RASUVO Rx

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RASUVO

Arthritis/rheumatic disorders
Psoriasis
Only 4 drugs may be compared at once

Generic Name and Formulations:

Methotrexate 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, 27.5mg/0.55mL, 30mg/0.60mL; soln for SC inj; preservative-free.

Select therapeutic use:

Indications for RASUVO:

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.

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.

Contraindications:

Alcoholism. Chronic liver disease. Immunodeficiency syndromes. Preexisting blood dyscrasias. Pregnancy (Cat.X). Nursing mothers.

Warnings/Precautions:

Be fully experienced in the use of antimetabolite therapy. Discontinue if malignant lymphomas occur. Risk of severe toxic reactions. 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. Rule out pregnancy in women of childbearing potential; use effective contraception during therapy and for at least 1 ovulatory cycle afterwards for women and for at least 3 months afterwards for men. 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.

Interactions:

Avoid live virus vaccines. 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.

Pharmacological Class:

Folic acid antagonist.

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.

How Supplied:

Single-dose auto-injector—1, 4

RASUVO 4 auto-injectors of 25mg packages (Qty:1)

appx. price $489.00

Indications for RASUVO:

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.

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.

Contraindications:

Alcoholism. Chronic liver disease. Immunodeficiency syndromes. Preexisting blood dyscrasias. Pregnancy (Cat.X). Nursing mothers.

Warnings/Precautions:

Be fully experienced in the use of antimetabolite therapy. Discontinue if malignant lymphomas occur. Risk of severe toxic reactions. 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. Rule out pregnancy in women of childbearing potential; use effective contraception during therapy and for at least 1 ovulatory cycle afterwards for women and for at least 3 months afterwards for men. 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.

Interactions:

Avoid live virus vaccines. 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.

Pharmacological Class:

Folic acid antagonist.

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.

How Supplied:

Single-dose auto-injector—1, 4

RASUVO 4 auto-injectors of 25mg packages (Qty:1)

appx. price $489.00