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Talimogene Laherparepvec

Also known as: Imlygic

Route: Intralesional

Check Talimogene Laherparepvec Interactions →

2 interactions on record

Talimogene Laherparepvec has 2 known drug interactions based on U.S. FDA drug labeling data. 2 are classified as major interactions requiring close medical supervision. Notable interactions include combinations with Acidifying Agents, Acyclovir. Patients taking Talimogene Laherparepvec should inform their healthcare provider of all current medications — including over-the-counter drugs and supplements — to avoid potentially harmful combinations. Data sourced from OpenFDA and the NIH National Library of Medicine.

Total: 2
Major: 2

Major (2)

Talimogene Laherparepvec + Acidifying Agents— Other antiherpetic viral agents may interfere with the effectiveness of IMLYGIC.
Talimogene Laherparepvec + Acyclovir— Acyclovir may interfere with the effectiveness of IMLYGIC (talimogene laherparepvec). IMLYGIC is sensitive to acyclovir.

Talimogene Laherparepvec + Acidifying Agents⚠️Major

Other antiherpetic viral agents may interfere with the effectiveness of IMLYGIC.

Talimogene Laherparepvec + Acyclovir⚠️Major

Acyclovir may interfere with the effectiveness of IMLYGIC (talimogene laherparepvec). IMLYGIC is sensitive to acyclovir.

Contraindications

4 CONTRAINDICATIONS Immunocompromised Patients ( 4.1 ) Pregnant Patients ( 4.2 ) 4.1 Immunocompromised Patients IMLYGIC is a live, attenuated herpes simplex virus and may cause life-threatening disseminated herpetic infection in patients who are immunocompromised. Do not administer IMLYGIC to immunocompromised patients, including those with a history of primary or acquired immunodeficient states, leukemia, lymphoma, AIDS or other clinical manifestations of infection with human immunodeficiency viruses, and those on immunosuppressive therapy [see Nonclinical Toxicology ( 13.2 )] . 4.2 Pregnant Patients Do not administer IMLYGIC to pregnant patients.

Pregnancy & Breastfeeding

8.1 Pregnancy Risk Summary Adequate and well-controlled studies with IMLYGIC 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 [see Data]. 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. Clinical Considerations If the patient becomes pregnant while taking IMLYGIC, 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 IMLYGIC. 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 IMLYGIC infections in pregnant women, there could be a risk to the fetus or neonate if IMLYGIC were to act in the same manner. Data Animal Data No effects on embryo-fetal development were observed when IMLYGIC was intravenously administered during organogenesis to immunocompetent pregnant mice at doses up to 4 x 10 8 (400 million) PFU per kg (60-fold higher, on a PFU per kg basis, compared to the maximum clinical dose). Levels of IMLYGIC DNA in pooled fetal blood were at or below the assay detection level. Study design limitations included: 1) administration of IMLYGIC expressing human granulocyte-macrophage colony-stimulating factor (huGM-CSF), which is not biologically active in mice; 2) unknown transplacental kinetics of IMLYGIC

Data sourced from U.S. FDA drug labeling via openFDA and the NIH National Library of Medicine. For informational purposes only. Always consult your pharmacist or physician.