Fosaprepitant powder for solution for infusion
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Fosaprepitant powder for solution for infusion.
Drugs List
Therapeutic Indications
Uses
Chemotherapy induced nausea and vomiting
Prevention of nausea and vomiting with highly and moderately emetogenic cancer chemotherapy in adults and children aged 6 months and above.
Dosage
Fosaprepitant is administered in combination with a corticosteroid (such as dexamethasone) and a 5HT3 antagonist. Inclusion of the corticosteroid is optional in children.
Due to a potential drug interaction between fosaprepitant and dexamethasone, the manufacturer recommends a specific dose regime and/or dose reduction for dexamethasone. Recommended doses are not provided for concomitant 5HT3 antagonists, prescribing should follow the relevant product literature for the chosen product.
Adults
Highly Emetogenic Chemotherapy
Day 1: Fosaprepitant 150mg by intravenous infusion (initiated 30 minutes before chemotherapy), dexamethasone 12mg orally (30 minutes before chemotherapy) and a standard dose of a 5-HT3 antagonist.
Day 2: Dexamethasone 8mg orally in the morning.
Day 3: Dexamethasone 8mg orally twice a day (morning and evening).
Day 4: Dexamethasone 8mg orally twice a day (morning and evening).
Moderately Emetogenic Chemotherapy
Day 1: Fosaprepitant 150mg by intravenous infusion (initiated 30 minutes before chemotherapy), dexamethasone 12mg orally (30 minutes before chemotherapy) and a standard dose of a 5-HT3 antagonist.
Children
Fosaprepitant should be administered with a 5HT3 antagonist, prescribed in line with the relevant product literature for the chosen product. Inclusion of a corticosteroid is optional (see below).
Single or multi-day regimens of Highly Emetogenic Chemotherapy (HEC) or Moderately Emetogenic Chemotherapy (MEC)
If a corticosteroid, such as dexamethasone, is used the dose should be reduced by 50% and administered on days 1 to 4. On day 1, dexamethasone should be given 30 minutes before chemotherapy.
Children aged 12 to 18 years:
Day 1: Fosaprepitant 115mg by intravenous infusion, completed 30 minutes before chemotherapy.
Day 2: Fosaprepitant 80mg by intravenous infusion, completed 30 minutes before chemotherapy. Alternatively, oral aprepitant may be used (consult product literature for details).
Day 3: Fosaprepitant 80mg by intravenous infusion, completed 30 minutes before chemotherapy. Alternatively, oral aprepitant may be used (consult product literature for details).
Children aged 6 months to 12 years weighing 6kg or more:
Day 1: Fosaprepitant 3mg/kg (maximum 115mg) by intravenous infusion, completed 30 minutes before chemotherapy
Day 2: Fosaprepitant 2mg/kg (maximum 80mg) by intravenous infusion, completed 30 minutes before chemotherapy. Alternatively, oral aprepitant may be used (consult product literature for details).
Day 3: Fosaprepitant 2mg/kg (maximum 80mg) by intravenous infusion, completed 30 minutes before chemotherapy. Alternatively, oral aprepitant may be used (consult product literature for details).
Alternative dosing for single day regimens of HEC or MEC
If a corticosteroid, such as dexamethasone, is used the dose should be reduced by 50% and administered on days 1 and 2. On day 1, dexamethasone should be given 30 minutes before chemotherapy.
Children aged 12 to 18 years:
Day 1: Fosaprepitant 150mg by intravenous infusion, completed 30 minutes before chemotherapy.
Children aged 2 to 12 years:
Day 1: Fosaprepitant 4mg/kg (maximum 150mg) by intravenous infusion, completed 30 minutes before chemotherapy.
Children aged 6 months to 2 years weighing 6kg or more:
Day 1: Fosaprepitant 5mg/kg (maximum 150mg) by intravenous infusion, completed 30 minutes prior to chemotherapy.
Administration
Slow intravenous infusion.
Administer via a central venous catheter in children aged 6 months to 18 years.
Contraindications
Children under 6 months
Children weighing less than 6kg
Breastfeeding
Precautions and Warnings
Moderate hepatic impairment
Pregnancy
Advise ability to drive/operate machinery may be affected by side effects
Dilute and use as an infusion
If extravasation occurs follow local policy & seek expert help immediately
If local infusion site reaction develops, use alternative infusion site
Monitor INR for 2 weeks after treatment in patients on warfarin therapy
Discontinue if hypersensitivity reactions occur
Advise patient not to take St John's wort concurrently
Female: Non-hormonal contraception advised until 2 months after treatment
Pregnancy and Lactation
Pregnancy
Use fosaprepitant with caution during pregnancy.
The manufacturer states that fosaprepitant should not be used during pregnancy unless clearly necessary.
No data is available regarding the use of fosaprepitant (or its active metabolite aprepitant) during human pregnancy. Animal studies do not indicate any direct or indirect harmful effects but were only completed at low doses. The overall risk is not established. Transfer across the placenta is unknown but considered likely due to the drugs molecular weight and elimination half life. Potential effects of exposure are unknown, in particular the impact of altered neurokinin regulation.
Lactation
Fosaprepitant is contraindicated during breastfeeding.
The manufacturer does not recommend breastfeeding during treatment with fosaprepitant.
There are no reports describing the use of fosaprepitant (or its active metabolite aprepitant) during breast feeding in humans. Excretion into breast milk has been demonstrated in animal studies and is considered likely to occur in humans due to the drugs molecular weight and elimination half life. Potential effects on exposed infants are unknown.
Side Effects
Abdominal distension
Abdominal pain
Abnormal bowel sounds
Abnormal faeces
Acne
Anaemia
Anaphylactic shock
Anxiety
Asthenia
Bradycardia
Candidiasis
Cardiovascular disturbances
Chest discomfort
Cognitive impairment
Conjunctivitis
Constipation
Cough
Disorientation
Disturbances of appetite
Dizziness
Dry mouth
Dysarthria
Dysgeusia
Dyspepsia
Dyspnoea
Dysuria
Eructation
Erythema
Erythema at injection site
Euphoria
Fatigue
Febrile neutropenia
Flatulence
Flushing
Gait abnormality
Gastroesophageal reflux disease
Glycosuria
Haematuria
Headache
Hiccups
Hyperhidrosis
Hypersensitivity reactions including anaphylaxis
Hypoaesthesia
Hyponatraemia
Increase in alkaline phosphatase
Increase in serum ALT/AST
Increased blood pressure
Induration (injection site)
Injection site reactions
Insomnia
Itching (injection site)
Lethargy
Local pain (injection site)
Malaise
Miosis
Muscle spasm
Muscle weakness
Nausea
Neutropenic colitis
Oedema
Oropharyngeal pain
Palpitations
Perforating duodenal ulcer
Photosensitivity
Pollakiuria
Polydipsia
Polyuria
Postnasal drip
Pruritic rash
Pruritus
Rash
Reduced neutrophil count
Reduced visual acuity
Seborrhoea
Sensory disturbances
Skin lesions
Sneezing
Somnolence
Staphylococcal infection
Stevens-Johnson syndrome
Stomach discomfort
Stomatitis
Sub-ileus
Throat irritation
Thrombophlebitis
Tinnitus
Toxic epidermal necrolysis
Urticaria
Vomiting
Weight loss
Wheezing
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: March 2019
Reference Sources
Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3rd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.
Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.
Summary of Product Characteristics: IVEMEND 150mg powder for solution for infusion. Merck Sharp & Dohme Ltd. Revised November 2018.
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.