Managing Side Effects of Novel Agents - A Presentation Developed by the International Myeloma Foundation Nurse Leadership Board
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Managing Side Effects of
Novel Agents
A Presentation Developed by the
International Myeloma Foundation
Nurse Leadership BoardIntroduction to the International Myeloma
Foundation Nurse Leadership Board
The IMF has formed a Nurse Leadership Board which
is made up
p of 20 expert
p nurses from around the United
States. Through their affiliation with myeloma
treatment centers, they have been chosen to assist in
dispersing information to patients, families and health
care providers dealing with multiple myeloma.
The following information is intended to help you
better understand possible treatment options, side
effects to treatments and management of those side
effects Please be sure to consult your provider if you
effects.
have any questions or concerns regarding your
diagnosis, symptoms or treatment plan.
1How Will Your Health Care Provider
Decide on Treatment?
• Treatment is individualized for each patient based
upon:
– Physical exam and laboratory test results
– Disease stage, symptoms and complications
at time of diagnosis
– Whether the p patient has been treated p
previously
y
for multiple myeloma
– Age and general health
– Lifestyle and quality of life
– Information from current clinical trials
From International Myeloma Foundation. Multiple myeloma: patient handbook. 2006. IMF, North Hollywood, CA. www.myeloma.org 2Goals of Treatment
• Stop
St di
disease from
f damaging
d i organs
• Extend length of time without evidence of disease
• Prolong life expectancy
• Relieve pain and other symptoms
• Maintain normal levels of activity and a good
quality of life
3Treatments Used for Multiple Myeloma
• Chemotherapy (Drug therapy)
– Conventional therapy:
• Steroids (Dexamethasone
(Dexamethasone, Prednisone)
• Alkylating Agents (Melphalan, Cyclophosphamide)
• Anthracyclines (Doxorubicin, Liposomal doxorubicin)
– Novel chemotherapy:
• Bortezomib (Velcade®)
• Thalidomide (Thalomid®)
• Lenalidomide (Revlimid®)
• Drugs are can be given alone or in combination
From International Myeloma Foundation. Multiple myeloma: Concise Review of the Disease and Treatment Options.
2006. IMF, North Hollywood, CA. www.myeloma.org 4Treatment for Multiple Myeloma
(continued)
• St
Stem cell
ll transplantation
t l t ti - use off very high
hi h d
dose
chemotherapy, requiring a stem cell rescue for bone
marrow recovery
• Radiation therapy - use of high-energy external beam
radiation to destroy cancer cells or stop them from
growing
• Treatments under clinical investigation
From International Myeloma Foundation. Multiple myeloma: Concise Review of the Disease and Treatment Options.
2006. IMF, North Hollywood, CA. www.myeloma.org 5Why Are Some People Treated in
C
Clinical Trials?
?
Your provider may recommend you participate in a
clinical
li i l trial.
t i l Clinical
Cli i l trials
t i l help
h l find
fi d new and
d safe
f
treatments. These trials are monitored by the FDA for
safety and effectiveness.
In order to participate in a clinical trial:
• Physicians follow specific instructions, which ensure excellent
care
• Patients are told all of the details of the study and willingly agree
to participate
• Patients need to meet specific eligibility criteria
• Patients can withdraw from a clinical trial at any time
6Types of Trials
Dose-seeking trial to identify side
Phase 1
effects
Determine response rate for a
Phase 2
particular disease
Compare new treatment to standard
Phase 3
treatment
ClinicalTrials.gov Understanding Clinical Trials. 7Use of Novel Agents for
Treatment of Multiple Myeloma
Thalidomide (Thalomid®)
Lenalidomide (Revlimid®)
Bortezomib (Velcade®)Novel Agents –
What is Targeted Therapy
Normal
Cells
Cancer
Cells
•Drugs targeted at pathways
pathways, processes and physiology which are
uniquely disrupted in cancer cells:
– Receptors
– Genes
– Angiogenesis
– Tumor pH
•New agents
g improve
p outcomes either alone or combined with
chemotherapy and/or radiation
9Novel Treatments for Multiple Myeloma -
Thalidomide and Lenalidomide
• These medications are called Immune-Modulating
therapies because they act to improve the
immune system
• Oral administration
• Strong evidence that these drugs kill cancer cells
in two ways
– Improve body’s immune system response to cancer
– Block the blood supply to cancer cells, so that tumors
cannot grow
• Indications
– Thalidomide: newly diagnosed and relapsed disease
– Lenalidomide: combination with dexamethasone for patients
who have received at least one prior therapy
From Understanding Thalidomide. The International Myeloma Foundation, North Hollywood, CA. 2006 10Potential Side Effects - Thalomid
(
(thalidomide))
• Blood clots, particularly in combination with steroids or
chemotherapy
h th
• Peripheral neuropathy – numbness or tingling in your
hands or feet
• Sedation, fatigue
• Constipation
• Rash, usually on trunk, back, arms, legs
• Teratogenic - severe birth defects if taken during
pregnancy
11Potential Side Effects - Revlimid
(lenalidomide)
• Blood clots, particularly in combination with steroids or
chemotherapy
• Low blood counts
• Rash
• Itchyy scalp
p
• Diarrhea
• Fatigue
• Muscle cramping
12Novel Treatments for Multiple Myeloma –
Velcade (bortezomib)
• Bortezomib is the first drug in a class called
Proteasome Inhibitors which inhibit cancer cell growth
• Normal cells can recover from effects of proteasome
inhibitor, whereas myeloma cells are more likely to be
effected
• Administered by intravenous injection (IV) several
days during a month
• Indications
– In June 2008, VELCADE® was approved for use in
previously untreated myeloma patients
13Potential Side Effects - Velcade
(bortezomib)
• Peripheral neuropathy – numbness or tingling in your
hands or feet
• Low platelet counts
• Weakness and fatigue
• Loss of appetite, nausea, vomiting, diarrhea, or
constipation
ti ti
• Fever
• Joint pain, muscle cramps
• Shortness of breath, dizziness, blurred vision,
hypotension
14Managing Side Effects of
Myeloma Treatment
Gastrointestinal
M l
Myelosuppression
i
Thromboembolic
Peripheral Neuropathy
SteroidsPossible Side Effect of Treatment:
Gastrointestinal (GI)
GI side effects can happen individually or in
combination and commonly include:
• Nausea
• Vomiting
• Diarrhea
• Constipation
16Possible Gastrointestinal Side Effect of
Treatment - Managing Nausea/Vomiting
Things that may help - Nausea and Vomiting
• Concentrate on staying hydrated • Restrict fluids with meals
• Eat before getting too hungry • Chew food thoroughly
• Eat bland food, cold or at room • Suck on mints or hard candy;
temperature popsicles or ice chips.
• Find fresh air when possible • Try peppermint or ginger tea
• Use relaxation techniques • Apply a cool compress to the
• Try hypnosis or acupuncture forehead, neck, wrists
Medications to control nausea may be ordered by your health care
provider. Take as directed.
17Possible Gastrointestinal Side Effect of
Treatment - Managing Nausea and Vomiting
Things
g to avoid - Nausea and Vomiting
g
• Avoid strong odors • Avoid favorite foods (they
• Do not lie flat after eating may become associated with
• Avoid sweet, salty, fatty, nausea or vomiting)
spicy, heavy foods • Avoid citrus and tomatoes
• Do not exercise after eating
If nausea and vomiting continue,
continue your health care provider
may add more anti-nausea medication and/or lower the
dose of treatment medication.
18Possible Gastrointestinal Side Effect
off Treatment
T t t - Managing
M i Diarrhea
Di h
Medications that may cause diarrhea
• Laxatives
• Antibiotics
• Antacids with magnesium
• Antidepressants
• Prescription medications: check with your provider
Herbal supplements that may cause diarrhea
• Milk thistle
• Aloe
• Cayenne
• Saw palmetto
• Ginseng
19Possible Gastrointestinal Side Effect
of Treatment - Managing Diarrhea
E ti
Eating hints
hi t for
f diarrhea
di h
• Increase fluid intake (water, Ricelyte ®, Pedialyte®, sports
drinks, diluted fruit juice, and broth)
• Avoid caffeinated, carbonated, or heavily sugared beverages
• BRAT diet (bananas, rice, applesauce, and toast)
Take anti-diarrheal medication
• Imodium® or Lomotil® if recommended by a clinician
• Fiber binding agents – Metamucil®, Citracil®
20Possible Gastrointestinal Side Effect
of Treatment - Managing Constipation
Eating hints for constipation
• Increase fluid intake
• Drink warm/hot beverage prior to normal timing for bowel
movement
• Eat foods high in fiber, for example….
Other techniques to manage constipation
• Ensure comfort, privacy, and convenience during bowel movement
• Increase physical activity
• Use stool softeners or laxatives or fiber binding agents –
Metamucil®, Citracil®
Contact your provider if symptoms continue
continue. Your
medications may need to be changed.
21Possible Side Effect of Treatment:
Myelosuppression (low blood counts)
• The healthy bone marrow cells include:
– Red Blood Cells (RBC)– transport oxygen
– White Blood Cells (WBC)– fight against infection
– Platelets – protect against bleeding and bruising
• These cells can be effected by active disease, myeloma
treatment and other medications or medical conditions.
treatment, conditions
• Decreased function of the bone marrow is called
“Myelosuppression”
• Your health care provider will monitor blood counts
regularly during therapy
Miceli, Colson, Gavino, Lilleby CJON Supplement, June, 2008. In press 22Anemia (low red blood cells)
Commonly seen with myeloma. May also be a
result of decreased kidney function, myeloma
t t
treatment t or other
th medications.
di ti
Symptoms of anemia
• Fatigue,
F ti low
l energy llevell
• Unable to do regular activities
• Shortness of breath or chest pain with activity
• Pale appearance
Treatment
• Use off red
U d bl
blood
d cellll supplements,
l t with
ith caution
ti
• Possible red blood cell transfusion
• “Energy-sparing” activities
• Reduced dose of medications
Miceli, Colson, Gavino, Lilleby CJON Supplement, June, 2008. In press 23Neutropenia (low white blood cells)
May be a result of myeloma disease, treatment or other
medications.
The greatest concern with this side effect is infection.
Symptoms to watch for –
• Fever and shaking g chills
• Dizziness or fainting
• Redness or swelling of skin or open wound
• Respiratory symptoms such as cough or sinus congestion
Precautions –
• Thorough hand washing to reduce contact exposure
• Use of mask as instructed
• Avoid crowds and potential contagion
• Preventative antibiotic therapy as prescribed
Miceli, Colson, Gavino, Lilleby CJON Supplement, June, 2008. In press 24Thrombocytopenia (low platelets)
May be a result of myeloma disease, treatment or other
medications.
W t h for
Watch f symptomst that
th t may include
i l d
• Frequent or large bruises
• Blood in urine or stool
• Spontaneous nosebleeds
• Small red or purple spots on the body (petechiae)
• Bleeding that does not stop with pressure
To reduce risk of bleeding these practices are recommended:
• Do not take aspirin, ibuprofen or naproxen unless instructed
• Avoid activities that can cause bruising or bleeding such as contact
sports and heavy lifting
• May need platelet transfusion at signs of bruising or bleeding or
before any necessary invasive procedure
Miceli, Colson, Gavino, Lilleby CJON Supplement, June, 2008. In press 25Possible Side Effect of Treatment: Deep
Vein Thrombosis and Pulmonary Embolism
Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE)
p by
develop y a blood clot partially
p y or completely
p y blocking
ga
blood vein or artery.
Risk factors for developing blood clots:
- Multiple myeloma
- Diabetes
- Recent surgery
- Immobility
- Obesity
- Smoking
- Family history of clots
- Current use of oral contraceptives or hormones
- Cardiac problems
- Varicose veins
- Some combination treatments such as steroids
with
ith th
thalidomide
lid id or lenalidomide
l lid id
26Possible Side Effect of Treatment: Deep
Vein Thrombosis and Pulmonary Embolism
Symptoms of DVT Symptoms of PE
•Swollen,
S ll warm extremity i • Sh
Shortness off bbreath,
h diffi
difficult
l
•Dull ache, pain or tight feeling or labored breathing
•Rapid heart rate • New onset of chest or
•Abnormal redness of skin shoulder
h ld blade/arm
bl d / pain
i
•Bluish color and cool skin • Anxiety
• Rapid heart rate
Report
p DVT and PE symptoms
y p immediately
y
These events are considered a medical emergency
and require immediate care
27Managing Side Effects of Treatment: Deep
Vein Thrombosis and Pulmonary Embolism
Strategies to reduce risk of clots:
• Anti-embolism
t e bo s stoc
stockings
gs (e
(elastic
ast c stoc
stockings)
gs)
• Exercise regimen
• Low-dose aspirin
• Moving frequently when sitting long periods
• Travel precautions
When taking Thalidomide or Lenalidomide,
Lenalidomide medications
may be adjusted to reduce the risk of a a clot from
occurring:
• Lower drug doses
• Different dosing schedule
• Blood thinning with warfarin or heparin therapy
28Possible Side Effect of Treatment:
Peripheral Neuropathy
Peripheral Neuropathy develops by injury, inflammation,
or degeneration to the peripheral nerve fibers of one
one’s
s
extremities
Symptoms of peripheral neuropathy include:
• Numbness
• Tingling
• Prickling sensations
• Sensitivity
y to touch
• Muscle weakness
• Burning Pain or Cold Sensation
Report symptoms of peripheral neuropathy to
your health care provider early
29What to Do in Case of Numbness or Pain
Due to Peripheral Neuropathy
If you experience numbness, tingling, freezing, throbbing or
shooting pain due to peripheral neuropathy, you might:
• Massage the affected area with cocoa butter regularly
• Take B-complex vitamins (B1, B6, B12) supplements
• Take folic acid supplements
• Take amino acid supplements
If these symptoms worsen you should call your health care
provider, who may recommend:
• T
To stop
t treatment
t t t or reduce
d the
th ddose off Th
Thalidomide,
lid id
Lenalidomide, or Bortezomib
• A pain medication like gabapentin or Lidoderm® patch
• Physical
y therapy
py
Proper management of PN will promote safety, increase
mobility, and prevent unnecessary pain and discomfort.
30Steroid Therapy
Steroids are a very important part of the treatment for
multiple myeloma. Dexamethasone and prednisone are
commonly l used.
d
They have been used as a single drug or in
g for many
combination with other drugs y years.
y
Steroids target the myeloma cells for programmed cell
death.
− A recent study found benefit in using lower doses of
steroids over the conventional higher doses. Using
lower doses represented better overall survival and
less side effects. (Rajkumar, et al, 2007)
31Potential Side Effects - Steroids:
Increase in blood sugar levels – this can cause or worsen
diabetes
Fatigue/Hyperactivity
g yp y
Difficulty sleeping (Insomnia)
Flushing/Sweating
Irritability, mood swings, depression
Increased in risk of gastrointestinal complications including
stomach bloating, hiccups, heartburn, ulcers or gas.
Body image changes - Weight gain,
gain hair thinning/loss,
thinning/loss skin
rashes
Increase in blood pressure and water retention
Increased susceptibility to infections
f
Sexual dysfunction
p g
Muscle weakness or muscle cramping
Blurred vision
32Managing Side Effects to Steroid Therapy
Things to consider while taking steroids:
Take with food
Over-the-counter
O th t or prescription
i ti medications
di ti are
recommended to prevent stomach discomfort
Steroid schedule ((am vs. pm)
p )
Medications to prevent shingles, thrush or other
infections may also be prescribed
Report signs and symptoms of infection (fever
(f off more
than 100.5 ° F, shaking chills even without fever, dizziness,
shortness of breath, low blood pressure)
Do not stop or adjust steroid doses without
discussing it with your health care provider.
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