Thalidomide Celgene - Thalidomide uses, dose and side effects

WARNINGThalidomide causes birth defects and fetal death. Do not take thalidomide if you are pregnant or may become pregnant. You must follow your doctor’s instructions about contraception.

What Thalidomide Celgene is and what it is used for

What Thalidomide Celgene is

Thalidomide Celgene contains the active substance thalidomide. This belongs to a group of medicines that affect how your immune system works.

What Thalidomide Celgene is used for

Thalidomide Celgene is used together with two other medicines called melphalan and prednisone to treat adults with a type of cancer called multiple myeloma. It is used in people who have recently been diagnosed and have not been prescribed any other medicine for multiple myeloma in the past and who are 65 years of age or older, or in people who are younger than 65 years of age who cannot be treated with high- dose chemotherapy, which may be very difficult for the body to cope with.

What is multiple myeloma?

Multiple myeloma is a type of cancer that affects a certain type of white blood cells, called plasma cells. These cells accumulate in the bone marrow and divide uncontrollably. It can damage the bones and kidneys. Multiple myeloma generally cannot be cured. However, the signs and symptoms may be significantly reduced or disappear completely over some time. This is called remission.

How Thalidomide Celgene works

Thalidomide Celgene works by helping the body’s immune system and attacking cancer directly. It works in different ways:

by preventing the cancer cells from developing
by preventing blood vessels from growing in the cancer
by stimulating parts of the immune system to attack the cancer cells.

What you need to know before you take Thalidomide Celgene

Do not use Thalidomide Celgene

You will receive specific information from the doctor, in particular about the effects of thalidomide on the fetus (according to the Thalidomide Celgene Pregnancy Prevention Program).

You have received an information leaflet for patients from your doctor. Read it carefully and follow all instructions.

If you do not fully understand these instructions, ask your doctor to explain them again before taking thalidomide. See also additional information in this section under “Warnings and precautions” and “Pregnancy and breast-feeding”.

Do not take Thalidomide Celgene

if you are pregnant, think you may be pregnant or plan to have a baby because Thalidomide Celgene causes birth defects and stillbirths
if you can become pregnant, unless you follow all instructions on contraception to prevent pregnancy (see section 2 “Warnings and precautions” and “Pregnancy and breast-feeding”)
if you can become pregnant, your doctor will record with each prescription that the necessary measures have been taken and provide you with this information
if you are allergic to thalidomide or any other ingredient in this medicine (specified in section 6 “Contents of the package and other information”).

Do not take Thalidomide Celgene if any of the above apply to you. If you are not sure, ask your doctor or pharmacist before taking Thalidomide Celgene.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before taking this medicine.

For women taking Thalidomide Celgene

Before starting treatment, you must ask your doctor if you are fertile (capable of becoming pregnant), even if you think it is unlikely. Even if you don’t have a period after cancer treatment, you can still get pregnant.

The following applies if you can become pregnant:

The doctor makes sure you can take pregnancy tests
- before treatment
- every 4 weeks during treatment
- 4 weeks after the end of treatment
You must use an effective birth control method:
- for at least 4 weeks before the start of treatment
- during treatment
- for at least 4 weeks after the end of treatment

The doctor will advise you on suitable contraceptive methods.

If you are fertile, the doctor will record with each prescription that the necessary measures, as described above, have been taken.

For men taking Thalidomide Celgene

Thalidomide passes into the seminal fluid. Therefore, avoid unprotected intercourse, even if you have undergone a vasectomy.

Pregnancy and any exposure during pregnancy must be avoided. Always use a condom:
- during treatment
- for at least 7 days after the end of treatment.
You may not donate sperm:
- during treatment
- for at least 7 days after the end of treatment

For all patients

Talk to your doctor before taking Thalidomide Celgene

if you do not understand the contraceptive advice given to you by the doctor or if you realize that you cannot follow this advice.
you have had a heart attack, if you have ever had a blood clot in the past or if you smoke, have high blood pressure, or have high cholesterol. During treatment with Thalidomide Celgene, the risk of blood clots forming in the veins and arteries increases ( see also section 4, “Possible side effects”).
you have or have had neuropathy, i.e. nerve damage that causes tingling, abnormal coordination, or pain in the hands or feet (see also section 4, “Possible side effects”).
you have or have had slow heartbeats (this may be a sign of bradycardia ).
you have high blood pressure in the pulmonary arteries (see also section 4, “Possible side effects”).
you have a reduced number of white blood cells ( neutropenia ) accompanied by fever and infection.
you have a reduced number of blood platelets. You will be more prone to bleeding and bruising.
you have or have had liver damage (liver diseases) including abnormal liver function values.
you have or have had in the past severe skin reactions called Stevens-Johnson syndrome, toxic epidermal necrolysis, or DRESS syndrome (also called DRESS or drug hypersensitivity syndrome). (Description of the symptoms can be found in section 4 “Potential side effects”.)
you have had an allergic reaction when taking Thalidomide Celgene, e.g. rash, itching, swelling, dizziness, or difficulty breathing.
you have been abnormally sleepy.
you have had fever, chills, and severe shaking, possibly with further complications such as low blood pressure and confusion (these may be signs of severe infection ).
you have or have previously had a viral infection, especially varicella zoster, hepatitis B or HIV. Talk to your doctor if you are unsure. Treatment with Thalidomide Celgene can cause the virus to become active again in patients who carry it, meaning that the infection will recur. Your doctor should check if you have ever had a hepatitis B infection.
you have liver or kidney problems (see also section 4, “Possible side effects”).

Your thyroid function may be checked before taking thalidomide and monitored during treatment.

Tell your doctor or nurse immediately if at any time during or after treatment you experience any of the following: blurred vision, loss of vision or double vision, difficulty speaking, weakness in an arm or leg, change in the way you walk, or problems with balance, persistent numbness, impaired sensation or loss of feeling, memory loss or confusion. All of these symptoms may indicate a serious and potentially life-threatening brain disease called progressive multifocal leukoencephalopathy (PML). If you had these symptoms before treatment with Thalidomide Celgene, tell your doctor if the symptoms change in any way.

Your doctor can check if you have a large total amount of tumor throughout your body, including the bone marrow. This can lead to a condition where the tumors break down and release abnormal amounts of chemicals into the body, which can lead to kidney failure (this condition is called tumor lysis syndrome) (see also section 4, “Possible side effects”).

Your doctor should evaluate whether you develop additional types of hematological malignancies (ie types of blood cancer called acute myeloid leukemia and myelodysplastic syndrome) during treatment with Thalidomide Celgene (see also section 4, “Possible side effects”).

You must not donate blood during treatment with Thalidomide Celgene and for at least 7 days after treatment has ended.

Talk to your doctor before taking Thalidomide Celgene if you are not sure if the above applies to you.

Children and young people

Thalidomide Celgene is not recommended for use in children and adolescents under 18 years of age.

Other medicines and Thalidomide Celgene

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This also applies to non-prescription drugs and herbal remedies.

Be sure to tell the doctor if you are taking medicines such as

make you sleepy because thalidomide can increase its effectiveness. This includes sedatives (such as anxiolytics, sleeping pills, antipsychotics, H 1 – antihistamines, opiate derivatives, and barbiturates )
make the heart beat more slowly (causing bradycardia, eg anticholinesterases and beta blockers )
used for heart problems and heart complications (eg digoxin ) or to thin the blood (eg warfarin )
are associated with neuropathy, e.g. other anticancer drugs
used as a contraceptive.

Thalidomide Celgene with food, drink, and alcohol

Do not drink alcohol while taking Thalidomide Celgene, as alcohol can make you sleepy and Thalidomide Celgene can make you even more sleepy.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Pregnancy

Thalidomide Celgene causes severe birth defects and fetal death.

As little as one capsule taken by a pregnant woman can cause serious birth defects.
These injuries can include shortened arms or legs, deformed hands or feet, eye and ear damage, and damage to the internal organs.

If you are pregnant, you should not take Thalidomide Celgene. In addition, you must avoid becoming pregnant while taking Thalidomide Celgene.

If you are a woman of childbearing potential, you must therefore use a safe method of contraception (see section 2, “What you need to know before you take Thalidomide Celgene”).

You must stop the treatment and immediately inform the doctor if:

You missed or think you missed a menstrual period or if you have unexpected menstrual bleeding or suspect you are pregnant.
You have heterosexual intercourse without using an effective contraceptive method.

If you become pregnant during treatment with thalidomide, you must stop treatment and inform your doctor immediately.

Men taking Thalidomide Celgene who have a fertile female partner should read section 2, “What you need to know before you take Thalidomide Celgene”. If your partner becomes pregnant while taking thalidomide, you should inform your doctor immediately.

Breast-feeding

You should not breastfeed while taking Thalidomide Celgene because it is not known whether thalidomide passes into breast milk.

Driving ability and use of machinery

Do not drive or use machines if you experience side effects such as dizziness, fatigue, sleepiness, or blurred vision.

How to take Thalidomide Celgene

Always take Thalidomide Celgene exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

How many doses you should take

The recommended dose is 200 mg (4 x 50 mg capsules) per day for adults under 75 or 100 mg (2 x 50 mg capsules) per day for adults over 75. The doctor will decide which dose of Thalidomide Celgene is right for you, monitor your condition, and make any adjustments to the dose. The doctor will tell you how to take Thalidomide Celgene and how long you need to take it (see section 2, “What you need to know before you take Thalidomide Celgene”).

Thalidomide Celgene is taken daily in treatment cycles, with each cycle lasting 6 weeks, in combination with melphalan and prednisone which are taken on days 1 to 4 of each 6-week cycle.

Ingestion of this medicine

The capsules must not be crushed, opened, or chewed. If powder from a broken capsule of Thalidomide Celgene comes into contact with the skin, immediately wash the area thoroughly with soap and water.
Healthcare professionals, carers, and family members should use disposable gloves when handling the blister or capsule. Gloves should then be removed carefully to prevent skin contact, placed in a resealable polyethylene plastic bag, and disposed of by local regulations. Afterward, hands should be washed thoroughly with soap and water. Women who are pregnant or suspect they may be pregnant should not handle the blister or capsule.
Take this medicine by mouth.
Swallow the capsule whole with a full glass of water.
Do not crush or chew the capsule.
Take the capsules as a single dose at bedtime. This way you feel less sleepy at other times.

When you remove the capsule from the blister, just press one end of it so that it is pushed out through the foil. Do not press the center of the capsule, as this may cause it to break.

If you have taken too much Thalidomide Celgene

If you have taken more Thalidomide Celgene than you should, contact a doctor or go to a hospital straight away. If possible, take the medicine packaging and the package leaflet with you.

If you forget to take Thalidomide Celgene

If you have forgotten to take Thalidomide Celgene at the usual time and

it has been less than 12 hours: take the capsules immediately
it has been more than 12 hours: do not take the capsules. Take the next capsules at the usual time the next day.

If you have any further questions about this medicine, ask your doctor, pharmacist, or nurse.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects may occur with this medicine:

Stop taking Thalidomide Celgene and see a doctor straight away if you get the following serious side effects – you may need urgent medical attention:

Very strong and serious skin reactions. Skin side effects can appear as a rash with or without blisters. Skin irritation, sores or swelling in the oral cavity, pharynx, eyes, nose, and around the genitals, edema, and fever as well as flu-like symptoms may occur. These symptoms may be signs of rare and serious skin reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, or DRES’s syndrome.
Allergic reactions such as localized or generalized skin rash, angioedema, and anaphylactic reaction (severe types of allergic reaction that may manifest as hives, rash, swelling of the eyes, mouth, or face, difficulty breathing, or itching ).

Talk to your doctor straight away if you experience the following serious side effects:

Numbness, tingling, abnormal coordination, or pain in the hands and feet. It can be due to nerve damage (so-called “peripheral neuropathy”), which is a very common side effect. It can be very serious, painful, and disabling. If you experience such symptoms, talk to your doctor immediately who may lower the dose or stop the treatment. This side effect usually occurs if you have been taking this medicine for several months but may occur earlier. It can also occur in some cases after the treatment has ended. Symptoms may not go away or may only subside slowly.
Sudden chest pain or difficulty breathing.
This can be due to blood clots in arteries that go to the lungs (so-called “pulmonary embolism”), which is a common side effect. This can occur during the treatment or after the treatment has ended.
Pain or swelling in the legs, especially in the lower part of the legs or in the calves. This may be due to blood clots in the veins of the legs (deep vein thrombosis ), which is a common side effect. This can occur during the treatment or after the treatment has ended.
Chest pain that spreads to the arms, neck, jaw, back, or stomach, you may feel sweaty and short of breath, feel sick, or vomit. These may be symptoms of a heart attack (which may be due to blood clots in the arteries of the heart).
Temporary visual or speech difficulties. These may be symptoms of a stroke (which may be due to a blockage in an artery in the brain).
Fever, chills, sore throat, cough, mouth sores, or other symptoms of infection.
Bleeding or bruising without injury.

Other side effects include:

It is important to note that a small proportion of patients with multiple myeloma develop other types of cancer, particularly hematological malignancies and that treatment with Thalidomide Celgene may increase this risk. Your doctor should therefore carefully evaluate the benefits and risks when you are prescribed Thalidomide Celgene.

Very common (affects more than 1 in 10 users)

Constipation.
Dizziness.
Drowsiness or feeling tired.
Shaking ( tremors ).
Decreased or abnormal sensation (dysesthesia).
Swelling in hands and feet.
Low blood cell count, can mean that you are more likely to develop an infection. The doctor will check your blood cell count during treatment with Thalidomide Celgene.

Common (affects up to 1 in 10 users)

Indigestion, nausea, vomiting, dry mouth.
Rash, dry skin.
Decreased number of white blood cells ( neutropenia ) accompanied by fever and infection.
Decreased number of red and white blood cells and platelets at the same time (pancytopenia).
Feeling weak, faint or unsteady, lack of energy or strength, low blood pressure.
Fever, general malaise.
Cramps
Dizziness makes it difficult to stand up and move normally.
Blurred vision.
Infection in the chest ( pneumonia ), lung disease.
Low heart rate, heart failure.
Depression, confusion, mood swings, anxiety.
Impaired hearing or deafness.
Kidney disease ( kidney failure ).

Uncommon (affects up to 1 in 100 users)

Inflammation and swelling of the airways of the lungs ( bronchitis ).
Inflammation of the cells that line the inside of the stomach.
Hole in part of the large intestine ( colon ), can cause infection.
Narrowing of the intestines.
Drop in blood pressure when standing which can lead to fainting.
Irregular heartbeats (heart block or atrial fibrillation ), feeling weak or fainting.

Frequency not known (cannot be calculated from available data)

Impaired function of the thyroid gland ( hypothyroidism )
Reduced sexual ability, e.g. impotence.
Severe blood infection ( sepsis ) with fever, chills, and severe shaking, possibly with complications in the form of low blood pressure and confusion ( septic shock )
Tumor lysis syndrome – metabolic complications that can occur during cancer treatment and sometimes even without treatment. These complications are caused by the waste products of dying cancer cells and can include the following: changes in blood chemistry, high levels of potassium, phosphorus, and uric acid, and low calcium levels, which consequently lead to changes in kidney function and heart rhythm, as well as seizures and sometimes death.
Liver damage (liver disease) including abnormal liver function values
Bleeding from the stomach or intestines ( gastrointestinal bleeding)
Worsening symptoms of Parkinson’s disease (such as tremors, depression, or confusion)
Pain in the upper abdomen and/or back which may be severe and last for a few days, possibly with nausea, vomiting, fever, and rapid pulse – these symptoms may be due to inflammation of the pancreas ( pancreatitis )
Increased blood pressure in blood vessels supplying the lungs, which can lead to shortness of breath, tiredness, dizziness, chest pain, faster heartbeat, or swelling of the legs or ankles ( pulmonary hypertension )
Viral infections, including herpes zoster (also called ‘shingles’, a viral disease that causes a painful skin rash with blisters) and recurrent hepatitis B infection (which can cause yellowing of the skin and eyes, dark brown urine, right-sided abdominal pain, fever and nausea or vomiting ).
A condition of the brain with symptoms such as vision changes, headaches, seizures, and confusion, with or without high blood pressure (posterior reversible encephalopathy syndrome or PRES)
A condition that affects the skin and is caused by inflammation of small blood vessels, accompanied by joint pain and fever (leukocytoclastic vasculitis ).

How to store Thalidomide Celgene

Keep this medicine out of the sight and reach of children.

Use before the expiry date which is stated on the pocket pack and the plastic cover (blister card) after EXP. The expiration date is the last day of the specified month.

Do not use the medicine if you notice any damage or signs of damage.

No special storage instructions.

Leftover capsules must be returned to the pharmacy or the doctor after treatment. These measures are to prevent improper use.

Contents of the packaging and other information

Contents declaration

The active substance is thalidomide. Each capsule contains 50 mg of thalidomide.
Other ingredients are:
- The capsule contains pregelatinized starch and magnesium stearate.
- The capsule consists of gelatin and titanium dioxide (E171).
- The printing ink consists of shellac, black iron oxide (E172), and propylene glycol.

Appearance and package sizes of the medicine

Thalidomide Celgene are white hard capsules marked “Thalidomide Celgene 50 mg”. The capsules are supplied in a pocket pack of 28 capsules (2 blisters of 14 capsules each).

Marketing Authorisation Holder

Marketing Authorization Holder
Celgene Europe BV

Orteliuslaan 1000

3528 BD Utrecht

Netherlands

Manufacturer

Celgene Distribution BV