CLINICAL NEWS
“ These results may lead to [ the consideration of ] preventive sperm cryostorage for adult [ men with ] SCA requiring [ hydroxyurea ] treatment ,” the authors concluded .
The authors report no financial conflicts .
REFERENCE
Berthaut I , Bachir D , Kotti S , et al . Adverse effect of hydroxyurea on spermatogenesis in patients with sickle cell anemia after six months of treatment . Blood . 2017 September 28 . [ Epub ahead of print ]
REVLIMID ® [ lenalidomide ] capsules , for oral use
REVLIMID REMS program Because of the risk of embryo-fetal toxicity , REVLIMID is only available through a restricted program called the REVLIMID REMS program [ see Warnings and Precautions ( 5.2 )].
• Patients must sign a Patient-Physician agreement form and comply with the requirements to receive REVLIMID . In particular , females of reproductive potential must comply with the pregnancy testing , contraception requirements and participate in monthly telephone surveys . Males must comply with the contraception requirements [ see Use in Specific Populations ( 8.3 )].
• REVLIMID is available only from pharmacies that are certified in REVLIMID REMS program . Provide patients with the telephone number and website for information on how to obtain the product .
Pregnancy Exposure Registry
Inform females there is a Pregnancy Exposure Registry that monitors pregnancy outcomes in females exposed to REVLIMID during pregnancy and that they can contact the Pregnancy Exposure Registry by calling
1-888-423-5436 [ see Use in Specific Populations ( 8.1 )].
Hematologic Toxicity
Inform patients that REVLIMID is associated with significant neutropenia and thrombocytopenia [ see Boxed Warnings and Warnings and Precautions ( 5.3 )].
Venous and Arterial Thromboembolism
Inform patients of the risk of thrombosis including DVT , PE , MI , and stroke and to report immediately any signs and symptoms suggestive of these events for evaluation [ see Boxed Warnings and Warning and Precautions ( 5.4 )].
Increased Mortality in Patients with CLL
Inform patients that REVLIMID had increased mortality in patients with CLL and serious adverse cardiovascular reactions , including atrial fibrillation , myocardial infarction , and cardiac failure [ see Warning and Precautions ( 5.5 )].
Second Primary Malignancies
Inform patients of the potential risk of developing second primary malignancies during treatment with REVLIMID [ see Warnings and Precautions ( 5.6 )].
Hepatotoxicity
Inform patients of the risk of hepatotoxicity , including hepatic failure and death , and to report any signs and symptoms associated with this event to their healthcare provider for evaluation [ see Warnings and Precautions ( 5.7 )].
Can Genomics Predict Which Patients With Aplastic Anemia Will Develop MDS ?
Patients with aplastic anemia ( AA ) can develop clonal disorders , such as paroxysmal nocturnal hemoglobinuria ( PNH ) and secondary myelodysplastic syndromes ( sMDS ). “ Distinguishing [ patients at risk for developing sMDS following AA ] from those with primary hypocellular MDS ( hypo-MDS ) resembling AA is important for the timely initiation of appropriate therapy ,” according to Eiju Negoro , MD , PhD , from the Department of Translational Hematology and Oncology Research
Allergic Reactions
Inform patients of the potential for allergic reactions including hypersensitivity , angioedema , Stevens-Johnson Syndrome , or toxic epidermal necrolysis if they had such a reaction to THALOMID and report symptoms associated with these events to their healthcare provider for evaluation [ see Warnings and Precautions ( 5.8 )].
Tumor Lysis Syndrome
Inform patients of the potential risk of tumor lysis syndrome and to report any signs and symptoms associated with this event to their healthcare provider for evaluation [ see Warnings and Precautions ( 5.9 )].
Tumor Flare Reaction
Inform patients of the potential risk of tumor flare reaction and to report any signs and symptoms associated with this event to their healthcare provider for evaluation [ see Warnings and Precautions ( 5.10 )].
Dosing Instructions
Inform patients how to take REVLIMID [ see Dosage and Administration ( 2 )]
• REVLIMID should be taken once daily at about the same time each day ,
• REVLIMID may be taken either with or without food .
• The capsules should not be opened , broken , or chewed . REVLIMID should be swallowed whole with water .
• Instruct patients that if they miss a dose of REVLIMID , they may still take it up to 12 hours after the time they would normally take it . If more than 12 hours have elapsed , they should be instructed to skip the dose for that day . The next day , they should take REVLIMID at the usual time . Warn patients to not take 2 doses to make up for the one that they missed .
Manufactured for :
Celgene Corporation Summit , NJ 07901
REVLIMID ® , REVLIMID REMS ® and THALOMID ® are registered trademarks of Celgene Corporation .
Pat . www . celgene . com / therapies
© 2005-2017 Celgene Corporation , All Rights Reserved . REV _ MM _ MAINT _ HCP _ BSv . 21 2 _ 2017 at Cleveland Clinic in Ohio , and co-authors , who published a Letter to the Editor in Blood .
To determine potential discriminating features between patients with AA , PNH , sMDS , hypo-MDS , and typical primary hypercellular MDS ( hyper-MDS ), the researchers analyzed mutational disease evolution patterns within bone marrow and / or blood samples from 258 patients with AA and 59 with PNH , 35 of whom progressed to sMDS . Patients were enrolled from the Cleveland Clinic in Ohio and University Hospital Basel in Switzerland . For comparison , the authors included another cohort of 853 patients with primary MDS ( pMDS ), including 28 with hypo-MDS and 825 with hyper-MDS .
They detected somatic mutations via whole-exome sequencing in 69 of 133 ( 52 %) patients with AA ( 32 / 71 [ 45 %] at presentation and 42 / 74 [ 57 %] cases after immunosuppressive therapy [ IST ]). “ In contrast , acquired alterations were detected in 15 of 23 ( 65 %) patients with sMDS and 657 of 853 ( 77 %) patients with pMDS ,” the authors noted .
The average number of somatic mutations was :
• 0.8 in patients with PNH
• 1.0 in patients with AA
• 1.5 in patients with sMDS
• 1.5 in patients with hypo-MDS
• 2.0 in patients with hyper-MDS
The spectrum of mutations differed among patients with AA , sMDS , and pMDS , the researchers reported . Compared with patients with AA , patients with sMDS had a higher prevalence of ASXL1 , RUNX1 , splicing factors , and CBL mutations ; however , compared with patients with pMDS , patients with sMDS had a higher prevalence of RUNX1 mutations , but a lower prevalence of SF3B1 mutations .
DNMT3A mutations occurred in two of the 69 patients with AA but did not occur in any of the 15 patients with post-AA MDS , “ suggesting that the mutagenic event did not initiate the MDS clonal cascade ,” the authors wrote . BCOR / BCORL1 mutations were also present in AA and expanded during treatment with IST ; “ however , the clonal burden was lower for [ these ] mutations , … [ which ] suggests the secondary role
ASH Clinical News 47