Pomalidomide oral
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral formulations of pomalidomide.
Drugs List
Therapeutic Indications
Uses
Myeloma - multiple
Treatment of multiple myeloma in combination with bortezomib and dexamethasone in patients who have received at least one previous treatment regimen containing lenalidomide.
Treatment of relapsed and refractory multiple myeloma in combination with dexamethasone in patients who have received at least two prior treatment regimens, including both lenalidomide and bortezomib, and have demonstrated disease progression on the last therapy.
Dosage
Whilst the doses stated below are those recommended by the manufacturer, local cancer network protocols for the relevant indication should be consulted. Refer to the product information for the products used in combination for additional information.
Dosing based on clinical and laboratory findings. Treatment should be discontinued upon progression of disease or unacceptable toxicity.
Adults
Pomalidomide in combination with bortezomib and dexamethasone
4mg of pomalidomide once a day on days 1 to 14 of each 21-day treatment cycle.
Pomalidomide in combination with dexamethasone
4mg of pomalidomide once a day on days 1 to 21 of each 28-day treatment cycle.
Patients with Renal Impairment
Patients on haemodialysis
Patients should take the pomalidomide dose after haemodialysis.
Additional Dosage Information
Missed dose
If the patient forgets to take a dose of pomalidomide on one day, then the patient should take the normal prescribed dose as scheduled on the next day. Patients should not adjust the dose to make up for a missing dose on previous days.
Pomalidomide dose modification
To start a new cycle of pomalidomide, the neutrophil count must be greater than or equal to 1 x 10 to the power of 9 per litre and the platelet count must be greater than or equal to 50 x 10 to the power of 9 per litre.
If adverse reactions occur after the dose of pomalidomide has been reduced to 1mg, discontinue therapy.
Neutropenia
Absolute neutrophil count (ANC) is less than 0.5 x 10 to the power of 9 per litre or febrile neutropenia with a fever at 38.5 degrees centigrade and ANC below 1 x 10 to the power of 9 per litre
Interrupt pomalidomide treatment for remainder of treatment cycle. Follow Complete Blood Count (CBC) weekly. If ANC returns to equal to or greater than 1 x 10 to the power of 9 per litre, resume pomalidomide treatment at 3mg once a day.
For each subsequent ANC drop below 0.5 x 10 to the power of 9 per litre:
Interrupt pomalidomide treatment. If ANC returns to equal or greater than 1 x 10 to the power of 9 per litre, then resume pomalidomide treatment at 1mg less than previous dose.
Thrombocytopenia
Platelet count falls to less than 25 x 10 to the power of 9 per litre:
Interrupt pomalidomide treatment for remainder of treatment cycle. Follow CBC weekly. If the platelet count returns to equal or greater than 50 x 10 to the power of 9 per litre, then resume pomalidomide treatment at 3mg daily.
For each subsequent platelet drop below 25 x 10 to the power of 9 per litre:
Interrupt pomalidomide treatment. If the platelet count returns to equal or greater than 50 x 10 to the power of 9 per litre, then resume pomalidomide treatment at 1mg less than previous dose.
Rash
Grade 2 to 3
Consider dose interruption or discontinuation of pomalidomide.
Grade 4 or blistering (including Steven-Johnson syndrome, Toxic Epidermal Necrolysis (TEN) or Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)
Permanently discontinue treatment.
For other Grade 3 or 4 adverse reactions related to pomalidomide
Interrupt pomalidomide treatment for remainder of the treatment cycle. Resume pomalidomide treatment at 1mg less than the previous dose if adverse reactions have resolved to grade 2 or less.
Contraindications
Children under 18 years
Neutrophil count below 1 x 10 to the power of 9 / L on day 1 of cycle
Patients not compliant with Pregnancy Prevention Programme
Patients not registered with Pregnancy Prevention Programme
Platelet count below 50 x 10 to the power of 9 / L on day 1 of cycle
Breastfeeding
Pregnancy
Precautions and Warnings
Absolute neutrophil count below 0.5 x 10 to the power of 9 / L
Females of childbearing potential
Patients over 75 years
Platelet count below 25 x 10 to the power of 9 / L
Predisposition to thromboembolic disease
Risk factors for cardiovascular disorder
Cardiac disorder
Dehydration
Haemodialysis
Hepatic impairment
Hepatitis B
History of hepatitis B
Peripheral neuropathy
Dose adjustment may be necessary in patients with hepatic impairment
Haemodialysis patients: administer drug after dialysis
Advise ability to drive/operate machinery may be affected by side effects
Before initiating screen all patients for hepatitis B infection
Consider use of anticoagulant prophylaxis if at risk of thromboembolism
Maintain adequate hydration of patient prior / during treatment
Staff & patients: Must comply with Pregnancy Prevention Programme
Treatment to be prescribed under the supervision of a specialist
Consult local policy on the safe use of oral anti-cancer drugs
Staff: Not to be handled by pregnant staff
Monitor thyroid function prior to and periodically during treatment
Ensure negative monthly pregnancy tests throughout treatment
Exclude pregnancy before issuing each prescription
Monitor blood counts weekly for first 8 weeks and then monthly thereafter
Monitor cardiac function in patients with cardiac disease
Monitor closely patient at risk of cardiovascular disorders
Monitor for and manage hepatitis reactivation during treatment
Monitor for bleeding during treatment
Monitor for signs and symptoms of interstitial lung disease
Monitor hepatic function regularly during first 6 months, then as indicated
Monitor patients at risk for signs & symptoms of thromboembolism
Monitor patients at risk of tumour lysis syndrome
Monitor patients for development of second primary malignancies
Advise patient of thromboembolic symptoms and to report them if they occur
Advise patient to report unexplained fever, sore throat, bruising, bleeding
Advise patient to seek immediate medical advice if rash occurs
Discontinue treatment if DRESS is suspected
Discontinue treatment if Stevens-Johnson Syndrome suspected
Discontinue treatment if toxic epidermal necrolysis is suspected
Consider suspending treatment if grade 2 or 3 skin reaction occurs
Discontinue if angioedema occurs
Discontinue if grade 4 skin reaction occurs
Suspend therapy if neutrophils fall below 0.5 x 10 to the power of 9 / L
Suspend therapy if platelets fall below 25 x10 to the power of 9 / L
Suspend treatment and reduce dose if febrile neutropenia occurs
Suspend treatment if interstitial lung disease is suspected
Female: Contraception required during and for 1 month after treatment
Female: Contraception required for 1 month before initiation of treatment
Male: Contraception required for partners if patient unable to use condoms
Male: Use of condoms required during and for 1 week after treatment
Patients must not donate blood during or for 1 week after treatment
Patients must not donate semen during or for 1 week after treatment
Pregnancy Prevention Programme
This agent is a powerful human teratogen, inducing a high frequency of severe and life-threatening birth defects. It must never be used by women who are pregnant or by women who could become pregnant unless all the conditions of the manufacturers Pregnancy Prevention Programme (PPP) are met. The conditions of the PPP must be fulfilled for all male and female patients. Refer to the manufacturer's documentation for full details and requirements for the PPP.
Only prescribers and pharmacies registered with the programme are allowed to prescribe and dispense the product. Prescriber, patient and dispensing pharmacist must each comply fully with the PPP.
The PPP outlines specific criteria for determination of child bearing potential, required testing, suitable contraception, specific patient counselling, prescribing and dispensing requirements.
The prescriber must ensure that: The patient complies with the conditions of the PPP. The patient confirms that they understand the conditions of the PPP.
Thromboembolic events
There is an increased risk of venous and arterial thromboembolic events with pomalidomide treatment. Consider thromboprophylaxis in patients with risk factors for thromboembolism and where possible minimise any modifiable risk factors.
Use of combined oral contraceptive pills are not recommended during treatment because of the increased risk of thromboembolism.
This risk continues for 4 to 6 weeks after discontinuing combined oral contraception. The efficacy of contraceptive steroids may also be reduced during co-treatment with dexamethasone.
Pregnancy and Lactation
Pregnancy
Pomalidomide is contraindicated during pregnancy.
Pomalidomide is expected to have teratogenic effects in humans.
Refer to the manufacturer's documentation for requirements and responsibilities under the Pregnancy Prevention Programme in the event of pregnancy.
Lactation
Pomalidomide is contraindicated in breastfeeding.
It is not known if pomalidomide is excreted in human milk. Pomalidomide has been detected in milk of lactating rats. A risk to neonates cannot be excluded.
Counselling
Advise patient to swallow capsule whole with water at the same time each day. Avoid crushing or chewing.
Advise female patients that combined oral contraceptive pills are not recommended as a method of contraception and an alternate method should be used, due to the increased risk of venous thromboembolism.
Advise patient of thromboembolic symptoms and to report them if they occur.
Advise patient to seek immediate medical advice if rash occurs.
Advise patient to report unexplained fever, sore throat, bruising and bleeding.
Advise females to use contraception 1 month before, during and 1 month after treatment.
Advise males to use contraception during and for 1 week after treatment.
Advise patients not to donate blood during and for 1 week after treatment.
Advise male patients not to donate semen during and for 1 week after treatment.
Advise patient that dizziness and confusional state may occur. Patients must avoid situations where dizziness or confusion may be a problem and should not to take other medicinal products that may cause dizziness or confusion without first seeking medical advice.
Advise patient that their ability to drive/operate machinery may be affected by side effects.
Side Effects
Abdominal distension
Acute hepatic failure
Acute kidney injury
Alanine aminotransferase increased
Anaemia
Angioedema
Atrial fibrillation
Basal cell carcinoma
Bone pain
Bronchiolitis obliterans
Bronchitis
Bronchopneumonia
Bullous reactions
Cardiac failure
Cataracts
Cerebrovascular accident
Clostridium difficile diarrhoea
Constipation
Cough
Decreased appetite
Deep vein thrombosis (DVT)
Depression
Diarrhoea
Dizziness
Drug rash with eosinophilia and systemic symptoms (DRESS)
Dry mouth
Dysgeusia
Dyspnoea
Epistaxis
Exfoliative rash
Falls
Fatigue
Febrile neutropenia
Gastro-intestinal haemorrhage
Hepatitis
Herpes zoster
Hyperbilirubinaemia
Hyperglycaemia
Hyperkalaemia
Hypertension
Hyperuricaemia
Hypocalcaemia
Hypomagnesaemia
Hyponatraemia
Hypophosphataemia
Hypotension
Hypothyroidism
Impaired consciousness
Increases in hepatic enzymes
Influenza
Insomnia
Interstitial lung disease
Intracranial bleeding
Leucopenia
Lung infection
Lymphopenia
Muscle spasm
Myocardial infarction
Nasopharyngitis
Nausea
Neutropenia
Neutropenic sepsis
Oedema
Opportunistic infections
Pancytopenia
Paraesthesia
Pelvic pain
Peripheral oedema
Peripheral sensory neuropathy
Pneumonia
Pneumonitis
Pruritus
Pulmonary embolism
Pyrexia
Rash
Reactivation of hepatitis B
Reduced neutrophil count
Reduced platelet count
Renal failure
Respiratory tract infection
Reversible confusional states
Sepsis
Septic shock
Solid organ graft rejection
Squamous cell carcinoma
Stevens-Johnson syndrome
Stomatitis
Syncope
Thrombocytopenia
Thromboembolism
Toxic epidermal necrolysis
Tremor
Tumour lysis syndrome
Urinary retention
Urinary tract infections
Urticaria
Vertigo
Vomiting
Weight loss
White blood cell count decreased
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: August 2019
Reference Sources
Summary of Product Characteristics: Imnovid 1mg, 2mg, 3mg, 4mg hard capsules. Bristol Myers Squibb Pharmaceuticals. Revised February 2022.
MHRA Drug Safety Update May 2020
Available at: https://www.mhra.gov.uk
Last accessed: 17 June 2020
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.