Applies to talimogene laherparepvec: injection suspension.

Serious side effects

Along with its needed effects, talimogene laherparepvec may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking talimogene laherparepvec:

More common

• Chills
• cough
• diarrhea
• fever
• general feeling of discomfort or illness
• headache
• joint pain
• loss of appetite
• muscle aches and pains
• nausea
• pain at the injection site
• runny nose
• shivering
• sore throat
• sweating
• trouble sleeping
• unusual tiredness or weakness
• vomiting

Incidence not known

• Break in the skin, especially associated with blue-black discoloration, swelling, or drainage of fluid
• burning or stinging of the skin
• painful cold sores or blisters on the lips, nose, eyes, or genitals

Other side effects

Some side effects of talimogene laherparepvec may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Abdominal or stomach pain
• difficulty having a bowel movement (stool)
• difficulty with moving
• dizziness
• muscle pain or stiffness
• pain in the arms or legs
• weight loss

For Healthcare Professionals

Applies to talimogene laherparepvec: injectable suspension.

General

-The most commonly reported (25% or more) adverse drug reactions were fatigue, chills, pyrexia, nausea, influenza-like illness, and injection site pain.

-Pyrexia, chills, and influenza-like illness can occur at any time during treatment, but were more frequent during the first 3 months.

-Most adverse reactions were mild or moderate in severity and generally resolved within 72 hours.

-Cellulitis was the most common grade 3 or higher adverse reaction.^[Ref]

Other

Very common (10% or more): Fatigue (50.3%), chills (48.6%), pyrexia (42.8%), influenza-like illness (30.5%), injection site pain (27.7%)

Common (1% to 10%): Decreased weight

Frequency not reported: Herpetic infection, injection site complications (cellulitis, systemic bacterial infection, impaired healing)^[Ref]

Gastrointestinal

Very common (10% or more): Nausea (35.6%), vomiting (21.2%), diarrhea (18.8%), constipation (11.6%)

Common (1% to 10%): Abdominal pain

Frequency not reported: Oral herpes^[Ref]

Nervous system

Very common (10% or more): Headache (18.8%)

Common (1% to 10%): Dizziness^[Ref]

Musculoskeletal

Very common (10% or more): Myalgia (17.5%), arthralgia (17.1%), extremity pain (16.4%)^[Ref]

Immunologic

Frequency not reported: Immune-mediated events (glomerulonephritis, vasculitis, pneumonitis, psoriasis, vitiligo)^[Ref]

Oncologic

Frequency not reported: Plasmacytoma^[Ref]

Respiratory

Common (1% to 10%): Oropharyngeal pain^[Ref]

Metabolic

Common (1% to 10%): Decreased weight^[Ref]