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Pomalidomide Krka is a brand name for Pomalidomide. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Pomalidomide Krka in combination with bortezomib and dexamethasone is indicated in the treatment of adult patients with multiple myeloma who have received at least one prior treatment regimen including lenalidomide. Pomalidomide Krka in combination with dexamethasone is indicated in the treatment of adult patients…
Verbatim from this product's EMA label. Tap a section to expand.
Treatment must be initiated and monitored under the supervision of physicians experienced in the management of multiple myeloma. 4). Posology Pomalidomide in combination with bortezomib and dexamethasone The recommended starting dose of pomalidomide is 4 mg taken orally once daily on Days 1 to 14 of repeated 21-day cycles.
Pomalidomide is administered in combination with bortezomib and dexamethasone, as shown in Table 1. 3 mg/m2 intravenous or subcutaneous once daily, on the days shown in Table 1. The recommended dose of dexamethasone is 20 mg taken orally once daily, on the days shown in Table 1.
Treatment with pomalidomide combined with bortezomib and dexamethasone should be given until disease progression or until unacceptable toxicity occurs. Table 1. 3 mg/m2) • • Dexamethasone (20 mg)* • • • • * For patients > 75 years of age, see Special populations.
Pomalidomide dose modification or interruption To initiate a new cycle of pomalidomide, the neutrophil count must be ≥ 1 x 109/l and the platelet count must be ≥ 50 x 109/l. Instructions on dose interruptions or reductions for pomalidomide related adverse reactions are outlined in the Table 2 and dose levels are defined in Table 3 below: Table 2.
5°C and ANC < 1 x 109/l) Interrupt pomalidomide treatment for remainder of cycle. Follow CBC*** weekly. ANC return to ≥ 1 x 109/l Resume pomalidomide treatment at one dose level lower than previous dose. 5 x 109/l Interrupt pomalidomide treatment.
ANC return to ≥ 1 x 109/l Resume pomalidomide treatment at one dose level lower than the previous dose. Thrombocytopenia Platelet count < 25 x 109/l Interrupt pomalidomide treatment for remainder of cycle. Follow CBC*** weekly. Platelet count return to ≥ 50 x 109/l Resume pomalidomide treatment at one dose level lower than previous dose.
For each subsequent drop < 25 x 109/l Interrupt pomalidomide treatment. Platelet count return to ≥ 50 x 109/l Resume pomalidomide treatment at one dose level lower than the previous dose. Rash Rash = Grade 2-3 Consider dose interruption or discontinuation of pomalidomide treatment.
4). 5 Other Other ≥ Grade 3 pomalidomide-related adverse events Interrupt pomalidomide treatment for remainder of cycle. Resume at one dose level lower than previous dose at next cycle (adverse event must be resolved or improved to ≤ Grade 2 before restarting dosing).
0%). 3%). 1%). 2%). 9%). 7%). 3% of patients. 3%). 3%). 7%). Adverse reactions tended to occur more frequently within the first 2 cycles of treatment with pomalidomide. 15 Tabulated list of adverse reactions The adverse reactions observed in patients treated with pomalidomide in combination with bortezomib and dexamethasone, pomalidomide in combination with dexamethasone and from post-marketing surveillance are listed in Table 7 by system organ class (SOC) and frequency for all adverse reactions and for Grade 3 or 4 adverse reactions.
Frequencies are defined in accordance with current guidance, as: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1 000 to < 1/100) and not known (frequency cannot be determined). Table 7. Adverse reactions (ADRs) reported in clinical trials and post-market settings Combination of treatment Pomalidomide/ bortezomib/dexamethasone Pomalidomide/ dexamethasone System Organ Class /Preferred term All ADRs Grade 3−4 ADRs All ADRs Grade 3−4 ADRs Infections and infestations Pneumonia Very common Very common - - Pneumonia (bacterial, viral and fungal infections, including opportunistic infections) - - Very common Common Bronchitis Very common Common Common Uncommon Upper respiratory tract infection Very common Common Common Common Viral upper respiratory tract infection Very common - - - Sepsis Common Common - - Septic shock Common Common - - Neutropenic sepsis - - Common Common Clostridium difficile colitis Common Common - - Bronchopneumonia - - Common Common Respiratory tract infection Common Common Common Common Lower respiratory tract infection Common Common - - Lung infection Common Uncommon - - Influenza Very common Common - - Bronchiolitis Common Common - - Urinary tract infection Very common Common - - Nasopharyngitis - - Common - Herpes zoster - - Common Uncommon Hepatitis B reactivation - - Not known* Not known* 16 Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma Common Uncommon - - Basal cell carcinoma of the skin - - Uncommon Uncommon Squamous cell carcinoma of the skin - - Uncommon Uncommon Blood and lymphatic system disorders Neutropenia Very common Very common Very common Very common Thrombocytopenia Very common Very common Very common Very common Leucopenia Very common Common Very common Common Anaemia Very common Very common Very common Very common Febrile neutropenia Common Common Common Common Lymphopenia Common Common - - Pancytopenia - - Common* Common* Immune system disorders Angioedema - - Common* Uncommon* Urticaria - - Common* Uncommon* Anaphylactic reaction Not known* Not known* - - Solid organ transplant rejection Not known* - - - Endocrine disorders Hypothyroidism Uncommon* - - - Metabolism and nutrition disorders Hypokalaemia Very common Common - - Hyperglycaemia Very common Common - - Hypomagnesaemia Common Common - - Hypocalcaemia Common Common - - Hypophosphataemia Common Common - - Hyperkalaemia Common Common Common Common Hypercalcaemia Common Common - - Hyponatraemia - - Common Common Decreased appetite - - Very common Uncommon Hyperuricaemia - - Common* Common* Tumour lysis syndrome - - Uncommon* Uncommon* 17 Psychiatric disorders Insomnia Very common Common - - Depression Common Common - - Confusional state - - Common Common Nervous system disorders Peripheral sensory neuropathy Very common Common Common Uncommon Dizziness Very common Uncommon Common Uncommon Tremor Very common Uncommon Common Uncommon Syncope Common Common - - Peripheral sensorimotor neuropathy Common Common - - Paraesthesia Common - - - Dysgeusia Common - - - Depressed level of consciousness - - Common Common Intracranial haemorrhage - - Common* Uncommon* Cerebrovascular accident - - Uncommon* Uncommon* Eye disorders Cataract Common Common - - Ear and labyrinth disorders Vertigo - - Common Common Cardiac disorders Atrial fibrillation Very common Common Common* Common* Cardiac failure - - Common* Common* Myocardial infarction - - Common* […]
Teratogenicity Pomalidomide must not be taken during pregnancy, since a teratogenic effect is expected. Pomalidomide is structurally related to thalidomide. Thalidomide is a known human teratogen that causes severe life-threatening birth defects.
3). The conditions of the Pregnancy Prevention Programme must be fulfilled for all patients unless there is reliable evidence that the patient does not have childbearing potential. Criteria for women of non-childbearing potential A female patient or a female partner of a male patient is considered of non-childbearing potential if she meets at least one of the following criteria: - Age ≥ 50 years and naturally amenorrhoeic for ≥ 1 year (amenorrhoea following cancer therapy or during breast-feeding does not rule out childbearing potential) - Premature ovarian failure confirmed by a specialist gynaecologist - Previous bilateral salpingo-oophorectomy, or hysterectomy - XY genotype, Turner syndrome, uterine agenesis.
Counselling For women of childbearing potential, pomalidomide is contraindicated unless all of the following are met: - She understands the expected teratogenic risk to the unborn child - She understands the need for effective contraception, without interruption, at least 4 weeks before starting treatment, throughout the entire duration of treatment, and at least 4 weeks after the end of treatment - Even if a woman of childbearing potential has amenorrhoea she must follow all the advice on effective contraception - She should be capable of complying with effective contraceptive measures - She is informed and understands the potential consequences of pregnancy and the need to rapidly consult if there is a risk of pregnancy - She understands the need to commence the treatment as soon as pomalidomide is dispensed following a negative pregnancy test - She understands the need and accepts to undergo pregnancy testing at least every 4 weeks except in case of confirmed tubal sterilisation - She acknowledges that she understands the hazards and necessary precautions associated with the use of pomalidomide.
Pregnancy. 6). 4). 1.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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∞ Dose modification instructions in this table are applicable to pomalidomide in combination with bortezomib and dexamethasone and to pomalidomide in combination with dexamethasone. *In case of neutropenia, the physician should consider the use of growth factors.
**ANC – Absolute Neutrophil Count; ***CBC – Complete Blood Count. Table 3. Pomalidomide dose reduction∞ Dose level Oral pomalidomide dose Starting dose 4 mg Dose level -1 3 mg Dose level -2 2 mg Dose level -3 1 mg ∞Dose reduction in this table is applicable to pomalidomide in combination with bortezomib and dexamethasone and to pomalidomide in combination with dexamethasone.
If adverse reactions occur after dose reductions to 1 mg, then the treatment should be discontinued. g. 2). Bortezomib dose modification or interruption For instructions on dose interruptions or reductions for bortezomib related adverse reactions, physicians should refer to bortezomib Summary of Product Characteristics (SmPC).
Dexamethasone dose modification or interruption Instructions on dose interruptions or reductions for low-dose dexamethasone related adverse reactions are outlined in Tables 4 and 5 below. However, dose interruption or resumption decisions are at the physician’s discretion per Summary of Product Characteristics (SmPC).
Table 4. Dexamethasone dose modification instructions Toxicity Dose Modification Dyspepsia = Grade 1-2 Maintain dose and treat with histamine (H2) blockers or equivalent. Decrease by one dose level if symptoms persist. Dyspepsia ≥ Grade 3 Interrupt dose until symptoms are controlled.
Add H2 blocker or equivalent and resume at one dose level lower than previous dose. Oedema ≥ Grade 3 Use diuretics as needed and decrease dose by one dose level. Confusion or mood alteration ≥ Grade 2 Interrupt dose until symptoms resolve.
Resume at one dose level lower than previous dose. Muscle weakness ≥ Grade 2 Interrupt dose until muscle weakness ≤ Grade 1. Resume at one dose level lower than previous dose. 6 Hyperglycaemia ≥ Grade 3 Decrease dose by one dose level.
Treat with insulin or oral hypoglycaemic agents as needed. Acute pancreatitis Discontinue dexamethasone from treatment regimen. Other ≥ Grade 3 dexamethasone-related adverse events Stop dexamethasone dosing until the adverse event resolves to ≤ Grade 2.
Resume at one dose level lower than previous dose. If […]
The prescriber must ensure that for women of childbearing potential: - The patient complies with the conditions of the Pregnancy Prevention Programme, including confirmation that she has an adequate level of understanding - The patient has acknowledged the aforementioned conditions.
For male patients taking pomalidomide, pharmacokinetic data has demonstrated that pomalidomide is present in human semen during treatment. As a precaution, and taking into account special populations with potentially prolonged elimination time such as hepatic impairment, all male patients taking pomalidomide must meet the following conditions: 9 - He understands the expected teratogenic risk if engaged in sexual activity with a pregnant woman or a woman of childbearing potential - He understands the need for the use of a condom if engaged in sexual activity with a pregnant woman or a woman of childbearing potential not using effective contraception, throughout treatment duration, during dose interruption and for 7 days after dose interruptions and/or cessation of treatment.
This includes vasectomised males who should wear a condom if engaged in sexual activity with a pregnant woman or a woman of childbearing potential as seminal fluid may still contain pomalidomide in the absence of spermatozoa. - He understands that if his female partner becomes pregnant whilst he is taking pomalidomide or 7 days after he has stopped taking pomalidomide, he should inform his treating physician immediately and that it is recommended to refer the female partner to a physician specialised or experienced in teratology for evaluation and advice.
Contraception Women of childbearing potential must use at least one effective method of contraception for at least 4 weeks before therapy, during therapy, and until at least 4 weeks after pomalidomide therapy and even in case of dose interruption unless the patient commits to absolute and continuous abstinence confirmed on a monthly basis.
If not established on effective contraception, the patient must be referred to an appropriately trained health care professional for contraceptive advice in order that contraception can be initiated. e. 5). If a patient is currently using combined oral contraception the patient should switch to one of the effective methods listed above.
The risk of venous thromboembolism continues for 4-6 weeks after discontinuing combined oral contraception. 5). Implants and levonorgestrel-releasing intrauterine systems are associated with an increased risk of infection at the time of insertion and irregular vaginal bleeding.
Prophylactic antibiotics should be considered particularly in patients with neutropenia. Insertion of copper-releasing intrauterine devices is not recommended due to the potential risks of infection at the time of insertion and menstrual blood loss which may compromise patients with severe neutropenia or severe thrombocytopenia.
Pregnancy testing According to local practice, medically supervised pregnancy tests with a minimum sensitivity of 25 mIU/mL must be performed for women of […]