Talimogene laherparepvec
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From MedlinePlus, U.S. National Library of Medicine
Dosing in kidney impairment
Renal Impairment No clinical studies have been conducted to evaluate the effect of renal impairment on the pharmacokinetics of IMLYGIC.
Dosing in liver impairment
Hepatic Impairment No clinical studies have been conducted to evaluate the effect of hepatic impairment on the pharmacokinetics of IMLYGIC.
Preparation and administration
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Preparation and Handling Healthcare providers who are immunocompromised or pregnant should not prepare or administer IMLYGIC and should not come into direct contact with the IMLYGIC injection sites, dressings, or body fluids of treated patients [see Warnings and Precautions] . Avoid accidental exposure to IMLYGIC and follow below instructions for preparation, administration, and handling of IMLYGIC: Wear personal protective equipment (protective gown or laboratory coat, safety glasses or face shield, and gloves) while preparing or administering IMLYGIC.
Avoid accidental exposure to IMLYGIC, especially contact with skin, eyes, and mucous membranes. ○ Cover any exposed wounds before handling. ○ In the event of an accidental occupational exposure (e.g., through a splash to the eyes or mucous membranes), flush with clean water for at least 15 minutes. ○ In the event of exposure to broken skin or needle stick, clean the affected area thoroughly with soap and water and/or a disinfectant.
Clean all surfaces that may have come in contact with IMLYGIC and treat all IMLYGIC spills with a virucidal agent such as 1% sodium hypochlorite or 70% isopropyl alcohol and blot using absorbent materials. Dispose of all materials that may have come in contact with IMLYGIC (e.g., vial, syringe, needle, cotton gauze, gloves, masks, or dressings) as biohazardous waste.
Advise patients to place used dressings and cleaning materials into a sealed plastic bag and dispose in household waste. Thawing IMLYGIC Vials 1. Determine the total volume required for injection, up to 4 mL [see Dosage and Administration ]. 2. Thaw frozen IMLYGIC vials at room temperature [20°C to 25°C (68°F to 77°F)] until IMLYGIC is liquid.
The time to achieve complete vial thaw is expected to be 30 to 70 minutes, depending on the ambient temperature. Do not expose the vial to higher temperatures. Keep the vial in original carton during thawing. 3. Swirl gently. Do NOT shake. 4. After thawing, administer IMLYGIC immediately or store in its original vial and carton, as follows: Thawed IMLYGIC is stable when stored at temperatures of 2°C (36°F) up to 25°C (77°F) protected from light in its original vial and carton for the storage times specified in Table 3.
Do not exceed the storage times specified in Table 3. IMLYGIC must not be refrozen once it is thawed. Discard any thawed IMLYGIC in the vial stored longer than the specified times in Table 3. [See table below.] 1 week (7 days) up to 25°C (77°F) 12 hours 24 hours 5. Prepare sterile syringes and needles. A detachable 18-26 G needle or nondetachable 22-26 G staked needle (which minimizes hold up volume) may be used for IMLYGIC withdrawal and a detachable or nondetachable staked needle of 22–26 G may be used for injection.
Small unit syringes (e.g., 0.5 mL insulin syringes) are recommended for better injection control. 6. Using aseptic technique, remove the vial cap and withdraw the product from the vial into the syringe(s), noting the total volume. Avoid generating aerosols when loading syringes with product and use a biologic safety cabinet if available.
Administration Follow the steps below to administer IMLYGIC to patients: Pre-Injection Clean the lesion and surrounding areas with an alcohol swab and let dry. Treat the injection site with a topical or local anesthetic agent, if necessary. Do not inject anesthetic agent directly into the lesion. Inject anesthetic agent around the periphery of the lesion.
Injection Inject IMLYGIC intralesionally into cutaneous, subcutaneous, and/or nodal lesions that are visible, palpable, or detectable by ultrasound guidance. Using a single insertion point, inject IMLYGIC along multiple tracks as far as the radial reach of the needle allows within the lesion to achieve even and complete dispersion.
Multiple insertion points may be used if a lesion is larger than the radial reach of the needle. Figure 1: Injection administration for cutaneous lesions Figure 2: Injection administration for subcutaneous lesions Figure 3: Injection administration for nodal lesions Inject IMLYGIC evenly and completely within the lesion by pulling the needle back without exiting the lesion.
Redirect the needle as many times as necessary while injecting the remainder of the dose of IMLYGIC. Continue until the full dose is evenly and completely dispersed. When removing the needle, withdraw it from the lesion slowly to avoid leakage of IMLYGIC at the insertion point. Repeat steps 1-2 under pre-injection and steps 1-3 under injection for other lesions to be injected.
Use a new needle any time the needle is completely removed from a lesion and each time a different lesion is injected. Figure 1 Figure 2 Figure 3 Post-Injection Apply pressure to the injection site(s) with sterile gauze for at least 30 seconds. Swab the injection site(s) and surrounding area with alcohol. Change gloves and cover the injected lesion(s) with an absorbent pad and dry occlusive dressing.
Wipe the exterior of occlusive dressing with alcohol. Advise patients to: Keep the injection site(s) covered for at least the first week after each treatment visit or longer if the injection site is weeping or oozing. Replace the dressing if it falls off.
| Treatment | Treatment Interval | Maximum Injection Volume per Treatment Visit (all lesions combined) | Dose Strength | Prioritization of Lesions to be Injected |
| Initial | – | 4 mL | 106 (1 million) PFU per mL | Inject largest lesion(s) first. Prioritize injection of remaining lesion(s) based on lesion size until maximum injection volume is reached or until all injectable lesion(s) have been treated. |
| Second | 3 weeks after initial treatment | 4 mL | 108 (100 million) PFU per mL | Inject any new lesion(s) (lesions that have developed since initial treatment) first. Prioritize injection of remaining lesion(s) based on lesion size until maximum injection volume is reached or until all injectable lesion(s) have been treated. |
| All subsequent treatments (including reinitiation) | 2 weeks after previous treatment | 4 mL | 108 (100 million) PFU per mL | Inject any new lesion(s) (lesions that have developed since previous treatment) first. Prioritize injection of remaining lesion(s) based on lesion size until maximum injection volume is reached or until all injectable lesion(s) have been treated. |
| Lesion Size (longest dimension) | Injection Volume |
| > 5 cm | up to 4 mL |
| > 2.5 cm to 5 cm | up to 2 mL |
| > 1.5 cm to 2.5 cm | up to 1 mL |
| > 0.5 cm to 1.5 cm | up to 0.5 mL |
| ≤ 0.5 cm | up to 0.1 mL |
Drug interactions
Check talimogene laherparepvec against a medication listLabel text (1 paragraph)
7 DRUG INTERACTIONS IMLYGIC is sensitive to acyclovir. Acyclovir or other antiherpetic viral agents may interfere with the effectiveness of IMLYGIC. No drug interaction studies have been conducted with IMLYGIC.
Contraindications
Immunocompromised Patients ( 4.1 ) Pregnant Patients ( 4.2 )
4.1 Immunocompromised Patients IMLYGIC is a live, attenuated herpes simplex virus and may cause life-threatening disseminated herpetic infection in patients who are immunocompromised. Do not administer IMLYGIC to immunocompromised patients, including those with a history of primary or acquired immunodeficient states, leukemia, lymphoma, AIDS or other clinical manifestations of infection with human immunodeficiency viruses, and those on immunosuppressive therapy [see Nonclinical Toxicology ( 13.2 )] .
4.2 Pregnant Patients Do not administer IMLYGIC to pregnant patients.
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary Adequate and well-controlled studies with IMLYGIC have not been conducted in pregnant women. No effects on embryo-fetal development have been observed in a study conducted in pregnant mice. The design of the study limits application of the animal data to humans [see Data]. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Clinical Considerations If the patient becomes pregnant while taking IMLYGIC, the patient should be apprised of the potential hazards to the fetus and neonate.
Women of childbearing potential should be advised to use an effective method of contraception to prevent pregnancy during treatment with IMLYGIC. If a pregnant woman has an infection with wild-type Herpes Simplex Virus Type 1 (HSV-1) (primary or reactivation), there is potential for the virus to cross the placental barrier and also a risk of transmission during birth due to viral shedding. Infections with wild-type HSV-1 have been associated with serious adverse effects, including multi-organ failure and death, if a fetus or neonate contracts the wild-type herpes infection.
While there are no clinical data to date on IMLYGIC infections in pregnant women, there could be a risk to the fetus or neonate if IMLYGIC were to act in the same manner. Data Animal Data No effects on embryo-fetal development were observed when IMLYGIC was intravenously administered during organogenesis to immunocompetent pregnant mice at doses up to 4 x 10 8 (400 million) PFU per kg (60-fold higher, on a PFU per kg basis, compared to the maximum clinical dose). Levels of IMLYGIC DNA in pooled fetal blood were at or below the assay detection level.
Study design limitations included: 1) administration of IMLYGIC expressing human granulocyte-macrophage colony-stimulating factor (huGM-CSF), which is not biologically active in mice; 2) unknown transplacental kinetics of IMLYGIC following intravenous administration in pregnant mice; and 3) unknown significance of IMLYGIC dose extrapolation from animal to human based on body weight.
For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
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