Thalomid

Thalomid

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Questions & Answers

Side Effects & Adverse Reactions

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Legal Issues

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FDA Safety Alerts

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Manufacturer Warnings

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FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

1.1 Multiple Myeloma

THALOMID in combination with dexamethasone is indicated for the treatment of patients with newly diagnosed multiple myeloma (MM).

1.2 Erythema Nodosum Leprosum

THALOMID is indicated for the acute treatment of the cutaneous manifestations of moderate to severe erythema nodosum leprosum (ENL).

THALOMID is not indicated as monotherapy for such ENL treatment in the presence of moderate to severe neuritis.

THALOMID is also indicated as maintenance therapy for prevention and suppression of the cutaneous manifestations of ENL recurrence.

History

There is currently no drug history available for this drug.

Other Information

THALOMID, α-(N-phthalimido) glutarimide, is an immunomodulatory agent. The empirical formula for thalidomide is C13H10N2O4 and the gram molecular weight is 258.2. The CAS number of thalidomide is 50-35-1.

                                  Chemical Structure of Thalidomide

Chemical Structure of Thalidomide

Thalidomide is an off-white to white, odorless, crystalline powder that is soluble at 25°C in dimethyl sulfoxide and sparingly soluble in water and ethanol. The glutarimide moiety contains a single asymmetric center and, therefore, may exist in either of two optically active forms designated S-(-) or R-(+). THALOMID is an equal mixture of the S-(-) and R-(+) forms and, therefore, has a net optical rotation of zero.

THALOMID is available in 50 mg, 100 mg, 150 mg and 200 mg capsules for oral administration. Active ingredient: thalidomide. Inactive ingredients: pregelatinized starch and magnesium stearate. The 50 mg capsule shell contains gelatin, titanium dioxide, and black ink. The 100 mg capsule shell contains black iron oxide, yellow iron oxide, titanium dioxide, gelatin, and black ink. The 150 mg capsule shell contains FD&C blue #2, black iron oxide, yellow iron oxide, titanium dioxide, gelatin, and black and white ink. The 200 mg capsule shell contains FD&C blue #2, titanium dioxide, gelatin, and white ink.

Thalomid Manufacturers


  • Celgene Corporation
    Thalomid (Thalidomide) Capsule [Celgene Corporation]

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