Indications and Usage
NiktimvoTM (axatilimab-csfr) is a prescription medicine used to treat adults and children who weigh at least 88.2 pounds (40 kg) with chronic graft-versus-host disease (cGVHD) after receiving at least 2 prior treatments (systemic therapy) and they did not work.
It is not known if Niktimvo is safe and effective in adults and children weighing less than 88.2 pounds (40 kg).
IMPORTANT SAFETY INFORMATION
What are the possible side effects of Niktimvo?
Niktimvo may cause serious side effects, including:
Infusion-related reactions. Infusion-related reactions are common with Niktimvo and can be serious. Your healthcare provider will monitor you for infusion-related reactions during your treatment. If you have a reaction, your healthcare provider may temporarily or completely stop your treatment with Niktimvo. Tell your healthcare provider right away if you have fever, chills, rash, flushing, shortness of breath, trouble breathing, nausea, vomiting, or symptoms of high blood pressure such as chest pain, headaches, or blurred vision during an infusion of Niktimvo.
The most common side effects of Niktimvo include:
These are not all the possible side effects of Niktimvo. Call your doctor for medical advice about side effects.
Before receiving Niktimvo, tell your healthcare provider about all of your medical conditions, including if you:
Females who are able to become pregnant:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Please see the Full Prescribing Information, which includes a more complete discussion of the risks associated with Niktimvo.
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.
You may also report side effects to Incyte Medical Information at 1-855-463-3463.
Indications and Usage
NiktimvoTM (axatilimab-csfr) is a prescription medicine used to treat adults and children who weigh at least 88.2 pounds (40 kg) with chronic graft-versus-host disease (cGVHD) after receiving at least 2 prior treatments (systemic therapy) and they did not work.
It is not known if Niktimvo is safe and effective in adults and children weighing less than 88.2 pounds (40 kg).
IMPORTANT SAFETY INFORMATION
What are the possible side effects of Niktimvo?
Niktimvo may cause serious side effects, including:
Infusion-related reactions. Infusion-related reactions are common with Niktimvo and can be serious. Your healthcare provider will monitor you for infusion-related reactions during your treatment. If you have a reaction, your healthcare provider may temporarily or completely stop your treatment with Niktimvo. Tell your healthcare provider right away if you have fever, chills, rash, flushing, shortness of breath, trouble breathing, nausea, vomiting, or symptoms of high blood pressure such as chest pain, headaches, or blurred vision during an infusion of Niktimvo.
The most common side effects of Niktimvo include:
These are not all the possible side effects of Niktimvo. Call your doctor for medical advice about side effects.
Before receiving Niktimvo, tell your healthcare provider about all of your medical conditions, including if you:
Females who are able to become pregnant:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Please see the Full Prescribing Information, which includes a more complete discussion of the risks associated with Niktimvo.
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.
You may also report side effects to Incyte Medical Information at 1-855-463-3463.