IMPORTANT SAFETY INFORMATION
WARNING: EMBRYO-FETAL TOXICITY, HYPERSENSITIVITY REACTIONS, and SEVERE ADVERSE REACTIONS
• Methotrexate can cause embryo-fetal toxicity, including fetal death. For non-neoplastic diseases, JYLAMVO is contraindicated in pregnancy. For neoplastic diseases, advise patients of reproductive potential of the potential risk to a fetus and to use effective contraception during and after treatment with JYLAMVO.
• JYLAMVO is contraindicated in patients with a history of severe hypersensitivity reactions to methotrexate, including anaphylaxis.
•Serious adverse reactions, including death, have been reported with methotrexate. Closely monitor for infections and adverse reactions of the bone marrow, gastrointestinal tract, liver, lungs, skin, and kidneys. Withhold or discontinue JYLAMVO as appropriate.
CONTRAINDICATIONS
- JYLAMVO is contraindicated in pregnant women for treatment of non-neoplastic diseases and patients with a history of severe hypersensitivity reactions, including anaphylaxis, to methotrexate.
WARNINGS AND PRECAUTIONS
- Embryo-Fetal Toxicity: Methotrexate can cause fetal harm, including death. Do not use in pregnancy for non-cancer conditions. Consider the benefits and risks when prescribing Jylamvo to a pregnant patient with cancer. Advise females of reproductive potential to use effective contraception during treatment with Jylamvo, and for 6 months after the last dose. Advise males with female partners to use contraception during treatment and for 3 months after the last dose.
- Hypersensitivity Reactions: Serious allergic reactions, including anaphylaxis, have occurred. Instruct patients to seek immediate medical attention for signs of a hypersensitivity reaction. Stop Jylamvo permanently if a serious hypersensitivity reaction occurs
- Serious Infections: Patients treated with methotrexate are at increased risk for developing severe infections. Monitor for signs of infection during and after treatment.
- Neurotoxicity: Methotrexate can cause severe acute and chronic neurotoxicity, which may be progressive and fatal. The risk of leukoencephalopathy is higher in patients who had prior cranial radiation. Advise patients to report new neurological symptoms immediately.
- Secondary Malignancies: Methotrexate can cause secondary cancers. Advise patients about the risk of second cancers.
- Tumor Lysis Syndrome: Methotrexate may cause tumor lysis syndrome in patients with rapidly growing tumors. Provide appropriate prophylaxis before starting Jylamvo in at-risk patients.
- Immunization and Live Vaccines: Immunizations with live vaccines is not recommended. Follow current vaccination practice guidelines
- Infertility: Based on published reports, methotrexate can cause impairment of fertility, oligospermia, and menstrual dysfunction. It is not known if the infertility may be reversible. Discuss the risk of infertility with females and males of reproductive potential.
ADVERSE REACTIONS
In clinical trials, common adverse reactions were: ulcerative stomatitis, leukopenia, nausea, and abdominal distress. Other clinically relevant adverse reactions were infection, malaise, fatigue, chills, fever, and dizziness.
DRUG INTERACTIONS
Drugs that increase Methotrexate Exposure which may increase risk of methotrexate severe adverse reactions. In some cases, these products may also decrease the clinical effectiveness of methotrexate. Increased organ adverse reactions may occur when methotrexate is co-administered with hepatotoxic or nephrotoxic products.
Refer to the full Prescribing Information for list of drug interactions with JYLAMVO.
USE IN SPECIFIC POPULATIONS
Because of the potential for serious adverse reactions in a breastfed child, including myelosuppression, advise women not to breastfeed during treatment with JYLAMVO and for 1 week after the final dose.
To report suspected adverse reactions, contact Shorla Oncology at 844-9-SHORLA (844-974-6752) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please see full prescribing information, including Boxed Warning here.
