Cemiplimab parenteral
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Parenteral formulations of cemiplimab.
Drugs List
Therapeutic Indications
Uses
Advanced/metastatic non-small cell lung cancer as monotherapy
Basal cell carcinoma
Squamous cell carcinoma
Monotherapy for adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma ineligible for curative surgery of curative radiation.
Monotherapy for adult patients with locally advanced or metastatic basal cell carcinoma who have progressed on or are intolerant to a hedgehog pathway inhibitor (HHI).
Monotherapy for the first-line treatment of adult patients with non-small cell lung cancer (NSCLC) expressing PD-L1, with no EGFR, ALK or ROS1 aberrations, who have locally advanced NSCLC who are not candidates for definitive chemoradiation or have metastatic NSCLC.
Dosage
Adults
350mg every 3 weeks, administered by intravenous infusion over 30 minutes.
Additional Dosage Information
No dose reductions are recommended. Dose delay or discontinuation may be required based on individual safety and tolerability.
The use of systemic corticosteroids or immunosuppressants before starting cemiplimab, except for physiological doses of systemic corticosteroid (less than or equal to 10mg/day prednisone or equivalent), should be avoided because of their potential interference with the pharmacodynamic activity and efficacy of cemiplimab. However, systemic corticosteroids or other immunosuppressants can be used after starting cemiplimab to treat immune-related adverse reactions.
Treatment modifications
Pneumonitis
Grade 2: Interrupt treatment. Initial dose of 1 to 2 mg/kg/day prednisone or equivalent followed by a taper. Resume treatment if pneumonitis improves and remains at Grade 0 to 1 after corticosteroid taper to less than or equal to 10 mg/day prednisone or equivalent.
Grade 3 or 4 or recurrent grade 2: Permanently discontinue treatment. Initial dose of 2 to 4 mg/kg/day prednisone or equivalent followed by a taper.
Colitis
Grade 2 or 3: Interrupt treatment. Initial dose of 1 to 2 mg/kg/day prednisone or equivalent followed by a taper. Resume treatment if colitis or diarrhoea improves and remains at Grade 0 to 1 after corticosteroid taper to less than or equal to 10 mg/day prednisone or equivalent.
Grade 4 or recurrent grade 3: Permanently discontinue treatment. Initial dose of 1 to 2 mg/kg/day prednisone or equivalent followed by a taper.
Hepatitis
Grade 2 with AST or ALT between 3 to 5 times upper limit of normal: Interrupt treatment. Initial dose of 1 to 2 mg/kg/day prednisone or equivalent followed by a taper. Resume treatment if hepatitis improves and remains at Grade 0 to 1 after corticosteroid taper to less than or equal to 10 mg/day prednisone or equivalent or returns to baseline AST or ALT after completion of corticosteroid taper.
Total bilirubin greater between 1.5 to 3 times upper limit of normal: Interrupt treatment. Initial dose of 1 to 2 mg/kg/day prednisone or equivalent followed by a taper. Resume treatment if hepatitis improves and remains at Grade 0 to 1 after corticosteroid taper to less than or equal to 10 mg/day prednisone or equivalent or returns to baseline AST or ALT after completion of corticosteroid taper.
Grade 3 or greater with AST or ALT greater than 5 times upper limit of normal: Permanently discontinue treatment. Initial dose of 1 to 2 mg/kg/day prednisone or equivalent followed by a taper.
Total bilirubin greater than 3 times upper limit of normal: Permanently discontinue treatment. Initial dose of 1 to 2 mg/kg/day prednisone or equivalent followed by a taper.
Hypothyroidism
Grade 3 or 4: Interrupt treatment. Initiate thyroid hormone replacement as clinically indicated. Resume treatment when hypothyroidism returns to Grade 0 or 1 or is otherwise clinically stable.
Hyperthyroidism
Grade 3 or 4: Interrupt treatment. Initiate symptomatic management. Resume treatment when hyperthyroidism returns to Grade 0 or 1 or is otherwise clinically stable.
Thyroiditis
Grade 3 or 4: Interrupt treatment. Initiate symptomatic management. Resume treatment when thyroiditis returns to Grade 0 or 1 or is otherwise clinically stable.
Hypophysitis
Grade 2 to 4: Interrupt treatment. Initial dose of 1 to 2 mg/kg/day prednisone or equivalent followed by a taper and hormone replacement as clinically indicated. Resume treatment if hypophysitis improves and remains at Grade 0 to 1 after corticosteroid taper to less than or equal to 10 mg/day prednisone or equivalent or is otherwise clinically stable.
Adrenal insufficiency
Grade 2 to 4: Interrupt treatment. Initial dose of 1 to 2 mg/kg/day prednisone or equivalent followed by a taper. Resume treatment if adrenal insufficiency improves and remains at Grade 0 to 1 after corticosteroid taper to less than or equal to 10 mg/day prednisone or equivalent or is otherwise clinically stable.
Type 1 diabetes mellitus
Grade 3 or 4 (hyperglycaemia): Interrupt treatment. Initiate treatment with anti-hyperglycaemics as clinically indicated. Resume treatment if diabetes mellitus improves and remains at Grade 0 to 1 or is otherwise clinically stable.
Skin adverse reactions
Grade 2 lasting longer than 1 week: Interrupt treatment. Initial dose of 1 to 2 mg/kg/day prednisone or equivalent followed by a taper. Resume treatment if skin reaction improves and remains at Grade 0 to 1 after corticosteroid taper to less than or equal to 10 mg/day prednisone or equivalent.
Grade 3: Interrupt treatment. Initial dose of 1 to 2 mg/kg/day prednisone or equivalent followed by a taper. Resume treatment if skin reaction improves and remains at Grade 0 to 1 after corticosteroid taper to less than or equal to 10 mg/day prednisone or equivalent.
Suspected Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN): Interrupt treatment. Initial dose of 1 to 2 mg/kg/day prednisone or equivalent followed by a taper. Resume treatment if skin reaction improves and remains at Grade 0 to 1 after corticosteroid taper to less than or equal to 10 mg/day prednisone or equivalent.
Grade 4 or confirmed Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN): Permanently discontinue. Initial dose of 1 to 2 mg/kg/day prednisone or equivalent followed by a taper.
Immune-related adverse reactions in patients with prior treatment with idelalisib
Grade 2: Interrupt treatment. Initiate symptomatic management immediately, including initial dose of 1 to 2 mg/kg/day prednisone or equivalent followed by a taper. Resume treatment if skin reaction or other immune-related adverse reaction improves and remains at Grade 0 to 1 after corticosteroid taper to less than or equal to 10 mg/day prednisone or equivalent.
Grade 3 or 4 (excluding endocrinopathies) or recurrent Grade 2: Permanently discontinue. Initiate symptomatic management immediately, including initial dose of 1 to 2 mg/kg/day prednisone or equivalent followed by a taper.
Nephritis
Grade 2: Interrupt treatment. Initial dose of 1 to 2 mg/kg/day prednisone or equivalent followed by a taper. Resume treatment if nephritis improves and remains at Grade 0 to 1 after corticosteroid taper to less than or equal to 10 mg/day prednisone or equivalent.
Grade 3 or 4: Permanently discontinue. Initial dose of 1 to 2 mg/kg/day prednisone or equivalent followed by a taper.
Other immune-related adverse reactions
Grade 2 or 3 signs or symptoms of an immune-related adverse reaction not described above: Interrupt treatment. Initiate symptomatic management. Resume treatment if other immune-related adverse reaction improves and remains at Grade 0 to 1 after corticosteroid taper to less than or equal to 10 mg/day prednisone or equivalent.
Grade 4 adverse reaction (excluding endocrinopathies): Permanently discontinue. Initial dose of 1 to 2 mg/kg/day prednisone or equivalent followed by a taper. Recurrent severe Grade 3: Permanently discontinue. Initial dose of 1 to 2 mg/kg/day prednisone or equivalent followed by a taper. Persistent Grade 2 or 3 lasting 12 weeks or longer (excluding endocrinopathies): Permanently discontinue. Initial dose of 1 to 2 mg/kg/day prednisone or equivalent followed by a taper. Inability to reduce corticosteroid dose to 10 mg or less of prednisone or equivalent per day within 12 weeks: Permanently discontinue. Initial dose of 1 to 2 mg/kg/day prednisone or equivalent followed by a taper.
Infusion-related reaction
Grade 1 or 2: Interrupt or slow rate of infusion. Initiate symptomatic management.
Grade 3 or 4: Permanently discontinue. Initiate symptomatic management.
Administration
For intravenous infusion.
Contraindications
Children under 18 years
Breastfeeding
Pregnancy
Precautions and Warnings
Immunosuppression
Infection
Solid organ transplant recipients
Renal impairment - creatinine clearance below 30 ml/minute
Severe hepatic impairment
Advise ability to drive/operate machinery may be affected by side effects
Avoid corticosteroids and immunosuppressants before treatment
Consider use of corticosteroids if adverse reactions occur
May increase risk of solid organ graft rejection
NSCLC: Confirm PD-L1 expression of tumour prior to treatment
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
Staff: Not to be handled by pregnant staff
Monitor thyroid function prior to and periodically during treatment
Perform liver function tests before commencing therapy and during therapy
Monitor for adrenal insufficiency during and after treatment
Monitor for signs and symptoms of colitis
Monitor for signs and symptoms of hypophysitis
Monitor for signs and symptoms of pneumonitis
Monitor for signs and symptoms of type 1 diabetes mellitus
Monitor patient for infusion-associated reactions (IARs)
Monitor periodically for signs or symptoms of hyperglycaemia
Suspected pneumonitis should be confirmed by radiographic imaging
Advise patient to report diarrhoea
Advise patient to seek medical advice if severe skin reaction occurs
Discontinue if grade 3 or recurrent grade 2 immune-related skin reaction
Discontinue treatment if Stevens-Johnson syndrome is confirmed
Discontinue treatment if toxic epidermal necrolysis is confirmed
Suspend treatment if grade 2 adrenal insufficiency occurs
Suspend treatment if grade 2 immune-related skin reactions occur
Suspend treatment if grade 2 skin reactions persist for > 7 days
Suspend treatment if grade 3 or worse skin reaction occurs
Suspend treatment if Stevens-Johnson syndrome is suspected
Suspend treatment if toxic epidermal necrolysis is suspected
Discontinue if grade 3 or higher infusion reaction occurs
Discontinue if grade 4 skin reaction occurs
Discontinue if severe immune reaction recurs or is life threatening
Discontinue permanently if grade 4 colitis occurs
Discontinue treatment if grade 3 or greater nephritis occurs
Discontinue treatment if grade 3 or greater pneumonitis occurs
Permanent discontinuation if AST/ALT >5 x ULN or total bilirubin >3 x ULN
Permanent discontinuation if grade 3 recurrent colitis occurs
Permanent discontinuation in recurrent grade 2 immune related pneumonitis
Suspend treatment if AST/ALT is 3-5 times upper limit of normal
Suspend treatment if grade 2 hypophysitis occurs
Suspend treatment if grade 2 immune related hepatitis occurs
Suspend treatment if grade 2 nephritis occurs
Suspend treatment if grade 2 or 3 colitis occurs
Suspend treatment if grade 2 pneumonitis occurs
Suspend treatment if grade 3 hyperthyroidism occurs
Suspend treatment if grade 3 hypothyroidism occurs
Suspend treatment if grade 3 or 4 thyroiditis occurs
Suspend treatment if grade 3 or greater hyperglycaemia occurs
Suspend treatment if total bilirubin between 1.5 and 3 times ULN
Female: Contraception required during and for 4 months after treatment
Breastfeeding: Do not breastfeed during & for 4 months after treatment
Ensure patient receives a Patient Alert Card
Pregnancy and Lactation
Pregnancy
Cemiplimab is contraindicated during pregnancy.
The manufacturer states that cemiplimab is not recommended during pregnancy and in women of childbearing potential not using effective contraception unless the clinical benefit outweighs the potential risk. No data for the use in pregnant women is available. Animal studies suggest that the mechanism of action of cemiplimab may result in an increased risk of immune-mediated rejection of the foetus, resulting in foetal death. Human IgG4 is known to cross the placental barrier, as cemiplimab is an IgG4 it has the potential to be transmitted from the mother to the developing foetus.
Lactation
Cemiplimab is contraindicated during breastfeeding.
The manufacturer recommends that if a woman chooses to be treated with cemiplimab, she should be instructed not to breastfeed while being treated with cemiplimab and for at least 4 months after the last dose. It is unknown whether cemiplimab is excreted in human breast milk, it is known that antibodies (including IgG4) are secreted in human milk. Therefore the risk to the breastfed infant cannot be excluded.
Side Effects
Abdominal pain
Actinic keratosis
Adrenal insufficiency
Alanine aminotransferase increased
Altered thyroid hormone levels
Anaemia
Arthralgia
Arthritis
Aspartate aminotransferase increased
Central nervous system inflammation
Colitis
Constipation
Cough
Decreased appetite
Diabetes mellitus
Diarrhoea
Dyspnoea
Encephalitis
Fatigue
Gastritis
Guillain-Barre syndrome
Headache
Hepatitis
Hypertension
Hyperthyroidism
Hypophysitis
Hypothyroidism
Increase in alkaline phosphatase
Increase in serum transaminases
Inflammatory polyradiculoneuropathy
Infusion related reaction
Keratitis
Meningitis
Muscle weakness
Musculoskeletal pain
Myasthenia
Myocarditis
Nausea
Nephritis
Noninfective cystitis
Oedema
Paraneoplastic encephalomyelitis
Pericarditis
Peripheral neuropathy
Pneumonitis
Polymyalgia rheumatica
Pruritus
Pyrexia
Rash
Serum bilirubin increased
Serum creatinine increased
Sjogren's syndrome
Stevens-Johnson syndrome
Stomatitis
Thrombocytopenia
Thyroiditis
Toxic epidermal necrolysis
Upper respiratory tract infection
Urinary tract infections
Vasculitis
Vomiting
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: January 2023
Reference Sources
Summary of Product Characteristics: Libtayo 350mg concentrate for solution for infusion. Sanofi. Revised December 2022.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 23 January 2023
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.