Neulasta shot

Kgirl said:

Neulasta - carcinogen?
I believe that the doctor was talking about procrit which is used to increase your red blood cell count. Starting last year, some studies were suggesting that this drug might promote cancer as well as its desired effect. The latest I've heard is that several oncology professional associations are discouraging its use. Personally, I feel more comfortable with a blood transfusion instead of this drug and that's what I've done so far.

Kathy

lindaprocopio said:

There is a 'Black Box' Warning on Procrit, Aranesp, & Epogen
There was a Black Box Warning issued on Procrit in 2007:

Published: March 09, 2007
Reviewed by Robert Jasmer, MD; Associate Clinical Professor of Medicine, University of California, San Francisco . Earn CME/CE credit
for reading medical news


ROCKVILLE, Md., March 9, 2007 -- The FDA warned today that aggressive use of erythropoiesis-stimulating agents to raise hemoglobin to a target of 12 g/dL or higher was associated with "serious and life-threatening side-effects and/or death." The agency ordered a black-box warning for the drugs that recommended the lowest possible dose to slowly raise the hemoglobin concentration to the lowest level that will avoid the need for a blood transfusion. Moreover, FDA said that there has never been any evidence to support claims made in direct-to-consumer advertising that treatment with darbepoetin (Aranesp), epoetin alfa (Epogen), or epoetin alfa (Procrit) could increase energy or ease fatigue in patients undergoing cancer therapy.

For cancer patients who are not on chemotherapy, the FDA said that erythropoiesis-stimulating agents did not benefit anemia. But they appeared to shorten time to death.

At a press briefing, Richard Pazdur, M.D., director of the Office of Oncology Drug Products at the FDA's Center for Drug Evaluation and Research, said that on the basis of data from several recently reported clinical trials, a black box warning had been added to the labels of the three drugs.

The warning states:

"Avoid serious cardiovascular and arterial and venous thromboembolic events by using the lowest dose of Aranesp, Epogen, or Procrit that will gradually raise the hemoglobin concentration to the lowest level sufficient to avoid the need for blood transfusion.
Aranesp, Epogen, and Procrit and other erythropoiesis-stimulating agents increased the risk for death and for serious cardiovascular events when dosed to achieve a target a hemoglobin of greater than 12 g/dL.

Use of erythropoiesis-stimulating agents to achieve a target hemoglobin of 12 g/dL or greater in cancer patients shortened the time to tumor progression in patients with advanced head and neck cancer receiving radiation therapy; shortened overall survival and increased deaths attributed to disease progression in patients with metastatic breast cancer receiving chemotherapy; and increased the risk of death in patients with active malignant disease not under treatment with chemotherapy or radiation therapy. Erythropoiesis-stimulating agents are not indicated for this patient population."

Patients treated before surgery with epoetin alfa to reduce allogenic red blood cell transfusions had a higher incidence of deep vein thrombosis. Aranesp is not approved for this indication.

Karen Weiss, M.D., deputy director of the FDA's Office of Oncology Drug Products, said the FDA became concerned when it started to receive results from a number of trials investigating aggressive use of erythropoiesis-stimulating agents to raise hemoglobin to targets higher than the targets on the drug label.

The results of those "more is better" studies were uniformly bad-ranging from increased cardiovascular events to progression of cancer.

A puzzling aspect of the FDA action today was the acknowledgement that there was no evidence to support marketing claims that the drugs could restore energy or reduce fatigue for patient in chemotherapy or radiation therapy.

Rafel Dwain Rieves, M.D., acting director, division of medical imaging and hematology products, said those claims were an extension of quality-of-life labeling from studies in renal dialysis patients.

But Dr. Rieves said that even the renal labeling was not supported by good quality-of-life measures, but rather results of a series of questionnaires that asked open-ended questions about a wide range of topics including sex life, appetite, happiness, and energy.


Dr. Pazdur said that going forward, all patients should be started on the lowest possible dose of Aranesp, Epogen, or Procrit.

Additionally, for all patients, physicians should:

Measure hemoglobin twice a week for two to six weeks after any dosage adjustment to ensure that hemoglobin has stabilized in response to the dose change.
Withhold the dose of the erythropoiesis-stimulating agents if the hemoglobin increase exceeds 12 g/dL or rises by 1g/dL in any two-week period.

The label was also changed to include this evidence from recently reported clinical trials:

Interim results from the Danish Head and Neck Cancer Study Group trial (DAHANCA 10), an open-label, randomized trial that compared radiation therapy alone to radiation plus Aranesp in treatment of advanced head and neck cancer found that three-year loco-regional control was significantly worse for patients in the Aranesp arm (P=0.01) and overall survival favored those not treated with Aranesp, but the difference was not statistically significant. The trial was terminated Dec. 1, 2006.

Results similar to the DAHANCA 10 study-increased tumor progression and decreased survival-were reported by Henke, et al at the May 4, 2004, meeting of the Oncologic Drugs Advisory Committee.

In January 2007 the FDA was notified of the results of a 989 patient, multi-center, double-blind, randomized, placebo-controlled study of Aranesp in anemic cancer patients who are not receiving chemotherapy. The target hemoglobin in the Aranesp treatment group was 12 g/dl. The study results provided to the FDA show Aranesp did not reduce the need for red blood cell transfusions and showed an increase in mortality in patients receiving Aranesp compared to those receiving placebo (hazard ratio 1.25; 95% confidence interval: 1.04, 1.51).
The FDA was notified in February 2007 of the final results of a double-blind, placebo controlled study to evaluate whether use of epoetin alpha in anemic non-small cell lung cancer patients not on chemotherapy improved their quality of life. The epoetin alfa dose was titrated to maintain a hemoglobin level of 12 to 14 g/dL; epoetin alfa was dosed at 40,000 IU every week. The study was terminated early when the data safety monitoring committee determined that the median time to death was 68 days in the epoetin alfa arm versus 131 days in the placebo arm (P=0.040 and the majority of deaths were due to disease progression. Also treatment with epoetin alfa did not significantly reduce the need for transfusion or improve the quality of life.

In February 2007, the FDA was notified by Roche that it was suspending a study of a new erythropoiesis-stimulating agent because of safety concerns. The study was a multi-center, randomized, dose-finding assessment of a pegylated epoetin beta product in anemic patients with Stage IIIB or IV non-small cell lung cancer who were receiving first line chemotherapy. Three dosing regimens of the investigational drug were being compared with Aranesp (given according to an FDA-approved dosing regimen). The dose of pegylated epoetin beta was titrated to maintain the hemoglobin level between 11 and 13 g/dL. An interim analysis, after randomization of 153 patients, demonstrated a numerical imbalance in the number of deaths across the four arms of the study.

The FDA was notified in February 2007 of the preliminary results of a 681-patient, multicenter, randomized, open-label, non-inferiority study of Procrit compared with the standard of care in adult patients undergoing elective spinal surgery. Procrit was administered according to the dosage and administration section of the label for pretreatment hemoglobin values >10 and < 13 g/dL. The frequency of deep venous thrombosis in patients treated with Procrit was 4.7% (16 patients), more than twice that of patients who received usual blood conservation care (frequency of 2.1%, seven patients).

Two clinical studies and an editorial published in the New England Journal of Medicine last November addressed safety concerns about the use of erythropoiesis stimulating agents in the treatment of anemia of chronic renal failure. The 1,400-patient CHOIR study demonstrated increases in serious and potentially life-threatening cardiovascular events when Procrit was administered to reach target hemoglobin levels 13.5 g/dL compared with a lower target-11.3 g/dL. The 600-patient CREATE study trended toward more cardiovascular events in a pattern similar to the CHOIR study, thus strengthening the findings of the CHOIR study. The CREATE study examined the use of epoetin beta, a product not approved in the U.S.

Finally, the Centers for Medicare and Medicaid Services responded quickly to the FDA action by instructing local Medicare carriers that it plans to deny reimbursement for darbepoetin alfa and epoetin alfa used for anemia of cancer, although it will continue to cover the drugs when they are used to treat anemia due to chemotherapy.

(http://www.medpagetoday.com/ProductAlert/Prescriptions/5231 )

Linn1 said:

Stage 4 also with Neulasta
Hi-
I was (am) stage 4 - currently receiving experimental trmt for 2nd recurrence. However, the first round I had 4 shots and several transfusions due to the intensity of the chemo and level of cancer. I really became ill after the neulasta...honestly, I'm not sure which was worse - the chemo or neulasta for me. The bone pain was intense. Almost like the worse flu you could experience. It went to my core. Also, I can't really say whether it was the shot or transfusions that ultimately raised my wbc and rbc. Regardless, I needed the assistance, the alternative was not good.

Do your best to rest, move your body as you are able to, and keep your strength and maintain your nutrition. Are you well enough to get to a restorative yoga class for cancer patients, that may prove to be soothing for you? I was on numerous pain meds at the time and definitely had to rely on those to get me thru the treatment and shots.

We all say it on this site...but, hang in there and keep communicating.

Javary said:

neulasta side effects
Hello

I have had primary peritoneal cancer which is treated the same as ovarian cancer. I am in my 4th reoccurance. Am just starting treatment again. Have had neulasta shots with all my treatments. Yes the side effects are miserable. Bed ridden for 3-4 days can't eat or drink usually become very dehydrated. But am usually able to recover very quickly, try gatorade the mild flavored ones to sip on during this time. by day #6 post shot you will feel 100% better. As with any medication every person reacts differently. It depends on how weak you are when you take it in the first place, that goes for the chemo treatments also. For nausea I take sublingual zofran 8mg every 12 hours. works immediately and is very effective.
With out it the nausea and vomiting are miserable, but is temporary. Having been an RN for 15 years one of my favorite sayings about cancer and its treatments is " which is worse the disease or the treatment". But I guess the alternative is dead. But I am not to the point where that is a good alternative yet. I feel great most of the time, am fat and sassy and do what ever I want. One thing everyone needs to remember is that When we hear the word cancer our brain goes numb and that becomes our focus. Remember the old saying stop and smell the roses, watch for Gods little daily miracles, sunrises, children, unexpected little things that happen each day, that we miss because we have that nasty disease and its even nastier treatments. God Bless you all.

lindaprocopio said:

Here's something more recent, from April, 2009:
THURSDAY, April 30 — Two new studies provide more evidence that drugs such as Procrit and Aranesp, often used by cancer patients to fight anemia-linked fatigue, may boost the risk of death and serious adverse events such as blood clots.

These drugs, called erythropoiesis-stimulating agents (ESAs), have also been associated in prior studies with increased risk of heart attack, stroke and tumor growth. The primary argument for the continued use of these drugs is that they help reduce the number of blood transfusions some cancer patients need, while improving quality of life.

However, a co-author of one paper, Dr. Anthony Reiman, from the University of Alberta, Canada, said his team is “supporting other groups that are recommending great caution in using these drugs for cancer patients, and in routine circumstances they may not be indicated. We hope the drugs would still be made available for people for whom transfusion isn’t a good option — but those are very limited circumstances.”

ESAs include erythropoietin (Epogen, Procrit) and darbepoetin (Aranesp). They work by stimulating the bone marrow to produce new red blood cells, according to the U.S. National Institutes of Health. They are used to treat anemia caused by chemotherapy and to treat anemia in people with chronic kidney disease who are on dialysis.

But rising concern led the U.S. Food and Drug Administration in 2007 to ask the drugs’ manufacturers to add a “black box” warning to the medications. The warning indicates that the medications should be used at the lowest possible doses to avoid risks such as blood clots, heart attacks, stroke, congestive heart failure, increased tumor growth and an increased risk of death. The FDA also recommended that the medications be prescribed at the lowest doses possible because trials generally indicated an increased risk when blood levels were raised above 12 grams per deciliter.

The two new studies may buttress that move. In the first study, Reiman and other researchers analyzed data from 52 clinical trials that included more than 12,000 people.

The result: “The use of drugs to encourage red blood cell formation in cancer patients with anemia increases the risk of death and serious adverse events such as blood clots,” according to co-researcher Dr. Scott Klarenbach, an assistant professor at the University of Alberta.

Although risk of death was only 15 percent to 16 percent higher among patients who used the drugs than those who did not, the high death rates among cancer patients means this increase could affect a significant number of people, the researchers say.

“These medications should not routinely be used as an alternative to blood transfusions in patients with anemia related to cancer, unless future studies demonstrate safety and clinical benefits,” Klarenbach said. “While use of medications [instead of blood transfusion] may be appealing to both patients and practitioners, their use is associated with an increased risk of death.”

azgrandma said:

They give it to me
I have not had a chocice, they give it afte reach chemo treatment
Did not know you could refuse to get the neulasta

Do yu think we shuld contnue to get it