Welcome to the Kytril.com’s Professional Center. Kytril.com has been designed to be a reliable resource for you, your patients and their caregivers for the management of chemotherapy and radiation-induced nausea and vomiting (N & V).

In the Professional Center, you can review complete product information about Kytril Tablets and Injection, view Frequently Asked Questions for Healthcare Professionals, download Fact Sheets about Kytril Tablets and Injection to share with your patients and learn more about how Roche can help with financial reimbursement for your patients.

This Web site also features a Get the Facts section for patients and caregivers with helpful tips on how to ease emesis, how to communicate with healthcare professionals, what to expect during cancer treatment and much more. Click here to familiarize yourself with these tip sheets, should a patient want to discuss them with you or should you choose to share them with a patient.

We strongly encourage all cancer patients to talk with their healthcare team if they experience chemotherapy or radiation therapy induced nausea and vomiting because you, as a healthcare professional, are your patients’ best advocate against emesis. A Symptom Diary has been made available to your patients so that they can keep track of how they are feeling on a daily basis and share their experiences with you. Click here to view the Symptom Diary or to download it for one of your patients.

Nausea and vomiting are two of the most distressing chemotherapy side effects for patients. Serotonin (5HT-₃¹) receptor inhibition is crucial for managing acute emesis¹. Serotonin is released in response to some chemotherapy and radiation therapy. It is believed that serotonin binds to the 5-HT₃ receptors that activate vagal afferent neurons, causing an emetic response¹. Patients who have poor control of acute N & V are more likely to experience delayed emesis². The physiologic mechanisms for acute N & V differ from those of anticipatory or delayed chemotherapy-induced nausea and vomiting (CINV).¹

Why choose Kytril?

Efficacy
Safety
Simplicity

Kytril provides critical first-round protection covering both early-onset and late-onset acute N&V. A single dose of Kytril has the proven efficacy to prevent the nausea and vomiting caused by early-onset acute emetogenic agents like cisplatin ^3,4 and the long-acting efficacy to prevent the nausea and vomiting caused by late-onset acute emetogenic agents like cyclophosphamide.⁵ Kytril has been used safely for over 7 years.

Efficacy

Effective control is the measure of success for any antiemetic.

• A single dose of Kytril, injection or oral, has the proven efficacy to protect against moderately and highly emetogenic chemotherapy agents for 24 hours in CINV³

• A 2-mg single oral dose of Kytril Tablets provides efficacy equal to 32 mg of Zofran®* IV in CINV.^5,6
  
  *Zofran (ondansetron HCl) is a registered trademark of The GlaxoSmithKline Group of Companies.

	N=1054 Mean cisplatin=79 mg/m2 Most patients received concomitant dexamethasone
	N=1085 Most patients received concomitant dexamethasone

A single 10µg/kg Kytril Injection offers patients 24-hour control

62% of patients experienced a complete response^§ when given Kytril injection with high-dose cisplatin^||(n=52)

* Defined as no emesis, no nausea and no use of antiemetic rescue medication.
† Defined as no emesis and no use of antiemetic rescue medication.
‡ Defined as no nausea and no use of antiemetic rescue medication.
§ No vomiting and no moderate or severe nausea.
II Randomized dose-response study of cancer patients receiving cisplatin ≥75 mg/m².

Safety

• Kytril is not associated with QTc prolongation^7,8

• No clinically significant risk of cardiovascular events—even with the 30 second infusion⁹
  • Cardiovascular events reported in clinical trials with Kytril Injection included hypertension (2%); hypotension, arrhythmias such as sinus bradycardia, atrial fibrillation, varying degrees of A-V block, ventricular ectopy including nonsustained tachycardia and ECG abnormalities have been observed rarely

• No restrictions in patients with underlying cardiac conditions, hepatic or renal impairment

• No dosage adjustment of Kytril Injection is required for children experiencing CINV (aged 2 to 16 years), elderly patients or those with hepatic or renal impairment

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Simplicity

Kytril Tablets and Oral Solution

• As a single dose: Two 1-mg tablets or 10-mL oral solution taken anytime within 1 hour before chemotherapy offers 24-hour control in CINV

• As a divided dose: The first 1-mg tablet or 1 teaspoon (5 mL) of oral solution taken anytime within 1 hour before chemotherapy and the second tablet or teaspoon taken 12 hours after the first

Kytril IV

• Same easy 10-µg/kg dosage for all CINV patients (including children 2 years of age and older) administered within 30 minutes before initiation of chemotherapy

• Rapid 30-second infusion for added convenience
  — Reduces preparation time and administration costs
  — Administered undiluted directly into the Y-site

• Same dose provides patients optimal protection regardless of emetogenic potential of chemotherapy regimen or patients’ propensity for N&V

• Half-life consistent with single-dose schedule

• Availability
  — Convenient 4-mL multi-dose vials
  — 1-mL single-dose vials

Metabolism

Compatibility

Kytril does not induce or inhibit the cytochrome P-450 3A4 drug-metabolizing system^*

• It is the only 5-HT₃ receptor antagonist with no CYP2D6 metabolism^10-13

• Drug metabolism may be important in choosing medications for cancer patient^14,15

Agent	P-450 Enzymes Involved in Metabolism
	CYP2D6	CYP1A2	CYP3A4
Kytril10
Zofran10,11
Anzemet®?12
Aloxi™‡13

^*Because Kytril is metabolized by hepatic cytochrome P-450 drug - metabolyzing enzymes, inducers or exhibitors of these  enzymes may change the clearance and, hence the half-life of Kytril.

?Anzemet (dolasetron mesylate) is a registered trademark of Aventis Pharmaceuticals Products Inc.

‡Aloxi (palonosetron HCl) is a trademark of MGI Pharma, Inc.

Compatibility^§

Kytril is compatible with a wide range of chemotherapy agents in a Y-site injection model.¹⁶

	Kytril17	Zofran17	Anzemet18
Carboplatin
Cisplatin
Cyclophosphamide
Fluorouracil		Incompatible	Incompatible
Ifosfamide
Paclitaxel			Data not available

Kytril is compatible with three commonly used corticosteroids

	Kytril17	Zofran17	Anzemet18	Aloxi13
Dexamethasone			|| Incompatible¶	Data not available
Methlyprednisolone		Incompatible	Incompatible	Data not available
Hydrocortisone				Data not available

§As a general precaution, Kytril Injection should not be mixed in a solution with other drugs. Parenteral drug products should be inspected visually for particulate matter and discoloration before administration whenever solution and container permit.

|| 100 mg Anzemet combined with 10 mg dexamethasone sodium phosphate (Schein or American Regent) was compatible for at least 2 hours.

¶ 100 mg Anzemet combined with 20 mg dexamethasone sodium phosphate (Schein or American Regent) showed signs of incompatibility.

Kytril Injection and Tablets have been studied in combination with Emend®^#19-22

• Kytril Tablets is the only oral 5-HT₃ receptor antagonist with published data in combination with the FDA-approved dose of Emend.**

#Emend(aprepitant) is a registered trademark of Merck & Co. Inc.

** As per the Emend Prescribing Information, Emend is indicated in combination with other antiemetic agents.

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Confidence for RINV

In patients receiving TBI (total body irradiation),⁺⁺ Kytril Tablets provided significantly greater antiemetic protection than that of historical controls.^‡‡

Significantly more (P<.01) patients who received Kytril had complete control (no emesis, no rescue medication) vs the control group²³

No patient who received Kytril experienced more than 5 emetic episodes vs 56% of control patients (P<.01)²³

61% of Kytril patients experienced zero emetic episodes vs 7% of control patients (P<.01) at 24 hours²³

In patients receiving FAR (fractionated abdominal radiation),^§§ Kytril Tablets provided significantly greater antiemetic protection than placebo.

• Kytril Tablets provided significantly longer median times to first emesis (35 vs 9 days; P<.001) and first nausea (11 days vs 1 day; P<.001) vs placebo²⁴

• The proportion of patients receiving Kytril Tablets who had no emesis and no nausea at 24-hours was significantly superior to placebo (P<.001)²⁴
  

• Kytril was superior to placebo in patients receiving up to 10 daily fractions of radiation, but was not superior to placebo in patients receiving 20 fractions²⁴
  

^??TBI consisted of 11 fractions of 120 cGy administered over 4 days with 3 fractions on each of the first 3 days and 2 fractions on the fourth day.

^‡‡ Historical negative control group (n=90) who received conventional (non-5-HT₃ antagonist) antiemetics.

^§§ Dose of upper abdominal fractionated radiation: 180 - 300 cGy per fraction (weekly ≥ 900 cGy).

Confidence in its Simplicity

• The only once-a-day 5-HT₃ receptor antagonist approved for the prevention of RINV
  
• A single 2-mg dose (two 1-mg tablets) or 10 mL of oral solution taken anytime within 1 hour of TBI or FAR
  
• Kytril Oral Solution offers an easy-to-swallow alternative for patients
  
• 2-mg dose of Kytril Oral Solution is bioequivalent to the 2-mg dose of Kytril Tablets

Reliability

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• Patient Education Brochure (Adobe® PDF)

• Read an excerpt from my Healing Companion

• Download Activity Sheets
  from Beverly Kirkhart's book