Pulling Back the Curtain: Jerald Radich, MD
How do you balance work and life?
What makes finding that balance
difficult?
Well, the good thing about modern life is
that it’s easy to communicate and stay on
the job; the bad thing is that it’s too easy
to stay on the job. It can be a trap, but I’ve
tried to use it to my advantage. There are
things that I can do mindlessly at home
and things that need to be done in the
context of the workplace, so I think I’ve
found a balance where I’m able to leave
the office at a reasonable hour, go home
and enjoy my family, and then do those
mindless tasks at night.
Obviously, I try to spend as much time
as possible with my family, but I also have
another family at the lab. When I first
started running the lab, I had no idea that
it was like running a small business. Our
lab now has 18 children under 10 years of
age, and I view it as my responsibility to
ELOCTATE™ [Antihemophilic Factor (Recombinant), Fc Fusion Protein]
Lyophilized Powder for Solution For Intravenous Injection.
keep shoes on all their feet. I would never
have imagined being too concerned about
that 20 years ago.
Do you think that having your own
family has changed how you run
your lab?
One advantage of having a family and
having gone through these situations is
that I better understand the full scope of
family commitments that may require my
Table 3: Adverse Reactions Reported for ELOCTATE (N=164)
MedDRA System Organ Class
MedDRA Preferred Term
Brief Summary of Full Prescribing Information.
1 INDICATIONS AND USAGE
ELOCTATE, Antihemophilic Factor (Recombinant), Fc Fusion Protein, is a recombinant
DNA derived, antihemophilic factor indicated in adults and children with Hemophilia A
(congenital Factor VIII deficiency) for:
• Control and prevention of bleeding episodes,
• Perioperative management (surgical prophylaxis),
• Routine prophylaxis to prevent or reduce the frequency of bleeding episodes.
ELOCTATE is not indicated for the treatment of von Willebrand disease.
4 CONTRAINDICATIONS
ELOCTATE is contraindicated in patients who have had life-threatening hypersensitivity
reactions to ELOCTATE, including anaphylaxis.
5.1 Hypersensitivity Reactions
Hypersensitivity reactions, including anaphylaxis, are possible with ELOCTATE. Early signs
of hypersensitivity reactions that can progress to anaphylaxis may include angioedema,
chest tightness, dyspnea, wheezing, urticaria, and pruritus. Immediately discontinue
administration and initiate appropriate treatment if hypersensitivity reactions occur.
5.2 Neutralizing Antibodies
Formation of neutralizing antibodies (inhibitors) to Factor VIII can occur following
administration of ELOCTATE. Monitor all patients for the development of Factor VIII
inhibitors by appropriate clinical observations and laboratory tests. If the plasma
Factor VIII level fails to increase as expected or if bleeding is not controlled after
ELOCTATE administration, suspect the presence of an inhibitor (neutralizing antibody).
[see Monitoring Laboratory Tests (5.3)]
5.3 Monitoring Laboratory Tests
• Monitor plasma Factor VIII activity by performing a validated test (e.g., one stage
clotting assay), to confirm that adequate Factor VIII levels have been achieved and
maintained. [see Dosage and Administration (2)]
• Monitor for the development of Factor VIII inhibitors. Perform a Bethesda inhibitor
assay if expected Factor VIII plasma levels are not attained, or if bleeding is not
controlled with the expected dose of ELOCTATE. Use Bethesda Units (BU) to report
inhibitor levels.
6 ADVERSE REACTIONS
Common adverse reactions (≥1% of subjects) reported in clinical trials were arthralgia
and malaise.
6.1 Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction
rates observed in the clinical trials of one drug cannot be directly compared to rates in
clinical trials of another drug and may not reflect the rates observed in practice.
In the multi-center, prospective, open-label, clinical trial of ELOCTATE, 164 adolescent
and GV