IMLYGIC (talimogene laherparepvec)

There are 2 contraindications. Absolute contraindication.

Contraindication List
Lactation
Pregnancy

There are 0 severe contraindications.

There are 1 moderate contraindications. Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.

Moderate List
Herpes simplex infection

There are 6 severe adverse reactions.

More Frequent	Less Frequent
None.	None.

Rare/Very Rare
Glomerulonephritis Herpes simplex infection Herpes simplex keratitis Interstitial pneumonitis Plasmacytoma Vasculitis

There are 18 less severe adverse reactions.

More Frequent	Less Frequent
Chills Fatigue Fever Flu-like symptoms Injection site sequelae Nausea	Acute abdominal pain Arthralgia Constipation Diarrhea Dizziness Headache disorder Myalgia Pain Sore throat Vomiting Weight loss

Rare/Very Rare
Vitiligo

Adequate and well-controlled studies with talimogene laherparepvec 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.

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.

If a patient becomes pregnant while taking talimogene laherparepvec, 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 talimogene laherparepvec. 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 talimogene laherparepvec infections in pregnant women, there could be a risk to the fetus or neonate if talimogene laherparepvec were to act in the same manner.

There is no information regarding the presence of talimogene laherparepvec in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for talimogene laherparepvec and any potential adverse effects on the breastfed infant from talimogene laherparepvec or from the underlying maternal condition. Because medicinal products can be found in human milk, a decision should be made whether to discontinue nursing or to discontinue talimogene laherparepvec while nursing.

In clinical studies, no overall differences in safety or efficacy were observed between geriatric patients ( 65 years of age) and younger patients.