Folpace Rx

Pronunciation: muhl-tee-VYE-ta-mins/MIN-er-als/FOE-lik AS-id
Generic Name: Multivitamins with Minerals/Folic Acid
Brand Name: Examples include Glutofac-ZX and Folpace Rx

Folpace Rx is used for:

Treating or preventing low levels of vitamins, folic acid, or minerals. It may also be used for other conditions as determined by your doctor.

Folpace Rx is a vitamin, folic acid, and mineral supplement. It works by providing extra vitamins, minerals, and folic acid to the body when you need more than what you get in your diet.

Do NOT use Folpace Rx if:

• you are allergic to any ingredient in Folpace Rx


• you have decreased liver or kidney function

Contact your doctor or health care provider right away if any of these apply to you.

Before using Folpace Rx:

Some medical conditions may interact with Folpace Rx. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have a history of bowel problems (eg, a bowel blockage), a certain eye problem (Leber optic atrophy), certain blood disorders (eg, megaloblastic anemia, pernicious anemia), high blood calcium levels, kidney problems, kidney stones, liver problems, sarcoidosis, or parathyroid gland problems

Some MEDICINES MAY INTERACT with Folpace Rx. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Anticoagulants (eg, warfarin) or fluorouracil because the risk of their side effects may be increased by Folpace Rx


• Hydantoins (eg, phenytoin) or penicillamine because their effectiveness may be decreased by Folpace Rx


• Many other prescription and nonprescription medicines (eg, used for infections, heart problems, high blood pressure, immune system suppression, cancer, low blood platelets, osteoporosis, thyroid problems, bladder problems, Parkinson disease, psoriasis, swelling, other conditions) may interact with Folpace Rx. This may increase the risk of side effects or decrease the effectiveness of your other medicines. Ask your doctor or pharmacist if any medicines you take may interact with Folpace Rx and how to take them with Folpace Rx

This may not be a complete list of all interactions that may occur. Ask your health care provider if Folpace Rx may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Folpace Rx:

Use Folpace Rx as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Folpace Rx by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.


• Take Folpace Rx with a full glass of water (8 oz/240 mL).


• If you miss a dose of Folpace Rx, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Folpace Rx.

Important safety information:

• Do NOT take more than the recommended dose without checking with your doctor.


• Do not take large doses of vitamins (megadoses or megavitamin therapy) while you use Folpace Rx unless your doctor tells you to.


• Tell your doctor or dentist that you take Folpace Rx before you receive any medical or dental care, emergency care, or surgery.


• Folpace Rx has many vitamins (eg, pyridoxine [vitamin B₆], cyanocobalamin [vitamin B₁₂], ascorbic acid [vitamin C], vitamin E), minerals (eg, zinc), and folic acid in it. Before you start any medicine, check the label to see if it has any vitamins, minerals, or folic acid in it too. If it does or if you are not sure, check with your doctor or pharmacist.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of taking Folpace Rx while you are pregnant. Folpace Rx is found in breast milk. If you are or will be breast-feeding while you take Folpace Rx, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Folpace Rx:

All medicines may cause side effects, but many people have no, or minor, side effects. No COMMON side effects have been reported with Folpace Rx. Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); decreased coordination; numbness or tingling of the skin; severe drowsiness, headaches, or nausea; severe or persistent constipation or diarrhea.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Folpace Rx side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include bone pain; confusion; dark urine; diarrhea; fever; lower back or side pain; mental or mood changes; nausea, vomiting, or stomach cramps; sluggishness; unexplained skin or mouth sores; yellowing of the skin or eyes.

Proper storage of Folpace Rx:

Store Folpace Rx at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Folpace Rx out of the reach of children and away from pets.

General information:

• If you have any questions about Folpace Rx, please talk with your doctor, pharmacist, or other health care provider.


• Folpace Rx is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Folpace Rx. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Folpace Rx resources

• Folpace Rx Side Effects (in more detail)
• Folpace Rx Use in Pregnancy & Breastfeeding
• Folpace Rx Drug Interactions
• Folpace Rx Support Group
• 0 Reviews for Folpace Rx - Add your own review/rating

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• Vitamin/Mineral Supplementation and Deficiency

Gleevec

Dosage Form: tablet
FULL PRESCRIBING INFORMATION

Indications and Usage for Gleevec

Newly Diagnosed Philadelphia Positive Chronic Myeloid Leukemia (Ph+ CML)

 Newly diagnosed adult and pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia in chronic phase.

Ph+ CML in Blast Crisis (BC), Accelerated Phase (AP) or Chronic Phase (CP) After Interferon-alpha (IFN) Therapy

Patients with Philadelphia chromosome positive chronic myeloid leukemia in blast crisis, accelerated phase, or in chronic phase after failure of interferon-alpha therapy.

Ph+ Acute Lymphoblastic Leukemia (ALL)

Adult patients with relapsed or refractory Philadelphia chromosome positive acute lymphoblastic leukemia.

Myelodysplastic/Myeloproliferative Diseases (MDS/MPD)

Adult patients with myelodysplastic/ myeloproliferative diseases associated with PDGFR (platelet-derived growth factor receptor) gene re-arrangements.

Aggressive Systemic Mastocytosis (ASM)

Adult patients with aggressive systemic mastocytosis without the D816V c-Kit mutation or with c-Kit mutational status unknown.

Hypereosinophilic Syndrome (HES) and/or Chronic Eosinophilic Leukemia (CEL)

Adult patients with hypereosinophilic syndrome and/or chronic eosinophilic leukemia who have the FIP1L1-PDGFRα fusion kinase (mutational analysis or FISH demonstration of CHIC2 allele deletion) and for patients with HES and/or CEL who are FIP1L1-PDGFRα fusion kinase negative or unknown.

Dermatofibrosarcoma Protuberans (DFSP)

Adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans.

Kit+ Gastrointestinal Stromal Tumors (GIST)

Patients with Kit (CD117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumors.

Adjuvant Treatment of GIST

Adjuvant treatment of adult patients following complete gross resection of Kit (CD117) positive GIST.

Gleevec Dosage and Administration

Therapy should be initiated by a physician experienced in the treatment of patients with hematological malignancies or malignant sarcomas, as appropriate. The prescribed dose should be administered orally, with a meal and a large glass of water. Doses of 400 mg or 600 mg should be administered once daily, whereas a dose of 800 mg should be administered as 400 mg twice a day.

In children, Gleevec treatment can be given as a once-daily dose or alternatively the daily dose may be split into two - once in the morning and once in the evening. There is no experience with Gleevec treatment in children under 2 years of age.

For patients unable to swallow the film-coated tablets, the tablets may be dispersed in a glass of water or apple juice. The required number of tablets should be placed in the appropriate volume of beverage (approximately 50 mL for a 100 mg tablet, and 200 mL for a 400 mg tablet) and stirred with a spoon. The suspension should be administered immediately after complete disintegration of the tablet(s).

For daily dosing of 800 mg and above, dosing should be accomplished using the 400 mg tablet to reduce exposure to iron.

Treatment may be continued as long as there is no evidence of progressive disease or unacceptable toxicity.

Adult Patients with Ph+ CML CP, AP and BC

The recommended dose of Gleevec is 400 mg/day for adult patients in chronic phase CML and 600 mg/day for adult patients in accelerated phase or blast crisis.

In CML, a dose increase from 400 mg to 600 mg in adult patients with chronic phase disease, or from 600 mg to 800 mg (given as 400 mg twice daily) in adult patients in accelerated phase or blast crisis may be considered in the absence of severe adverse drug reaction and severe non-leukemia related neutropenia or thrombocytopenia in the following circumstances: disease progression (at any time), failure to achieve a satisfactory hematologic response after at least 3 months of treatment, failure to achieve a cytogenetic response after 6-12 months of treatment, or loss of a previously achieved hematologic or cytogenetic response.

Pediatric Patients with Ph+ CML CP

The recommended dose of Gleevec for children with newly diagnosed Ph+ CML is 340 mg/m2/day (not to exceed 600 mg).

Ph+ ALL

The recommended dose of Gleevec is 600 mg/day for adult patients with relapsed/refractory Ph+ ALL.

MDS/MPD

The recommended dose of Gleevec is 400 mg/day for adult patients with MDS/MPD.

ASM

The recommended dose of Gleevec is 400 mg/day for adult patients with ASM without the D816V c-Kit mutation. If c-Kit mutational status is not known or unavailable, treatment with Gleevec 400 mg/day may be considered for patients with ASM not responding satisfactorily to other therapies. For patients with ASM associated with eosinophilia, a clonal hematological disease related to the fusion kinase FIP1L1-PDGFRα, a starting dose of 100 mg/day is recommended. Dose increase from 100 mg to 400 mg for these patients may be considered in the absence of adverse drug reactions if assessments demonstrate an insufficient response to therapy.

HES/CEL

The recommended dose of Gleevec is 400 mg/day for adult patients with HES/CEL. For HES/CEL patients with demonstrated FIP1L1-PDGFRα fusion kinase, a starting dose of 100 mg/day is recommended. Dose increase from 100 mg to 400 mg for these patients may be considered in the absence of adverse drug reactions if assessments demonstrate an insufficient response to therapy. 

DFSP

The recommended dose of Gleevec is 800 mg/day for adult patients with DFSP.

Metastatic or Unresectable GIST

The recommended dose of Gleevec is 400 mg/day for adult patients with unresectable and/or metastatic, malignant GIST. A dose increase up to 800 mg daily (given as 400 mg twice daily) may be considered, as clinically indicated, in patients showing clear signs or symptoms of disease progression at a lower dose and in the absence of severe adverse drug reactions.

Adjuvant GIST 

The recommended dose of Gleevec is 400 mg/day for the adjuvant treatment of adult patients following complete gross resection of GIST. In clinical trials one year of Gleevec and three years of Gleevec were studied. In the patient population defined in Study 2, three years of Gleevec is recommended [see Clinical Studies (14.8)]. The optimal treatment duration with Gleevec is not known.

Dose Modification Guidelines

Concomitant Strong CYP3A4 inducers: The use of concomitant strong CYP3A4 inducers should be avoided (e.g., dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, rifampacin, phenobarbital). If patients must be co-administered a strong CYP3A4 inducer, based on pharmacokinetic studies, the dosage of Gleevec should be increased by at least 50%, and clinical response should be carefully monitored [see Drug Interactions (7.1)].

Hepatic Impairment: Patients with mild and moderate hepatic impairment do not require a dose adjustment and should be treated per the recommended dose. A 25% decrease in the recommended dose should be used for patients with severe hepatic impairment [see Use in Specific Populations (8.6)].

Renal Impairment: Patients with moderate renal impairment (CrCL = 20-39 mL/min) should receive a 50% decrease in the recommended starting dose and future doses can be increased as tolerated. Doses greater than 600 mg are not recommended in patients with mild renal impairment (CrCL = 40-59 mL/min). For patients with moderate renal impairment doses greater than 400 mg are not recommended.

Imatinib should be used with caution in patients with severe renal impairment. A dose of 100 mg/day was tolerated in two patients with severe renal impairment [See Warnings and Precautions (5.3),Use in Specific Populations (8.7)].

Dose Adjustment for Hepatotoxicity and Non-Hematologic Adverse Reactions

If elevations in bilirubin >3 x institutional upper limit of normal (IULN) or in liver transaminases >5 x IULN occur, Gleevec should be withheld until bilirubin levels have returned to a <1.5 x IULN and transaminase levels to <2.5 x IULN. In adults, treatment with Gleevec may then be continued at a reduced daily dose (i.e., 400 mg to 300 mg, 600 mg to 400 mg or 800 mg to 600 mg). In children, daily doses can be reduced under the same circumstances from 340 mg/m2/day to 260 mg/m2/day.

If a severe non-hematologic adverse reaction develops (such as severe hepatotoxicity or severe fluid retention), Gleevec should be withheld until the event has resolved. Thereafter, treatment can be resumed as appropriate depending on the initial severity of the event.

Dose Adjustment for Hematologic Adverse Reactions

Dose reduction or treatment interruptions for severe neutropenia and thrombocytopenia are recommended as indicated in Table 1.

Table 1 Dose Adjustments for Neutropenia and Thrombocytopenia

ASM associated with eosinophilia (starting dose 100 mg)	ANC <1.0 x 109/L and/or platelets <50 x 109/L	Stop Gleevec until ANC ≥1.5 x 109/L and platelets ≥75 x 109/L Resume treatment with Gleevec at previous dose (i.e., dose before severe adverse reaction)
HES/CEL with FIP1L1-PDGFRα fusion kinase (starting dose 100 mg)	ANC <1.0 x 109/L and/or platelets <50 x 109/L	Stop Gleevec until ANC ≥1.5 x 109/L and platelets ≥75 x 109/L Resume treatment with Gleevec at previous dose (i.e., dose before severe adverse reaction)
Chronic Phase CML (starting dose 400 mg) MDS/MPD, ASM and HES/CEL (starting dose 400 mg) GIST (starting dose 400 mg)	ANC <1.0 x 109/L and/or platelets <50 x 109/L	Stop Gleevec until ANC ≥1.5 x 109/L and platelets ≥75 x 109/L Resume treatment with Gleevec at the original starting dose of 400 mg If recurrence of ANC <1.0 x 109/L and/or platelets <50 x 109/L, repeat step 1 and resume Gleevec at a reduced dose of 300 mg
Ph+ CML : Accelerated Phase and Blast Crisis (starting dose 600 mg) Ph+ ALL (starting dose 600 mg)	ANC <0.5 x 109/L and/or platelets <10 x 109/L	Check if cytopenia is related to leukemia (marrow aspirate or biopsy) If cytopenia is unrelated to leukemia, reduce dose of Gleevec to 400 mg If cytopenia persists 2 weeks, reduce further to 300 mg If cytopenia persists 4 weeks and is still unrelated to leukemia, stop Gleevec until ANC ≥1 x 109/L and platelets ≥20 x 109/L and then resume treatment at 300 mg
DFSP (starting dose 800 mg)	ANC <1.0 x 109/L and/or platelets <50 x 109/L	Stop Gleevec until ANC ≥1.5 x 109/L and platelets ≥75 x 109/L Resume treatment with Gleevec at 600 mg In the event of recurrence of ANC <1.0 x 109/L and/or platelets <50 x 109/L, repeat step 1 and resume Gleevec at reduced dose of 400 mg
Pediatric newly diagnosed chronic phase CML (starting dose 340 mg/m2)	ANC <1.0 x 109/L and/or platelets <50 x 109/L	Stop Gleevec until ANC ≥1.5 x 109/L and platelets ≥75 x 109/L Resume treatment with Gleevec at previous dose (i.e., dose before severe adverse reaction) In the event of recurrence of ANC <1.0 x 109/L and/or platelets <50 x 109/L, repeat step 1 and resume Gleevec at reduced dose of 260 mg/m2

Dosage Forms and Strengths

100 mg film coated tablets

Very dark yellow to brownish orange, film-coated tablets, round, biconvex with bevelled edges, debossed with “NVR” on one side, and “SA” with score on the other side

400 mg film coated tablets

Very dark yellow to brownish orange, film-coated tablets, ovaloid, biconvex with bevelled edges, debossed with “400” on one side with score on the other side, and “SL” on each side of the score

Contraindications

None

Warnings and Precautions

Fluid Retention and Edema

Gleevec is often associated with edema and occasionally serious fluid retention [see Adverse Reactions (6.1)]. Patients should be weighed and monitored regularly for signs and symptoms of fluid retention. An unexpected rapid weight gain should be carefully investigated and appropriate treatment provided. The probability of edema was increased with higher Gleevec dose and age >65 years in the CML studies. Severe superficial edema was reported in 1.5% of newly diagnosed CML patients taking Gleevec, and in 2%-6% of other adult CML patients taking Gleevec. In addition, other severe fluid retention (e.g., pleural effusion, pericardial effusion, pulmonary edema, and ascites) reactions were reported in 1.3% of newly diagnosed CML patients taking Gleevec, and in 2%-6% of other adult CML patients taking Gleevec. Severe fluid retention was reported in 9% to 13.1% of patients taking Gleevec for GIST [see Adverse Reactions (6.11)].

Hematologic Toxicity

Treatment with Gleevec is associated with anemia, neutropenia, and thrombocytopenia. Complete blood counts should be performed weekly for the first month, biweekly for the second month, and periodically thereafter as clinically indicated (for example, every 2-3 months). In CML, the occurrence of these cytopenias is dependent on the stage of disease and is more frequent in patients with accelerated phase CML or blast crisis than in patients with chronic phase CML. In pediatric CML patients the most frequent toxicities observed were Grade 3 or 4 cytopenias including neutropenia, thrombocytopenia and anemia. These generally occur within the first several months of therapy [see Dosage and Administration (2.12)].

Severe Congestive Heart Failure and Left Ventricular Dysfunction

Severe congestive heart failure and left ventricular dysfunction have been reported in patients taking Gleevec. Most of the patients with reported cardiac reactions have had other co-morbidities and risk factors, including advanced age and previous medical history of cardiac disease. In an international randomized phase 3 study in 1,106 patients with newly diagnosed Ph+ CML in chronic phase, severe cardiac failure and left ventricular dysfunction were observed in 0.7% of patients taking Gleevec compared to 0.9% of patients taking IFN + Ara-C. Patients with cardiac disease or risk factors for cardiac or history of renal failure should be monitored carefully and any patient with signs or symptoms consistent with cardiac or renal failure should be evaluated and treated.

Hepatotoxicity

Hepatotoxicity, occasionally severe, may occur with Gleevec [see Adverse Reactions (6.3)]. Cases of fatal liver failure and severe liver injury requiring liver transplants have been reported with both short-term and long-term use of Gleevec. Liver function (transaminases, bilirubin, and alkaline phosphatase) should be monitored before initiation of treatment and monthly, or as clinically indicated. Laboratory abnormalities should be managed with Gleevec interruption and/or dose reduction [see Dosage and Administration (2.11)].

When Gleevec is combined with chemotherapy, liver toxicity in the form of transaminase elevation and hyperbilirubinemia has been observed. Additionally, there have been reports of acute liver failure. Monitoring of hepatic function is recommended.

Hemorrhage

In the newly diagnosed CML trial, 1.8% of patients had Grade 3/4 hemorrhage. In the Phase 3 unresectable or metastatic GIST studies 211 patients (12.9%) reported Grade 3/4 hemorrhage at any site. In the Phase 2 unresectable or metastatic GIST study 7 patients (5%) had a total of 8 CTC Grade 3/4 hemorrhages; gastrointestinal (GI) (3 patients), intra-tumoral (3 patients) or both (1 patient). Gastrointestinal tumor sites may have been the source of GI hemorrhages. Patients should therefore be monitored for gastrointestinal symptoms at the start of therapy. 

Gastrointestinal Disorders

Gleevec is sometimes associated with GI irritation. Gleevec should be taken with food and a large glass of water to minimize this problem. There have been rare reports, including fatalities, of gastrointestinal perforation.

Hypereosinophilic Cardiac Toxicity

In patients with hypereosinophilic syndrome and cardiac involvement, cases of cardiogenic shock/left ventricular dysfunction have been associated with the initiation of Gleevec therapy. The condition was reported to be reversible with the administration of systemic steroids, circulatory support measures and temporarily withholding Gleevec. Myelodysplastic/myeloproliferative disease and systemic mastocytosis may be associated with high eosinophil levels. Performance of an echocardiogram and determination of serum troponin should therefore be considered in patients with HES/CEL, and in patients with MDS/MPD or ASM associated with high eosinophil levels. If either is abnormal, the prophylactic use of systemic steroids (1-2 mg/kg) for one to two weeks concomitantly with Gleevec should be considered at the initiation of therapy.

Dermatologic Toxicities

Bullous dermatologic reactions, including erythema multiforme and Stevens-Johnson syndrome, have been reported with use of Gleevec. In some cases of bullous dermatologic reactions, including erythema multiforme and Stevens-Johnson syndrome reported during postmarketing surveillance, a recurrent dermatologic reaction was observed upon re-challenge. Several foreign post-marketing reports have described cases in which patients tolerated the reintroduction of Gleevec therapy after resolution or improvement of the bullous reaction. In these instances, Gleevec was resumed at a dose lower than that at which the reaction occurred and some patients also received concomitant treatment with corticosteroids or antihistamines.

Hypothyroidism

Clinical cases of hypothyroidism have been reported in thyroidectomy patients undergoing levothyroxine replacement during treatment with Gleevec. TSH levels should be closely monitored in such patients.

Toxicities from Long-Term Use

It is important to consider potential toxicities suggested by animal studies, specifically, liver, kidney and cardiac toxicity and immunosuppression. Severe liver toxicity was observed in dogs treated for 2 weeks, with elevated liver enzymes, hepatocellular necrosis, bile duct necrosis, and bile duct hyperplasia. Renal toxicity was observed in monkeys treated for 2 weeks, with focal mineralization and dilation of the renal tubules and tubular nephrosis. Increased BUN and creatinine were observed in several of these animals. An increased rate of opportunistic infections was observed with chronic imatinib treatment in laboratory animal studies. In a 39-week monkey study, treatment with imatinib resulted in worsening of normally suppressed malarial infections in these animals. Lymphopenia was observed in animals (as in humans). Additional long-term toxicities were identified in a 2-year rat study. Histopathological examination of the treated rats that died on study revealed cardiomyopathy (both sexes), chronic progressive nephropathy (females) and preputial gland papilloma as principal causes of death or reasons for sacrifice. Non-neoplastic lesions seen in this 2-year study which were not identified in earlier preclinical studies were the cardiovascular system, pancreas, endocrine organs and teeth. The most important changes included cardiac hypertrophy and dilatation, leading to signs of cardiac insufficiency in some animals.

Use in Pregnancy

Pregnancy Category D

Gleevec can cause fetal harm when administered to a pregnant woman.  Imatinib mesylate was teratogenic in rats when administered during organogenesis at doses approximately equal to the maximum human dose of 800 mg/day based on body surface area. Significant post-implantation loss was seen in female rats administered imatinib mesylate at doses approximately one-half the maximum human dose of 800 mg/day based on body surface area. Sexually active female patients of reproductive potential taking Gleevec should use highly effective contraception. If this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus [see Use in Specific Populations (8.1)].

Children and Adolescents

 Growth retardation has been reported in children and pre-adolescents receiving Gleevec. The long term effects of prolonged treatment with Gleevec on growth in children are unknown. Therefore, close monitoring of growth in children under Gleevec treatment is recommended [see Adverse Reactions (6.13)].

Tumor Lysis Syndrome

 Cases of Tumor Lysis Syndrome (TLS), including fatal cases, have been reported in patients with CML, GIST, ALL and eosinophilic leukemia receiving Gleevec. The patients at risk of TLS are those with tumors having a high proliferative rate or high tumor burden prior to treatment. These patients should be monitored closely and appropriate precautions taken. Due to possible occurrence of TLS, correction of clinically significant dehydration and treatment of high uric acid levels are recommended prior to initiation of Gleevec. 

Driving and Using Machinery

 Reports of motor vehicle accidents have been received in patients receiving Gleevec. While most of these reports are not suspected to be caused by Gleevec, patients should be advised that they may experience undesirable effects such as dizziness, blurred vision or somnolence during treatment with Gleevec. Therefore, caution should be recommended when driving a car or operating machinery.

Adverse Reactions

Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed cannot be directly compared to rates on other clinical trials and may not reflect the rates observed in clinical practice.

Chronic Myeloid Leukemia

The majority of Gleevec-treated patients experienced adverse reactions at some time. Most reactions were of mild-to-moderate grade, but drug was discontinued for drug-related adverse reactions in 2.4% of newly diagnosed patients, 4% of patients in chronic phase after failure of interferon-alpha therapy, 4% in accelerated phase and 5% in blast crisis.

The most frequently reported drug-related adverse reactions were edema, nausea and vomiting, muscle cramps, musculoskeletal pain, diarrhea and rash (Table 2 for newly diagnosed CML, Table 3 for other CML patients). Edema was most frequently periorbital or in lower limbs and was managed with diuretics, other supportive measures, or by reducing the dose of Gleevec [see Dosage and Administration (2.11)]. The frequency of severe superficial edema was 1.5%-6%.

A variety of adverse reactions represent local or general fluid retention including pleural effusion, ascites, pulmonary edema and rapid weight gain with or without superficial edema. These reactions appear to be dose related, were more common in the blast crisis and accelerated phase studies (where the dose was 600 mg/day), and are more common in the elderly. These reactions were usually managed by interrupting Gleevec treatment and using diuretics or other appropriate supportive care measures. A few of these reactions may be serious or life threatening, and one patient with blast crisis died with pleural effusion, congestive heart failure, and renal failure.

Adverse reactions, regardless of relationship to study drug, that were reported in at least 10% of the Gleevec treated patients are shown in Tables 2 and 3.

Table 2 Adverse Reactions Regardless of Relationship to Study Drug Reported in Newly Diagnosed CML Clinical Trial (≥10% of Gleevec Treated Patients)(1)

	All Grades		CTC Grades 3/4
	Gleevec	IFN+Ara−C	Gleevec	IFN+Ara−C
Preferred Term	N=551 (%)	N=533 (%)	N=551 (%)	N=533 (%)
Fluid Retention	61.7	11.1	2.5	0.9
− Superficial Edema	59.9	9.6	1.5	0.4
− Other Fluid Retention Reactions2	6.9	1.9	1.3	0.6
Nausea	49.5	61.5	1.3	5.1
Muscle Cramps	49.2	11.8	2.2	0.2
Musculoskeletal Pain	47.0	44.8	5.4	8.6
Diarrhea	45.4	43.3	3.3	3.2
Rash and Related Terms	40.1	26.1	2.9	2.4
Fatigue	38.8	67.0	1.8	25.1
Headache	37.0	43.3	0.5	3.8
Joint Pain	31.4	38.1	2.5	7.7
Abdominal Pain	36.5	25.9	4.2	3.9
Nasopharyngitis	30.5	8.8	0	0.4
Hemorrhage	28.9	21.2	1.8	1.7
- GI Hemorrhage	1.6	1.1	0.5	0.2
- CNS Hemorrhage	0.2	0.4	0	0.4
Myalgia	24.1	38.8	1.5	8.3
Vomiting	22.5	27.8	2.0	3.4
Dyspepsia	18.9	8.3	0	0.8
Cough	20.0	23.1	0.2	0.6
Pharyngolaryngeal Pain	18.1	11.4	0.2	0
Upper Respiratory Tract Infection	21.2	8.4	0.2	0.4
Dizziness	19.4	24.4	0.9	3.8
Pyrexia	17.8	42.6	0.9	3.0
Weight Increased	15.6	2.6	2.0	0.4
Insomnia	14.7	18.6	0	2.3
Depression	14.9	35.8	0.5	13.1
Influenza	13.8	6.2	0.2	0.2
Bone Pain	11.3	15.6	1.6	3.4
Constipation	11.4	14.4	0.7	0.2
Sinusitis	11.4	6.0	0.2	0.2
(1)All adverse reactions occurring in ≥10% of Gleevec treated patients are listed regardless of suspected relationship to treatment. (2)Other fluid retention reactions include pleural effusion, ascites, pulmonary edema, pericardial effusion, anasarca, edema aggravated, and fluid retention not otherwise specified.

Table 3 Adverse Reactions Regardless of Relationship to Study Drug Reported in Other CML Clinical Trials (≥10% of All Patients in any Trial)(1)

	Myeloid Blast Crisis (n= 260)		Accelerated Phase (n=235)		Chronic Phase, IFN Failure (n=532)
	%		%		%
Preferred Term	All Grades	Grade 3/4	All Grades	Grade 3/4	All Grades	Grade 3/4
Fluid Retention	72	11	76	6	69	4
-Superficial Edema	66	6	74	3	67	2
-Other Fluid Retention Reactions (2)	22	6	15	4	7	2
Nausea	71	5	73	5	63	3
Muscle Cramps	28	1	47	0.4	62	2
Vomiting	54	4	58	3	36	2
Diarrhea	43	4	57	5	48	3
Hemorrhage	53	19	49	11	30	2
- CNS Hemorrhage	9	7	3	3	2	1
- GI Hemorrhage	8	4	6	5	2	0.4
Musculoskeletal Pain	42	9	49	9	38	2
Fatigue	30	4	46	4	48	1
Skin Rash	36	5	47	5	47	3
Pyrexia	41	7	41	8	21	2
Arthralgia	25	5	34	6	40	1
Headache	27	5	32	2	36	0.6
Abdominal Pain	30	6	33	4	32	1
Weight Increased	5	1	17	5	32	7
Cough	14	0.8	27	0.9	20	0
Dyspepsia	12	0	22	0	27	0
Myalgia	9	0	24	2	27	0.2
Nasopharyngitis	10	0	17	0	22	0.2
Asthenia	18	5	21	5	15	0.2
Dyspnea	15	4	21	7	12	0.9
Upper Respiratory Tract Infection	3	0	12	0.4	19	0
Anorexia	14	2	17	2	7	0
Night Sweats	13	0.8	17	1	14	0.2
Constipation	16	2	16	0.9	9	0.4
Dizziness	12	0.4	13	0	16	0.2
Pharyngitis	10	0	12	0	15	0
Insomnia	10	0	14	0	14	0.2
Pruritus	8	1

Mobic Suppositories 7.5mg

Mobic 7.5 mg

Suppositories

(Meloxicam)

What You Should Know About MOBIC 7.5 mg Suppositories

Please read this leaflet carefully. It contains a summary of the information available on your medicine. The information in the leaflet applies to MOBIC 7.5 mg Suppositories only. If after reading this you have any questions, ask your doctor or pharmacist.

The name of your medicine is MOBIC 7.5 mg Suppositories. Each suppository contains 7.5 mg meloxicam as the active ingredient.

The suppositories also contain the following inactive ingredients: hard fat and macrogolglycerolhydroxystearate.

MOBIC 7.5 mg Suppositories are available in cartons containing 12 suppositories.

MOBIC 7.5 mg Suppositories belong to a group of medicines called non-steroidal anti-inflammatory drugs which are used to reduce inflammation and pain in the joints and muscles.

The Marketing Authorisations for MOBIC 7.5 mg Suppositories in the U.K. and Republic of Ireland are held by:

Boehringer Ingelheim International GmbH

D-55216 Ingelheim am Rhein

Germany

and the suppositories are manufactured by:

Istituto De Angeli S.r.l.

Regello (Fl)

Italy

In the U.K. and the Republic of Ireland the product is distributed by:

Boehringer Ingelheim Limited

Ellesfield Avenue

Bracknell

Berkshire

RG12 8YS

United Kingdom

How MOBIC 7.5 mg Suppositories Help You

MOBIC 7.5 mg Suppositories are for the short-term treatment of flare-ups of osteoarthritis and for the long-term treatment of rheumatoid arthritis.

Before Using MOBIC 7.5 mg Suppositories

Do not take this medicine if:

• You are pregnant, planning to become pregnant or if you are breastfeeding


• You are allergic to meloxicam or to any of the other ingredients listed


• You are allergic to aspirin or other anti-inflammatory medicines


• You have ever suffered from wheezing, nasal polyps (nasal obstruction due to swellings in the lining in your nose) along with a runny nose, swelling of the skin, urticaria (nettle rash) when taking aspirin or other anti-inflammatory medicines


• You have or have ever had gastrointestinal ulcer (ulcer of the stomach or intestines)


• You have ever suffered from rectal bleeding or inflammation of the rectum


• You have any kind of bleeding disorder or have ever suffered from gastrointestinal bleeding (bleeding in the stomach or intestines) or cerebrovascular bleeding (bleeding in the brain)


• You have serious liver disease


• You have serious kidney disease and are not undergoing dialysis


• You have severe heart failure

Take special care when taking this medicine if:

• You have ever suffered from oesophagitis (inflammation of the gullet) or gastritis (inflammation of the stomach) or any other gastrointestinal disease e.g. ulcerative colitis, Crohn’s disease


• You have high blood pressure


• You are elderly


• You have heart, liver or kidney disease


• You have diabetes


• You have hypovolaemia (reduced blood volume) which may occur if you have serious blood loss or burns, surgery or low fluid intake


• You have ever been diagnosed with high potassium levels in the blood

Your doctor may monitor your progress whilst on treatment.

Warnings

Medicines such as MOBIC 7.5 mg Suppositories may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke. Any risk is more likely with high doses and prolonged treatment.

Do not exceed the recommended dose or duration of treatment.

If you have heart problems, previous stroke or think that you might be at risk of these conditions (for example if you have high blood pressure, diabetes or high cholesterol or are a smoker) you should discuss your treatment with your doctor or pharmacist.

Pregnancy

This product should not be used during pregnancy. If you are planning to become pregnant, if you think or know you are pregnant you should talk to your doctor for advice.

Breast feeding

This product should not be given to breast feeding mothers.

Driving and using machinery

Visual disturbances, drowsiness, vertigo (dizziness) may occur with this product. If affected do not drive or operate machinery.

Taking Other Medicines

As MOBIC 7.5mg Suppositories may affect or be affected by other medicines, please tell your doctor or pharmacist if you are taking, or have recently taken any other medicines, even those not prescribed.

In particular please tell your doctor or pharmacist if you are taking/have taken any of the following:

• Other anti-inflammatory drugs, including aspirin


• Medicines which prevent blood clotting e.g. warfarin


• Medicines which break down blood clots (thrombolytics)


• Medicines to treat high blood pressure


• Corticosteroids


• Cyclosporin - a medicine often used after organ transplants, or for severe skin conditions, rheumatoid arthritis or nephrotic syndrome


• Any diuretic medicine ("water tablets"). Your doctor may monitor your kidney function if you are taking diuretics


• Lithium - a medicine used to treat mood disorders


• Selective Serotonin re-uptake inhibitors used in the treatment of depression


• Methotrexate - a medicine mainly used to treat tumours or severe uncontrolled skin conditions and active rheumatoid arthritis


• Cholestyramine - mainly used to lower cholesterol levels


• You are a woman who uses an intrauterine contraceptive device (IUD), usually known as a coil

If in doubt, ask your doctor or pharmacist.

How To Insert MOBIC 7.5 mg Suppositories

Follow your doctor’s instructions about when and how to use your medicine and always read the label. If you are unsure, ask your doctor or pharmacist.

The usual recommended doses are given below. As there are two strengths of suppositories (7.5 mg and 15 mg) your doctor will ensure that you are given the right strength.

Flare-ups of osteoarthritis: 7.5 mg (one 7.5 mg suppository) once a day. This may be increased to 15 mg (one 15 mg suppository) once a day.

Rheumatoid arthritis: 15 mg (one 15 mg suppository) once a day. This may be reduced to 7.5 mg (one 7.5 mg suppository) once a day.

The suppositories are for rectal use and should be used as follows.

They should not be swallowed.

1. Remove foil wrapping.

2. Lie on your left side and draw your knees up towards your chest, with your right leg drawn up a little more than your left.

3. Using your forefinger (index finger) or middle finger, whichever you find easier, gently push the suppository into the rectum, pointed end first. The suppository should be inserted as far as possible.

4. Lower your legs to a comfortable position to help you to hold the suppository in place.

If you feel uncomfortable and feel that the suppository must come out immediately, it has probably not been inserted high enough.

Do not exceed the recommended maximum dose of 15 mg a day.

If any of the statements listed under the heading ‘Take special care when taking this medicine if’ apply to you, your doctor may restrict your dose to 7.5 mg (one suppository) once a day.

MOBIC 7.5 mg Suppositories should not be given to children under 15 years of age.

If you feel that the effect of MOBIC 7.5 mg Suppositories is too strong or too weak, talk to your doctor or pharmacist.

If you take more MOBIC 7.5 mg Suppositories than you should, talk to your doctor or pharmacist immediately.

If you forget to take MOBIC 7.5 mg Suppositories do not take a double dose (two suppositories) to make up for the missed dose.

If after several days you do not feel any improvement in your condition then you should talk to your doctor or pharmacist.

After Using MOBIC 7.5 mg Suppositories

All medicines can cause side effects. Medicines such as MOBIC 7.5 mg Suppositories may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke.

The side effects described below have been experienced by people taking MOBIC and they are listed as either common, uncommon or rare.

If a side effect is listed as

• Common it has been experienced by between 1 in 10 and 1 in 100 people


• Uncommon it has been experienced by between 1 in 100 and 1 in 1000 people


• Rare it has been experienced by between 1 in 1000 and 1 in 10000 people

Side effects associated with the digestive system (stomach and intestines)

Common: indigestion, feeling sick or being sick, abdominal pain, constipation, flatulence, diarrhoea

Uncommon: gastrointestinal bleeding (causing offensive, tar-coloured stools), ulcers of the stomach or intestines, inflammation or soreness of the mouth or the gullet

Rare: gastrointestinal perforation (a hole in the wall of the bowel), inflammation or soreness of the stomach or the colon

Ulcers of the stomach or intestines, gastrointestinal bleeding and gastrointestinal perforation can occur at any time and can sometimes be severe, especially in the elderly and very rarely have been fatal.

If you have a history of gastrointestinal symptoms whilst taking anti-inflammatory drugs, your doctor may monitor your progress whilst on treatment.

Side effects associated with the skin

Common: itching, rash

Uncommon: urticaria (nettle rash)

Rare: severe blistering of the skin or peeling, swelling around the eyes, lips and face, rashes caused by exposure to sunlight

Side effects associated with the central nervous system

Common: lightheadedness, headache

Uncommon: vertigo (dizziness), tinnitus (noises in the ear), drowsiness

Rare: Confusion, mood disorders, insomnia (inability to sleep), nightmares

If affected by any of these side effects do not drive or operate machinery.

Side effects associated with the eye

Rare: visual disturbances, for example blurred vision

If affected by visual disturbances do not drive or operate machinery.

Side effects associated with the cardiovascular system

Common: swelling caused by fluid retention, including swollen ankles/legs

Uncommon: palpitations, increase in blood pressure, hot flushes

Side effects associated with the blood

Common: anaemia

Uncommon: abnormality of white blood cell or platelet numbers

Side effects associated with the immune system

Rare: severe allergic reactions which may include fainting, shortness of breath and skin reactions

Side effects associated with the respiratory system

Rare: Asthma attacks (seen in people who are allergic to aspirin or other non-steroidal anti-inflammatory drugs)

Side effects associated with the liver

Uncommon: changes in tests of liver function

Rare: inflammation of the liver (hepatitis)

Side effects associated with the kidney

Uncommon: salt and water retention, increased potassium levels in the blood, changes in tests of kidney function

Rare: kidney failure

Side effects associated with the route of administration

Irritation of the rectum - especially if suppositories are used for long periods, frequently or at high doses.

The following side effects have been seen with other medicines similar to MOBIC but have not yet been reported by patients taking MOBIC:

Changes to the kidney structure resulting in kidney failure: isolated cases kidney inflammation, death of some of the cells within the kidney, proteinuria (protein in the urine).

If you experience any of these side effects and they persist or become troublesome, consult your doctor.

If you experience any other side effects not mentioned above, consult your doctor or pharmacist.

How To Store MOBIC 7.5 mg Suppositories

The suppositories should not be used after the expiry date which is printed on the packaging.

Store below 30°C.

Keep this medicine out of the sight and reach of children.

This leaflet was revised in April 2007.

Remember this medicine is for you

. Only a doctor can prescribe it for you.

Never

give it to others as it may harm them even if their symptoms are the same as yours.

© Boehringer Ingelheim Limited 2007

437854/GB/9