Jylamvo

Serious warning

The strongest warning the FDA requires. It is printed in a box at the top of the label.

Quoted from the official label, section “Boxed Warning”.

Do not take it if

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

• Verify pregnancy status in females of reproductive potential before starting JYLAMVO.
• ( 2.1, 4, 5.1 ) Instruct patients and caregivers to take the recommended dosage as directed, because medication errors have led to deaths.
• ( 2.1, 5.9 ) ALL :
• The recommended dosage is 20 mg/m 2 orally once weekly as a part of a combination chemotherapy maintenance regimen.
• ( 2.2 ) Mycosis fungoides :
• The recommended dosage is 25 mg to 75 mg orally once weekly as monotherapy; 10 mg/m 2 orally twice weekly as part of combination chemotherapy.
• ( 2.2 ) Relapsed or refractory non-Hodgkin lymphoma :
• The recommended dosage is 2.5 mg orally two to four times per week as part of metronomic combination chemotherapy.
• ( 2.2 ) Rheumatoid Arthritis :
• The recommended starting dosage is 7.5 mg orally once weekly; adjust dose to achieve an optimal response.
• ( 2.3 ) pJIA :
• The recommended starting dosage is 10 mg/m 2 orally once weekly; adjust dose to achieve an optimal response.
• ( 2.4 ) Psoriasis :
• The recommended dosage is 10 mg to 25 mg orally once weekly until adequate response is achieved.
• ( 2.5 )
• 2.1 Important Dosage and Safety Information Verify pregnancy status in females of reproductive potential before starting JYLAMVO [see Contraindications (4), Warnings and Precautions (5.1) ].
• Instruct patients and caregivers on how to measure and administer the recommended dosage using the copackaged syringe and bottle adaptor as directed, because medication errors have led to deaths [see Warnings and Precautions (5.9) ].
• Ensure patients and caregivers understand the instructions provided in the Patient Information on proper dosing of JYLAMVO based on volume (mL) utilizing the copackaged syringe before use.
• Advise patients and caregivers to only use the copackaged syringe to measure JYLAMVO and that a teaspoon is not an appropriate measuring device.
• The dosing syringe utilizes mL as the unit of measure; ensure that the correct dose expressed in volume (mL) is prescribed.
• JYLAMVO contains 2 mg of methotrexate in each mL of solution.
• JYLAMVO is intended for oral use only.
• When switching the patient’s dosing regimen from a methotrexate product for oral administration to a methotrexate product for intravenous, intramuscular, or subcutaneous administration, an alternative dosing regimen may be necessary due to potential differences in bioavailability.
• JYLAMVO is a hazardous drug.
• Follow applicable special handling and disposal procedures 1 .
• 2.2 Recommended Dosage for Neoplastic Diseases Acute Lymphoblastic Leukemia The recommended starting dosage of JYLAMVO is 20 mg/m 2 orally once weekly, as part of a combination chemotherapy maintenance regimen.
• After initiating JYLAMVO, periodically monitor absolute neutrophil count (ANC) and platelet count and adjust the dose to maintain ANC at a desirable level and for excessive myelosuppression.
• Mycosis Fungoides The recommended dosage of JYLAMVO is 25 mg to 75 mg orally once weekly when administered as a single agent or 10 mg/m 2 orally twice weekly as part of a combination chemotherapy regimen.
• Relapsed or Refractory Non-Hodgkin Lymphomas The recommended dosage of JYLAMVO is 2.5 mg orally 2 to 4 times per week (maximum 10 mg per week) as part of a metronomic combination chemotherapy regimen.
• 2.3 Recommended Dosage for Rheumatoid Arthritis The recommended starting dosage of JYLAMVO is 7.5 mg orally once weekly with escalation to achieve optimal response.
• Dosages of more than 20 mg once weekly result in an increased risk of serious adverse reactions, including myelosuppression.
• When responses are observed, the majority occur between 3 and 6 weeks from initiation of treatment; however, responses have occurred up to 12 weeks after treatment initiation.
• Administer folic acid or folinic acid to reduce the risk of methotrexate adverse reactions [see Warnings and Precautions (5.10) ] .
• 2.4 Recommended Dosage for Polyarticular Juvenile Idiopathic Arthritis The recommended starting dose of JYLAMVO is 10 mg/m2 orally once weekly with escalation to achieve optimal response.
• Dosages of more than 30 mg/m 2 once weekly result in an increased risk of serious adverse reactions, including myelosuppression.
• When responses are observed, the majority occurred between 3 and 6 weeks from initiation of treatment; however, responseshave occurred up to 12 weeks after treatment initiation.
• Administer folic acid or folinic acid to reduce the risk of methotrexate adverse reactions [see Warnings and Precautions (5.10) ].
• 2.5 Recommended Dosage for Psoriasis The recommended dosage of JYLAMVO is 10 mg to 25 mg orally once weekly until an adequate response is achieved.
• Adjust the dose gradually to achieve optimal clinical response;
• do not exceed a dose of 30 mg per week.
• Once optimal clinical response has been achieved, reduce the dosage to the lowest possible dosing regimen.
• Administer folic acid or folinic acid supplementation to reduce the risk of methotrexate adverse reactions [see Warnings and Precautions (5.10) ] .
• 2.6 Dosage Modifications for Adverse Reactions Discontinue JYLAMVO for:
• Anaphylaxis or other severe hypersensitivity reactions [see Warnings and Precautions (5.2) ] Lymphoproliferative disease [see Warnings and Precautions (5.13) ] Withhold, dose reduce or discontinue JYLAMVO as appropriate for:
• Myelosuppression [see Warnings and Precautions (5.3) ] Withhold or discontinue JYLAMVO as appropriate for:
• Severe gastrointestinal toxicity [see Warnings and Precautions (5.4) ] Hepatotoxicity [see Warnings and Precautions (5.5) ] Pulmonary toxicity [see Warnings and Precautions (5.6) ] Severe dermatologic reactions [see Warnings and Precautions (5.7) ] Severe renal toxicity [see Warnings and Precautions (5.8) ] Serious infections [see Warnings and Precautions (5.11) ] Neurotoxicity [see Warnings and Precautions (5.12) ]

Quoted from the official label, section “Dosage & Administration”.

Other warnings

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

Quoted from the official label, section “Drug Interactions”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

Quoted from the official label, section “Overdosage”.

Use in children

• The safety and effectiveness of JYLAMVO in pediatric patients have been established for the treatment of ALL as part of the combination chemotherapy maintenance regimen and the treatment of pJIA [see Indications and Usage (1) , Dosage and Administration (2) , and Adverse Reactions (6.1) ].
• The safety and effectiveness of JYLAMVO have not been established in pediatric patients for the other indications [see Indications and Usage (1) ].

Quoted from the official label, section “Pediatric Use”.

Use in older people

Clinical studies of methotrexate did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

Quoted from the official label, section “Geriatric Use”.

Side effects

• The following clinically significant adverse reactions are described elsewhere in the labeling:
• Hypersensitivity Reactions [see Warnings and Precautions (5.2) ] Myelosuppression [see Warnings and Precautions (5.3) ] Gastrointestinal Toxicity [see Warnings and Precautions (5.4) ] Hepatotoxicity [see Warnings and Precautions (5.5) ] Pulmonary Toxicity [see Warnings and Precautions (5.6) ] Dermatologic Reactions [see Warnings and Precautions (5.7) ] Renal Toxicity [see Warnings and Precautions (5.8) ] Serious Infections [see Warnings and Precautions (5.11) ] Neurotoxicity [see Warnings and Precautions (5.12) ] Secondary Malignancies [see Warnings and Precautions (5.13) ] Tumor Lysis Syndrome [see Warnings and Precautions (5.14) ] Increased Risk of Adverse Reactions Due to Third-Space Accumulation [see Warnings and Precautions (5.17) ] Common adverse reactions include ulcerative stomatitis, leukopenia, nausea, abdominal distress.
• ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Shorla Oncology at 844-9-SHORLA or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
• 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
• Common adverse reactions were:
• ulcerative stomatitis, leukopenia, nausea, and abdominal distress.
• Other clinically relevant adverse reactions were infection, malaise, fatigue, chills, fever, and dizziness.
• Rheumatoid Arthritis The most common adverse reactions of methotrexate that exceeded the rate of placebo in 12- to 18-week double-blind studies in patients (n=128) with rheumatoid arthritis are listed below.
• Patients received methotrexate 7.5 mg to 15 mg orally once weekly.
• Most patients received concomitant nonsteroidal anti-inflammatory drugs (NSAIDs) and some also received corticosteroids.
• Hepatic histology was not examined in these short-term studies.
• Incidence ≥10%:
• Elevated liver tests 15%, nausea/vomiting 10% Incidence 3% to <10%:
• Stomatitis, thrombocytopenia (platelet count < 100,000/mm 3 ) Incidence 1% to <3%:
• Rash/pruritus/dermatitis, diarrhea, alopecia, leukopenia (white blood cell count < 3000/mm 3 ), pancytopenia, dizziness Two other controlled trials of patients (n=680) with rheumatoid arthritis who received methotrexate 7.5 mg to 15 mg orally once weekly showed the following serious adverse reaction:
• Incidence 1%:
• Interstitial pneumonitis Other less common adverse reactions were:
• anemia, headache, upper respiratory infection, anorexia, arthralgias, chest pain, coughing, dysuria, eye discomfort, epistaxis, fever, infection, sweating, tinnitus, vaginal discharge.
• Polyarticular Juvenile Idiopathic Arthritis (pJIA) The most common adverse reactions reported in patients 2 to 18 years of age with pJIA treated with methotrexate 5 mg/m 2 to 20 mg/m 2 orally once weekly or 0.1 mg/kg to 0.65 mg/kg orally once weekly were as follows:
• elevated liver tests 14%; gastrointestinal reactions (e.g., nausea, vomiting, diarrhea) 11%; stomatitis 2%; leukopenia 2%; headache 1.2%; alopecia 0.5%; dizziness 0.2%; rash 0.2%.
• Most patients received concomitant NSAIDs and some also received corticosteroids.
• Psoriasis In two published series of
• adults with psoriasis (n=204, 248) who received methotrexate up to 25 mg per week for up to 4 years, adverse reaction rates were similar to those in patients with rheumatoid arthritis, except for alopecia, photosensitivity, and “burning of skin lesions” (3% to 10% each).
• Painful plaque erosions have been reported.
• 6.2 Postmarketing Experience The following adverse reactions have been identified during postapproval use of methotrexate.
• Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
• Cardiovascular:
• Thromboembolic events (including arterial thrombosis, cerebral thrombosis, deep vein thrombosis, retinal vein thrombosis, thrombophlebitis, and pulmonary embolus), pericarditis, pericardial effusion, hypotension, sudden death Endocrine:
• Diabetes Eye:
• Optic neuropathy, blurred vision, ocular pain, conjunctivitis, xerophthalmia Gastrointestinal:
• Hemorrhagic enteritis, intestinal perforation, gingivitis, pancreatitis, pharyngitis, hematemesis, melena, gastrointestinal ulceration Hematology:
• Aplastic anemia, lymphadenopathy, hypogammaglobulinemia Hepatobiliary:
• Acute hepatitis, decreased serum albumin, fibrosis, cirrhosis Immune system:
• Anaphylaxis, anaphylactoid reactions, vasculitis Metabolism:
• Hyperglycemia Musculoskeletal:
• Stress fracture, soft tissue and bone necrosis, arthralgia, myalgia, osteoporosis Nervous system:
• Headaches, drowsiness, blurred vision, speech impairment (including dysarthria and aphasia), transient cognitive dysfunction, mood alteration, unusual cranial sensations, paresis, encephalopathy, and convulsions.
• Renal:
• Azotemia, hematuria, proteinuria, cystitis Reproductive:
• Defective oogenesis or spermatogenesis, loss of libido, impotence, gynecomastia, menstrual dysfunction Respiratory:
• Pulmonary fibrosis, respiratory failure, chronic interstitial obstructive pulmonary disease, pleuritic pain and thickening, alveolitis Skin:
• Toxic epidermal necrolysis, Stevens-Johnson syndrome, exfoliative dermatitis, skin necrosis, and erythema multiforme, erythematous rashes, pruritus, alopecia, skin ulceration, accelerated nodulosis, urticaria, pigmentary changes, ecchymosis, telangiectasia, photosensitivity, acne, furunculosis

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

• Advise the patient to read the FDA-approved patient labeling (Patient Information).
• Embryo-Fetal Toxicity Advise females of reproductive potential of the potential risk to a fetus and to inform their healthcare provider of a known or suspected pregnancy [see Contraindications (4), Warnings and Precautions (5.1), Use in Specific Populations (8.1) ].
• Advise females of reproductive potential to use effective contraception during treatment with JYLAMVO and for 6 months after the final dose [see Use in Specific Populations (8.3) ].
• Advise males of reproductive potential to use effective contraception during treatment with JYLAMVO and for at least 3 months after the final dose [see Use in Specific Populations (8.3) ].
• Hypersensitivity Reactions Advise patients and their caregivers of the potential risk of hypersensitivity and that JYLAMVO is contraindicated in patients with a history of hypersensitivity reactions to methotrexate.
• Instruct patients to seek immediate medical attention for signs of a hypersensitivity reaction [see Warnings and Precautions (5.2) ].
• Myelosuppression and Serious Infections Inform patients and their caregivers that JYLAMVO can cause myelosuppression and the need for frequent monitoring of blood cell counts.
• Advise patients and their caregivers to immediately report new onset fever, symptoms of infection, easy bruising or persistent bleeding to their healthcare provider [see Warnings and Precautions (5.3 , 5.11) ].
• Gastrointestinal Toxicity Advise patients and their caregivers to report new or worsening diarrhea, vomiting, or stomatitis to their healthcare provider.
• Advise patients to immediately contact their healthcare provider for high fever, rigors, persistent or severe abdominal pain, severe constipation, hematemesis, or melena [see Warnings and Precautions (5.4) ].
• Hepatotoxicity Advise patients and their caregivers to report signs or symptoms of hepatic toxicity to their healthcare provider [see Warnings and Precautions (5.5) ].
• Pulmonary Toxicity Advise patients and their caregivers to report new or worsening cough, fever, or dyspnea to their healthcare provider [see Warnings and Precautions (5.6) ].
• Dermatologic Reactions Advise patients and their caregivers that JYLAMVO can cause serious skin rash and to immediately contact their healthcare provider for new or worsening skin rash.
• Advise patients and their caregivers to
• avoid excessive sun exposure and use sun protection measures [see Warnings and Precautions (5.7) ].
• Renal Toxicity Advise patients and their caregivers to immediately contact their healthcare provider for signs or symptoms of renal toxicity, such as marked increases or decreases in urinary output [see Warnings and Precautions (5.8) ].
• Risk of Fatal Adverse Reactions with Medication Error For patients who are prescribed a once weekly dosing regimen, advise patients and caregivers that the recommended dosage is to be taken once weekly as a single dose and that mistakenly taking the recommended weekly dosage once daily has led to death [see Warnings and Precautions (5.9) ].
• Importance of Proper Dosage and Administration Before use, instruct patients and caregivers on how to measure and administer the recommended dosage, utilizing the copackaged syringe and bottle adaptor and that a teaspoon is not an appropriate measuring device.
• Advise patients and caregivers to only use the copackaged syringe and that a household spoon is not an accurate measuring device [see Dosage and Administration (2) ].
• Neurotoxicity Advise patients and their caregivers to report new neurological signs or symptoms to their healthcare provider [see Warnings and Precautions (5.12) ].
• Secondary Malignancies Advise patients on the risk of second primary malignancies during treatment with JYLAMVO [see Warnings and Precautions (5.13) ].
• Ineffective Immunization and Risks Associated with Live Vaccines Advise patients to
• avoid receiving vaccines during treatment with JYLAMVO because they may not be effective and live virus vaccines may cause infections [see Warnings and Precautions ( 5.15 ) ] .
• Lactation Instruct women not to breastfeed during treatment with JYLAMVO and for 1 week after the final dose [see Use in Specific Populations (8.2) ].
• Infertility Advise females and males of reproductive potential that methotrexate may impair fertility [see Warnings and Precautions (5.16), Use in Specific Populations (8.3) ].
• Drug Interactions Advise patients and caregivers to inform their healthcare provider of all concomitant medications, including prescription medicines, over-the-counter drugs, vitamins, and herbal products [see Drug Interactions (7) ].
• Proper Storage and Disposal Advise patients to store JYLAMVO at room temperature (20°C to 25°C/ 68°F to 77°F).
• Once the bottle has been opened, any remaining medication must be disposed of after 90 days.
• Inform patients and caregivers of the need for proper disposal of the medication, bottle, and syringe [see References (15) ].
• This medicine should not be disposed of in wastewater or household waste.

Quoted from the official label, section “Patient Counseling Information”.

Strengths and forms

• FORMS AND STRENGTHS Oral solution:
• clear yellow solution containing methotrexate 2 mg/mL. Oral solution:
• 2 mg/mL ( 3 )

Quoted from the official label, section “Dosage Forms & Strengths”.

What it looks like and how it is packed

• JYLAMVO is supplied as a clear yellow oral solution that contains 2 mg of methotrexate per mL.
• It is packaged in an amber type III glass bottle with tamper evident child-resistant closure (polypropylene with expanded polyethylene liner) containing 60 mL of oral solution.
• Each pack contains one bottle, a low-density polyethylene (LDPE) bottle adaptor and a 10 mL white polypropylene dosing syringe (with major graduations at every 1 mL and minor graduations at every 0.25 mL) (NDC 81927-204-01).
• Store JYLAMVO at 20°C to 25°C (68°F to 77°F) excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
• In Use storage conditions: Store JYLAMVO 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 3 months.
• JYLAMVO is a hazardous drug.
• Follow applicable special handling and disposal procedures. 1

Quoted from the official label, section “How Supplied”.

What is in it

• Methotrexate is a folate analog metabolic inhibitor with the chemical name of N-[4-[[(2,4 diamino-6-pteridinyl) methyl]methylamino]benzoyl]-L glutamic acid.
• The molecular formula is C 20 H 22 N 8 O 5 and the molecular weight is 454.4 g/mol.
• The structural formula is:
• JYLAMVO (methotrexate) oral solution is a clear yellow solution that contains methotrexate, 2 mg/mL.
• Inactive ingredients include citric acid, ethylparaben, glycerin, methylparaben sodium, orange flavoring powder, polyethylene glycol, purified water, sodium citrate and sucralose.
• The target pH of the oral solution is 6.8.
• Structural Formula

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

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Details

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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