Generic Name: Sipuleucel-T

Trade Name: Provenge®

How is this drug used? Provenge is used for the treatment of prostate cancer that has few or no symptoms, but has spread to other parts of the body and does not respond to hormone therapy (metastatic, hormone-refractory prostate cancer).

What is the mechanism of action? Provenge mixes your own immune cells with a protein that prompts an immune response against cancer cells.

How is Provenge given (administered)? Provenge is given as an intravenous (IV) infusion. You will receive a total of three infusions about two weeks apart. Approximately three days before each infusion, a sample of your immune cells will be collected through a process known as leukapheresis; the cells are used to produce Provenge.

How are patients monitored? Patients will usually have scheduled meetings with their healthcare provider while they are being treated with Provenge. Patients may undergo physical examinations, lab tests, or imaging to assess side effects and response to therapy.

What are the most common side effects of treatment with Provenge?

• Chills
• Fatigue
• Fever
• Back pain
• Nausea
• Joint ache
• Headache

This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.

Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.
What can patients do to help alleviate or prevent discomfort and side effects?

• Pay careful attention to the physician’s instructions, and discuss side effects with your physician.

Are there any special precautions patients should be aware of before starting treatment?

• Patients should inform their physician about all medical conditions, including heart problems, lung problems, and history of stroke.
• Patients should inform their physician of any other medication or supplement they are taking (whether prescription or over-the-counter).

When should patients notify their physician?

Tell your doctor if you experience any side effects that bother you or don’t go away. Watch for signs of serious side effects and report these to your doctor immediately: breathing problems, chest pains, racing heart or irregular heartbeats, dizziness, nausea or vomiting, a fever over 100º F, or redness or pain at the infusion or collection sites.

What is a package insert?
A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers. A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.

Copyright © 2012 CancerConnect Last updated 05/12.

Important Limitations of Use

The information provided above on the drug you have selected is provided for your information only and is not a substitute for consultation with an appropriate medical doctor. We are providing this information solely as a courtesy and, as such, it is in no way a recommendation as to the safety, efficacy or appropriateness of any particular drug, regimen, dosing schedule for any particular cancer, condition or patient nor is it in any way to be considered medical advice. Patients should discuss the appropriateness of a particular drug or chemotherapy regimen with their physician.

As with any printed reference, the use of particular drugs, regimens and drug dosages may become out-of-date over time, since new information may have been published and become generally accepted after the latest update to this printed information. Please keep in mind that health care professionals are fully responsible for practicing within current standards, avoiding use of outdated regimens, employing good clinical judgment in selecting drugs and/or regimens, in calculating doses for individual patients, and verifying all dosage calculations.

DISCLAIMER OF WARRANTIES

CANCERCONSULTANTS.COM SPECIFICALLY DISCLAIMS AND EXCLUDES ALL EXPRESSED OR IMPLIED WARRANTIES, INCLUDING ANY IMPLIED WARRANTIES AS TO QUALITY, ACCURACY (INCLUDING TYPOGRAPHICAL ERRORS), MERCHANTABILITY, OR FITNESS FOR ANY PARTICULAR PURPOSE OF THE INFORMATION CONTAINED HEREIN. CANCERCONSULTANTS.COM DISCLAIMS ALL LIABILITY OR DAMAGES ARISING FROM ANY USE OF THE INFORMATION.

The prescribing physician is solely responsible for making all decisions relating to appropriate patient care including, but not limited to, drugs, regimens, dose, schedule, and any supportive care.

Generic Name: Sipuleucel-T

Trade Name: Provenge®

How is this drug used? Provenge is used for the treatment of prostate cancer that has few or no symptoms, but has spread to other parts of the body and does not respond to hormone therapy (metastatic, hormone-refractory prostate cancer).

What is the mechanism of action? Provenge mixes your own immune cells with a protein that prompts an immune response against cancer cells.

How is Provenge given (administered)? Provenge is given as an intravenous (IV) infusion. You will receive a total of three infusions about two weeks apart. Approximately three days before each infusion, a sample of your immune cells will be collected through a process known as leukapheresis; the cells are used to produce Provenge.

How are patients monitored? Patients will usually have scheduled meetings with their healthcare provider while they are being treated with Provenge. Patients may undergo physical examinations, lab tests, or imaging to assess side effects and response to therapy.

What are the most common side effects of treatment with Provenge?

• Chills
• Fatigue
• Fever
• Back pain
• Nausea
• Joint ache
• Headache

This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.

Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.
What can patients do to help alleviate or prevent discomfort and side effects?

• Pay careful attention to the physician’s instructions, and discuss side effects with your physician.

Are there any special precautions patients should be aware of before starting treatment?

• Patients should inform their physician about all medical conditions, including heart problems, lung problems, and history of stroke.
• Patients should inform their physician of any other medication or supplement they are taking (whether prescription or over-the-counter).

When should patients notify their physician?

Tell your doctor if you experience any side effects that bother you or don’t go away. Watch for signs of serious side effects and report these to your doctor immediately: breathing problems, chest pains, racing heart or irregular heartbeats, dizziness, nausea or vomiting, a fever over 100º F, or redness or pain at the infusion or collection sites.

What is a package insert?
A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers. A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.

Copyright © 2012 CancerConnect Last updated 05/12.

Important Limitations of Use

The information provided above on the drug you have selected is provided for your information only and is not a substitute for consultation with an appropriate medical doctor. We are providing this information solely as a courtesy and, as such, it is in no way a recommendation as to the safety, efficacy or appropriateness of any particular drug, regimen, dosing schedule for any particular cancer, condition or patient nor is it in any way to be considered medical advice. Patients should discuss the appropriateness of a particular drug or chemotherapy regimen with their physician.

As with any printed reference, the use of particular drugs, regimens and drug dosages may become out-of-date over time, since new information may have been published and become generally accepted after the latest update to this printed information. Please keep in mind that health care professionals are fully responsible for practicing within current standards, avoiding use of outdated regimens, employing good clinical judgment in selecting drugs and/or regimens, in calculating doses for individual patients, and verifying all dosage calculations.

DISCLAIMER OF WARRANTIES

CANCERCONSULTANTS.COM SPECIFICALLY DISCLAIMS AND EXCLUDES ALL EXPRESSED OR IMPLIED WARRANTIES, INCLUDING ANY IMPLIED WARRANTIES AS TO QUALITY, ACCURACY (INCLUDING TYPOGRAPHICAL ERRORS), MERCHANTABILITY, OR FITNESS FOR ANY PARTICULAR PURPOSE OF THE INFORMATION CONTAINED HEREIN. CANCERCONSULTANTS.COM DISCLAIMS ALL LIABILITY OR DAMAGES ARISING FROM ANY USE OF THE INFORMATION.

The prescribing physician is solely responsible for making all decisions relating to appropriate patient care including, but not limited to, drugs, regimens, dose, schedule, and any supportive care.

Multiple myeloma is a cancer of plasma cells, which are a special type of white blood cell that are part of the body’s immune system. Patients with multiple myeloma have increased numbers of abnormal plasma cells that may produce increased quantities of dysfunctional antibodies detectable in the blood and/or urine.

Revlimid is an oral medication that can stop or slow the growth of cancerous myeloma cells within the bone marrow. It has been approved in combination with dexamethasone for multiple myeloma patients who have received at least one prior therapy. Revlimid has been associated with an increased risk of new cancers and the FDA recently made a safety announcement regarding the drug.[1]

Despite the increased risk of new cancers, Revlimid continues to be studied for its use as maintenance therapy in multiple myeloma. Three double-blind, phase 3, multi-center, randomized trials evaluated Revlimid maintenance therapy. Two studies randomly assigned patients to Revlimid or placebo after stem-cell transplantation. The third study included patients who were ineligible for stem-cell transplantation; these patients were randomly assigned to Revlimid or placebo after oral induction therapy. In all three studies, study-drug assignments were unblended early after Revlimid maintenance showed significant benefit.

In the first study, researchers assigned 614 patients under age 65 to Revlimid or placebo after transplantation.[2] They found that maintenance therapy with Revlimid improved progression-free survival, with a progression-free survival of 41 months in the Revlimid group compared to 23 months in the placebo group. After a median follow-up of 45 months, more than 70 percent of patients in both groups were alive at 4 years. There was an increased rate of new cancers in the Revlimid group, with 32 new cancers in the Revlimid group and 12 in the placebo group. However, the researchers concluded that the benefit of Revlimid outweighed the risk of new cancers.

In the second study, 460 patients age 71 or younger were randomly assigned to Revlimid or placebo after transplantation.[3] Patients in the Revlimid group had a significantly longer time to disease progression compared to those in the placebo group—the median time to progression was 46 months in the Revlimid group and 27 months in the placebo group. Patients in the Revlimid group experienced more grade 3 and 4 adverse events and 18 (8%) patients in the Revlimid group had second primary cancers, compared with 6 (3%) in the placebo group. A total of 35 patients who received Revlimid (15%) and 53 patients who received placebo (23%) died.

The third study involved patients who were ineligible for transplantation.[4] In this study, patients were randomly assigned to one of three groups:152 patients received oral melphalan-prednisone-Revlimid induction followed by Revlimid (MPR-R); 153 patients patients received oral melphalan-prednisone-Revlimid followed by placebo (MPR); and 154 patients received melphalan-prednisone followed by placebo (MP). The median progression-free survival was significantly longer with Revlimid maintenance therapy—the MPR-R group had a median progression-free survival of 31 months, compared to 14 months for the MPR group and 13 months for the MP group. The rate of new cancers was 7% with MPR-R, 7% with MPR, and 3% with MP.

In an accompanying editorial, Ashraf Badros notes that while Revlimid appears to offer benefit as maintenance therapy for multiple myeloma, it does come with risks, namely the increased risk of second primary cancers.[5] Furthermore, he questions whether progression-free survival is the optimal endpoint for maintenance therapy and whether it is the most cost-effective treatment.

References:

Copyright © 2012 CancerConsultants. All Rights Reserved.

Multiple myeloma is a cancer of plasma cells, which are a special type of white blood cell that are part of the body’s immune system. Patients with multiple myeloma have increased numbers of abnormal plasma cells that may produce increased quantities of dysfunctional antibodies detectable in the blood and/or urine.

Revlimid is an oral medication that can stop or slow the growth of cancerous myeloma cells within the bone marrow. It has been approved in combination with dexamethasone for multiple myeloma patients who have received at least one prior therapy. Revlimid has been associated with an increased risk of new cancers and the FDA recently made a safety announcement regarding the drug.[1]

Despite the increased risk of new cancers, Revlimid continues to be studied for its use as maintenance therapy in multiple myeloma. Three double-blind, phase 3, multi-center, randomized trials evaluated Revlimid maintenance therapy. Two studies randomly assigned patients to Revlimid or placebo after stem-cell transplantation. The third study included patients who were ineligible for stem-cell transplantation; these patients were randomly assigned to Revlimid or placebo after oral induction therapy. In all three studies, study-drug assignments were unblended early after Revlimid maintenance showed significant benefit.

In the first study, researchers assigned 614 patients under age 65 to Revlimid or placebo after transplantation.[2] They found that maintenance therapy with Revlimid improved progression-free survival, with a progression-free survival of 41 months in the Revlimid group compared to 23 months in the placebo group. After a median follow-up of 45 months, more than 70 percent of patients in both groups were alive at 4 years. There was an increased rate of new cancers in the Revlimid group, with 32 new cancers in the Revlimid group and 12 in the placebo group. However, the researchers concluded that the benefit of Revlimid outweighed the risk of new cancers.

In the second study, 460 patients age 71 or younger were randomly assigned to Revlimid or placebo after transplantation.[3] Patients in the Revlimid group had a significantly longer time to disease progression compared to those in the placebo group—the median time to progression was 46 months in the Revlimid group and 27 months in the placebo group. Patients in the Revlimid group experienced more grade 3 and 4 adverse events and 18 (8%) patients in the Revlimid group had second primary cancers, compared with 6 (3%) in the placebo group. A total of 35 patients who received Revlimid (15%) and 53 patients who received placebo (23%) died.

The third study involved patients who were ineligible for transplantation.[4] In this study, patients were randomly assigned to one of three groups:152 patients received oral melphalan-prednisone-Revlimid induction followed by Revlimid (MPR-R); 153 patients patients received oral melphalan-prednisone-Revlimid followed by placebo (MPR); and 154 patients received melphalan-prednisone followed by placebo (MP). The median progression-free survival was significantly longer with Revlimid maintenance therapy—the MPR-R group had a median progression-free survival of 31 months, compared to 14 months for the MPR group and 13 months for the MP group. The rate of new cancers was 7% with MPR-R, 7% with MPR, and 3% with MP.

In an accompanying editorial, Ashraf Badros notes that while Revlimid appears to offer benefit as maintenance therapy for multiple myeloma, it does come with risks, namely the increased risk of second primary cancers.[5] Furthermore, he questions whether progression-free survival is the optimal endpoint for maintenance therapy and whether it is the most cost-effective treatment.

References:

Copyright © 2012 CancerConsultants. All Rights Reserved.

Infections with certain viruses, bacteria, and parasites have been identified as strong risk factors for specific cancers. To examine the link between infections and cancer, researchers performed a systematic analysis of the proportion of cancer cases attributable to infection in 2008. They used data on cancer incidence from the GLOBOCAN project along with epidemiological data regarding the causal effects of infection on cancer. The data included information on 27 types of cancer from 182 countries.

They found that of the 12.7 million new cancer cases that occurred worldwide in 2008, 16 percent—or roughly two million—were attributable to infections. The rate of infection-related cancer was about three times higher in developing countries. For example, 3.3 percent of cancers in Australia and New Zealand were infection related, whereas 32.7 percent of cancers in sub-Saharan Africa were attributable to infections. The four main infections associated with cancer were human papillomavirus, hepatitis C, hepatitis B, and Helicobacter pylori. These infections were responsible for approximately 1.9 million cancer cases in 2008, mainly gastric, liver, and cervical cancers.

Cervical cancer accounted for about half of the infection-related cancers in women. Liver and gastric cancers accounted for more than 80 percent of the infection-related cancers in men.  About 30 percent of infection-related cancers occurred in people younger than 50 years. It’s important to note that it takes decades of chronic infection before an infection progresses to cancer.

Based on the statistics, the researchers noted that approximately two million cancer cases each year might be preventable with better public health methods for preventing infection. In an accompanying editorial, Dr. Goodarz Danaei, an assistant professor of global health at Harvard School of Public Medicine in Boston, noted that vaccines for HPV and hepatitis B are effective and that increasing their availability should be a priority for higher risk countries.[2] He suggests that increasing vaccine coverage could reduce the global burden of cancer.

References:

Copyright © 2012 CancerConsultants. All Rights Reserved.

Generic Name: Sipuleucel-T

Trade Name: Provenge®

How is this drug used? Provenge is used for the treatment of prostate cancer that has few or no symptoms, but has spread to other parts of the body and does not respond to hormone therapy (metastatic, hormone-refractory prostate cancer).

What is the mechanism of action? Provenge mixes your own immune cells with a protein that prompts an immune response against cancer cells.

How is Provenge given (administered)? Provenge is given as an intravenous (IV) infusion. You will receive a total of three infusions about two weeks apart. Approximately three days before each infusion, a sample of your immune cells will be collected through a process known as leukapheresis; the cells are used to produce Provenge.

How are patients monitored? Patients will usually have scheduled meetings with their healthcare provider while they are being treated with Provenge. Patients may undergo physical examinations, lab tests, or imaging to assess side effects and response to therapy.

What are the most common side effects of treatment with Provenge?

• Chills
• Fatigue
• Fever
• Back pain
• Nausea
• Joint ache
• Headache

This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.

Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.
What can patients do to help alleviate or prevent discomfort and side effects?

• Pay careful attention to the physician’s instructions, and discuss side effects with your physician.

Are there any special precautions patients should be aware of before starting treatment?

• Patients should inform their physician about all medical conditions, including heart problems, lung problems, and history of stroke.
• Patients should inform their physician of any other medication or supplement they are taking (whether prescription or over-the-counter).

When should patients notify their physician?

Tell your doctor if you experience any side effects that bother you or don’t go away. Watch for signs of serious side effects and report these to your doctor immediately: breathing problems, chest pains, racing heart or irregular heartbeats, dizziness, nausea or vomiting, a fever over 100º F, or redness or pain at the infusion or collection sites.

What is a package insert?
A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers. A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.

Copyright © 2012 CancerConnect Last updated 05/12.

Important Limitations of Use

The information provided above on the drug you have selected is provided for your information only and is not a substitute for consultation with an appropriate medical doctor. We are providing this information solely as a courtesy and, as such, it is in no way a recommendation as to the safety, efficacy or appropriateness of any particular drug, regimen, dosing schedule for any particular cancer, condition or patient nor is it in any way to be considered medical advice. Patients should discuss the appropriateness of a particular drug or chemotherapy regimen with their physician.

As with any printed reference, the use of particular drugs, regimens and drug dosages may become out-of-date over time, since new information may have been published and become generally accepted after the latest update to this printed information. Please keep in mind that health care professionals are fully responsible for practicing within current standards, avoiding use of outdated regimens, employing good clinical judgment in selecting drugs and/or regimens, in calculating doses for individual patients, and verifying all dosage calculations.

DISCLAIMER OF WARRANTIES

CANCERCONSULTANTS.COM SPECIFICALLY DISCLAIMS AND EXCLUDES ALL EXPRESSED OR IMPLIED WARRANTIES, INCLUDING ANY IMPLIED WARRANTIES AS TO QUALITY, ACCURACY (INCLUDING TYPOGRAPHICAL ERRORS), MERCHANTABILITY, OR FITNESS FOR ANY PARTICULAR PURPOSE OF THE INFORMATION CONTAINED HEREIN. CANCERCONSULTANTS.COM DISCLAIMS ALL LIABILITY OR DAMAGES ARISING FROM ANY USE OF THE INFORMATION.

The prescribing physician is solely responsible for making all decisions relating to appropriate patient care including, but not limited to, drugs, regimens, dose, schedule, and any supportive care.

Generic Name: Fluorouracil (fler-oh-YOO-rah-sil), 5-FU, 5-fluorouracil

For which conditions is this drug approved? Fluorouracil is FDA approved for the treatment of the following conditions: colon cancer, rectal cancer, breast cancer, stomach (gastric) cancer, and pancreatic cancer.  Fluorouracil may also come in a topical form that is FDA approved for the treatment of superficial basal cell carcinoma. It is important for patients to remember that physicians have the ability to prescribe medication for conditions other than those for which the drug has been approved by the FDA. Patients who have received a prescription of this drug for a condition other than which it is approved may wish to discuss this issue with their physician.

What is the mechanism of action? Fluorouracil belongs to a class of agents called antimetabolites. Antimetabolites produce their anti-cancer effects by inhibiting the ability of a cell to produce or repair DNA, thereby making the cell unable to replicate or repair itself and ultimately causing cellular death.

How is fluorouracil typically given (administered)? Fluorouracil may be given intravenously (into a vein), and may be applied topically as a skin cream. The information on this sheet mainly covers the intravenous formulation. The dose depends on several factors, including the condition being treated, the size of the patient, the particular regimen being used, and the overall health of the patient.

How are patients typically monitored? Patients will usually have scheduled meetings with their healthcare provider while they are being treated with flourouracil.  Typically, blood will be drawn to check levels of blood cells and to monitor functions of some organ systems, such as the kidneys or liver.  Patients may also undergo physical examinations, scans or other measures to assess side effects and response to therapy.  In addition, patients will have their heart function monitored, as treatment with fluorouracil may produce damage to the heart. Patients should notify their healthcare provider if they notice changes in heart rate or rhythm, or experience chest pain. Patients who are using the topical fluorouracil will also undergo skin assessments.

What are the common (occur in 30% or more of patients) side effects of treatment with fluorouracil?

• Low levels of white blood cells – increases the risk of infection
• Low levels of red blood cells – increases the risk of anemia and blood transfusions
• Low levels of platelets – increases the risk of bleeding
• Mouth sores
• Diarrhea
• Loss of appetite
• Changes in taste, metallic taste in mouth following IV bolus injection
• Reactions of the eyes resulting in watery eyes or sensitivity to sunlight
• Discoloration of vein in which the drug was administered

What are the less common (occur in 10% to 29% of patients) side effects of treatment with fluorouracil?

• Pain, peeling, redness, rash, or swelling of the palms of the hands or soles of the feet (hand-foot syndrome)
• Discoloration of the skin
• Darkening of the skin where previous radiation was administered?
• Rash or itching
• Skin sensitivity to sunlight
• Hair loss
• Discoloration of nails, loss of nails
• Cracking, peeling or excessively dry skin

What are possible late side effects of treatment with fluorouracil? With the use of this drug, there is risk of developing damage to the heart after treatment is completed, although this is uncommon. Patients experiencing chest or jaw pain, difficulty breathing,  sweating or noticeable changes in heart rate or rhythm should contact their healthcare provider immediately.

This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.

Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.

What can patients do to help alleviate or prevent discomfort and side effects?

• Pay careful attention to the physician’s instructions and inform the physician of any side effects.
• Maintain adequate rest and nutrition.
• Wear sunscreen and protective clothing and try to minimize sun exposure.
• Drink plenty of fluids. (Patients should ask their physician about the amount of liquid to consume during a day.)
• If possible, avoid large crowds or people who are sick or not feeling well, as this drug may leave some patients susceptible to infection.
• Wash hands often to reduce the risk of infection.
• Eat small meals frequently to help alleviate nausea.
• If patients have been prescribed an anti-nausea medication, they should be sure to take the prescribed doses.
• Avoid activities that may cause injury or bruising.
• Use a soft toothbrush and an electric razor to prevent cuts on the mouth or skin.
• For mouth sores, patients should rinse their mouth three times a day with a salt and soda solution (8 ounces of water mixed with ½ to 1 tsp baking soda and/or ½ to 1 tsp salt) and brush their teeth with a soft toothbrush to help prevent the development of mouth sores.

Are there any special precautions patients should be aware of before starting treatment?

• Patients should inform their physician if they are pregnant, breastfeeding or planning a family in the near future. This drug may cause birth defects. It is important to use some kind of birth control while undergoing treatment. Also, patients may want to talk to their physician if they are considering having children in the future, since some drugs may cause fertility problems.
• It is important that patients inform their physician of any pre-existing conditions (chicken pox, heart disease, kidney disease, liver disease, lung disease, etc.) as they may worsen with this drug.
• Patients should inform their physician of any other medication they are taking (whether prescription or over-the-counter, including vitamins, herbs, etc.) as they may interfere with treatment.
• Patients should check with their physician before starting any new drug or nutritional supplement.
• Patients should inform their physician of any known drug or food allergies or any reactions to medications they have experienced in the past.

When should patients notify their physician?

• Chest pain or palpitations
• Noticeable changes in heart rate or rhythm
• Excessive pain or peeling of the palms of the hands or soles of the feet
• Excessive peeling or cracking of skin
• Flu or cold-like symptoms: fever, chills, sore throat, cough
• Signs of infection – redness, swelling, pus, tenderness, painful urination
• Persistent or severe fatigue
• Unexplained or pronounced bleeding (nosebleeds, bruising, blood in the urine, black tarry stools, etc.)
• Mouth sores
• Persistant nausea, vomiting or abdominal pain
• Persistant or severe diarrhea
• Vision changes
• Confusion, mental changes
• Allergic reaction including swelling of the mouth, lips, and/or throat, wheezing or difficulty breathing, hives or rash

What is a package insert?
A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers.  A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.

Copyright © 2010 CancerConnect Last updated 01/05.

Important Limitations of Use
The information provided above on the drug you have selected is provided for your information only and is not a substitute for consultation with an appropriate medical doctor. We are providing this information solely as a courtesy and, as such, it is in no way a recommendation as to the safety, efficacy or appropriateness of any particular drug, regimen, dosing schedule for any particular cancer, condition or patient nor is it in any way to be considered medical advice. Patients should discuss the appropriateness of a particular drug or chemotherapy regimen with their physician.

As with any printed reference, the use of particular drugs, regimens and drug dosages may become out-of-date over time, since new information may have been published and become generally accepted after the latest update to this printed information.  Please keep in mind that health care professionals are fully responsible for practicing within current standards, avoiding use of outdated regimens, employing good clinical judgment in selecting drugs and/or regimens, in calculating doses for individual patients, and verifying all dosage calculations.

DISCLAIMER OF WARRANTIES

CANCERCONSULTANTS.COM SPECIFICALLY DISCLAIMS AND EXCLUDES ALL EXPRESSED OR IMPLIED WARRANTIES, INCLUDING ANY IMPLIED WARRANTIES AS TO QUALITY, ACCURACY (INCLUDING TYPOGRAPHICAL ERRORS), MERCHANTABILITY, OR FITNESS FOR ANY PARTICULAR PURPOSE OF THE INFORMATION CONTAINED HEREIN.  CANCERCONSULTANTS.COM DISCLAIMS ALL LIABILITY OR DAMAGES ARISING FROM ANY USE OF THE INFORMATION.

The prescribing physician is solely responsible for making all decisions relating to appropriate patient care including, but not limited to, drugs, regimens, dose, schedule, and any supportive care.

Generic Name: Sipuleucel-T

Trade Name: Provenge®

How is this drug used? Provenge is used for the treatment of prostate cancer that has few or no symptoms, but has spread to other parts of the body and does not respond to hormone therapy (metastatic, hormone-refractory prostate cancer).

What is the mechanism of action? Provenge mixes your own immune cells with a protein that prompts an immune response against cancer cells.

How is Provenge given (administered)? Provenge is given as an intravenous (IV) infusion. You will receive a total of three infusions about two weeks apart. Approximately three days before each infusion, a sample of your immune cells will be collected through a process known as leukapheresis; the cells are used to produce Provenge.

How are patients monitored? Patients will usually have scheduled meetings with their healthcare provider while they are being treated with Provenge. Patients may undergo physical examinations, lab tests, or imaging to assess side effects and response to therapy.

What are the most common side effects of treatment with Provenge?

• Chills
• Fatigue
• Fever
• Back pain
• Nausea
• Joint ache
• Headache

This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.

Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.
What can patients do to help alleviate or prevent discomfort and side effects?

• Pay careful attention to the physician’s instructions, and discuss side effects with your physician.

Are there any special precautions patients should be aware of before starting treatment?

• Patients should inform their physician about all medical conditions, including heart problems, lung problems, and history of stroke.
• Patients should inform their physician of any other medication or supplement they are taking (whether prescription or over-the-counter).

When should patients notify their physician?

Tell your doctor if you experience any side effects that bother you or don’t go away. Watch for signs of serious side effects and report these to your doctor immediately: breathing problems, chest pains, racing heart or irregular heartbeats, dizziness, nausea or vomiting, a fever over 100º F, or redness or pain at the infusion or collection sites.

What is a package insert?
A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers. A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.

Copyright © 2012 CancerConnect Last updated 05/12.

Important Limitations of Use

The information provided above on the drug you have selected is provided for your information only and is not a substitute for consultation with an appropriate medical doctor. We are providing this information solely as a courtesy and, as such, it is in no way a recommendation as to the safety, efficacy or appropriateness of any particular drug, regimen, dosing schedule for any particular cancer, condition or patient nor is it in any way to be considered medical advice. Patients should discuss the appropriateness of a particular drug or chemotherapy regimen with their physician.

As with any printed reference, the use of particular drugs, regimens and drug dosages may become out-of-date over time, since new information may have been published and become generally accepted after the latest update to this printed information. Please keep in mind that health care professionals are fully responsible for practicing within current standards, avoiding use of outdated regimens, employing good clinical judgment in selecting drugs and/or regimens, in calculating doses for individual patients, and verifying all dosage calculations.

DISCLAIMER OF WARRANTIES

CANCERCONSULTANTS.COM SPECIFICALLY DISCLAIMS AND EXCLUDES ALL EXPRESSED OR IMPLIED WARRANTIES, INCLUDING ANY IMPLIED WARRANTIES AS TO QUALITY, ACCURACY (INCLUDING TYPOGRAPHICAL ERRORS), MERCHANTABILITY, OR FITNESS FOR ANY PARTICULAR PURPOSE OF THE INFORMATION CONTAINED HEREIN. CANCERCONSULTANTS.COM DISCLAIMS ALL LIABILITY OR DAMAGES ARISING FROM ANY USE OF THE INFORMATION.

The prescribing physician is solely responsible for making all decisions relating to appropriate patient care including, but not limited to, drugs, regimens, dose, schedule, and any supportive care.

Generic Name: Sipuleucel-T

Trade Name: Provenge®

How is this drug used? Provenge is used for the treatment of prostate cancer that has few or no symptoms, but has spread to other parts of the body and does not respond to hormone therapy (metastatic, hormone-refractory prostate cancer).

What is the mechanism of action? Provenge mixes your own immune cells with a protein that prompts an immune response against cancer cells.

How is Provenge given (administered)? Provenge is given as an intravenous (IV) infusion. You will receive a total of three infusions about two weeks apart. Approximately three days before each infusion, a sample of your immune cells will be collected through a process known as leukapheresis; the cells are used to produce Provenge.

How are patients monitored? Patients will usually have scheduled meetings with their healthcare provider while they are being treated with Provenge. Patients may undergo physical examinations, lab tests, or imaging to assess side effects and response to therapy.

What are the most common side effects of treatment with Provenge?

• Chills
• Fatigue
• Fever
• Back pain
• Nausea
• Joint ache
• Headache

This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.

Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.
What can patients do to help alleviate or prevent discomfort and side effects?

• Pay careful attention to the physician’s instructions, and discuss side effects with your physician.

Are there any special precautions patients should be aware of before starting treatment?

• Patients should inform their physician about all medical conditions, including heart problems, lung problems, and history of stroke.
• Patients should inform their physician of any other medication or supplement they are taking (whether prescription or over-the-counter).

When should patients notify their physician?

Tell your doctor if you experience any side effects that bother you or don’t go away. Watch for signs of serious side effects and report these to your doctor immediately: breathing problems, chest pains, racing heart or irregular heartbeats, dizziness, nausea or vomiting, a fever over 100º F, or redness or pain at the infusion or collection sites.

What is a package insert?
A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers. A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.

Copyright © 2012 CancerConnect Last updated 05/12.

Important Limitations of Use

The information provided above on the drug you have selected is provided for your information only and is not a substitute for consultation with an appropriate medical doctor. We are providing this information solely as a courtesy and, as such, it is in no way a recommendation as to the safety, efficacy or appropriateness of any particular drug, regimen, dosing schedule for any particular cancer, condition or patient nor is it in any way to be considered medical advice. Patients should discuss the appropriateness of a particular drug or chemotherapy regimen with their physician.

As with any printed reference, the use of particular drugs, regimens and drug dosages may become out-of-date over time, since new information may have been published and become generally accepted after the latest update to this printed information. Please keep in mind that health care professionals are fully responsible for practicing within current standards, avoiding use of outdated regimens, employing good clinical judgment in selecting drugs and/or regimens, in calculating doses for individual patients, and verifying all dosage calculations.

DISCLAIMER OF WARRANTIES

CANCERCONSULTANTS.COM SPECIFICALLY DISCLAIMS AND EXCLUDES ALL EXPRESSED OR IMPLIED WARRANTIES, INCLUDING ANY IMPLIED WARRANTIES AS TO QUALITY, ACCURACY (INCLUDING TYPOGRAPHICAL ERRORS), MERCHANTABILITY, OR FITNESS FOR ANY PARTICULAR PURPOSE OF THE INFORMATION CONTAINED HEREIN. CANCERCONSULTANTS.COM DISCLAIMS ALL LIABILITY OR DAMAGES ARISING FROM ANY USE OF THE INFORMATION.

The prescribing physician is solely responsible for making all decisions relating to appropriate patient care including, but not limited to, drugs, regimens, dose, schedule, and any supportive care.

Generic Name: Sipuleucel-T

Trade Name: Provenge®

How is this drug used? Provenge is used for the treatment of prostate cancer that has few or no symptoms, but has spread to other parts of the body and does not respond to hormone therapy (metastatic, hormone-refractory prostate cancer).

What is the mechanism of action? Provenge mixes your own immune cells with a protein that prompts an immune response against cancer cells.

How is Provenge given (administered)? Provenge is given as an intravenous (IV) infusion. You will receive a total of three infusions about two weeks apart. Approximately three days before each infusion, a sample of your immune cells will be collected through a process known as leukapheresis; the cells are used to produce Provenge.

How are patients monitored? Patients will usually have scheduled meetings with their healthcare provider while they are being treated with Provenge. Patients may undergo physical examinations, lab tests, or imaging to assess side effects and response to therapy.

What are the most common side effects of treatment with Provenge?

• Chills
• Fatigue
• Fever
• Back pain
• Nausea
• Joint ache
• Headache

This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.

Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.
What can patients do to help alleviate or prevent discomfort and side effects?

• Pay careful attention to the physician’s instructions, and discuss side effects with your physician.

Are there any special precautions patients should be aware of before starting treatment?

• Patients should inform their physician about all medical conditions, including heart problems, lung problems, and history of stroke.
• Patients should inform their physician of any other medication or supplement they are taking (whether prescription or over-the-counter).

When should patients notify their physician?

Tell your doctor if you experience any side effects that bother you or don’t go away. Watch for signs of serious side effects and report these to your doctor immediately: breathing problems, chest pains, racing heart or irregular heartbeats, dizziness, nausea or vomiting, a fever over 100º F, or redness or pain at the infusion or collection sites.

What is a package insert?
A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers. A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.

Copyright © 2012 CancerConnect Last updated 05/12.

Important Limitations of Use

The information provided above on the drug you have selected is provided for your information only and is not a substitute for consultation with an appropriate medical doctor. We are providing this information solely as a courtesy and, as such, it is in no way a recommendation as to the safety, efficacy or appropriateness of any particular drug, regimen, dosing schedule for any particular cancer, condition or patient nor is it in any way to be considered medical advice. Patients should discuss the appropriateness of a particular drug or chemotherapy regimen with their physician.

As with any printed reference, the use of particular drugs, regimens and drug dosages may become out-of-date over time, since new information may have been published and become generally accepted after the latest update to this printed information. Please keep in mind that health care professionals are fully responsible for practicing within current standards, avoiding use of outdated regimens, employing good clinical judgment in selecting drugs and/or regimens, in calculating doses for individual patients, and verifying all dosage calculations.

DISCLAIMER OF WARRANTIES

CANCERCONSULTANTS.COM SPECIFICALLY DISCLAIMS AND EXCLUDES ALL EXPRESSED OR IMPLIED WARRANTIES, INCLUDING ANY IMPLIED WARRANTIES AS TO QUALITY, ACCURACY (INCLUDING TYPOGRAPHICAL ERRORS), MERCHANTABILITY, OR FITNESS FOR ANY PARTICULAR PURPOSE OF THE INFORMATION CONTAINED HEREIN. CANCERCONSULTANTS.COM DISCLAIMS ALL LIABILITY OR DAMAGES ARISING FROM ANY USE OF THE INFORMATION.

The prescribing physician is solely responsible for making all decisions relating to appropriate patient care including, but not limited to, drugs, regimens, dose, schedule, and any supportive care.