Revlimid

Active material: Lenalidomide
When ATH: L04AX04
CCF: Immunomodulator with antiangiogenic
ICD-10 codes (testimony): C90.0
When CSF: 14.02
Manufacturer: REPRESENTED INTERNATIONAL Sarl. (Switzerland)

PHARMACEUTICAL FORM, COMPOSITION AND PACKAGING

Capsules hard gelatin, №2, cylindrical shape, opaque, with the body and lid white, or almost white in color, with black markings “5 mg” (on the body) and “REV” (of krыshechke); contents of capsules – powder from almost white to bledno-jeltogo color.

Excipients: lactose, microcrystalline cellulose, Croscarmellose sodium, magnesium stearate, Titanium dioxide, gelatin, ink black (TekPrint SW-9008/SW-9009) – shellac, ethanol, isopropanol, Butanol, propylene glycol, water, ammonia water, potassium hydroxide, dye iron oxide black.

7 PC. – blisters (3) – packs cardboard.

Capsules hard gelatin, №0, cylindrical shape, opaque, with a corps of pale yellow and blue Cap-Green, with black markings “10 mg” (on the body) and “REV” (of krыshechke); contents of capsules – powder from almost white to bledno-jeltogo color.

Excipients: lactose, microcrystalline cellulose, Croscarmellose sodium, magnesium stearate, the dye Indigo Carmine FD&c Blue 2, dye iron oxide yellow, Titanium dioxide, gelatin, ink black (TekPrint SW-9008/SW-9009) – shellac, ethanol, isopropanol, Butanol, propylene glycol, water, ammonia water, potassium hydroxide, dye iron oxide black.

7 PC. – blisters (3) – packs cardboard.

Capsules hard gelatin, №0, cylindrical shape, opaque, with the body white or almost white and blue Cap, with black markings “15 mg” (on the body) and “REV” (of krыshechke); contents of capsules – powder from almost white to bledno-jeltogo color.

Excipients: lactose, microcrystalline cellulose, Croscarmellose sodium, magnesium stearate, the dye Indigo Carmine FD&c Blue 2, Titanium dioxide, gelatin, ink black (TekPrint SW-9008/SW-9009) – shellac, ethanol, isopropanol, Butanol, propylene glycol, water, ammonia water, potassium hydroxide, dye iron oxide black.

7 PC. – blisters (3) – packs cardboard.

Capsules hard gelatin, №0, cylindrical shape, opaque, with the body and lid white, or almost white in color, with black markings “25 mg” (on the body) and “REV” (of krыshechke); contents of capsules – powder from almost white to bledno-jeltogo color.

Excipients: lactose, microcrystalline cellulose, Croscarmellose sodium, magnesium stearate, Titanium dioxide, gelatin, ink black (TekPrint SW-9008/SW-9009) – shellac, ethanol, isopropanol, Butanol, propylene glycol, water, ammonia water, potassium hydroxide, dye iron oxide black.

7 PC. – blisters (3) – packs cardboard.

Pharmacological action

Revlimid (lenalidomide) is a representative of a new class of immunomodulators (IMiDsSM), which possesses immunomodulatory, and antiangiogenic properties.

Lenalidomide inhibited the secretion of proinflammatory cytokines, including tumor necrosis factor alpha (ФНО-a), Interleukin-1β (Il-1β), IL-6 and IL-12, from liposaharid (LDOS)-stimulated peripheral mononuclear blood cells (PMKK).

Lenalidomide increases the production of the anti-inflammatory cytokine IL-10 of LPS-induced PMKK, as a result of which there is inhibition of the expression of, but not the activity of the enzyme Cox-2.

Lenalidomide induces proliferatiou cells and increases the synthesis of IL-2 and interferon-1γ, as well as increases the cytotoxic activity of cells-killers.

Lenalidomide ingibiruet proliferatiou cells of different lines of hematopoietic tumors, mainly those, which are cytogenetic chromosome defects 5.

On the model of differentiation of erythroid cells — predecessors lenalidomide induces expression of fetal hemoglobin, Judging from the differentiation of CD34⁺ hematopoietic stem cells.

Lenalidomide inhibited angiogenesis, by blocking the formation of microvessels and endothelial channels, as well as the migration of endothelial cells on angiogenesis in vitro model. Besides, lenalidomide ingibiruet synthesis of proangiogennogo vascular endothelial growth factor by means of PC-3 cells tumours prostate gland.

Clinical efficacy and safety of Revlimida was confirmed by the results of two randomized trials multicentre phase III, in which patients received multiple myeloma Revlimid with dexamethasone together or just one dexamethasone as therapy 2-nd line. On all performance criteria, including the percentage of full and partial responses, combination therapy Revlimidom and dexamethasone surpassed aciclovir dexamethasone.

Pharmacokinetics

Absorption and distribution

Lenalidomide is a razemicescuu mixture of two optically active forms: S(-) and R(+) with a total optical rotation, zero.

After intake of rapidly absorbed lenalidomide. Thus C_max achieved through 0.625-1.5 h after a single dose. Food does not affect absorption. Pharmacokinetic distribution has a linear nature. C_max and AUC increased in proportion to the dose. Repeated receptions of the drug does not cause its cumulation.

In patients with multiple myeloma lenalidomide is rapidly absorbed, wherein C_max achieved through 0.5-4 h after administration, as in 1-St day, and on the 28th day. C_max and AUC increased in proportion to how the one-time, and the readmission of preparation. According to data from_makh and AUC lenalidomida Exposition in patients with multiple myeloma above, than in healthy volunteers, because of the lower clearance ratio to filtering (CL/F) multiple myeloma patients compared with healthy volunteers, respectively 300 and 200 ml / min.

In vitro binding (¹⁴FROM)-lenalidomida plasma protein in patients with multiple myeloma and healthy volunteers was 22.7% and 29.2% respectively.

Deduction

About 60% lenalidomida displayed kidneys in an unmodified form. This exceeds the rate of glomeruliarna filtering and, so, the process is as passive, and proactive. T_1/2 increases with dose, approximately 3 h dose 5 mg to approximately 9 h dose 400 mg. The equilibrium is achieved on the 4th day. Data on excretion in breast milk no lenalidomida.

Pharmacokinetics in special clinical situations

Lenalidomida pharmacokinetics in patients with impaired liver was not studied.

In patients with impaired kidney removals lenalidomida does not change.

C_max not differ in patients with normal and with compromised renal function. While inferring lenalidomida slowed down in proportion to the extent of the violation of kidney function. Decrease QC less 50 mL/min has been accompanied by increased AUC on 56%. T_1/2 lenalidomida increases roughly with 3.5 no (in patients with CC more 50 ml / min) to approximately 9 no (in patients with CC less 50 ml / min).

Testimony

— in combination with dexamethasone for the treatment of patients with multiple myeloma, who got, at least, one line therapy.

Dosage regimen

Revlimid is only intended for oral administration.

Revlimida capsules cannot be crush or chew. It is recommended to take the drug every day, at the same time before or after a meal, drinking water.

The recommended initial dose is Revlimida 25 mg 1 times/day 1-21 day 28-day repeat cycles.

Dexamethasone dose 40 mg prescribed 1 times/day 1-4, 9-12 and 17-20 days of each 28-day cycle during the first 4 therapy cycles, and then – by 40 mg 1 times/day 1-4 each subsequent days 28-day cycle.

Modification of the dosage during treatment or its renewal

Below are the possible modification of dose in developing neutropenia, thrombocytopenia or other types of toxicity 3 and 4 severity, whose relationship with the use of Revlimida cannot be deleted.

Thrombocytopenia

Neutropenia

Pharmacokinetics lenalidomida y elderly patients I have not been studied. During clinical trials of lenalidomide was appointed patients under the age of 95 years. No differences in efficacy and safety lenalidomida depending on age, Although you cannot delete a great sensitivity to the drug patients older age group. Since elderly patients the chance of kidney function more, drug dose must be chosen very carefully, wherein, during treatment to monitor kidney function.

Pharmacokinetics was not studied lenalidomida y patients with compromised liver function, It is therefore not possible to submit recommendations regarding the correction doses in these patients.

Lenalidomide is allocated, mainly, kidney. In this regard, the risk of toxic reactions may increase when impaired renal function. In appointing Revlimida for patients with compromised renal function We recommend that you follow the below recommendations.

Initial dose lenalidomida depending on the degree of kidney function

* The dose may be increased to 15 mg 1 times/day after 2 cycles of therapy if there is no response to therapy, but good its portability.

Side effect

Patients, receive Revlimid/dexamethasone, the most frequent adverse reactions: neutropenia (39.4%), muscular weakness (27.2%), asthenia (17.6%), constipation (23.5%), muscle cramps (20.1%), thrombocytopenia (18.4%), anemia (17%), diarrhea (14.2%), rash (10.2%).

The most severe side reactions were:

- Venous thromboembolism (deep vein thrombosis, pulmonary embolism);

-neutropenia 4 severity.

Neutropenia and thrombocytopenia showed the greatest dependence on dose, that allows them to successfully control by reducing the dose Revlimida (deksametazona).

The frequency of adverse reactions, below, determined respectively following graduation: Often: (≥1/10), often (≥ 1/100, <1/10), infrequently (≥1/1000, <1/100), rarely (≥ 1/10 000, <1/1000), rarely (<1/10 000, including isolated cases).

For most side effects not detected differences in incidence depending on the kind of therapy (Revlimid/dexamethasone or placebo/dexamethasone). Only marked (*) side effects met often significantly in patients, treated Revlimidom/dexamethasone.

From the hematopoietic system: Often – neutropenia *, thrombocytopenia *, anemia *; often – febrile neutropenia, pancytopenia, lakopenia *, lymphopenia *; infrequently – granulocytopenia, gemoliticheskaya anemia, autoimmunnaya gemoliticheskaya anemia, gemoliz, monocitopenija, leukocytosis, lymphadenopathy.

Cardio-vascular system: often – Atrial fibrillation, heartbeat, deep vein thrombosis *, reducing ad *, increased blood pressure, orthostatic hypotension, flushing; infrequently – congestive heart failure, pulmonary edema, heart valve insufficiency, auricular flutter, trigeminija, bradycardia, tachycardia, QT prolongation on the ECG, vascular collapse, thrombosis and/or throm superficial or deep vein limbs, petechiae, hematoma, postflebitichesky syndrome, peripheral vascular ischemia.

On the part of the endocrine system: often – Cushing's syndrome; infrequently – adrenocortical insufficiency, gipotireoz, girsutizm.

On the part of the organ of hearing: often – dizziness; infrequently – deafness, hearing loss, tinnitus, pain or itching in the ears.

On the part of the organ of vision: often – blurred vision, Cataract, reduced visual acuity, increasing lacrimation; infrequently – blindness, atherosclerosis of retinal vessels, retinal vein thrombosis, keratit, swelling of the century, conjunctivitis, itchy eyes, red eyes, eye inflammation, syndrome “dry eyes”.

Co side of the digestive system: Often – constipation, diarrhea, nausea; often – vomiting, dyspepsia, epigastric pain, gastritis, stomach ache, stomatitis, dry mouth, flatulence; infrequently – gastrointestinal bleeding, esophagitis, hastroэzofahealnыy reflux, colitis, gastroduodenit, the absence of salivation, gastroenteritis, pain in the esophagus, dysphagia, thrush, coated tongue, numbness of the oral mucosa, pain in the tongue and other organs of the oral cavity, feeling discomfort epigastrii, krovotochivosty right, gingivitis, proctitis, hemorrhoids.

Infections and infestations: often – pneumonia *, infections of the upper and lower respiratory tract, herpetic infection, urinary tract infection, sinusitis, Candida and other fungal defeat mucous membranes of the oral cavity; infrequently – septic shock, meningitis, sepsis (incl. against the backdrop of neutropenia), Subacute endocarditis, bronchopneumonia, Pneumonia, SARS, viral lesion (shingles) optic nerve, fungal stop, ʙursit, otitis, pustular rash, bacteriemia genus Enterobacter, erysipelas, Genital Candidiasis, esophagus; prostatitis, cellulitis, ʙursit, sinusitis, furunculosis, viral lesion area area.

Laboratory findings: often – giperglikemiâ, kaliopenia, hypocalcemia; infrequently – hyperuricemia, giperfosfatemiя, hypoalbuminemia, giponatriemiya, gipomagniemiya, gipofosfatemiя, prolonged prothrombin time, increased MPE, elongation of activated partial thromboplastin time (APTT), reducing the level of urea in serum, increase in serum ALP activity, LDH, GOLD, C-reactive protein, urea and creatinine, increase or decrease the activity of thyroid-stimulating hormone, positive for Cytomegalovirus, acquired hypogammaglobulinemia, chromosomal anomalies.

Metabolism and nutrition: Often – increase and decrease in body weight; often – anorexia, degidratatsiya, fluid retention; infrequently – metabolic acidosis, diabetes or its progress, degidratatsiya, kaxeksija, gout, increased appetite.

On the part of the musculoskeletal system: Often – muscle cramps *, muscular weakness; often – myopathy (incl. steroidnaya myopathy), myalgia, arthralgia, pain in the extremities, backache, bone pain, chest pain; infrequently – osteonecrosis, amyotrophy, muscle spasms, amyotrophy, swelling of the joints, stiffness in joints, night cramps, deformation of the big toe, pain in the bones and muscles.

From the central and peripheral nervous system: often – stroke, loss of consciousness, perifericheskaya neuropathy (incl. touch), dizziness, dysgeusia, loss of taste sensitivity, paresthesia, headache, tremor *, hypoesthesia *, drowsiness, memory decline; infrequently – intracranial hemorrhage, venous sinus thrombosis, tromboticheskij stroke, cerebral ischemia, transient ischemic attack, lejkojencefalopatija, vasovagal variety bouts, neurotoxicity, peripheral motor neuropathy, dysesthesia, afonija, disfonija, attention deficit disorder, ataxia, imbalance, afonija, postural dizziness, involuntary muscle contractions, dyskinesia, giperesteziya, motor dysfunction, myasthenic syndrome, paresthesias of the mucous membranes of the oral cavity, psychomotor hyperactivity, anosmia.

Mental disorders: Often – insomnia; often – the loss of orientation, hallucinations, depression, aggression, excitation, nervousness, irritability, mood swings; infrequently – psychosis, delirium, changes in mental status, worsening of depression, sleep disorders, vivid dreaming, dejection, affective lability, apathy, loss of libido, nightmares, personality changes, panic attacks, anxiety.

From the urinary system: often – renal failure; infrequently – acute renal failure, increased urination, renal tubular necrosis, cystitis, hematuria, urinary retention, dizurija, acquired Fanconi syndrome, urinary incontinence, polyuria, nocturia.

Reproductive system: often – erectile dysfunction, gynecomastia, metrorragija, sore nipples.

The respiratory system: often – pulmonary embolism, shortness of breath * (incl. during physical exercise), cough, bronchitis, hoarseness, Ikotech, pharyngitis, nazofaringit; infrequently – bronhopnevmopatija, bronchial asthma, pleural pain, respiratory distress, nasal congestion, stuffy sinuses and pain in them, increased discharge from throat, laringit, rhinorrhea, the feeling of dryness in the throat.

Skin and subcutaneous fat: Often – skin rash *; often – swelling of the face, xerosis, itchy skin *, эritema, folliculitis, dermatomelasma, rash, increased sweating, night sweats, alopecia; infrequently – uzlovataya эritema, skin rash, incl. eritematosnaya rashes and itchy rashes, pigmentation lips, eczema, erythroderma, superficial cracks in the skin, hyperkeratosis, aggravation of acne, bedsores, rosacea, seborrheic dermatitis, prurigo, burning sensation skin, desquamation of the skin, petechiae, photosensitive reactions, depigmentation of the skin.

Neoplasms: infrequently – ʙazalioma, glioblastoma multiforme.

Systemic reactions: Often – weakness *, fatigue *, peripheral edema; often – fever, chills, mucositis, drowsiness, feeling of uneasiness; infrequently – temperature rise, chest pain, feeling “mortgage” chest, unsteady gait, thirst, flu-like symptoms, decreased performance, slowing the healing of wounds.

Contraindications

- Pregnancy;

- Lactation (breast-feeding);

-saved childbearing potential, except, whenever possible the observance of all the necessary conditions of protection against pregnancy;

-impossibility or inability to comply with necessary measures contraception, described in pregnancy and lactation;

- Children's age (insufficient clinical experience of application);

-hereditary lactose intolerance, lactase deficiency or impaired absorption of glucose-Galactose, tk. Revlimida capsules contain lactose;

-hypersensitivity to lenalidomidu or other components of the drug.

Pregnancy and lactation

The drug is contraindicated in pregnancy and lactation (breast-feeding).

Lenalidomide – structural analogue of Thalidomide have gone, which has a pronounced teratogenic effect. Known, that the admission of those people affected pregnant women causes severe and zhizneugrozhajushhie violation of internal organs of fetus (with up to 30%). Experimental studies in monkeys showed results, similar to previously described results for those people affected. The risk of birth defects is very large, If Revlimid is taken during pregnancy.

Strict observance of all requirements of contraception, must extend to women, and men.

For women, not of childbearing age

Woman-patient or a woman, sexual partner male patient, not considered able to procreate if at least one of the listed factors:

age ≥ 50 years and the duration of natural amenorrhea ≥ 1 year *;

— early ovarian failure, confirmed by a gynaecologist;

-two-sided sal'pingooforjektomija or hysterectomy in history;

-XY genotype, Syndrome Ternera, anatomical defect of the uterus.

*- amenorrhea due to cancer therapy does not preclude the existence of childbearing potential.

A woman of childbearing age must:

-know about teratogennom action Revlimida on unborn child;

-understand the need for the continuous use of effective contraceptive methods during the 4 weeks prior to the start of treatment, during treatment and 4 weeks after treatment Revlimidom;

even in case of amenorrhoea to abide by all the rules of effective contraception;

-be able to comply with all the rules of effective contraception;

-to know and understand the possible consequences of pregnancy, as well as the need for rapid treatment for advice in case of future pregnancy;

-understand the need for the immediate admission of Revlimida after receiving a negative pregnancy test results;

is aware of the need for and perform a pregnancy test every 4 of the week;

-reaffirm the understanding of all potential adverse effects and their prevention during treatment Revlimidom.

For men:

There is no clinical evidence that, that lenalidomide is found in seminal fluid, Therefore, men, taking Revlimid, should:

-understand the risk of teratogenicity Revlimida when sexual contact with a pregnant woman;

— use condoms with sexual contact with pregnant women or women of childbearing age, do not use reliable methods of contraception.

Doctor, assigns treatment Revlimidom, should:

-to be sure that, the patient meets all of the program requirements of contraception;

— obtain the consent of the patient compliance with all conditions/the above-mentioned programme.

Contraception rules

Women of childbearing age must use one of the highly effective contraceptive method during the 4 weeks prior to the start of treatment, during therapy, and for Revlimidom 4 weeks after treatment, even in the event of interruptions in treatment. The only exceptions are the patient, who abstain from heterosexual relationships throughout the specified period, that is documented on a monthly basis. If necessary, patients should be directed to a specialist for the selection of effective contraception method.

The highly effective contraceptive methods include:

-subcutaneous hormonal implants;

-intrauterine system, Emit levonorgestrel;

-depo-medroxyprogesterone acetate medication;

is tubal ligation;

-vasectomy partner (by two negative tests of semen);

-progesterone-containing pills, inhibiting ovulation (eg, desogestrel).

Welcome to combined oral contraceptives not shown multiple myeloma patients in connection with the increased risk of thromboembolic complications during treatment Revlimidom and dexamethasone. Effective contraception for these patients, it is recommended that you use one of the methods listed above. Increased risk of thromboembolism is stored within 4-6 weeks after you stop taking combined contraceptives. The effectiveness of hormonal contraceptives can be reduced while appointing dexamethasone.

Patients with neutropenia, use as a means of contraception hypodermic hormonal implants or intrauterine system, Emit levonorgestrel, It is necessary to prescribe antibiotics prophylactically in connection with the increased risk of infectious complications at the time of installation of these therapeutic systems.

The use of intrauterine systems, producing copper, usually, not recommended due to the high risk of infectious complications at the time of implantation and increased blood loss during menstruation, which can increase the severity of neutropenia or thrombocytopenia patient.

Pregnancy tests (the sensitivity of not less 25 mIU / ml) must be performed in the presence of a medical practitioner for all women of childbearing age, including those, who abstain from heterosexual relationships. Tests are performed on the day of the appointment or treatment for 3 the day before the visit to the pharmacist, and then every 4 of the week, incl. and after receiving Revlimida. The test results should confirm the absence of pregnancy the patient during treatment Revlimidom.

Male patients should use condoms during the entire course of treatment Revlimidom and over 1 weeks after the interruption or discontinuation of treatment in case, If your sexual partner – a woman of childbearing age, not using highly effective methods of contraception.

Additional precautions

Patients should not transmit Revlimid to others. Unused product should be returned to a medical institution.

Patients are not allowed to donate blood or sperm donor throughout the duration of treatment Revlimidom and in one week after the end of.

Training materials

To improve the security of Revlimidom therapy and reduce the risk of teratogenic effect in patients are provided with educational materials, which include all the necessary information about the product, as well as a programme of contraception. The holder of the registration certificate provides physicians with the necessary materials for their patients. Detailed information on teratogennom risk Revlimida and measures for the protection from pregnancy doctor sends patients, of childbearing age and sexually active men.

Cautions

Revlimidom treatment should be under the supervision of hematologist or chemotherapeutist.

Venous thromboembolism

On the background of Revlimidom and dexamethasone combination therapy, increasing the frequency of deep vein thrombosis and pulmonary embolism in patients with multiple myeloma. The greatest predictive value have thromboembolic complications in history, concomitant therapy with erythropoietin, hormone replacement therapy. Hemoglobin concentration above 13 g% in patients with multiple myeloma, receiving treatment Revlimidom and dexamethasone, involves the cessation of therapy with erythropoietin. Patients should be alerted to the need for immediate treatment to a doctor in case of symptoms such as shortness of breath, chest pain, swelling of the upper or lower limb.

For prevention of venous thromboembolism, especially in patients, have additional risk factors, It is recommended that you use a low molecular weight heparins or warfarin. The decision to appoint protivotromboticheskoj therapy should be taken after a careful assessment of individual risk factors.

Neutropenia and thrombocytopenia

The risk of neutropenia 4 severity in patients with multiple myeloma while appointing Revlimida and dexamethasone is very high (5.1% in patients, treated with Revlimid/dexamethasone, and 0.6% in patients, treated with placebo/dexamethasone). Episodes of febrile neutropenia is recorded infrequently (0.6% in patients, treated with Revlimid/dexamethasone, and 0.0% in patients, treated with placebo/dexamethasone). Patients should be informed of the need to inform the attending doctor about any increases in temperatures above 38° c. If necessary, the dose can be reduced. When expressed neutropenia appropriate prescribing growth factor.

High incidence of thrombocytopenia 3 and 4 the severity indicated in patients with multiple myeloma while appointing Revlimida and dexamethasone (9.9% and 1.4%, respectively, treatment patients Revlimidom/dexamethasone, and 2.3% and 0.0% – treatment with placebo/dexamethasone). It is recommended that thorough monitoring by the physician and, and patient symptoms increased bleeding, including petechiae and hemoptysis. If necessary, the dose can be reduced.

During the first 2 months of treatment Revlimidom it is recommended each week to carry out a detailed analysis of blood, including determination of the number of leukocytes, blood formula, platelet count, Hemoglobin, gematokrita. In a subsequent blood tests should be performed on a monthly basis. The decrease in the number of blood cells may require lower doses Revlimida.

Manifestations of toxicity Revlimida, most often limit its use, included neutropenia and thrombocytopenia. Concerning, decision on the joint appointment of Revlimida and other immunosuppressive drugs should be clinically justified.

Renal failure

Taking into account the preferential allocation of kidney Revlimida, in patients with renal insufficiency should carefully monitor the condition of kidneys and a dose of Revlimida.

Function of the thyroid gland

Requires regular monitoring of thyroid function in connection with the possibility of Revlimida cause hypothyroidism.

Perifericheskaya neuropathy

You cannot exclude the possibility of neurotoxic action Revlimida in the long-term it is received, given the structural similarity of Revlimida molecules and those people affected, which is known for its pronounced neurotoxic side-effect.

Tumor Lysis syndrome

In response to antineoplasticheskoj activity Revlimida tumor Lysis syndrome may develop, especially in patients, with a large tumor mass. These patients should be organized by the relevant monitoring, and the application of generally accepted preventive measures.

Effects on ability to drive vehicles and management mechanisms

Some side effects of Revlimida, such as dizziness, weakness, drowsiness and unclear vision can have a negative impact on the ability to control the car and perform potentially hazardous activities, require high concentration and speed of psychomotor reactions. In this regard, when driving and working with the mechanisms should exercise particular caution.

Overdose

Currently not received information on the cases of overdose.

Drug Interactions

Reciprocal influence on the metabolism of other drugs and unlikely lenalidomida because, that lenalidomide is not metabolised by cytochrome P450 system.

The simultaneous appointment with digoxin lenalidomida accompanied by an increase in the plasma concentration of Digoxin (C_max digoxin was 114%, AUC – 108%). Thus, in the face of treatment lenalidomidom it is recommended that you monitor the concentration of Digoxin.

Dexamethasone, that is a required component of therapeutic scheme with Revlimidom, may reduce the effectiveness of oral contraceptives. To effectively prevent pregnancy should use funds, specified in the programme of contraception.

There has been mutual influence on the pharmacokinetic parameters lenalidomida and warfarin. Given the use in combination with dexamethasone lenalidomidom, You cannot exclude the influence of the latter on the effects of warfarin. Thus, on the background of lenalidomidom and dexamethasone treatment recommended careful monitoring of concentrations of warfarin.

Conditions of supply of pharmacies

The drug is released under the prescription.

Conditions and terms

The drug should be stored out of reach of children, dry place at temperatures no higher than 25 ° C. Shelf life – 3 year.