Aloxi is indicated in the adult in

• prevention of acute nausea and vomiting associated with anti-cancer chemotherapy, highly emetogenic

• prevention of nausea and vomiting associated with anti-cancer chemotherapy, moderately emetogenic

Aloxi is indicated in children aged 1 months and older, and adolescents in

• prevention of acute nausea and vomiting associated with anti-cancer chemotherapy, highly emetogenic

• prevention of nausea and vomiting associated with anti-cancer chemotherapy, moderately emetogenic

Aloxi should only be administered prior to chemotherapy. This medicinal product should be administered by a health professional under appropriate medical supervision.


Adults

250 micrograms of palonosetron in single administration as an intravenous bolus about 30 minutes before the onset of chemotherapy. Aloxi must be administered in 30 seconds.

In the prevention of nausea and vomiting induced by highly emetogenic chemotherapy, the co-administration of a corticosteroid prior to chemotherapy can improve the efficacy of Aloxi. >

Elderly people

No, dose adjustment is necessary in elderly people

Population, pediatric

Children and adolescents (aged 1 month to 17 years)

20 micrograms / kg (the maximum total dose should not exceed 1,500 micrograms) of single administered palonosetron as an intravenous infusion of 15 minutes beginning approximately 30 minutes prior to onset of chemotherapy Br>

The safety and efficacy of Aloxi in children under one month of age have not been established. No data available. Data on the use of Aloxi in the prevention of nausea and vomiting in children under 2 years of age are limited.
Hepatic Insufficiency

None, dosage adjustment is required in patients with hepatic impairment

Renal insufficiency

No dosage adjustment is necessary in patients with renal insufficiency. There is no clinical data available in hemodialysis patients with renal impairment at the terminal stage

Administration mode




Intravenous use of
Solution: clear, colorless injectable.

Class: Pharmacotherapeutic: Antiemetic and antinauseous, serotonin antagonists (5HT 3), ATC Code: A04AA05
Palonosetron is a selective antagonist with high affinity for serotonin 5HT3 receptors.

In two randomized, double-blind studies conducted in 1,132 patients receiving chemotherapy, moderately emetogenic, including cisplatin at ≤ 50 mg / m 2, carboplatin, cyclophosphamide at ≤ 1,500 mg / m 2 and doxorubicin at> 25 Mg / m 2, palonosetron (250 micrograms and 750 micrograms) was compared with ondansetron 32 mg (half-life 4 hours) or dolasetron 100 mg (half-life 7.3 hours) administered by Intravenous route on the first day, without dexamethasone.

In a randomized double-blind study conducted on 667 patients receiving highly emetogenic chemotherapy including cisplatin at ≥ 60 mg / m 2, cyclophosphamide at> 1500 mg / m 2 and dacarbazine, palonosetron 250 micrograms And 750 micrograms was compared with ondansetron 32 mg administered intravenously on the first day. Prophylactic treatment with dexamethasone was administered prior to chemotherapy in 67% of patients.

Pivotal studies were not designed to evaluate the efficacy of palonosetron for delayed nausea and vomiting. The antiemetic action was observed for 0-24 hours, 24-120 hours and 0-120 hours. The results of studies on moderately emetogenic chemotherapy and the study on highly emetogenic chemotherapy are summarized in the tables below.
In both contexts, moderately and highly emonating treatments, palonosetron was not inferior to comparators in the acute phase of vomiting.

Aloxi

250 micrograms

(N '= 189)

Ondansetron

32 milligrams

(N '= 185)

Delta

%

%

%

Response, complete (no vomiting and no rescue medication) IC to 97.5% b

0 - 24; hours

81,0

68,6

12,4

[1.8%, 22.8%]

24 - 120 hours

74,0

55.1

19,0

[7.5%, 30.3%]

0 - 120 hours

69,3

50.3

19,0

[7,4%, 30,7%]

Control: complete (complete response and only a few, moderate nausea)

P c

Value

0 - 24; hours

76,2

65,4

10,8

NS

24 - 120 hours

66,7

50.3

16,4

0.001

0 - 120 hours

63,0

44,9

18.1

0.001

Absence of nausea (Likert scale)

Value, p c

0 - 24; hours

60,3

56,8

3,5

NS

24 - 120 hours

51,9

39,5

12,4

NS

0 - 120 hours

45,0

36,2

8,8

NS

A: Cohort, Intention to process.

C; Chi test 2. Level of significance at; α '= 0.05.

Table 2: Percentage of responders per group, treatment and phase (in the chemotherapy study moderately, emetic versus dolasetron)
Aloxi

250 micrograms

(N; '= 185)

Dolasetron; 100 milligrams

(N; '= 191)

Delta

%

%

%

Response, complete (no vomiting and no rescue medication) IC to 97.5% b

0 - 24; hours

63,0

52,9

10.1

[-1,7%, 21,9%]

24 - 120 hours

54,0

38,7

15,3

[3,4%, 27,1%]

0 - 120 hours

46,0

34,0

12,0

[0.3%, 23.7%]

Control: complete (complete response and only a few, moderate nausea)

Value

0 - 24; hours

57.1

47,6

9,5

NS

24 - 120 hours

48.1

36.1

12,0

0.018

0 - 120 hours

41,8

30,9

10,9

0.027

Absence of nausea (Likert scale)

Value, p c

0 - 24; hours

48,7

41,4

7,3

NS

24 - 120 hours

41,8

26,2

15,6

0.001

0 - 120 hours

33,9

22,5

11,4

0.014

A: Cohort, Intention to process.