Imlygic Side Effects

Generic Name: talimogene laherparepvec

Note: This page contains information about the side effects of talimogene laherparepvec. Some of the dosage forms included on this document may not apply to the brand name Imlygic.

For the Consumer

Applies to talimogene laherparepvec: injection suspension

In addition to its needed effects, some unwanted effects may be caused by talimogene laherparepvec (the active ingredient contained in Imlygic). In the event that any of these side effects do occur, they may require medical attention.

If any of the following side effects occur while taking talimogene laherparepvec, check with your doctor or nurse immediately:

• 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

• 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

Minor Side Effects

Some of the side effects that can occur with talimogene laherparepvec may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

• 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]

Not all side effects for Imlygic may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

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