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Latest & Greatest
NKT Therapeutics also announced that
the company has completed dosing in a
Phase Ib trial of NKTT120 in patients
with SCD. This trial will determine the
drug’s safety, as well as its effects on markers of inflammation, daily pain scores, and
quality of life.
Source: NKT Therapeutics, Inc. press release. Accessed from http://www.
prnewswire.com/news-releases/fda-grants-fast-track-designationto-nkt-therapeutics-nktt120-for-the-treatment-of-sickle-celldisease-277871461.html
ASH and the FDA
Present Updates
on Idelalisib for the
Treatment of CLL, FL,
and SLL
Earlier this year, the FDA approved idelalisib (Zydelig® tablets) for the treatment
of patients with relapsed follicular B-cell
non-Hodgkin lymphoma (FL), relapsed
small lymphocytic lymphoma (SLL), and
relapsed chronic lymphocytic leukemia
(CLL), in combination with rituximab. To
offer hematologists/oncologists guidance in understanding how this drug fits
into the treatment landscape for these
conditions, ASH, in collaboration with the
FDA, recently hosted a webinar explaining idelalisib’s approval.
The FDA’s approval of idelalisib for
CLL was based on the results of an
international, multicenter, randomized
(1:1), placebo-controlled trial of 220
patients who were treated with either
twice-daily idelalisib 150 mg + rituximab or placebo + rituximab. Median
progression-free survival, the study’s
primary efficacy endpoint, was not
reached in the idelalisib arm and was 5.5
months in the placebo arm [HR=0.18
(95% CI 0.10-0.32); p<0.0001]. Accelerated approval for FL and SLL was
T:7”
T:10”
17 PATIENT COUNSELING INFORMATION
8.6 Females of Reproductive Potential and Males
REVLIMID can cause fetal harm when administered during pregnancy
See FDA-approved Patient labeling (Medication Guide)
[see Use in Specific Populations (8.1)]. Females of reproductive potential
Embryo-Fetal Toxicity
must avoid pregnancy 4 weeks before therapy, while taking REVLIMID,
Advise patients that REVLIMID is contraindicated in pregnancy [see
during dose interruptions and for at least 4 weeks after completing therapy.
Contraindicatons (4.1)]. REVLIMID is a thalidomide analog and can cause
Females
serious birth defects or death to a developing baby. [see Warnings and
Precautions (5.1) and Use in Specific Populations (8.1)].
Females of reproductive potential must commit either to abstain
continuously from heterosexual sexual intercourse or to use two methods
• Advise females of reproductive potential that they must avoid pregnancy
of reliable birth control simultaneously (one highly effective form of
while taking REVLIMID and for at least 4 weeks after completing therapy.
contraception – tubal ligation, IUD, hormonal (birth control pills, injections,
• Initiate REVLIMID treatment in females of reproductive potential only
hormonal patches, vaginal rings or implants) or partner’s vasectomy and
following a negative pregnancy test.
one additional effective contraceptive method – male latex or synthetic
• Advise females of reproductive potential of the importance of monthly
condom, diaphragm or cervical cap. Contraception must begin 4 weeks
pregnancy tests and the need to use two different forms of contraception
prior to initiating treatment with REVLIMID, during therapy, during dose
including at least one highly effective form simultaneously during
interruptions and continuing for 4 weeks following discontinuation of
REVLIMID therapy, during dose interruption and for 4 weeks after she
REVLIMID therapy. Reliable contraception is indicated even where there
has completely finished taking REVLIMID. Highly effective forms of
has been a history of infertility, unless due to hysterectomy. Females of
contraception other than tubal ligation include IUD and hormonal (birth
reproductive potential should be referred to a qualified provider of
control pills, injections, patch or implants) and a partner’s vasectomy.
contraceptive methods, if needed.
Additional effective contraceptive methods include latex or synthetic
Females of reproductive potential must have 2 negative pregnancy tests
condom, diaphragm and cervical cap.
before initiating REVLIMID. The first test should be performed within
• Instruct patient to immediately stop taking REVLIMID and contact her
10-14 days, and the second test within 24 hours prior to prescribing
doctor if she becomes pregnant while taking this drug, if she misses her
REVLIMID. Once treatment has started and during dose interruptions,
menstrual period, or experiences unusual menstrual bleeding, if she
pregnancy testing for females of reproductive potential should occur
stops taking birth control, or if she thinks FOR ANY REASON that she
weekly during the first 4 weeks of use, then pregnancy testing should be
may be pregnant.
repeated every 4 weeks in females with regular menstrual cycles. If
• Advise patient that if her doctor is not available, she can call
menstrual cycles are irregular, the pregnancy testing should occur every
1-888-668-2528 for information on emergency contraception [see
2 weeks. Pregnancy testing and counseling should be performed if a
Warnings and Precautions (5.1) and Use in Specific Populations (8.6)].
patient misses her period or if there is any abnormality in her menstrual
• Advise males to always use a latex or synthetic condom during any
bleeding. REVLIMID treatment must be discontinued during this evaluation.
sexual contact with females of reproductive potential while taking
REVLIMID and for up to 28 days after discontinuing REVLIMID, even
Males
if they have undergone a successful vasectomy.
Lenalidomide is present in the semen of males who take REVLIMID.
• Advi