thalidomide

Before taking thalidomide, tell your doctor if you have:

• liver disease;

• kidney disease;

• a history of stroke or blood clots;

• heart disease;

• HIV or AIDS;

• epilepsy or seizures;

• a weak immune system; or

• nerve problems, such as numbness or tingling in your hands or feet.

If you have any of these conditions, you may not be able to take thalidomide, or you may need a dosage adjustment or special tests during treatment.

Thalidomide can cause severe, life-threatening birth defects or death of a baby if the mother or the father is taking this medication at the time of conception or during pregnancy. Even one dose of thalidomide can cause major birth defects of the baby’s arms and legs, bones, ears, eyes, face, and heart. Never use thalidomide if you are pregnant.

It is not known if thalidomide passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

For Women: You will be required to use two reliable forms of birth control beginning 4 weeks before you start taking thalidomide and ending 4 weeks after you stop taking it. Any woman who has not had a hysterectomy or has not been in menopause for at least 24 months in a row must agree in writing to use birth control before, during, and after taking thalidomide. Even women with fertility problems are required to use birth control while taking this medication. You must also have a negative pregnancy test within 24 hours before you start thalidomide treatment. While you are taking thalidomide, you will need to have a pregnancy test weekly during the first month of treatment, and then every 4 weeks thereafter.

The birth control method you use must be proven highly effective: hormonal birth control (pills, implants, or injections), an intrauterine device (IUD), a tubal ligation, or a sexual partner’s vasectomy. The extra form of birth control you use must be a barrier method such as a latex condom, a diaphragm, or a cervical cap.

Stop using thalidomide and call your doctor at once if you quit using birth control, if your period is late, or if you think you might be pregnant.

For Men: You must not cause a woman to become pregnant while you are taking thalidomide because the medicine may affect your sperm and cause birth defects in the baby. You must agree in writing to always use latex condoms when having sex with a woman who is able to get pregnant, even if you have had a vasectomy. Avoid ejaculating without a condom because thalidomide can be passed in your sperm.

Thalidomide is available only under a special program called "System for Thalidomide Education and Prescribing Safety” (S.T.E.P.S.). You must be registered in the program and sign documents stating that you understand the dangers of this medication and that you agree to use birth control as required by the program. For patients between 12 and 18 years, a parent or legal guardian must read and sign all written requirements for the S.T.E.P.S. program. Do not give this medicine to a child younger than 12 years old.

While you are using thalidomide, you will be required to be listed on a patient registry and participate in occasional telephone surveys. You will be limited to a 28-day supply of thalidomide each time your prescription is refilled. You may continue getting refills only if you participate fully in the S.T.E.P.S. program and commit to all agreements.

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Your doctor may occasionally change your dose to make sure you get the best results from this medication.

Take each dose with a full glass of water.

Swallow the capsule whole, without breaking it open.

Thalidomide is usually taken at bedtime. Take the medicine on an empty stomach, at least 1 hour after eating a meal.

To be sure this medication is helping your condition, your progress will need to be checked on a regular basis. It is important that you not miss any scheduled visits to your doctor.

You must not donate blood or sperm while you are using thalidomide. Avoid exposing another person to your blood or semen through casual or sexual contact.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Never give thalidomide to another person, even if he or she has the same disorder for which you are being treated.

Store thalidomide at room temperature away from moisture and heat. Keep each capsule in its blister pack until you are ready to take it.

Do not allow another person to handle your medicine without wearing disposable gloves. Caregivers should avoid handling broken capsules or inhaling the powder from a damaged capsule.

Take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take only the next regularly scheduled dose. Do not take extra medicine to make up the missed dose.

Stop using this medicine and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

• chest pain, sudden shortness of breath, coughing up blood;

• pain or swelling in your arm, thigh, or calf;

• easy bruising, unusual bleeding or weakness;

• slow heartbeats, shallow breathing;

• feeling light-headed, fainting;

• fever, chills, body aches, flu symptoms;

• a red, blistering, peeling skin rash;

• red, raised skin rash (especially if you also have fever, fast heart rate, and dizziness or fainting);

• numbness, burning, pain, or tingly feeling; or

• seizure (convulsions).

Other less serious side effects are more likely to occur, such as:

• feeling drowsy or sleepy;

• anxiety, confusion, tremors or shaking;

• bone pain, muscle weakness;

• sleep problems (insomnia); or

• nausea, constipation, loss of appetite.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

Thalidomide can cause severe, life-threatening birth defects or death of a baby if the mother or the father is taking this medication at the time of conception or during pregnancy. Even one dose of thalidomide can cause major birth defects of the baby’s arms and legs, bones, ears, eyes, face, and heart. Never use thalidomide if you are pregnant.

For Women: You will be required to use two reliable forms of birth control beginning 4 weeks before you start taking thalidomide and ending 4 weeks after you stop taking it. Any woman who has not had a hysterectomy or has not been in menopause for at least 24 months in a row must agree in writing to use birth control before, during, and after taking thalidomide. Even women with fertility problems are required to use birth control while taking this medication. You must also have a negative pregnancy test within 24 hours before you start thalidomide treatment. While you are taking thalidomide, you will need to have a pregnancy test weekly during the first month of treatment, and then every 4 weeks thereafter.

Stop using thalidomide and call your doctor at once if you quit using birth control, if your period is late, or if you think you might be pregnant.

For Men: You must not cause a woman to become pregnant while you are taking thalidomide because the medicine may affect your sperm and cause birth defects in the baby. You must agree in writing to always use latex condoms when having sex with a woman who is able to get pregnant, even if you have had a vasectomy. Avoid ejaculating without a condom because thalidomide can be passed in your sperm.

Thalidomide is available only under a special program called "System for Thalidomide Education and Prescribing Safety” (S.T.E.P.S.). You must be registered in the program and sign documents stating that you understand the dangers of this medication and that you agree to use birth control as required by the program. For patients between 12 and 18 years, a parent or legal guardian must read and sign all written requirements for the S.T.E.P.S. program.

Do not donate blood or sperm while you are using thalidomide. Avoid exposing another person to your blood or semen through casual or sexual contact.

Thalidomide can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Avoid drinking alcohol, which can increase some of the side effects of thalidomide.

Avoid using other medicines that make you sleepy (such as cold medicine, pain medication, muscle relaxers, and medicine for seizures, depression or anxiety). They can add to sleepiness caused by thalidomide.

If you use hormonal birth control (pills, implants, injections) to prevent pregnancy: There are certain drugs that can make hormonal birth control less effective in your body. Below is a list of some of these drugs. This list may not include all drugs with the potential to affect hormonal birth control.

• HIV medicines such as amprenavir (Agenerase), tipranavir (Aptivus), indinavir (Crixivan), saquinavir (Invirase), lopinavir/ritonavir (Kaletra), fosamprenavir (Lexiva), ritonavir (Norvir), atazanavir (Reyataz), or nelfinavir (Viracept);

• griseofulvin (Gris-PEG, Grifulvin V, Grisactin, or Fulvicin);

• rifampin (Rimactane, Rifadin);

• rifabutin (Mycobutin);

• phenytoin (Dilantin); or

• carbamazepine (Tegretol).

If you rely on hormonal contraception as one of the two forms of birth control during your treatment with thalidomide, tell your doctor about all other medicines you use. You may also need to replace your hormonal birth control method with another effective form of contraception. Not having sexual intercourse (abstinence) is the most effective method of preventing pregnancy.

There may be other drugs not listed that can affect thalidomide. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of thalidomide is not expected to produce life-threatening symptoms.