B-cell chromic lymphocytic leukemia ( B- CLL )

Adverse reactions-

Cardiovascular -  hypertension  12%     hypotension  14%     tachycardia  8%

CNS -                    anxiety   7%   headache  12%    insomnia  8%    tremor 2%

Dermatologic -   erythema  3%     rash  12%     urticaria   14%

Hematologic/lymphatic -      anemia    73%     lynphopenia    95%  neutropenia  75%
                                                thrombocytopenia   70%

Miscellaneous -    chills    50%    CMV infection   14%   CMV viremia    52%   dyspnea  12%
                               other infections    72%    pyrexia    65%

Hypersensitivity to gemtuzumab or any of its components

Special Precautions/Warnings

Cytopentas - serious including ,fatal,  pantycytopenia/marrow hypoplasia autoimmune
idiopathic thrombocytopenia and autoimmune hemolytic anemia have occured.
Single doses of alemtuzumab of more than 30mg or cummulative doses of more than 
30mg per week increase the incidence of pancytopenia

Infusion reactions- alemutuzumab administration can result in serious including fatal , infusion reactions. Carefully monitor patients during infusions and withhold if the reactions beceomes severe.

Infections- serious including fatal bacterial ,viral ,fungal and protozoan infections can occur in patients receiving alemtuzumab . Administer prophylaxis against Pneumocystis jiroveci
 pneumonia PCP  and herpes viral infections.

Pregnancy - administer alemuzumab to a pregnant women only if clearly indicated

Lactation- decide whether to discontinue breast feeding or the drug taking into account
the importance of the drug to the mother.

Children- safety and efficacy of alemutuzumab in children have not been established.

Monitoring- obtain complete blood counts at weekly intervals during alemutuzumab
therapy and more frequently if worsening anemia , neutropenia or thrombocytopenia
occurs.

Access CD4 + counts after treatment until recovery to at least 200 cells/mcL

Monitor signs and symptoms of infusion reactions  

Indication-

B-cell chromic lymphocytic leukemia ( B- CLL )

Dosage-
Gradually escalate to the maximum recommended single dose of 30mg .
Escalation is required at initiation of dosing or if dosing is withheld for at least 7 days during
treatment. Escalation to 30mg ordinarily can be accompanied in 3 to 7 days.

Concomittant medications-
premedicate with diphenhydramine 50mg ans acetoaminophen 500 to 1000mg 30 minutes prior to first infusion and each dose escalation. Institute apppropiate medical management
eg epineprine ,meperidine, steroids, for infusion reactions as PCP  prophylaxis.

Administer famecoclovir250mg  twice daily or equivalent as herpetic prophylaxis
.
Continue PCP  and herpes viral prophylaxis for a minimum of 2 months after completion of
alemutuzumab therapy or until the CD4 + count is at least 200 cells/mcL, wichever occurs later

Dose modification- withhold alemtuzumab therapy during serious infusion reactions. 

1. Advice patients to report any signs of or symptoms such as bleeding, easy bruising, petechiae or purpura , pallor, weakness, fatigue. to their doctor.

2. Advice patients of the signs and symptoms of infusion reactions and of the need to take
premedication as prescribed

3. Advice patients to immediately report symptoms of infection eg, pyrexia, and to take
prophylactic anti-infectives for PCP ( trimethoprim /sulfamethoxazole  double strength ) and
for herpes virus eg famciclovir, or eqyivalent as prescribed

4. Advice patients that irradiation of blood products is required until  adequate lymphocyte
recovery.

5. Advice patients that they should not be imunized with live viral vaccines if they have
recently been treated with alemtuzumab

6. Advice men and women with reproductive potential to use effective  concentraceptive
methods during the treatment and for a minimu of 6 months folowing alemtuzumab therapy

Pregnancy -
Administer alemuzumab to a pregnant women only if clearly indicated

Lactation-
Decide whether to discontinue breast feeding or the drug taking into account
the importance of the drug to the mother.

Children-
Safety and efficacy of alemutuzumab in children have not been established.