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Reddy-Lenalidomide Patient Medication Information

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PATIENT MEDICATION INFORMATION

READ THIS FOR SAFE AND EFFECTIVE USE OF YOUR MEDICINE

^PrReddy-Lenalidomide
Lenalidomide Capsules

MYELODYSPLASTIC SYNDROMES

Read this carefully before you start taking Reddy-Lenalidomide and each time you get a refill. This leaflet is a summary and will not tell you everything about this drug. Talk to your healthcare professional about your medical condition and treatment and ask if there is any new information about Reddy-Lenalidomide.

Reddy-Lenalidomide can only be given to patients who are registered in and meet all conditions of the Reddy-Lenalidomide RMP program. Reddy-Lenalidomide RMP is a controlled distribution program of Reddy-Lenalidomide.

What is Reddy-Lenalidomide used for?

Reddy-Lenalidomide is used in adults who require blood transfusions due to myelodysplastic syndromes (MDS) with a chromosome problem in which part of chromosome 5 is missing. This type of MDS is known as deletion 5q MDS.

How does Reddy-Lenalidomide work?

It is not known exactly how Reddy-Lenalidomide works. When patients with deletion 5q MDS are treated with Reddy-Lenalidomide, abnormal cells in their bone marrow are often eliminated and replaced by normal-appearing cells. Reddy-Lenalidomide can also stimulate the bone marrow to produce red blood cells. These effects can improve anemia, and reduce or
eliminate the need for transfusions in patients with deletion 5q MDS.

What are the ingredients in Reddy-Lenalidomide?

Medicinal ingredients: lenalidomide
Non-medicinal ingredients: croscarmellose sodium, FD&C blue #2 (10 mg capsule), gelatin, iron oxide yellow (10 mg capsule), magnesium stearate, mannitol, microcrystalline cellulose, povidone, and titanium dioxide.

Reddy-Lenalidomide comes in the following dosage forms:

Capsules: 5 mg, 10 mg

Do not use Reddy-Lenalidomide if:

• you are allergic to lenalidomide, pomalidomide or thalidomide or any of the other ingredients in Reddy-Lenalidomide (see What are the ingredients in Reddy-Lenalidomide?)
• you are pregnant or could become pregnant.
• you are breastfeeding
• you are a male patient and are unable to follow or comply with the birth control measures of the Reddy-Lenalidomide RMP Program
• you have low levels of platelets in your blood

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Reddy-Lenalidomide. Talk about any health conditions or problems you may have, including if you:

• have chronic lymphocytic leukemia (CLL) and are not part of a clinical trial. Reddy-Lenalidomide can cause an increased risk of death in people who have CLL.
• have kidney problems
• have liver problems
• have blood problems
• have or have had heart problems, such as an irregular heartbeat or heart attack
• smoke
• have high blood pressure
• have high cholesterol
• have had a previous viral infection including herpes zoster infection (shingles) and/or hepatitis B virus infection (a viral infection of the liver)
• have had an organ transplant
• are lactose intolerant (Note: Reddy-Lenalidomide does not contain lactose, but other Lenalidomide capsules may contain lactose) or have one of the following rare hereditary diseases:
  • galactose intolerance
  • Lapp lactase deficiency
  • glucose-galactose malabsorption

Other warnings you should know about:

Reddy-Lenalidomide may cause birth defects, stillbirths and spontaneous abortions. In order to take this medicine you must meet the following conditions:

1. Females who can get pregnant:

• Talk to your healthcare professional about the birth control options that are right for you while you are taking Reddy-Lenalidomide.
• You must use at least two effective methods of birth control at the same time.
• Use these two effective methods of birth control:
  • For at least 4 weeks before starting Reddy-Lenalidomide treatment
  • During interruptions of Reddy-Lenalidomide treatment
  • During Reddy-Lenalidomide treatment
  • For at least 4 weeks after stopping Reddy-Lenalidomide treatment
• You must have two negative pregnancy tests before starting treatment:
  • The first 7-14 days prior to starting treatment
  • The second within 24 hours of starting treatment
• You must have negative pregnancy tests during treatment:
  • Once weekly for the first 4 weeks
  • Once every 4 weeks (or once every 2 weeks if your period is irregular) for the duration of your treatment and during treatment interruption
• You must have a final pregnancy test 4 weeks after stopping Reddy-Lenalidomide.

2. Males:

• Reddy-Lenalidomide is present in the sperm of males who take this drug. You must use a condom every time you have sexual intercourse with a woman who is pregnant or can get pregnant. This must be done even if you have undergone a successful vasectomy.
• The condom must be used while:
  • You are taking Reddy-Lenalidomide
  • During interruptions of treatment
  • For 4 weeks after stopping Reddy-Lenalidomide
• Do not donate sperm while taking Reddy-Lenalidomide and for 4 weeks after stopping Reddy-Lenalidomide.
• Inform your sexual partner who can get pregnant that:
  • You are taking Reddy-Lenalidomide
  • There is a risk of birth defects, stillbirths, and spontaneous abortions if a fetus is exposed to your sperm
  • You must use a condom

3. All Patients:

• Reddy-Lenalidomide may cause birth defects, stillbirths and spontaneous abortions and any method of birth control can fail.
• Talk to your healthcare professional immediately if you think you or your female partner may be pregnant.
• Talk to your healthcare professional if you or your female partner misses a period or experiences unusual menstrual bleeding.
• Do not give blood while you take Reddy-Lenalidomide and for 4 weeks after stopping Reddy-Lenalidomide.
• Do not share Reddy-Lenalidomide with other people.
• Do not take Reddy-Lenalidomide if you are not enrolled in or do not meet the requirements of the Reddy-Lenalidomide RMP controlled distribution program.
• You will have regular blood tests during your treatment with Reddy-Lenalidomide. You should have your blood tested every week during your first 8 weeks of treatment, and at least monthly after that. Your healthcare professional may adjust your dose of Reddy-Lenalidomide or interrupt your treatment based on the results of your blood tests and on your general condition.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with Reddy-Lenalidomide:

• digoxin, used to treat heart problems
• medicines containing hormones (estrogens and progestins), such as Hormonal Replacement Therapy and hormonal birth control

How to take Reddy-Lenalidomide:

• Take Reddy-Lenalidomide exactly as prescribed.
• Swallow Reddy-Lenalidomide capsules whole with water once a day. You should try to take it at about the same time each day.
• Do not break, chew, or open your capsules.
• Reddy-Lenalidomide can be taken with or without food.
• Your healthcare professional will decide on the dose that is right for you and how long you will take Reddy-Lenalidomide. Depending on how you respond to treatment they may change your dose. If you don’t respond within 4 months of starting Reddy-Lenalidomide, your healthcare professional may decide to stop the treatment.
• Females who could become pregnant, or who plan to become pregnant can only handle Reddy-Lenalidomide capsules if they are using latex gloves. If someone is helping you with your medication make sure they are aware of this.
• Wash your hands with soap and water after handling Reddy-Lenalidomide capsules.

Usual dose:

Myelodysplastic Syndrome: Starting dose: 10 mg daily on days 1-21 of 28-day cycles.

Overdose:

If you think you, or a person you are caring for, have taken too much Reddy-Lenalidomide, contact a healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms.

Missed Dose:

If less than 12 hours have passed since missing a dose, take the dose. If more than 12 hours have passed since missing a dose, do not take the dose. Take the next dose at the normal time on the following day. Do not take 2 doses at the same time to make up for a missed dose.

What are possible side effects from using Reddy-Lenalidomide?

These are not all the possible side effects you may have when taking Reddy-Lenalidomide. If you experience any side effects not listed here, tell your healthcare professional.

Side effects may include:

• nausea, vomiting, diarrhea
• constipation, gas
• loss of appetite, weight loss
• abdominal pain
• change in taste
• toothache
• itchy skin, red skin
• rash, dry skin
• sensation of pricking, tingling, or creeping on the skin
• increased sweating
• tiredness
• trouble sleeping
• dizziness, fainting
• headache
• joint pain, back pain
• pain in the arms or legs
• muscle cramps, muscle pain
• falls
• hair loss
• ear pain
• dry eye, eye redness, eye pain

Serious Side Effects, How Often They Happen and What To Do About Them

Symptom/Effect		Talk to your healthcare professional		Stop taking drug and get immediate medical help
		Only if severe	In all cases
Very common	Neutropenia (low levels of white blood cells): fever, chills, signs of infection
Very common	Thrombocytopenia (low levels of platelets): bruising, red or purple spots on the skin,cuts bleeding longer than normal, blood in stool or urine, nose bleeds, bleeding gums
Very common	Infections: cough, sore throat, runny nose, sinus pain, headache, fever, chills, difficulty breathing, shortness of breath, difficulty or pain when urinating, urgent need to urinate, redness and swelling around cuts, flu-like symptoms
Very common	Anemia (low levels of red blood cells): fatigue, shortness of breath, pale skin, fast heartbeat, lack of energy, weakness
Very common	Acute leukemia: pale skin, fatigue, shortness of breath, infections, unusual bleeding, bruising, fever, night sweats, bone and joint pain
Very common	Pancytopenia (low levels of platelets, red and white blood cells): bruising, red or purple spots on the skin, cuts bleeding longer than normal, blood in stool or urine, nose bleeds, bleeding gums, shortness of breath, pale skin, fast heartbeat, lack of energy, weakness, fever, chills, signs of infection
Very common	Pulmonary embolism (blood clot in or around the lungs): coughing up blood, sharp pain in chest, or sudden shortness of breath
Very common	Lung problems (pleural effusion, pulmonary hypertension, pulmonary edema): cough, chest pain, shortness of breath, difficult or painful breathing, wheezing
Very common	Heart failure (heart does not pump blood as well as it should): shortness of breath, fatigue and weakness, swelling in ankles, legs and feet, cough, fluid retention, lack of appetite, nausea, rapid or irregular heartbeat, reduced ability to exercise
Common	Hyponatremia (low levels of sodium in the blood): nausea, vomiting, headache, confusion, restlessness, muscle cramps, seizures
Common	Hypokalemia (low levels of potassium in the blood): muscle weakness, lack of strength, irregular heartbeat
Common	Edema: swelling of the hands or feet
Common	Kidney problems (including kidney failure): decreased urination or lack of urination, blood in the urine, nausea, vomiting, swelling of the arms or legs, fatigue
Common	Deep vein thrombosis (blood clot in the arm or leg): swelling, pain, arm or leg may be warm to the touch and may appear red
Common	High blood pressure: headache, chest pain, vision problems, ringing in the ears
Common	Heart problems: heart palpitations, abnormal or irregular heartbeats, chest pain
Common	Stroke: sudden severe headache or vomiting, dizziness or fainting, disturbances of vision or speech, weakness or numbness in an arm or leg
Common	Heart attack: sudden pain, discomfort, pressure, heaviness, sensation of squeezing or fullness in the shoulder, chest, arm, or below the breastbone; discomfort radiating to the back, jaw, throat, arm, stomach, feeling of being full, having indigestion or choking; sweating, nausea, vomiting or dizziness; extreme weakness, anxiety, or shortness of breath; rapid or irregular heartbeat
Common	Mental health problems: having physical symptoms but originating from mental or emotional causes, confusion, depression
Common	Dehydration: dry mouth, excessive thirst, dark yellow urine
Common	Angioedema: rapid swelling of the skin, face, eyes, mouth and lips, stomach cramps, trouble breathing
Common	Difficulty swallowing
Rare	Severe skin reactions (Stevens-Johnson Syndrome [SJS], Toxic Epidermal Necrolysis [TEN], Drug reaction with eosinophilia and systemic symptoms [DRESS]): severe skin peeling, scaling or blistering which may affect the mouth, eyes, nose or genitals, itching, severe rash, swelling and redness of the eyes or face, flulike feeling, fever, chills, body aches, swollen lymph nodes, cough, yellow skin or eyes, chest pain or discomfort, feeling thirsty, urinating less often, less urine or dark urine
Rare	Tumor lysis syndrome: lack of urination, severe muscle weakness, heart rhythm disturbances, seizures
Rare	Tumor flare reaction: tender swollen lymph nodes, low-grade fever, pain, rash
Rare	Graft-versus-host disease following transplant (days/months): itchy and/or painful rash, diarrhea, abdominal pain, yellowing of the skin or whites of the eyes
Rare	Thyroid problems: Low thyroid hormone: fatigue, increased sensitivity to cold, constipation, dry skin, unexplained weight gain, puffy face, muscle weakness, slow heart rate, thinning hair, impaired memory High thyroid hormone: anxiety or nervousness, weight loss, frequent and loose bowel movements, breathlessness, feeling hot, feelings of having rapid, fluttering or pounding heart
Rare	Allergic reaction: rapid swelling of the skin, face and lips, tongue, trouble breathing or swallowing, severe rash, itching, hives, fainting, very rapid heartbeat
Very Rare	Reactivation of viral infections: herpes zoster (shingles): painful skin rash with blisters hepatitis B (inflammation of the liver): itchy skin, yellowing of the skin or whites of eyes, fever, tiredness, joint/muscle pain, loss of appetite, nausea and vomiting, pain in the upper right abdomen, pale stools and dark urine
Very Rare	Rhabdomyolysis: muscle pain that you cannot explain, muscle tenderness or weakness, dark urine
Unknown	Organ transplant rejection: flu- like symptoms (fever, chill, body ache, nausea, cough, shortness of breath, feeling unwell or tired), pain at the area of the transplant, less urine, sudden weight gain
Unknown	Progressive multifocal leukoencephalopathy: vision changes, difficulty speaking, weakness in limbs, change in the way you walk or balance, persistent numbness, decreased or loss sensation, memory loss or confusion
Unknown	Liver problems: yellowing of the skin or whites of eyes, fever, tiredness, joint/muscle pain, loss of appetite, nausea and vomiting, pain in the upper right abdomen, pale stools and dark urine

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Storage:

Store Reddy-Lenalidomide at 15-30° C. Keep out of the reach and sight of children. Contact Reddy-Lenalidomide RMP to return any unused Reddy-Lenalidomide capsules.

If you want more information about Reddy-Lenalidomide:

• Talk to your healthcare professional.
• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: https://www.canada.ca/en/health-canada/services/drugs-health-products/drugproducts/drug- product-database.html; the manufacturer’s website (www.drreddys.com) or by calling 1-855-845-1739.

This leaflet was prepared by Dr. Reddy’s Laboratories Ltd.

Last Revised: April 25, 2023

PATIENT MEDICATION INFORMATION

READ THIS FOR SAFE AND EFFECTIVE USE OF YOUR MEDICINE

^PrReddy-Lenalidomide
Lenalidomide Capsules

MULTIPLE MYELOMA

Read this carefully before you start taking Reddy-Lenalidomide and each time you get a refill. This leaflet is a summary and will not tell you everything about this drug. Talk to your healthcare professional about your medical condition and treatment and ask if there is any new information about Reddy-Lenalidomide.

Reddy-Lenalidomide can only be given to patients who are registered in and meet all conditions of the Reddy-Lenalidomide RMP program. Reddy-Lenalidomide RMP is a controlled distribution program of Reddy-Lenalidomide.

What is Reddy-Lenalidomide used for?

Reddy-Lenalidomide is used with dexamethasone to treat adult patients with multiple myeloma who are not eligible for stem cell transplant. Multiple myeloma is a cancer of plasma cells. Plasma cells are found in the bone marrow. Plasma cells produce a protein called antibodies. Some antibodies can attack and kill disease causing germs. Patients with this type of cancer may have low blood cell counts and immune problems giving them a higher chance for getting infections such as pneumonia. The bones can be affected leading to bone pain and breaks (fractures).

How does Reddy-Lenalidomide work?

Reddy-Lenalidomide works in multiple ways within the bone marrow to stop or slow the growth of cancerous myeloma cells.

What are the ingredients in Reddy-Lenalidomide?

Medicinal ingredients: lenalidomide
Non-medicinal ingredients: croscarmellose sodium, FD&C blue #2 (2.5 mg, 10 mg, 15 mg, 20 mg capsules), gelatin, iron oxide yellow (2.5 mg, 10 mg, 20 mg capsules), magnesium stearate, mannitol, microcrystalline cellulose, povidone, and titanium dioxide.

Reddy-Lenalidomide comes in the following dosage forms:

Capsules: 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, 25 mg.

Do not use Reddy-Lenalidomide if:

• you are allergic to lenalidomide, pomalidomide or thalidomide or any of the other ingredients in Reddy-Lenalidomide (see What are the ingredients in Reddy-Lenalidomide?)
• you are pregnant or could become pregnant.
• you are breastfeeding
• you are a male patient and are unable to follow or comply with the birth control measures of the Reddy-Lenalidomide RMP Program
• you have low levels of platelets in your blood

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Reddy-Lenalidomide. Talk about any health conditions or problems you may have, including if you:

• have chronic lymphocytic leukemia (CLL) and are not part of a clinical trial. Reddy-Lenalidomide can cause an increased risk of death in people who have CLL.
• have kidney problems
• have liver problems
• have blood problems
• have or have had heart problems, such as an irregular heartbeat or heart attack
• smoke
• have high blood pressure
• have high cholesterol
• have had a previous viral infection including herpes zoster infection (shingles) and/or hepatitis B virus infection (a viral infection of the liver)
• have had an organ transplant
• are lactose intolerant (Note: Reddy-Lenalidomide does not contain lactose, but other Lenalidomide capsules may contain lactose) or have one of the following rare hereditary diseases:
  • galactose intolerance
  • Lapp lactase deficiency
  • glucose-galactose malabsorption

Other warnings you should know about:

Reddy-Lenalidomide may cause birth defects, stillbirths and spontaneous abortions. In order to take this medicine you must meet the following conditions:

1. Females who can get pregnant:

• Talk to your healthcare professional about the birth control options that are right for you while you are taking Reddy-Lenalidomide.
• You must use at least two effective methods of birth control at the same time.
• Use these two effective methods of birth control:
  • For at least 4 weeks before starting Reddy-Lenalidomide treatment
  • During interruptions of Reddy-Lenalidomide treatment
  • During Reddy-Lenalidomide treatment
  • For at least 4 weeks after stopping Reddy-Lenalidomide treatment
• You must have two negative pregnancy tests before starting treatment:
  • The first 7-14 days prior to starting treatment
  • The second within 24 hours of starting treatment
• You must have negative pregnancy tests during treatment:
  • Once weekly for the first 4 weeks
  • Once every 4 weeks (or once every 2 weeks if your period is irregular) for the duration of treatment and during treatment interruption
• You must have a final pregnancy test 4 weeks after stopping Reddy-Lenalidomide.

2. Males:

• Reddy-Lenalidomide is present in the sperm of males who take this drug. Use a condom every time you have sexual intercourse with a woman who is pregnant or can get pregnant. This must be done even if you have undergone a successful vasectomy. The condom must be used while:
  • You are taking Reddy-Lenalidomide
  • During interruptions of treatment
  • For 4 weeks after stopping Reddy-Lenalidomide
• Do not donate sperm while taking Reddy-Lenalidomide and for 4 weeks after stopping Reddy-Lenalidomide.
• Inform your sexual partner who can get pregnant that:
  • You are taking Reddy-Lenalidomide
  • There is a risk of birth defects, stillbirths, and spontaneous abortions if a fetus is exposed to your sperm
  • You must use a condom

3. All Patients:

• Reddy-Lenalidomide may cause birth defects, stillbirths and spontaneous abortions and any method of birth control can fail.
• Talk to your healthcare professional immediately if you think you or your female partner may be pregnant.
• Talk to your healthcare professional if you or your female partner misses a period or experiences unusual menstrual bleeding.
• Do not give blood while you take Reddy-Lenalidomide and for 4 weeks after stopping Reddy-Lenalidomide.
• Do not share Reddy-Lenalidomide with other people.
• Do not take Reddy-Lenalidomide if you are not enrolled in or do not meet the requirements of the Reddy-Lenalidomide RMP controlled distribution program.
• You will have regular blood tests during your treatment with Reddy-Lenalidomide. You should have your blood tested once every week during the first 2 cycles (8 weeks) of treatment, every 2 weeks during the third cycle, and at least monthly after that. Your healthcare professional may adjust your dose of Reddy-Lenalidomide or interrupt your treatment based on the results of your blood tests and on your general condition.
• Second cancers such as skin cancers, blood cancers, and solid tumor cancers have been reported in a small number of patients while taking Reddy-Lenalidomide or after treatment with Reddy-Lenalidomide is completed. Talk to your healthcare professional if you have any concerns about your increased risk of having other cancers.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with Reddy-Lenalidomide:

• digoxin, used to treat heart problems
• medicines containing hormones (estrogens and progestins), such as Hormonal Replacement Therapy and hormonal birth control

How to take Reddy-Lenalidomide:

• Take Reddy-Lenalidomide exactly as prescribed.
• Swallow Reddy-Lenalidomide capsules whole with water once a day. You should try to take it at about the same time each day.
• Do not break, chew, or open your capsules.
• Reddy-Lenalidomide can be taken with or without food.
• Your healthcare professional will decide on the dose that is right for you and how long you will take Reddy-Lenalidomide. Depending on how you respond to treatment they may change your dose.
• Females who could become pregnant, or who plan to become pregnant can only handle Reddy-Lenalidomide capsules if they are using latex gloves. If someone is helping you with your medication make sure they are aware of this.
• Wash your hands with soap and water after handling Reddy-Lenalidomide capsules.

Usual dose:

Multiple Myeloma: Starting dose: 25 mg daily on days 1-21 of 28 day cycles in combination with dexamethasone.

Missed Dose:

If less than 12 hours have passed since missing a dose, take the dose. If more than 12 hours have passed since missing a dose, do not take the dose. Take the next dose at the normal time on the following day. Do not take 2 doses at the same time to make up for a missed dose.

What are possible side effects from using Reddy-Lenalidomide?

These are not all the possible side effects you may have when taking Reddy-Lenalidomide. If you
experience any side effects not listed here, tell your healthcare professional.

Side effects may include:

• nausea, vomiting, diarrhea
• constipation, hard stool, gas
• change in appetite, change in weight
• abdominal pain
• mouth sores, mouth pain or swelling
• heartburn
• hiccups
• change in taste
• toothache
• hoarse voice
• itchy skin, red skin
• rash, skin discolouration
• increased sweating
• hot flashes
• tiredness/lethargy
• trouble sleeping
• dizziness, fainting
• headache
• nervousness, irritability
• general feeling of discomfort or uneasiness
• joint pain, back pain
• bone pain
• pain in the arms or legs
• muscle cramps, muscle pain
• falls
• hair loss
• hearing loss
• dry eye, eye redness, eye pain or itching
• eye tearing
• cloudy or blurred vision
• decreased sex drive

Serious Side Effects, How Often They Happen and What To Do About Them

Symptom/Effect		Talk to your healthcare professional		Stop taking drug and get immediate medical help
		Only if severe	In all cases
Very common	Neutropenia (low levels of white blood cells): fever, chills, signs of infection
Very common	Hypokalemia (low levels of potassium in the blood) Hypophosphatemia (low levels of phosphate in the blood): muscle weakness, lack or loss of strength
Very common	Anemia (low levels of red blood cells): fatigue, shortness of breath, pale skin, fast heartbeat, lack of energy, weakness
Very common	Thrombocytopenia (low levels of platelets): bruising, red or purple spots on the skin, cuts bleeding longer than normal, blood in stool or urine, nose bleeds, bleeding gums
Very common	Infections: cough, sore throat, runny or stuffy nose, headache, fever, chills, difficulty breathing, shortness of breath, difficulty or pain when urinating, urgent need to urinate, redness and swelling around cuts, flulike symptoms
Very common	Deep vein thrombosis (blood clot in the arm or leg): swelling, pain, arm or leg may be warm to the touch and may appear red
Very common	Hypocalcaemia (low levels of calcium in the blood): “pins and needles” in hands and feet, muscle spasms
Common	Hyperglycemia (high blood sugar): frequent hunger, excessive thirst or urination
Common	Pulmonary embolism (blood clot in or around the lungs): coughing up blood, sharp pain in chest, or sudden shortness of breath
Common	Lung problems (pulmonary edema): cough, chest pain, shortness of breath, difficult or painful breathing, wheezing
Common	Heart failure (heart does not pump blood as well as it should): shortness of breath, fatigue and weakness, swelling in ankles, legs and feet, cough, fluid retention, lack of appetite, nausea, rapid or irregular heartbeat, reduced ability to exercise
Common	Hypotension (low blood pressure): lightheadedness, dizziness or fainting
Common	Heart problems: heart palpitations, abnormal or irregular heartbeats, chest pain
Common	Nervous system problems: depression, mood changes, confusion, memory impairment, trouble with balance, walking abnormally, mental status changes, non-coordinated muscle movement
Common	Neuropathy (a disease of the nerves): numbness, abnormal sensations, reduced sense of touch
Common	High blood pressure: headache, chest pain, vision problems, ringing in the ears
Common	Dehydration: dry mouth, excessive thirst, dark yellow urine
Common	Angioedema: rapid swelling of the skin, face, eyes, mouth and lips, stomach cramps, trouble breathing
Common	Heart attack: sudden pain, discomfort, pressure, heaviness, sensation of squeezing or fullness in the shoulder, chest, arm, or below the breastbone; discomfort radiating to the back, jaw, throat, arm, stomach, feeling of being full, having indigestion or choking; sweating, nausea, vomiting or dizziness; extreme weakness, anxiety, or shortness of breath; rapid or irregular heartbeat
Common	Stroke: sudden severe headache or vomiting, dizziness or fainting, disturbances of vision or speech, weakness or numbness in an arm or leg
Common	Kidney problems (including kidney failure): decreased urination or lack of urination, blood in the urine, nausea, vomiting, swelling of the arms or legs, fatigue
Rare	Severe skin reactions (Stevens- Johnson Syndrome [SJS], Toxic Epidermal Necrolysis [TEN], Drug reaction with eosinophilia and systemic symptoms [DRESS]): severe skin peeling, scaling or blistering which may affect the mouth, eyes, nose or genitals, itching, severe rash, swelling and redness of the eyes or face, flu-like feeling, fever, chills, body aches, swollen lymph nodes, cough, yellow skin or eyes, chest pain or discomfort, feeling thirsty, urinating less often, less urine or dark urine
Rare	Tumor lysis syndrome: lack of urination, severe muscle weakness, heart rhythm disturbances, seizures
Rare	Tumor flare reaction: tender swollen lymph nodes, low-grade fever, pain, rash
Rare	Graft-versus-host disease following transplant (days/months): itchy and/or painful rash, diarrhea, abdominal pain, yellowing of the skin or whites of the eyes
Rare	Thyroid problems: Low thyroid hormone: fatigue, increased sensitivity to cold, constipation, dry skin, unexplained weight gain, puffy face, muscle weakness, slow heart rate, thinning hair, impaired memory High thyroid hormone: anxiety or nervousness, weight loss, frequent and loose bowel movements, breathlessness, feeling hot, feelings of having rapid, fluttering or pounding heart
Rare	Allergic reaction: rapid swelling of the skin, face and lips, tongue, trouble breathing or swallowing, severe rash, itching, hives, fainting, very rapid heartbeat
Very Rare	Reactivation of viral infections: herpes zoster (shingles): painful skin rash with blisters hepatitis B (inflammation of the liver): itchy skin, yellowing of the skin or whites of eyes, fever, tiredness, joint/muscle pain, loss of appetite, nausea and vomiting, pain in the upper right abdomen, pale stools and dark urine
Very Rare	Rhabdomyolysis: muscle pain that you cannot explain, muscle tenderness or weakness, dark urine
Unknown	Organ transplant rejection: flu-like symptoms (fever, chill, body ache, nausea, cough, shortness of breath, feeling unwell or tired), pain at the area of the transplant, less urine, sudden weight gain
Unknown	Progressive multifocal leukoencephalopathy: vision changes, difficulty speaking, weakness in limbs, change in the way you walk or balance, persistent numbness, decreased or loss sensation, memory loss or confusion
Unknown	Difficulty swallowing
Unknown	Liver problems: yellowing of the skin or whites of eyes, fever, tiredness, joint/muscle pain, loss of appetite, nausea and vomiting, pain in the upper right abdomen, pale stools and dark urine

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Storage:

Store Reddy-Lenalidomide at 15-30° C. Keep out of the reach and sight of children. Contact Reddy-Lenalidomide RMP to return any unused Reddy-Lenalidomide capsules.

If you want more information about Reddy-Lenalidomide:

• Talk to your healthcare professional.
• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: https://www.canada.ca/en/health-canada/services/drugs-health-products/drugproducts/drug-product-database.html; the manufacturer’s website (www.drreddys.com) or by calling 1-855-845-1739.

This leaflet was prepared by Dr. Reddy’s Laboratories Ltd.

Last Revised: April 25, 2023