Aloxi

Main information

  • Trade name:
  • Aloxi 250µg/5mL Solution for injection
  • Dosage:
  • 250µg/5mL
  • Pharmaceutical form:
  • Solution for injection
  • Units in package:
  • Vial, glass, single dose, 5 mL
  • Class:
  • Prescription
  • Prescription type:
  • Prescription
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug
  • Manufactured by:
  • Helsinn Advanced Synthesis SA

Documents

Localization

  • Available in:
  • Aloxi 250µg/5mL Solution for injection
    New Zealand
  • Language:
  • English

Therapeutic information

  • Therapeutic indications:
  • Aloxi is indicated for prevention of nausea and vomiting induced by cytotoxic chemotherapy.

Other information

Status

  • Source:
  • Medsafe - Medicines Safety Authority - New Zealand
  • Authorization number:
  • 11833
  • Authorization date:
  • 13-10-2004
  • Last update:
  • 09-05-2018

Summary of Product characteristics: dosage,interactions,side effects

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PRODUCT INFORMATION

ALOXI

palonosetron HCl injection

NAME OF THE DRUG

ALOXI Injection

(palonosetron hydrochloride)

Structural Formula

DESCRIPTION

Palonosetron hydrochloride is a white to off-white crystalline powder. It is freely soluble in water,

soluble in propylene glycol, and slightly soluble in ethanol and 2-propanol.

Chemically, palonosetron hydrochloride is: (3aS)-2-[(S)-1-Azabicyclo[2.2.2]oct-3-yl]-2,3,3a,4,5,6-

hexahydro-1-oxo-1Hbenz[de]isoquinoline hydrochloride. The empirical formula is C

O.HCl, with

a molecular weight of 332.87. Palonosetron hydrochloride exists as a single isomer.

Chemical Abstracts Service (CAS) registry number:

135729-61-2 Palonosetron

135729-62-3 Palonosetron Hydrochloride

ALOXI injection is a sterile, clear, colourless, non-pyrogenic, isotonic, buffered solution for intravenous

administration. Each 5 ml vial of ALOXI injection contains 250 µg equivalent palonosetron base

as hydrochloride.

Inactive Ingredients:

Mannitol 207.5 mg, disodium edetate and citrate buffer in water for intravenous administration. The

pH of the solution is 4.5 to 5.5.

PHARMACOLOGY

Palonosetron hydrochloride is an antiemetic and antinauseant agent. It is a selective serotonin

subtype 3 (5-HT

) receptor antagonist with a strong binding affinity for this receptor.

Pharmacodynamics

Cancer chemotherapy may be associated with a high incidence of nausea and vomiting, particularly

when certain agents, such as cisplatin, are used. 5-HT

receptors are located on the nerve terminals

of the vagus in the periphery and centrally in the chemoreceptor trigger zone of the area postrema. It

is thought that chemotherapeutic agents produce nausea and vomiting by releasing serotonin from

the enterochromaffin cells of the small intestine and that the released serotonin then activates 5-HT

receptors located on vagal afferents to initiate the vomiting reflex.

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The effect of palonosetron on blood pressure, heart rate, and ECG parameters including QTc were

comparable to ondansetron and dolasetron in clinical trials. In non-clinical studies palonosetron

possesses the ability to block ion channels involved in ventricular de- and re-polarization and to

prolong action potential duration. The effect of palonosetron on QTc interval was evaluated in a

double blind, randomized, parallel, placebo and positive (moxifloxacin) controlled trial in adult men

and women. The objective was to evaluate the ECG effects of IV administered palonosetron at single

doses of 0.25, 0.75 or 2.25 mg in 221 healthy subjects. The study demonstrated no effect on QT/QTc

interval duration as well as any other ECG interval at doses up to 2.25 mg. No clinically significant

changes were shown on heart rate, atrioventricular (AV) conduction and cardiac repolarisation.

Pharmacokinetics

After intravenous dosing of palonosetron in healthy subjects and cancer patients, an initial decline in

plasma concentrations is followed by a slow elimination from the body. Mean maximum plasma

concentration (C

) and area under the concentration-time curve (AUC

0-oo

) are generally dose-

proportional over the dose range of 0.3–90 µg/kg in healthy subjects and in cancer patients. Following

single IV dose of palonosetron at 3 µg/kg (or 0.21 mg/70 kg) to six cancer patients, mean (±SD)

maximum plasma concentration was estimated to be 5.6 ± 5.5 ng/mL and mean AUC was 35.8 ± 20.9

nghr/mL.

Following intravenous administration of palonosetron 0.25 mg once every other day for 3

doses in 11 testicular cancer patients, the mean (± SD) increase in the initial phase of the

plasma concentration-time curve (AUC

0-2.5hr

) from Day 1 to Day 5 was 42 ± 34 %; how this

finding relates to more conventional measures of systemic exposure is not known.

After intravenous administration of palonosetron 0.25 mg once daily for 3 days in 12 healthy

subjects, the mean (± SD) increase in systemic exposure over 24 hours (AUC

0-24hr

) from Day

1 to Day 3 was 110 ± 45 %.

Drug accumulation may be greater in the 10% of patients with prolonged elimination half-life.

Distribution: Palonosetron has a volume of distribution of approximately 8.3 ± 2.5 L/kg.

Approximately 62% of palonosetron is bound to plasma proteins.

Metabolism: Palonosetron is eliminated by multiple routes with approximately 50% metabolized to

form two primary metabolites: N-oxide-palonosetron and 6-S-hydroxy-palonosetron. These

metabolites each have less than 1% of the 5-HT

receptor antagonist activity of palonosetron. In vitro

metabolism studies have suggested that CYP2D6 and to a lesser extent, CYP3A and CYP1A2 are

involved in the metabolism of palonosetron. However, clinical pharmacokinetic parameters are not

significantly different between poor and extensive metabolizers of CYP2D6 substrates.

Elimination: After a single intravenous dose of 10 µg/kg [

C]-palonosetron, approximately 80% of

the dose was recovered within 144 hours in the urine with palonosetron representing approximately

40% of the administered dose. In healthy subjects the total body clearance of palonosetron was 160

± 35 mL/h/kg and renal clearance was 66.5± 18.2 mL/h/kg . Mean terminal elimination half life is

approximately 40 hours.

CLINICAL TRIALS

Single-dose palonosetron administration

Efficacy of single-dose palonosetron injection in preventing nausea and vomiting induced by

moderately and highly emetogenic chemotherapy was studied in a phase 2 dose-ranging trial and

three phase 3 trials. In the phase 3 trials, the primary efficacy endpoint was complete response rate

(no emetic episodes and no rescue medication). Prevention of nausea was assessed as a secondary

efficacy endpoint. The safety and efficacy of palonosetron in repeated courses of chemotherapy was

also studied.

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Moderately Emetogenic Chemotherapy

Two Phase 3, double-blind trials involving 1132 patients compared single-dose IV palonosetron with

either single-dose IV ondansetron (study 1) or dolasetron (study 2) given 30 minutes prior to

moderately emetogenic chemotherapy including carboplatin, cisplatin ≤ 50 mg/m², cyclophosphamide

< 1500 mg/m², doxorubicin > 25 mg/m², epirubicin, irinotecan, and methotrexate > 250 mg/m².

Concomitant corticosteroids were not administered prophylactically in study 1 and were only used by

4-6% of patients in study 2. The majority of patients in these studies were women (77%), White

(65%) and naïve to previous chemotherapy (54%). The mean age was 55 years, (age range 18-97).

Highly Emetogenic Chemotherapy

A Phase 2, double-blind, dose-ranging study evaluated the efficacy of single-dose IV palonosetron

from 0.3 to 90 µg/kg (equivalent to < 0.1 mg to 6 mg fixed dose) in 161 chemotherapy-naïve adult

cancer patients receiving highly-emetogenic chemotherapy (either cisplatin ≥ 70 mg/m² or

cyclophosphamide > 1100 mg/m²). Concomitant corticosteroids were not administered

prophylactically. Analysis of data from this trial indicates that 250 µg is the lowest effective dose in

preventing acute nausea and vomiting induced by highly emetogenic chemotherapy.

A Phase 3, double-blind trial involving 667 patients compared single-dose IV palonosetron with single-

dose IV ondansetron (study 3) given 30 minutes prior to highly emetogenic chemotherapy including

cisplatin ≥ 60 mg/m², cyclophosphamide > 1500 mg/m², and dacarbazine. Highly emetogenic

chemotherapy was given only for the first day of the chemotherapy cycle. For the remainder of the

cycle, low to moderately (max grade 3 of Hesketh scale) emetogenic chemotherapy was allowed.

Corticosteroids were co-administered prophylactically before chemotherapy in 67% of patients. Of the

667 patients, 51% were women, 60% White, and 59% naïve to previous chemotherapy. The mean

age was 52 years; (age range 18-86).

Efficacy Results

Intent-to-treat analyses are presented. The conclusions of the per protocol analyses were similar.

Palonosetron was non-inferior to the comparators in the prevention of acute vomiting (within 24h) after

moderately and highly emetogenic chemotherapy and comparable in the prevention of nausea

(Tables 1-3). Efficacy was greater when corticosteroids were administered concomitantly in the highly

emetogenic setting. The secondary efficacy endpoint of the study assessed delayed onset (24-120h)

nausea and vomiting, the results are shown below (Tables 1-3). The comparative efficacy of

palonosetron 250 µg in multiple cycles of chemotherapy has not been demonstrated.

Table 1: Study - Efficacy after Moderately Emetogenic Chemotherapy

Palonosetron

250 µg

(n=189)

Ondansetron 32

mg IV

(n=185)

Difference

[97.5%CI]

Complete

Response (%)

0-24h

24-120h

0-120h

81.0

74.1

69.3

68.6

55.1

50.3

12.4[1.8.22.8]

19.0[7.5,30.3]

19.0[7.4,30.7]

No Nausea (%)

0-24h

24-120h

0-120h

60.3

51.9

45.0

56.8

39.5

36.2

3.5[not sig]

12.4[not sig]

8.8[not sig]

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Table 2: Study 2 - Efficacy after Moderately Emetogenic Chemotherapy

Palonosetron

250 µg

(n=189)

Dolasetron 100

mg IV

(n=191)

Difference

[97.5%CI]

Complete

Response (%)

0-24h

24-120h

0-120h

63.0

54.0

46.0

52.9

38.7

34.0

10.1 [-1.7,21.9]

15.3 [3.4,27.1]

12.0 [0.3,23.7]

No Nausea (%)

0-24h

24-120h

0-120h

48.7

41.8

33.9

41.4

26.2

22.5

7.3 [not sig]

15.6 [p=0.001]

11.4[p=0.01]

Table 3: Study 3 - Efficacy after Highly Emetogenic Chemotherapy

Palonosetron

250 µg

(n=223)

Ondansetron 32

mg IV

(n=221)

Difference

[97.5%CI]

Complete

Response (%)

0-24h

24-120h

0-120h

59.2

45.3

40.8

57.0

38.9

33.0

2.2 [-8.8,13.1]

6.4[-4.6,17.3]

7.8[-2.9,18.5]

No Nausea (%)

0-24h

24-120h

0-120h

53.8

35.4

33.6

49.3

32.1

32.1

4.5[not sig]

3.3[not sig]

1.5[not sig]

The studies were designed to show non-inferiority in complete response. A lower bound > -15% demonstrates non-inferiority

between palonosetron and comparator. Absence of nausea (Likert Scale) was compared using a Chi-square test at p=0.05

significance level.

Multiple-dose palonosetron administration

Published randomised, controlled studies have not been designed to show, or have not shown,

improvement in primary efficacy endpoints related to nausea and vomiting in patient arms given

ALOXI daily or on alternate days, relative to single dose use, in the context of multiple day

chemotherapy. It has not been clearly established that such repeated dosing provides significant

additional benefit compared to a single dose.

INDICATIONS

ALOXI is indicated for prevention of nausea and vomiting induced by cytotoxic chemotherapy.

CONTRAINDICATIONS

ALOXI is contraindicated in patients known to have hypersensitivity to the drug or any of its

components.

PRECAUTIONS

General

Hypersensitivity reactions may occur in patients who have exhibited hypersensitivity to other selective

5-HT

receptor antagonists. ALOXI should not be used to prevent or treat nausea and vomiting in the

days following chemotherapy if not associated with another chemotherapy administration.

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There have been reports of serotonin syndrome with the use of 5-HT

antagonists either alone

or in combination with other serotonergic drugs including selective serotonin reuptake

inhibitors (SSRI) and serotonin noradrenaline reuptake inhibitors (SNRIs).

Cardiac Conduction

At all dose levels tested, palonosetron did not induce clinically relevant prolongation of the QTc

interval. A specific thorough QT/QTc study was conducted in healthy volunteers for definitive

data demonstrating the effect of palonosetron on QT/QTc (see Pharmacodynamics). However,

as for the other 5-HT

antagonists, caution should be exercised in the concomitant use of

palonosetron with medicinal products that increase the QT interval or in patients who have or are

likely to develop prolongation of the QT interval.

Effects on ability to drive and use machines: No studies on the effects on the ability to drive and

use machines have been performed.

Carcinogenicity

In a 104-week carcinogenicity study in CD-1 mice, animals were treated with oral doses of

palonosetron at 10, 30 and 60 mg/kg/day. Treatment with palonosetron was not tumorigenic.

The highest tested dose produced a systemic exposure to palonosetron (plasma AUC) of > 600

times the human exposure at the recommended intravenous dose of 250 µg.

In a 104-week carcinogenicity study in Sprague-Dawley rats, male and female rats were treated

with oral doses of 15, 30 and 60 mg/kg/day and 15, 45 and 90 mg/kg/day, respectively. The

lowest and highest doses, respectively, produced a systemic exposure to palonosetron (plasma

AUC) of > 25 times and > 500 times the human exposure at the recommended dose.

Treatment with palonosetron produced increased incidences of adrenal benign

pheochromocytoma and combined benign and malignant pheochromocytoma in both male and

female rats, of pancreatic Islet cell adenoma and combined adenoma and carcinoma of

pancreatic acinar cell adenoma and combined adenoma and adenocarcinoma and of pituitary

adenoma in male rats. Increased incidences of skin keratocanthomas and tail squamous cell

papillomas were also observed, mainly in males. In female rats, palonosetron produced

hepatocellular adenoma and combined hepatocellular adenoma and carcinoma, and increased

the incidences of thyroid C-cell adenoma and combined adenoma and carcinoma, and of

mammary gland adrenocarcinoma.

Genotoxicity

Palonosetron was not genotoxic in the Ames test, the Chinese hamster ovarian cell

(CHO/HGPRT) forward mutation test, the ex vivo hepatocyte unscheduled DNA synthesis test or

the mouse micronucleus test. It was, however, positive for clastogenic effects in the CHO cell

chromosomal aberration test.

Effects on Fertility

Palonosetron at oral doses of up to 60 mg/kg/day (>170 times the recommended human

intravenous dose based on estimated plasma AUC) was found to have no effect on fertility and

reproductive performance of male and female rats. Oral doses of 60 and 120 mg/kg/day given to

male rats for 2 months prior to mating associated with complete infertility at the 120 mg/kg/day

dose. Testicular degeneration was confirmed in a 3 month general toxicity study at oral doses of

60 and 120 mg/kg/day. An IV dose of up to 10 mg/kg/day (>250 times the recommended human

intravenous dose based on plasma AUC) had no effect on male fertility and reproductive

performance.

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Special populations:

Geriatrics: Population pharmacokinetic analysis and clinical safety and efficacy data did not

reveal any differences between cancer patients ≥ 65 years of age and younger patients (18 to 64

years). No dose adjustment is required for these patients.

Race: Intravenous palonosetron pharmacokinetics was characterized in twenty-four healthy

Japanese subjects over the dose range of 3 – 90 µg/kg. Total body clearance was 25% higher in

Japanese subjects compared to Whites; however, no dose adjustment is required. The

pharmacokinetics of palonosetron in Blacks has not been adequately characterized.

Renal Impairment: Mild to moderate renal impairment does not significantly affect palonosetron

pharmacokinetic parameters. Total systemic exposure increased by approximately 28% in severe

renal impairment relative to healthy subjects. Dosage adjustment is not necessary in patients with any

degree of renal impairment.

Hepatic Impairment: Hepatic impairment does not significantly affect total body clearance of

palonosetron compared to the healthy subjects. Dosage adjustment is not necessary in patients with

any degree of hepatic impairment.

Children: There are no data on efficacy and safety in patients below 18 years.

Use in Pregnancy (Category B1)

Palonosetron had no effect on foetal development at oral doses of up to 18 mg/kg/day in rats and 90

mg/kg/day in rabbits. At 60 and 120 mg/kg/day in rats, foetal weight was reduced. Palonosetron did

not cause foetal abnormalities at these dose levels. However, palonosetron had toxic effects on the

dams at 120 mg/kg in rats and 90 mg/kg/day in rabbits.

Because animal reproduction studies are not always predictive of human response, palonosetron

should not be used during pregnancy unless it is considered essential.

Use during Lactation

It is not known whether palonosetron is excreted in human milk, but some other drugs of the same

class are known to be excreted in rat milk. Because of the potential for serious adverse reactions in

nursing infants, a decision should be made whether to discontinue breastfeeding or to discontinue the

drug, taking into account the importance of the drug to the mother.

INTERACTIONS WITH OTHER MEDICINES

Palonosetron is eliminated from the body through both renal excretion and metabolic pathways with

the latter mediated via multiple CYP enzymes. Further in vitro studies indicated that palonosetron is

not an inhibitor of CYP1A2, CYP2A6, CYP2B6, CYP2C9, CPY2D6, CYP2E1 and CYP3A4/5

(CYP2C19 was not investigated) nor does it induce the activity of CYP1A2, CYP2D6, or CYP3A4/5.

Therefore, the potential for clinically significant drug interactions with palonosetron appears to be low.

A study in healthy volunteers involving single-dose IV palonosetron (0.75 mg) and steady state oral

metoclopramide (10 mg four times daily) demonstrated no significant pharmacokinetic interaction.

In controlled clinical trials, ALOXI injection has been safely administered with corticosteroids,

analgesics, antiemetics/antinauseants, antispasmodics and anticholinergic agents.

Palonosetron did not inhibit the antitumor activity of the five chemotherapeutic agents tested (cisplatin,

cyclophosphamide, cytarabine, doxorubicin and mitomycin C) in murine tumor models.

There have been reports of serotonin syndrome following concomitant use of 5-HT

antagonists and other serotonergic drugs (including SSRIs and SNRIs).

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ADVERSE EVENTS

In clinical trials for the prevention of nausea and vomiting induced by moderately or highly emetogenic

chemotherapy, 1374 adult patients received palonosetron. Adverse reactions were similar in

frequency and severity with ALOXI and ondansetron or dolasetron. Following is a listing of all

adverse reactions reported by ≥ 2% of patients in these trials (Table 4).

Table 4: Adverse Reactions from Chemotherapy-Induced Nausea and Vomiting Studies, ≥ 2% in any

Treatment Group

Event

ALOXI

250 µg

(N=633)

Ondansetron

32 mg IV

(N=410)

Dolasetron

100 mg IV

(N=194)

Headache

60 (9%)

34 (8%)

32 (16%)

Constipation

29 (5%)

8 (2%)

12 (6%)

Diarrhoea

8 (1%)

7 (2%)

4 (2%)

Dizziness

8 (1%)

9 (2%)

4 (2%)

Fatigue

3 (< 1%)

4 (1%)

4 (2%)

Abdominal Pain

1 (< 1%)

2 (< 1%)

3 (2%)

Insomnia

1 (< 1%)

3 (1%)

3 (2%)

In other studies, 2 subjects experienced severe constipation following a single palonosetron dose of

approximately 0.75 mg, three times the recommended dose. One patient received a 10 µg/kg oral

dose in a post-operative nausea and vomiting study and one healthy subject received a 0.75 mg IV

dose in a pharmacokinetic study.

In clinical trials, the following infrequently reported adverse reactions, assessed by investigators as

treatment-related or causality unknown, occurred following administration of ALOXI to adult patients

receiving concomitant cancer chemotherapy:

Cardiovascular: 1%: non-sustained tachycardia, bradycardia, hypotension, < 1%: hypertension,

myocardial ischemia, extrasystoles, sinus tachycardia, sinus arrhythmia, supraventricular

extrasystoles and QT prolongation. In many cases, the relationship to ALOXI was unclear.

Dermatological: < 1%: allergic dermatitis, pruritic rash.

Hearing and Vision: < 1% motion sickness, tinnitus, eye irritation and amblyopia.

Gastrointestinal system: 1%: diarrhoea, < 1%: dyspepsia, upper abdominal pain, dry mouth,

hiccups and flatulence.

General: 1%: weakness, asthenia < 1%: fatigue, fever, hot flash, flu-like syndrome.

Liver: < 1%: transient, asymptomatic increases in AST and/or ALT and bilirubin. These changes

occurred predominantly in patients receiving highly emetogenic chemotherapy.

Metabolic: 1%: hyperkalemia, < 1%: electrolyte fluctuations, hypocalcemia, hyperglycemia, metabolic

acidosis, glycosuria, appetite decrease, anorexia.

Musculoskeletal: < 1%: arthralgia.

Nervous System: 1%: dizziness, < 1%: somnolence, insomnia, hypersomnia, paresthesia, and

peripheral sensory neuropathy.

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Psychiatric: 1%: anxiety, < 1%: euphoric mood.

Urinary System: < 1%: urinary retention.

Vascular: < 1%: vein discoloration, vein distention.

Post-marketing experience

In post-marketing reports there have been very rare cases of :

Hypersensitivity reactions including anaphylaxis and shock, and

Injection site reactions such as burning, induration, discomfort and pain

DOSAGE AND ADMINISTRATION

Dosage for Adults

The recommended dosage of ALOXI is 250 µg administered as a single dose approximately 30

minutes before the start of chemotherapy.

Drug accumulation was observed in subjects administered ALOXI on consecutive days or once every

two days for three doses (see Pharmacokinetics). Safety and efficacy data available regarding

repeated dosing of ALOXI within a course of multi-day chemotherapy are limited (see Clinical Trials).

Use in Geriatric Patients and in Patients with Impaired Renal or Hepatic Function

No dosage adjustment is recommended.

Dosage for Paediatric Patients

A recommended intravenous dosage has not been established for paediatric patients.

Administration

ALOXI should only be used before chemotherapy administration. ALOXI is to be infused intravenously

over 30 seconds.

Instructions for use/handling

This medicinal product must not be mixed with other medicinal products.

Flush the infusion line with normal saline before and after administration of ALOXI.

Contains no antimicrobial agent. ALOXI is for single use in one patient only. Discard any residue.

OVERDOSAGE

There is no known antidote to ALOXI. Overdose should be managed with supportive care. Fifty adult

cancer patients were administered palonosetron at a dose of 90 µg/kg (equivalent to 6 mg fixed dose)

as part of a dose ranging study. This is approximately 25 times the recommended dose of 250 µg.

This dose group had a similar incidence of adverse events compared to the other dose groups and no

dose response effects were observed. Dialysis studies have not been performed; however, due to

the large volume of distribution, dialysis is unlikely to be an effective treatment for palonosetron

overdose. A single intravenous dose of palonosetron at 30 mg/kg (947 and 474 times the human

dose for rats and mice, respectively, based on body surface area) was lethal to rats and mice. The

major signs of toxicity were convulsions, gasping, pallor, cyanosis and collapse.

PRESENTATION AND STORAGE CONDITIONS

ALOXI 250 µg / 5 mL solution for injection is sold as a single pack of 1 vial.

Store below 25°C. Protect from light.

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NAME AND ADDRESS OF THE SPONSOR

Specialised Therapeutics Australia

Level 1, 711 High Street

Kew East VIC 3102 Australia

Tel: 1300 798 820 Fax: 1800 798 829

www.specialisedtherapeutics.com.au

Specialised Therapeutics

23 Albert Street

Auckland 1140

New Zealand

POISON SCHEDULE / MEDICINE SCHEDULE

S4 / Prescription Medicine

Date of first inclusion in the Australian register of Therapeutic Goods (ARTG): 26 June 2006

Date of most recent amendment: 10 June 2014

Under licence of Helsinn Healthcare SA, Lugano, Switzerland.

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Certain Option and Personelle sunscreens voluntarily recalled because of bacterial contamination

Certain Option and Personelle sunscreens voluntarily recalled because of bacterial contamination

One lot each of Option Family Sunscreen Lotion SPF 50 and Personnelle Sport Sunscreen Lotion SPF 50 have been voluntarily recalled by Empack Spraytech Inc. because of bacterial contamination.

Health Canada

15-11-2018

Safety and efficacy of Monimax® (monensin sodium and nicarbazin) for chickens for fattening and chickens reared for laying

Safety and efficacy of Monimax® (monensin sodium and nicarbazin) for chickens for fattening and chickens reared for laying

Published on: Wed, 14 Nov 2018 The coccidiostat Monimax® (monensin sodium and nicarbazin) is considered safe for chickens for fattening and chickens reared for laying at the highest use level of 50 mg monensin and 50 mg nicarbazin/kg complete feed. This conclusion is extended to chickens reared for laying. For both active substances, the metabolic pathways in the chicken are similar to those in the turkey and rat. Nicarbazin, when ingested, is rapidly split in its two components dinitrocarbanilide (DNC)...

Europe - EFSA - European Food Safety Authority Publications

9-11-2018

Safety assessment of the substance Ln 1,4‐benzene dicarboxylic acid (with Ln = La, Eu, Gd, Tb) for use in food contact materials

Safety assessment of the substance Ln 1,4‐benzene dicarboxylic acid (with Ln = La, Eu, Gd, Tb) for use in food contact materials

Published on: Wed, 07 Nov 2018 00:00:00 +0100 The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP Panel) assessed the safety of the additive Ln 1,4‐benzene dicarboxylic acid (with Ln = La, Eu, Gd, Tb) for use in food contact materials. It is a family of mixtures combining the four lanthanides lanthanum (La), europium (Eu), gadolinium (Gd) and/or terbium (Tb) in different proportions as their 1,4‐benzene dicarboxylate complexes, used as a taggant in plastics for authentication and ...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos when used as a feed flavouring for all animal species

Safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos when used as a feed flavouring for all animal species

Published on: Tue, 30 Oct 2018 00:00:00 +0100 Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos (hop strobiles) when used as a sensory feed additive for all animal species. The additive is specified to containing 40% beta acids and less than 0.2% alpha acids. Known substances of conce...

Europe - EFSA - European Food Safety Authority Publications

17-10-2018

Lumpy skin disease: scientific and technical assistance on control and surveillance activities

Lumpy skin disease: scientific and technical assistance on control and surveillance activities

Published on: Tue, 16 Oct 2018 00:00:00 +0200 The duration of the vaccination campaign sufficient to eliminate lumpy skin disease (LSD) mainly depends on the vaccination effectiveness and coverage achieved. By using a spread epidemiological model, assuming a vaccination effectiveness of 65%, with 50% and 90% coverage, 3 and 4 years campaigns, respectively, are needed to eliminate LSD. When vaccination effectiveness is 80% to 95%, 2 years of vaccination at coverage of 90% is sufficient to eliminate LSD vir...

Europe - EFSA - European Food Safety Authority Publications

7-9-2018

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Montelukast Tablets USP, 10mg 30Ct. due to Product/Label Mix-Up

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Montelukast Tablets USP, 10mg 30Ct. due to Product/Label Mix-Up

Camber Pharmaceuticals, Inc. is voluntarily recalling one single lot of Montelukast Sodium Tablets, USP 10mg, to the consumer level. This recall of one batch of Montelukast Sodium Tablets, USP 10mg, lot# MON17384 Exp. 12/31/2019, was prompted because a complaint of a sealed bottle labeled as Montelukast 10mg 30 ct found to contain 90 tablets of Losartan Potassium Tablets, USP 50mg

FDA - U.S. Food and Drug Administration

3-8-2018

Scientific guideline:  Cholic acid capsules 50 mg and 250 mg product-specific bioequivalence guidance, adopted

Scientific guideline: Cholic acid capsules 50 mg and 250 mg product-specific bioequivalence guidance, adopted

Cholic acid capsules 50 mg and 250 mg product-specific bioequivalence guidance

Europe - EFSA - European Food Safety Authority EFSA Journal

25-7-2018

AMPI Recalls Limited Amount of Dry Whey Powder Because of Possible Health Risk

AMPI Recalls Limited Amount of Dry Whey Powder Because of Possible Health Risk

Associated Milk Producers Inc. (AMPI) of New Ulm, Minn., is recalling dry whey powder packaged in 50-pound and 25-kg bags that were produced at the cooperative’s Blair, Wis., dry whey plant from May 1-5, 2018; May 24-29, 2018; June 2-5, 2018; and June 7-14, 2018 due to the potential to be contaminated with Salmonella. This is a precautionary recall. All products shipped to the marketplace tested negative for Salmonella.

FDA - U.S. Food and Drug Administration

17-7-2018

July 17, 2018: Former President of Cumberland Distribution, Inc. Sentenced to 15 Years in Federal Prison for $50 Million Drug Diversion Scheme

July 17, 2018: Former President of Cumberland Distribution, Inc. Sentenced to 15 Years in Federal Prison for $50 Million Drug Diversion Scheme

July 17, 2018: Former President of Cumberland Distribution, Inc. Sentenced to 15 Years in Federal Prison for $50 Million Drug Diversion Scheme

FDA - U.S. Food and Drug Administration

11-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Octenidine (dihydrochloride), decision type: , therapeutic area: , PIP number: P/0240/2018

Opinion/decision on a Paediatric investigation plan (PIP): Octenidine (dihydrochloride), decision type: , therapeutic area: , PIP number: P/0240/2018

Opinion/decision on a Paediatric investigation plan (PIP): Octenidine (dihydrochloride), decision type: , therapeutic area: , PIP number: P/0240/2018

Europe - EMA - European Medicines Agency

13-12-2018


Overview of comments received on 'Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance' (EMA/CHMP/800775/2017)

Overview of comments received on 'Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance' (EMA/CHMP/800775/2017)

Overview of comments received on 'Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance' (EMA/CHMP/800775/2017)

Europe - EMA - European Medicines Agency

13-12-2018


Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance

Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance

Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance

Europe - EMA - European Medicines Agency

11-12-2018


Epinephrine mepivacaine hydrochloride, mepivacaine norepinephrine, mepivacaine: List of nationally authorised medicinal products - PSUSA/00001979/201803

Epinephrine mepivacaine hydrochloride, mepivacaine norepinephrine, mepivacaine: List of nationally authorised medicinal products - PSUSA/00001979/201803

Epinephrine mepivacaine hydrochloride, mepivacaine norepinephrine, mepivacaine: List of nationally authorised medicinal products - PSUSA/00001979/201803

Europe - EMA - European Medicines Agency

28-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): Fenfluramine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0177/2018

Opinion/decision on a Paediatric investigation plan (PIP): Fenfluramine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0177/2018

Opinion/decision on a Paediatric investigation plan (PIP): Fenfluramine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0177/2018

Europe - EMA - European Medicines Agency

28-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): Mexiletine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0210/2018

Opinion/decision on a Paediatric investigation plan (PIP): Mexiletine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0210/2018

Opinion/decision on a Paediatric investigation plan (PIP): Mexiletine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0210/2018

Europe - EMA - European Medicines Agency

28-11-2018

Econor (Elanco GmbH)

Econor (Elanco GmbH)

Econor (Active substance: Valnemulin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8038 of Wed, 28 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/42/T/54

Europe -DG Health and Food Safety

28-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): ( 2R)-2-Amino-1-[3-( {2-[p-( 4-{3-[ (3,S-diamino-6-chloro-2-pyrazinyl)ca rbonyl ]guanidino }butyl )phenoxy ]ethyl}{ 3-[ ( 2R)-2-am ino-6-guanidinohexanoyla mino] propyl }amino )propylamino ]-6-gu

Opinion/decision on a Paediatric investigation plan (PIP): ( 2R)-2-Amino-1-[3-( {2-[p-( 4-{3-[ (3,S-diamino-6-chloro-2-pyrazinyl)ca rbonyl ]guanidino }butyl )phenoxy ]ethyl}{ 3-[ ( 2R)-2-am ino-6-guanidinohexanoyla mino] propyl }amino )propylamino ]-6-gu

Opinion/decision on a Paediatric investigation plan (PIP): ( 2R)-2-Amino-1-[3-( {2-[p-( 4-{3-[ (3,S-diamino-6-chloro-2-pyrazinyl)ca rbonyl ]guanidino }butyl )phenoxy ]ethyl}{ 3-[ ( 2R)-2-am ino-6-guanidinohexanoyla mino] propyl }amino )propylamino ]-6-guanidino-1-hexanone hexahydrochloride, decision type: , therapeutic area: , PIP number: P/0134/2018

Europe - EMA - European Medicines Agency

28-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): naloxone (hydrochloride), decision type: , therapeutic area: , PIP number: P/0146/2018

Opinion/decision on a Paediatric investigation plan (PIP): naloxone (hydrochloride), decision type: , therapeutic area: , PIP number: P/0146/2018

Opinion/decision on a Paediatric investigation plan (PIP): naloxone (hydrochloride), decision type: , therapeutic area: , PIP number: P/0146/2018

Europe - EMA - European Medicines Agency

27-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): (R)-2-amino-3-phenylpropylcarbamate hydrochloride (solriamfetol), decision type: , therapeutic area: , PIP number: P/0207/2018

Opinion/decision on a Paediatric investigation plan (PIP): (R)-2-amino-3-phenylpropylcarbamate hydrochloride (solriamfetol), decision type: , therapeutic area: , PIP number: P/0207/2018

Opinion/decision on a Paediatric investigation plan (PIP): (R)-2-amino-3-phenylpropylcarbamate hydrochloride (solriamfetol), decision type: , therapeutic area: , PIP number: P/0207/2018

Europe - EMA - European Medicines Agency

27-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): Akynzeo,Fosnetupitant,palonosetron, decision type: , therapeutic area: , PIP number: P/0140/2018

Opinion/decision on a Paediatric investigation plan (PIP): Akynzeo,Fosnetupitant,palonosetron, decision type: , therapeutic area: , PIP number: P/0140/2018

Opinion/decision on a Paediatric investigation plan (PIP): Akynzeo,Fosnetupitant,palonosetron, decision type: , therapeutic area: , PIP number: P/0140/2018

Europe - EMA - European Medicines Agency

26-11-2018

Today, #FDA’s device center also posted performance report highlighting measures taken to increase predictability, transparency of 510(k) review process, incl. 50 final guidance documents on important medical device policy issues issued since 2009.  https

Today, #FDA’s device center also posted performance report highlighting measures taken to increase predictability, transparency of 510(k) review process, incl. 50 final guidance documents on important medical device policy issues issued since 2009. https

Today, #FDA’s device center also posted performance report highlighting measures taken to increase predictability, transparency of 510(k) review process, incl. 50 final guidance documents on important medical device policy issues issued since 2009. https://go.usa.gov/xPHdn 

FDA - U.S. Food and Drug Administration

26-11-2018

Wakix (Bioprojet Pharma)

Wakix (Bioprojet Pharma)

Wakix (Active substance: Pitolisant hydrochloride) - Centralised - Yearly update - Commission Decision (2018)7974 of Mon, 26 Nov 2018

Europe -DG Health and Food Safety

21-11-2018

EU/3/18/2082 (Takeda Pharma A/S)

EU/3/18/2082 (Takeda Pharma A/S)

EU/3/18/2082 (Active substance: 5-{(1R,2R)-2-[(cyclopropylmethyl)amino]cyclopropyl}-N-(tetrahydro-2H-pyran-4-yl)thiophene-3-carboxamide monohydrochloride) - Orphan designation - Commission Decision (2018)7791 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/040/18

Europe -DG Health and Food Safety

13-11-2018

EU/3/17/1836 (Zogenix GmbH)

EU/3/17/1836 (Zogenix GmbH)

EU/3/17/1836 (Active substance: Fenfluramine hydrochloride) - Transfer of orphan designation - Commission Decision (2018)7576 of Tue, 13 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/233/16/T/01

Europe -DG Health and Food Safety

13-11-2018

EU/3/13/1219 (Zogenix GmbH)

EU/3/13/1219 (Zogenix GmbH)

EU/3/13/1219 (Active substance: Fenfluramine hydrochloride) - Transfer of orphan designation - Commission Decision (2018)7575 of Tue, 13 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/140/13/T/01

Europe -DG Health and Food Safety

1-11-2018

Dexdomitor (Orion Corporation)

Dexdomitor (Orion Corporation)

Dexdomitor (Active substance: dexmedetomidine hydrochloride) - Centralised - Yearly update - Commission Decision (2018)7380 of Thu, 01 Nov 2018

Europe -DG Health and Food Safety

31-10-2018

Evista (Daiichi Sankyo Europe GmbH)

Evista (Daiichi Sankyo Europe GmbH)

Evista (Active substance: Raloxifene hydrochloride) - Centralised - Yearly update - Commission Decision (2018)7342 of Wed, 31 Oct 2018

Europe -DG Health and Food Safety

8-10-2018

Palonosetron Hospira (Pfizer Europe MA EEIG)

Palonosetron Hospira (Pfizer Europe MA EEIG)

Palonosetron Hospira (Active substance: palonosetron) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6606 of Mon, 08 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4069/T/04

Europe -DG Health and Food Safety

26-9-2018

Sileo (Orion Corporation)

Sileo (Orion Corporation)

Sileo (Active substance: Dexmedetomidine hydrochloride) - Centralised - Yearly update - Commission Decision (2018)6325 of Wed, 26 Sep 2018

Europe -DG Health and Food Safety

19-9-2018

Targretin (Eisai GmbH)

Targretin (Eisai GmbH)

Targretin (Active substance: bexarotene) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6098 of Wed, 19 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/326/T/50

Europe -DG Health and Food Safety

10-9-2018

Akynzeo (Helsinn Birex Pharmaceuticals Ltd)

Akynzeo (Helsinn Birex Pharmaceuticals Ltd)

Akynzeo (Active substance: netupitant / palonosetron) - Centralised - Yearly update - Commission Decision (2018)5947 of Mon, 10 Sep 2018

Europe -DG Health and Food Safety

10-8-2018

Brinavess (Correvio)

Brinavess (Correvio)

Brinavess (Active substance: vernakalant hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5523 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1215/T/31

Europe -DG Health and Food Safety

30-7-2018

Segluromet (Merck Sharp and Dohme B.V.)

Segluromet (Merck Sharp and Dohme B.V.)

Segluromet (Active substance: ertugliflozin / metformin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5103 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4314/T/2

Europe -DG Health and Food Safety

30-7-2018

Ceplene (Noventia Pharma Srl)

Ceplene (Noventia Pharma Srl)

Ceplene (Active substance: Histamine dihydrochloride) - Centralised - Renewal - Commission Decision (2018)5116 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/796/R/36

Europe -DG Health and Food Safety

23-7-2018

Optruma (Eli Lilly Nederland B.V.)

Optruma (Eli Lilly Nederland B.V.)

Optruma (Active substance: Raloxifene hydrochloride) - Centralised - Yearly update - Commission Decision (2018)4893 of Mon, 23 Jul 2018

Europe -DG Health and Food Safety

12-7-2018

Econor (Elanco Europe Ltd)

Econor (Elanco Europe Ltd)

Econor (Active substance: Valnemulin hydrochloride) - Centralised - Yearly update - Commission Decision (2018)4580 of Thu, 12 Jul 2018

Europe -DG Health and Food Safety

11-7-2018

Ariclaim (Eli Lilly Nederland B.V.)

Ariclaim (Eli Lilly Nederland B.V.)

Ariclaim (Active substance: duloxetine hydrochloride) - Centralised - Withdrawal - Commission Decision (2018)4515 of Wed, 11 Jul 2018

Europe -DG Health and Food Safety

5-7-2018

Scientific guideline:  Draft pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance, draft: consultation open

Scientific guideline: Draft pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance, draft: consultation open

This document provides product-specific guidance on the demonstration of the bioequivalence of pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml.

Europe - EMA - European Medicines Agency

3-7-2018

Efficib (Merck Sharp and Dohme B.V.)

Efficib (Merck Sharp and Dohme B.V.)

Efficib (Active substance: sitagliptin / metformin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 4254 of Tue, 03 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/896/T/90

Europe -DG Health and Food Safety

3-7-2018

Ristfor (Merck Sharp and Dohme B.V.)

Ristfor (Merck Sharp and Dohme B.V.)

Ristfor (Active substance: sitagliptin / metformin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 4249 of Tue, 03 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1235/T/77

Europe -DG Health and Food Safety

3-7-2018

Velmetia (Merck Sharp and Dohme B.V.)

Velmetia (Merck Sharp and Dohme B.V.)

Velmetia (Active substance: sitagliptin / metformin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 4252 of Tue, 03 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/862/T/93

Europe -DG Health and Food Safety

3-7-2018

Janumet (Merck Sharp and Dohme B.V.)

Janumet (Merck Sharp and Dohme B.V.)

Janumet (Active substance: sitagliptin / metformin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 4251 of Tue, 03 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/861/T/90

Europe -DG Health and Food Safety