Talimogene laherparepvec

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Generic Name: Talimogene laherparepvec Brand Name(s): Generics only. No brands available. Avability: Rx Pregnancy Category: N

Uses

What is Talimogene laherparepvec used for?

Talimogene laherparepvec is used to treat a certain type of skin cancer (melanoma). It contains a live virus (cold sore virus) that has been weakened. Talimogene laherparepvec infects the cancer cells and works by slowing or stopping their growth.

How should I take Talimogene laherparepvec?

This medication is given by injection into your tumor(s) by a health care professional. It is given as directed by your doctor, usually every 2 weeks. However, your second treatment should be 3 weeks after your first treatment.

The dosage is based on your medical condition and response to treatment.

After getting this medication, you may be able to make others sick with the cold sore virus. To prevent the spread of infection, do not touch or scratch the injection site(s). Keep the injection site(s) covered with airtight and watertight dressing(s) for at least 1 week after each treatment. If the injection site is still oozing or weeping after 1 week, you will need to keep it covered for longer. Ask your doctor for more details. If the dressing comes loose or falls off, replace it right away with a clean dressing. Always wear gloves when changing the dressing. Throw away all used dressings and medical supplies in a sealed plastic bag.

Since you may be able to make others sick with the cold sore virus, people close to you (such as household members, caregivers, sexual partners) should not touch your injection site(s), dressing(s), and body fluids. Caregivers should wear gloves when changing the dressing. Women who are pregnant or who may become pregnant and people with weakened immune systems should not change your dressing or clean your injection site. If someone touches your injection site(s), dressing(s), or body fluids, they should clean the skin that touched you with a disinfectant or soap and water right away. If they have any signs of infection (such as cold sores), they should tell their doctor right away.

Use this medication regularly to get the most benefit from it. To help you remember, mark the days on your calendar when you should get this medication.

How do I store Talimogene laherparepvec?

Talimogene laherparepvec 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.

There may be different brands of Talimogene laherparepvec that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.

You should not flush Talimogene laherparepvec down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

Precautions & warnings

What should I know before using Talimogene laherparepvec?

Before using talimogene laherparepvec, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: immune system problems (such as HIV infection, autoimmune disease), certain types of cancer (such as leukemia, lymphoma, multiple myeloma), psoriasis.

This drug may make you dizzy. Alcohol or marijuana can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This medication must not be used during pregnancy. It may harm an unborn baby. Discuss the use of reliable forms of birth control (such as condoms, birth control pills) with your doctor. Men and women should use condoms to prevent spreading the cold sore virus to their sexual partner. If you become pregnant or think you may be pregnant, tell your doctor right away.

It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

Is it safe during pregnancy or breast-feeding?

There are no adequate studies in women for determining risk when using this Talimogene laherparepvec during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking Talimogene laherparepvec. Talimogene laherparepvec is pregnancy risk category N according to the US Food and Drug Administration (FDA).

FDA pregnancy risk category reference below:

  • A=No risk,
  • B=No risk in some studies,
  • C=There may be some risk,
  • D=Positive evidence of risk,
  • X=Contraindicated,
  • N=Unknown

Side effects

What side effects can occur from Talimogene laherparepvec?

Diarrhea, constipation, abdominal pain, dizziness, pain at injection site, white patches on the skin, or flu-like symptoms (such as body aches, cough, sneezing, chills, fever, unusual tiredness, headache, nausea, vomiting) may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: cold sores/blisters, eye infection (such as vision changes, eye redness/pain, light sensitivity, eye discharge), open sore/wound at the injection site, slow wound healing at the injection site, signs of kidney problems (such as change in the amount of urine, pink/bloody urine), joint pain, muscle pain.

Get medical help right away if you have any very serious side effects, including: trouble breathing.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with Talimogene laherparepvec?

Diarrhea, constipation, abdominal pain, dizziness, pain at injection site, white patches on the skin, or flu-like symptoms (such as body aches, cough, sneezing, chills, fever, unusual tiredness, headache, nausea, vomiting) may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: cold sores/blisters, eye infection (such as vision changes, eye redness/pain, light sensitivity, eye discharge), open sore/wound at the injection site, slow wound healing at the injection site, signs of kidney problems (such as change in the amount of urine, pink/bloody urine), joint pain, muscle pain.

Get medical help right away if you have any very serious side effects, including: trouble breathing.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Talimogene laherparepvec may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Does food or alcohol interact with Talimogene laherparepvec?

Talimogene laherparepvec may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with Talimogene laherparepvec?

Talimogene laherparepvec may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using this Talimogene laherparepvec.

What is the dose of Talimogene laherparepvec for an adult?

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.

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.

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.

What is the dose of Talimogene laherparepvec for a child?

The dosage has not been established in pediatric patients. It may be unsafe for your child. It is always important to fully understand the safety of the drug before using. Please consult with your doctor or pharmacist for more information.

How is Talimogene laherparepvec available?

Talimogene laherparepvec is available in the following dosage forms and strengths:

  • Injectable suspension.

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of Talimogene laherparepvec, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.

Hello Health Group does not provide medical advice, diagnosis or treatment.

Review Date: August 9, 2018 | Last Modified: August 9, 2018

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