(BPT) – May is Melanoma Awareness Month, which promotes dialogue, educates and raises awareness of one of the most aggressive forms of skin cancer. This year, the American Cancer Society estimates there will be 87,110 new cases of melanoma diagnosed in the United States, affecting patients like Jim, a husband, former manufacturing business worker and Vietnam veteran.
When detected in the early stages, melanoma is highly curable. However, metastatic melanoma that has spread throughout the body is more difficult to treat because it is highly aggressive and can require multiple treatment approaches over the course of the disease.
Jim was diagnosed with melanoma after his wife, Francesca, noticed a spot on his back while they were on vacation. When he returned home, his dermatologist performed a biopsy and diagnosed Jim with melanoma, suggesting he visit a cancer center.
According to Jim, the diagnosis came as a surprise. “When I was diagnosed, I didn’t know anything about melanoma. I wasn’t even sure how to spell the word, and I really didn’t know what to expect.”
Following his diagnosis, Jim underwent several surgeries called excisions and attempted various approved treatments, including multiple rounds of chemotherapy, to try to stop the tumors from spreading. In more than 10 percent of melanoma patients, disease has spread regionally or distantly. Even after surgical removal, recurrence rates for patients with advanced melanoma remain high.
Six months after Jim’s final surgery, but with persistent lesions remaining, treatment options were limited and his oncologist identified him as an appropriate candidate for IMLYGIC® (talimogene laherparepvec), because his tumors could no longer be surgically removed. IMLYGIC® is a prescription medication injected on the skin, beneath the skin, or in your lymph nodes, to treat a type of skin cancer called melanoma when it can no longer be surgically removed. IMLYGIC® may not help you live longer and may not shrink cancer in your visceral organs (for example, lung or liver).
IMPORTANT SAFETY INFORMATION
- IMLYGIC® is a weakened form of Herpes Simplex Virus Type 1, which is commonly called the cold sore virus. Your health care provider will inject IMLYGIC® directly into your tumor(s).
- Your health care provider will decide which tumor(s) to inject and may not inject every one. It is important to care for the treatment sites properly so that IMLYGIC® does not spread to other people. Your health care provider will show you how to do this.
When discussing treatment with his doctor, Jim learned that IMLYGIC® is an oncolytic therapy and is made by modifying a virus. It is injected directly into melanoma tumors where it multiplies inside the cancer cells and destroys them. The immune system can be activated and may promote an antitumor response. Exactly how IMYLGIC® works is unknown.
Before receiving IMLYGIC®, as his caregiver, Francesca helped ensure that they both stayed educated and asked questions as they determined Jim’s treatment plan. Jim received his treatment with IMLYGIC® over a period of time, which included multiple injections. Throughout his treatment journey, Jim worked with his medical team to understand the known side effects as well as the procedure for administering IMLYGIC®.
As he continued treatment, Jim began to feel connected to the process as he better understood the treatment and its impact on his body and his cancer.
Working closely with his medical team and having an open dialogue was an important part of Jim’s treatment experience. Jim encourages patients who have been diagnosed with melanoma to, “be proactive and listen to your doctor, get as involved as you can, because there are many different options out there.”
Jim hopes by sharing his story he can help other patients and let them know they aren’t alone. “It’s very important for a patient to have open communication with their medical team. After I felt comfortable telling my medical team what I was experiencing, it put me more at ease. Everybody was very supportive and they thoroughly understood every phase of the treatment I was going through,” he said. “And if you have a family member or a caregiver, make sure they’re totally involved. Fran, she was backing me up and forcing me to stay focused.”
Jim now makes sure he avoids the sun and takes steps to protect himself. In addition to skin protection, Jim understands the value of early detection. He commented, “If I could go back, I would react much quicker to when I first noticed that there was something different on my skin, because melanoma can be very aggressive.”
If you have been diagnosed with advanced melanoma, talk to your doctor about your treatment options. To learn more about IMLYGIC® and download a patient brochure, visit www.IMLYGIC.com/patient.
IMPORTANT SAFETY INFORMATION, CONTINUED
Who should not take IMLYGIC®?
You should not get IMLYGIC® if you are pregnant or have a weakened immune system (for example, an immune deficiency, blood or bone marrow cancer, steroid use, or HIV/AIDS).
What should you tell your healthcare provider before getting IMLYGIC®?
- Because IMLYGIC® may affect the way other medicines work and other medicines may affect how IMLYGIC® works, tell your doctor about all the medications you take.
- Because certain medications can affect your immune system, or affect how IMLYGIC® works, tell your doctor if you are taking steroids or are taking antiviral medications to treat or prevent herpes, like acyclovir.
- Tell your doctor if you have or ever had certain medical conditions like: HIV infection or AIDS, blood or bone marrow cancer, autoimmune disease, or other medical conditions that can weaken your immune system.
- Tell your doctor if you have close contact with someone who has a weakened immune system or is pregnant.
- IMLYGIC® may harm your unborn baby. Tell your doctor if you are pregnant or planning to become pregnant, nursing, or planning to breastfeed. Your doctor will determine whether you should receive IMLYGIC®.
- Talk with your healthcare provider about effective birth control methods.
The IMLYGIC® virus can spread to other areas of your body or to your close contacts (household members, caregivers, sex partners, or persons sharing the same bed). Do the following to avoid spreading IMLYGIC® to other areas of your body or to your close contacts. You should share this information with them:
- Avoid direct contact between your treatment sites, dressings, or body fluids and close contacts (for example, use condoms when engaging in sexual activity, avoid kissing close contacts if either of you has an open mouth sore).
- Don’t touch or scratch the parts of your body that have been injected with IMLYGIC®.
- Wear gloves while putting on or changing your dressings.
- Keep treatment sites covered with airtight and watertight dressings for at least 1 week after each treatment (or longer if the treatment site is weeping or oozing).
- Replace dressings right away with a clean dressing if they become loose or come off.
- Place all used dressings and cleaning materials in a sealed plastic bag, and throw them away in the garbage.
What are the possible side effects of IMLYGIC®?
- Common side effects of IMLYGIC® include tiredness, chills, fever, nausea, flu-like symptoms, and pain at treatment site.
- Tell your doctor right away if you get any of the following:
- Pain, burning, or tingling in a blister around the mouth or genitals or on the fingers or ears
- Eye pain, light sensitivity, discharge from the eyes, or blurry vision
- Weakness in arms or legs
- Extreme drowsiness
- Mental confusion
- If you think you have a herpes infection, inform your healthcare provider. You or your healthcare provider should call Amgen at 1-855-IMLYGIC (1-855-465-9442) for follow-up testing, if needed.
- Tell your healthcare provider if you have any side effect that bothers you or does not go away.
- These are not all the possible side effects of IMLYGIC®.
If you would like more information, talk with your healthcare provider.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Please see full Prescribing Information and Medication Guide for more information about IMLYGIC®.
USA-678-046589
