report stroke to fda for patient on xeloda

What are the warnings and precautions for Xeloda?

2 Reference ID: 3891191 ----------------------- WARNINGS AND PRECAUTIONS Coagulopathy : May result in bleeding, death. Monitor anticoagulant response (e.g., INR) and adjust anticoagulant dose accordingly. Diarrhea : May be severe. Interrupt XELODA treatment immediately until diarrhea resolves or decreases to grade 1.

What is the Xeloda model number for Xeloda?

XELODA 00004110020 XELODA 00004110051 XELODA 00004110116 XELODA 00004110150 XELODA 00004110175 XELODA 54569571700 XELODA 54868414300

When was Xeloda approved for oral use in the US?

XELODA (capecitabine) tablets, for oral use Initial U.S. Approval: 1998 WARNING: XELODA-WARFARIN INTERACTION See full prescribing information for complete boxed warning.

What should I monitor when taking Xeloda and phenytoin together?

• Phenytoin: Monitor phenytoin levels in patients taking XELODA concomitantly with phenytoin. The phenytoin dose may need to be reduced. • Leucovorin: The concentration of 5-fluorouracil is increased and its toxicity may be enhanced

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 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.

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.

How do you manage 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.

How long can you stay on 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).

When do Xeloda side effects start?

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.

Does Xeloda affect the heart?

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. These effects may be more common in people who have ever had heart disease before.

Can capecitabine cause blood clots?

Having capecitabine increases the risk of blood clots such as deep vein thrombosis (DVT). People with a DVT are at risk of developing a pulmonary embolism (PE). This is when part of the blood clot breaks away and travels to the lung.

What drugs interact with Xeloda?

Most frequently checked interactionsamlodipine.aspirin.atorvastatin.Cymbalta (duloxetine)dexamethasone.gabapentin.levothyroxine.lisinopril.More items...

How can I reduce the side effects of capecitabine?

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.

Can Xeloda cause neuropathy?

Peripheral neuropathy secondary to 5-flourouracil and capecitabine (Xeloda) has been reported. We report the first case of exacerbation of peripheral neuropathy related to topical 5-flourouracil (Efudex).

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.

Clinical Context

Acute ischemic stroke occurs when the blood supply to part of the brain is reduced or interrupted, resulting in the death of brain cells in that area.

Device Description

The Trevo Retriever family (510 (k) clearance K173352 ), including the Trevo ProVue and Trevo XP ProVue Retriever, are Class II medical devices cleared in February 2018.

Indications for Use

A clinical study was used to support an expanded indication for use of the Trevo Retriever to include the following:

Context of Clinical Outcome Assessment (COA) Use

In the clinical study used to support the expanded indications for use, the co-primary effectiveness endpoint included:

Lessons Learned

The use of the UW-mRS along with a more traditional ClinRO like the dichotomized mRS can be used to validate this new ClinRO as it is used more in clinical studies of acute ischemic stroke therapies.

What is the phase 1 study of Xeloda?

A Phase 1 study evaluated the effect of XELODA on the pharmacokinetics of docetaxel ( Taxotere) and the effect of docetaxel on the pharmacokinetics of XELODA was conducted in

What is Xeloda used for?

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

Does leucovorin increase fluorouracil 5?

The concentration of-fluorouracil 5 is increased and its toxicity may be enhanced by leucovorin.Deaths from severe enterocolitis, diarrhea, and dehydration have been reported in elderly patientsreceiving weekly leucovorin and fluorouracil.

Can Xeloda cause fetal harm?

XELODA may cause fetal harm when given to a pregnant woman. Capecitabinecausedembryolethality and teratogenicity in mice and embryolethalityin monkeys when administeredduring organogenesis. If this drug is used during pregnancy, or if a patientegnant becomes prwhile receiving XELODA, the patient should be apprised of the potential hazardfetus [seeto theUse in Specific Populations (8.1)].

Is Xeloda a contraindication?

XELODA is contraindicated in patients with known hypersensitivity to capecitabine or to any of its components. XELODA is contraindicated in patients who have a known hypersensitivity to 5-fluorouracil.