all of sudden [3000/mm:<100,000/mm 3 ) in 6 patients, and pancytopenia in 2 patients. In psoriasis and rheumatoid arthritis, methotrexate should be stopped immediately if there is a significant drop in blood counts. In the treatment of neoplastic diseases, methotrexate should be continued only if the potential benefit warrants the risk of severe myelosuppression. Patients with profound granulocytopenia and fever should be evaluated immediately and usually require parenteral broad-spectrum antibiotic therapy. Hepatic : Methotrexate has the potential for acute (elevated transaminases) and chronic (fibrosis and cirrhosis) hepatotoxicity. Chronic toxicity is potentially fatal; it generally has occurred after prolonged use (generally two years or more) and after a total dose of at least 1.5 grams. In studies in psoriatic patients, hepatotoxicity appeared to be a function of total cumulative dose and appeared to be enhanced by alcoholism, obesity, diabetes and advanced age. An accurate incidence rate has not been determined; the rate of progression and reversibility of lesions is not known. Special caution is indicated in the presence of preexisting liver damage or impaired hepatic function. In psoriasis, liver function tests, including serum albumin, should be performed periodically prior to dosing but are often normal in the face of developing fibrosis or cirrhosis. These lesions may be detectable only by biopsy. The usual recommendation is to obtain a liver biopsy at 1) pretherapy or shortly after initiation of therapy (2 - 4 months), 2) a total cumulative dose of 1.5 grams, and 3) after each additional 1.0 to 1.5 grams. Moderate fibrosis or any cirrhosis normally leads to discontinuation of the drug; mild fibrosis normally suggests a repeat biopsy in 6 months. Milder histologic findings such as fatty change and low grade portal inflammation are relatively common pretherapy. Although these mild changes are usually not a reason to avoid or discontinue methotrexate therapy, the drug should be used with caution. In rheumatoid arthritis, age at first use of methotrexate and duration of therapy have been reported as risk factors for hepatotoxicity; other risk factors, similar to those observed in psoriasis, may be present in rheumatoid arthritis but have not been confirmed to date. Persistent abnormalities in liver function tests may precede appearance of fibrosis or cirrhosis in this population. There is a combined reported experience in 217 rheumatoid arthritis patients with liver biopsies both before and during treatment (after a cumulative dose of at least 1.5 g) and in 714 patients with a biopsy only during treatment. There are 64 (7%) cases of fibrosis and 1 (0.1%) case of cirrhosis. Of the 64 cases of fibrosis, 60 were deemed mild. The reticulin stain is more sensitive for early fibrosis and its use may increase these figures. It is unknown whether even longer use will increase these risks. Liver function tests should be performed at baseline and at 4-8 week intervals in patients receiving methotrexate for rheumatoid arthritis. Pretreatment liver biopsy should be performed for patients with a history of excessive alcohol consumption, persistently abnormal baseline liver function test values or chronic hepatitis B or C infection. During therapy, liver biopsy should be performed if there are persistent liver function test abnormalities or there is a decrease in serum albumin below the normal range (in the setting of well controlled rheumatoid arthritis). If the results of a liver biopsy show mild changes (Roenigk grades I, II, IIIa), methotrexate may be continued and the patient monitored as per recommendations listed above. Methotrexate should be discontinued in any patient who displays persistently abnormal liver function tests and refuses liver biopsy or in any patient whose liver biopsy shows moderate to severe changes (Roenigk grade IIIb or IV). Infection or Immunologic States : Methotrexate should be used with extreme caution in the presence of active infection, and is usually contraindicated in patients with overt or laboratory evidence of immunodeficiency syndromes. Immunization may be ineffective when given during methotrexate therapy. Immunization with live virus vaccines is generally not recommended. There have been reports of disseminated vaccinia infections after smallpox immunization in patients receiving methotrexate therapy. Hypogammaglobulinemia has been reported rarely. Potentially fatal opportunistic infections, especially Pneumocystis carinii pneumonia, may occur with methotrexate therapy. When a patient presents with pulmonary symptoms, the possibility of Pneumocystis carinii pneumonia should be considered. Pulmonary : Pulmonary symptoms (especially a dry nonproductive cough) or a nonspecific pneumonitis occurring during methotrexate therapy may be indicative of a potentially dangerous lesion and require interruption of treatment and careful investigation. Although clinically variable, the typical patient with methotrexate induced lung disease presents with fever, cough, dyspnea, hypoxemia, and an infiltrate on chest X-ray; infection (including pneumonia) needs to be excluded. This lesion can occur at all dosages. Renal : Methotrexate may cause renal damage that may lead to acute renal failure. Nephrotoxicity is due primarily to the precipitation of methotrexate and 7-hydroxymethotrexate in the renal tubules. Close attention to renal function including adequate hydration, urine alkalinization and measurement of serum methotrexate and creatinine levels are essential for safe administration. Skin : Severe, occasionally fatal, dermatologic reactions, including toxic epidermal necrolysis, Stevens-Johnson syndrome, exfoliative dermatitis, skin necrosis, and erythema multiforme, have been reported in children and adults, within days of oral, intramuscular, intravenous, or intrathecal methotrexate administration. Reactions were noted after single or multiple, low, intermediate or high doses of methotrexate in patients with neoplastic and non-neoplastic diseases. Other Precautions : Methotrexate should be used with extreme caution in the presence of debility. Methotrexate exits slowly from third space compartments (eg, pleural effusions or ascites). This results in a prolonged terminal plasma half-life and unexpected toxicity. In patients with significant third space accumulations, it is advisable to evacuate the fluid before treatment and to monitor plasma methotrexate levels. Lesions of psoriasis may be aggravated by concomitant exposure to ultraviolet radiation. Radiation dermatitis and sunburn may be recalled by the use of methotrexate. Adverse Reactions IN GENERAL, THE INCIDENCE AND SEVERITY OF ACUTE SIDE EFFECTS ARE RELATED TO DOSE AND FREQUENCY OF ADMINISTRATION. THE MOST SERIOUS REACTIONS ARE DISCUSSED ABOVE UNDER ORGAN SYSTEM TOXICITY IN THE PRECAUTION SECTION. THAT SECTION SHOULD ALSO BE CONSULTED WHEN LOOKING FOR INFORMATION ABOUT ADVERSE REACTIONS WITH METHOTREXATE. The most frequently reported adverse reactions include ulcerative stomatitis, leukopenia, nausea, and abdominal distress. Other frequently reported adverse effects are malaise, undue fatigue, chills and fever, dizziness and decreased resistance to infection. Other adverse reactions that have been reported with methotrexate are listed below by organ system. In the oncology setting, concomitant treatment and the underlying disease make specific attribution of a reaction to methotrexate difficult. Alimentary System : gingivitis, pharyngitis, stomatitis, anorexia, nausea, vomiting, diarrhea, hematemesis, melena, gastrointestinal ulceration and bleeding, enteritis, pancreatitis. Blood and Lymphatic System Disorders : suppressed hematopoiesis causing anemia, aplastic anemia, pancytopenia, leukopenia, neutropenia and/or thrombocytopenia, lymphadenopathy and lymphoproliferative disorders (including reversible). Hypogammaglobulinemia has been reported rarely. Cardiovascular : pericarditis, pericardial effusion, hypotension, and thromboembolic events (including arterial thrombosis, cerebral thrombosis, deep vein thrombosis, retinal vein thrombosis, thrombophlebitis, and pulmonary embolus). Central Nervous System : headaches, drowsiness, blurred vision, transient blindness, speech impairment including dysarthria and aphasia, hemiparesis, paresis and convulsions have also occurred following administration of methotrexate. Following low doses, there have been occasional reports of transient subtle cognitive dysfunction, mood alteration, unusual cranial sensations, leukoencephalopathy, or encephalopathy. Hepatobiliary : disorders, hepatotoxicity, acute hepatitis, chronic fibrosis and cirrhosis, decrease in serum albumin, liver enzyme elevations. Infection : There have been case reports of sometimes fatal opportunistic infections in patients receiving methotrexate therapy for neoplastic and non-neoplastic diseases. Pneumocystis carinii pneumonia was the most common opportunistic infection. There have also been reports of infections, pneumonia, sepsis, nocardiosis, histoplasmosis, cryptococcosis, herpes zoster, H. simplex hepatitis, and disseminated H. simplex. Musculoskeletal System : stress fracture. Ophthalmic : conjunctivitis, serious visual changes of unknown etiology. Pulmonary System : respiratory fibrosis, respiratory failure, interstitial pneumonitis; deaths have been reported, and chronic interstitial obstructive pulmonary disease has occasionally occurred. Skin : erythematous rashes, pruritus, urticaria, photosensitivity, pigmentary changes, alopecia, ecchymosis, telangiectasia, acne, furunculosis, erythema multiforme, toxic epidermal necrolysis, Stevens-Johnson Syndrome, skin necrosis, skin ulceration, and exfoliative dermatitis. Urogenital System : severe nephropathy or renal failure, azotemia, cystitis, hematuria; defective oogenesis or spermatogenesis, transient oligospermia, menstrual dysfunction, vaginal discharge, and gynecomastia; infertility, abortion, fetal defects. Other rarer reactions related to or attributed to the use of methotrexate such as nodulosis, vasculitis, arthralgia/myalgia, loss of libido/impotence, diabetes, osteoporosis, sudden death, reversible lymphomas, tumor lysis syndrome, soft tissue necrosis and osteonecrosis. Anaphylactoid reactions have been reported. Adverse Reactions in Double-Blind Rheumatoid Arthritis Studies The approximate incidences of methotrexate attributed (ie, placebo rate subtracted) adverse reactions in 12 to 18 week double-blind studies of patients (n=128) with rheumatoid arthritis treated with low-dose oral (7.5 to 15 mg/week) pulse methotrexate, are listed below. Virtually all of these patients were on concomitant nonsteroidal anti-inflammatory drugs and some were also taking low dosages of corticosteroids. Hepatic histology was not examined in these short-term studies. (See PRECAUTIONS .) Incidence greater than 10%: Elevated liver function tests 15%, nausea/vomiting 10%. Incidence 3% to 10%: Stomatitis, thrombocytopenia, (platelet count less than 100,000/mm 3 ). Incidence 1% to 3%: Rash/pruritus/dermatitis, diarrhea, alopecia, leukopenia (WBC less than 3000/mm 3 ), pancytopenia, dizziness. Two other controlled trials of patients (n=680) with Rheumatoid Arthritis on 7.5 mg 15 mg/wk oral doses showed an incidence of interstitial pneumonitis of 1%. (See PRECAUTIONS .) Other less common reactions included decreased hematocrit, headache, upper respiratory infection, anorexia, arthralgias, chest pain, coughing, dysuria, eye discomfort, epistaxis, fever, infection, sweating, tinnitus, and vaginal discharge. Adverse Reactions in Psoriasis There are no recent placebo-controlled trials in patients with psoriasis. There are two literature reports (Roenigk, 1969 and Nyfors, 1978) describing large series (n=204, 248) of psoriasis patients treated with methotrexate. Dosages ranged up to 25 mg per week and treatment was administered for up to four years. With the exception of alopecia, photosensitivity, and burning of skin lesions (each 3% to 10%), the adverse reaction rates in these reports were very similar to those in the rheumatoid arthritis studies. Rarely, painful plaque erosions may appear. Adverse Reactions in JRA Studies The approximate incidences of adverse reactions reported in pediatric patients with JRA treated with oral, weekly doses of methotrexate (5 to 20 mg/m 2 /wk or 0.1 to 0.65 mg/kg/wk) were as follows (virtually all patients were receiving concomitant nonsteroidal anti-inflammatory drugs, and some also were taking low doses of cortico-steroids): elevated liver function tests, 14%; gastrointestinal reactions (eg, nausea, vomiting, diarrhea), 11%; stomatitis, 2%; leukopenia, 2%; headache, 1.2%; alopecia, 0.5%; dizziness, 0.2%; and rash, 0.2%. Although there is experience with dosing up to 30 mg/m 2 /wk in JRA, the published data for doses above 20 mg/m 2 /wk are too limited to provide reliable estimates of adverse reaction rates. Overdosage Leucovorin is indicated to diminish the toxicity and counteract the effect of inadvertently administered overdosages of methotrexate. Leucovorin administration should begin as promptly as possible. As the time interval between methotrexate administration and leucovorin initiation increases, the effectiveness of leucovorin in counteracting toxicity decreases. Monitoring of the serum methotrexate concentration is essential in determining the optimal dose and duration of treatment with leucovorin. In cases of massive overdosage, hydration and urinary alkalinization may be necessary to prevent the precipitation of methotrexate and/or its metabolites in the renal tubules. Generally speaking, neither hemodialysis nor peritoneal dialysis have been shown to improve methotrexate elimination. However, effective clearance of methotrexate has been reported with acute, intermittent hemodialysis using a high-flux dialyzer (Wall, SM et al: Am J Kidney Dis 28(6): 846-854, 1996). In postmarketing experience, overdose with methotrexate has generally occurred with oral and intrathecal administration, although intravenous and intramuscular overdose have also been reported. Reports of oral overdose often indicate accidental daily administration instead of weekly (single or divided doses). Symptoms commonly reported following oral overdose include those symptoms and signs reported at pharmacologic doses, particularly hematologic and gastrointestinal reaction. For example, leukopenia, thrombocytopenia, anemia, pancytopenia, bone marrow suppression, mucositis, stomatitis, oral ulceration, nausea, vomiting, gastrointestinal ulceration, gastrointestinal bleeding. In some cases, no symptoms were reported. There have been reports of death following overdose. In these cases, events such as sepsis or septic shock, renal failure, and aplastic anemia were also reported. Rheumatrex Dosage and Administration Neoplastic Diseases Oral administration in tablet form is often preferred when low doses are being administered since absorption is rapid and effective serum levels are obtained. Choriocarcinoma and similar trophoblastic diseases : Methotrexate is administered orally or intramuscularly in doses of 15 to 30 mg daily for a five-day course. Such courses are usually repeated for 3 to 5 times as required, with rest periods of one or more weeks interposed between courses, until any manifesting toxic symptoms subside. The effectiveness of therapy is ordinarily evaluated by 24 hour quantitative analysis of urinary chorionic gonadotropin (hCG), which should return to normal or less than 50 IU/24 hr usually after the third or fourth course and usually be followed by a complete resolution of measurable lesions in 4 to 6 weeks. One to two courses of methotrexate after normalization of hCG is usually recommended. Before each course of the drug careful clinical assessment is essential. Cyclic combination therapy of methotrexate with other antitumor drugs has been reported as being useful. Since hydatidiform mole may precede choriocarcinoma, prophylactic chemotherapy with methotrexate has been recommended. Chorioadenoma destruens is considered to be an invasive form of hydatidiform mole. Methotrexate is administered in these disease states in doses similar to those recommended for choriocarcinoma. Leukemia : Acute lymphoblastic leukemia in pediatric patients and young adolescents is the most responsive to present day chemotherapy. In young adults and older patients, clinical remission is more difficult to obtain and early relapse is more common. Methotrexate alone or in combination with steroids was used initially for induction of remission in acute lymphoblastic leukemias. More recently corticosteroid therapy, in combination with other antileukemic drugs or in cyclic combinations with methotrexate included, has appeared to produce rapid and effective remissions. When used for induction, methotrexate in doses of 3.3 mg/m 2 in combination with 60 mg/m 2 of prednisone, given daily, produced remissions in 50% of patients treated, usually within a period of 4 to 6 weeks. Methotrexate in combination with other agents appears to be the drug of choice for securing maintenance of drug-induced remissions. When remission is achieved and supportive care has produced general clinical improvement, maintenance therapy is initiated, as follows: Methotrexate is administered 2 times weekly either by mouth or intramuscularly in total weekly doses of 30 mg/m 2 . It has also been given in doses of 2.5 mg/kg intravenously every 14 days. If and when relapse does occur, reinduction of remission can again usually be obtained by repeating the initial induction regimen. A variety of combination chemotherapy regimens have been used for both induction and maintenance therapy in acute lymphoblastic leukemia. The physician should be familiar with the new advances in antileukemic therapy. Lymphomas : In Burkitt s tumor, Stages I-II, methotrexate has produced prolonged remissions in some cases. Recommended dosage is 10 to 25 mg/day orally for 4 to 8 days. In Stage III, methotrexate is commonly given concomitantly with other anti-tumor agents. Treatment in all stages usually consists of several courses of the drug interposed with 7 to 10 day rest periods. Lymphosarcomas in Stage III may respond to combined drug therapy with methotrexate given in doses of 0.625 to 2.5 mg/kg daily. Mycosis Fungoides (cutaneous T cell lymphoma) : Therapy with methotrexate as a single agent appears to produce clinical responses in up to 50% of patients treated. Dosage in early stages is usuallly 5 to 50 mg once weekly. Dose reduction or cessation is guided by patient response and hematologic monitoring. Methotrexate has also been administered twice weekly in doses ranging from 15 to 37.5 mg in patients who have responded poorly to weekly therapy. Psoriasis, Rheumatoid Arthritis, and Juvenile Rheumatoid Arthritis Adult Rheumatoid Arthritis : Recommended Starting Dosage Schedules Single oral doses of 7.5 mg once weekly. Divided oral dosages of 2.5 mg at 12 hour intervals for 3 doses given as a course once weekly Polyarticular-Course Juvenile Rheumatoid Arthritis : The recommended starting dose is 10 mg/m 2 given once weekly. For either adult RA or polyarticular-course JRA dosages may be adjusted gradually to achieve an optimal response. Limited experience shows a significant increase in the incidence and severity of serious toxic reactions, especially bone marrow suppression, at doses greater than 20 mg/wk in adults. Although there is experience with doses up to 30 mg/m 2 /wk in children, there are too few published data to assess how doses over 20 mg/m 2 /wk might affect the risk of serious toxicity in children. Experience does suggest, however, that children receiving 20 to 30 mg/m 2 /wk (0.65 to 1.0 mg/kg/wk) may have better absorption and fewer gastrointestinal side effects if methotrexate is administered either intramuscularly or subcutaneously. Therapeutic response usually begins within 3 to 6 weeks and the patient may continue to improve for another 12 weeks or more. The optimal duration of therapy is unknown. Limited data available from long-term studies in adults indicate that the initial clinical improvement is maintained for at least two years with continued therapy. When methotrexate is discontinued, the arthritis usually worsens within 3 to 6 weeks. The patient should be fully informed of the risks involved and should be under constant supervision of the physician. (See Information for Patients under PRECAUTIONS .) Assessment of hematologic, hepatic, renal, and pulmonary function should be made by history, physical examination, and laboratory tests before beginning, periodically during, and before reinstituting methotrexate therapy. (See PRECAUTIONS .) Appropriate steps should be taken to avoid conception during methotrexate therapy. (See PRECAUTIONS and CONTRAINDICATIONS .) Weekly therapy may be instituted with the Rheumatrex Methotrexate Tablets, USP, 2.5 mg Dose Packs which are designed to provide doses over a range of 5 mg to 20 mg administered as a single weekly dose. The dose packs are not recommended for administration of methotrexate in weekly doses greater than 20 mg. All schedules should be continually tailored to the individual patient. An initial test dose may be given prior to the regular dosing schedule to detect any extreme sensitivity to adverse effects. (See ADVERSE REACTIONS .) Maximal myelosuppression usually occurs in seven to ten days. Psoriasis: Recommended Starting Dose Schedules Weekly single oral, IM or IV dose schedule: 10 to 25 mg per week until adequate response is achieved. Divided oral dose schedule: 2.5 mg at 12-hour intervals for three doses. Dosages in each schedule may be gradually adjusted to achieve optimal clinical response; 30 mg/week should not ordinarily be exceeded. Once optimal clinical response has been achieved, each dosage schedule should be reduced to the lowest possible amount of drug and to the longest possible rest period. The use of methotrexate may permit the return to conventional topical therapy, which should be encouraged. HANDLING AND DISPOSAL Procedures for proper handling and disposal of anticancer drugs should be considered. Several guidelines on this subject have been published. 1-5 There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate. How is Rheumatrex Supplied Oral: Description Methotrexate Tablets, USP contain an amount of methotrexate sodium equivalent to 2.5 mg of methotrexate and are round, convex, yellow tablets, scored in half on one side, engraved with M above the score, and 1 below. Rheumatrex Methotrexate Tablets, USP, 2.5 mg Dose Packs - (each tablet equivalent to 2.5 mg of methotrexate) NDC 67253-580-42 - Rheumatrex Methotrexate Tablets, USP Dose Pack 4 cards each containing two 2.5 mg tablets, i.e., 5 mg per week. NDC 67253-580-43 - Rheumatrex Methotrexate Tablets, USP Dose Pack 4 cards each containing three 2.5 mg tablets, i.e., 7.5 mg per week. NDC 67253-580-44 - Rheumatrex Methotrexate Tablets, USP Dose Pack 4 cards each containing four 2.5 mg tablets, i.e., 10 mg per week. NDC 67253-580-45 - Rheumatrex Methotrexate Tablets, USP Dose Pack 4 cards each containing five 2.5 mg tablets, i.e., 12.5 mg per week. NDC 67253-580-46 - Rheumatrex Methotrexate Tablets, USP Dose Pack 4 cards each containing six 2.5 mg tablets, i.e., 15 mg per week. NDC 67253-580-47 - Rheumatrex Methotrexate Tablets, USP Dose Pack 4 cards each containing seven 2.5 mg tablets, i.e., 17.5 mg per week. NDC 67253-580-48 - Rheumatrex Methotrexate Tablets, USP Dose Pack 4 cards each containing eight 2.5 mg tablets, i.e., 20 mg per week. Store at 20 -25 C (68 -77 F) [See USP Controlled Room Temperature]. Protect from light. REFERENCES Controlling occupational exposure to hazardous drugs (OSHA Work-Practice Guidelines). Am J Health Syst Pharm 1996: 53: 1669-1685. National Study Commission on Cytotoxic Exposure - Recommendations for Handling Cytotoxic Agents. Available from Louis P. Jeffrey, Sc D, Chairman, National Study Commission on Cytotoxic Exposure, Massachusetts College of Pharmacy and Allied Health Sciences, 179 Longwood Avenue, Boston, Massachusetts 02115. Clinical Oncological Society of Australia: Guidelines and recommendations for safe handling of antineoplastic agents. Med J Australia 1983; 1:426-428. Jones RB, et al. Safe handling of chemotherapeutic agents: A report from the Mount Sinai Medical Center. CA - A Cancer Journal for Clinicians Sept/Oct 1983; 258-263. American Society of Hospital Pharmacists technical assistance bulletin on handling cytotoxic and hazardous drugs. Am J Hosp Pharm 1990; 47:1033-1049. Manufactured For: DAVA Pharmaceuticals, Inc. Fort Lee, NJ 07024 USA By: EXCELLA GmbH Feucht, Germany Rev. 01/16 Patient Information Rheumatrex DOSE PACK (ROO-mah-trex) (Methotrexate Tablets) Read the Patient Instructions that come with Rheumatrex before you start using it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your doctor about your condition. What is the most important information I should know about Rheumatrex ? Rheumatrex can cause serious side effects that may be life-threatening (see "What are the possible or reasonably likely side effects of Rheumatrex ?"). Most side effects can be found by medical tests before they become serious. Your doctor may do regular tests to check how Rheumatrex is affecting your body. It is important that you stay under a doctor's care while taking Rheumatrex . Call your doctor right away to report any side effects or symptoms you get. Rheumatrex can cause birth defects or death of an unborn child. Therefore, if you are pregnant or your sexual partner is pregnant, or plans to become pregnant, do not take Rheumatrex . Neither you nor your partner should become pregnant while taking Rheumatrex . Women should wait at least 1 menstrual cycle after stopping treatment with Rheumatrex before getting pregnant. Men should wait at least 3 months after stopping treatment with Rheumatrex before getting their partner pregnant. Women who can become pregnant should have a pregnancy test before starting Rheumatrex . During treatment with Rheumatrex men whose partners and women who are able to get pregnant should use effective birth control. What is Rheumatrex ? Rheumatrex is a prescription medicine used in treating certain cancers, severe rheumatoid arthritis including polyarticular juvenile rheumatoid arthritis, and severe psoriasis. Who should not take Rheumatrex ? Do not take Rheumatrex if: you are pregnant or planning to become pregnant. Rheumatrex can cause birth defects or death to your unborn child. See "What is the most important information I should know about Rheumatrex ?" you are breast-feeding. Rheumatrex can harm your baby. You will need to decide either to breast-feed or to take Rheumatrex , but not both. you have any conditions that weaken your immune system (immunodeficiency conditions). your bone marrow does not make enough blood cells, or if you have low white blood cell counts, low platelet counts, or serious anemia. you drink alcohol or have liver problems from alcohol abuse. you have chronic liver disease. you are allergic to methotrexate or any of the ingredients in Rheumatrex . See the end of this leaflet for a complete list of ingredients in Rheumatrex . Before using Rheumatrex tell your doctor: about all your medical problems including if you: have kidney problems or are getting dialysis treatments have liver problems have fluid in your stomach area (ascites) have lung problems or fluid in your lungs (pleural effusion) about all the medicines you take including prescription and nonprescription medicines, vitamins and herbal supplements. Rheumatrex and certain other medicines can affect each other and cause serious side effects. Do not start or change any medicines unless you have talked to your doctor and your doctor has told you it is safe. Know all the medicines that you take and keep a list of them with you at all times to show doctors and pharmacists. How should I take Rheumatrex ? Take Rheumatrex exactly as prescribed by your doctor. Your dose of Rheumatrex and when you take it will depend on the condition that is being treated. Do not take more Rheumatrex than prescribed. Do not change your dose of Rheumatrex unless your doctor has told you to. For treatment of severe psoriasis, and severe rheumatoid arthritis including juvenile rheumatoid arthritis, Rheumatrex should be taken weekly, not every day. This weekly dose is taken either at one time or in several doses. The Rheumatrex Dose Pack may help you remember to take the right dose of medicine on this weekly schedule. If you miss a dose of Rheumatrex call your doctor to ask if you should take the dose or not. If you take too much Rheumatrex call your doctor or go to your nearest emergency room right away. You will need to take a medicine called an antidote as soon as possible. Call your doctor right away for further instructions if you get dehydrated (lose a large amount of body fluids). This can happen if you are sick and have a fever, vomiting, or diarrhea. Dehydration can also happen when you sweat a lot with activities or exercise and don't drink enough fluids. Stop taking Rheumatrex if you get diarrhea, or if you get sores in your mouth. Call your doctor right away. If you keep taking Rheumatrex with these symptoms, you could get serious bleeding or tearing of your digestive tract. Your doctor should do regular tests to monitor how Rheumatrex is affecting your body. Check with your doctor after having any blood tests before taking Rheumatrex again. Your doctor will tell you if it is safe to take more Rheumatrex . Certain side effects such as mouth sores may be reduced by folate supplementation with Rheumatrex . What should I avoid while taking Rheumatrex ? Do not: get pregnant or try to become pregnant. See "What is the most important information I should know about Rheumatrex ?" breastfeed. See "Who should not take Rheumatrex ?" drink alcohol. Alcohol drinks, including beer and wine, may increase some of the side effects with Rheumatrex , including the chance of liver damage. take certain live virus vaccines. What are the possible or reasonably likely side effects of Rheumatrex ? Rheumatrex can cause serious and life-threatening problems including (see "What is the most important information I should know about Rheumatrex ?): birth defects and death of an unborn child serious anemia, lower white cells, red cells, and platelets in your blood liver damage kidney damage lung disease cancer of the lymph system (lymphoma) severe skin reactions and rashes opportunistic infections such as Pneumocystis carini pneumonia soft tissue and bone damage if you are getting radiation therapy at the same time you are taking Rheumatrex The most common side effects of Rheumatrex include: mouth sores low white blood cells nausea, upset stomach feeling poorly tiredness, chills, fever, dizziness higher chance for getting infections diarrhea vomiting hair loss easy bruising Stop taking Rheumatrex and call your doctor right away if you get diarrhea, mouth sores, a fever, dehydration, cough, bleeding, shortness of breath, any signs of infection, or a skin rash. If you have any questions about these or other side effects, talk to your doctor. These are not all the side effects of Rheumatrex . Ask your doctor or pharmacist for more information. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. How should I store Rheumatrex ? Store Rheumatrex at room temperature between 68 to 77 F (20 to 25 C). Keep Rheumatrex away from light. Keep Rheumatrex and all medicines out of the reach of children. General information about Rheumatrex Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Rheumatrex for a condition for which it was not prescribed. Do not give Rheumatrex to other people, even if they have the same symptoms that you have. It may harm them. This leaflet summarizes the most important information about Rheumatrex . If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about Rheumatrex that is written for healthcare professionals. For additional information, please contact DAVA Pharmaceuticals, Inc. at our toll free number: 800-444-4011. W even supposing
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