Rasuvo

— THERAPEUTIC CATEGORIES —
  • Arthritis/rheumatic disorders
  • Psoriasis

Rasuvo Generic Name & Formulations

General Description

Methotrexate (MTX) 7.5mg/0.15mL, 10mg/0.20mL, 12.5mg/0.25mL, 15mg/0.30mL, 17.5mg/0.35mL, 20mg/0.40mL, 22.5mg/0.45mL, 25mg/0.50mL, 30mg/0.60mL; soln for SC inj; preservative-free.

Pharmacological Class

Folic acid antagonist.

How Supplied

Single-dose auto-injector—1, 4

Manufacturer

Rasuvo Indications

Indications

Management of adults with severe, active rheumatoid arthritis (RA) or children with active polyarticular juvenile idiopathic arthritis (pJIA), who are intolerant of or had an inadequate response to first-line therapy.

Limitations of Use

Not for treating neoplastic diseases.

Rasuvo Dosage and Administration

Adult

Administer by SC inj in abdomen or thigh. Initially 7.5mg once weekly using oral or SC formulation. Switching from oral to Rasuvo SC inj: consider differences in bioavailability. Adjust dose gradually. Use alternative MTX form in patients requiring oral, IM, IV, intra-arterial, or intrathecal dosing, doses <7.5mg/week or >30mg/week, high-dose regimens, or dose adjustments <2.5mg increments.

Children

<2yrs: not established. Administer by SC inj in abdomen or thigh. 2–16yrs: Initially 10mg/m2 once weekly. Switching from oral to Rasuvo SC inj: consider differences in bioavailability. Adjust dose gradually. Use alternative MTX form in patients requiring oral, IM, IV, intra-arterial, or intrathecal dosing, doses <7.5mg/week or >30mg/week, high-dose regimens, or dose adjustments <2.5mg increments.

Rasuvo Contraindications

Contraindications

Alcoholism. Chronic liver disease. Immunodeficiency syndromes. Preexisting blood dyscrasias. Pregnancy.

Rasuvo Boxed Warnings

Boxed Warning

Severe toxic reactions, including embryo-fetal toxicity and death.

Rasuvo Warnings/Precautions

Warnings/Precautions

Be fully experienced in the use of antimetabolite therapy. Increased risk of severe toxic reactions. Discontinue if malignant lymphomas occur. Obtain baseline and monitor CBCs with differential, platelet counts, chest X-ray, and hepatic, renal and pulmonary function. During therapy monitor hematology monthly, renal and hepatic function, every 1–2 months, more often if increasing dose or predisposed to toxicity (eg, dehydration). Discontinue immediately if blood counts drop significantly. Obtain liver biopsy prior to treatment if history of alcoholism, persistently abnormal LFTs, or chronic HBV/HCV infection; discontinue if persistently abnormal LFTs develop or liver biopsy shows moderate to severe changes. Interrupt therapy if vomiting, diarrhea, ulcerative stomatitis, or pulmonary symptoms occur. Peptic ulcer. Ulcerative colitis. Active infection. Renal impairment, ascites, or pleural effusions; monitor for toxicity and reduce dose or discontinue if needed. Obesity, diabetes, hepatic fibrosis, steatohepatitis; increased risk for hepatic injury. Maintain adequate hydration. Folate deficiency. Elderly. Debilitated. Embryo-fetal toxicity. Exclude pregnancy in females of reproductive potential prior to initiation. Advise use of effective contraception during and for 6 months (females) and for ≥3 months (males w. female partners) after the last dose. Nursing mothers: not recommended (during and for 1 week after the last dose).

Rasuvo Pharmacokinetics

See Literature

Rasuvo Interactions

Interactions

Avoid concomitant live virus vaccines, nitrous oxide. Toxicity increased by NSAIDs, salicylates, PPIs (eg, omeprazole, esomeprazole, pantoprazole), phenylbutazone, phenytoin, sulfonamides, probenecid, folic acid antagonists, penicillins (monitor). May be antagonized by oral antibiotics (eg, tetracycline, chloramphenicol, non-absorbable broad spectrum antibiotics). Increased hepatotoxicity with concomitant other hepatotoxins (eg, azathioprine, retinoids, sulfasalazine); monitor. May potentiate theophylline, mercaptopurine; monitor. Increased risk of soft tissue necrosis and osteonecrosis with radiotherapy.

Rasuvo Adverse Reactions

Adverse Reactions

Nausea, abdominal pain, dyspepsia, stomatitis/mouth sores, rash, nasopharyngitis, diarrhea, liver function test abnormalities, vomiting, headache, bronchitis, thrombocytopenia, alopecia, leukopenia, pancytopenia, dizziness, photosensitivity, “burning of skin lesions”; myelosuppression, hepatotoxicity, renal toxicity, CNS toxicity, tumor lysis syndrome, interstitial pneumonitis, fatal skin reactions, opportunistic infections, effects on reproduction.

Rasuvo Clinical Trials

See Literature

Rasuvo Note

Not Applicable

Rasuvo Patient Counseling

See Literature

Rasuvo Generic Name & Formulations

General Description

Methotrexate (MTX) 7.5mg/0.15mL, 10mg/0.20mL, 12.5mg/0.25mL, 15mg/0.30mL, 17.5mg/0.35mL, 20mg/0.40mL, 22.5mg/0.45mL, 25mg/0.50mL, 30mg/0.60mL; soln for SC inj; preservative-free.

Pharmacological Class

Folic acid antagonist.

How Supplied

Single-dose auto-injector—1, 4

Manufacturer

Rasuvo Indications

Indications

Symptomatic control of severe, recalcitrant, disabling psoriasis in adults who are not adequately responsive to other forms of therapy.

Limitations of Use

Not for treating neoplastic diseases.

Rasuvo Dosage and Administration

Adult

Administer by SC inj in abdomen or thigh. 10–25mg once weekly using an oral, IM, SC, or IV formulation; max 30mg/week. Switching from oral to Rasuvo SC inj: consider differences in bioavailability. Adjust dose gradually. Use alternative MTX form in patients requiring oral, IM, IV, intra-arterial, or intrathecal dosing, doses <7.5mg/week or >30mg/week, high-dose regimens, or dose adjustments <2.5mg increments.

Children

Not established.

Rasuvo Contraindications

Contraindications

Alcoholism. Chronic liver disease. Immunodeficiency syndromes. Preexisting blood dyscrasias. Pregnancy.

Rasuvo Boxed Warnings

Boxed Warning

Severe toxic reactions, including embryo-fetal toxicity and death.

Rasuvo Warnings/Precautions

Warnings/Precautions

Be fully experienced in the use of antimetabolite therapy. Increased risk of severe toxic reactions. Discontinue if malignant lymphomas occur. Obtain baseline and monitor CBCs with differential, platelet counts, chest X-ray, and hepatic, renal and pulmonary function. During therapy monitor hematology monthly, renal and hepatic function, every 1–2 months, more often if increasing dose or predisposed to toxicity (eg, dehydration). Discontinue immediately if blood counts drop significantly. Obtain liver biopsy prior to treatment if history of alcoholism, persistently abnormal LFTs, or chronic HBV/HCV infection; discontinue if persistently abnormal LFTs develop or liver biopsy shows moderate to severe changes. Interrupt therapy if vomiting, diarrhea, ulcerative stomatitis, or pulmonary symptoms occur. Peptic ulcer. Ulcerative colitis. Active infection. Renal impairment, ascites, or pleural effusions; monitor for toxicity and reduce dose or discontinue if needed. Obesity, diabetes, hepatic fibrosis, steatohepatitis; increased risk for hepatic injury. Maintain adequate hydration. Folate deficiency. Elderly. Debilitated. Embryo-fetal toxicity. Exclude pregnancy in females of reproductive potential prior to initiation. Advise use of effective contraception during and for 6 months (females) and for ≥3 months (males w. female partners) after the last dose. Nursing mothers: not recommended (during and for 1 week after the last dose).

Rasuvo Pharmacokinetics

See Literature

Rasuvo Interactions

Interactions

Avoid concomitant live virus vaccines, nitrous oxide. Toxicity increased by NSAIDs, salicylates, PPIs (eg, omeprazole, esomeprazole, pantoprazole), phenylbutazone, phenytoin, sulfonamides, probenecid, folic acid antagonists, penicillins (monitor). May be antagonized by oral antibiotics (eg, tetracycline, chloramphenicol, non-absorbable broad spectrum antibiotics). Increased hepatotoxicity with concomitant other hepatotoxins (eg, azathioprine, retinoids, sulfasalazine); monitor. May potentiate theophylline, mercaptopurine; monitor. Increased risk of soft tissue necrosis and osteonecrosis with radiotherapy.

Rasuvo Adverse Reactions

Adverse Reactions

Nausea, abdominal pain, dyspepsia, stomatitis/mouth sores, rash, nasopharyngitis, diarrhea, liver function test abnormalities, vomiting, headache, bronchitis, thrombocytopenia, alopecia, leukopenia, pancytopenia, dizziness, photosensitivity, “burning of skin lesions”; myelosuppression, hepatotoxicity, renal toxicity, CNS toxicity, tumor lysis syndrome, interstitial pneumonitis, fatal skin reactions, opportunistic infections, effects on reproduction.

Rasuvo Clinical Trials

See Literature

Rasuvo Note

Not Applicable

Rasuvo Patient Counseling

See Literature