Talimogene laherparepvec

What is Talimogene laherparepvec?

• Talimogene laherparepvec (Imlygic) is a genetically modified oncolytic viral therapy used to treat melanoma that cannot be operated on.

What are the uses of this medicine?

• Talimogene laherparepvec (Imlygic) is a prescription medicine used to treat a type of cancer called melanoma when it is on your skin or in your lymph glands.
• Imlygic is a weakened form of Herpes Simplex Virus Type 1, which is commonly called the cold sore virus.
• It is used as local treatment in patients whose disease has recurred (come back) after being treated with surgery.

How does this medicine work?

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Talimogene laherparepvec MOA

• Talimogene laherparepvec (Imlygic) is a oncolytic herpes simplex type-1 virus (HSV-1) based on the JS1 strain, and encoding the immunostimulating factor human cytokine granulocyte-macrophage colony stimulating factor (GM-CSF) with potential immunostimulating and antineoplastic activities.
• Upon intratumoral injection, talimogene laherparepvec selectively infects and replicates in tumor cells, thereby inducing tumor cell lysis.
• In addition, GM-CSF attracts dendritic cells (DCs) and may stimulate a cytotoxic T cell response against tumor cells, which results in immune-mediated tumor cell death.
• Deletion of the gene encoding for ICP34.5 provides tumor selectivity and prevents replication in healthy cells.
• As ICP47 blocks antigen presentation in HSV-infected cells, deletion of this gene may induce a more potent antitumor immune response in the tumor cells.
• Additionally, deletion of ICP47 causes increased expression of the HSV US11 gene and allows US11 to be expressed as an immediate early and not a late gene.
• This further enhances the degree of viral replication and oncolysis of tumor cells.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• are pregnant
• have a weakened immune system (for example, an immune deficiency, blood or bone marrow cancer, steroid use, or HIV/AIDS).

What drug interactions can this medicine cause?

• Tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.
• Tell your doctor if you are taking any medications that weaken your immune system such as antithymocyte globulin (Atgam, Thymoglobulin), azathioprine (Azasan, Imuran), basiliximab (Simulect), belatacept (Nulojix), belimumab (Benlysta), cortisone, cyclosporine (Gengraf, Neoral, Sandimmune), dexamethasone, fludrocortisone, methotrexate (Otrexup, Rasuvo, Trexall), methylprednisolone (Depo-medrol, Medrol, Solu-medrol), mycophenolate mofetil (Cellcept), prednisolone (Flopred, Orapred, Pediapred), prednisone (Rayos), sirolimus (Rapamune), and tacrolimus (Astagraf XL, Prograf, Envarsus XR).

Be sure to mention any of the following:

• any antiviral medications such as acyclovir (Sitavig, Zovirax), cidofovir, docosanol (Abreva), famciclovir (Famvir), foscarnet (Foscavir), ganciclovir (Cytovene), penciclovir (Denavir), trifluridine (Viroptic), valacyclovir (Valtrex), and valganciclovir (Valcyte).

Is this medicine FDA approved?

• It was one of the first oncolytic immunotherapy approved globally; it was approved in the US in October 2015 and approved in Europe in December 2015.

How should this medicine be used?

Recommended dosage:

• Recommended starting dose is up to a maximum of 4 mL of Imlygic at a concentration of 106 (1 million) plaque-forming units (PFU) per mL.
• Subsequent doses should be administered up to 4 mL of Imlygic at a concentration of 108 (100 million) PFU per mL.

Administration:

• Administer Imlygic by injection into cutaneous, subcutaneous, and/or nodal lesions.
• Your healthcare provider will inject Imlygic directly into your tumor(s) with a needle and syringe.
• You will get a second treatment 3 weeks after the first treatment.
• After that, you will get treatments every 2 weeks for as long as you have tumor(s).
• You can get treated for 6 months or longer.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Injection: 106 (1 million) PFU per mL, 108 (100 million) PFU per mL in single-use vials

This medicine is available in fallowing brand namesː

• Imlygic

What side effects can this medication cause?

The most common side effects of this medicine include:

• Tiredness
• Chills
• Fever
• Nausea
• Flu-like symptoms
• Pain at treatment site

What special precautions should I follow?

• Accidental exposure may lead to transmission of Imlygic and herpetic infection. Healthcare providers and close contacts should avoid direct contact with injected lesions, dressings, or body fluids of treated patients.
• Healthcare providers who are immunocompromised or pregnant should not prepare or administer Imlygic. If accidental exposure occurs, exposed individuals should clean the affected area.
• Patients who develop herpetic infections should be advised to follow standard hygienic practices to prevent viral transmission.
• Consider the risks and benefits before continuing Imlygic treatment if persistent infection or delayed healing develops.
• Consider the risks and benefits of Imlygic before initiating treatment in patients who have underlying autoimmune disease or before continuing treatment in patients who develop immune-mediated events.
• Consider the risks and benefits in patients with multiple myeloma or in whom plasmacytoma develops during treatment.
• Use caution when injecting lesions close to major airways.
• Imlygic is not indicated for treatment via transcutaneous intrahepatic route of administration.
• Imlygic virus can spread to other areas of your body or to your close contacts (household members, caregivers, sex partners, or persons sharing the same bed).
• Avoid direct contact between your treatment sites, dressings, or body fluids and close contacts (for example, use condoms when engaging in sexual activity, avoid kissing close contacts if either 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).
• If the dressing comes loose or falls off, replace it right away with a clean dressing.
• Place all used dressings and cleaning materials in a sealed plastic bag and throw them away in the garbage.
• Do not touch or scratch the treatment sites.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• There is no clinical experience with an overdose with Imlygic.

Management of overdosage:

• In the event of a suspected overdose, the patient should be treated symptomatically and supportive measures instituted as required.

Can this medicine be used in pregnancy?

• Adequate and well-controlled studies with Imlygic have not been conducted in pregnant women.
• Imlygic may harm your unborn baby.
• You should not become pregnant during treatment with Imlygic.

Can this medicine be used in children?

• Safety and effectiveness of Imlygic have not been established in pediatric patients.

What are the active and inactive ingredients in this medicine?

• Active ingredient: talimogene laherparepvec
• Inactive ingredients: di-sodium hydrogen phosphate dihydrate, sodium dihydrogen phosphate dihydrate, sodium chloride, myo-inositol, sorbitol, and water for injection

Who manufactures and distributes this medicine?

Manufactured by:

• BioVex, Inc., a subsidiary of Amgen Inc.
• One Amgen Center Drive
• Thousand Oaks, California

What should I know about storage and disposal of this medication?

• Store and transport Imlygic at −90°C to −70°C (−130°F to −94°F).
• Protect Imlygic from light.
• Store Imlygic in the carton until use.
• Thaw Imlygic immediately prior to administration.
• Do not draw Imlygic into a syringe until immediately prior to administration.

• Dailymed label info on Talimogene laherparepvec
• FDA Talimogene laherparepvec

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