Drug interactions-

Use caution when administering drugs that may potentiate the myeloproliferative effects of
sargramostim eg lithium, corticosteroids

Acute Myelogenous Leukemia

Adverse reactions-

Cardiovascular-      hemorrhage   23%

CNS-                        CNS disorder  11%

Dermatologic-          alopecia   73%       rash   44%

GI -                            nausea   90%         diarrhea  89%      vomiting 85%    anorexia  54%
                                  GI disorder  37%   GI hemorrhage  27%                      Liver damage 13%

GU-                           urinary tract disorder  14%        kidney function abnormal 8%

Metabolic/nutrional -     edema   34%                         peripheral edema 11%

Respiratory -                 dyspnea  28%                        lung disorder  20%

Miscellaneous-            fever  85%   mucuous membrane disorder 75%    asthenia  66%
                                      malaise  57%            sepsis 11%          

Sargramostim should not administered simultaneously with cytotoxic chemotherapy or radiotherapy

Special Precautions-

Fluid retention- sargramostim  should be used with caution in patients with pre-existing fluid retention,
pulmonary infiltrates or congestive heart failure.

Respiratory syndrome-   in patients displaying dyspnea during sagramostim adminstration , the rate of
infusion should be reduced to half. Use caution when administering sagramostim to patients with
preexting cardiac disease

Cardiovascular symptoms- transcient supreventricular arrhthymias has been reported in uncontrolled
studies during sagromostim administration.
Use caution when administering to patients with preexisting cardiac disease

Hypersensitivity reactions- serious allergic or anaohylactic reactions have occurred. if any serious
allergic reactions immediately discontinue sagramostim therapy and initiate appropiate therapy

First dose effect-  a syndrome characterised by respiratory distress hypoxia, flushing, hypotension,
has been reported folowing the first administration of sagramostim in a paricular cycle.
These signs have resolved with symptomatic treatrment and usually do not recur with subsequent
doses in the same cycle of treatment.

Hematologic effect-stimulation of marrow precursors with sagramostim may result in rapid rise in
white blood cells WBC count. Perform twice weekly monitoring of CBC  with differential (including
examination  for the presence of blast cells ) to preclude development of excessive counts. 

Growth factor potential-  because of the possiblity of tumor growth factor  potentiation, when using
this drug in any malignacy with myeloid characterstics

Use in patients receiving purged bone marrow - sagramostim is useful in accelrating myeloid
recovery in patients receiving bone marrow purged by anti-B lymphocyte  monoclonal antibodies.
Data obtaned from uncontrolled studies suggest that if in vivo marrow purging with chemical
agents cause sufficient decrease in the number of responsive   hematopoeitic progenitors,
the patient may not respond to sagramostim.  

Renal/hepatic impairment- monitoring of renal and hepatic function in patients displaying
renal or hepatic  dysfunction prior to initiation of treatment is recommended at least every
other week during sagromostim administeration

Pregnancy- give sagramostim to pregnant woman only if clerarly needed.

Lactation- administer sagramostim to a nursing woman only if clearly need.

Children- safety and efective in children have not been established, however, safety data
indicate that sagramostim does not exhibit any greater toxicity in children than in adults.

Lab test abnormalites- sagramostim can induce variable increases in WBC  or platelet counts..
A cBc is recommended twice weekly during sagramostim administration.

Monitoring- monitoring of renaland hepatic funtion in patients displaying hepatic dysfunction
prior to initiation of sagramostim administration. Body weight and hydration status should be
monirored.

Dosage-
Acute Myelogenous Leukemia

Dosage-
250mcg/m2 /day administered over a 4-hour period starting approximately on day 11 or 4 days
following the completion of induction therapy, if the day 10 bone marrow is hypoplastic with less than
5% blasts.

Pharmacology-
Granulocyte -macrophage colony stimulating factor ( GMCSF ) is a multileaneage factor,
belongs to a group of growth factors termed colony stimulating factors that support survival,
clonal expansion  and differentiation of hemotopoietic progentor cells.
 
 

Pregnancy-
Give sagramostim to pregnant woman only if clerarly needed.

Lactation-
Administer sagramostim to a nursing woman only if clearly need.

Children-
Safety and effectiveness  in children have not been established, however, safety data
indicate that sagramostim does not exhibit any greater toxicity in children than in adults.