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Thailogem 50/100 Capsules

Generic Name- Thalidomide

Drug Class- Antineoplastic agent

Thalidomide is an immunomodulatory agent, considered as a standard approach for the treatment of relapsed and refractory myeloma. It acts through several mechanisms such as antiangiogenic effects, induction of apoptosis or G1 arrest of the cell cycle, the inhibition of growth factor production, the regulation of interactions between tumor and stromal cells, and the modulation of tumor immunity.

Category

Product Description

Thailogem 50/100 (Thalidomide) is a capsule formulation containing active drug concentrate for oral administration.

Indications and Usage

Indications and Usage

  • Thalidomide is indicated for the treatment of newly diagnosed multiple myeloma patients, in combination with dexamethasone

Limitations of Use

  • This formulation is not intended for treatment of the cutaneous manifestations of moderate to severe erythema nodosum leprosum (ENL)

Dosage and Administration

Dosage and Administration

  • Dosage Regimen for Multiple Myeloma2
Thalidomide/Dexamethasone Regimen
Thalidomide 200 mg orally once daily, followed by
Dexamethasone 40 mg/day on days 1-4, 9-12, and 17-20 every 28 days
  • Another treatment regimen which is used3
Bortezomib, Melphalan, Prednisone and Thalidomide (VMPT) Regimen
Bortezomib 1.3 mg/m2 on days 1, 4, 8, 11, 22, 25, 29, 32 of cycles 1–4 and days 1, 8, 22, 29 of cycles 5–9
Melphalan 9 mg/m2 on days 1–4
Prednisone 60 mg/m2 on days 1–4
Thalidomide 50 mg on days 1–42
Followed by maintenance Bortezomib and Thalidomide(VT) Regimen
Bortezomib 1.3 mg/m2 every 14 days
Thalidomide 50 mg/day

Dosage Form and Strengths

  • Supplied as capsules
  • Available in 50 mg and 100 mg strengths

Clinical Efficacy

  • Effective and well-tolerated alternative front-line therapy for multiple myeloma treatment1,4
  • Increases response rate to 45–75% when used in combination with dexamethasone and improves survival when used as a single agent in maintenance therapy of multiple myleoma4
  • Shows efficacy in one-third of refractory cases and provides a response rate of more than 50% in combination with glucocorticoids and/or antineoplastic drugs1

Adverse Reactions

  • The most common adverse reactions which may occur following treatment with thalidomide are nausea, vomiting, constipation, fever, fatigue, hypocalcemia, edema, neuropathy, dyspnea, muscle weakness, leukopenia, neutropenia, rash, anorexia, anxiety, asthenia, tremor, weight loss, thrombosis/embolism, weight gain, and dizziness

Contraindications

  • It is contraindicated in patients with a known hypersensitivity to thalidomide or its components

Special Precautions

  • Monitor the risk of ischemic heart disease (including myocardial infarction) and stroke in patients treated with thalidomide and dexamethasone
  • Advise patients to avoid situations where drowsiness may be a problem as thalidomide induces drowsiness
  • Examine patients at monthly intervals for the first 3 months of thalidomide therapy and periodically thereafter for signs or symptoms of peripheral neuropathy
  • Consider electrophysiological testing at baseline and every 6 months to detect asymptomatic neuropathy
  • Advise patients to sit upright for a few minutes prior to standing up from a recumbent position due to potential risk of dizziness with thalidomide use
  • Consider dose reduction or dose interruption in patients developing neutropenia
  • Evaluate viral load after the first and third months of treatment and every 3 months thereafter
  • Monitor patients for bradycardia and possible syncope and consider dose reduction or discontinuation accordingly
  • Discontinue use of thalidomide in patients with Stevens-Johnson syndrome and toxic epidermal necrolysis
  • Monitor patients with a history of seizures and those with a risk of seizures for clinical changes that could precipitate acute seizure activity
  • Use thalidomide with caution and take appropriate precautions in patients with tumor lysis syndrome
  • Thalidomide can cause potential harm to fetus, therefore not recommended for use in pregnant and nursing mothers
Cancer Tablet Thalidomide 50 / 100 mg Manufacturer | ADMAC