Pharmaceutical grade:
Anticancer
Drug form:
5, 10, 15 and 25 mg capsules
Drug combinations:
Lenalidomide
mechanism of action of Mylodeq:
Modulator of the immune system
Uses of Mylodeq:
This drug is used to treat a type of blood cancer called multiple myeloma. Also, other blood cancers, including myelodysplastic syndrome and mantle cell lymphoma, are among the other uses of this drug.
Usage in pregnancy and breastfeeding Mylodeq:
Pregnancy:
• Classification of use in pregnancy: X
Lenalidomide is an analog of thalidomide (a human teratogen) and can potentially cause severe birth defects or fetal death. You cannot use the medicine during pregnancy or prevent pregnancy if you use it. Before treatment, two negative pregnancy tests should be done. Two methods of preventing pregnancy (or avoiding sexual intercourse) must be used at least 4 weeks before the treatment, during the treatment and 4 weeks after the end of the treatment (and during the treatment break). In order to reduce the risk of fetal death, lenalidomide is available only through a limited distribution program.
Reproduction studies in mammals with lenalidomide have shown abnormalities similar to those observed in humans with thalidomide.
Treatment with lenalidomide in women of childbearing age should be given only when they are able to comply with the lenalidomide schedule status (REMS).
Women of childbearing age should avoid pregnancy at least 4 weeks before treatment, during treatment and 4 weeks after the end of treatment.
Lenalidomide should be stopped immediately in situations such as after a missed menstrual period, abnormal pregnancy test, abnormal menstrual bleeding, and in case of pregnancy, a specialist should be consulted.
• Male fertility: Lenalidomide has also been observed in men’s semen. Men (including those who have had a vasectomy) should use a condom during the treatment, the treatment break and 4 weeks after the end of the treatment if they have sex with women of reproductive age.
Breastfeeding: Since the secretion of the drug in breast milk is not known, due to serious side effects on babies, the appropriate decision regarding stopping breastfeeding or stopping the use of the drug should be taken by the doctor.
Regarding the correct way to use this medicine, pay attention to the following points:
1- You should take the medicine once a day at a certain time with a glass of water. Swallow the capsule completely and avoid opening, chewing and crushing it separately. Always take the medicine with or without food.
2- To remove the capsule from the blister, press only one part of the capsule so that it comes out through the foil. Do not apply pressure to the center of the capsule, as this may cause the capsule to break.
3- If the powder inside the capsule comes into contact with your skin, wash your skin quickly with soap and water.
4- If the powder inside the capsule comes into contact with the eyes, nose and mouth, wash with a quick stream of water.
5- If you happen to consume more than the recommended amount, inform the doctor immediately.
6- If you forget to take the medicine, if less than 12 hours have passed since taking the medicine, take it as soon as you remember. But if more than 12 hours have passed since taking the medicine, do not take the medicine and wait for the next appointment. Do not double the dose.
7- If you have more questions about taking medicine, consult your doctor or pharmacist.
Mylodeq drug interactions:
If you have recently used or are taking other medicines, consult your doctor:
BCG: Immunosuppressants may reduce the therapeutic effect of BCG. Avoid combining the two.
Dexamethasone (systemic): May increase the thrombogenic effects of lenalidomide. Consider therapeutic changes.
Digoxin: Lenalidomide may increase digoxin serum levels. Monitoring of treatment is recommended.
Echinacea: May reduce the therapeutic effects of immune system inhibitors. Consider therapeutic changes.
Stimulators of erythrocyte production: may increase the thrombogenic effects of lenalidomide. Monitoring of treatment is recommended.
Estrogen derivatives: may increase the thrombogenic effects of lenalidomide. Monitoring of treatment is recommended.
Leflunomide: Immune system inhibitors may increase the side effects of leflunomide, especially the risk of blood complications such as pancytopenia, agranulocytosis, or thrombocytopenia. Administration of the maximum amount of leflunomide with other immunosuppressants should not be done. In patients who use leflunomide with other immunosuppressants, the effects of bone marrow suppression should be checked monthly. Consider therapeutic changes.
Pimecrolimus: may increase the side effects of immunosuppression. Avoid combining the two.
Tacrolimus (topical): May increase immunosuppressive side effects. Avoid combining the two.
Inactivated vaccine: Immune system suppressors may reduce the therapeutic effects of inactivated vaccine and reduce the effectiveness of vaccination. Annual vaccination should be done at least two weeks before starting the administration of immune system inhibitors. If the vaccination is done at the same time as receiving immune system inhibitors, the vaccination should be repeated at least three months after stopping the use of immune system inhibitors. Consider therapeutic changes.
Live vaccine: Immune system suppressants may increase the side effects of live vaccine. Vaccination-induced infection may occur. Immunosuppressants may reduce the therapeutic effects of live vaccines. Avoid combining the two. Vaccines containing live and weakened microorganisms should not be administered for at least three months after stopping immunosuppressants.
Warfarin: Administration of multiple doses of lenalidomide (10 mg) with a single dose of warfarin (25 mg) had no effect on the pharmacokinetics of lenalidomide or S-warfarin or R-warfarin. Predicted changes in PT and INR laboratory results were observed after warfarin administration, but these changes were not affected by lenalidomide coadministration. It is not known whether there is an interaction between the simultaneous administration of dexamethasone and warfarin. Close monitoring of PT and INR is recommended in MM patients taking warfarin.
Precautions Mylodeq:
Blood donation: Patients should not donate blood during the treatment and for 1 month after the treatment.
Risk assessment program and its reduction in the use of lenalidomide: due to the risk to the fetus, lenalidomide can only be used if the risk is assessed and the harms of use are reduced. Doctors and pharmacists must be aware of the program or stop taking the drug. Lenalidomide should only be prescribed to patients (male and female) who can follow the schedule.
Bone marrow suppression: Hematological toxicity (neutropenia and thrombocytopenia) occurs in the majority of patients, and dose reduction or interruption in treatment, blood transfusion, or growth factors may be necessary. Blood tests should be performed weekly during the first 8 weeks of treatment and at least monthly thereafter in patients treated for 5q myelodysplastic syndrome. In multiple myeloma patients, blood tests should be done weekly for the first two periods, every 2 weeks during the third period, and then monthly. In patients treated for mantle cell lymphoma, blood tests should be done weekly for the first period, every two weeks during the second to fourth period, and then monthly. In case of infection, bleeding, or bruising, dose adjustment is required.
Thromboembolic complications: In patients undergoing treatment for multiple myeloma, a significant increase in the risk of arterial and venous thromboembolism has been observed with combined use of lenalidomide and dexamethasone. Thrombosis has occurred in the lower veins, lung and stroke. It is necessary to monitor the signs and symptoms of thromboembolism (shortness of breath, chest pain, or swelling of the arm or leg) and you should inform your doctor if the symptoms develop. Prophylaxis of thromboembolism is recommended. The choice of treatment regimen should be based on the underlying risk factors of the patient. Erythropoietin-stimulating agents (ESAs) and estrogen may contribute to the risk of thromboembolism. Therefore, they should be used with caution. Patients with a history of arterial thromboembolic events may be at increased risk. Important factors such as blood lipids, high blood pressure, and smoking should be minimized. Anticoagulant use is the safest and easiest way to prevent the risk of venous thromboembolism in the selected combined treatment regimen.
Secondary malignancy: including leukemia (acute myeloid leukemia, myelodysplastic syndrome, and B-cell malignancy including Hodgkin’s lymphoma), solid tumor cancer, and skin cancer, have been reported in patients treated for myelodysplastic syndrome and multiple myeloma with lenalidomide. The incidence of malignancy may be increased when lenalidomide is administered with an alkylating agent. Investigation of secondary malignant tumors should be done.
Hepatic failure: Hepatic failure, including death, has occurred in patients treated with the combination of lenalidomide and dexamethasone, and hepatocellular, cholestasis, or combination complications may also occur. Risk factors may include a history of viral liver disease, elevated liver enzymes at baseline, and concomitant medication use. Close monitoring, discontinuation of therapy in patients with abnormal liver function tests should be considered. It may be possible to start the treatment with a lower dose after returning to the initial state.
Skin reactions: Angioedema, Stevens-Johnson syndrome, and fatal skin necrosis have been reported, which can be fatal. Therefore, if you observe grade 2 or 3 skin reactions, stop taking the drug, and in case of angioedema, grade 4 skin reactions, scaling, red rash, or the possibility of Steven Johnson syndrome and fatal skin necrosis, do not consider starting the treatment. Patients with grade 4 rash should not receive lenalidomide while taking thalidomide.
Tumor lysis syndrome: Patients with high-volume tumors may be at risk for tumor lysis syndrome; Careful monitoring, appropriate management of hyperuricemia is necessary. Tumor lysis syndrome (fatal) has been reported with lenalidomide.
• Tumor recurrence: In studies of lenalidomide for the treatment of chronic lymphocytic leukemia and lymphoma, clinical manifestations including low-grade fever, pain, rash, and lymph node swelling have been observed. In patients with mantle cell lymphoma, tumor recurrence may mimic disease progression, close monitoring is recommended in clinical trials, most cases of tumor recurrence occurred during the first course of treatment. Treatment with corticosteroids, NSAIDs, or analgesics may be considered; discontinuation may be necessary.
• Mobilization of TB stem cells: The use of lenalidomide (4 cycles or more) may reduce the number of CD34+ cells required for autologous stem cell transplantation. Transplant-eligible patients receiving lenalidomide should be referred to an appropriate transplant center for timely stem cell collection.
• CNS effects: It may cause dizziness or fatigue, so patients should be careful in performing tasks that require full alertness (for example, working with machines, driving).
• Hazardous materials: appropriate precautions for product transportation and disposal must be considered.
• Appropriate use: In a clinical trial, comparing lenalidomide and chlorambucil as the only therapeutic agent in patients over 65 years of age with chronic lymphocytic leukemia patients (not approved by the FDA), it showed an increase in mortality in patients treated with lenalidomide. Atrial fibrillation, heart failure and heart infarction were observed more in patients who are treated with lenalidomide. Lenalidomide (alone or in combination) is not recommended as first-line therapy in the treatment of chronic lymphocytic leukemia.
• Renal dysfunction: use with caution in patients with renal impairment, toxicity may increase due to decreased clearance and increased half-life. Initial dose adjustment is recommended in patients with moderate to severe renal impairment and dialysis.
• Patient monitoring: differential blood cell count (CBC) (mantel cell lymphoma: weekly for the first course, every two weeks during the second to fourth courses; myelodysplastic syndrome: weekly for the first 8 weeks, multiple myeloma: weekly at the beginning of the first two courses, every two weeks during the third period), and then monthly thereafter, serum creatinine, liver tests, thyroid tests (thyrotropin initially and then every 2-3 months during lenalidomide therapy); Electrocardiogram when clinical symptoms are observed. Monitor for signs and symptoms of infection (if neutropenia), secondary malignancies, thromboembolism, lystomore syndrome, or tumor recurrence. Women of childbearing potential – pregnancy test 10 to 14 days and 24 hours before starting treatment, weekly during the first 4 weeks of treatment, and then every 2 to 4 weeks until 4 weeks after stopping treatment.
• In case of dizziness, fatigue, drowsiness, blurred vision, avoid driving and working with machines that require concentration.
• Lenalidomide contains lactose: If your doctor has prohibited you from consuming some sugars, inform your doctor before taking Lenalidomide.
Mylodeq contraindications:
Patients with a history of allergy to lenalidomide or side ingredients in lenalidomide (reactions include shock angioedema and Steven Johnson syndrome, epidermal necrosis)
Pregnancy and breastfeeding
Was this helpful?
0 / 0
