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Lenalidomide Accord is a brand name for Lenalidomide. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Multiple myeloma Lenalidomide Accord as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. Lenalidomide Accord as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan…
Verbatim from this product's EMA label. Tap a section to expand.
Lenalidomide treatment should be supervised by a physician experienced in the use of anti-cancer therapies. 4). • Dose adjustments, during treatment and restart of treatment, are recommended to manage Grade 3 or 4 thrombocytopenia, neutropenia, or other Grade 3 or 4 toxicity judged to be related to lenalidomide.
• In case of neutropenia, the use of growth factors in patient management should be considered. • If less than 12 hours has elapsed since missing a dose, the patient can take the dose. If more than 12 hours has elapsed since missing a dose at the normal time, the patient should not take the dose, but take the next dose at the normal time on the following day.
Posology Newly diagnosed multiple myeloma (NDMM) Lenalidomide maintenance in patients who have undergone autologous stem cell transplantation (ASCT) Lenalidomide maintenance should be initiated after adequate haematologic recovery following ASCT in patients without evidence of progression.
0 x 109/L, and/or platelet counts are < 75 x 109/L. 5 Recommended dose The recommended starting dose is lenalidomide 10 mg orally once daily continuously (on days 1 to 28 of repeated 28-day cycles) given until disease progression or intolerance.
After 3 cycles of lenalidomide maintenance, the dose can be increased to 15 mg orally once daily if tolerated. Dose reduction steps Starting dose (10 mg) If dose increased (15 mg) a Dose level -1 5 mg 10 mg Dose level -2 5 mg (days 1-21 every 28 days) 5 mg Dose level -3 Not applicable 5 mg (days 1-21 every 28 days) Do not dose below 5 mg (days 1-21 every 28 days) a After 3 cycles of lenalidomide maintenance, the dose can be increased to 15 mg orally once daily if tolerated.
5 x 109/L Resume lenalidomide at next lower dose level once daily a At the physician’s discretion, if neutropenia is the only toxicity at any dose level, add granulocyte colony stimulating factor (G-CSF) and maintain the dose level of lenalidomide.
0 x 109/L, and/or platelet counts are < 50 x 109/L. Recommended dose The recommended starting dose of lenalidomide is 25 mg orally once daily on days 1 to 21 of repeated 28-day cycles. The recommended dose of dexamethasone is 40 mg orally once daily on days 1, 8, 15 and 22 of repeated 28-day cycles.
Patients may continue lenalidomide and dexamethasone therapy until disease progression or intolerance. 5 mg Not applicable ª Dose reduction for both medicinal products can be managed independently 6 • Thrombocytopenia When platelets Recommended course Falls to < 25 x 109/L Stop lenalidomide dosing for remainder of cycleª Returns to ≥ 50 x 109/L Decrease by one dose level when dosing resumed at next cycle ª If Dose limiting toxicity (DLT) occurs on > day15 of a cycle, lenalidomide dosing will be interrupted for at least the remainder of the current 28-day cycle.
Summary of the safety profile Newly diagnosed multiple myeloma: patients who have undergone ASCT treated with lenalidomide maintenance 27 A conservative approach was applied to determine the adverse reactions from CALGB 100104. The adverse reactions described in Table 1 included events reported post-HDM/ASCT as well as events from the maintenance treatment period.
A second analysis that identified events that occurred after the start of maintenance treatment suggests that the frequencies described in Table 1 may be higher than actually observed during the maintenance treatment period. In IFM 2005-02, the adverse reactions were from the maintenance treatment period only.
5 %). 8 %]). 0 %). 5 %). 0 %). Multiple myeloma: patients with at least one prior therapy In two phase 3 placebo-controlled studies, 353 patients with multiple myeloma were exposed to the lenalidomide/dexamethasone combination and 351 to the placebo/dexamethasone combination.
4). 2 %). 1). In the phase 2, all 148 patients were on lenalidomide treatment. In the phase 3 study, 69 patients were on lenalidomide 5 mg, 69 patients on lenalidomide 10 mg and 67 patients were on placebo during the double-blind phase of the study.
Most adverse reactions tended to occur during the first 16 weeks of therapy with lenalidomide. 4). 7%). Mantle […]
When lenalidomide is given in combination with other medicinal products, the corresponding Summary of Product Characteristics must be consulted prior to initiation of treatment. 15 Pregnancy warning Lenalidomide is structurally related to thalidomide.
Thalidomide is a known human teratogenic active substance that causes severe life-threatening birth defects. 3). If lenalidomide is taken during pregnancy, a teratogenic effect of lenalidomide in humans is expected. 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 to have childbearing potential unless 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, lenalidomide 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 amenorrhea 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 lenalidomide 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 lenalidomide.
1. • Women who are pregnant. 6).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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5 x 109/L Resume lenalidomide at next lower dose level once daily. a At the physician’s discretion, if neutropenia is the only toxicity at any dose level, add granulocyte colony stimulating factor (G-CSF) and maintain the dose level of lenalidomide.
For hematologic toxicity the dose of lenalidomide may be re-introduced to the next higher dose level (up to the starting dose) upon improvement in bone marrow function (no hematologic toxicity for at least 2 consecutive cycles: ANC ≥ 1,5 x 109/L with a platelet count ≥ 100 x 109/L at the beginning of a new cycle).
0 x 109/L, and/or platelet counts are < 50 x 109/L. The recommended starting dose is lenalidomide 25 mg orally once daily days 1-14 of each 21-day cycle in combination with bortezomib and dexamethasone. 3 mg/m2 body surface area) twice weekly on days 1, 4, 8 and 11 of each 21- day.
1 and the corresponding Summary of Product Characteristics. Up to eight […]
2). As a precaution and taking into account special populations with prolonged elimination time such as renal impairment, all male patients taking lenalidomide must meet the following conditions: • Understand the expected teratogenic risk if engaged in sexual activity with a pregnant woman or a woman of childbearing potential • Understand 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 (even if the man has had a vasectomy), during treatment and for at least 7 days after dose interruptions and/or cessation of treatment.
• Understand that if his female partner becomes pregnant whilst he is taking lenalidomide or shortly after he has stopped taking lenalidomide, 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.
16 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.
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 lenalidomide 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. Copper-releasing intrauterine devices are generally not recommended due to the potential risks of infection at the time of insertion and menstrual blood loss […]