Description
Vusolimogene oderparepvec-wtpg injection is used in combination with nivolumab to treat unresectable advanced cutaneous melanoma (skin cancer that cannot be removed by surgery) in patients who have received other cancer treatments (eg, PD-1 blocking antibody-based medicine).
This medicine is to be given only by or under the supervision of your doctor.
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of vusolimogene oderparepvec-wtpg injection in the pediatric population. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of vusolimogene oderparepvec-wtpg injection in the elderly.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Herpes infection, history of—Use with caution. May make this condition worse.
Proper Use
Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
A nurse or other trained health professional will give you this medicine in a medical facility. This medicine is injected directly into the tumor.
Take this medicine 72 hours after using an antiviral medicine.
To prevent the risk of accidental exposure to this medicine:
- Avoid unprotected direct contact with the injection sites, dressing, and bodily fluid of the patient. Do not touch or scratch the injection site.
- Wash hands before and after changing the dressing.
- Cover the injection site with the dressing for at least 48 hours. Replace the dressing if it falls off. Wear gloves when removing and replacing the dressing.
- Place used dressing, gloves, and cleaning items in sealed plastic.
- If accidental exposure occurs, clean the affected area with soap and water.
Precautions
It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests are needed to check for unwanted effects.
Receiving this medicine while you are pregnant can harm your unborn baby. It may also cause birth defects if the father is receiving it when his sexual partner becomes pregnant. If you can get pregnant, your doctor may do tests to make sure you are not pregnant before starting the treatment. Female patients should use effective birth control during treatment with this medicine and for at least 90 days after the last dose. Male patients who have female partners should use effective birth control during treatment with this medicine and for at least 90 days after the last dose. If you think you have become pregnant while receiving the medicine, tell your doctor right away.
Male patients should not donate sperm during treatment with this medicine and for at least 90 days after the last dose.
This medicine may cause herpes infection or reactivation. Check with your doctor right away if you have small bumps that turn into blisters or sores.
This medicine may cause injection procedure complications, including bleeding, infection, and lung problems. Check with your doctor right away if you have bleeding gums, chest pain, cough or hoarseness, coughing up blood, difficulty in swallowing, dizziness, fever or chills, headache, increased menstrual flow or vaginal bleeding, lower back or side pain, nosebleeds, painful or difficult urination, paralysis, prolonged bleeding from cuts, red or dark brown urine, red or black, tarry stools, or trouble breathing.
Colitis (inflammation of the colon) may occur with this medicine. Tell your doctor right away if you have stomach pain or tenderness, watery or bloody diarrhea, or a fever after receiving the medicine.
Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, a loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.
This medicine may cause inflammation of the heart muscle (myocardium) called myocarditis. Check with your doctor right away if you have chest pain or discomfort, fever, chills, a fast heartbeat, or trouble breathing.
This medicine may cause a condition called capillary leak syndrome. It can cause fluid to leak from the blood vessels into your body's tissues. Call your doctor right away if you have swelling or puffiness and are urinating less often, trouble breathing, feeling of fullness, dizziness, or fainting.
Check with your doctor right away if you have blistering, cracking, crusting, discoloration, dryness, irritation, itching, redness, scaling, or swelling of the skin. These may be symptoms of skin reactions (eg, dermatitis, vitiligo).
This medicine may cause neuropathy (nerve problem). Check with your doctor right away if you have burning, tingling, numbness or pain in the hands, arms, feet, or legs, sensation of pins and needles, or stabbing pain.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects
Along with its needed effects, a medicine 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:
More common
- Bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
- bleeding gums
- chills
- cough or hoarseness
- coughing up blood
- diarrhea
- difficulty in swallowing
- dizziness
- fever
- general feeling of discomfort or illness
- headache
- increased menstrual flow or vaginal bleeding
- joint pain
- loss of appetite
- lower back or side pain
- muscle aches and pains
- nausea
- nosebleeds
- painful or difficult urination
- paralysis
- prolonged bleeding from cuts
- red or dark brown urine
- red or black, tarry stools
- runny nose
- shivering
- sore throat
- sweating
- trouble breathing
- trouble sleeping
- unusual tiredness or weakness
- vomiting
Incidence not known
- Blistering, crusting, irritation, itching, or reddening of the skin
- burning, tingling, numbness or pain in the hands, arms, feet, or legs
- chest pain or discomfort
- cracked, dry, scaly skin
- dark urine
- decrease or increase in amount of urine
- fainting or lightheadedness
- fast heartbeat
- light-colored stools
- sensation of pins and needles
- stabbing pain
- stomach cramps, tenderness, or pain
- swelling of the hands, ankles, feet, or lower legs
- upper right abdominal or stomach pain
- watery or bloody diarrhea
- yellow eyes and skin
Some side effects 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
- Constipation
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
DRG-80011968
