Jylamvo Dosage

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, dose, and administer the recommended dosage 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 cytotoxic drug. Follow applicable special handling and disposal procedures1.

Recommended Dosage for Neoplastic Diseases

Acute Lymphoblastic Leukemia

The recommended starting dosage of JYLAMVO is 20 mg/m2 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 to 75 mg orally once weekly when administered as a single agent or 10 mg/m2 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.

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)].

Recommended Dosage for Psoriasis

The recommended dosage of JYLAMVO is 10 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)].

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)]