
Total body clearance of thalidomide is about 170-200 ml/min,  but the unmetabolized drug is only cleared at a rate of 1 to1.5 ml/min by kidneys, and less than 1% of the drug is excreted unchanged in the urine.  So probably thalidomide is hydrolyzed and metabolized to other substances.  It is not known what the exact route of elimination is.

Store at room temperature between 59 and 86 degrees F (15-30 degrees C) away from sunlight and moisture.  NOT in the bathroom. In the container it came in, tightly closed.

Do not share this medicine with others. 
Keep this medicine away from children.
Talk to your pharmacist about the proper disposal of your medication. DO NOT FLUSH IT OR THROW IT IN THE TRASH.                  

<b>Administration</b>
Thalidomide is taken by mouth, either at bedtime or at least an hour after the evening meal, because fatty meals delay its absorption. If taken in divided doses, it can be given with water at least one hour after meals.  

<b>Dosage</b>
Is usually between 100 and 400 mg daily, but will be individualized for you by your doctor.
If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not "double-up" the dose to catch up. 

In case of overdose, call your local poison control center at 1-800-222-1212. If the victim has collapsed or is not breathing, call local emergency services at 911.

Overdosage of thalidomide may cause prolonged sleep as a result of the drug's sedative and hypnotic effects, but since the drug does not cause respiratory depression, fatalities are unlikely. Three cases of deliberate ingestion of up to 14 g of thalidomide resulted in recovery without reported sequelae. 

<b>Precautions While Using Thalidomide:
Thalidomide may only be used within the S.T.E.P.S. Program (System for Thalidomide Education and Prescribing Safety) guidelines, in order to avoid any possible fetal exposure to the drug.</b>

For women of childbearing age: If you are able to bear children, you must have a pregnancy test within 24 hours before starting thalidomide treatment, once a week during the first month of treatment, and every 2 to 4 weeks after that. Also, you must have effective contraception, or else refrain from sexual activity, for one month prior to thalidomide therapy, during the therapy, and for one month after therapy stops.

For men taking thalidomide: If you have heterosexual sexual contact with women of childbearing potential you must always use a condom during sexual contact while taking thalidomide and for 4 weeks after you stop taking it, even if you have had a vasectomy.

If you have a missed period or abnormal vaginal bleeding, tell your doctor immediately. Thalidomide must not be used during pregnancy. If you think you might be pregnant inform your doctor immediately. Even ONE dose of thalidomide taken during a pregnancy can cause severe birth defects. If pregnancy does occur during treatment, this drug must be discontinued immediately.       

<b>Before Using This Medicine:</b>
Allergies-Tell your doctor if you have ever had any unusual or allergic reaction to thalidomide or to any other substances, including foods, preservatives, dyes.

<b>Pregnancy-Thalidomide must not be used by pregnant women </b>

Breast-feeding-It is not known if thalidomide passes into breast milk. It is probably NOT a good idea to breastfeed while on this treatment.

Older adults- Thalidomide has been tested on some patients up 
to 90 years of age and there do not seem to be any different side effects or other problems in older as compared to younger adults. 

Other medical problems-- Make sure you tell your doctor if you have any other medical problems, especially:
  Decreased white blood cell counts or 
  Epilepsy or risk of seizures or 
  Peripheral neuropathy.
Thalidomide may make these conditions worse.

Tell your doctor every medicine you are taking, including herbals, vitamins, and other supplements.

<b>Drug Interactions with Oral Contraceptives</b>
Thalidomide doesn't interact with the contraceptive hormones, so is unlikely to interfere with them.  However, OTHER drugs can affect the reliability of oral contraceptives.
SOME of the drugs that interact with oral contraceptives:

HIV protease inhibitors
Griseofulvin
Rifampicin
Rifabutin
Tetracycline
Other Antibiotics
Phenytoin
Carbamazepine
Other anticonvulsants
Check ALL the medications you are taking from a contraceptive standpoint as well. Discuss with your doctor.  

If you are a woman who is capable of getting pregnant, it is mandatory that you use effective contraceptive measures for at least 1 month prior to, throughout, and for at least 1 month after completion of thalidomide therapy.  Women of childbearing potential receiving thalidomide at the same time with another drug that can reduce the reliability of oral contraceptives must use 2 other effective methods of contraception or abstain from heterosexual intercourse.

<b>CNS Agents
Thalidomide has sedative properties.</b> It will add to the effects of alcohol and other CNS depressants (medicines that may make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. 
Caution is advised when performing tasks requiring alertness.

<b>Dependence or Addiction:</b> Physical and/or psychological dependence have NOT been reported in individuals receiving thalidomide. However, the manufacturer states that like other anxiolytic, sedative, and hypnotic drugs, it is possible that habituation to the sedative and hypnotic effects of thalidomide could occur.     

<b>Check with your doctor before taking any of these while you are using thalidomide:</b>
alcohol
Some allergy or hay fever medicines
anesthetics
antihistamines
barbiturates
chlorpromazine
cold and flu remedies
muscle relaxants
reserpine
sleeping medicines
tranquilizers
Tricyclic antidepressants [amitriptyline & others[


<b>Drugs Associated with Peripheral Neuropathy    </b>              
The central nervous system is the brain and spinal cord.  All the nerves outside the central nervous system are peripheral nerves.  Neuropathy means that nerves are being damaged.
Peripheral neuropathy can start with tingling, burning, numbness, or pain, often in hands or feet, which can progress to inability to use the extremities well.  
Peripheral neuropathies can be temporary or permanent.
If you get symptoms of peripheral neuropathy, tell your doctor promptly.

Ongoing use of thalidomide may result in severe peripheral neuropathy, which can be irreversible. To ensure early detection of neuropathy, patients should be examined regularly. (Probably monthly for the first 3 months of thalidomide therapy, and periodically thereafter). Consideration should be given to using electrophysiologic testing [sensory nerve action potential (SNAP) amplitude measurement] at baseline and every 6 months thereafter.

Because of the potential for additive effects, drugs known to be associated with peripheral neuropathy should be used with caution in patients receiving thalidomide. These drugs include:
       
Some antiretroviral agents used for treating HIV infections
<b>Some chemotherapy agents </b> [for example, paclitaxel; platinum-containing drugs such as cisplatin; vinca alkaloids such as vincristine])                   
Chloramphenicol 
Dapsone (Avlosulfon)  
Ethambutol (Myambutol)  
Ethionamide (Trecator-SC)  
Hydralazine (Apresoline)  
Isoniazid (Nydrazid)  
Lithium (Eskalith, Lithobid)  
Metronidazole (Flagyl)  
Nitrofurantoin (Furadantin, Macrodantin)  
Nitrous oxide  
Phenytoin (Dilantin)  

  
<b>Side Effects 
The "A" group.  If these occur, check with your doctor immediately:</b>

<b>Allergic reaction</b> -- seek immediate medical attention. Symptoms include rash, itching, swelling, dizziness or trouble breathing.. 

<b>Peripheral neuropathy</b>: tingling, burning, numbness, or pain in the hands, arms, feet or legs.  Call your doctor right away.
Continuing use of thalidomide may result in severe peripheral       neuropathy, possibly irreversible. Regular examinations will pick it up earlier.

<b>Muscle weakness</b>: whether associated with tingling or not.

<b>Urine</b>: blood or decreased urination

<b>Fever</b>: alone or with chills and sore throat 

<b>Heart</b>: irregular heartbeat 

<b>Low Blood Pressure</b> 

<b>Skin</b>: rash or blistering or itching or peeling and loosening of skin

</b>Mouth</b>: sores, ulcers, or white spots

<b>Eyes</b>: red or irritated

<b>Convulsions, or Faints, or Muscular jerking of arms and legs.</b>

In addition to these problems, thalidomide can cause <b>low white cell counts. </b>
Thalidomide has been associated with <b>thyroid problems. </b>
Thalidomide has also been associated with too high or too low <b>blood sugar levels.</b>


<b>The "B" Group.  Other side effects that usually do not need medical attention. </b>
These side effects may go away during treatment as your body adjusts to the medicine. If they continue or are bothersome, however, check with your doctor. If you notice any effects not listed, check with your doctor.

<b>Gastrointestinal: </b>Constipation, diarrhea, nausea, stomach pain  

<b>Dizziness or drowsiness:</b> Caution is advised when performing tasks requiring alertness. Thalidomide may cause dizziness and decreases in blood pressure that could result in falls. After lying down, you should sit upright for a few minutes before standing up. 

<b>Sun Sensitivity</b>: Avoid unnecessary or prolonged exposure to sunlight and sun lamps and wear protective clothing, sunglasses, and sunscreen. Thalidomide may make your skin sensitive to sunlight.

<b>DO NOT DONATE: </b> You should not give blood or donate sperm during treatment with thalidomide.

<b>Dry mouth

Dry skin

Mood changes

Increased appetite

Swelling of legs  
  
Dependence or Addiction:</b> Physical and/or psychological dependence have not been reported in individuals receiving thalidomide. However, the manufacturer states that like other anxiolytic, sedative, and hypnotic drugs, it is possible that habituation to the sedative and hypnotic effects of thalidomide could occur.     
