Best Drug Stores:
Super Saver Meds Pharmacy 4U New Pharm
Popular Searches:

drugs
viagra
diet pills
drugs prescription drugs weight loss drugs drugs online discount drugs drugstore drugs for depression online drugstore online drugs canadian drugs cheap drugs nc drugs facilities fertility drugs canada drugs brands only drugs acyclovir adipex ambien antibiotic carisoprodol celebrex didrex diet pills discount xenical hydrocodone ionamin lortab meridia online soma paxil penis enlargement phentermine prevacid prilosec propecia prozac renova retin-a senior health soma sonata tenuate tramadol ultram valium valtrex vaniqa viagra vicodin vioxx vitamin wagering weight weight loss wellbutrin women health xanax xenical xenical online zocor zoloft zovirax zyban zyrtec
Other Drugs (P1):
Pah Pancrecarb Pandel Panhematin Panretin Papaverine Parafon Paraplatin Paremyd Parlodel Parnate Paser Patanol Paxil Paxil-CR Pb Pce 333 Pediapred Pediatric Gentamicin Pediazole Pediotic Pegasys Penetrex Penlac Nail Lacquer Pentasa Cr Pentothal Pepcid Pepcid Percocet Percodan Pergonal Periactin Periochip Permax Persantine IV Persantine Pfizerpen Phenergan Phenergan Vc Phenergan-Cod Phisohex Phospholine Photofrin Pilopine Pima Pipracil Pitocin Pitressin Plan B Plaquenil Platinol Plavix Plenaxis Plendil Pletal Plexion Pneumovax Pododerm Poly-Pred Poly-Vi-Flor Polymyxin B
A1, A2, B, C1, C2, D, E, F, G-H, I-K, L, M, N, O, P1, P2, Q-R, S, T, U-V, W-Z

Paraplatin Side Effects, and Drug Interactions - Carboplatin

Paraplatin Side Effects, and Drug Interactions - Carboplatin

SIDE EFFECTS

For a comparison of toxicities when carboplatin or cisplatin was given in combination with cyclophosphamide, see the CLINICAL PHARMACOLOGY: CLINICAL STUDIES: Comparative Toxicity subsection.

ADVERSE EXPERIENCES IN PATIENTS WITH OVARIAN CANCER
.
First Line Combination Therapy* Percent
Second Line Single Agent Therapy** Percent
Bone Marrow
Thrombocytopenia, < 100,000/ mm3
66
62
                                    < 50,000/ mm3
33
35
Neutropenia,             < 2,000 cells/ mm3
96
67
                                    < 1,000 cells/ mm3
82
21
Leukopenia,              < 4,000 cells/ mm3
97
85
                                    < 2,000 cells/ mm3
71
26
Anemia,                     < 11 g/ dL
90
90
                                    < 8 g/ dL
14
21
Infections
16
5
Bleeding
8
5
Transfusions
35
44
Gastrointestinal
Nausea and vomiting
93
92
Vomiting
83
81
Other GI side effects
46
21
Neurologic
Peripheral neuropathies
15
6
Ototoxicity
12
1
Other sensory side effects
5
1
Central neurotoxicity
26
5
Renal
Serum creatinine elevations
6
10
Blood urea elevations
17
22
Hepatic
Bilirubin elevations
5
5
SGOT elevations
20
19
Alkaline phosphatase elevations
29
37
Electrolytes loss
Sodium
10
47
Potassium
16
28
Calcium
16
31
Magnesium
61
43
Other side effects
Pain
44
23
Asthenia
41
11
Cardiovascular
19
6
Respiratory
10
6
Allergic
11
2
Genitourinary
10
2
Alopecia
49
2
Mucositis
8
1

In the narrative section that follows, the incidences of adverse events are based on data from 1,893 patients with various types of tumors who received PARAPLATIN as single-agent therapy.

Hematologic toxicity: Bone marrow suppression is the dose-limiting toxicity of PARAPLATIN. Thrombocytopenia with platelet counts below 50,000/ mm3 occurs in 25% of the patients (35% of pretreated ovarian cancer patients); neutropenia with granulocyte counts below 1,000/ mm3 occurs in 16% of the patients (21% of pretreated ovarian cancer patients); leukopenia with WBC counts below 2,000/ mm3 occurs in 15% of the patients (26% of pretreated ovarian cancer patients). The nadir usually occurs about day 21 in patients receiving single-agent therapy. By day 28, 90% of patients have platelet counts above 100,000/ mm3; 74% have neutrophil counts above 2,000/ mm3; 67% have leukocyte counts above 4,000/ mm3.

Marrow suppression is usually more severe in patients with impaired kidney function. Patients with poor performance status have also experienced a higher incidence of severe leukopenia and thrombocytopenia.

The hematologic effects, although usually reversible, have resulted in infectious or hemorrhagic complications in 5% of the patients treated with PARAPLATIN (carboplatin for injection), with drug related death occurring in less than 1% of the patients. Fever has also been reported in patients with neutropenia.

Anemia with hemoglobin less than 11 g/dL has been observed in 71% of the patients who started therapy with a baseline above that value. The incidence of anemia increases with increasing exposure to PARAPLATIN. Transfusions have been administered to 26% of the patients treated with PARAPLATIN (44% of previously treated ovarian cancer patients).

Bone marrow depression may be more severe when PARAPLATIN is combined with other bone marrow suppressing drugs or with radiotherapy.

Gastrointestinal toxicity: Vomiting occurs in 65% of the patients (81% of previously treated ovarian cancer patients) and in about one-third of these patients it is severe. Carboplatin, as a single agent or in combination, is significantly less emetogenic than cisplatin; however, patients previously treated with emetogenic agents, especially cisplatin, appear to be more prone to vomiting. Nausea alone occurs in an additional 10 to 15% of patients. Both nausea and vomiting usually cease within 24 hours of treatment and are often responsive to antiemetic measures. Although no conclusive efficacy data exist with the following schedules, prolonged administration of PARAPLATIN, either by continuous 24-hour infusion or by daily pulse doses given for five consecutive days, was associated with less severe vomiting than the single dose intermittent schedule. Emesis was increased when PARAPLATIN was used in combination with other emetogenic compounds. Other gastrointestinal effects observed frequently were pain, in 17% of the patients; diarrhea, in 6%; and constipation, also in 6%.

Neurologic toxicity: Peripheral neuropathies have been observed in 4% of the patients receiving PARAPLATIN (6% of pretreated ovarian cancer patients) with mild paresthesias occurring most frequently. Carboplatin therapy produces significantly fewer and less severe neurologic side effects than does therapy with cisplatin. However, patients older than 65 years and/ or previously treated with cisplatin appear to have an increased risk (10%) for peripheral neuropathies. In 70% of the patients with pre-existing cisplatin-induced peripheral neurotoxicity, there was no worsening of symptoms during therapy with PARAPLATIN. Clinical ototoxicity and other sensory abnormalities such as visual disturbances and change in taste have been reported in only 1% of the patients. Central nervous system symptoms have been reported in 5% of the patients and appear to be most often related to the use of antiemetics.

Although the overall incidence of peripheral neurologic side effects induced by PARAPLATIN is low, prolonged treatment, particularly in cisplatin pretreated patients, may result in cumulative neurotoxicity.

Nephrotoxicity: Development of abnormal renal function test results is uncommon, despite the fact that carboplatin, unlike cisplatin, has usually been administered without high-volume fluid hydration and/or forced diuresis. The incidences of abnormal renal function tests reported are 6% for serum creatinine and 14% for blood urea nitrogen (10% and 22%, respectively, in pretreated ovarian cancer patients). Most of these reported abnormalities have been mild and about one-half of them were reversible.

Creatinine clearance has proven to be the most sensitive measure of kidney function in patients receiving PARAPLATIN, and it appears to be the most useful test for correlating drug clearance and bone marrow suppression. Twenty-seven percent of the patients who had a baseline value of 60 mL/ min or more demonstrated a reduction below this value during PARAPLATIN therapy.

Hepatic toxicity: The incidences of abnormal liver function tests in patients with normal baseline values were reported as follows: total bilirubin, 5%; SGOT, 15%; and alkaline phosphatase, 24%; (5%, 19%, and 37%, respectively, in pretreated ovarian cancer patients). These abnormalities have generally been mild and reversible in about one-half of the cases, although the role of metastatic tumor in the liver may complicate the assessment in many patients. In a limited series of patients receiving very high dosages of PARAPLATIN and autologous bone marrow transplantation, severe abnormalities of liver function tests were reported.

Electrolyte changes: The incidences of abnormally decreased serum electrolyte values reported were as follows: sodium, 29%; potassium, 20%; calcium, 22%; and magnesium, 29%; (47%, 28%, 31%, and 43%, respectively, in pretreated ovarian cancer patients). Electrolyte supplementation was not routinely administered concomitantly with PARAPLATIN, and these electrolyte abnormalities were rarely associated with symptoms.

Allergic reactions: Hypersensitivity to PARAPLATIN has been reported in 2% of the patients. These allergic reactions have been similar in nature and severity to those reported with other platinum-containing compounds, i.e., rash, urticaria, erythema, pruritus, and rarely bronchospasm and hypotension. These reactions have been successfully managed with standard epinephrine, corticosteroid, and antihistamine therapy. Anaphylactic reactions have been reported as part of postmarketing surveillance (see WARNINGS)

Injection Site Reactions: Injection site reactions, including redness, swelling, and pain, have been reported during postmarketing surveillance. Necrosis associated with extravasation has also been reported

Other events: Pain and asthenia were the most frequently reported miscellaneous adverse effects; their relationship to the tumor and to anemia was likely. Alopecia was reported (3%). Cardiovascular, respiratory, genitourinary, and mucosal side effects have occurred in 6% or less of the patients. Cardiovascular events (cardiac failure, embolism, cerebrovascular accidents) were fatal in less than 1% of the patients and did not appear to be related to chemotherapy. Cancer-associated hemolytic uremic syndrome has been reported rarely.

Malaise, anorexia, and hypertension have been reported as part of postmarketing surveillance.

DRUG INTERACTIONS

The renal effects of nephrotoxic compounds may be potentiated by PARAPLATIN.

top


Popular Searches:

weight loss
ultram
penis enlargement
hydrocodone
antibiotic