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SUBJECTS
Headaches Ill Feeling Bone Pain Day After Neupogen Treatment 2 Days
Headaches Ill Feeling Bone Pain Again Day After 2nd Neupogen Treatme

2304 -
2304 -    ..
2305 - Summary/Objective
2306 -
230601 - Follow up ref SDS 11 0000. ref SDS 10 0000.
230602 -
230603 -
230604 -
230605 -
230607 -  ..
2307 -
2308 -
2309 - Progress
2310 -
231001 - Millie did not feel well again this morning, and so did not go hiking.
231002 - She slept most of the day, but began to feel better after dinner about
231003 - 1900.  She talked about going hiking tomorrow.
231005 -  ..
231006 - She has a headache and complained of bone pain, and general fatigue,
231007 - like yesterday. ref SDS 11 6Q5J
231008 -
231009 -        [On 080702 Millie notified medical team about on set of
231010 -        side effects from Neupogen treatments prescribed for Millie
231011 -        to get cancer treatments. ref SDS 12 EP4Y
231013 -         ..
231014 -        [On 080710 Neupogen side effects have not recurred since
231015 -        today. ref SDS 13 SB8I
231017 -         ..
231018 -        [On 080713 Millie reported recurrence of Neupogen side effects.
231019 -        ref SDS 14 RM99
231021 -  ..
231022 - Research today shows bone pain associated with Neupogen. ref SDS 0
231023 - TR5L, and ref SDS 0 6M6G  Fatigue and headache are also listed in the
231024 - research based on clinical trials. ref SDS 0 025H
231026 -  ..
231027 - Millie has been described as Neutropenic, for example on 080502
231028 - meeting with the doctor at Kaiser. ref SDS 5 NL4W
231030 -  ..
231031 - Mounting side effects of Neupogen align with the doctor's explanation
231032 - that oncology practice balances reducing dose of chemotherapy to
231033 - increase blood counts without using a lot of Neupogen.
231035 -  ..
231036 - Research on the Internet shows...
231037 -
231038 -
231039 -    Drugs.com
231040 -    Drug Information Online
231041 -    Iphone Edition for Health Professionals
231043 -     ..
231044 -    Neupogen Side Effects
231045 -
231046 -
231047 -              http://www.drugs.com/sfx/neupogen-side-effects.html
231048 -
231049 -    Please note - some side effects for Neupogen may not be reported.
231050 -    Always consult your doctor or healthcare specialist for medical
231051 -    advice. You may also report side effects to the FDA at
231053 -     ..
231054 -    http://www.fda.gov/medwatch/
231055 -
231056 -    ...or 1-800-FDA-1088 (1-800-332-1088).
231058 -     ..
231059 -    Neupogen
231061 -     ..
231062 -    All medicines may cause side effects, but many people have no, or
231063 -    minor, side effects. Check with your doctor if any of these most
231064 -    COMMON side effects persist or become bothersome when using
231065 -    Neupogen:
231066 -
231067 -        Bone pain; cough; headache; inflammation of the mucous
231068 -        membranes; nausea; nosebleed; skeletal/muscle pain; vomiting.
231070 -     ..
231071 -    Seek medical attention right away if any of these SEVERE side
231072 -    effects occur when using Neupogen:
231073 -
231074 -        Severe allergic reactions (rash; hives; itching; difficulty
231075 -        breathing; tightness in the chest; swelling of the mouth, face,
231076 -        lips, or tongue); chest pain; chills; diarrhea; fast or
231077 -        irregular heartbeat; fever; lump, swelling, or bruising at an
231078 -        injection site; mouth sores; redness, swelling, or pain around
231079 -        a cut or sore; severe weakness; shoulder pain; sore throat;
231080 -        stomach pain.
231082 -     ..
231083 -    For the professional
231085 -     ..
231086 -    Neupogen
231088 -     ..
231089 -    Cancer Patients Receiving Myelosuppressive Chemotherapy
231091 -     ..
231092 -    In clinical trials involving over 350 patients receiving Neupogen
231093 -    following nonmyeloablative cytotoxic chemotherapy, most adverse
231094 -    experiences were the sequelae of the underlying malignancy or
231095 -    cytotoxic chemotherapy.
231097 -     ..
231098 -    In all phase 2 and 3 trials, medullary bone pain, reported in 24%
231099 -    of patients, was the only consistently observed adverse reaction
231100 -    attributed to Neupogen therapy.  This bone pain was generally
231101 -    reported to be of mild-to-moderate severity, and could be
231102 -    controlled in most patients with non-narcotic analgesics;
231103 -    infrequently, bone pain was severe enough to require narcotic
231104 -    analgesics.  Bone pain was reported more frequently in patients
231105 -    treated with higher doses (20 to 100 mcg/kg/day) administered IV,
231106 -    and less frequently in patients treated with lower SC doses of
231107 -    Neupogen (3 to 10 mcg/kg/day).
231109 -     ..
231110 -    In the randomized, double-blind, placebo-controlled trial of
231111 -    Neupogen therapy following combination chemotherapy in patients
231112 -    (n = 207) with small cell lung cancer, the following adverse
231113 -    events were reported during blinded cycles of study medication
231114 -    (placebo or Neupogen at 4 to 8 mcg/kg/day). Events are reported
231115 -    as exposure-adjusted since patients remained on double-blind
231116 -    Neupogen a median of 3 cycles versus 1 cycle for placebo.
231117 -
231118 -                                     % of Blinded Cycles with Events
231119 -                                          Neupogen      Placebo
231121 -            ..
231122 -           Nausea/Vomiting                    57            64
231123 -           Skeletal Pain                      22            11
231124 -           Alopecia                           18            27
231125 -           Diarrhea                           14            23
231126 -           Neutropenic Fever                  13            35
231127 -           Mucositis                          12            20
231128 -           Fever                              12            11
231129 -            ..
231130 -           Fatigue                            11            16
231131 -           Anorexia                            9            11
231132 -           Dyspnea                             9            11
231133 -            ..
231134 -           Headache                            7             9
231135 -           Cough                               6             8
231136 -           Skin Rash                           6             9
231137 -           Chest Pain                          5             6
231138 -           Generalized Weakness                4             7
231139 -           Sore Throat                         4             9
231140 -           Stomatitis                          5            10
231141 -           Constipation                        5            10
231142 -           Pain (Unspecified)                  2             7
231144 -     ..
231145 -    In this study, there were no serious, life-threatening, or fatal
231146 -    adverse reactions attributed to Neupogen therapy.  Specifically,
231147 -    there were no reports of flu-like symptoms, pleuritis,
231148 -    pericarditis, or other major systemic reactions to Neupogen.
231150 -     ..
231151 -    Spontaneously reversible elevations in uric acid, lactate
231152 -    dehydrogenase, and alkaline phosphatase occurred in 27% to 58% of
231153 -    98 patients receiving blinded Neupogen therapy following cytotoxic
231154 -    chemotherapy; increases were generally mild-to-moderate.  Transient
231155 -    decreases in blood pressure (< 90/60 mmHg), which did not require
231156 -    clinical treatment, were reported in 7 of 176 patients in phase 3
231157 -    clinical studies following administration of Neupogen.  Cardiac
231158 -    events (myocardial infarctions, arrhythmias) have been reported in
231159 -    11 of 375 cancer patients receiving Neupogen in clinical studies;
231160 -    the relationship to Neupogen therapy is unknown.  No evidence of
231161 -    interaction of Neupogen with other drugs was observed in the course
231162 -    of clinical trials.
231164 -     ..
231165 -    There has been no evidence for the development of antibodies or of
231166 -    a blunted or diminished response to Neupogen in treated patients,
231167 -    including those receiving Neupogen daily for almost 2 years.
231168 -
231169 -    .....
231171 -     ..
231172 -    Patients With Severe Chronic Neutropenia
231173 -
231174 -    Mild-to-moderate bone pain was reported in approximately 33% of
231175 -    patients in clinical trials.  This symptom was readily controlled
231176 -    with non-narcotic analgesics.  Generalized musculoskeletal pain was
231177 -    also noted in higher frequency in patients treated with Neupogen.
231178 -    Palpable splenomegaly was observed in approximately 30% of
231179 -    patients.  Abdominal or flank pain was seen infrequently, and
231180 -    thrombocytopenia (< 50,000/mm3) was noted in 12% of patients with
231181 -    palpable spleens.  Fewer than 3% of all patients underwent
231182 -    splenectomy, and most of these had a prestudy history of
231183 -    splenomegaly.  Fewer than 6% of patients had thrombocytopenia (<
231184 -    50,000/mm3) during Neupogen therapy, most of whom had a
231185 -    pre-existing history of thrombocytopenia.  In most cases,
231186 -    thrombocytopenia was managed by Neupogen dose reduction or
231187 -    interruption.  An additional 5% of patients had platelet counts
231188 -    between 50,000 to 100,000/mm3.  There were no associated serious
231189 -    hemorrhagic sequelae in these patients.  Epistaxis was noted in 15%
231190 -    of patients treated with Neupogenr, but was associated with
231191 -    thrombocytopenia in 2% of patients.  Anemia was reported in
231192 -    approximately 10% of patients, but in most cases appeared to be
231193 -    related to frequent diagnostic phlebotomy, chronic illness, or
231194 -    concomitant medications.  Other adverse events infrequently
231195 -    observed and possibly related to Neupogenr therapy were: injection
231196 -    site reaction, rash, hepatomegaly, arthralgia, osteoporosis,
231197 -    cutaneous vasculitis, hematuria/proteinuria, alopecia, and
231198 -    exacerbation of some pre-existing skin disorders (eg, psoriasis).
231200 -     ..
231201 -    Cytogenetic abnormalities, transformation to MDS, and AML have been
231202 -    observed in patients treated with Neupogenr for SCN.  As of 31
231203 -    December 1997, data were available from a postmarketing
231204 -    surveillance study of 531 SCN patients with an average follow-up of
231205 -    4.0 years.  Based on analysis of these data, the risk of developing
231206 -    MDS and AML appears to be confined to the subset of patients with
231207 -    congenital neutropenia.  A life-table analysis of these data
231208 -    revealed that the cumulative risk of developing leukemia or MDS by
231209 -    the end of the 8th year of Neupogenr treatment in a patient with
231210 -    congenital neutropenia was 16.5 % (95% C.I. = 9.8%, 23.3%); this
231211 -    represents an annual rate of approximately 2%.  Cytogenetic
231212 -    abnormalities, most commonly involving chromosome 7, have been
231213 -    reported in patients treated with Neupogen who had previously
231214 -    documented normal cytogenetics.  It is unknown whether the
231215 -    development of cytogenetic abnormalities, MDS, or AML is related to
231216 -    chronic daily Neupogen administration or to the natural history of
231217 -    congenital neutropenia.  It is also unknown if the rate of
231218 -    conversion in patients who have not received Neupogenris different
231219 -    from that of patients who have received Neupogen.  Routine
231220 -    monitoring through regular CBCs is recommended for all SCN
231221 -    patients.  Additionally, annual bone marrow and cytogenetic
231222 -    evaluations are recommended in all patients with congenital
231223 -    neutropenia.
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2313 -