THALOMID

What it is

THALOMID is thalidomide supplied as 50 mg and 100 mg capsules. The 50 mg capsules are white, opaque, imprinted with "BMS" and "50 mg" on the body, with a "Do not get pregnant" symbol in black ink on the cap. The 100 mg capsules are tan, opaque, imprinted with "BMS" and "100 mg" on the body with a "Do not get pregnant" symbol in black ink on the cap.

Approved indications

— THALOMID in combination with melphalan and prednisone for the treatment of patients with untreated multiple myeloma, aged 65 years or older or ineligible for high dose chemotherapy. — THALOMID in combination with dexamethasone for induction therapy prior to high dose chemotherapy with autologous stem cell rescue, for the treatment of patients with untreated multiple myeloma. — THALOMID as monotherapy for the treatment of multiple myeloma after failure of standard therapies. — THALOMID for the acute treatment of the cutaneous manifestations of moderate to severe erythema nodosum leprosum. — THALOMID as maintenance therapy for prevention and suppression of the cutaneous manifestations of erythema nodosum leprosum recurrence.

Dosing overview

Treatment must be initiated and monitored under the supervision of a specialist in oncology or haematology experienced in the management of haematological malignancies, or under the supervision of a specialist in the management of leprosy experienced in the treatment of erythema nodosum leprosum. THALOMID is normally taken as a single dose in the evening to reduce central nervous system effects during the day. THALOMID capsules should be taken at least one hour after food. The required total duration of treatment should be individually determined for each patient depending on tolerability and disease progression, and lower maintenance doses can be used depending on tolerance and observed toxicity.

Key safety warnings

Thalidomide has caused severe birth defects when taken during pregnancy, and should never be used by women who are pregnant or who could become pregnant whilst taking the medicine or could become pregnant within 4 weeks after stopping the medicine. Even a single dose can cause birth defects. Thalidomide has been shown to be present in the semen of male patients.

Contraindications

Thalidomide should never be used by women who are pregnant or who could become pregnant whilst taking the medicine or could become pregnant within 4 weeks after stopping the medicine.

PBS listing

The 50 mg capsule is listed on the PBS with 2 items, streamlined restriction, and an ex-manufacturer price of A$265.35. The 100 mg capsule is listed on the PBS with 2 items, streamlined restriction, and an ex-manufacturer price of A$530.69.

Regulatory history

THALOMID was first registered on the ARTG on 22 December 2009 with two entries: 50 mg hard capsule (ARTG 156729) and 100 mg hard capsule (ARTG 156902). In November 2017, PBAC noted a report on multiple myeloma use, noting improved survival and acknowledging administrative burden for haematologists, and requested advice from clinical groups regarding whether PBS restrictions adequately reflect current clinical practice, especially concerning combination therapies and maintenance regimens not in the Product Information.