| What
are the indications for Kytril?
What are the pharmacologic features of Kytril? 1-4
How effective is Kytril?
Is Kytril well tolerated?
What were the most common adverse events in patients who received
Kytril Tablets?
What were the most common adverse events in patients who received
Kytril Injection for CINV?
Are there any clinically significant cardiovascular risks associated
with Kytril?
What is the safety profile in elderly patients?
What is the safety profile of Kytril in pediatric patients?
Are there any contraindications to Kytril?
How is Kytril dosed and administered?
What are the indications for Kytril?
Kytril Injection is indicated for the prevention of nausea and
vomiting associated with initial and repeat courses of emetogenic
cancer therapy, including high-dose cisplatin.
Kytril Injection is also indicated for the prevention treatment
of postoperative nausea and vomiting.
Kytril Tablets and Oral Solution are indicated for the prevention
of:
- Nausea and vomiting associated with initial
and repeat courses of emetogenic cancer therapy, including
high dose cisplatin.
- Nausea and vomiting associated with radiation, including
total body irradiation, and fractionated abdominal radiation.
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What are
the pharmacologic features of Kytril?1-4
Granisetron prevents nausea and vomiting by binding to 5-hydroxytrypatamine2
(5-HT3) receptors. From animal studies, it is believed
that binding of granisetron to 5-HT3 receptor sites located
in the
proximal
gut is the way in which the antiemetic effect is
mediated. These sites play a pivotal role in producing the
emetic
response to
chemotherapeutic drugs.1,2
When chemotherapy is administered, the cells in the
gut are believed to release serotonin, which binds
to the
5-HT3 receptor
sites
in the proximal gut.3 These
receptor sites are located on vagal afferent nerves,
which conduct
messages
from the gut to the
brain.2 When
these nerves are stimulated by serotonin binding,
they send
impulses to the emetic center, triggering nausea
and vomiting.4 By
blocking the 5-HT3 receptor sites, granisetron prevents
serotonin binding, thereby averting the emetic response.1
How effective is Kytril?
Kytril Tablets, Oral Solution and Injection effectively
prevent nausea and vomiting in patients undergoing
highly emetogenic
chemotherapy, as well as in patients receiving moderately
emetogenic chemotherapy. A single dose of Kytril Injection,
Tablets or
Oral Solution provide 24-hour protection against chemotherapy
induced
nausea and vomiting, and maintains efficacy in patients
receiving repeat cycles of chemotherapy.
- 1. The efficacy of Kytril Injection has not been
evaluated in patients receiving radiation or in children
less than 2 years of age receiving chemotherapy
- 2. The efficacy of Kytril Tablets and Oral Solutions
have not been evaluated in children receiving chemotherapy
or radiation
back to top Is Kytril well tolerated?
Extensive research has shown that Kytril is well
tolerated and can be safely used in a wide range
of patient types.
Furthermore, the adverse events reported with
Kytril are generally mild
to
moderate.
What were the most
common adverse events in patients who received
Kytril Tablets?
The most frequently reported adverse events were
headache (21%), usually
mild to moderate in severity; constipation (18%);
asthenia (14%); diarrhea (8%) and abdominal pain
(6%). Adverse
events were determined
in controlled clinical trials in which 978 patients
received two 1-mg Kytril Tablets as a divided
dose for 1, 7 or
14 days. Adverse events (whether or not related
to Kytril) were recorded
for 7 days when Kytril Tablets were given on
a single day and for up to 28 days when Kytril
Tablets
were
administered for
7 or 14 days.
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What were the most
common adverse events in patients who received
Kytril Injection for CINV?
The most common adverse events reported by 1268
chemotherapy patients who received single doses
of Kytril injection
in controlled clinical trials were headache
(14%), asthenia (5%), somnolence
(4%), diarrhea (4%) and constipation (3%).
Are there any clinically
significant cardiovascular risks associated
with Kytril?
There are no clinically significant cardiovascular
risks associated with Kytril. With Kytril Tablets,
hypertension,
hypotension,
angina pectoris, atrial fibrillation and syncope
have been observed rarely. With Kytril Injection,
hypertension,
hypotension,
arrhythmias
such as sinus bradycardia, atrial fibrillation,
varying degrees of A-V block, ventricular ectopy,
including
non-sustained tachycardia,
and ECG abnormalities have been observed rarely.
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What is the safety profile in elderly patients?
During clinical trials, 325 patients 65 years
of age or older received Kytril Tablets. Efficacy
and safety were maintained with increasing age.
What is
the safety profile of Kytril in pediatric
patients?
Although neither the tablet nor oral solution
have been studied in pediatric patients, clinical
trials
of the
intravenous formulation
indicate that granisetron is well tolerated
by children 2 through 16 years of age receiving
chemotherapy. In
children less than
2 years of age receiving chemotherapy, the
safety and efficacy of Kytril has not been
evaluated. Kytril has not
been evaluated in children receiving radiation
therapy.
Are there any contraindications
to Kytril?
The only known contraindication to Kytril is
hypersensitivity to the drug or any of its components.
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How is Kytril dosed and administered?
Kytril Injection
For the treatment of CINV. The recommended dose of Kytril Injection is 10 mcg/kg and can be administered in either
of two ways: undiluted and infused over just
30 seconds or
diluted and infused
over
5 minutes. With the 30-second infusion, Kytril
Injection can be infused undiluted directly
into the Y-site, anytime within 30 minutes before initiation of chemotherapy and only on the day(s) chemotherapy is given.
If administered as a 5-minute infusion, Kytril
Injection should be diluted
at the time of administration in 0.9% Sodium Chloride or
5% Dextrose and infused anytime
within 30 minutes prior to chemotherapy, and only on the day(s) chemotherapy is given.
For the prevention and treatment of PONV. The recommended dose is 1mg, undiluted, administered
intravenously over 30 seconds, before induction of anesthesia or immediately before
reversal of anesthesia.
Kytril Tablets / Oral Solution
For the treatment of CINV. The recommended adult dosage of Kytril Tablets is a
single 2-mg dose (two 1-mg tablets or 10mL/2 teaspoons) given anytime
within
1 hour before chemotherapy.
Kytril Tablets can also be administered as a
divided dose, with the first 1-mg tablet or one teaspoon (5mL) administered
anytime
within 1 hour
before
chemotherapy and the second 1-mg tablet or second teaspoon (5mL) given
12 hours after the first. Either regimen is administered only on the day(s) chemotherapy is given.
For the treatment of RINV. The recommended adult dosage is 2 mg once daily. Two 1 mg tablets or 10 mL
of oral solution (2 teaspoons) taken within 1 hour of radiation (total body irradiation or fractionated
abdominal radiation.)
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