Lenalidomide (Oral)

Overview

As Lenalidomide has many different functions, it can be used to treat various different conditions. Commonly, Lenalidomide is prescribed to patients who have been diagnosed with myelodysplastic syndromes (MDS). Affecting the bone marrow, myelodysplastic syndrome prevents the body from making healthy blood cells. As a result, patients can suffer from anemia, extreme tiredness, bruising and bleeding. In addition to this, patients with myelodysplastic syndrome can be prone to infections.

As myelodysplastic syndromes are classified as cancers, they are routinely treated with stem cell transplants or chemotherapy. Most appropriate for patients with deletion 5q myelodysplastic syndrome, Lenalidomide lowers the patient's malignant clone number and facilitates the development and differentiation of healthy erythroid cells. As a result, the patient's symptoms can be relieved and their prognosis improved.

When patients are diagnosed with multiple myeloma, it means that cancer is affecting their plasma cells. As these cells are usually responsible for producing antibodies, patients with multiple myeloma can suffer from bone pain, frequent infections, anemia and/or excessive bleeding. For many patients, chemotherapy, followed by a stem cell transplant, is the first-choice treatment for multiple myeloma. However, stem cell transplants are not a viable option for all patients.

If an alternative course of treatment is required, Lenalidomide may be used in conjunction with Dexamethasone. As Lenalidomide has a direct cytotoxic effect on myeloma cells, it can be used to destroy the existing cancer cells in the patient's body. In addition to this, Lenalidomide increases the production of other cells, such as T-cells, which are also able to target myeloma cells. Furthermore, Lenalidomide inhibits the growth of tumor necrosis factor alpha (TNF-a) which helps to prevent myeloma cells from replicating and growing. As a result, Lenalidomide can be used to prevent additional myeloma cells from developing and to destroy myeloma cells which are already present in the patient's body.

As well as being used to treat myelodysplastic syndromes and multiple myeloma, Lenalidomide can be prescribed to patients with mantle cell lymphoma (MCL). As a form of Non-Hodgkin's lymphoma, MCL occurs when the growth of B-lymphocytes (B-cells) increases to an uncontrollable level. Often, there is also a significant overproduction of Cyclin D protein in cases of MCL and this can be used to assist in providing the patient with an accurate diagnosis.

Although Lenalidomide is not typically a first-line treatment for patients with MCL, it may be used when other treatments have failed to produce a positive outcome. By down-regulating Cyclin D, Lenalidomide can facilitate the destruction of lymphoma cells. In addition to this, Lenalidomide prevents the cells from replicating and the cancer spreading further. By increasing the number of T-cells and natural killer (NK) cells, Lenalidomide can also enable the patient's body to destroy existing cancer cells more effectively.

Myelodysplastic syndrome, multiple myeloma and mantle cell lymphoma can all be difficult conditions to treat. As these conditions all involve the bone marrow, Lenalidomide can be effective as it acts as an immunomodulatory when metabolized in the patient's body. By affecting the way the immune system works, Lenalidomide can suppress certain elements, such as the growth of cancer cells, whilst enhancing other functions of the immune system, such as the production of healthy cells.

Although Lenalidomide is a relatively new form of treatment, is has been effective for a significant number of patients. As well as relieving the patient's symptoms, Lenalidomide can be used to increase survival rates and improve the patient's quality of life.

Whilst Lenalidomide can sometimes be used in isolation, it is typically prescribed in conjunction with at least one other medication, such as Dexamethasone. Although Lenalidomide can be effective in treating patients with the above conditions, it is only available through a restricted distribution program. Patients will, therefore, need to be registered in order to receive treatment with Lenalidomide, and have their physician's support.

Conditions Treated

  • Myelodysplastic syndrome
  • Multiple Myeloma
  • Mantle cell lymphoma

Type Of Medicine

  • Immunomodulator

Side Effects

When patients are taking Lenalidomide, they may experience the following side effects:

  • Decreased or abnormal touch sensation
  • Muscle twitching, spasms or stiffness
  • Bloody nose
  • Loss of pleasure or interest
  • Blurred vision
  • Loose stools
  • Body pain or aches
  • Trouble swallowing
  • Large, flat, purplish or blue patches in the skin
  • Bruising
  • Loss or lack of strength
  • Burning while urinating
  • Irritability
  • Tingling, painful, numbness or burning sensations
  • Night sweats
  • Change in taste
  • Increased sweating
  • Cough-producing mucus
  • Redness or flushing of the skin
  • Difficulty with moving
  • Tiredness or drowsiness
  • Ear congestion
  • Pounding, slow, irregular, racing or fast pulse or heartbeat
  • Warmth, itching, redness, pain, tenderness or swelling on the skin
  • Tenderness or pain around the cheekbones and eyes
  • Shivering
  • Voice changes
  • Seizures
  • Awkwardness or unsteadiness
  • Swollen, tender glands in the neck
  • Pain in the stomach or upper abdomen
  • Trembling
  • Weakness in the hands, arms, feet or legs
  • Trouble concentrating

The above side effects may occur most commonly when the patient first starts taking Lenalidomide and may diminish over time. However, if the patient's side effects are severe or continuous, they should obtain medical help.

In addition to this, patients will need to obtain immediate medical attention if they exhibit any of the following side effects when taking Lenalidomide:

  • Tarry, black stools
  • Red, pinpoint spots on the skin
  • Bleeding gums
  • Pale skin
  • Blood in the stools or urine
  • Difficult or painful urination
  • Chest pain
  • Tingling or numbness in the feet, lips or hands
  • Chills
  • Nausea or vomiting
  • Convulsions
  • Muscle cramps or pain
  • Cough
  • Mood changes
  • Decreased urine
  • Labored or difficult breathing
  • Pain in the lower back or side
  • Dry mouth
  • Loss of appetite
  • Fever
  • Sore throat
  • Increased thirst
  • Ulcers, white spots or sores in the mouth or on the lips
  • Irregular heartbeat
  • Swollen glands
  • Chest discomfort
  • Tightness in the chest
  • Dark-colored urine
  • Unusual bruising or bleeding
  • Clay-colored stools
  • Unusual weakness or tiredness
  • Confusion
  • Anxiety
  • Difficulty with speaking
  • Sweating
  • Double vision
  • Slow speech
  • Headache
  • Discomfort or pain in the back, neck, jaw or arms
  • Loosening, peeling or blistering of the skin
  • Inability to move the legs, facial muscles or arms
  • Depressed mood
  • Inability to speak
  • Diarrhea
  • Husky voice or hoarseness
  • Difficulty having a bowel movement (stool)
  • Lightheadedness or dizziness
  • Dry hair and skin
  • Hair loss
  • Fainting
  • Sensitivity to heat
  • Fast heartbeat
  • Irritated, red eyes
  • Feeling cold
  • Rash or itching
  • General feeling of weakness or tiredness
  • Sudden troubled breathing or shortness of breath
  • Muscle stiffness and cramps
  • Joint swelling, stiffness or pain
  • Redness, swelling or pain in the leg or arm
  • Large, hive-like swelling on the eyelids, face, tongue, lips, hands, throat, feet, legs or sex organs
  • Red skin lesions, sometimes with a purple center
  • Yellowing of the skin or eyes
  • Slowed heartbeat
  • Weight loss or gain
  • Stomach pain, may be continuing
  • Vomiting of blood
  • Swelling of the lower legs or feet
  • Unpleasant breath odor
  • Trouble sleeping

If patients experience any other side effects when taking Lenalidomide, they should also seek medical help.

Dosage

When patients are prescribed Lenalidomide, their dose will depend on their condition, age, weight, medical history and any other medications they may be taking. Generally, if patients are being treated for anemia caused by myelodysplastic syndrome, they are instructed to take 10mg of Lenalidomide once per day, although this may be increased if necessary.

Alternatively, if patients are being treated for multiple myeloma or mantle cell lymphoma, they are usually advised to take 25mg once per day. However, treatment with Lenalidomide is generally based on a 28 day cycle when patients are being treated for either of these conditions. Typically, patients should take 25mg per day for a period of 21 days, followed by seven days without taking Lenalidomide at all.

Although this is a typical treatment regime for Lenalidomide therapy, patients should follow the instructions given to them by their physician. In most cases, Lenalidomide can be taken with or without food but patients should take their medication at the same time each day.

Lenalidomide is usually prescribed in capsule format but patients will need to swallow the capsule whole, rather than breaking it, chewing it or crushing it. If patients accidentally open a capsule and come into contact with the medication, they should wash their skin with clear water and soap immediately. Similarly, if the medication comes into contact with a patient's eyes, mouth or nose, they should rinse the affected area with water.

If patients forget to take a dose of Lenalidomide but less than 12 hours have passed since the dose should have been taken, patients can take the dose of medication that they've missed. However, if more than 12 hours have passed since the medication should have been taken, patients should skip the missed dose and take their next dose as normal. Patients should not attempt to take a double dose of Lenalidomide, even if a previous dose has been missed.

It's important to take Lenalidomide in accordance with an appropriate treatment schedule. If patients are unsure how to take Lenalidomide or when to take it, they should contact their physician or pharmacist for advice.

Potential Drug Interactions:

Although some medications can be taking in conjunction with one another, others should not be taken at the same time. Due to this, patients should tell their doctor if they are using any other medicines, supplements or vitamins before they start taking Lenalidomide.

Similarly, patients should seek medical advice before using any new medicines, vitamins or supplements once they have started taking Lenalidomide.

If Lenalidomide is taken alongside the following medication, patients may have an increased risk of side effects occurring:

  • Digoxin

Warnings

If patients have any existing health problems or a history of certain medical conditions, it may affect their use of Lenalidomide. Patients should discuss their medical history with their physician prior to taking Lenalidomide. The following conditions are particularly relevant if treatment with this medication is being considered:

  • Lactose intolerance
  • Kidney disease
  • Blood clotting problems
  • Infection
  • Liver disease
  • Heart attack
  • Smoking
  • Low number of white blood cells (Neutropenia)
  • Stroke
  • Low number of platelets (Thrombocytopenia)
  • High cholesterol or fats in the blood (Hyperlipidemia)
  • High blood pressure (Hypertension)

As the safety of Lenalidomide has not been tested on the pediatric population, this medication is not normally prescribed to children or infants.

Although Lenalidomide can be taken by elderly patients, their dose may need to be modified. As geriatric patients are more likely to have age-related heart, liver, kidney or blood clotting problems, they may be unable to process medications at the usual rate. In order to prevent toxicity, a lower dose of Lenalidomide may need to be prescribed.

Lenalidomide may cause a tumor flare reaction in some patients. If patients experience the following symptoms, they should notify their physician:

  • Fever
  • Rash on the skin
  • Pain
  • Swollen or painful lymph nodes

Taking Lenalidomide may increase the patient's risk of developing certain types of cancers. If patients are concerned about this, they should discuss the risk with their physician before they start using Lenalidomide.

When taking Lenalidomide, patients may be given an additional medication to try and prevent a reaction known as tumor lysis syndrome. If patients exhibit the following symptoms, they should obtain immediate medical help:

  • Pain in the joints
  • Change or decrease in urine amount
  • Joint swelling or stiffness
  • Pain in the stomach, side or lower back
  • Unusual weakness or tiredness
  • Swelling in the lower legs or feet
  • Rapid weight gain

When taking Lenalidomide, patients may experience a serious skin reaction and should obtain medical attention if they experience the following symptoms:

  • Loosening, peeling or blistering of the skin
  • Fever
  • Chills
  • Ulcers or sores on the skin
  • Severe rash or acne
  • Red skin lesions

Patients may experience serious liver problems when taking Lenalidomide. If patients exhibit the following symptoms, they should obtain immediate medical help:

  • Pale stools
  • Dark-colored urine
  • Loss of appetite
  • Yellowing of the skin or eyes
  • Pain in the upper stomach
  • Nausea or vomiting

Taking Lenalidomide can increase the patient's risk of suffering strokes and/or heart attacks. This is more likely to affect patients who already have heart disease, have high cholesterol and those who smoke. If patients exhibit the following symptoms when taking this medication, they should seek immediate medical attention:

  • Irregular or fast heartbeat
  • Chest discomfort or pain
  • Shortness of breath
  • Nausea or vomiting
  • Sweating
  • Discomfort or pain in the jaw, neck arms or back

Lenalidomide can also increase the patient's risk of developing blood clots. Due to this, patients will need to access urgent medical help if they experience the following symptoms:

  • Chest pain
  • Anxiety
  • Fainting
  • Sudden troubled breathing or shortness of breath
  • Redness, swelling or pain in the leg or arm
  • Fast heartbeat

Lenalidomide lowers the amount of certain blood cells in the patient's body. As a result, patients may be more likely to contract infections and/or bleed when taking Lenalidomide. Due to this, patients should take extra care not to cut themselves or to become unwell when taking this medicine.

For example, patients should avoid people who they know are unwell and may want to avoid busy areas and crowds as they may be more likely to contract an illness in this environment. If patients begin to feel unwell or develop symptoms associated with an infection, they should seek medical advice straight away.

Patients should also avoid strenuous exercise, contact sports and potentially dangerous activities when taking Lenalidomide. In addition to this, patients should take particular care when using dental floss, razors and/or nail scissors or clippers. If necessary, patients should modify their oral hygiene routine to prevent bleeding gums.

Patients should not donate blood whilst taking Lenalidomide or for at least one month after they have finished taking this medication.

Lenalidomide can cause fetal abnormalities and birth defects if it is taken by patients who are pregnant. Due to this, pregnant patients should not be treated with Lenalidomide as the risk is always deemed to outweigh the possible benefits. If patients are pregnant, they should notify their physician before they start taking Lenalidomide.

At least four weeks before patients start taking this medicine, and whilst taking Lenalidomide, female patients should use two effective forms of birth control. Patients should continue to use two forms of birth control for at least four weeks after their final dose of Lenalidomide.

Patients will need to undergo routine pregnancy tests when taking Lenalidomide, even if they do not think they are pregnant. If patients become pregnant when taking Lenalidomide, they should contact their physician immediately or contact the Emergency Contraception Hotline on 1-888-668-2528.

Male patients must also use effective birth control before taking Lenalidomide and whilst they are receiving treatment with this medication. Similarly, male patients should continue to use effective birth control for at least four weeks after taking their last dose of Lenalidomide. Due to the risks of impregnating a sexual partner whilst taking this medicine, even male patients who have previously undergone a vasectomy should use birth control.

If male patients believe they have impregnated a sexual partner whilst taking Lenalidomide or soon after their last dose, they should notify their physician immediately or contact the Emergency Contraception Hotline on 1-888-668-2528.

If patients have any allergies, they should inform their physician before they start taking Lenalidomide. In some cases, patients may exhibit an allergic reaction when taking this medicine. If so, patients will need to obtain emergency medical treatment. The symptoms of an allergic reaction may include:

  • Shortness of breath
  • Wheezing
  • Difficulty breathing
  • Hives
  • Rash on the skin
  • Itching
  • Hoarseness
  • Difficulty swallowing
  • Swelling of the throat, lips, tongue, mouth, face or hands

Storage

When storing Lenalidomide at home, it is essential that patients keep the medicine in a safe and secure location. Patients should use a locked medicine cabinet or lockable medicine box to ensure that no-one else can access the medicine. It is particularly important that children and/or pets cannot gain access to Lenalidomide.

In order to store the medicine properly, patients should follow the manufacturer's guidelines. Typically, Lenalidomide can be kept at room temperature but should be protected from heat, light and moisture.

If Lenalidomide reaches its expiration date or if patients are advised to stop taking the medication, they should dispose of it responsibly. Lenalidomide should never be thrown out with regular household waste due to the risk it poses to other people. Patients should contact their physician's office or pharmacist and use a designated medicine disposal service.

Summary

When bone marrow isn't functioning properly, it can cause patients to suffer a wide range of symptoms. As bone marrow is responsible for the production of blood cells, the patient's immune system can weaken as a result of their condition as this can lead to further health complications.

If patients are suffering from anemia caused by myelodysplastic syndrome, multiple myeloma and/or mantle cell lymphoma, Lenalidomide can be used to successfully treat their condition. By affecting the functioning of the immune system, Lenalidomide can increase the production of certain cells and prevent harmful cells from replicating. As a result, existing cancer cells can be destroyed and removed from the body and the patient's immune system is able to function more effectively.