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Neupogen Side Effects, and Drug Interactions - Filgrastim

Neupogen Side Effects, and Drug Interactions - Filgrastim

SIDE EFFECTS

Cancer Patients Receiving Myelosuppressive Chemotherapy

In clinical trials involving over 350 patients receiving NEUPOGEN following nonmyeloablative cytotoxic chemotherapy‚ most adverse experiences were the sequelae of the underlying malignancy or cytotoxic chemotherapy. In all phase 2 and 3 trials‚ medullary bone pain‚ reported in 24% of patients‚ was the only consistently observed adverse reaction attributed to NEUPOGEN therapy. This bone pain was generally reported to be of mild-to-moderate severity‚ and could be controlled in most patients with non-narcotic analgesics; infrequently‚ bone pain was severe enough to require narcotic analgesics. Bone pain was reported more frequently in patients treated with higher doses (20 to 100 mcg/kg/day) administered IV‚ and less frequently in patients treated with lower SC doses of NEUPOGEN (3 to 10 mcg/kg/day).

In the randomized‚ double-blind‚ placebo-controlled trial of NEUPOGEN therapy following combination chemotherapy in patients (n = 207) with small cell lung cancer‚ the following adverse events were reported during blinded cycles of study medication (placebo or NEUPOGEN at 4 to 8 mcg/kg/day). Events are reported as exposure adjusted since patients remained on double-blind NEUPOGEN a median of 3 cycles versus 1 cycle for placebo.

Type of
Malignancy

Regimen

Chemotherapy Dose

No. Pts.

Trial Phase

NEUPOGEN Daily Dosagea
 
Small Cell Lung Cancer Cyclophosphamide 1 g/m2/day

210

3

4-8 mcg/kg SC
  Doxorubicin 50 mg/m2/day    

days 4-17
  Etoposide 120 mg/m2/day x 3      
    q 21 days      
 
Small Cell Lung Cancer11 Ifosfamide 5 g/m2/day

12

1/2

5.75-46 mcg/kg IV
  Doxorubicin 50 mg/m2/day    

days 4-17
  Etoposide 120 mg/m2/day x 3      
  Mesna 8 g/m2/day      
    q 21 days      
 
Urothelial Cancer12 Methotrexate 30 mg/m2/day x 2

40

1/2

3.45-69 mcg/kg IV
  Vinblastine 3 mg/m2/day x 2    

days 4-11
  Doxorubicin 30 mg/m2/day      
  Cisplatin 70 mg/m2/day      
    q 28 days      
 
Various Nonmyeloid Malignancies13 Cyclophosphamide 2.5 g/m2/day x 2

18

1/2

23-69 mcg/kgb IV
  Etoposide 500 mg/m2/day x 3    

days 8-28
  Cisplatin 50 mg/m2/day x 3      
    q 28 days      
 
Breast/Ovarian Cancer14 Doxorubicinc 75 mg/m2

21

2

11.5 mcg/kg IV
    100 mg/m2    

days 2-9
    125 mg/m2    

5.75 mcg/kg IV
    150 mg/m2    

days 10-12
    q 14 days      
           
           
 
Neuroblastoma Cyclophosphamide 150 mg/m2 x 7

12

2

5.45-17.25 mcg/kg SC
  Doxorubicin 35 mg/m2    

days 6-19
  Cisplatin 90 mg/m2      
    q 28 days      
    (cycles 1,3,5) d      
a NEUPOGEN doses were those that accelerated neutrophil production. Doses which provided no additional acceleration beyond that achieved at the next lower dose are not reported.
b Lowest dose(s) tested in the study.
c Patients received doxorubicin at either 75,100,125 or 150 mg/m2.
d Cycles 2,6 = cyclophosphamide 150 mg/m2 x 7 and etoposide 280 mg/m2 x 3.
Cycle 4 = cisplatin 90 mg/m2 x 1 and etoposide 280 mg/m2 x 3.

In this study‚ there were no serious‚ life-threatening‚ or fatal adverse reactions attributed to NEUPOGEN therapy. Specifically‚ there were no reports of flu-like symptoms‚ pleuritis‚ pericarditis‚ or other major systemic reactions to NEUPOGEN.

Spontaneously reversible elevations in uric acid‚ lactate dehydrogenase‚ and alkaline phosphatase occurred in 27% to 58% of 98 patients receiving blinded NEUPOGEN therapy following cytotoxic chemotherapy; increases were generally mild-to-moderate. Transient decreases in blood pressure (< 90/60 mmHg)‚ which did not require clinical treatment‚ were reported in 7 of 176 patients in phase 3 clinical studies following administration of NEUPOGEN. Cardiac events (myocardial infarctions‚ arrhythmias) have been reported in 11 of 375 cancer patients receiving NEUPOGEN in clinical studies; the relationship to NEUPOGEN therapy is unknown. No evidence of interaction of NEUPOGEN with other drugs was observed in the course of clinical trials (see PRECAUTIONS).

There has been no evidence for the development of antibodies or of a blunted or diminished response to NEUPOGEN in treated patients‚ including those receiving NEUPOGEN daily for almost 2 years.

Patients With Acute Myeloid Leukemia

In a randomized phase 3 clinical trial, 259 patients received NEUPOGEN and 262 patients received placebo postchemotherapy. Overall, the frequency of all reported adverse events was similar in both the NEUPOGEN and placebo groups (83% vs 82% in Induction 1, 61% vs 64% in Consolidation 1). Adverse events reported more frequently in the NEUPOGEN-treated group included: petechiae (17% vs 14%), epistaxis (9% vs 5%), and transfusion reactions (10% vs 5%). There were no significant differences in the frequency of these events.

There were a similar number of deaths in each treatment group during induction (25 NEUPOGEN vs 27 placebo). The primary causes of death included infection (9 vs 18), persistent leukemia (7 vs 5), and hemorrhage (6 vs 3). Of the hemorrhagic deaths, five cerebral hemorrhages were reported in the NEUPOGEN group and one in the placebo group. Other serious nonfatal hemorrhagic events were reported in the respiratory tract (4 vs 1), skin (4 vs 4), gastrointestinal tract (2 vs 2), urinary tract (1 vs 1), ocular (1 vs 0), and other nonspecific sites (2 vs 1). While 19 (7%) patients in the NEUPOGEN group and five (2%) patients in the placebo group experienced severe or fatal hemorrhagic events, overall, hemorrhagic adverse events were reported at a similar frequency in both groups (40% vs 38%). The time to transfusion-independent platelet recovery and the number of days of platelet transfusions were similar in both groups.

Cancer Patients Receiving Bone Marrow Transplant

In clinical trials‚ the reported adverse effects were those typically seen in patients receiving intensive chemotherapy followed by bone marrow transplant (BMT). The most common events reported in both control and treatment groups included stomatitis, nausea, and vomiting‚ generally of mild-to-moderate severity and were considered unrelated to NEUPOGEN. In the randomized studies of BMT involving 167 patients who received study drug‚ the following events occurred more frequently in patients treated with Filgrastim than in controls: nausea (10% vs 4%)‚ vomiting (7% vs 3%)‚ hypertension (4% vs 0%)‚ rash (12% vs 10%)‚ and peritonitis (2% vs 0%). None of these events were reported by the Investigator to be related to NEUPOGEN. One event of erythema nodosum was reported moderate in severity and possibly related to NEUPOGEN.

Generally‚ adverse events observed in nonrandomized studies were similar to those seen in randomized studies‚ occurred in a minority of patients, and were of mild-to-moderate severity. In one study (n = 45)‚ three serious adverse events reported by the Investigator were considered possibly related to NEUPOGEN. These included two events of renal insufficiency and one event of capillary leak syndrome. The relationship of these events to NEUPOGEN remains unclear since they occurred in patients with culture-proven infection with clinical sepsis who were receiving potentially nephrotoxic antibacterial and antifungal therapy.

Cancer Patients Undergoing Peripheral Blood Progenitor Cell Collection and Therapy

In clinical trials‚ 126 patients received NEUPOGEN for PBPC mobilization. In this setting‚ NEUPOGEN was generally well tolerated. Adverse events related to NEUPOGEN consisted primarily of mild-to-moderate musculoskeletal symptoms‚ reported in 44% of patients. These symptoms were predominantly events of medullary bone pain (33%). Headache was reported related to NEUPOGEN in 7% of patients. Transient increases in alkaline phosphatase related to NEUPOGEN were reported in 21% of the patients who had serum chemistries measured; most were mild-to-moderate.

All patients had increases in neutrophil counts during mobilization‚ consistent with the biological effects of NEUPOGEN. Two patients had a WBC count > 100‚000/mm3. No sequelae were associated with any grade of leukocytosis.

Sixty-five percent of patients had mild-to-moderate anemia and 97% of patients had decreases in platelet counts; five patients (out of 126) had decreased platelet counts to < 50‚000/mm3. Anemia and thrombocytopenia have been reported to be related to leukapheresis; however‚ the possibility that NEUPOGEN mobilization may contribute to anemia or thrombocytopenia has not been ruled out.

Patients With Severe Chronic Neutropenia

Mild-to-moderate bone pain was reported in approximately 33% of patients in clinical trials. This symptom was readily controlled with non-narcotic analgesics. Generalized musculoskeletal pain was also noted in higher frequency in patients treated with NEUPOGEN. Palpable splenomegaly was observed in approximately 30% of patients. Abdominal or flank pain was seen infrequently and thrombocytopenia (< 50‚000/mm3) was noted in 12% of patients with palpable spleens. Fewer than 3% of all patients underwent splenectomy‚ and most of these had a prestudy history of splenomegaly. Fewer than 6% of patients had thrombocytopenia (< 50‚000/mm3) during NEUPOGEN therapy‚ most of whom had a pre-existing history of thrombocytopenia. In most cases‚ thrombocytopenia was managed by NEUPOGEN dose reduction or interruption. An additional 5% of patients had platelet counts between 50‚000 to 100‚000/mm3. There were no associated serious hemorrhagic sequelae in these patients. Epistaxis was noted in 15% of patients treated with NEUPOGEN‚ but was associated with thrombocytopenia in 2% of patients. Anemia was reported in approximately 10% of patients‚ but in most cases appeared to be related to frequent diagnostic phlebotomy‚ chronic illness, or concomitant medications. In clinical trials‚ myelodysplasia or myeloid leukemia was reported to have developed during NEUPOGEN therapy in approximately 3% of patients (9 of 325) (see WARNINGS). Twelve patients from a subset of 102 who had normal cytogenetic evaluations at baseline were subsequently found to have abnormalities‚ including monosomy 7‚ on routine repeat evaluation conducted after 18 to 52 months of NEUPOGEN therapy. It is unknown whether the development of these findings is related to chronic daily NEUPOGEN administration or reflects the natural history of SCN. Other adverse events infrequently observed and possibly related to NEUPOGEN therapy were: injection site reaction‚ rash‚ hepatomegaly‚ arthralgia‚ osteoporosis‚ cutaneous vasculitis‚ hematuria/proteinuria‚ alopecia‚ and exacerbation of some pre-existing skin disorders (eg‚ psoriasis).

DRUG INTERACTIONS

Drug interactions between NEUPOGEN and other drugs have not been fully evaluated. Drugs which may potentiate the release of neutrophils‚ such as lithium‚ should be used with caution.

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