Jylamvo

— THERAPEUTIC CATEGORIES —
  • Arthritis/rheumatic disorders
  • Leukemias, lymphomas, and other hematologic cancers
  • Psoriasis

Jylamvo Generic Name & Formulations

General Description

Methotrexate sodium 2mg/mL; oral soln.

Pharmacological Class

Folic acid antagonist.

How Supplied

Oral Soln—460mL (w. adapter & dosing syringe)

Manufacturer

Mechanism of Action

The mechanism of action in rheumatoid arthritis is unknown.

Jylamvo Indications

Indications

Treatment of adults with rheumatoid arthritis (RA).

Jylamvo Dosage and Administration

Adult

Initially 7.5mg as a single dose once weekly; max 20mg/week. Give with folic or folinic acid to reduce adverse reactions.

Children

Not established.

Jylamvo Contraindications

Contraindications

Pregnancy in patients with non-neoplastic diseases.

Jylamvo Boxed Warnings

Boxed Warning

Embryo-fetal toxicity. Hypersensitivity reactions. Severe adverse reactions.

Jylamvo Warnings/Precautions

Warnings/Precautions

Be fully familiar with this drug's toxicity before use. Obtain baseline and periodically monitor CBCs with differential, platelet counts, chest X-ray, and hepatic, renal and pulmonary function. Permanently discontinue if anaphylaxis or other severe hypersensitivity, or severe dermatologic reactions occur. Discontinue if lymphoproliferative disease occurs. Withhold, reduce dose, or discontinue if myelosuppression occurs. Withhold or discontinue if severe gastrointestinal toxicity, pulmonary toxicity, severe renal toxicity, or neurotoxicity occur. Peptic ulcer disease. Ulcerative colitis. Increased risk for hepatotoxicity with alcoholism or receiving total cumulative dose (≥1.5g); withhold or discontinue if occurs. Increased risk for serious infections (eg, bacterial, fungal, viral) including opportunistic infections; monitor during and after treatment; withhold or discontinue if occur. Folate deficiency. Ascites, pleural effusions: evacuate fluid, monitor for toxicity and reduce dose or discontinue if needed. Hepatic or renal impairment: monitor closely and reduce dose or discontinue as appropriate. Update immunizations according to current guidelines prior to initiation. Elderly. Embryo-fetal toxicity. Advise to use effective contraception during and for 6 months (females of reproductive potential) or 3 months (males w. female partners) after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 1 week after the last dose).

Jylamvo Pharmacokinetics

Absorption

Mean bioavailability: ~60%. Peak plasma concentrations are reached within 0.75 to 6 hours. 

Distribution

Approximately 50% protein bound. 

Metabolism

Hepatic and intracellular metabolism.

Elimination

Renal. Half-life: 3–10 hours.

Jylamvo Interactions

Interactions

Avoid concomitant live virus vaccines, nitrous oxide. Avoid concomitant hepatotoxic or nephrotoxic drugs (eg, oral antibiotics [neomycin], oral or IV penicillin, sulfonamide antibiotics), antifolate drugs [eg, dapsone, premetrexed, pyrimethamine, sulfonamides], aspirin and other NSAIDs, highly protein-bound drugs [eg, oral anticoagulants, phenytoin, salicylates, sulfonamides, sulfonylureas, tetracyclines], probenecid, PPIs, weak acids); if unavoidable, monitor closely for toxicitiy. Increased risk of leukoencephalopathy with prior cranial radiotherapy. May be antagonized by folic acid.

Jylamvo Adverse Reactions

Adverse Reactions

Ulcerative stomatitis, leukopenia, nausea, abdominal distress, elevated liver function tests, malaise, fatigue, chills, fever, dizziness; myelosuppression, infections, renal toxicity, GI toxicity, hepatotoxicity, pulmonary toxicity, dermatologic reactions, secondary malignancies, tumor lysis syndrome, infertility.

Jylamvo Clinical Trials

See Literature

Jylamvo Note

Not Applicable

Jylamvo Patient Counseling

See Literature

Jylamvo Generic Name & Formulations

General Description

Methotrexate sodium 2mg/mL; oral soln.

Pharmacological Class

Folic acid antagonist.

How Supplied

Oral Soln—460mL (w. adapter & dosing syringe)

Manufacturer

Mechanism of Action

Methotrexate inhibits dihydrofolic acid reductase. Dihydrofolates must be reduced to tetrahydrofolates by this enzyme before they can be utilized as carriers of one-carbon groups in the synthesis of purine nucleotides and thymidylate. Therefore, methotrexate interferes with DNA synthesis, repair, and cellular replication. Actively proliferating tissues such as malignant cells, bone marrow, fetal cells, buccal and intestinal mucosa, and cells of the urinary bladder are in general more sensitive to this effect of methotrexate.

Jylamvo Indications

Indications

Treatment of adults with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen. Treatment of adults with mycosis fungoides (cutaneous T-cell lymphoma) as a single agent or as part of a combination chemotherapy regimen. Treatment of adults with relapsed or refractory non-Hodgkin lymphomas (NHL) as part of a metronomic combination chemotherapy regimen.

Jylamvo Dosage and Administration

Adult

ALL: initially 20mg/m2 once weekly; adjust subsequent dosing based on ANC and platelet count. Mycosis fungoides (as single agent): 25–75mg once weekly; (as part of combination regimen): 10mg/m2 twice weekly. Relapsed/refractory NHL: 2.5mg 2–4 times weekly; max 10mg/week.

Children

Not established.

Jylamvo Contraindications

Contraindications

Pregnancy in patients with non-neoplastic diseases.

Jylamvo Boxed Warnings

Boxed Warning

Embryo-fetal toxicity. Hypersensitivity reactions. Severe adverse reactions.

Jylamvo Warnings/Precautions

Warnings/Precautions

Be fully familiar with this drug's toxicity before use. Obtain baseline and periodically monitor CBCs with differential, platelet counts, chest X-ray, and hepatic, renal and pulmonary function. Permanently discontinue if anaphylaxis or other severe hypersensitivity, or severe dermatologic reactions occur. Discontinue if lymphoproliferative disease occurs. Withhold, reduce dose, or discontinue if myelosuppression occurs. Withhold or discontinue if severe gastrointestinal toxicity, pulmonary toxicity, severe renal toxicity, or neurotoxicity occur. Peptic ulcer disease. Ulcerative colitis. Increased risk for hepatotoxicity with alcoholism or receiving total cumulative dose (≥1.5g); withhold or discontinue if occurs. Increased risk for serious infections (eg, bacterial, fungal, viral) including opportunistic infections; monitor during and after treatment; withhold or discontinue if occur. Folate deficiency. Ascites, pleural effusions: evacuate fluid, monitor for toxicity and reduce dose or discontinue if needed. Hepatic or renal impairment: monitor closely and reduce dose or discontinue as appropriate. Update immunizations according to current guidelines prior to initiation. Elderly. Embryo-fetal toxicity. Advise to use effective contraception during and for 6 months (females of reproductive potential) or 3 months (males w. female partners) after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 1 week after the last dose).

Jylamvo Pharmacokinetics

Absorption

Mean bioavailability: ~60%. Peak plasma concentrations are reached within 0.75 to 6 hours. 

Distribution

Approximately 50% protein bound. 

Metabolism

Hepatic and intracellular metabolism.

Elimination

Renal. Half-life: 3–10 hours.

Jylamvo Interactions

Interactions

Avoid concomitant live virus vaccines, nitrous oxide. Avoid concomitant hepatotoxic or nephrotoxic drugs (eg, oral antibiotics [neomycin], oral or IV penicillin, sulfonamide antibiotics), antifolate drugs [eg, dapsone, premetrexed, pyrimethamine, sulfonamides], aspirin and other NSAIDs, highly protein-bound drugs [eg, oral anticoagulants, phenytoin, salicylates, sulfonamides, sulfonylureas, tetracyclines], probenecid, PPIs, weak acids); if unavoidable, monitor closely for toxicitiy. Increased risk of leukoencephalopathy with prior cranial radiotherapy. May be antagonized by folic acid.

Jylamvo Adverse Reactions

Adverse Reactions

Ulcerative stomatitis, leukopenia, nausea, abdominal distress, elevated liver function tests, malaise, fatigue, chills, fever, dizziness; myelosuppression, infections, renal toxicity, GI toxicity, hepatotoxicity, pulmonary toxicity, dermatologic reactions, secondary malignancies, tumor lysis syndrome, infertility.

Jylamvo Clinical Trials

See Literature

Jylamvo Note

Not Applicable

Jylamvo Patient Counseling

See Literature

Jylamvo Generic Name & Formulations

General Description

Methotrexate sodium 2mg/mL; oral soln.

Pharmacological Class

Folic acid antagonist.

How Supplied

Oral Soln—460mL (w. adapter & dosing syringe)

Manufacturer

Mechanism of Action

The mechanism of action in psoriasis is unknown.

Jylamvo Indications

Indications

Treatment of adults with severe psoriasis.

Jylamvo Dosage and Administration

Adult

Initially 10–25mg once weekly until adequate response; adjust gradually to achieve optimal response; max 30mg/week. Give with folic or folinic acid to reduce adverse reactions.

Children

Not established.

Jylamvo Contraindications

Contraindications

Pregnancy in patients with non-neoplastic diseases.

Jylamvo Boxed Warnings

Boxed Warning

Embryo-fetal toxicity. Hypersensitivity reactions. Severe adverse reactions.

Jylamvo Warnings/Precautions

Warnings/Precautions

Be fully familiar with this drug's toxicity before use. Obtain baseline and periodically monitor CBCs with differential, platelet counts, chest X-ray, and hepatic, renal and pulmonary function. Permanently discontinue if anaphylaxis or other severe hypersensitivity, or severe dermatologic reactions occur. Discontinue if lymphoproliferative disease occurs. Withhold, reduce dose, or discontinue if myelosuppression occurs. Withhold or discontinue if severe gastrointestinal toxicity, pulmonary toxicity, severe renal toxicity, or neurotoxicity occur. Peptic ulcer disease. Ulcerative colitis. Increased risk for hepatotoxicity with alcoholism or receiving total cumulative dose (≥1.5g); withhold or discontinue if occurs. Increased risk for serious infections (eg, bacterial, fungal, viral) including opportunistic infections; monitor during and after treatment; withhold or discontinue if occur. Folate deficiency. Ascites, pleural effusions: evacuate fluid, monitor for toxicity and reduce dose or discontinue if needed. Hepatic or renal impairment: monitor closely and reduce dose or discontinue as appropriate. Update immunizations according to current guidelines prior to initiation. Elderly. Embryo-fetal toxicity. Advise to use effective contraception during and for 6 months (females of reproductive potential) or 3 months (males w. female partners) after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 1 week after the last dose).

Jylamvo Pharmacokinetics

Absorption

Mean bioavailability: ~60%. Peak plasma concentrations are reached within 0.75 to 6 hours. 

Distribution

Approximately 50% protein bound. 

Metabolism

Hepatic and intracellular metabolism.

Elimination

Renal. Half-life: 3–10 hours.

Jylamvo Interactions

Interactions

Avoid concomitant live virus vaccines, nitrous oxide. Avoid concomitant hepatotoxic or nephrotoxic drugs (eg, oral antibiotics [neomycin], oral or IV penicillin, sulfonamide antibiotics), antifolate drugs [eg, dapsone, premetrexed, pyrimethamine, sulfonamides], aspirin and other NSAIDs, highly protein-bound drugs [eg, oral anticoagulants, phenytoin, salicylates, sulfonamides, sulfonylureas, tetracyclines], probenecid, PPIs, weak acids); if unavoidable, monitor closely for toxicitiy. Increased risk of leukoencephalopathy with prior cranial radiotherapy. May be antagonized by folic acid.

Jylamvo Adverse Reactions

Adverse Reactions

Ulcerative stomatitis, leukopenia, nausea, abdominal distress, elevated liver function tests, malaise, fatigue, chills, fever, dizziness; myelosuppression, infections, renal toxicity, GI toxicity, hepatotoxicity, pulmonary toxicity, dermatologic reactions, secondary malignancies, tumor lysis syndrome, infertility.

Jylamvo Clinical Trials

See Literature

Jylamvo Note

Not Applicable

Jylamvo Patient Counseling

See Literature