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Netupitant and palonosetron oral

Presentation

Oral formulations of netupitant and palonosetron hydrochloride.

Drugs List

  • AKYNZEO 300mg+0.5mg capsules
  • netupitant 300mg and palonosetron hydrochloride 0.5mg capsules
  • Therapeutic Indications

    Uses

    Prevention of CINV with highly emetogenic cisplatin based chemotherapy
    Prevention of CINV with moderately emetogenic chemotherapy

    Dosage

    Adults

    One capsule administered approximately one hour prior to the start of each chemotherapy cycle.

    Contraindications

    Children under 18 years
    Breastfeeding
    End stage renal disease
    Hereditary fructose intolerance
    Long QT syndrome
    Pregnancy
    Torsade de pointes

    Precautions and Warnings

    Constipation
    Family history of long QT syndrome
    Females of childbearing potential
    Patients over 75 years
    Suspected gastrointestinal obstruction
    Electrolyte imbalance
    Glucose-galactose malabsorption syndrome
    History of torsade de pointes
    Severe hepatic impairment

    Correct electrolyte disorders before treatment
    Advise ability to drive/operate machinery may be affected by side effects
    Contains soya or soya derivative
    Preparation contains sucrose
    Presentations with sorbitol unsuitable in hereditary fructose intolerance
    Exclude pregnancy prior to initiation of treatment
    Consider monitoring ECG in patients at risk of QT prolongation
    Monitor patients for signs and symptoms of Serotonin Syndrome
    Monitor patients with signs of sub-acute intestinal obstruction
    Monitor serum electrolytes
    May induce or worsen existing constipation
    Advise patient not to take St John's wort concurrently
    Female: Contraception required during and for 1 month after treatment
    Breastfeeding: Do not breastfeed during & for 1 month after treatment

    Pregnancy and Lactation

    Pregnancy

    Netupitant and palonosetron is contraindicated during pregnancy.

    Use of netupitant and palonosetron during pregnancy is contraindicated by the manufacturer.
    There is no data regarding the use of netupitant in pregnant women. Animal studies have shown reproductive toxicity including teratogenic effects in rabbit without safety margin.
    There is no data regarding the use of palonosetron in pregnant women. Animal studies do not indicate direct or indirect harmful effects of palonosetron with the respect to reproductive toxicity.

    Lactation

    Netupitant and palonosetron is contraindicated during breastfeeding.

    It is unknown whether palonosetron or netupitant are excreted in human milk. A risk to the suckling child cannot be excluded. The manufacturer recommends breastfeeding should be discontinued during treatment with netupitant and palonosetron and for 1 month after the last dose.

    Side Effects

    Abdominal pain
    Alopecia
    Arrhythmias
    Asthenia
    Atrioventricular block
    Back pain
    Blurred vision
    Bundle branch block
    Cardiomyopathy
    Coated tongue
    Conduction disturbances
    Conjunctivitis
    Constipation
    Creatine phosphokinase increased
    Cystitis
    Decreased appetite
    Diarrhoea
    Dizziness
    Dyspepsia
    Dysphagia
    ECG changes
    Fatigue
    Feeling hot
    Flatulence
    Headache
    Hiccups
    Hypertension
    Hypoaesthesia
    Hypokalaemia
    Hypotension
    Increase in alkaline phosphatase
    Increase of liver transaminases
    Insomnia
    Leucocytosis
    Leukopenia
    Lymphocytosis
    Mitral insufficiency
    Mood changes
    Myocardial ischaemia
    Nausea
    Neutropenia
    Non-cardiac chest pain
    Product taste abnormal
    Prolongation of QT interval
    Psychosis
    Serum bilirubin increased
    Serum creatinine increased
    Sleep disturbances
    Troponin increased
    Urticaria
    Ventricular extrasystoles
    Vertigo

    Overdosage

    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

    Further Information

    Last Full Review Date: November 2019

    Reference Sources

    Summary of Product Characteristics: Akynzeo 300mg 0.5mg hard capsules. Chugai Pharma Ltd. Revised September 2017.

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