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Quadramet

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Quadramet

Quadramet

SIDE EFFECTS

Adverse events were evaluated in a total of 580 patients who received QUADRAMET® (samarium sm 153 lexidronam) in clinical trials. Of the 580 patients, there were 472 men and 108 women with a mean age of 66 (range 20 to 87).

Of these patients, 472 (83%) had at least one adverse event. In a subgroup of 399 patients who received QUADRAMET® (samarium sm 153 lexidronam) 1.0 mCi/kg, there were 23 deaths and 46 serious adverse events. The deaths occurred an average of 67 days (9 to 130) after QUADRAMET® (samarium sm 153 lexidronam) . Seriou events occurred an average of 46 days (1 - 118) after QUADRAMET® (samarium sm 153 lexidronam) . Although most of the patient deaths and serious adverse events appear to be related to the underlying disease, the relationship of end stage disease, marrow invasion by cancer cells, previous myelotoxic treatmen and QUADRAMET® (samarium sm 153 lexidronam) toxicity can not be easily distinguished. In clinical studies, two patients with rapidly progressive prostate cancer developed thrombocytopenia and died 4 weeks after receiving QUADRAMET® (samarium sm 153 lexidronam) . One of the patients showed evidence of disseminated intravascular coagulation (DIC); the other patient experienced a fatal cerebrovascular accident, with a suspicion of DIC. The relationship of the DIC to the bone marrow suppressive effect of Samarium is not known. Marrow toxicity occurred in 277 (47%) patients (See WARNINGS section).

In controlled studies, 7% of patients receiving 1.0 mCi/kg QUADRAMET® (samarium sm 153 lexidronam) (as compared to 6% of patients receiving placebo) reported a transient increase in bone pain shortly after injection (flare reaction). This was usually mild, self-limiting, and responded to analgesics.

The most common adverse events observed in controlled clinical studies of QUADRAMET® (samarium sm 153 lexidronam) , are given in Table 6.

TABLE 6: SELECTED ADVERSE EVENTS REPORTED IN GREATER THAN OR EQUAL TO 1.0 % OF PEOPLE WHO RECEIVED QUADRAMET® (samarium sm 153 lexidronam) OR PLACEBO IN CONTROLLED CLINICAL TRIALS

ADVERSE EVENT Placebo QUADRAMET® 1.0 mCi/kg
N = 90 N = 199
# Patients with Any Adverse Event 72 (80%) 169 (85%)
Body As A Whole 56 (62%) 100 (50%)
Pain Flare Reaction 5 (5.6%) 14 (7.0%)
Cardiovascular 19 (21%) 32 (16%)
Arrhythmias 2 (2.2%) 10 (5.0%)
Chest Pain 4 (4.4%) 8 (4.0%)
Hypertension 0 6 (3.0%)
Hypotension 2 (2.2%) 4 (2.0%)
Digestive 44 (49%) 82 (41%)
Abdominal Pain 7 (7.8%) 12 (6.0%)
Diarrhea 3 (3.3%) 12 (6.0%)
Nausea &/or Vomiting 37 (41.1%) 65 (32.7%)
Hematologic & Lymphatic 12 (13%) 54 (27%)
Coagulation Disorder 0 3 (1.5%)
Hemoglobin Decreased 21 (23.3%) 81 (40.7%)
Leukopenia 6 (6.7%) 118(59.3%)
Lymphadenopathy 0 4 (2.0%)
Thrombocytopenia 8 (8.9%) 138(69.3%)
Any Bleeding Manifestations* 8 (8.9%) 32 (16.1%)
Ecchymosis 1 (1.1%) 3 (3.0%)
Epistaxis 1 (1.1%) 4 (2.0%)
Hematuria 3 (3.3%) 10 (5%)
Infection 10 (11.1%) 34 (17.1%)
Fever and/or Chills 10 (11.1%) 17 (8.5%)
Infection, Not Specified 4 (4.4%) 14 (7.0%)
Oral Moniliasis 1 (1.1%) 4 (2.0%)
Pneumonia 1 (1.1%) 3 (1.5%)
Musculoskeletal 28 (31%) 55 (27%)
Myasthenia 8 (8.9%) 13 (6.5%)
Pathologic Fracture 2 (2.2%) 5 (2.5%)
Nervous 39 (43%) 59 (30%)
Dizziness 1 (1.1%) 8 (4.0%)
Paresthesia 7 (7.8%) 4 (2.0%)
Spinal Cord Compression 5 (5.5%) 13 (6.5%)
Cerebrovascular Accident/Stroke 0 2 (1.0%)
Respiratory 24 (27%) 35 (18%)
Bronchitis/Cough Increased 2 (2.2%) 8 (4.0%)
Special Senses 11 (12%) 11 (6%)
Skin & Appendages 17 (19%) 13 (7%)
Purpura 0 2 (1%)
Rash 2 (2.2%) 2 (1%)
*Includes hemorrhage (gastrointestinal, ocular) reported in <1%.

In an additional 200 patients who received QUADRAMET® (samarium sm 153 lexidronam) in uncontrolled clinical trials, adverse events that were reported at a rate of greater than or equal to 1.0% were similar except for 9 (4.5%) patients who had agranulocytosis. Other selected adverse events that were reported in <1% of the patients who received QUADRAMET® (samarium sm 153 lexidronam) 1.0 mCi/kg in any clinical trial include: alopecia, angina, congestive heart failure, sinus bradycardia, and vasodilation.

Read the Quadramet (samarium sm 153 lexidronam) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

The potential for additive bone marrow toxicity of QUADRAMET® (samarium sm 153 lexidronam) with chemotherapy or external beam radiation has not been studied. QUADRAMET® (samarium sm 153 lexidronam) should not be given concurrently with chemotherapy or external beam radiation therapy unless the benefit outweighs the risks. QUADRAMET® (samarium sm 153 lexidronam) should not be given after either of these treatments until there has been time for adequate marrow recovery. (See WARNINGS Section).

Last reviewed on RxList: 10/8/2008
This monograph has been modified to include the generic and brand name in many instances.

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