Thalidomide

Mechanism :

Thalidomide is an immunomodulatory agent. It works on the immune system to decrease certain substances that cause skin inflammation in patients who have ENL. In cancer patients, it appears to increase certain natural substances that help to kill cancer cells.

Indication :

Moderate to severe erythema nodosum leprosum (ENL) in leprosy.
Moderate to severe nerve inflammation due to ENL.
As an orphan drug for the treatment of multiple myeloma in adults.
As an orphan drug for AIDS-associated wasting syndrome and cancer cachexia in adults.
As an orphan drug for the treatment of recurrent aphthous ulcer and stomatitis in severely immunocompromised patients in adults.
As an orphan drug for treatment of chronic graft-versus-host-disease (GVHD) in combination with steroids and either cyclosporine or tacrolimus.
As an orphan drug for treatment of AIDS-related Kaposi’s sarcoma in adults.
As an orphan drug for treatment of primary malignant glioma in adults.
For the treatment of cutaneous manifestations of systemic lupus erythematosus in adults.
For the treatment of Behcet’s syndrome in adults.
As an orphan drug for treatment of Crohn’s disease in adults.
For the treatment of peripheral T-cell lymphoma in adults.

Contraindications :

Allergic to any ingredient in thalidomide; Sodium oxybate (GHB).

Pregnant, planning to become pregnant, or become pregnant during treatment with thalidomide.

Not using at least 2 forms of effective birth control or are not avoiding sexual contact with men.

Dosing :

Erythema nodosum leprosum:

12 years or older:

Initial dose: 100 to 300 mg orally once a day with water, preferably at bedtime and at least 1 hour after the evening meal; patients less than 50 kg should be started at the low end of the dose range. Duration 2-4 weeks. For patients with severe reactions

Chronic graft-versus-host-disease (GVHD) in combination with steroids and either cyclosporine or tacrolimus:

3 mg/kg PO once daily gradually increased to a target dose of 3 mg/kg PO 4 times daily.

Adverse Effect :

Thalidomide is contraindicated for use during pregnancy. Thalidomide is a known human teratogen and even a single dose taken by a pregnant woman may cause severe birth defects. Hypotension, leukopenia, neutropenia, increased bilirubin, hematuria, headache, thrombosis/embolism, dyspnea, hypocalcemia, peripheral neuropathy, constipation, hyperbilirubinemia, myocardial infarction, hypothyroidism, weakness, tremor, anxiety, dizziness.

Interaction :

Pamidronate: Using pamidronate together with thalidomide may increase your risk of developing kidney problems. Symptoms of kidney damage include swelling, weight gain, feeling short of breath, drowsiness, confusion, mood changes, increased thirst, loss of appetite, nausea and vomiting, pain in your lower back, and urinating more or less than usual or not at all. If you take both medications together, tell your doctor if you have any of these symptoms.
Paroxetine: Using Paroxetine together with thalidomide may increase side effects such as dizziness, drowsiness, and difficulty concentrating. Some people may also experience some impairment in thinking and judgment. You should avoid or limit the use of alcohol while being treated with these medications.

Renal Dose :

Dose in Renal Impairment GFR (mL/min)

20-50	Dose as in normal renal function
10-20	Dose as in normal renal function
<10	Dose as in normal renal function

Dose in Patients undergoing Renal Replacement Therapies

CAPD	Unlikely to be dialysed. Dose as in normal renal function
HD	Unlikely to be dialysed. Dose as in normal renal function
HDF/High flux	Not dialysed. Dose as in normal renal function
CAV/VVHD	Unknown dialysability. Dose as in normal renal function

Hepatic Dose :

No dose adjustment recommended as it undergoes minimal hepatic metabolism. However use with caution and monitor as abnormal liver function tests have been reported.