituted as required.
• This drug is provided as a sterile frozen suspension in 1 mL single-use vials in 2 different dose strengths: 10(6) [1 million] PFU per mL (light green cap) for initial dose only, and 10(8) [100 million] PFU per mL (royal blue cap) for all subsequent doses.
• Each drug vial may contain residual components of VERO cells including DNA, protein, and trace quantities of fetal bovine serum.

Patient Advice:
Following are some recommendations on how to prevent spreading this drug to other areas of your body and to your close contacts; talk to your healthcare provider about other ways to prevent accidental drug exposure.

• Avoid direct contact between your treatment sites/dressings/bodily fluids and your close contacts (for example, do not kiss a close contact if either person has an open mouth sore);
• Wear gloves while putting on or changing your dressings;
• Keep treatment sites covered with airtight and watertight dressings for at least 1 week after each treatment (or longer if the treatment site is weeping or oozing);
• Replace dressings right away if they come loose or fall off;
• Place all used dressings and cleaning materials in a sealed plastic bag before throwing them away in the garbage;
• Avoid touching or scratching your treatment sites.