Thalidomide

Multiple Myeloma:The recommended thalidomide dosage in combination with dexamethasone is 200 mg once daily (in 28 day treatment cycles) orally with water, routinely at bedtime and at least 60 minutes after the evening meal. The dose of dexamethasone is 40 mg daily administered orally on days 1 to 4, 9 to 12, and 17 to 20 every 28 days.

Erythema Nodosum Leprosum: The recommended dose of Thalidomide for an episode of cutaneous ENL is 100 to 300 mg/day once daily by mouth with water, routinely at bedtime and at least 60 minutes after the evening meal. Initiate dosing for patients weighing less than 50 kg at the low end of the dose range.

Consider dosing in the higher dosage range for patients with a severe cutaneous Erythema Nodosum Leprosum reaction, or in those who have previously needed higher doses to control the reaction (possibly up to 400 mg/day) once daily at bedtime or in divided doses with water, at least 60 minutes after meals.

The most commonly reported side effects due to Thalidomide Capsules may include:

MM:fatigue, hypocalcemia, edema, neuropathy-sensory, constipation, dyspnea, muscle weakness, leukopenia, neutropenia, rash/desquamation, confusion, anorexia, nausea, anxiety/agitation, asthenia, tremor, fever, weight loss, neuropathy-motor, thrombosis/embolism, weight gain, dizziness, and dry skin.

ENL:somnolence, rash, and headache.

• Consider concomitant administration of corticosteroids in patients with moderate-severe neuritis associated with a severe Erythema Nodosum Leprosum reaction. Usage of Steroid can be tapered and interrupted when the neuritis has ameliorated.
• Thalidomide frequently causes somnolence and drowsiness. Instruct patients as to the possible impairment of mental/physical abilities required for the performance of hazardous tasks, such as driving a car or operating other machinery. Dose reductions may be needed.
• The thalidomide use may be responsible for causing dizziness and orthostatic hypotension and that, therefore, patients should sit upright for a few minutes before standing up from a recumbent position.
• Examine patients at monthly intervals for the first 3 months of Thalidomide therapy to enable the clinician to detect the early signs/symptoms of neuropathy, which include numbness, tingling or pain in the hands and feet. Evaluate patients periodically thereafter during treatment. Evaluate patients regularly for signs and symptoms of peripheral neuropathy.
• Decreased WBC counts, including neutropenia, have been seen in association with the clinical use of Thalidomide. Start therapy with an ANC of <750/mm3. Monitor WBC count and differential on an ongoing basis, mainly in patients who may be more prone to neutropenia, such as patients who are HIV-seropositive.
• Thrombocytopenia (Grade 3 or 4) may occur with the use of Thalidomide. Monitor blood counts, including platelet counts. Dose reduction, delay, or interruption may be needed. Monitor for signs and symptoms of bleeding including epistaxis, petechiae, and gastrointestinal bleeding, mainly if concomitant medicine may increase the risk of bleeding.
• Bradycardia in association with thalidomide 200 mg may occur. Monitor patients for syncope and bradycardia. Dose reduction or interruption may be needed. Cautiously use medicines known to decrease heart rate in patients with Thalidomide.
• Hypersensitivity, including angioedema and anaphylactic reactions may occur. Signs/symptoms have included the occurrence of erythematous macular rash, possibly associated with tachycardia, fever, and hypotension, and if severe, may necessitate therapy interruption. If the reaction recurs when dosing is resumed, discontinue Thalidomide. Do not resume therapy after angioedema and anaphylaxis.
• Thalidomide is a powerful human teratogen that induces an intense frequency of severe and life-threatening birth defects, even after a single dose. Females of reproductive age must avoid pregnancy for at least 4 weeks prior to beginning therapy, during therapy, during dose interruptions and for at least 4 weeks after completing therapy
• Patients must not donate blood during treatment with thalidomide 100 mg therapy and for 4 weeks after discontinuation of the medication because the blood might be given to a pregnant female patient whose fetus must not be exposed to Thalidomide.

Thalidomide must not be repackaged. Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Protect it from light.

• Impose caution if other medicines which have sedative and hypnotic properties, slow cardiac conduction or cause peripheral neuropathy must be used.
• It is not specified whether concomitant use of hormonal contraceptives further increases the risk of thromboembolism with Thalidomide.
• Patients with concomitant therapies such as erythropoietin stimulating agents or estrogen containing therapies may have an increased risk of thromboembolism.