Isatuximab parenteral
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Infusions of isatuximab.
These products have been produced by recombinant technology using Chinese Hamster Ovary (CHO) cell lines.
Drugs List
Therapeutic Indications
Uses
Multiple myeloma: resistant to one previous therapy
Relapsed and refractory multiple myeloma
In combination with pomalidomide and dexamethasone for the treatment of adult patients with relapsed and refractory multiple myeloma (MM) who have at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on the last therapy.
In combination with carfilzomib and dexamethasone for the treatment of adult patients with MM who have received at least one prior therapy.
Dosage
Whilst the doses stated below are those recommended by the manufacturer, local cancer network protocols for the relevant indication should be consulted.
Adults
Premedication
Dexamethasone: 40mg oral or intravenous (or 20mg for patients 75 years or older), as part of the premedication and the backbone treatment, before isatuximab and pomalidomide administration.
20mg intravenous, as part of the premedication and the backbone treatment, before isatuximab and carfilzomib administration on the days of isatuximab and/or carfilzomib infusions and 20mg oral on the other days. Paracetamol: 650mg to 1000mg oral. Diphenhydramine: 25mg to 50mg intravenous or oral. Intravenous infusion is preferred for at least the first 4 infusions.
The recommended premedication treatment should be administered 15-60 minutes prior to starting the isatuximab infusion. Patients who do not experience an infusion reaction upon their first 4 administrations of isatuximab may have their need for subsequent premedication reconsidered.
Isatuximab infusion
Cycle 1 10mg/kg body weight on days 1, 8, 15 and 22 (weekly).
Cycle 2 and beyond 10mg/kg body weight on days 1 and 15 of each 28 day cycle (every 2 weeks).
Additional Dosage Information
Infusion rates
First infusion: 250ml infused at initial rate of 25ml/hour. If there is an absence of an infusion reaction for 60 minutes, the infusion rate can be increased in 25ml/hour increments every 30 minutes, until a maximum rate of 150ml/hour. Second infusion: 250ml infused at initial rate of 50ml/hour. If there is an absence of an infusion reaction for 30 minutes, the infusion rate can be increased by 50ml/hour increments for 30 minutes, then increase by 100ml/hr every 30 minutes until a maximum rate of 200ml/hour. Subsequent infusions: 250ml infused at initial rate of 200ml/hour. Grade 2 infusion reactions: Interrupt infusion and administer additional symptomatic medicinal products. After improvement to grade 1 or lower, infusion may be resumed at half the initial infusion rate. If symptoms do not recur after 30 minutes, the infusion rate may be increased to the initial rate, then increased incrementally as stated above. If symptoms do not resolve rapidly or do not improve to grade 1 or lower after interruption, or persist or worsen despite appropriate medical products, or require hospitalisation or are life-threatening (grade 3 or greater), treatment should be permanently discontinued.
Contraindications
Children under 18 years
Breastfeeding
Pregnancy
Precautions and Warnings
Patients over 85 years
Moderate hepatic impairment
Pre-medicate with a corticosteroid, antihistamine and paracetamol
Premedication with anti-infective recommended during treatment
Prophylactic G-CSF should be considered
Treatment to be initiated and supervised by a specialist
Consult local policy on the safe use of anti-cancer drugs
Record name and batch number of administered product
Resuscitation facilities must be immediately available
Staff: Not to be handled by pregnant staff
Monitor full blood count regularly
Monitor patient closely for haemolysis
Monitor patient for infusion-associated reactions (IARs)
Monitor patients for development of second primary malignancies
Monitor vital signs and ECG every day during infusion
Advise patient to report symptoms of infection immediately
Advise patients at risk of neutropenia to report any signs of infection
Interrupt therapy/reduce infusion rate if infusion-related reactions occur
Test interference: May cause false positive Coombs test
May interfere with antibody tests
May interfere with certain laboratory measurements
Discontinue permanently if life threatening infusion reactions occur
Female: Contraception required during & for at least 5 months after therapy
Pregnancy and Lactation
Pregnancy
Isatuximab is contraindicated during pregnancy.
The manufacturer suggests that the use of isatuximab is not recommended in pregnancy. There are no data on the safety of isatuximab in pregnant women and no animal reproduction toxicity studies have been conducted. Immunoglobulin G1 monoclonal antibodies are known to cross the placenta after the first trimester of pregnancy.
Lactation
Isatuximab is contraindicated during breastfeeding.
The manufacturer recommends that women must discontinue breastfeeding during isatuximab treatment. It is not known whether isatuximab is excreted in human breast milk, although immunoglobulins are known to be excreted in breast milk, therefore a risk to the breastfeeding infant cannot be excluded. A decision must be made whether to discontinue breastfeeding or discontinue from isatuximab therapy.
Side Effects
Anaemia
Anaphylactic reaction
Atrial fibrillation
Back pain
Bronchitis
Bronchospasm
Cough
Decreased appetite
Diarrhoea
Dyspnoea
Fatigue
Febrile neutropenia
Hypertension
Infusion related reaction
Insomnia
Lymphopenia
Nausea
Neutropenia
Pneumonia
Skin carcinoma
Squamous cell carcinoma
Thrombocytopenia
Upper respiratory tract infection
Vomiting
Weight loss
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: July 2020
Reference Sources
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 21 July 2021
Summary of Product Characteristics: Sarclisa 20mg/ml concentrate for solution for infusion. Sanofi Genzyme. Revised February 2022.
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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