- The chance of blood clots in your child’s veins or lungs may be raised with this drug. Tell your child’s doctor right away if your child has any chest pain or pressure; coughing up blood; shortness of breath; or pain, warmth, or swelling of the legs or arms.
- You may only get this drug from the Thalomid REMS™ program.
If your child is able to get pregnant:
- Your child must have 2 pregnancy tests that show she is NOT pregnant before starting this drug. Your child must have pregnancy tests done while taking this drug. Talk with the doctor.
- Your child must use 2 kinds of birth control to prevent pregnancy for at least 4 weeks before care begins, during care, and for at least 4 weeks after care ends.
If your child is or may be sexually active:
- If your child has sex without using 2 kinds of birth control, if you think your child may be pregnant, or if your child misses her period, call the doctor right away.
- If your child is a male and has sex with a pregnant female or a female who can get pregnant, be sure he always uses a latex or synthetic condom during sex. Do this even if your child has had a vasectomy. Be sure he uses a latex or synthetic condom during care, during any breaks in care, and for at least 4 weeks after care ends.
- If your child is a male and has unprotected sex with a female who is or could get pregnant, or if his female partner gets pregnant, call the doctor right away.
If your child is pregnant:
- Do not give this drug to your child if she is pregnant. Use during pregnancy may cause birth defects or loss of the unborn baby. If your child gets pregnant while taking this drug or within 4 weeks after care ends, call the doctor right away.
- It is used to treat skin signs of leprosy.
- It is used to treat multiple myeloma.
- It may be given to your child for other reasons. Talk with the doctor.
- If your child has an allergy to this drug or any part of this drug.
- If your child is allergic to any drugs like this one or any other drugs, foods, or other substances. Tell the doctor about the allergy and what signs your child had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
If your child is breast-feeding a baby:
- Be sure your child does not breast-feed a baby while taking this drug.
- Tell all of your child’s health care providers that your child is taking this drug. This includes your child’s doctors, nurses, pharmacists, and dentists.
- Talk with the doctor before your child gets any vaccines. Use with this drug may either raise the chance of very bad infection or make the vaccine not work as well.
- Have your child avoid tasks or actions that call for alertness until you see how this drug affects your child. These are things like riding a bike, playing sports, or using items such as scissors, lawnmowers, electric scooters, toy cars, or motorized vehicles.
- To lower the chance of feeling dizzy or passing out, have your child get up slowly over a few minutes when sitting or lying down. Have your child be extra careful climbing stairs.
- Have your child’s blood work checked often. Talk with your child’s doctor.
- Be sure your child does not donate blood while using this drug and for 1 month after stopping.
- If you touch a broken capsule, or the drug inside the capsule, wash the area with soap and water.
- Your child may have more chance of getting infections. Avoid crowds and people with infections, colds, or flu.
- Your child may bleed more easily. Make sure your child is careful and avoids injury. Be sure your child has a soft toothbrush.
- Alcohol may interact with this drug. Be sure your child does not drink alcohol.
- Avoid giving your child other drugs and natural products that may slow your child’s actions.
- This drug may cause nerve problems. Most of the time, nerve problems have happened after long-term use over a few months. Nerve problems have also happened after short-term use. Signs of nerve problems may happen some time after care has stopped. The signs may go away slowly or may not go away at all. Talk with your doctor.
- Pregnant women or females of childbearing age must not touch the capsules. Talk with the doctor.
- If your child is male, be sure he does not donate sperm while using this drug and for 1 month after stopping.
If your child is or may be sexually active:
- Certain drugs may cause birth control pills and other hormone-based birth control not to work. Be sure to tell the doctor or pharmacist about all drugs your child takes. You will need to see if your child needs to use other forms of birth control while taking this drug.
- Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
- Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
- Signs of bleeding like throwing up blood or throw up that looks like coffee grounds; coughing up blood; blood in the urine; black, red, or tarry stools; bleeding from the gums; vaginal bleeding that is not normal; bruises without a reason or that get bigger; or any bleeding that is very bad or that you cannot stop.
- Signs of low calcium levels like muscle cramps or spasms, numbness and tingling, or seizures.
- A burning, numbness, or tingling feeling that is not normal.
- Very bad dizziness or passing out.
- Fast or slow heartbeat.
- Feeling very tired or weak.
- Patients with cancer who take this drug may be at greater risk of getting a bad and sometimes deadly health problem called tumor lysis syndrome (TLS). Call your child’s doctor right away if your child has a fast heartbeat; a heartbeat that does not feel normal; any passing out; trouble passing urine; muscle weakness or cramps; upset stomach, throwing up, loose stools, or not able to eat; or feel sluggish.
- A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if your child has signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in the mouth, throat, nose, or eyes.
- The chance of heart attack or stroke due to blood clots may be raised. Call the doctor right away if your child has signs of heart attack like chest pain that may spread to the arms, neck, jaw, back, or stomach; sweating that is not normal; or feeling sick or throwing up. Call the doctor right away if your child has signs of stroke like change in strength on 1 side is greater than the other; eyesight, speech, or balance problems; change in thinking clearly and with logic; or very bad headache.
- Feeling tired or weak.
- Hard stools (constipation).
- Upset stomach.
- Not hungry.
- Dry skin.
- Feeling sleepy.
- Weight gain or loss.
If your child is or may be sexually active:
- Change in sex ability.
- Give this drug with water at bedtime at least 1 hour after the evening meal.
- Give this drug with a full glass of water.
- Have your child swallow whole. Do not let your child chew, break, or crush.
- Wear gloves when touching this drug.
- If it has been less than 12 hours since a normal dose, give a missed dose as soon as you think about it and go back to your child’s normal time.
- If it has been 12 hours or more since the missed dose, skip the missed dose and go back to your child’s normal time.
- Do not give 2 doses at the same time or extra doses.
- Store in the original container at room temperature.
- Protect from light.
- Store in a dry place. Do not store in a bathroom.
- Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
- Check with your pharmacist about how to throw out unused drugs.
- If your child’s symptoms or health problems do not get better or if they become worse, call your child’s doctor.
- Do not share your child’s drug with others and do not give anyone else’s drug to your child.
- Keep a list of all your child’s drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your child’s doctor.
- Talk with your child’s doctor before giving your child any new drug, including prescription or OTC, natural products, or vitamins.
- Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your child’s doctor, nurse, pharmacist, or other health care provider.
- If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.