Cipla Lenalidomide

WARNING: Lenalidomide is structurally related to ‘thalidomide’, which is known to cause severe life-threatening human birth defects (deformed babies) and death to an unborn baby if taken during pregnancy. If lenalidomide is taken during pregnancy, it may cause birth defects or death to an unborn baby. Do not take lenalidomide if you are pregnant or think that you are pregnant.

Cipla Lenalidomide

Active ingredient(s): lenalidomide

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Consumer Medicine Information (CMI)

This leaflet provides important information about using Cipla Lenalidomide. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using Cipla Lenalidomide.

Where to find information in this leaflet:

1. Why am I using Cipla Lenalidomide?
2. What should I know before I use Cipla Lenalidomide?
3. What if I am taking other medicines?
4. How do I use Cipla Lenalidomide?
5. What should I know while using Cipla Lenalidomide?
6. Are there any side effects?
7. Product details

1. Why am I using Cipla Lenalidomide?

Cipla Lenalidomide contains the active ingredient lenalidomide. Cipla Lenalidomide belongs to a group of medicines called immunomodulating agents that work by acting on the cells involved in the body’s immune system. The immune system is part of the body’s defence which helps to fight illness and infection.

Cipla Lenalidomide is used for the treatment of Multiple Myeloma.

• Multiple myeloma (MM) is a cancer of the bone marrow.

Cipla Lenalidomide is also used for the treatment of Myelodysplastic Syndromes

• Myelodysplastic syndromes (MDS) are a condition where the bone marrow does not produce enough mature blood cells. This causes a lack of healthy blood cells in the body. There are different types of MDS.

Cipla Lenalidomide is approved to treat a type of MDS where part of chromosome 5 is missing. This type of MDS is known as deletion 5q MDS (or 5q minus). Patients with this type of MDS often have low red blood cell counts that require treatment with blood transfusions. It is hoped that the use of Cipla Lenalidomide will reduce the need for blood transfusions.

Cipla Lenalidomide is used for the treatment of Mantle Cell Lymphoma (MCL)

Cipla Lenalidomide is used to treat adult patients who have been diagnosed with and previously treated for Mantle Cell Lymphoma (MCL).

MCL is a cancer of the lymph tissue (part of the immune system), affecting a type of white blood cell called ‘B-lymphocytes’. MCL is a disease where B-cells grow in an uncontrolled way and accumulate in the lymph tissue, bone marrow or blood.

Ask your doctor if you have any questions about how Cipla Lenalidomide works, or why this medicine has been prescribed for you.

Cipla Lenalidomide will only be prescribed to you by a doctor who has experience in medicines to treat cancers of bone marrow and blood.

2. What should I know before I use Cipla Lenalidomide?

Warnings

Please read the Consumer Medicine Information leaflets of any medicinal products to be taken in combination with Cipla Lenalidomide before starting treatment with Cipla Lenalidomide.

Do not use Cipla Lenalidomide if:

• you are allergic to lenalidomide, or any of the ingredients listed at the end of this leaflet.
  Some of the symptoms of an allergic response may include:
  – shortness of breath
  – wheezing or difficulty breathing
  – swelling of the face, lips, tongue or other parts of the body
  – rash, itching or hives on the skin.
  Always check the ingredients to make sure you can use this medicine.
• you are able to become pregnant, unless you are willing to follow the required pregnancy prevention measures (outlined in Cipla Lenalidomide-Pregnancy Prevention Program).
  Cipla Lenalidomide may cause birth defects (deformed babies), and may affect your developing baby if you take it during pregnancy.
• you have the rare hereditary problems of glucose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption, as Cipla Lenalidomide contains lactose.
• Do not give this medicine to a child or adolescent under the age of 18 years.
  Safety and effectiveness in children younger than 18 years have not been established.

Check with your doctor if you:

• have any other medical conditions.
• have had a heart attack, blood clots, high blood pressure or high cholesterol
• have frequent bleeding or bruising
• have frequent infections
• have Hepatitis B virus infection
• have peripheral neuropathy (numbness, tingling, weakness, abnormal co-ordination or pain in your hands or feet)
• have thyroid problems
• have abnormal kidney function
• have liver problems e.g. liver infections
• have allergic reactions to thalidomide, pomalidomide or lenalidomide.

If you have not told your doctor about any of the above, tell him/her before you start taking Cipla Lenalidomide.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Follow your doctor’s instructions carefully.

You will have been given specific instructions by your doctor particularly on the potential effects of lenalidomide on unborn babies.

If you have not fully understood these instructions, ask your doctor again before taking Cipla Lenalidomide.

Your doctor will have enrolled you in the Cipla Lenalidomide-Pregnancy Prevention Program to ensure that lenalidomide is used safely.

THE CIPLA LENALIDOMIDE-PREGNANCY PREVENTION PROGRAM

Cipla Lenalidomide (lenalidomide) is structurally related to ‘thalidomide’, which is known to cause severe life-threatening human birth defects (deformed babies) and can cause death to an unborn baby if taken during pregnancy. If Cipla Lenalidomide is taken during pregnancy, it may cause birth defects or death of an unborn baby.

To avoid exposure to unborn babies, Cipla Lenalidomide has restricted availability under a Pregnancy Prevention Program (Cipla Lenalidomide-Pregnancy Prevention Program). This program is designed to ensure that this medicine is always prescribed and taken in the recommended way. Importantly, only patients who are formally enrolled in this program and agree to fully comply with all the requirements of this program can receive Cipla Lenalidomide.

Some of the requirements of the Cipla Lenalidomide – Pregnancy Prevention Program are outlined in the following sections. Your doctor will discuss all the details with you.

FOR WOMEN TAKING CIPLA LENALIDOMIDE

Before starting this treatment, your doctor will discuss your potential to become pregnant, even if you think this is unlikely e.g. if your periods have stopped.

If you are able to become pregnant:

• Your doctor will discuss the potential risk to unborn babies if Cipla Lenalidomide is taken during pregnancy.
• You will be required to have pregnancy tests before treatment, every 4 weeks during treatment, and 4 weeks after stopping treatment.
• You should start your Cipla Lenalidomide treatment as soon as you get it from the pharmacy following a negative pregnancy test.
• Use a reliable means of contraception for at least 4 weeks before starting Cipla Lenalidomide treatment, during treatment and treatment interruption, and for at least 4 weeks after Cipla Lenalidomide treatment has stopped.

Your doctor will tell you what method of contraception to use.

Effective methods of contraception include the following:

• Implant
• Levonorgestrel-releasing intrauterine system (IUS)
• Medroxyprogesterone acetate depot injection
• Tubal sterilisation
• Sexual intercourse with a vasectomised male partner only; vasectomy must be confirmed by two negative semen analyses
• Ovulation inhibitory progesterone-only pills (i.e. desogestrel).

Combined oral contraceptive pills are not recommended as they can increase the risk of blood clots blocking blood vessels in patients with MM being treated with this medicine.

You must stop taking Cipla Lenalidomide and tell your doctor straight away if:

• You miss or think you have missed a period, or you have unusual menstrual bleeding, or suspect you are pregnant.
• You have heterosexual intercourse without using reliable means of contraception.

Discuss with your doctor if you should breast-feed whilst taking this medicine.

It is not known if Cipla Lenalidomide is excreted in human milk. Therefore, you should discuss with your doctor whether to stop breast-feeding while you are receiving this medicine.

FOR MEN TAKING CIPLA LENALIDOMIDE

Before starting this treatment, discuss with your doctor if your partner is able to become pregnant.

If your partner is able to become pregnant, use barrier methods of contraception (e.g. condoms) even if you are vasectomised, during Cipla Lenalidomide treatment, during treatment interruption, and for at least 7 days after treatment has stopped.

Tell your doctor immediately if your partner becomes pregnant whilst you are taking this medicine.

Do not donate semen during treatment or during treatment interruption, or for 7 days after stopping treatment.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines may interfere with Cipla Lenalidomide and affect how it works. e.g.

• medicines used to prevent pregnancy, such as oral contraceptives
• medicines used to treat symptoms of menopause e.g. hormone replacement therapy
• medicines used for heart problems e.g. digoxin
• medicines used to thin the blood e.g. warfarin.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect Cipla Lenalidomide.

4. How do I use Cipla Lenalidomide?

Follow all directions given to you by your doctor carefully.

They may differ from the information contained in this leaflet.

How much to take

Your doctor will tell you how much Cipla Lenalidomide to take and for how long you will need to take it.

• Your doctor will monitor your progress and may adjust your dose of Cipla Lenalidomide or stop your treatment based on the results of your regular blood tests and on your general condition.
• If you are older than 65 years, in addition to these blood tests, your doctor may also check your kidney function with other tests.
• Follow the instructions provided and use Cipla Lenalidomide until your doctor tells you to stop.

When to take Cipla Lenalidomide

• Take your medicine either one hour before or two hours after eating food.

How to take Cipla Lenalidomide

• Swallow the capsules whole, preferably with water, once a day as directed by your doctor.
• Do not open, break or chew the capsules.
• If powder from inside the capsules leaks out and contacts the skin, wash the skin immediately and thoroughly with soap and water. If lenalidomide contacts the mucous membranes e.g. the eyes, flush thoroughly with water.

If you forget to use Cipla Lenalidomide

Cipla Lenalidomide should be used regularly at the same time each day. If you miss your dose at the usual time and if it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.

Do not take a double dose to make up for the dose you missed.

• If it is less than 12 hours before your next dose, skip the dose you missed and take the next dose when you are meant to. Otherwise, take it as soon as you remember, and then go back to taking your medicine as you would normally.
• If you are not sure what to do, ask your doctor or pharmacist.
• If you have trouble remembering when to take your medicine, ask your pharmacist for some hints.

If you use too much Cipla Lenalidomide

If you think that you have used too much Cipla Lenalidomide, you may need urgent medical attention.

You should immediately:

• phone the Poisons Information Centre
  (by calling 13 11 26), or
• contact your doctor, or
• go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

5. What should I know while using Cipla Lenalidomide?

Things you should do

Remind any doctor, dentist or pharmacist you visit that you are taking Cipla Lenalidomide.

• Your doctor will ask you to have regular blood tests and will check your general condition to make sure the medicine is working and to prevent unwanted side effects.
• Continue taking Cipla Lenalidomide as instructed by your doctor, until your doctor tells you to stop. Your doctor will keep a close check on you to make sure you continue to benefit from Cipla Lenalidomide

Keep all of your doctor’s appointments so that your progress can be checked.

Call your doctor straight away if you:

• become pregnant or suspect that you may be pregnant. You should also immediately stop taking Cipla Lenalidomide in this case.

Things you should not do

• Do not donate blood during treatment or treatment interruption, or for at least 1 week after stopping treatment.
  In Australia, patients with some types of cancer are permanently excluded from donating blood.
• Do not stop taking Cipla Lenalidomide (unless you suspect that you are pregnant) or change the dose without first checking with your doctor.
• Do not let yourself run out of medicine over the weekend or on holidays.

FEMALE PATIENTS:

• Do not become pregnant whilst taking Cipla Lenalidomide.
• Do not have sexual intercourse without using effective means of contraception described to you by your doctor.

MALE PATIENTS:

• Do not donate sperm during treatment or treatment interruption, or for at least 7 days after stopping treatment.
  Cipla Lenalidomide can pass into human semen.
• Do not have sexual intercourse without using effective means of contraception described to you by your doctor.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how Cipla Lenalidomide affects you.

Cipla Lenalidomide may cause dizziness, tiredness or blurred vision in some people. If you have any of these symptoms, do not drive, operate machinery or do anything else that could be dangerous.

Drinking alcohol

Tell your doctor if you drink alcohol.

Looking after your medicine

• Keep your capsules in a cool dry place where the temperature stays below 25°C.
• Keep your capsules in the original package until it is time to take them.
• A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Follow the instructions in the carton on how to take care of your medicine properly.

Store it in a cool dry place away from moisture, heat or sunlight; for example, do not store it:

• in the bathroom or near a sink, or
• in the car or on window sills.

Keep it where young children cannot reach it.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date.

Do not throw the medicine out in the rubbish or flush it down the sink or toilet. These measures will help to protect the environment.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Less serious side effects

Less serious side effects

What to do

Diarrhoea; constipation; feeling sick (also called nausea); vomiting; stomach pain; indigestion, dehydration; dry mouth; sore mouth: mouth ulcers: difficulty in speaking, toothache; increase or decrease in weight; increase or decrease in appetite; loss of taste. Itchiness; rash; redness of the skin; dry skin; bruising; excessive sweating. dizziness; fainting; headache; shaking or tremors; unusual weakness; night sweats; reduced sense of touch. difficulty sleeping; depression; anxiety; feeling of confusion. back pain; muscle spasms; muscle and/or joint pain; swollen joints; bone pain; muscular weakness; pain in the extremities, feeling tired; fall. swelling of hands, ankles or feet.

Speak to your doctor if you have any of these less serious side effects and they worry you.

Serious side effects

Serious side effects

What to do

Shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, mouth, tongue or other parts of the body; rash, itching or hives on the skin. These could be symptoms of an allergic reaction. Severe blisters and bleeding in the lips, eyes, mouth, nose and genitals; painful red area on the skin that spreads quickly; peeling of the skin. You may have a high temperature, chills and muscle ache at the same time. These could be due to rare but severe skin reactions such as Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis and Drug Reaction with Eosinophilia and Systemic Symptoms. Blurred vision; severe headache; weakness or numbness in the face, arm or leg; trouble speaking or understanding; loss of balance. This may be due to a stroke which could be a result of blood clots in the blood vessels of your brain. Sudden pain in your chest or difficulty in breathing. This may be due to a heart attack or blood clots in the artery leading to your lungs. These blood clots can happen during treatment, or after treatment has stopped. Chest pain, severe weakness, rapid or irregular heartbeat, and/or sudden, severe shortness of breath and coughing up pink, foamy mucus. This could be due to heart failure, a condition where the heart muscle cannot pump blood strongly enough to supply blood throughout the body. Pain or swelling in your legs, especially in your lower leg or calves. This may be due to blood clots in the veins of your leg. These can happen during treatment, or after treatment has stopped. Fever; severe chills; decreased urination; rapid pulse; rapid breathing; confusion; nausea; vomiting; diarrhoea; pain or burning when you urinate; hacking cough; phlegm; sore mouth or throat; flu-like symptoms; feeling of tension in the nose, cheeks and behind your eyes; or mouth ulcers. These could symptoms of sepsis (blood infection) or other serious infections such as pneumonia. Passing little or no urine; drowsiness; nausea; vomiting; or breathlessness. These could be symptoms of kidney disease. Abdominal pain, dark urine, fever, joint pain, loss of appetite, nausea and vomiting, yellowing of the skin and/or eyes. These are symptoms of liver failure, which in some cases, may be due to Hepatitis B virus infection. Some cases of Hepatitis B virus infection may not result in symptoms initially. Heart palpitations or fast heart beat, chest pains, dizziness or fainting, shortness of breath, weakness, or reduced ability to exercise. These could be symptoms of atrial fibrillation (irregular heart beat) or tachycardia (fast heart beat). Bleeding (including nose-bleeds) or bruising more easily than normal. Cipla Lenalidomide can reduce the number of platelets, which are responsible for making the blood clot properly. Your doctor may monitor your blood cell numbers during treatment with cipla lenalidomide. Tiredness, headaches, shortness of breath, dizziness and looking pale. Cipla Lenalidomide can reduce the number of red blood cells that carry oxygen around the body. Numbness, tingling, pins and needles or weakness of the arms and legs. This may be due to nerve damage. Blurred vision or difficulty seeing. This could be due to a cataract in your eye(s). Passing large amounts of urine, excessive thirst, and having a dry mouth and skin. These could be symptoms of high blood sugar or diabetes. Abnormal eye movements, convulsions, mood changes or irregular heart rhythms. These could be due to low levels of minerals such as potassium, calcium, magnesium or sodium. Tender swollen lymph nodes, low-grade fever, pain, or rash. This could be due to worsening of your tumour (for patients with MCL).

Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects. Tell your doctor immediately if you notice any of these serious side effects:

Some side effects (for example, changes in thyroid function, or blood pressure) can only be found when your doctor does tests from time to time to check your progress.

It is important to note that a small number of patients with MM may develop additional types of cancer (regardless of their type of therapy). It is not known if Cipla Lenalidomide increases this risk. Therefore, your doctor will carefully evaluate the benefit and risk when you are using this medicine.

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available with a doctor’s prescription.

What Cipla Lenalidomide contains

Active ingredient (main ingredient)

Lenalidomide

Other ingredients (inactive ingredients)

lactose microcrystalline cellulose croscarmellose sodium magnesium stearate. The capsule shells contain gelatin and titanium dioxide, and some strengths contain additional colours: 10 mg capsules: indigo carmine aluminium lake and iron oxide yellow 15 mg capsules; indigo carmine aluminium lake 20 mg capsules: indigo carmine aluminium lake and iron oxide yellow. The black printing ink contains shellac ethanol absolute isopropyl alcohol butan-1-ol; propylene glycol purified water strong ammonia solution potassium hydroxide black iron oxide (E172).

Do not take this medicine if you are allergic to any of these ingredients.

What Cipla Lenalidomide looks like

Cipla Lenalidomide 5 mg capsules are size ‘2’ hard gelatin white and white capsule with ‘Cipla 5 mg’ printed in black on the cap (AUST R 307042).

Cipla Lenalidomide 10 mg capsules are size ‘0’ hard gelatin blue green and pale yellow capsule with ‘Cipla 10 mg’printed in black on the cap (AUST R 307043).

Cipla Lenalidomide 15 mg capsules are size ‘0’ hard gelatin pale blue and white capsule with ‘Cipla 15 mg’ printed in black on the cap (AUST R 307063).

Cipla Lenalidomide 20 mg capsules are size ‘0’ hard gelatin blue green and pale blue capsule with ‘Cipla 20 mg’ printed in black on the cap (AUST R 307064).

Cipla Lenalidomide 25 mg capsules are size ‘0’ hard gelatin white and white capsule with ‘Cipla 25 mg’ printed in black on the cap (AUST R 307065).

The capsules are provided in packs. Each pack contains three blisters, each with seven capsules, giving a total of fourteen (14), twenty-one (21) and twenty eight (28) capsules per pack. Some strengths of Cipla Lenalidomide may not be available as not all strengths are being distributed.

Who distributes Cipla Lenalidomide

Cipla Australia Pty Ltd.,
Level 1 / 132-136 Albert Road,
South Melbourne VIC 3205
Phone no: 1 800 569 074
drugsafety@cipla.com

This leaflet was revised on April 2023.