THALIDOMIDE

COMMON BRAND NAME(S): Thalomid

GENERIC NAME(S): THALIDOMIDE

Description: Thalidomide is a synthetic glutamic acid derivative immunomodulator with anti-inflammatory, antiangiogenetic, sedative and hypnotic activity.

Pharmacokinetics:

Absorption: Slowly absorbed from GI tract. Peak plasma concentrations: 3 to 6 hr. Food may delay but does not significantly affect extent of absorption of thalidomide.

Distribution: Crosses the placenta, distributed into the semen. Elimination half-life: 5-7 hr.

Metabolism: Exact metabolic fate unknown, it appears to undergo non-enzymatic hydrolysis in plasma.

Uses

This medication treats certain skin conditions related to Hansen’s disease (once known as leprosy) and a certain type of cancer (multiple myeloma). It works in Hansen’s disease by reducing swelling and redness (inflammation). It also reduces the formation of blood vessels that feed tumors.

This drug may also be used to treat certain conditions caused by cancer and HIV infection.

How to use thalidomide

Read the Medication Guide and, if available, the Patient Information Leaflet provided by your pharmacist before you start using thalidomide and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth, usually once daily at bedtime at least 1 hour after the evening meal or as directed by your doctor. Swallow this medication whole with water.

Dosage is based on your medical condition and response to treatment. Do not increase your dose or take this medication more often than prescribed. Your condition will not improve any faster, and the risk of serious side effects may be increased.

Keep the capsules in their blister pack until ready to use. Do not open or break the capsules, or handle them any more than needed. If any of the powder from the capsule gets on your skin, wash the area with soap and water.

Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from broken capsules. All people should wash their hands thoroughly after handling this drug.

This medication passes into body fluids (e.g., urine). Avoid contact with body fluids from people taking this drug. Therefore, wear protective clothing (e.g., gloves) when handling these body fluids (e.g., during cleanup). If contact occurs, wash skin with soap and water.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day. If you are taking this medication for Hansen’s disease, your skin condition may become worse when the drug is suddenly stopped. Your dose may need to be gradually decreased.

Tell your doctor if your condition does not improve or if it worsens after 2 weeks.

Warnings

Not available.

Side Effects

Tell your doctor or pharmacist promptly if any of these effects persist or worsen:

drowsiness
dizziness
constipation
weakness
dry skin

Thalidomide may cause possibly severe nerve damage, which may be permanent.

People with multiple myeloma who are treated with this medication may rarely get other cancers (such as acute leukemia).

Tell your doctor right away if you have any serious side effects, including:

mental/mood changes (e.g., confusion, anxiety)
shaking (tremor)
shortness of breath
arm/leg swelling
fast/slow heartbeat
signs of infection (e.g., fever, persistent sore throat)

Get medical help right away if you have seizures.

A very serious allergic reaction to this drug is rare.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Precautions

Precautions:

Allergic reaction to this medication
Patients with certain immune system problem (neutropenia)
Patients with medical history of numbness/tingling of arms/legs or seizures
people with HIV may be more sensitive to the effects of the drug
This drug may make you dizzy or drowsy
women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from broken capsules
Thalidomide must not be used during pregnancy
Consult your doctor before breast-feeding

Consult your doctor regarding the precautions mentioned above.

Interactions:

Tell your doctor or pharmacist if you also take drugs that cause drowsiness such as:

alcohol
certain antihistamines (e.g., diphenhydramine)
anti-seizure drugs (e.g., carbamazepine)
narcotic pain relievers (e.g., codeine)
muscle relaxants
medicine for sleep or anxiety (e.g., alprazolam, diazepam, zolpidem)
psychiatric medicines (e.g., chlorpromazine, risperidone, amitriptyline, trazodone)

Some drugs may decrease the amount of birth control hormones in your body which can result in pregnancy. Examples include:

Griseofulvin
Modafinil
Rifamycins (such as rifampin, rifabutin)
John’s wort
Drugs used to treat seizures (such as barbiturates, carbamazepine, felbamate, phenytoin, primidone, topiramate)
HIV drugs (such as nelfinavir, nevirapine, ritonavir)

Tell your doctor when you start any new drug, and discuss if you should use additional reliable birth control while using the new drug and for 1 month after stopping the drug.

Overdose & Brands

Overdose:

If overdose is suspected, contact a poison control center or emergency room immediately. Symptoms of overdose may include: prolonged sleep.

Notes

Do not share this medication with others. Do not donate blood, organs, eggs, or sperm while taking thalidomide.

Laboratory and/or medical tests (e.g., pregnancy tests, white blood count) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

Missed Dose

If you miss a dose, take it as soon as you remember if it is less than 12 hours after the time you would usually take it. If more than 12 hours have passed, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Storage

Store at room temperature away from light and moisture. Keep capsules in the original blister pack until ready to use. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Brands:

Also marketed as

Thalidomide Celgene [ Celgene ]
Thalix [ Fresenius Kabi ]