fda report stroke for patient on xeloda

What is the prevalence of adverse events associated with Xeloda?

5% of Patients Clinically relevant adverse events reported in 5% of patients treated with XELODA either as monotherapy or in combination with docetaxel that were considered at least remotely related to treatment are shown below; occurrences of each grade 3 and 4 adverse event are provided in parentheses.

Is Xeloda safe in patients with absent DPD activity?

No XELODA dose has been proven safe in patients with absent DPD activity. (5.4) Dehydration and Renal Failure : Interrupt XELODA treatment until dehydration is corrected.

What is the reference ID for Xeloda?

See 17 for PATIENT COUNSELING INFORMATION and FDA- approved patient labeling Revised: 02/2019 Reference ID: 4394864 1 FULL PRESCRIBING INFORMATION: CONTENTS* WARNING: XELODA-WARFARIN INTERACTION 1 INDICATIONS AND USAGE 1.1 Colorectal Cancer 1.2 Breast Cancer 2 DOSAGE AND ADMINISTRATION 2.1 Important Administration Instructions

Which anticoagulants should be monitored with Xeloda?

Patients receiving concomitant XELODA and oral coumarin-derivative anticoagulants such as warfarin and phenprocoumon should have their anticoagulant response (INR or prothrombin time) monitored frequently in order to adjust the anticoagulant dose accordingly.

Can Xeloda cause blood clots?

What is the most important information I should know about XELODA? fast your blood clots, and can cause bleeding that can lead to death. This can happen as soon as a few days after you start taking XELODA, or later during treatment, and possibly even within 1 month after you stop taking XELODA.

What are the most common side effects of Xeloda?

The most common side effects of Xeloda include:diarrhea.hand and foot syndrome.nausea.vomiting.stomach-area (abdominal) pain.tiredness.weakness.increased amounts of red blood cell breakdown products (bilirubin) in your blood.

What would the nurse teach the patient about taking capecitabine?

Patient Education Call your provider if you miss a dose. Use emollients on your hands and feet and report any skin changes. Do not breastfeed while on treatment. Use effective contraception for six months after the last dose.

How long can you take Xeloda?

Xeloda is meant to be used as a long-term treatment. For metastatic breast or colorectal cancer, you'll usually take Xeloda for as long as it continues to be safe and effective for you. For adjuvant treatment of colon cancer, you'll usually take Xeloda for 6 months (eight 3-week cycles).

Can Xeloda cause heart problems?

These include mouth irritation or sores, diarrhea, low white blood cell counts, or nerve problems. Heart problems like heart attack, heart failure, and a heartbeat that does not feel normal have happened with this drug. Sudden deaths have also happened.

How do you stop the side effects of Xeloda?

Eating several small meals, not eating before treatment, or limiting activity may help lessen some of these effects. If any of these effects last or get worse, tell your doctor or pharmacist promptly. Diarrhea is a common side effect of this medication. Drink plenty of fluids unless directed otherwise.

When do side effects start with capecitabine?

This can happen as soon as a few days after you start taking capecitabine, during treatment, or up to a month after your last dose of capecitabine. The risk of bleeding is higher in people with cancer and those over age 60.

Is Xeloda a good chemo drug?

Xeloda also improved overall survival: 89.2% of the women treated with Xeloda were alive. 83.9% of the women who didn't get chemotherapy were alive.

Is there an alternative to capecitabine?

Possible alternative treatment options to be considered are to replace the oral capecitabine or intravenous 5-FU by a 5-FU bolus regimen, by uracil-tegafur or tegafur/gimeracil/oteracil, both oral fluoropyrimidines combining a 5-FU prodrug with a dihydropyrimidine dehydrogenase (DPD) inhibitor, or by raltitrexed, a ...

Does capecitabine cross the blood brain barrier?

Capecitabine may cross the BBB and has demonstrated activity in BCBM.

How many cycles of Xeloda can you have?

Adjuvant treatment in patients with Dukes' C colon cancer is recommended for a total of 6 months [ie, XELODA 1250 mg/m2 orally twice daily for 2 weeks followed by a 1-week rest period, given as 3-week cycles for a total of 8 cycles (24 weeks)].

How long can you be on oral chemo?

The exact schedule depends on the specific drugs you are on. Initial treatment is usually 4 to 6 cycles, but usually cycles are 3 to 4 weeks long.

What is a stroke?

A stroke happens when brain cells die because they are no longer receiving oxygen and nutrients from the blood supply. There are various types of stroke:

Who is affected by stroke?

Strokes occur more often in African American and American Indian/Alaska Native adults than any other group. African Americans have nearly twice the risk of having a first stroke than non-Hispanic white people and have the highest rate of death due to stroke.

How are strokes treated?

The main goal of treatment is to try to stop a stroke while it is happening by quickly dissolving or removing the blood clot causing the ischemic stroke or by stopping the bleeding of a hemorrhagic stroke. Depending on the type of stroke, it can be treated with either medications or surgical procedures.

Stroke and clinical trials

The FDA encourages diverse participation in clinical trials. If you think a clinical trial may be right for you, talk to your health care provider. You can also search for clinical trials in your area at www.ClinicalTrials.gov.

How to report a serious problem to MedWatch?

Complete and submit the report Online. Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

How is Lemtrada administered?

Lemtrada is administered by intravenous infusion. It is available only through the Lemtrada Risk Evaluation and Mitigation Strategy (REMS) Program External Link Disclaimer, a restricted distribution program to help ensure that the medicine’s benefits outweigh the risks.

What is Alemtuzumab used for?

Facts about Alemtuzumab (Lemtrada, Campath) Lemtrada is one of several medicines used to treat relapsing forms of multiple sclerosis (MS). This type of MS causes “attacks” or “relapses,” which are periods of time when MS symptoms worsen. Lemtrada is administered by intravenous infusion.

How long does it take for Lemtrada to cause headaches?

Sudden severe headache or neck pain. Most patients taking Lemtrada who developed stroke or tears in the artery linings, developed symptoms within 1 day of receiving Lemtrada. One patient reported symptoms that occurred 3 days after treatment.

What is it called when you have a stroke and you have a numbness in your face?

Patients or their caregivers should seek emergency treatment as soon as possible if the patient experiences signs or symptoms of a stroke or tears in the lining of the head and neck arteries, called arterial dissection , which can include: Sudden numbness or weakness in the face, arms, or legs, especially if it occurs on only one side of the body.

When was Alemtuzumab approved?

Alemtuzumab is also approved under the brand name Campath, which was approved in May 2001 to treat a type of cancer called B-cell chronic lymphocytic leukemia (B-CLL). The Campath drug label will also be updated to include these risks in the Adverse Reactions section under Postmarketing Experience. Patients or their caregivers should seek emergency ...

What happens when you have a stroke?

Sudden trouble with walking, dizziness, or loss of balance or coordination. Sudden severe headache or neck pain. A stroke can occur when blood flow to an area of the brain is cut off or when there is bleeding into the brain. When brain cells are deprived of blood flow and oxygen they can begin to die within minutes.

How long does Xeloda 1250 mg/m2 last?

485 In 875 patients with either metastatic breast or colorectal cancer who received at least one 486 dose of XELODA 1250 mg/m2 twice daily as monotherapy for 2 weeks followed by a 487 1-week rest period, grade 3 (1.5-3 x ULN) hyperbilirubinemia occurred in 15.2% (n=133) 488 of patients and grade 4 (>3 x ULN) hyperbilirubinemia occurred in 3.9% (n=34) of 489 patients. Of 566 patients who had hepatic metastases at baseline and 309 patients without 490 hepatic metastases at baseline, grade 3 or 4 hyperbilirubinemia occurred in 22.8% and 491 12.3%, respectively. Of the 167 patients with grade 3 or 4 hyperbilirubinemia, 18.6% 492 (n=31) also had postbaseline elevations (grades 1 to 4, without elevations at baseline) in 493 alkaline phosphatase and 27.5% (n=46) had postbaseline elevations in transaminases at 494 any time (not necessarily concurrent). The majority of these patients, 64.5% (n=20) and 495 71.7% (n=33), had liver metastases at baseline. In addition, 57.5% (n=96) and 35.3% 496 (n=59) of the 167 patients had elevations (grades 1 to 4) at both prebaseline and 497 postbaseline in alkaline phosphatase or transaminases, respectively. Only 7.8% (n=13) 498 and 3.0% (n=5) had grade 3 or 4 elevations in alkaline phosphatase or transaminases.

How long after a meal can you take Xeloda?

571 In all clinical trials, patients were instructed to administer XELODA within 30 minutes 572 after a meal. Since current safety and efficacy data are based upon administration with 573 food, it is recommended that XELODA be administered with food (see DOSAGE AND 574 ADMINISTRATION).

What is 360 Xeloda?

360 • XELODA in combination with docetaxel is indicated for the treatment of patients 361 with metastatic breast cancer after failure of prior anthracycline-containing 362 chemotherapy.

Can you stop taking Xeloda 565?

563 Patients experiencing grade 2 stomatitis (painful erythema, edema or ulcers of the mouth 564 or tongue, but able to eat) or greater should be instructed to stop taking XELODA 565 immediately. Initiation of symptomatic treatment is recommended (see DOSAGE AND 566 ADMINISTRATION).

Is Xeloda 372 a DPD?

XELODA is contraindicated in patients who have a known 374 hypersensitivity to 5-fluorouracil. XELODA is contraindicated in patients with known 375 dihydropyr imidine dehydrogenase (DPD) deficiency. XELODA is also contraindicated in 376 patients with severe renal impairment (creatinine clearance below 30 mL/min [Cockroft 377 and Gault]) (see CLINICAL PHARMACOLOGY: Special Populations).

Does Xeloda affect docetaxel?

XELODA was found to have no effect on the pharmacokinetics of docetaxel (Cmaxand AUC) and docetaxel has no effect on the pharmacokinetics of capecitabine and the 5-FU precursor 5’-DFUR. Special Populations .

Does capecitabine inhibit cytochrome P450?

147 In vitro enzymatic studies with human liver microsomes indicated that capecitabine and 148 its metabolites (5’-DFUR, 5’-DFCR, 5-FU, and FBAL) had no inhibitory effects on 149 substrates of cytochrome P450 for the major isoenzymes such as 1A2, 2A6, 3A4, 2C9, 150 2C19, 2D6, and 2E1.

What safety concern is FDA announcing?

Based on a completed U.S. Food and Drug Administration (FDA) review of a large randomized safety clinical trial, we have concluded there is an increased risk of serious heart-related events such as heart attack or stroke, cancer, blood clots, and death with the arthritis and ulcerative colitis medicines Xeljanz and Xeljanz XR (tofacitinib).

What is FDA doing?

We are requiring revisions to the Boxed Warning, FDA’s most prominent warning, for Xeljanz/Xeljanz XR, Olumiant, and Rinvoq to include information about the risks of serious heart-related events, cancer, blood clots, and death.

What should patients do?

Those taking Xeljanz/Xeljanz XR, Olumiant, or Rinvoq should tell your health care professional if you are a current or past smoker, or have had a heart attack, other heart problems, stroke, or blood clots in the past as these may put you at higher risk for serious problems with the medicines.

What should health care professionals do?

Health care professionals should consider the benefits and risks for the individual patient prior to initiating or continuing therapy with Xeljanz/Xeljanz XR, Olumiant, or Rinvoq.

What did FDA find?

When FDA first approved Xeljanz, we required the manufacturer, Pfizer, to conduct a safety clinical trial in patients with RA who were taking methotrexate to evaluate the risk of serious heart-related events, cancer, and infections.

What is my risk?

All medicines have side effects even when used correctly as prescribed, but in general the benefits of taking a medicine outweigh these risks. It is important to know that people respond differently to all medicines depending on their health, other medicines they are taking, the diseases they have, genetic factors, and many other factors.

How do I report side effects from Xeljanz, Olumiant, or Rinvoq?

To help FDA track safety issues with medicines, we urge patients and health care professionals to report side effects involving Xeljanz/Xeljanz XR, Olumiant, Rinvoq, or other medicines to the FDA MedWatch program, using the information in the “Contact FDA” box at the bottom of the page.

What is the FDA?

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.

How often do stroke survivors have problems?

According to the Centers for Disease Control and Prevention, someone in the United States has a stroke every 40 seconds.

Can stroke cause weakness?

Although stroke is a brain disease, it can affect the entire body and sometimes causes long-term disability such as complete paralysis of one side of the body (hem iplegia) or one-sided weakness (hemiparesis) of the body.

How long does Xeloda last?

twice daily orally for 2 weeks followed by a one week rest period in 3-week cycles (2.2) .  Adjuvant treatment is recommended for a total of 6 months (8 cycles) . (2.2)  In combination with docetaxel, the recommended dose of XELODA is 1250 mg/m.

Does fluorouracil affect the micronucleus?

Fluorouracil also causes chromosomal abnormalities in the mouse micronucleus test . in vivo. In studies of fertility and general reproductive performance in female mice, oral capecitabine doses of 760 mg/kg/day (about 2300 mg/m. 2/day) disturbed estrus and consequently caused a decrease in fertility.

When was the pulmonary stent label updated?

The Dosage and Administration, Warning and Precautions, and Patient Information sections of the labeling were updated September 2019 to include Interstitial Lung Disease/Pneumonitis.

When was the Interstitial Lung Disease label updated?

The Dosage and Administration, Warning and Precautions, and Patient Information sections of the labeling were updated September 2019 to include Interstitial Lung Disease/Pneumonitis. FDA is evaluating the need for regulatory action.