JYLAMVO HOME Product Brochure Package Insert Patient Instructions Ordering Information Patient Assistance

DOSING and ADMINISTRATION

JYLAMVO (methotrexate) oral solution has a concentration of 2 mg/mL which allows for easy dose calculation¹.

Recommended Dosage and equivalent dose of JYLAMvo in ml

Disease	Recommended Dosage	Equivalent Dose of JYLAMVO (mL)
Acute Lymphoblastic Leukemia for Adults and Pediatric Patients	20 mg/m² once weekly	10 mL/m² weekly
Mycosis Fungoides for Adults	25 mg – 75 mg once weekly*	12.5 mL to 37.5 mL weekly
Relapsed/Refractory Non-Hodgkin Lymphoma for Adults	2.5 mg 2 to 4 times weekly	1.25 mL 2 to 4 times weekly
Rheumatoid Arthritis for Adults	7.5 mg once weekly	3.75 mL weekly
Polyarticular Juvenile Idiopathic Arthritis for Pediatric Patients	10 mg/m² once weekly	5 mL/m² weekly
Severe Psoriasis for Adults	10 mg to 25 mg once weekly	5 mL to 12.5 mL weekly

Note: Refer to the prescribing information for full dosage information.

*25 mg to 75 mg once weekly when administered as a single agent or 10 mg/m² orally twice weekly as part of a combination chemotherapy regimen.

Doses shown are intended for illustrative purposes only and are not a replacement for clinical judgment.

Download Dosing Guide

Storage

No refrigeration required

Before opening¹:

Store at room temperature (20° C to 25° C; 68° F to 77° F)

After opening¹:

Store at room temperature (20° C to 25° C; 68° F to 77° F)
Keep the bottle tightly closed
After first opening, discard any unused medicine after 90 days

References: 1: JYLAMVO [prescribing information]. Cambridge, MA: Shorla Oncology; August 2026.

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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.